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protocolSection identificationModule nctId: NCT06338059, orgStudyIdInfo id: Gulcanozturkchatipchousein, briefTitle: Relationship Between Vitamin D and Vitamin B12 Levels and Neuropathic Pain in Lipedema, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Fatih Sultan Mehmet Training and Research Hospital, class: OTHER, descriptionModule briefSummary: Lipedema is a disease characterized by bilateral abnormal fat deposition in the upper and lower extremities. Pain is a common symptom in lipedema.Vitamin D plays an important role in chronic pain. Vitamin B have analgesic role in some neuropathic pain conditions.This study aimedto evaluate the relationship between vitamin D and vitamin B12 levels and neuropathic pain in lipedema., conditionsModule conditions: Vitamin D Deficiency, conditions: B12 Deficiency Vitamin, conditions: Lipedema, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 200, type: ACTUAL, armsInterventionsModule interventions name: Vitamin B12 Level, outcomesModule primaryOutcomes measure: Vitamin B12 Level, primaryOutcomes measure: 25 OH Vitamin D Level, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gulcan Ozturk, city: Istanbul, zip: 34752, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06338046, orgStudyIdInfo id: EAShi23M01, briefTitle: In Vivo Evaluation of NC65 - Vita D-Light SKIN ADAPTOGEN AND SEBUM BALANCE EFFICACY, acronym: Shitake, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2023-11-15, completionDateStruct date: 2023-12-22, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Ritamaria Di Lorenzo, class: OTHER, descriptionModule briefSummary: This double-blind placebo-controlled study intends to confirm skin adaptogen and sebum balance efficacy of the investigational active ingredient NC65 - Vita D-Light, transmitted at 0.5% w/w in a topical cosmetic formulation, on a panel of healthy human subjects.The study is performed by RD Cosmetics - University of Naples Federico II, from October to June 2024. The study involves female and male subjects, scheduled for eligibility screening at the study site. A total of 40 subjects were enrolled, and randomly divided into 2 groups: 20 subjects received the active treatment (cosmetic formulation with 0.5 %w/w NC65 - Vita D-Light) and 20 subjects the placebo one.The cosmetic effectiveness of the products was instrumentally detected, using innovative, non-invasive and worldwide recognized devices for skin analysis, like:* Corneometer CM 825 (C+K electronic GmbH) detects water's content of the stratum corneum.* Tewameter® TM Hex (C+K electronic GmbH) detects the trans-epidermal water loss (TEWL).* Sebumeter SM 815 accurately and reproducibly measures the level of sebum on the skin surface.* Visia VISIA® (Canfield Scientific, Inc.) for skin surface assessment.The monitored skin features parameters will be check after 1 hour (T1h) for the adaptogen test, and after 7, 14 and 28 days (T7 -T14-T28), for the detox test. Panelists will complete the self-assessment questionnaire at the end of the study period (T28)., conditionsModule conditions: SKIN ADAPTOGEN AND SEBUM BALANCE EFFICACY, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 2 parallel arm, double blind, randomized, placebo-controlled, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: neither the patient nor the investigator knows who is getting which treatment., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Corthellus Shiitake(Mushroom) Extract, interventions name: Placebo, outcomesModule primaryOutcomes measure: Soothing Test, secondaryOutcomes measure: Detox and adaptogen Test, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: RD Cosmetics Lab - Pharmacy Department, University of Naples Federico II, city: Naples, zip: 80131, country: Italy, geoPoint lat: 40.85216, lon: 14.26811, hasResults: False
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protocolSection identificationModule nctId: NCT06338033, orgStudyIdInfo id: 2024-03-23, briefTitle: Prognostic Study of Visceral Fat and Heart Failure With Preserved Ejection Fraction, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-09-19, primaryCompletionDateStruct date: 2023-08-28, completionDateStruct date: 2023-11-30, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Chongqing Medical University, class: OTHER, descriptionModule briefSummary: Obesity and heart failure with preserved ejection fraction (HFpEF) have multiple pathologic associations that affect the prognosis of HFpEF. Chinese people are more prone to visceral obesity, resulting in varying degrees of true obesity in individuals with the same body mass index (BMI). There are no prognostic studies of VFA/BMI in the HFpEF population., conditionsModule conditions: Heart Failure With Preserved Ejection Fraction and Visceral Fat, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 298, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: All-cause mortality, secondaryOutcomes measure: Rehospitalization for heart failure, otherOutcomes measure: Composite endpoints of all-cause mortality and rehospitalization for heart failure, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Chongqing Medical University, city: Chongqing, country: China, geoPoint lat: 29.56278, lon: 106.55278, hasResults: False
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protocolSection identificationModule nctId: NCT06338020, orgStudyIdInfo id: RHPT/0022/0042, briefTitle: Adaptive Variable-Resistance Training in Pediatric Survivors of Acute Lymphoblastic Leukemia, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-12-29, primaryCompletionDateStruct date: 2024-01-04, completionDateStruct date: 2024-01-04, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: This study was designed to investigate the effect of eight weeks of adaptive variable-resistance training (Adaptive-VRT) on chemotherapy-induced sarcopenia, fatigue, and functional restrictions in a convenience sample of pediatric survivors of acute lymphoblastic leukemia (ALL). Sixty-two pediatric survivors of ALL were randomly allocated to the experimental group (n = 31, received the adaptive variable-resistance training) or the Control group (n = 31, received standard physical therapy care). Both groups were assessed for muscle mass, strength, fatigue, and functional capacity before and after treatment., conditionsModule conditions: Acute Lymphoblastic Leukemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A prospective, dual-arm, randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: This was a single-blind protocol. The researcher who collected the data was blind to the allocation of treatment., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 62, type: ACTUAL, armsInterventionsModule interventions name: Adaptive variable-resistance training, interventions name: Standard physical therapy, outcomesModule primaryOutcomes measure: Thigh muscle thickness, primaryOutcomes measure: Muscle strength, secondaryOutcomes measure: Fatigue, secondaryOutcomes measure: Six-minute walk test, secondaryOutcomes measure: 4x10 meter Shuttle Run test, secondaryOutcomes measure: Timed up and down stairs test, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Ragab K. Elnaggar, city: Al Kharj, state: Riyadh, country: Saudi Arabia, geoPoint lat: 24.15541, lon: 47.33457, hasResults: False
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protocolSection identificationModule nctId: NCT06338007, orgStudyIdInfo id: 2012-KAEK-15/2702, briefTitle: Relationship Between Hand Dynamometer Measurements, PFT, and mFI With Postoperative Outcomes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital, class: OTHER, descriptionModule briefSummary: The study will take place at SBÜ Ankara Atatürk Sanatorium Training and Research Hospital and will include 100 patients over the age of 40 who are scheduled for lung malignancy surgery after 01 April 2024. Informed consent will be obtained from all patients, who will be assigned a number from 1 to 100.For patients over 40 years of age who are scheduled to undergo lung malignancy resection surgery, demographic data including age, gender, height, weight, body mass index (BMI), diagnosis, comorbidities, and ASA (American Society of Anaesthesiologist) score will be recorded. In addition, hand grip strength measurement, pulmonary function test, and modified frailty index (a scoring system that includes 11 parameters) will be recorded prior to surgery. Intraoperative and postoperative complications will be documented. The duration of the patient's stay in the intensive care unit, chest tube removal, length of hospital stay, and postoperative complications will also be recorded. A follow-up call will be made to the patient by the responsible researcher 90 days after the operation to inquire about any complications that may have developed within that time frame.The study aims to investigate the relationship between preoperative hand grip strength measurement, pulmonary function test analysis (PFT), and modified frailty index with the duration of intensive care unit stay, chest tube withdrawal time, hospital stay, and postoperative complications in patients undergoing lung resection due to malignancy., conditionsModule conditions: Complication,Postoperative, conditions: Lung Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Hand Dynamometer, interventions name: Pulmonary Function Test, interventions name: Modified Frailty Index, outcomesModule primaryOutcomes measure: Complication, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ankara Atatürk Sanatorium Training and Research Hospital, city: Ankara, state: Keçiören, zip: 06290, country: Turkey, contacts name: Gülay ÜLGER, specialist, role: CONTACT, phone: 05059532122, phoneExt: +9, email: gulayulger@gmail.com, contacts name: Onur KÜÇÜK, specialist, role: SUB_INVESTIGATOR, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
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protocolSection identificationModule nctId: NCT06337994, orgStudyIdInfo id: AUH-Neurol-TBI_2024, briefTitle: Memantine Hydrochloride for Treatment of Cognitive Dysfunction Due to Traumatic Brain Injury, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Posttraumatic consequences are common causes of disability and long-term morbidity. They include cognitive dysfunction, seizures, headache, dizziness, fatigue, sensory deficits, neurodegeneration and psychiatric disorders (e.g. posttraumatic stress disorder, depression, anxiety, etc). Diffuse axonal injury and disruption of normal neuronal function are the most common and important pathologic features of traumatic primary closed head injury. depression, anxiety, etc). Excitotoxicity and apoptosis caused by activation of N-methyl-D-aspartate (NMDA) glutamate receptors, are two main suggested mechanisms of traumatic neuronal cell death and posttraumtic neurologic adverse consequences. Experimental and clinical studies have demonstrated that memantine hydrochloride, NMDA-type glutamate receptor antagonist, could have beneficial effect in treatment of posttraumatic cognitive dysfunction. Memantine may contribute to cognitive improvements in TBI by decreasing the synaptic 'noise' resulting from excessive NMDA receptor activation, inhibition of β-amyloid mediated toxicity and readjustment of the balance between inhibition and excitation on neuronal networks in the central nervous system (CNS)., conditionsModule conditions: Treatment of Posttraumatic Cognitive Dysfunction, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: parallel assignment, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Memantine Hydrochloride, outcomesModule primaryOutcomes measure: The severity of traumatic brain injury (TBI), primaryOutcomes measure: The symptoms of depression, primaryOutcomes measure: The symptoms of anxiety, primaryOutcomes measure: The cognitive function, secondaryOutcomes measure: Quality of life, secondaryOutcomes measure: The cognitive function, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Assiut University, Faculty of Medicine, Hospital of Neurology, Psychiatry and Neurosurgery, status: RECRUITING, city: Assiut, zip: 71516, country: Egypt, contacts name: Sherifa A Hamed, M.D., role: CONTACT, phone: +201115324560, email: hamedsherifa@aun.edu.eg, contacts name: Sherifa A Hamed, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 27.18096, lon: 31.18368, hasResults: False
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protocolSection identificationModule nctId: NCT06337981, orgStudyIdInfo id: 21DE20901, briefTitle: Efficacy and Safety of AJU-S56 in Dry Eye Syndrome Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-11-22, primaryCompletionDateStruct date: 2022-06-14, completionDateStruct date: 2022-11-28, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: AJU Pharm Co., Ltd., class: INDUSTRY, collaborators name: GL Pharm Tech Corporation, descriptionModule briefSummary: This study is planned to Evaluate the Efficacy and Safety of test drug (AJU-S56) compared to control drug(vehicle) in Patients with Dry Eye Disease., conditionsModule conditions: Dry Eye Syndromes, 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: 99, type: ACTUAL, armsInterventionsModule interventions name: (AJU-S56 5% and placebo), interventions name: AJU-S56 5%, interventions name: Placebo(Vehicle), outcomesModule primaryOutcomes measure: Total corneal staining score (TCSS), secondaryOutcomes measure: LGCSS, secondaryOutcomes measure: TFBUT, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: AJU Pharm Co., Ltd., city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
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protocolSection identificationModule nctId: NCT06337968, orgStudyIdInfo id: Circum-Psoas Block LN, briefTitle: CPB for Arthroscopic Hip Surgery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-05-31, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: The Second Hospital of Shandong University, class: OTHER, descriptionModule briefSummary: Arthroscopic hip surgery is being increasingly performed to treat both intraarticular and extraarticular hip diseases. Despite the minimally invasive approach, patients undergoing arthroscopic hip surgery still suffer severe pain due to the complex nature of hip innervation. Postoperative pain reduces patient satisfaction and delay patient recovery and discharge. The efficacy of regional anesthesia techniques in postoperative pain management have been proved in various surgeries. However, it remains controversial whether or not peripheral nerve blocks can significantly improve postoperative analgesia after hip arthroscopy.Several studies have shown that the fascia iliac block cannot improve postoperative analgesia for hip arthroscopy because it blocks only some branches of the lumbar plexus but not the sacral plexus. Circum-Psoas Block (CPB) which has been defined in recent years is able to block the lumbar plexus nerves as well as sacral plexus such as the sciatic, superior gluteal, and inferior gluteal nerves. Therefore, the investigators predict that it can provide effective postoperative analgesia for hip arthroscopy. In this study, the researchers aim to investigate the effectiveness of CPB in hip arthroscopy., conditionsModule conditions: Acute Pain, conditions: Opioid Use, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 74, type: ESTIMATED, armsInterventionsModule interventions name: Circum-psoas Block, interventions name: Sham block, outcomesModule primaryOutcomes measure: pain severity at 6 hours postoperatively, secondaryOutcomes measure: Postoperative opioid consumption, secondaryOutcomes measure: Postoperative nausea and vomiting, secondaryOutcomes measure: neurologic evaluation, secondaryOutcomes measure: Patient satisfaction, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06337955, orgStudyIdInfo id: 20170007596, briefTitle: Non Primary HCMV Infection: Natural History and Immune Response, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2017-06-06, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Foundation IRCCS San Matteo Hospital, class: OTHER, collaborators name: Università degli Studi di Pavia, collaborators name: Merck Sharp & Dohme LLC, collaborators name: Fondazione Regionale per la Ricerca Biomedica (FRRB) - Regione Lombardia, descriptionModule briefSummary: The goals of this observational study are: i) investigate the natural history of non-primary (i.e. reactivation and reinfection) HCMV infection in HCMV-seropositive Italian women and the relevant humoral and cell-mediated immune response; ii) reliably distinguish between reactivation and reinfection.Prerequisite of the study is the availability of a maternal HCMV strain at baseline (original strain) to which subsequent strains detected during follow-up are compared in order to distinguish between reactivation (original strain) or reinfection (new strain).To increase the likelihood of exposure to different HCMV strains, the study population is restricted to mothers of children attending day care centers., conditionsModule conditions: Cytomegalovirus Infections, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 204, type: ACTUAL, outcomesModule primaryOutcomes measure: HCMV non-primary infection (reinfection or reactivation)., secondaryOutcomes measure: HCMV-specific humoral and cell-mediated immune response during non-primary infection., secondaryOutcomes measure: Maternal behaviours and occurrence of non-primary infection, otherOutcomes measure: Potential use of saliva swabs for antibody determination., eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione IRCCS Policlinico San Matteo, city: Pavia, state: PV, zip: 27100, country: Italy, geoPoint lat: 45.19205, lon: 9.15917, hasResults: False
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protocolSection identificationModule nctId: NCT06337942, orgStudyIdInfo id: 23-001621, briefTitle: Deceased Donor Bladder or Combined Kidney-bladder Transplantation: a Phase 0 First-in-human Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2027-04, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: University of California, Los Angeles, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to demonstrate the feasibility of bladder transplantation in patients with terminal bladder diseases who would benefit from a new bladder or a combined kidney and bladder transplant. The main questions it aims to answer are:* Is human bladder transplantation feasible and safe?* How will the new bladder function in terms of storage and emptying?Participants will undergo a bladder-only or combined kidney and bladder transplantation. They will then be followed for two years to evaluate the efficacy, safety, and functionality of the bladder transplant., conditionsModule conditions: Bladder Disease, conditions: Bladder, Neurogenic, conditions: Bladder Cancer, conditions: Kidney Failure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 5, type: ESTIMATED, armsInterventionsModule interventions name: Bladder Transplantation, interventions name: Combined Kidney and Bladder Transplantation, outcomesModule primaryOutcomes measure: Demonstrating the technical success of bladder or combined kidney-bladder transplantation, secondaryOutcomes measure: Incidence of adverse events after bladder or combined kidney-bladder transplantation, secondaryOutcomes measure: Incidence of immune rejection after bladder or combined kidney-bladder transplantation, secondaryOutcomes measure: Evaluate the functionality of the transplanted bladder, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UCLA, status: RECRUITING, city: Los Angeles, state: California, zip: 90095, country: United States, contacts name: Magdalena Mendez-Smith, role: CONTACT, phone: 310-267-7727, email: mmendezsmith@mednet.ucla.edu, contacts name: Nima Nassiri, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, hasResults: False
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protocolSection identificationModule nctId: NCT06337929, orgStudyIdInfo id: Ethics Approval: n. 6.683.936, briefTitle: Effects of Capoeira on the Physical and Psychological Performance of Adults, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-07-15, completionDateStruct date: 2024-12-13, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Universidade Federal do vale do São Francisco, class: OTHER, descriptionModule briefSummary: Regular physical activity (PA) promotes benefits for both physical and mental health. Among the numerous PA\'s with a collective nature that can add to the existing recommendations, combat sports training interventions are viable alternatives since they integrate benefits in different aspects for health. In this way, capoeira can be a strategy for the prescription of exercise, aiming to serve participants collectively and maintaining the adherence of this practitioner to the intervention. However, little is known about this issue. So, the aim of the present study is to verify the effect of 12 weeks of capoeira training on the physical performance and psychological aspects of previously physically inactive adults., conditionsModule conditions: Training, conditions: Mental Health, conditions: Physical Fitness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: CAPOEIRA TRAINING, interventions name: CONTROL GROUP, outcomesModule primaryOutcomes measure: Change from baseline in aerobic fitness (maximal oxygen uptake and anaerobic threshold) at week 12, primaryOutcomes measure: Change from baseline in anaerobic fitness (Peak, average and minimum power in the Wingate test) at week 12, primaryOutcomes measure: Change from baseline in muscle strength (Horizontal Leg Press) at week 12, primaryOutcomes measure: Change from baseline in muscle power (Vertical Jump Tests from Squat Jump and Counter Movement Jump) on force platform at week 12, primaryOutcomes measure: Change from baseline in balance (Center of Pressure) on force platform at week 12, primaryOutcomes measure: Change from baseline in motor coordination (Test of Gross Motor Development) at week 12, primaryOutcomes measure: Change from baseline in Emotional Intelligence to sport (Likert-type scales with 26 items) at week 12, primaryOutcomes measure: Change from baseline in Motivation for Sport II (Likert-type scales with 18 items) at week 12, primaryOutcomes measure: Change from baseline in Quality of life measuring by Questionnaire of Word Health Organization (WHOQOL-bref) at week 12, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 59 Years, stdAges: ADULT, contactsLocationsModule locations facility: UNIVASF, city: Petrolina, state: Pernambuco, zip: 56300000, country: Brazil, geoPoint lat: -9.39861, lon: -40.50083, hasResults: False
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protocolSection identificationModule nctId: NCT06337916, orgStudyIdInfo id: 2021/16-01, briefTitle: The Effect of Cervical Stabilization Exercises on the Cervical Proprioception in Patients With Chronic Neck Pain, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-10-07, primaryCompletionDateStruct date: 2022-11-25, completionDateStruct date: 2023-01-30, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Şenay Özdolap, class: OTHER, collaborators name: Zonguldak Bulent Ecevit University, descriptionModule briefSummary: Neck pain is one of the most common musculoskeletal complaints and its prevalence is between 10-22%. Approximately half of all individuals will experience a clinically important neck pain episode over the course of their lifetime. Neck pain is categorized by duration as acute, subacute and chronic neck pain (acute, \<6 weeks; subacute, ≤3 months; chronic, \>3 months). Chronic neck pain is more common in women and its incidence increases with age. Cervical disc herniation, cervical spondylosis, cervical stenosis, myofascial pain syndrome, cervical instability, whiplash injury, Klippel feil syndrome, thoracic outlet syndrome, cervical sprain, cervical strain, tumors, rheumatic diseases, torticollis, inflammatory neck pain are the main causes.Anterior tilt of the head is a common posture in neck pain. In this posture, the upper cervical vertebrae are extension, the lower cervical vertebrae are flexion and the cervical lordosis is decreased. With neck pain, inhibition occurs in the deep neck flexor (longus coli and capitis) and extensor (multifidus, rotator, semispinalis) muscles, increased fat infiltration, deterioration in type 1 and 2 fiber ratios, and muscle atrophy. The risk of micro and macro trauma increases and muscle support decreases. Thus, there is an increase in the activation response and fatigue of the neck superficial muscle group (trapeze, scalene, sternocleidomastoid muscles), and a decrease in neck joint movement and proprioception sense. As a result, it was determined that there are deficiencies in the sense of proprioception in patients with neck pain.Studies have shown that many receptors related to the sense of position are on deep cervical flexor muscles such as Musculus Longus Capitis and Musculus Longus Colli. In cases where there are changes such as atrophy and fat infiltration in these muscles, there is a decrease in proprioceptive sensation.Conservative treatment is the first choice in the treatment of neck pain. The important components of this treatment are stretching, strengthening, posture, stabilization, proprioception, relaxation, joint movement exercises and aerobic exercises. The purpose of stabilization exercises, which have been used in the treatment of chronic neck pain recently; to support the vertebral column by activating the stabilizing muscles and to improve posture by increasing kinesthetic awareness.This study will examine the relationship between the sense of cervical proprioception and cervical stabilization exercises in patients with chronic neck pain.In this study, between 15 June 2022 and 30 January 2023; 72 volunteers, aged between 18-55 years, with neck pain for more than 3 months, with good cognitive function, who applied to the our Physical Medicine and Rehabilitation Clinic will be included. The patients will be randomized to two groups as cervical stabilization exercise group and conventional cervical exercise treatment group. The patients in group 1 will receive cervical stabilization exercises 1 session a day, 3 days a week for 6 weeks, and the patients in group 2 will perform cervical stabilization exercises for 6 weeks, 3 days a week, 1 session a day. conventional cervical exercises will be given. Patients of both groups will do their exercises in the first 3 weeks accompanied by a physiotherapist, and in the last 3 weeks as a home exercise program.Before the start of the treatment, at the end of the 3rd week and at the end of the 6th week; pain intensity, level of neck disability, quality of life, cervical range of motion and cervical joint position sense will be evaluated and both groups will be compared in these parameters.Demographic information (address, telephone, age, occupation, height, weight, marital status, etc.) of the patients to be included in the study will be recorded and general musculoskeletal examinations will be performed. The patients will be compared to evaluate for Visual Analogue Scale (VAS), Neck Disability Index (NDI) and Short Form-36 (SF-36), cervical range of motion and cervical joint position sense after intervention. Cervical range of motion and cervical joint position sense will be evaluated with the Cervical Range of Motion Deluxe Device (CROM)., conditionsModule conditions: Neck Pain, conditions: Chronic Neck Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Cervical Stabilization Exercise, interventions name: Cervical Standard Exercise Group, outcomesModule primaryOutcomes measure: assessment of cervical joint position sense, secondaryOutcomes measure: assessment of cervical range of motion, secondaryOutcomes measure: assessment of neck disability, secondaryOutcomes measure: assessment of pain, secondaryOutcomes measure: assessment of life quality, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Zonguldak Bülent Ecevit University, city: Zonguldak, zip: 67100, country: Turkey, geoPoint lat: 41.45139, lon: 31.79305, hasResults: False
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protocolSection identificationModule nctId: NCT06337903, orgStudyIdInfo id: Self-compassion for PwMS, briefTitle: Self-compassion for People With Multiple Sclerosis: An Exploratory Feasibility Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Robert Simpson, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to develop and investigate a compassion-based intervention (Mindful Self-Compassion course) in people with multiple sclerosis. The main objectives are:1. Explore feasibility of trial processes including recruitment, adherence, retention, and follow-up2. Explore experiences of people with multiple sclerosis with the Compassion-based intervention, including perceived effects, barriers and facilitators to participation, suggestions for improvement3. Determine potential effects on stress, anxiety, depression, emotion regulation, illness adjustment, and self-compassion.Participants will be asked to take part in an 8-week online Mindful Self-Compassion course and report changes in levels of stress, anxiety, depression, self-compassion, adjustment, emotion, and quality of life from pre- to post-intervention and at 3-month follow-up. Additionally, participants will be asked to take part in a semi-structured interview to explore their experiences with the course, perceived effects, and suggestions for improvement., conditionsModule conditions: Multiple Sclerosis, conditions: Self-Compassion, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Self-compassion intervention (the Mindful Self-Compassion course), outcomesModule primaryOutcomes measure: Recruitment, primaryOutcomes measure: Retention, primaryOutcomes measure: Adherence, primaryOutcomes measure: Follow-up rates, secondaryOutcomes measure: Stress, secondaryOutcomes measure: Anxiety, secondaryOutcomes measure: Depression, secondaryOutcomes measure: Self-compassion, secondaryOutcomes measure: Emotion Regulation, secondaryOutcomes measure: Quality of Life using the Multiple Sclerosis Impact Scale (MSIS-29), secondaryOutcomes measure: Participant Experiences and Perspectives, secondaryOutcomes measure: Adjustment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Unity Health Toronto, city: Toronto, country: Canada, contacts name: Robert Simpson, PhD, role: CONTACT, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False
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protocolSection identificationModule nctId: NCT06337890, orgStudyIdInfo id: FEZECO, briefTitle: CO2 Automated Angiographies With Fusion Imaging for Zero- or Near Zero- Contrast FEVAR., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: University of Bologna, class: OTHER, descriptionModule briefSummary: Fenestrated endovascular aneurysm repair (FEVAR) is an established technique used to treat complex aortic aneurysms (TAAAs), with satisfactory early and midterm results.Postoperative renal function worsening is a common adverse event after FEVAR of complex aneurysms and is associated with prolonged hospital stay, higher morbidity, and long-term mortality in the peri-operative period and during follow-up. One of the more common causes of renal function worsening is contrast-induced nephropathy resulting from the use of iodinated contrast medium (ICM).Automated carbon dioxide (CO2) angiography has been proposed as an alternative to ICM for standard endovascular aneurysm repair (EVAR) in consideration of its absence of nephrotoxicity that can be of further help in preserving renal function.In adjunct, hybrid room and fusion imaging (FI) technologies are useful tools to reduce intraoperative contrast medium and fluoroscopy time.In literature there are few reports regarding the use of CO2 for fenestrated endografting repair of complex aortic aneurysms.The aim of the present study is to report the possibility to combine the use of automated CO2 angiographies and Fusion Imaging to obtain zero- or near zero- contrast FEVAR for complex aortic aneurysms., conditionsModule conditions: Aortic Aneurysm, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Zero contrast FEVAR, outcomesModule primaryOutcomes measure: Rate of technical success, primaryOutcomes measure: Reintervention and mortality, primaryOutcomes measure: Number of participants with perioperative renal function worsening, primaryOutcomes measure: Rate of TVVs instability, primaryOutcomes measure: Rate of survival, primaryOutcomes measure: Rate of reintervention, primaryOutcomes measure: Number of participants with renal function worsening, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Bologna, status: RECRUITING, city: Bologna, state: Emilia Romagna, zip: 40138, country: Italy, contacts name: Enrico Gallitto, MD, PhD, role: CONTACT, phone: +390512143288, email: enrico.gallitto@gmail.com, geoPoint lat: 44.49381, lon: 11.33875, hasResults: False
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protocolSection identificationModule nctId: NCT06337877, orgStudyIdInfo id: pEEG ARDS, briefTitle: Assessment of Sedation Depth in ARDS Patients Undergoing Therapeutic Paralysis, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2024-04-17, completionDateStruct date: 2024-04-24, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Tepecik Training and Research Hospital, class: OTHER, descriptionModule briefSummary: "In intensive care units, therapeutic paralysis has been a routine treatment method for many years in a select group of patients. Sufficient and appropriate sedation in patients undergoing therapeutic paralysis is crucial to prevent awareness and reduce the risk of excessive sedation. Both inadequate and excessive sedation levels can be highly detrimental to the patient. Clinical assessment may not always provide accurate information regarding sedation depth. Recently, the frequency and workload of therapeutic paralysis treatment in intensive care units have increased due to COVID-19 pneumonia. Therefore, the investigators believe that inadequate sedation may be common in these patients. Processed electroencephalogram parameters such as bispectral index or patient state index (PSI), routinely used in operating rooms and intensive care units, are commonly used to indicate sedation depth. In this study, the investigators aimed to determine sedation levels in patients during paralysis, assess the prevalence of inadequate or excessive sedation, and observe the doses of sedatives and analgesics used.", conditionsModule conditions: Sedation Complication, conditions: Acute Respiratory Distress Syndrome Due to COVID-19, conditions: Anesthesia Awareness, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 52, type: ACTUAL, armsInterventionsModule interventions name: Depth of sedation monitoring, outcomesModule primaryOutcomes measure: To determine the sedation levels of patients during paralysis, primaryOutcomes measure: The prevalence of inadequate or excessive sedation,, secondaryOutcomes measure: Evaluation of Concordance Between Richmond Agitation-Sedation Scale (RASS),, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Aykut Saritaş, city: İ̇zmi̇r, zip: 35640, country: Turkey, geoPoint lat: 38.41273, lon: 27.13838, hasResults: False
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protocolSection identificationModule nctId: NCT06337864, orgStudyIdInfo id: H-24017055, briefTitle: Evaluating the Efficacy and Safety of Large Neutral Amino Acids in the Treatment of Classical Phenylketonuria, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Rigshospitalet, Denmark, class: OTHER, descriptionModule briefSummary: This research investigates the effectiveness and safety of large neutral amino acid (LNAA) supplementation in patients with classical phenylketonuria (PKU). Advanced brain imaging techniques alongside comprehensive neuropsychological and functional assessments will be employed. Short-term and long-term follow-up of participants will be conducted., conditionsModule conditions: Brain Diseases, conditions: Brain Diseases, Metabolic, conditions: Brain Diseases, Metabolic, Inborn, conditions: Genetic Diseases, Inborn, conditions: Metabolism, Inborn Errors, conditions: Amino Acid Metabolism, Inborn Errors, conditions: Metabolic Disease, conditions: Phenylketonurias, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: To fully assess the effectiveness of LNAA, the following trials will be conducted:1. A crossover study comparing LNAA supplementation to no treatment2. A crossover study comparing LNAA supplementation to the Phe-free PKU diet3. Open-label extension study to assess the long-term safety and efficacy of LNAA supplementation4. Healthy control group, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: PreKUnil® LNAA Medical Food for PKU, outcomesModule primaryOutcomes measure: Dynamic positron emission tomography (PET) imaging with the fluorine-18-labeled tracer [18F]-(E)-N-(3-iodoprop-2-enyl)-2β-carbofluoroethoxy-3β-(4'-methyl phenyl)nortropane ([18F]FE-PE2I), primaryOutcomes measure: Computerized neuropsychological testing (responses over study iPad), secondaryOutcomes measure: Behaviour Rating Inventory of Executive Function - Adult version (BRIEF-A), secondaryOutcomes measure: Behaviour Rating Inventory of Executive Function - Second edition (BRIEF-2), secondaryOutcomes measure: Adult attention deficit hyperactivity disorder (ADHD) Self-Report Scale (ASRS v1.1), secondaryOutcomes measure: Adolescent ADHD Self-Report Scale, secondaryOutcomes measure: PKU-QOL Questionnaire Adolescent or Adult version, secondaryOutcomes measure: Symptom Checklist-90-Revised (SCL-90-R), secondaryOutcomes measure: Behavior Assessment System for Children, Third Edition (BASC-3), secondaryOutcomes measure: Neuropsychological testing of flexibility and verbal fluency, secondaryOutcomes measure: Urine peripheral biomarkers of neurotransmitters, secondaryOutcomes measure: Incidence and severity of treatment-emergent adverse events (TEAEs), otherOutcomes measure: Fasting plasma amino acids, dried blood spots (finger-prick method), otherOutcomes measure: Brain perfusion measures, otherOutcomes measure: Adherence to dietary treatment, otherOutcomes measure: Brain Magnetic Resonance Imaging (MRI), otherOutcomes measure: Wechsler Adult Intelligence Scale (WAIS) - IV, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 50 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Copenhagen University Hospital, Rigshospitalet, city: Copenhagen, country: Denmark, contacts name: Olivia Welle Fjellbirkeland, MD, role: CONTACT, email: olivia.welle.fjellbirkeland@regionh.dk, geoPoint lat: 55.67594, lon: 12.56553, hasResults: False
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protocolSection identificationModule nctId: NCT06337851, orgStudyIdInfo id: AtaturkTRH2003/9, briefTitle: Comparing Simultaneous and Consecutive Drainage of Bilateral Chronic Subdural Hematoma, statusModule overallStatus: COMPLETED, startDateStruct date: 2003-11, primaryCompletionDateStruct date: 2010-04, completionDateStruct date: 2011-04, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Ataturk Training and Research Hospital, class: OTHER, descriptionModule briefSummary: Surgical evacuation CSDH via burr hole craniostomy appears to be the most widely practiced treatment technique worldwide and outcomes are generally favorable.In previous reports, bilateral CSDH was raised as a predictor of rapid deterioration and worse outcomes attributable to brain herniation, in comparison with unilateral ones. Nevertheless, the optimal surgical considerations in bilateral CSDH still remain controversial. Thus, this study principally aims to finding out whether consecutive removal of bilateral CSDH really poses a complication risk. The secondary objectives of the study were to obtain information about the one-year prognosis of bilateral CSDH and to find factors that affect the prognosis, if any.Inclusion criteria Symptomatic adult (≥18 years-old) patients with bilateral hemispheric CSDHExclusion criteria Patients with hematoma thickness smaller than 10 mm on either side, and those who previously underwent any cranial surgeryRandomization Simple randomization, without blocking, will be used to divide patients into two groups simultaneous burr hole craniostomy (Group-1) and consecutive burr hole craniostomy (Group-2).Clinical Evaluation Neurological examination and scoring systems (Glasgow coma scale and Markwalder Grading) will be used.Radiological Evaluation Radiological evaluations will be made with CT and MR imaging.Operation Patients in group-1 were fixed in supine position with their heads in neutral and flexion position. Bilateral burr holes were made one after another, the dural surfaces were exposed at the same time, then the outer membranes of both sides opened and hematomas evacuated simultaneously. All the patients underwent a drainage system, performed with the insertion of a silicone tube into the subdural space and tunneled under the scalp to the exit point. In group-2, hematoma with a greater thickness was removed first (if thickness was equal on both sides, first incision was made on the right side). The head in supine position was rotated to the side with a smaller hemorrhage thickness. Previously, burr holes were made, the dural surfaces were exposed, the outer membrane opened, and the hematoma was evacuated at one side. Then, drainage system inserted into the subdural space. After the procedure of the first side was completed, as a consecutive process, the head was rotated to the other side, and the same procedure was repeated. The contralateral hematoma was evacuated.Follow-Up Depending on the subdural fluid collected, all drains will be removed within post-operative 36-48 hours.Only the patients with epileptic history and on epileptic medication will receive postoperative antiepileptics.In the postoperative period, a comprehensive evaluation encompassing neurological examinations and CT imaging will be performed.This evaluation protocol will be executed immediately following the surgical procedure, after the removal of surgical drains (usually on the second postoperative day), and at designated intervals of the 1st, 3rd, 6th, and 12th months to monitor patient progress and recovery., conditionsModule conditions: Subdural Hematoma, Chronic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: a prospective randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 43, type: ACTUAL, armsInterventionsModule interventions name: Simultaneous burr hole craniostomy, interventions name: Consecutive burr hole craniostomy, outcomesModule primaryOutcomes measure: The Primary Outcome: Mortality, primaryOutcomes measure: The Primary Outcome: Early Postoperative Success Rate (Redo Surgery), secondaryOutcomes measure: The secondary outcome: Follow-up assessment (Age), secondaryOutcomes measure: The secondary outcome: Follow-up assessment (Sex), secondaryOutcomes measure: The secondary outcome: Follow-up assessment (Trauma-Relation), secondaryOutcomes measure: The secondary outcome: Follow-up assessment (Concomitant Pathologies), secondaryOutcomes measure: The secondary outcome: Follow-up assessment (The Glasgow Coma Scale), secondaryOutcomes measure: The secondary outcome: Follow-up assessment (The Markwalder Grading Scale), secondaryOutcomes measure: The secondary outcome: Follow-up assessment (Neurological Examination - Motor), secondaryOutcomes measure: The secondary outcome: Follow-up assessment (Neurological Examination - fundus oculi), secondaryOutcomes measure: The secondary outcome: Follow-up assessment (Neurological Examination - babinski sign), secondaryOutcomes measure: The secondary outcome: Follow-up assessment (Radiological Assessments - midline shift), secondaryOutcomes measure: The secondary outcome: Follow-up assessment (Radiological Assessments - hematoma volum), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Izmir Ataturk Training and Research Hospital, city: Izmir, zip: 35360, country: Turkey, geoPoint lat: 38.41273, lon: 27.13838, hasResults: False
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protocolSection identificationModule nctId: NCT06337838, orgStudyIdInfo id: 2024.BRACKETS-Pilot, briefTitle: Bleeding Reduction in Acute and Chronic Kidney Patients Having Surgery (BRACKETS) Pilot Trial, acronym: BRACKETS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Population Health Research Institute, class: OTHER, descriptionModule briefSummary: The BRACKETS pilot study is a multicentre, prospective, randomized controlled trial of prophylactic preoperative tranexamic acid (TXA) versus placebo and, using a partial factorial design, of prophylactic preoperative desmopressin versus placebo., conditionsModule conditions: Chronic Kidney Diseases, conditions: Acute Kidney Injury, conditions: Bleeding, conditions: Surgery, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: 2x2 partial factorial design where patients are first randomized to receive prophylactic intravenous TXA versus placebo, and (when the study drug is available) to be randomized to receive prophylactic intravenous desmopressin versus placebo before noncardiac surgery., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Study drugs will be sourced locally and will be prepared by appropriately qualified center personnel who are independent of the study team to ensure blinding is maintained., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Desmopressin Injectable Solution, interventions name: Tranexamic Acid Injectable Product, interventions name: Placebo, outcomesModule primaryOutcomes measure: Rate of recruitment, primaryOutcomes measure: Receipt of the allocated study drug within 1 hour before start of surgery for the tranexamic acid factorial, primaryOutcomes measure: Receipt of the allocated study drug within 1 hour before start of surgery for the desmopressin factorial, primaryOutcomes measure: Completion of 30-day follow-up, secondaryOutcomes measure: Bleeding Independently Associated with Mortality after noncardiac Surgery (BIMS), secondaryOutcomes measure: Reoperation for reasons of bleeding, secondaryOutcomes measure: Blood (red blood cells or whole blood) transfused, secondaryOutcomes measure: Blood (red blood cells or whole blood) transfused, secondaryOutcomes measure: Any blood transfusion (red blood cells or whole blood), secondaryOutcomes measure: Any blood transfusion (red blood cells or whole blood), secondaryOutcomes measure: Lowest measured hemoglobin concentration, secondaryOutcomes measure: Most recent hemoglobin concentration, secondaryOutcomes measure: Death, secondaryOutcomes measure: Major arterial and venous thrombosis, secondaryOutcomes measure: Myocardial Injury after Noncardiac Surgery (MINS), secondaryOutcomes measure: Myocardial Injury after Noncardiac Surgery (MINS) that meets criteria for myocardial infarction, secondaryOutcomes measure: MINS that is an isolated ischemic troponin elevation, secondaryOutcomes measure: Stroke, secondaryOutcomes measure: Non-hemorrhagic stroke, secondaryOutcomes measure: Hemorrhagic stroke, secondaryOutcomes measure: Peripheral arterial thrombosis, secondaryOutcomes measure: Thrombosis of arteriovenous fistula or graft, secondaryOutcomes measure: Symptomatic proximal venous thromboembolism, secondaryOutcomes measure: Symptomatic pulmonary embolism, secondaryOutcomes measure: Symptomatic proximal leg or arm deep venous thrombosis (DVT), secondaryOutcomes measure: Non-fatal cardiac arrest, secondaryOutcomes measure: Coronary revascularization procedure, secondaryOutcomes measure: Clinically important atrial fibrillation or flutter, secondaryOutcomes measure: Acute heart failure, secondaryOutcomes measure: Acute kidney injury (for patients not receiving dialysis before surgery), secondaryOutcomes measure: New start of dialysis, secondaryOutcomes measure: Seizure, secondaryOutcomes measure: Clinically significant intraoperative hypotension, secondaryOutcomes measure: Clinically significant postoperative hypotension, secondaryOutcomes measure: Sepsis, secondaryOutcomes measure: Duration of surgery, secondaryOutcomes measure: Receipt of platelets, secondaryOutcomes measure: Receipt of fibrinogen, secondaryOutcomes measure: Receipt of fresh frozen plasma, secondaryOutcomes measure: Receipt of cryoprecipitate, secondaryOutcomes measure: Receipt of recombinant Factor VIIa, secondaryOutcomes measure: Receipt of prothrombin complex concentrate, secondaryOutcomes measure: Prescribed erythropoiesis stimulating agent, secondaryOutcomes measure: Severe hyponatremia, secondaryOutcomes measure: Duration of hospital stay after surgery, secondaryOutcomes measure: Duration of critical care stay after surgery, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06337825, orgStudyIdInfo id: 22-727, briefTitle: Object Assessment of Improvement in Non-Specific Symptoms After Parathyroidectomy for Primary Hyperparathyroidism, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-07-19, primaryCompletionDateStruct date: 2024-03-12, completionDateStruct date: 2024-06-29, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: The Cleveland Clinic, class: OTHER, descriptionModule briefSummary: Wearable electronic devices are becoming more prevalent in daily life, as they offer real time information on physiological parameters such as heart rate, activity level, oxygenation, and sleep patterns for their users. These wearable electronic devices are easy to install and offer no major risk or discomfort to the user. Implementation of these technologies into medicine has exponentially grown in the past decade with supporting evidence for their use in cardiovascular disease and sleep medicine. The investigators believe that these devices will be able to capture the changes associated with improvement in non-specific symptoms that have not been previously demonstrated., conditionsModule conditions: Primary Hyperparathyroidism, conditions: Multinodular Goiter, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Activity Tracker (Fitbit), interventions name: HbA1C, interventions name: The PROMPT Questionnaire, outcomesModule primaryOutcomes measure: Change in resting heart rate over time among study participants as monitored by fitness tracker, primaryOutcomes measure: Change in number of awakenings during sleep over time among study participants as monitored by fitness tracker, primaryOutcomes measure: Change in % Deep Sleep over Total Sleep Minutes over time among study participants as monitored by fitness tracker, primaryOutcomes measure: Change in steps over time among study participants as monitored by fitness tracker, primaryOutcomes measure: Change in total active minutes over time among study participants as monitored by fitness tracker, primaryOutcomes measure: Change in% Active Calorie over Total Calories over time among study participants as monitored by fitness tracker, primaryOutcomes measure: Change in glucose levels (HbA1C), primaryOutcomes measure: Correlation of Quality of Life surveys with the PROMPT survey, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Cleveland Clinic Foundation, city: Cleveland, state: Ohio, zip: 44195, country: United States, geoPoint lat: 41.4995, lon: -81.69541, hasResults: False
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protocolSection identificationModule nctId: NCT06337812, orgStudyIdInfo id: HUM00240473, briefTitle: Fiber Supplementation in Heart Failure With Preserved Ejection Fraction (HFpEF), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: University of Michigan, class: OTHER, descriptionModule briefSummary: The study team is studying how increasing dietary fiber, specifically through adding potato starch to participant's diet, may impact the species of bacteria in participant's gut microbiome. The study team also wants to understand if adding potato starch to participant's diet helps these bacteria make more short chain fatty acids, a byproduct the team thinks may benefit participant's health., conditionsModule conditions: Type2diabetes, conditions: Heart Failure With Preserved Ejection Fraction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Potato Starch, outcomesModule primaryOutcomes measure: Changes in Short Chain Fatty Acid (SCFA) butyrate levels - stool, primaryOutcomes measure: Changes in Short Chain Fatty Acid (SCFA) butyrate levels - plasma, primaryOutcomes measure: Changes in propionate levels - stool, primaryOutcomes measure: Changes in propionate levels- plasma, primaryOutcomes measure: Changes in acetate levels- stool, primaryOutcomes measure: Changes in acetate levels- plasma, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Michigan, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, contacts name: Hayley Billingsley, PhD, role: CONTACT, phone: 734-726-0308, email: hbilings@med.umich.edu, contacts name: Scott Hummel, MD, MS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.27756, lon: -83.74088, hasResults: False
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protocolSection identificationModule nctId: NCT06337799, orgStudyIdInfo id: 202210411, briefTitle: Use of Allied-health Professionals to Improve Treatment of Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2026-10, primaryCompletionDateStruct date: 2030-03, completionDateStruct date: 2030-03, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: University of Iowa, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn if allied-health professionals can recruit and follow research participants, sustain engagement, and improve and diagnose treatment of diseases by facilitating transitions of care.Participants will:Take their blood pressure at home and return it to the research team; Follow up with a research pharmacist for 12 months; Return for a follow up visit after 12 months., conditionsModule conditions: Preeclampsia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Research Pharmacist, outcomesModule primaryOutcomes measure: Number of Subjects at Risk for Hypertension, primaryOutcomes measure: Number of Subjects Exposed to a Screening Clinic, primaryOutcomes measure: Number of Subjects Screened at a Screening Clinic, primaryOutcomes measure: Number of Subjects Followed-Up by the Research Pharmacist, primaryOutcomes measure: Number of Subjects Diagnosed with Hypertension, primaryOutcomes measure: Number of Subjects Treated for Hypertension, if Diagnosed, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06337786, orgStudyIdInfo id: MSK-2023-TSJ1, briefTitle: Investigating the Effects of the Digital App Rheumabuddy4.1 in a Clinical Set-up in Patients With Rheumatoid Arthritis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Henning Bliddal, class: OTHER, collaborators name: Eurostars, collaborators name: DAMAN, collaborators name: Medical University of Vienna, descriptionModule briefSummary: Rheumatoid arthritis (RA) is one of the most frequently occurring autoimmune rheumatic diseases, affecting an estimated 1% of the global population (1). RA is a chronic inflammatory disease that leads to the development of synovial inflammation and effusion, ultimately followed by joint destruction and permanent disability.There is a discrepancy in the understanding of what's of importance when living a life with a chronic disease.The importance of patients' perspectives concerning disease- and treatment related impacts, is of crucial importance when involving patients in decisions about treatment, and to support the patients in optimal medication-taking behaviour to ensure patient health and reduce health care costs. There are still unmet needs that have a huge impact on quality of life (QoL) such as fatigue, pain, sleep and psychological issues, etc, which need to be taken seriously as these can have severe and debilitating consequences for the individual.The aim of this study is to investigate and evaluate the effects of the digital app RheumaBuddy4.1 (RB4.1) and the ability to provide support and increase quality of life in patients with RA, conditionsModule conditions: Rheumatoid Arthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The trial is an open-label matched register controlled clinical trial with two parallel groups (intervention and matched controls from the DANBIO register).The number of study participants is 40 in the intervention arm and up to 120 in the matched control arm., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Digital app RB4.1, interventions name: Control arm, outcomesModule primaryOutcomes measure: Primary Outcome, secondaryOutcomes measure: Disease-activity Score28 using C-reactive protein (DAS28-CRP), secondaryOutcomes measure: Self-Efficacy, secondaryOutcomes measure: Pain and Fatigue, secondaryOutcomes measure: Health related quality of life, secondaryOutcomes measure: Physical function/activity, secondaryOutcomes measure: Well-Being, otherOutcomes measure: Medication Adherence, otherOutcomes measure: Better alignment between patient and health care professionals, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 74 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Parker Institute, Bispebjerg and Frederiksberg Hospital, city: Frederiksberg, state: Copenhagen F, zip: 2000, country: Denmark, contacts name: Tanja Schjødt Jørgensen, role: CONTACT, phone: +4538164173, email: tanja.schjoedt.joergensen@regionh.dk, contacts name: Lars Erik Kristensen, role: CONTACT, phone: +4538164157, email: lars.erik.kristensen@regionh.dk, geoPoint lat: 55.67938, lon: 12.53463, hasResults: False
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protocolSection identificationModule nctId: NCT06337773, orgStudyIdInfo id: B-BR-112-036, briefTitle: Developing the Precision Nursing Education Program to Young Colorectal Cancer Survivors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2026-12-25, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Fooyin University, class: OTHER, descriptionModule briefSummary: This study is aimed to demonstrate the long-term effectiveness of 8-week precision nursing education program through the e-flipped classroom model for YCC survivors and provide a compliant strategy to improve quality of life and emotional status of these patients., conditionsModule conditions: Depression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 110, type: ESTIMATED, armsInterventionsModule interventions name: 8-weeks's on-line precision nursing education program, outcomesModule primaryOutcomes measure: The depression symptoms on young colorectal cancer survivors, secondaryOutcomes measure: Dispositional mindfulness status on young colorectal cancer survivors, secondaryOutcomes measure: General quality of life on young colorectal cancer survivors, secondaryOutcomes measure: Colorectal specific quality of life on young colorectal cancer survivors, secondaryOutcomes measure: Cancer threat appraisal on young colorectal cancer survivors, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06337760, orgStudyIdInfo id: IEO 1669, briefTitle: YOUNg Adults With Gastro-inteSTinal (GI) and nEuroendocrine canceRs., acronym: YOUNGSTER, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-10, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-06-30, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: The objective of the study is to create a common and unique platform for the acquisition of biological samples and, subsequently, the possible identification of predictive and prognostic biomarkers for young adults with gastrointestinal and neuroendocrine cancers.The definition "adolescent and young adults (AYA)" covers a broad group of patients ranging from the upper limit of the paediatric competence to the youngest patients usually considered and treated as adults. However, a well-defined and universally accepted age range is still not established. Young adults with cancer have distinct epidemiological, biological, and clinical characteristics, as well as special medical and psychosocial needs that are often unmet. In consideration of their poor representation in clinical studies, as well as the rarer, albeit increasing, frequency at an epidemiological level, knowledge of the risk factors associated with cancers in young adults is very poor. It is therefore of fundamental importance to focus attention on this specific cohort of patients, in order to describe in ever more detail any specific biomolecular aspects, and make full use of the pharmacological resources currently available., conditionsModule conditions: Neuroendocrine Neoplasm, conditions: Adenocarcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: OTHER, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Numbers of partecipants with genetic alterations, secondaryOutcomes measure: Number of partecipants with survival outcomes, secondaryOutcomes measure: Number of partecipants toxicities, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 39 Years, stdAges: ADULT, contactsLocationsModule locations facility: European Institute of Oncology, status: RECRUITING, city: Milan, country: Italy, contacts name: Lorenzo Gervaso, MD, role: CONTACT, contacts name: Chiara Alessandra Cella, MD, role: SUB_INVESTIGATOR, contacts name: Luca Mazzarella, MD, role: SUB_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06337747, orgStudyIdInfo id: 04-2023-PLLA, briefTitle: Comparing Injections With Poly-L-Lactic Acid in the Temporal Fossa vs. Extended Temporal Fossa + Hairline, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-19, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Erevna Innovations Inc., class: OTHER, descriptionModule briefSummary: The use of poly-L-Lactic acid (PLLA) has demonstrated significant improvement in multiple facial and body regions. Its use in the temporal fossa is the ideal location to demonstrate its impact on neocollagenesis given its distinct anatomic boundaries. Furthermore, the fact that the lateral boundary of the temporal region can extend into the hairline allows for a graded effect to be measured. Therefore, this study aims to extend these findings by evaluating the efficacy and safety of two injection techniques for volumizing temporal hollows., conditionsModule conditions: Aging, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: A prospective, randomized-controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Traditional technique, interventions name: Experimental technique, outcomesModule primaryOutcomes measure: To access the efficacy of the tradition and experimental technique, secondaryOutcomes measure: To access the safety of the tradition and experimental technique, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Erevna Innovations Inc, status: RECRUITING, city: Montreal, state: Quebec, zip: H3R 3A1, country: Canada, contacts name: Andreas Nikolis, MD, role: CONTACT, phone: 514-488-0163, email: research@vicpark.com, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False
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protocolSection identificationModule nctId: NCT06337734, orgStudyIdInfo id: 2, briefTitle: An Artificial Intelligence-Assisted Digital Health Lifestyle Intervention for Adults With Hypertension, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-11-01, primaryCompletionDateStruct date: 2023-08-01, completionDateStruct date: 2023-08-01, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: University of California, San Diego, class: OTHER, descriptionModule briefSummary: This study evaluates the impact of a fully digital, autonomous, and artificial intelligence (AI)-driven lifestyle coaching program on managing blood pressure (BP) among adults diagnosed with hypertension. Participants received a BP monitor and a wearable activity tracker to facilitate data collection. This data, along with responses from a questionnaire mobile app, were analyzed by an automated analytics engine employing statistical and machine learning techniques. The program delivered tailored lifestyle coaching directly to participants through a mobile app, aiming for precise and effective BP management., conditionsModule conditions: Hypertension, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 141, type: ACTUAL, armsInterventionsModule interventions name: AI-Driven Lifestyle Coaching Program, outcomesModule primaryOutcomes measure: Average change in systolic blood pressure (SBP) from baseline to 12 weeks, primaryOutcomes measure: Average change in diastolic blood pressure (DBP) from baseline to 12 weeks, primaryOutcomes measure: Average change in SBP from baseline to 24 weeks, primaryOutcomes measure: Average change in DBP from baseline to 24 weeks, primaryOutcomes measure: Percent change of participants with controlled BP (SBP<130 and DBP<80) from baseline to 12 weeks, primaryOutcomes measure: Percent change of participants with controlled BP (SBP<130 and DBP<80) from baseline to 24 weeks, primaryOutcomes measure: Percent change of participants with Stage 2 Hypertension (SBP≥140 or DBP≥90) from baseline to 12 weeks, primaryOutcomes measure: Percent change of participants with Stage 2 Hypertension (SBP≥140 or DBP≥90) from baseline to 24 weeks, secondaryOutcomes measure: Average weekly percentage of active participants measuring their BP, secondaryOutcomes measure: Average weekly percentage of active participants syncing their wearable, secondaryOutcomes measure: Average weekly percentage of active participants answering the mobile app questionnaire, secondaryOutcomes measure: Number of manual clinician outreaches based on the escalation rules set for the study, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of California, San Diego, city: La Jolla, state: California, zip: 92093, country: United States, geoPoint lat: 32.84727, lon: -117.2742, hasResults: False
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protocolSection identificationModule nctId: NCT06337721, orgStudyIdInfo id: R01AA030786, type: NIH, link: https://reporter.nih.gov/quickSearch/R01AA030786, briefTitle: Preventing Alcohol Use Disorders and Alcohol-Related Harms in Pacific Islander Young Adults, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2028-05, completionDateStruct date: 2028-08, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: University of California, Riverside, class: OTHER, descriptionModule briefSummary: This study will: (1) refine and finalize the SPEAR intervention manual for preventing alcohol use disorders (AUD) and associated harms for Pacific Islander young adults; and (2) test SPEAR for efficacy by conducting a pretest-posttest randomized controlled trial (RCT)., conditionsModule conditions: Alcohol Use Disorder, conditions: Alcohol; Harmful Use, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Will conduct a randomized controlled trial of the SPEAR intervention vs. control group., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 240, type: ESTIMATED, armsInterventionsModule interventions name: SPEAR (Strategies for Pacific Empowerment and Alcohol Reduction), outcomesModule primaryOutcomes measure: Heavy Episodic Drinking (HED) Days, secondaryOutcomes measure: Alcohol Consumption, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: UC Riverside, city: Riverside, state: California, zip: 91784, country: United States, geoPoint lat: 33.95335, lon: -117.39616, hasResults: False
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protocolSection identificationModule nctId: NCT06337708, orgStudyIdInfo id: STUDY00017286, secondaryIdInfos id: R01HL168170, type: NIH, link: https://reporter.nih.gov/quickSearch/R01HL168170, briefTitle: Smart Walk: A Culturally Tailored Smartphone-Delivered Physical Activity Intervention for African American Women, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-19, primaryCompletionDateStruct date: 2027-03-31, completionDateStruct date: 2028-03-31, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Arizona State University, class: OTHER, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule briefSummary: The purpose of this study is to test a culturally tailored, smartphone-delivered intervention designed to increase physical activity and reduce risk for heart disease and type 2 diabetes among African American women., conditionsModule conditions: Physical Activity, conditions: Exercise, conditions: Heart Diseases, conditions: Diabetes Mellitus, conditions: Physical Inactivity, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 240, type: ESTIMATED, armsInterventionsModule interventions name: Smart Walk, interventions name: Fitbit, outcomesModule primaryOutcomes measure: Change in accelerometer-measured moderate-to-vigorous intensity physical activity from baseline to 4- and 12-months, primaryOutcomes measure: Change in self-reported moderate-to-vigorous intensity physical activity from baseline to 4- and 12-months, secondaryOutcomes measure: Change in cardiorespiratory fitness from baseline to 4- and 12-months, secondaryOutcomes measure: Change in aortic pulse wave velocity from baseline to 4- and 12-months, secondaryOutcomes measure: Change in body weight from baseline to 4- and 12-months., secondaryOutcomes measure: Change in body mass index from baseline to 4- and 12-months, secondaryOutcomes measure: Change in waste circumference from baseline to 4- and 12-months, secondaryOutcomes measure: Change in blood pressure (mmHG) from baseline to 4- and 12-months, secondaryOutcomes measure: Change in tumor necrosis factor-alpha (TNF-α) from baseline to 4- and 12-months, secondaryOutcomes measure: Change in interleukin 6 (IL-6) from baseline to 4- and 12-months, secondaryOutcomes measure: Change in interleukin 10 (IL-10) from baseline to 4- and 12-months, secondaryOutcomes measure: Change in interleukin 15 (IL-15) from baseline to 4- and 12-months, secondaryOutcomes measure: Change in fasting blood glucose glucose from baseline to 4- and 12-months, secondaryOutcomes measure: Change in serum insulin from baseline to 4- and 12-months, secondaryOutcomes measure: Change in serum lipids (mg/DL) from baseline to 4- and 12-months, secondaryOutcomes measure: Change in insulin sensitivity (µIU/mL) from baseline to 4- and 12-months, secondaryOutcomes measure: Change in exercise self-efficacy from baseline to 4- and 12-months, secondaryOutcomes measure: Change in self-regulation for physical activity from baseline to 4- and 12-months, secondaryOutcomes measure: Change in social support for physical activity from baseline to 4- and 12-months, secondaryOutcomes measure: Change in outcome expectations for physical activity from baseline to 4- and 12-months, secondaryOutcomes measure: Change in behavioral capability for physical activity from baseline to 4- and 12-months, otherOutcomes measure: Treatment acceptance, otherOutcomes measure: Protocol Adherence, otherOutcomes measure: Program costs, otherOutcomes measure: Participant costs, otherOutcomes measure: Cost-effectiveness, otherOutcomes measure: Objectively-measured home neighborhood characteristics, otherOutcomes measure: Subjectively-measured Neighborhood environment walkability, otherOutcomes measure: Race-related Stress, otherOutcomes measure: Perceived Structural Racism, eligibilityModule sex: FEMALE, minimumAge: 24 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Arizona State University, status: RECRUITING, city: Phoenix, state: Arizona, zip: 85004, country: United States, contacts name: Carina Platte, PhD, role: CONTACT, phone: 602-543-2213, email: carina.platte@asu.edu, contacts name: Rodney Joseph, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.44838, lon: -112.07404, hasResults: False
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protocolSection identificationModule nctId: NCT06337695, orgStudyIdInfo id: HREBA.CC-23-0271, briefTitle: VERIFY: Vedolizumab for the Prevention of Immune Checkpoint Inhibitor Related Diarrhea or Colitis in Patients With Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2026-11-01, completionDateStruct date: 2026-12-01, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: University of Calgary, class: OTHER, descriptionModule briefSummary: The purpose of this study is to assess the prevention of immune checkpoint inhibitors (ICIs) related diarrhea/colitis using vedolizumab in participants with unresectable stage III or metastatic stage IV cancer, starting standard of care (SOC) immunotherapy, conditionsModule conditions: Cancer, conditions: Cancer Metastatic, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A Randomized, Double-Blinded, Placebo Controlled Trial, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 298, type: ESTIMATED, armsInterventionsModule interventions name: Vedolizumab, interventions name: Placebo, outcomesModule primaryOutcomes measure: Hazard Ratio of Patients achieving ICI-related diarrhea and colitis-free survival a 6-months, secondaryOutcomes measure: Proportion of patients with histologically confirmed colitis-free survival at 6 months, secondaryOutcomes measure: Proportion of patients with severe diarrhea or colitis at 6 months, secondaryOutcomes measure: Hazard Ratio of patients with diarrhea or colitis after 6 months, secondaryOutcomes measure: Total average dose of checkpoint inhibitor therapy received within 6 and 12 months, secondaryOutcomes measure: Proportion of participants who require temporary ICI discontinuation due to immune-related adverse events (irAEs), secondaryOutcomes measure: Proportion of participants who require permanent ICI discontinuation due to irAEs, secondaryOutcomes measure: Proportion of patients requiring rescue corticosteroids for ICI related diarrhea/colitis, secondaryOutcomes measure: Total average prednisone equivalent dose of rescue corticosteroids required, secondaryOutcomes measure: Proportion of participants requiring all-cause hospitalization by Day +180 and Day +365, secondaryOutcomes measure: Proportion of participants requiring ICI-related diarrhea/colitis-specific hospitalization by Day +180 and Day +365, secondaryOutcomes measure: Mean change in the EuroQol EQ-5D instrument at Day +180 and Day +365 compared to baseline, secondaryOutcomes measure: Overall survival (measured as death) at +180 and Day +365 compared to baseline, secondaryOutcomes measure: Progression-free survival at 6- and 12-months, defined using the Response Evaluation Criteria in Solid Tumors (RECIST), v1.176, secondaryOutcomes measure: Proportion of participants experiencing any adverse events (AEs), secondaryOutcomes measure: Proportion of participants experiencing serious AEs, secondaryOutcomes measure: Proportion of participants experiencing other irAEs, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06337682, orgStudyIdInfo id: CB_CY_P09_23_11, briefTitle: Blood Pressure Management in the Care Home Population, acronym: BPITCH, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2016-01, primaryCompletionDateStruct date: 2020-01, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: University of Leeds, class: OTHER, collaborators name: Bradford Teaching Hospitals NHS Foundation Trust, descriptionModule briefSummary: The UK care home population is projected to increase significantly over the coming decades. A high proportion of individuals in a care home have multiple long-term conditions and take large amounts of prescribed medication. This means they are routinely excluded from research studies and so there is little evidence on which to base treatment of long-term conditions such as high blood pressure. Furthermore, given that 1 in 4 people admitted into a care home die within 1 year, the benefit of treating high blood pressure to reduce the risk of heart attack or stroke must be balanced with the need to optimise quality of life. The aim of this study is to describe the health and social characteristics of the UK care home population with a particular focus on the management of blood pressure in the population. It is hoped that the findings of this study will help inform future research into the management of chronic conditions in care home residents., conditionsModule conditions: Aging, conditions: Hypertension, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 3000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Frequency of blood pressure measurements, primaryOutcomes measure: change in antihypertensive medication, primaryOutcomes measure: Injurious falls, secondaryOutcomes measure: Prevalence of hypertension, secondaryOutcomes measure: Antihypertensive medication, secondaryOutcomes measure: Blood pressure treatment, otherOutcomes measure: change in systolic pressure following care home admission, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Academic Unit for Ageing and Stroke Research, city: Bradford, state: West Yorkshire, zip: BD9 6RJ, country: United Kingdom, geoPoint lat: 53.79391, lon: -1.75206, hasResults: False
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protocolSection identificationModule nctId: NCT06337669, orgStudyIdInfo id: OSRSCP-GUP21006, briefTitle: Characterization of DupEx2 Duchenne Muscular Dystrophy, acronym: DMDDup2, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-01-31, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: IRCCS San Raffaele, class: OTHER, descriptionModule briefSummary: To characterize the clinical phenotype and possible predictive/prognostic factors of patients with Duchenne muscular dystrophy (DMD) due to duplication of exon 2 (Dup2). Specifically, we aim 1) to describe the progression of motor, respiratory and cardiac function; 2) to enquire if the phenotypic spectrum of Dup2 is milder than classic DMD, 3) to perform whole genome sequencing (WGS) to characterize DNA breakpoints to correlate with the phenotype; 4) to collect material for future proteomic/transcriptomic studies.Background/Rationale DMD is caused by mutations in the DMD gene and in 11% of cases is due to duplications. The most promising therapeutic approaches include mutation-specific therapies. Notably, there is increasing evidence that specific groups of mutations may underlie different disease trajectories compared to the "average" DMD population. It is thus mandatory to have more information on genotype-phenotype correlations and patterns of progression related to different genotypes.Dup2 is the most common DMD duplication and the only one for which a AAV-mediated exon skipping study is ongoing. Despite most case series and databases ascribe Dup2 to severe phenotype, our preliminary findings sustain that these patients have collectively a milder progression of the disease and in 1/3 of cases a significantly milder phenotype. Moreover, our attempts to reveal mechanism involved in attenuating the phenotype would confute the hypothesis of alternative spicing transcripts as previously described for DMD with deletion of exon 2.Research design and methods Clinical information regarding a cohort of 26 Italian Dup2 patients will be collected. Differences in time to loss of ambulation compared to a DMD control group will be achieved. Finally, we will retrieve DNA for correlative WGS studies.Anticipated output We expect that Dup2 patients present a milder DMD phenotype, which might be predicted by genomic studies., conditionsModule conditions: Muscular Dystrophy, Duchenne, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 26, type: ESTIMATED, outcomesModule primaryOutcomes measure: Age at loss of ambulation, secondaryOutcomes measure: Time test for motor function, secondaryOutcomes measure: Respiratory function, eligibilityModule sex: MALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dept. of Neurology, IRCCS Ospedale San Raffaele, status: RECRUITING, city: Milano, zip: 20132, country: Italy, contacts name: Stefano C Previtali, MD, role: CONTACT, phone: 00390226433036, email: neuromuscolare@hsr.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06337656, orgStudyIdInfo id: VITAL_0, briefTitle: Vibration Training Approach in Liver Cirrhosis, acronym: VITAL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-10-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: University Hospital of Cologne, class: OTHER, descriptionModule briefSummary: * Comprehensive Investigation of the Impact of Side-Alternating Whole-Body Vibration Training on Muscle Mass and Muscle Strength in Patients with Liver Cirrhosis and Sarcopenia* Simultaneous Characterization and Evaluation of Dynamic Changes in Health-Related Quality of Life in our Patient Cohort with Liver Cirrhosis and Sarcopenia through Side-Alternating Whole-Body Vibration Training., conditionsModule conditions: Liver Cirrhosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Galileo WBV, outcomesModule primaryOutcomes measure: Evaluation of the Effectiveness on muscle strength, primaryOutcomes measure: Evaluation of the Effectiveness on muscle strength, primaryOutcomes measure: Evaluation of the Effectiveness on muscle strength, primaryOutcomes measure: Evaluation of the Effectiveness on muscle strength, primaryOutcomes measure: Evaluation of the Effectiveness on muscle mass, primaryOutcomes measure: Evaluation of the Effectiveness on muscle thickness, primaryOutcomes measure: Evaluation of the Effectiveness on mobility, in particular the risk of falling, primaryOutcomes measure: Evaluation of the Effectiveness on physical function, secondaryOutcomes measure: Evaluation of Safety of the Training Method, secondaryOutcomes measure: Health-Related Quality of Life, secondaryOutcomes measure: Health-Related Quality of Life, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06337643, orgStudyIdInfo id: MVX01-01, briefTitle: A Study to Evaluate Tolerability, Safety and Immunogenicity of MVX01 Pneumococcal Vaccine, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-03-07, primaryCompletionDateStruct date: 2024-04-16, completionDateStruct date: 2024-04-16, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Matrivax Research and Development Corporation, class: INDUSTRY, descriptionModule briefSummary: The objectives of this first-in-human study is to evaluate the tolerability, safety, and immunogenicity of MVX01, a pneumococcal vaccine candidate, at four dose levels., conditionsModule conditions: Pneumococcal Vaccine, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, maskingDescription: Cohort 1 is open-label. Cohorts 2-5 include two open-label sentinel participants each and the remainder of the participants are randomized and double-blind to either MVX01 or MVX01 Placebo (Participant \& Site)., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: MVX01, interventions name: MVX01 Placebo, outcomesModule primaryOutcomes measure: Incidence of immediate reactogenicity adverse events, primaryOutcomes measure: Incidence of solicited reactogenicity events, primaryOutcomes measure: Incidence of adverse events (AEs), primaryOutcomes measure: Incidence of Serious Adverse Events (SAEs) and New-Onset Chronic Illness (NOCI), primaryOutcomes measure: Changes in safety laboratory results compared to baseline, primaryOutcomes measure: Changes in vital signs compared to baseline, primaryOutcomes measure: Geometric Mean Titer (GMT) post immunization of Anti-pneumolysin (PLY) and anti-choline binding protein A (CbpA), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Velocity (Meridian) Clinical Research, city: Savannah, state: Georgia, zip: 31406, country: United States, geoPoint lat: 32.08354, lon: -81.09983, locations facility: Alliance for Multispecialty Research (AMR), city: Knoxville, state: Tennessee, zip: 37909, country: United States, geoPoint lat: 35.96064, lon: -83.92074, hasResults: False
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protocolSection identificationModule nctId: NCT06337630, orgStudyIdInfo id: IC 2022-10, briefTitle: A Study on Tuvusertib (Oral ATR Inhibitor) in Combination With PLX038 (Topo1 Inhibitor) in Patients With Advanced Solid Tumors, acronym: POP-ART, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-15, primaryCompletionDateStruct date: 2025-06-15, completionDateStruct date: 2029-02-15, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Institut Curie, class: OTHER, collaborators name: ProLynx LLC, collaborators name: Merck Sharp & Dohme LLC, descriptionModule briefSummary: Phase I with a dose finding cohort, followed by expansion cohorts in pre-specified tumor types., conditionsModule conditions: Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Phase I with a dose finding cohort, followed by expansion cohorts in pre-specified tumor types., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 92, type: ESTIMATED, armsInterventionsModule interventions name: PLX038 + Tuvusertib, outcomesModule primaryOutcomes measure: Dose escalation step : Dose limiting toxicities (DLTs), primaryOutcomes measure: Expansion cohorts : Best tumor response, primaryOutcomes measure: Expansion cohorts : Serious Adverse Events (SAEs), primaryOutcomes measure: Expansion cohorts : Adverse Events (AEs), secondaryOutcomes measure: Dose escalation step : Pharmacokinetics effect of PLX038 and Tuvusertib, secondaryOutcomes measure: Dose escalation step : Pharmacodynamics effect of PLX038 and Tuvusertib, secondaryOutcomes measure: Dose escalation step : objective response rate (ORR), secondaryOutcomes measure: Dose escalation step : Time to response (TTR), secondaryOutcomes measure: Dose escalation step : Duration of Response (DoR), secondaryOutcomes measure: Dose escalation step : Progression free survival (PFS), secondaryOutcomes measure: Expansion cohorts : Time to response (TTR), secondaryOutcomes measure: Expansion cohorts : Duration of Response (DoR), secondaryOutcomes measure: Expansion cohorts : Progression free survival (PFS), secondaryOutcomes measure: Expansion cohorts : Overall Survival (OS), secondaryOutcomes measure: Expansion cohorts : Efficacy of PLX038 + Tuvusertib in pre-defined biomarker subgroups, secondaryOutcomes measure: Expansion cohorts : Pharmacokinetics effect of PLX038 and Tuvusertib, secondaryOutcomes measure: Expansion cohorts : Pharmacodynamics effect of PLX038 and Tuvusertib, secondaryOutcomes measure: Exploratory endpoints, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institut Curie, city: Paris, zip: 75005, country: France, contacts name: François-Clément BIDARD, role: CONTACT, email: francois-clement.bidard@curie.fr, contacts name: François-Clément BIDARD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Institut Curie, city: Saint-Cloud, zip: 92210, country: France, contacts name: François-Clément BIDARD, role: CONTACT, email: francois-clement.bidard@curie.fr, contacts name: François-Clément BIDARD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.84598, lon: 2.20289, hasResults: False
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protocolSection identificationModule nctId: NCT06337617, orgStudyIdInfo id: CDRB436B2407, briefTitle: A Multi-center Retrospective Study With Secondary Use of Data of Tafinlar (Dabrafenib) Plus Mekinist (Trametinib) in Chinese Patients With BRAF V600 Mutation Positive Melanoma, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-05-10, primaryCompletionDateStruct date: 2023-06-29, completionDateStruct date: 2023-06-29, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Novartis Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: This was a multi-center, observational, retrospective cohort study to evaluate the effectiveness and safety of dabrafenib in combination with trametinib in Chinese patients with unresectable or metastatic BRAF V600 mutation positive melanoma, for mucosal melanoma patients (Cohort A) and non-mucosal melanoma patients (Cohort B, cutaneous and acral melanoma), separately. Study population was identified as patients initiating dabrafenib plus trametinib from 01 May 2020 to 31 July 2022 who fulfilled the inclusion/exclusion criteria. The follow-up period ended at the earliest of the following: end of study observation period (i.e., 31 December 2022), death, upon withdrawal of consent or the last available record., conditionsModule conditions: BRAF V600 Mutation Positive Melanoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 90, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Real-world overall response rate (rwORR), secondaryOutcomes measure: Mean Age, secondaryOutcomes measure: Percentage of patients per sex, secondaryOutcomes measure: Number of years of disease history at treatment initiation since initial melanoma diagnosis, secondaryOutcomes measure: Number and percentage of patients per anatomic sites of origin, secondaryOutcomes measure: Number of years of disease history at treatment initiation since unresectable or metastatic melanoma diagnosis, secondaryOutcomes measure: Number and percentage of patients per tumor stage, secondaryOutcomes measure: Number and percentage of patients with occurrence of tumor metastasis, secondaryOutcomes measure: Number and percentage of patients per metastatic location, secondaryOutcomes measure: Number and percentage of patients per metastases, secondaryOutcomes measure: Lactate dehydrogenase (LDH) levels, secondaryOutcomes measure: Eastern Cooperative Oncology Group (ECOG) performance status, secondaryOutcomes measure: Number and percentage of patients who had at least one surgery for melanoma prior to D+T treatment, secondaryOutcomes measure: Number and percentage of patients per type of surgery, secondaryOutcomes measure: Number and percentage of patients per name of surgery, secondaryOutcomes measure: Number and percentage of patients per surgical and medical procedure, secondaryOutcomes measure: Number and percentage of patients who had at least one anti-neoplastic drug for melanoma prior to D+T treatment, secondaryOutcomes measure: Number and percentage of patients with prior anti-neoplastic drugs for melanoma per treatment intent, secondaryOutcomes measure: Number and percentage of patients with prior anti-neoplastic drug for melanoma per treatment setting, secondaryOutcomes measure: Number and percentage of patients with prior anti-neoplastic drug for melanoma per line of treatment, secondaryOutcomes measure: Number and percentage of patients with prior anti-neoplastic drug for melanoma per treatment type, secondaryOutcomes measure: Number and percentage of patients per reason for immunotherapy discontinuation, secondaryOutcomes measure: Number and percentage of patients with prior anti-neoplastic drug for melanoma with best overall tumor response, secondaryOutcomes measure: Number and percentage of patients per prior anti-neoplastic drug for melanoma, secondaryOutcomes measure: Number and percentage of patients who had at least one radiotherapy for melanoma prior to D+T treatment, secondaryOutcomes measure: Number and percentage of patients with prior radiotherapy for melanoma per treatment intent, secondaryOutcomes measure: Number and percentage of patients with prior radiotherapy for melanoma per treatment setting, secondaryOutcomes measure: Number and percentage of patients per radiation site, secondaryOutcomes measure: Mean total dosage for all radiotherapy, secondaryOutcomes measure: Number and percentage of patients with prior radiotherapy for melanoma with best overall tumor response, secondaryOutcomes measure: Number and percentage of patients with dabrafenib plus trametinib treatment per line of treatment, secondaryOutcomes measure: Number and percentage of patients with dabrafenib plus trametinib treatment per treatment intent, secondaryOutcomes measure: Number and percentage of patients with dabrafenib plus trametinib treatment per treatment setting, secondaryOutcomes measure: Number and percentage of patients per type of D+T treatment change, secondaryOutcomes measure: Number and percentage of patients per reason for D+T treatment change, secondaryOutcomes measure: Mean duration of D+T, if not ongoing to end of study follow-up, secondaryOutcomes measure: rwORR of dabrafenib plus trametinib among non-mucosal melanoma patients (FAS), secondaryOutcomes measure: Real-world disease control rate (rwDCR) of D+T (FAS), secondaryOutcomes measure: Real-world duration of response (rwDOR) of dabrafenib plus trametinib, secondaryOutcomes measure: Real-world progression-free survival (rwPFS) for dabrafenib plus trametinib (FAS), secondaryOutcomes measure: Real-world overall survival (rwOS) since D+T initiation (FAS), secondaryOutcomes measure: Time to treatment discontinuation (FAS), secondaryOutcomes measure: Number and percentage of patients with adverse events of special interest (AESIs) (FAS), secondaryOutcomes measure: Number and percentage of patients with serious adverse events (SAEs) (FAS), secondaryOutcomes measure: rwPFS for dabrafenib plus trametinib (MMS), by immunotherapy use, secondaryOutcomes measure: rwPFS for dabrafenib plus trametinib (NMS), by immunotherapy use, secondaryOutcomes measure: rwOS since D+T initiation (MMS), by immunotherapy use, secondaryOutcomes measure: rwOS since D+T initiation (NMS), by immunotherapy use, secondaryOutcomes measure: Number and percentage of patients with systemic anti-neoplastic treatment after D+T, secondaryOutcomes measure: Number and percentage of patients with systemic anti-neoplastic treatment after D+T per line of treatment, secondaryOutcomes measure: Number and percentage of patients with systemic anti-neoplastic treatment after D+T and treatment ongoing at end of follow up, secondaryOutcomes measure: Number and percentage of patients with systemic anti-neoplastic treatment after D+T per treatment type, secondaryOutcomes measure: Number and percentage of patients per reason for immunotherapy discontinuation, secondaryOutcomes measure: Number and percentage of patients with systemic anti-neoplastic treatment after D+T with best overall tumor response, secondaryOutcomes measure: Number and percentage of patients who had systemic anti-neoplastic treatment after D+T treatment, secondaryOutcomes measure: Number and percentage of patients who had systemic anti-neoplastic treatment after D+T treatment per medication, secondaryOutcomes measure: Number and percentage of patients per concomitant medication, secondaryOutcomes measure: Real-world overall survival since the first anti-neoplastic drug treatment for advanced/metastatic melanoma (FAS), secondaryOutcomes measure: Real-world overall survival since the first anti-neoplastic drug for advanced/metastatic melanoma (NMS), by immunotherapy use, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Novartis, city: Shanghai, zip: 201203, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06337604, orgStudyIdInfo id: TNP-2092-04, briefTitle: The Safety and Tolerability, Pharmacokinetics of TNP-2092 Capsules in Combination With Rabeprazole Sodium Enteric-coated Tablets, statusModule overallStatus: COMPLETED, startDateStruct date: 2017-10-10, primaryCompletionDateStruct date: 2017-11-23, completionDateStruct date: 2017-11-23, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: TenNor Therapeutics Inc., class: INDUSTRY, descriptionModule briefSummary: A phase 1, single-center, double-blind, randomized, placebo-controlled clinical trial to evaluate the safety and tolerability, pharmacokinetics, and preliminary efficacy of multiple administrations of TNP-2092 Capsules in combination with Rabeprazole Sodium Enteric-coated Tablets in asymptomatic healthy subjects with Helicobacter pylori infection, conditionsModule conditions: Helicobacter Pylori Infection, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 20, type: ACTUAL, armsInterventionsModule interventions name: TNP-2092 capsules, interventions name: TNP-2092 capsules placebo, interventions name: Rabeprazole sodium enteric-coated tablets, outcomesModule primaryOutcomes measure: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf), primaryOutcomes measure: Area Under the Plasma Concentration Versus Time Curve from 0 to the Last Measurable Concentration (AUC0-t), primaryOutcomes measure: Maximum Observed Plasma Concentration (Cmax) of TNP-2092, primaryOutcomes measure: Percentage of Participants With Adverse Events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: The First Hospital of Jilin University, city: Changchun, state: Jilin, country: China, geoPoint lat: 43.88, lon: 125.32278, hasResults: False
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protocolSection identificationModule nctId: NCT06337591, orgStudyIdInfo id: INRCA_003_2024, briefTitle: Diagnostic Performance of the Vesical Imaging-Reporting and Data System (VI-RADS) in Detecting Muscle-invasive Bladder Tumour (MIBC) in Clinical Practice: Comparison With Transurethral Resection of Bladder Cancer (TURB) and Evaluation of Diagnostic Accuracy According to Tumour Location, acronym: VI-RADS, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-10-15, primaryCompletionDateStruct date: 2024-03-10, completionDateStruct date: 2024-03-10, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Istituto Nazionale di Ricovero e Cura per Anziani, class: OTHER, descriptionModule briefSummary: VI-RADS was an observational, prospective, multicenter, no profit study. The aim of the study was to clarify the clinical validity of the Vesical Imaging-Reporting and Data System (VI-RADS) for the assessment of muscle invasion (MI) status in comparison with transurethral resection of bladder cancer (TURB) and to evaluate the diagnostic accuracy of the score according to the specific tumour location., conditionsModule conditions: Bladder Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ACTUAL, armsInterventionsModule interventions name: VI-RADS, outcomesModule primaryOutcomes measure: Sensitivity of Vescical Imaging-Reporting and Data System (VI-RADS) in predicting muscle-invasive bladder cancer after transurethral resection, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: AOU Hospital, city: Ancona, country: Italy, geoPoint lat: 43.5942, lon: 13.50337, locations facility: IRCCS INRCA Hospital, city: Ancona, country: Italy, geoPoint lat: 43.5942, lon: 13.50337, locations facility: Carlo Urbani Hospital, city: Jesi, country: Italy, geoPoint lat: 43.52142, lon: 13.24368, hasResults: False
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protocolSection identificationModule nctId: NCT06337578, orgStudyIdInfo id: 23C308, briefTitle: Advances in Telephone-based Cognitive Screening Procedures, acronym: TBCS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-25, primaryCompletionDateStruct date: 2026-10-25, completionDateStruct date: 2026-10-25, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: 1. Background Cognitive screening procedures via performance-based tests represent an essential, albeit preliminary, element within the diagnostic and interventional process as addressed to patients with chronic neurological disorders. Furthermore, in these populations, cognitive screening measures are often employed as outcomes in epidemiological settings, as well as endpoints in clinical trials. Therefore, cognitive screeners need to possess robust clinimetric and clinical usability properties - the investigation of which must be country-specific (i.e., specific to each language and culture). The need for such clinimetric and feasibility studies is even more true if referred to telephone-based cognitive screening (TBCS) procedures - which, until recently, have been mostly neglected in Italy, despite having the potential to bring clear benefits to clinical practice and research. In fact, TBCS techniques allow, through the use of a very widespread, accessible and easy-to-use telecommunication medium, to break down the geographical, logistical, socio-demographic and organizational barriers that make it difficult and/or prevent 1) access to these clinical services and 2) the continuity of their provision, as well as the creation and completion of 3) large-scale epidemiological studies and 4) decentralized clinical trials. However, although some TBCS tests have recently been developed and standardized in Italy, their clinimetric properties and clinical usability in populations with chronic neurological disorders have not yet been investigated. Furthermore, currently, the "paper-and-pencil" version of the international gold-standard for TBCS procedures . i.e. the Telephone Interview For Cognitive Status (TICS), which has been recently standardized in this country - is not available within the Italian scenario. In fact, although the feasibility of a de visu version of the TICS (i.e., In-Person TICS; IP-TICS) has been demonstrated in this country, an actual standardization of this test has not yet been implemented to date. Such a tool would, however, allow flexible use of screening assessments, regardless of the delivery method, both in clinical and experimental contexts.2. Aims The present study primarily aims to provide exhaustive evidence regarding the psychometric, diagnostic and both cross-sectional and longitudinal clinical usability of TBCS that are currently available within the Italian scenario in populations with chronic neurological disorders. Secondly, this study aims to derive, in normotypical Italian subjects, 1) normative data for the IP-TICS and 2) the conversion algorithms between the latter (and other widely used "paper-and-pencil" screeners ) and the TICS.3. MethodsThe study is monocentric, observational, prospective. Over a period of 3 years, patients who have already undergone an in-person cognitive screening session within 6 months prior to recruitment and falling under the following diagnostic categories will be recruited: 1) amyotrophic lateral sclerosis (N≥88); 2) Alzheimer's disease (N≥66); 3) Lewy body dementia (N≥30); 4) frontotemporal dementia (N≥30); 5) chronic cerebrovascular disorders (N≥66). Furthermore, N≥287 normotypical subjects representative of the Italian population will be recruited. The following TBCS tests will be administered to patients: 1) TICS; 2) Telephone-based Frontal Assessment Battery; 3) Telephone Language Screener; 4) Telephone-based Verbal Fluency Battery; 5) ALS Cognitive Behavioral Screen-Phone Version. Additionally, patients will undergo a functional evaluation using caregiver-report questionnaires evaluating instrumental and non-instrumental skills of daily living and behavioral changes. Normal subjects will instead be administered: 1) TICS; 2) IP-TICS; 3) Mini-Mental State Examination (MMSE); 4) Montreal Cognitive Assessment (MoCA). In patients, telephone follow-ups are expected after 6, 12 and 18 months. Statistical analyses will be carried out aimed at 1) the detailed study, in patients, of the psychometrics, diagnostics and cross-sectional/longitudinal clinical usability of the aforementioned TBCS test, as well as at 2) the derivation, in normotypical subjects, of the normative data of the IP-TICS and MoCA Memory Index Score (MIS), as well as the conversion algorithms between TICS and IP-TICS/MMSE/MoCA., conditionsModule conditions: Amyotrophic Lateral Sclerosis, conditions: Alzheimer's Disease, conditions: Lewy Body Dementia, conditions: Frontotemporal Degeneration, conditions: Cerebrovascular Disorders, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 280, type: ESTIMATED, armsInterventionsModule interventions name: Telephone-based neuropsychological assessment - ALS, interventions name: Telephone-based neuropsychological assessment - AD, LBD, FTD and CVD, interventions name: Telephone-based and in-person cognitive screening - NIs, outcomesModule primaryOutcomes measure: ALS Cognitive Behavioral Screen-Phone Version in ALS patients, primaryOutcomes measure: Telephone Interview for Cognitive Status in AD, LBD, FTD and CVD patients, primaryOutcomes measure: Telephone-based Frontal Assessment Battery in ALS, AD, LBD, FTD and CVD patients, primaryOutcomes measure: Telephone Language Screener in ALS, AD, LBD, FTD and CVD patients, primaryOutcomes measure: Telephone-based Verbal Fluency Battery in ALS, AD, LBD, FTD and CVD patients, primaryOutcomes measure: Mini-Mental State Examination in NI, primaryOutcomes measure: Montreal Cognitive Assessment in NI, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto Auxologico Italiano, status: RECRUITING, city: Milano, zip: 20149, country: Italy, contacts name: Barbara Poletti, Ph.D., role: CONTACT, phone: +390261911, phoneExt: 2609, email: b.poletti@auxologico.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06337565, orgStudyIdInfo id: GIS-DUMBO 2-2024, briefTitle: Safety of IBD Drugs During Pregnancy and Breasfeeding: Mothers and Babies' Outcomes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-20, primaryCompletionDateStruct date: 2030-05-20, completionDateStruct date: 2030-05-20, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, class: OTHER, descriptionModule briefSummary: This is an observational study where pregnant women treated with non-anti-TNF agents or targeted small molecules approved for IBD treatment will be included. Although it is a multicentre, nationwide study, the number of patients to be included is expected to be relatively low (in DUMBO 1, during 5 years of recruitment, 88 patients treated with ustekimunab, 34 treated with vedolizumab, and 2 exposed to tofacitinib were included); however, this registry involved over 60 Spanish centres and it is a paramount study providing with data on the safety of drugs during pregnancy, as patients with this condition are excluded from clinical trials. In this regard, no sample size estimation was made, as we plan to include all patients who meet the inclusion criteria and consent their enrolment., conditionsModule conditions: Drusgs for IBD, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, outcomesModule primaryOutcomes measure: To assess the safety of new drugs (non-anti-TNF biologics and targeted small molecules) used for IBD treatment both for pregnancy and in offspring, mainly focused on the risk of serious infections (from birth and in the first 4 years of life)., secondaryOutcomes measure: To know the risk of serious adverse events (including abortions) during pregnancy and delivery associated with new drugs used for the treatment of IBD., secondaryOutcomes measure: To assess the developmental status of children born from IBD mothers treated with new drugs during the first 4 years of life., secondaryOutcomes measure: To compare the relative risk of serious adverse events in children born from mothers with IBD who have been exposed in utero to different new drugs to treat IBD with that of children who were not exposed to these agents., secondaryOutcomes measure: To compare the prevalence of malformations in children exposed to new drugs to treat IBD in utero with that of children who were not exposed to these agents., secondaryOutcomes measure: To evaluate the relative risk of developing neoplasm in children exposed to new drugs to treat IBD., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Universitario de La Princesa, city: Madrid, zip: 28006, country: Spain, contacts name: Javier P. Gisbert, PhD, MD, role: CONTACT, phone: 913093911, email: javier.p.gisbert@gmail.com, contacts name: María G Donday, PhD, role: CONTACT, phone: 913093911, email: mariagdonday@gmail.com, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False
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protocolSection identificationModule nctId: NCT06337552, orgStudyIdInfo id: MCC-22709, briefTitle: High-Fermented Food Intervention Among Locally Advanced Rectal Cancer Patients (The FEED Trial), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: H. Lee Moffitt Cancer Center and Research Institute, class: OTHER, descriptionModule briefSummary: The purpose of the study is to evaluate the feasibility and acceptability of a dietary intervention (FEED-FF) that includes fermented foods (FF), among locally advanced rectal cancer patients, and to explore whether this diet can improve outcomes in rectal cancer patients receiving chemoradiotherapy (CRT)., conditionsModule conditions: Rectal Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomized to either the FEED-FF Arm or the Standard of Care (SUC) Arm, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: Clincial response will be determined in clinic when patients undergo blinded tumor assessments by standard digital rectal exam, endoscopy, and rectal MRI at baseline and at the end of the intervention., whoMasked: CARE_PROVIDER, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: FEED-FF, interventions name: Standard of Care (SUC), outcomesModule primaryOutcomes measure: Effects of the FEED-FF diet on clinical response to chemoradiation, primaryOutcomes measure: Effects of FEED-FF diet on the gut microbiome, primaryOutcomes measure: Effects of FEED-FF diet on local immune-related biomarkers, primaryOutcomes measure: Effects of FEED-FF diet on quality of life, primaryOutcomes measure: Efficacy of the FEED-FF intervention, primaryOutcomes measure: Feasibility of the FEED-FF intervention, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Moffitt Cancer Center, status: RECRUITING, city: Tampa, state: Florida, zip: 33612, country: United States, contacts name: Stephanie Hogue, role: CONTACT, phone: 813-745-1891, email: Stephanie.Hogue@moffitt.org, contacts name: Doratha (Armen) Byrd, MPH, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Sylvia Crowder, PhD, RDN, LDN, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 27.94752, lon: -82.45843, hasResults: False
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protocolSection identificationModule nctId: NCT06337539, orgStudyIdInfo id: PI-23-185, briefTitle: Precision Psychiatry for Depression: Immune Response and Affective Symptoms as Predictors of Response to Antidepressants, acronym: LYMPHODEP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-07-31, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Germans Trias i Pujol Hospital, class: OTHER, descriptionModule briefSummary: Objectives: To identify in patients with major depression different peripheral markers of neuroinflammation in relation to affective symptoms (anxiety, depression, irritability), fatigue and cognitive symptoms; and its relationship with the response to antidepressant treatment with selective serotonin reuptake inhibitors (SSRIs).Methodology: This is a prospective observational cohort study in patients with major depression naturally subjected to treatment with SSRIs. For this, 30 patients with major depression attended in the Outpatient Psychiatry Consultations will be selected. All of them will be evaluated at baseline and after 3 months of treatment, collecting demographic and clinical variables, Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) psychiatric diagnoses, psychopathological scales and immunological and biochemical variables. The correlation between immunological markers and affective and cognitive symptoms at baseline, as well as their variation with treatment, will be analyzed. A group of 20 healthy subjects will be used as a control group.Subsequently, a bivariate comparative analysis will be carried out, where the statistically significant or marginally significant variables associated with psychopathological variables will be used to build a multivariate binary logistic regression model., conditionsModule conditions: Depression, conditions: Inflammation, conditions: Antidepressants, conditions: Immunity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: SSRI, outcomesModule primaryOutcomes measure: Treatment Response, secondaryOutcomes measure: Lymphocyte subpopulations, secondaryOutcomes measure: Biochemical variables, secondaryOutcomes measure: Single-cell CITEseq, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Universitari Germans Trias i Pujol, city: Badalona, state: Catalonia, zip: 08916, country: Spain, geoPoint lat: 41.45004, lon: 2.24741, hasResults: False
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protocolSection identificationModule nctId: NCT06337526, orgStudyIdInfo id: IRB-71503, briefTitle: Predicting Pain Exacerbations in Children With Complex Regional Pain Syndrome (CRPS), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2026-03, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Stanford University, class: OTHER, collaborators name: Medeloop.ai, descriptionModule briefSummary: objectives: identify physiologic, dietary, and environment triggers of severe pain exacerbations in children with CRPS., conditionsModule conditions: Complex Regional Pain Syndromes, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Apple Watch v8, outcomesModule primaryOutcomes measure: Change from baseline in pain score, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Pediatric Pain Clinic, city: Stanford, state: California, zip: 94305, country: United States, geoPoint lat: 37.42411, lon: -122.16608, hasResults: False
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protocolSection identificationModule nctId: NCT06337513, orgStudyIdInfo id: S-20230055, briefTitle: Spondyloarthritis Inception Cohort of Southern Denmark, acronym: SPINCODE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2028-08, completionDateStruct date: 2028-08, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: The Danish Center for Expertise in Rheumatology, class: OTHER, descriptionModule briefSummary: People with axial spondyloarthritis (axSpA) experience a diagnostic delay of 6.5 years in men and up to 8.8 years in women. One of the reasons for the diagnostic delay seems to be limited awareness of the disease characteristics in the referring health care professionals in primary care. By raising awareness about the disease, the study aims at reducing the diagnostic delay and improving early treatment. In addition to diagnostic and pharmacological treatment, physical exercise and rehabilitation are recommended in people with axSpA. In Denmark, people with axSpA are only offered free of charge physiotherapy when the disease has progressed to a stage with radiographic changes of the spine even though people in the early stage of axSpA report a similar disease burden.The overall objective of Spondyloarthritis Inception Cohort of Southern Denmark (SPINCODE) is to set up an axSpA inception cohort among individuals with low back pain ≥ 3 months who are considered to be at risk for axSpA. The investigators aim to learn more about the course of axSpA during the early stage of disease appropriately assess outcomes, including novel imaging techniques and identify predictive outcomes. Moreover, the investigators want to test the effect of an outpatient physiotherapist-coordinated rehabilitation intervention in people suspected of having axSpA., conditionsModule conditions: Axial Spondyloarthritis, conditions: Back Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: In the rehabilitation feasibility study: pre-post design. In the rehabilitation RCT, participants are allocated to either the intervention or control group with standard care., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Blinding of the the health care professionals and patients is not possible in the rehabilitation intervention. The person analysing the data will be blinded to the group allocation., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Rehabilitation intervention, interventions name: Usual care, outcomesModule primaryOutcomes measure: Clinicians diagnosis of axSpA, primaryOutcomes measure: Health related quality of life, secondaryOutcomes measure: axSpA disease activity, secondaryOutcomes measure: axSpA disease mobility, secondaryOutcomes measure: axSpA patient-reported physical function, secondaryOutcomes measure: Inflammatory back pain (IBP) symptoms, secondaryOutcomes measure: Physical examination I, secondaryOutcomes measure: Physical examination II, secondaryOutcomes measure: Symptomatic SpA features I, secondaryOutcomes measure: Symptomatic SpA features II, secondaryOutcomes measure: Symptomatic SpA features III, secondaryOutcomes measure: Symptomatic SpA features IV, secondaryOutcomes measure: Symptomatic SpA features V, secondaryOutcomes measure: Symptomatic SpA features VI, secondaryOutcomes measure: Physicians global assessment of disease activity, secondaryOutcomes measure: Magnetic resonance imaging of sacroiliac joints (SIJ) and spine, secondaryOutcomes measure: low dose computed tomography of SIJ and spine, secondaryOutcomes measure: dual energy computed tomography of SIJ, secondaryOutcomes measure: radiography SIJ, secondaryOutcomes measure: Work, secondaryOutcomes measure: Fatigue, secondaryOutcomes measure: Physical activity, secondaryOutcomes measure: Sleep, secondaryOutcomes measure: Self-efficacy, secondaryOutcomes measure: Objective physical function, secondaryOutcomes measure: Aerobic capacity, otherOutcomes measure: Patient global assessment, otherOutcomes measure: Acceptable state, otherOutcomes measure: Mental state, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 48 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06337500, orgStudyIdInfo id: 2023/764, briefTitle: Validation of a Making Decision Hybrid (Ecologic and Virtual) Task, acronym: LABLife, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-02-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Besancon, class: OTHER, descriptionModule briefSummary: The aim of this study is to validate a new hybrid (ecological + virtual) decision-making tool. The difference in behavior (risky choices) between the "hybrid" task and the "virtual" task will be evaluated., conditionsModule conditions: Healthy Volunteers, conditions: Behavior and Behavior Mechanisms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Neurophysiological measure (EEG), interventions name: Survey, outcomesModule primaryOutcomes measure: Validation of the homemade "Lab-Life" interface as a tool for simulating an ecological task with sufficient fidelity, while meeting the conditions required for recording high-quality brain activity using an EEG-HR., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06337487, orgStudyIdInfo id: 2022/716, briefTitle: Quality of Life Assessment for Early Identification of Supportive Care Needs in Oncology Patients, acronym: SOS-DETEQT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Besancon, class: OTHER, collaborators name: Direction Générale de l'Offre de Soins, descriptionModule briefSummary: The aim of this study is to evaluate the value of the nurse's use of the Quality of Life (QoL) scores of the European Organisation for Research and Treatment of Cancer \[EORTC\] Quality of Life Questionnaire \[QLQ\] C30 as an aid in identifying the needs for supportive oncological care at the start of care, in patients followed up for locally advanced or metastatic cancer starting systemic antineoplastic treatment. The main questions it aims to answer are as follows:* Comparison of the personalised oncology support care plans proposed by the nurse before and after the QoL results were obtained* The nurse's assessment of the relevance of the information provided by the QOL scores.During the Care Support Stage (CSS), the nurse will assess the patient's situation during the interview and will fill in directly on an electronic form the Oncological Support Care proposed to the patient, making up the Personalised Pre-QoL Oncological Support Care Plan (PPSOS pre-QoL). The nurse will then give the patient the tablet to fill in the QoL questionnaire. She will then look at the results of the QoL questionnaire and the alerts in the event of deterioration, and will reassess the PPSOS using a new computerised PPSOS post-QoL form. The nurse will assess the relevance of the information provided by the QoL scores concerning the urgency of care, the need to go into certain subjects in greater depth, the identification of problems not addressed before or the discussion of sensitive subjects not addressed before. The nurse will give the patient the tablet to fill in a satisfaction questionnaire. In an attempt to control the biases inherent in an assessment carried out by a single healthcare professional, the clinical records of the patients included will be presented to a group of professionals who will also propose a PPSOS, known as Experts. The group will be made up of a nurse, a medical oncologist and at least two healthcare professionals and professionals in a similar field (dietician, psychologist, APA teacher, social worker, etc.). This group will analyse all the patient files included in the two study centres at dedicated meetings. In order to characterise patient care following the CSS, the oncological support care performed, unscheduled hospitalisations, emergency room visits and calls to the on-call medical team will be collected for the two months following the CSS., conditionsModule conditions: Oncology, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients, nurses and health professionals and professionals assimilated to the health are recruited in 3 different groups but no comparison will be made between them. Recruitment of patients will be stopped once 79 analyzable patients will be enrolled., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 93, type: ESTIMATED, armsInterventionsModule interventions name: QoL questionnaires, interventions name: Qualitative Interview (for one part of nurses only), interventions name: ORIC questionnaire, interventions name: Professionals satisfaction survey, interventions name: Patients satisfaction survey, outcomesModule primaryOutcomes measure: Change between pre and post QoL Questionnaires, primaryOutcomes measure: The nurse's assessement of the relevance of the information provided by each patients's QoL scores, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU de Besançon, city: Besançon, zip: 25000, country: France, contacts name: Magalie Pagnot, Nurse, role: CONTACT, email: m1courgey@chu-besancon.fr, geoPoint lat: 47.24878, lon: 6.01815, locations facility: Groupement Hospitalier de Haute-Saône, city: Vesoul, country: France, contacts name: Cathy Pothier, Nurse, role: CONTACT, geoPoint lat: 47.63333, lon: 6.16667, hasResults: False
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protocolSection identificationModule nctId: NCT06337474, orgStudyIdInfo id: [2023]YLJSA089, briefTitle: An Clinical Study of CD19 CAR NK Cells for the Treatment of Refractory Primary Immune Thrombocytopenia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2025-03-30, completionDateStruct date: 2026-03-30, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Changzhou No.2 People's Hospital, class: OTHER, collaborators name: Rui Therapeutics Co., Ltd, descriptionModule briefSummary: A single arm, open-label pilot study is designed to determine the safety and effectiveness of CD19 CAR NK cells (KN5501) in patients with refractory immune thrombocytopenia. 9 patients are planned to be enrolled in the dose-escalation trial (9×10\^9 cells, 13.5×10\^9 cells). The primary objective of the study is to evaluation of the safety and feasibility of KN5501 for the treatment of relapsed/refractory B-cell related autoimmune diseases. The secondary objective is to evaluate evaluation of KN5501 for the treatment of refractory immune thrombocytopenia. The exploratory objective is to evaluate expansion, persistence and ability to deplete CD19 positive B cells of KN5501 in patients with refractory immune thrombocytopenia., conditionsModule conditions: Thrombocytopenia Alloimmune, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 9, type: ESTIMATED, armsInterventionsModule interventions name: anti-CD19 CAR NK cells (KN5501), outcomesModule primaryOutcomes measure: Incidence of Dose Limiting Toxicity (DLTs), primaryOutcomes measure: Treatment Emergent Adverse Events (TEAEs), secondaryOutcomes measure: Objective Response Rate of subjects, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06337461, orgStudyIdInfo id: CCM1930, briefTitle: Computational mOdelliNg of myoCardial pERfusion to Improve ouTcome Prediction Based on cOronary Artery Stenosis and Atherosclerotic Plaque Burden Assessment by Computed Tomography, acronym: CONCERTO, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-22, primaryCompletionDateStruct date: 2025-05-30, completionDateStruct date: 2025-05-30, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Centro Cardiologico Monzino, class: OTHER, collaborators name: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari, collaborators name: Politecnico di Milano, descriptionModule briefSummary: Detection of coronary stenosis is of utmost importance in identifying vulnerable patients. The combined use of coronary computed tomography angiography at rest (CCTA) and stress myocardial computed tomography perfusion (stress-CTP) provides both anatomic and functional analysis of coronary artery disease (CAD) using a single imaging test. Stress-CTP evaluates myocardial perfusion by measuring myocardial blood flow (MBF) under pharmacologically induced stress conditions. The drawback is that stress-CTP requires additional scanning and administration of an intravenous stressor with an increase in radiation exposure and potential stressor-related side effects. The investigators recently patented a computational model that can reproduce MBF under stress conditions (Italian patent n. 102021000031475 Metodo implementato mediante computer per la simulazione del flusso sanguigno miocardico in condizioni di stress \[Computational method for simulating myocardial blood flow in stress conditions\], half owned by Centro Cardiologico Monzino, half by Politecnico di Milano).On top of this, CCTA can characterize plaque type and identify adverse plaque characteristics. Moreover, biomechanics analysis allows the study of luminal stenosis and stress within the plaque. Finally, radiomics, extracting quantitative features from medical images to create big data and identify novel imaging biomarkers, can be applied to improve the diagnostic accuracy of coronary plaques., conditionsModule conditions: Chronic Coronary Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 400, type: ESTIMATED, outcomesModule primaryOutcomes measure: Development of a computational model to predict MBF avoiding CT stress protocol, secondaryOutcomes measure: Improvement of CAD risk assesment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centro Cardiologico Monzino, status: RECRUITING, city: Milan, zip: 20131, country: Italy, contacts name: Chiara Centenaro, role: CONTACT, phone: 0258002031, phoneExt: +39, email: chiara.centenaro@cardiologicomonzino.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06337448, orgStudyIdInfo id: 74090923.9.0000.5544, briefTitle: Light Emitting Diode in the Treatment of Vulvodynia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-16, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Centro de Atenção ao Assoalho Pélvico, class: OTHER, descriptionModule briefSummary: Vulvar pain can be related to a specific cause (inflammation, cancer, trauma, infection) or can be classified as vulvodynia, when vulvar pain is idiopathic and lasts for at least three months. The main symptoms reported are pain, burning, erythema, increased sensitivity, itching and burning, which affect the quality of life, psycho-emotional well-being, relationships and sexual function of these women. Photobiomodulation has been described in the literature as an alternative to treat pain. Our group has studied blue LED for some vulvovaginal dysfunctions and, due to the positive sensory effects observed in patients with vaginal stenosis and genitourinary syndrome of menopause, it is hypothesized that this technique could also bring beneficial effects for women with vulvodynia. A pilot study will be carried out, with descriptive data, with 10 women with vulvodynia. Participants will be evaluated with a basic anamnestic questionnaire and sociodemographic data. The following questionnaires will be used: Female Sexual Function Index (FSFI), Sexual Quotient - Female Version, Vulvar Pain Assessment Questionnaire. After answering the questionnaires, the volunteer will undergo a perineal physical assessment by an experienced physiotherapist, which includes a) inspection of the genital region, reflex tests, assessment of the functions of the pelvic floor muscles, b) the cotton swab test to evaluate painful sensitivity in the vestibule, c) the tampon test to evaluate painful sensitivity in the introitus and vaginal canal. Pain assessments will be quantified by the visual analogue pain scale (VAS), which ranges from 0 (no pain) to 10 (maximum pain). At the end of the treatment, the participant will answer the questionnaires again, undergo reassessment of pain sensitivity in vulva, introitus and vaginal canal, of the function of the pelvic floor muscles and will be asked "What is your perception of improvement" and "What is your level of satisfaction with the treatment?". The answers will be giving according to a Likert Scale of five points. The LED application protocol will be carried out with external use equipment model Antares, from the company IBRAMED (Amparo, São Paulo, Brazil), with a cluster G2 applicator. The power will be 450mW/cm2 and dose 5J/cm2 for 2 minutes and 13 seconds (automatic programming) in 450nm waves (blue wavelength). The treatment consists of eight sessions, carried out daily, except on weekends., conditionsModule conditions: Vulvodynia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Blue LED, outcomesModule primaryOutcomes measure: Number of participants with treatment-related adverse events as assessed by Visual Analogue Scale., primaryOutcomes measure: Tolerability of participants to the treatment assessed by Likert Scale., primaryOutcomes measure: Evaluate the clinical response assessed by the Visual Analogue Scale., primaryOutcomes measure: Evaluate the clinical response assessed by a questionnaire., secondaryOutcomes measure: Evaluate the sexual function of women with vulvodynia by Female Sexual Function Index (FSFI)., secondaryOutcomes measure: Evaluate the sexual function of women with vulvodynia by Sexual Quotient - Female Version (SQ-FV)., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centro de Atenção ao assoalho pélvico, status: RECRUITING, city: Salvador, state: Bahia, zip: 40290000, country: Brazil, contacts name: Patricia Lordelo, post doc, role: CONTACT, phone: +5571988592400, email: pvslordelo@hotmail.com, geoPoint lat: -12.97111, lon: -38.51083, hasResults: False
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protocolSection identificationModule nctId: NCT06337435, orgStudyIdInfo id: 8223, briefTitle: Using Multi-looped Lingual Retainer to Relief Anterior Mandibular Crowding, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-12-15, primaryCompletionDateStruct date: 2023-07-10, completionDateStruct date: 2024-01-18, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: this study aim to evaluate the multi-looped lingual retainer activated by a new method to relief the anterior crowding, conditionsModule conditions: Crowding of Anterior Mandibular Teeth, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 12, type: ACTUAL, armsInterventionsModule interventions name: multi-looped wire, outcomesModule primaryOutcomes measure: The improvement of lower incisors irregularity using Little Irregularity Index., secondaryOutcomes measure: The stability of lower incisor positioning after ending treatment, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 25 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: faculty of dentistry Cairo university, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06337422, orgStudyIdInfo id: BE21-023, briefTitle: Bioequivalence Study of Generic Celecoxib 200 mg Capsules, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-23, primaryCompletionDateStruct date: 2024-09-27, completionDateStruct date: 2024-10-04, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: International Bio service, class: NETWORK, descriptionModule briefSummary: To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fasting conditions, conditionsModule conditions: Healthy Volunteer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Celecoxib 200 mg capsule, outcomesModule primaryOutcomes measure: Bioequivalence based on Cmax period, primaryOutcomes measure: Bioequivalence based on AUC parameters, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06337409, orgStudyIdInfo id: BE24-004, briefTitle: Bioequivalence Study of Empagliflozin 25 mg Film-coated Tablets in Healthy Thai Volunteers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2024-07-05, completionDateStruct date: 2024-07-13, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: International Bio service, class: NETWORK, descriptionModule briefSummary: To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fasting conditions, conditionsModule conditions: Healthy Volunteer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Generic empagliflozin 25 mg film-coated tablets, outcomesModule primaryOutcomes measure: Bioequivalence based on Cmax period, secondaryOutcomes measure: Bioequivalence based on AUC parameters, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06337396, orgStudyIdInfo id: 1001, briefTitle: Omic Approaches to Neurodevelopmental Disabilities, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-05-05, primaryCompletionDateStruct date: 2023-07-28, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: IRCCS Eugenio Medea, class: OTHER, descriptionModule briefSummary: to bridge the gap between the molecular structure of CNV and the effect on the phenotype, considering NDDs as complex diseases, as they are a consequence of the imbalance in several dosage-sensitive genes, we might try to approach them through different --omics investigations (genomics, epigenomics, transcriptomics) according to the emerging field of network medicine. This holistic can provide valuable insight into understanding peculiar molecular mechanisms and unsuspected molecular interactions that contribute to the pathogenesis of the condition and possibly pave the way for uncovering new drug strategies that even if they do not heal the patient may improve his performance and the social interaction, conditionsModule conditions: Neurodevelopmental Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 22, type: ACTUAL, armsInterventionsModule interventions name: WGS and transcriptome analysis, outcomesModule primaryOutcomes measure: Number of likely pathogenic structural variants, primaryOutcomes measure: Number of patients for whom a genotype-phenotype correlation is found, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Scientific Institute IRCCS Eugenio Medea, city: Bosisio Parini, state: LC, zip: 23842, country: Italy, geoPoint lat: 45.80075, lon: 9.29, hasResults: False
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protocolSection identificationModule nctId: NCT06337383, orgStudyIdInfo id: 12.2021 ANGELMAN, briefTitle: Study of the Prevalence of Autistic Traits in Angelman Syndrome, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-03-15, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: IRCCS Eugenio Medea, class: OTHER, descriptionModule briefSummary: The goal of this observational cross-sectional study is to establish the prevalence of autism spectrum disorder in children and adolescents with Angelman syndrome. The main questions it aims to answer are:* which clinical variables differentiate AS patients with and without Autism Spectrum Disorder between genetics, epilepsy, pharmacotherapy, behavioural problems, parenting style and parents' perceived stress.* which clinical variables differentiate parenting styles and levels of perceived stress.Data from neuropsychological, speech therapy and physiotherapeutic assessments are collected during regular clinical follow-ups, regarding: cognitive development ("Bayely Scales of Infant Development-III", Cognitive Scale) and adaptive behaviour; Autism and Autism Spectrum Disorder ("Autism Diagnostic Observational Schedule-2"); parental stress and parenting styles; social-communicative skills; motor development., conditionsModule conditions: Angelman Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 46, type: ESTIMATED, outcomesModule primaryOutcomes measure: Total score of the Autism Diagnostic Observation Schedule -2 (ADOS-2), Module 1,, secondaryOutcomes measure: Age-equivalent score at the Cognitive Scale of the Bayley Scales of Infant Development - 3rd version (Bayley-III), secondaryOutcomes measure: Total Stress score at the Parent Stress Index - 4th edition (PSI-4) questionnaire, secondaryOutcomes measure: Global score at the Aberrant Behaviour Checklist (ABC), secondaryOutcomes measure: Total Raw score at the Social Communication Questionnaire - Current version(SCQ), eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 14 Years, stdAges: CHILD, contactsLocationsModule locations facility: I.R.C.C.S. "E.Medea", status: RECRUITING, city: Conegliano, state: Treviso, zip: 31015, country: Italy, contacts name: Martina Baggio, role: CONTACT, phone: +39 340 802 1282, email: martina.baggio@lanostrafamiglia.it, geoPoint lat: 45.88805, lon: 12.30201, hasResults: False
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protocolSection identificationModule nctId: NCT06337370, orgStudyIdInfo id: 61284, briefTitle: Self-management Nursing Intervention for Women With Rheumatoid Arthritis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-06-10, completionDateStruct date: 2024-09-10, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Universidad Nacional de Colombia, class: OTHER, descriptionModule briefSummary: Introduction. Chronic autoimmune diseases are catalogued as catastrophic conditions that generate a negative impact on the health and well-being of the affected person. In this particular case, rheumatoid arthritis is its main representative, which is a predominant disease in women, affecting not only the musculoskeletal system but in general, all dimensions of the human being and generating great costs for health systems. Adaptation to living with the disease requires the individual to develop capacities for a positive management of the condition, and in this sense, the development of self-management behaviors becomes a crucial element. Method. The investigators propose a two-arm pragmatic randomized clinical trial with pre- and post-intervention measures, to evaluate the effect of the Chronic Disease Selfmanagement Program (CDSMP) on the increase in the levels of self-efficacy, self-management and health-related quality of life of women with RA who are attended by outpatient rheumatology consultation in a health institution in Bogota compared to usual care. Results. A description will be made of the sociodemographic and clinical variables present in you together with the measurement of the variables of health-related quality of life through the QOLRA-II; self-efficacy with the specific scale of self-efficacy in arthritis; and self-management behaviors by means of the scale of self-management in the disease. The measurement for the intervention group will be performed before and after the implementation of the program and for the control group an initial measurement and another one after six weeks. Discussion. The implementation of the CDSMP could generate a positive effect on the variables of self-management, self-efficacy and health-related quality of life in women with RA who are attended by outpatient consultation in a health institution in Bogota compared to usual care., conditionsModule conditions: Arthritis, Rheumatoid, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: CDSMP is a group-based chronic disease self-management education intervention comprised of 2.5-hour sessions, including time for a break and snack. The maximum number of participants per session ranges from 12 to 16. In total the program consists of 6 sessions that take place once a week for a total duration of 6 weeks. The development of each of the sessions is standardized and scripted; two group leaders previously trained by a Master Trainer, who in turn was trained to train leaders with Stanford University, guide the sessions. In the case of the present study, the main researcher and a nursing professional with experience in health education will receive the training from a Master Trainer of the program. Participants receive the book "Taking Control of Your Health" at the beginning of the program., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: TRIPLE, maskingDescription: In order to guarantee the objectivity and impartiality of the research team, randomization will be accompanied by blinding. A single-blind trial is proposed in which the participants during the conduct of the study will be unaware of their assignment to the experimental or control groups; likewise, the research assistants who perform the pre and post measurement will be unaware of their assignment to the groups; there will be specific assistants for the pre measurement and specific assistants for the post measurement with each group. Candidates will be invited to participate in the study, explaining to them that it is a randomized study in which they may be assigned to a specific intervention group, that their assignment will only be random, that neither the research team nor the treating health team will be able to interfere with their assignment and that this will be revealed to them once the study is completed., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 55, type: ESTIMATED, armsInterventionsModule interventions name: Chronic Disease Self Management Program, interventions name: Conventional Care Group, outcomesModule primaryOutcomes measure: Self-management behaviors, secondaryOutcomes measure: Perceived Self-efficacy,, secondaryOutcomes measure: Health-related quality of life, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fundación Santa Fe de Bogotá, city: Bogotá, country: Colombia, contacts name: Klaus Mieth Alviar, Dr., role: CONTACT, phone: 601 6030303, phoneExt: 5402, email: comiteinvestigativo@fsfb.org.co, geoPoint lat: 4.60971, lon: -74.08175, hasResults: False
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protocolSection identificationModule nctId: NCT06337357, orgStudyIdInfo id: NatGerHos-Sarcopenia, briefTitle: Results of Progressive Resistance Training in Older Type 2 Diabetic Patients With Sarcopenia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: National Geriatric Hospital, class: OTHER_GOV, descriptionModule briefSummary: A randomized controlled clinical trial that will test how progressive resistance training will impact outcomes of sarcopenia in older patients with type 2 diabetes who have been diagnosed as sarcopenia. The intervention will be 12 weeks in duration with approximately 24 sessions of resistance exercises. Outcome measures will be collected at baseline, 4, 8 weeks and 12 weeks., conditionsModule conditions: Sarcopenia, conditions: Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Progressive Resistance Training, outcomesModule primaryOutcomes measure: Physical performance 1 - Handgrip strength, primaryOutcomes measure: Physical performance 2 - Gait speed, primaryOutcomes measure: Physical performance 3 - Short Physical Performance Battery (SPPB), primaryOutcomes measure: Muscle mass, secondaryOutcomes measure: Nutritional status, secondaryOutcomes measure: Health-related Quality of Life, secondaryOutcomes measure: Activities of Daily Living (ADLs) and Instrumental Activities of Daily Living (IADLs), eligibilityModule sex: ALL, minimumAge: 60 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Geriatric Hospital, city: Hanoi, zip: 100000, country: Vietnam, contacts name: Huyen TT Vu, PhD, role: CONTACT, phone: +84913531579, email: vuthanhhuyen11@yahoo.com, geoPoint lat: 21.0245, lon: 105.84117, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2024-01-23, uploadDate: 2024-03-22T11:34, filename: ICF_000.pdf, size: 212556, hasResults: False
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protocolSection identificationModule nctId: NCT06337344, orgStudyIdInfo id: HSEARS20230213007, briefTitle: Neurophysiological Effects of Mind-body Exercise in Healthy Adults, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-04, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: The Hong Kong Polytechnic University, class: OTHER, descriptionModule briefSummary: There is some clinical evidence showing that Baduanjin (BDJ) practice, a type of mind-body based physical exercise, can improve executive function (EF). However, the neurophysiological changes associated with improved cognitive function remain elusive. Therefore, this study aims to carry out randomised controlled trial to explore how the single-session BDJ practice affect the function of prefrontal cortex(PFC) and also the EF of healthy adults, measure by fNIRS and verbal fluency test accordingly. A total of 60 healthy adults (based on power analysis 80% (β= 0.20) chance (α = 0.05, two-tailed)), aged 18 to 40 year old, without any physical, neurological, and neuropsychiatric disorder, classified as right-handed by Edinburgh Handedness Inventory, also with normal intelligence as verified by the Test of Nonverbal Intelligence will be recruited and randomly assigned to treatment(i.e. BDJ), active control(i.e, exercise), and passive control(i.e. video viewing) group. The investigator anticipate that this single-session BDJ practice will result in - (1) enhancing executive functioning, and (2) changes in functional brain activation pattern in PFC in adults. The result will give a spotlight to neurophysiological treatment effect of single-session Baduanjin on healthy adults, in developing intervention for improving executive functioning of adults., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Baduanjin, interventions name: Exercise, interventions name: Video Viewing, outcomesModule primaryOutcomes measure: Change in cognitive function as assessed by verbal fluency task (VFT), primaryOutcomes measure: Hemodynamic changes as assessed by fNIRS, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: The Hong Kong Polytechnic University, status: RECRUITING, city: Hung Hom, state: Kowloon, country: Hong Kong, contacts name: Yvonne Han, PhD, role: CONTACT, phone: +852 2766 7578, geoPoint lat: 22.30715, lon: 114.18532, hasResults: False
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protocolSection identificationModule nctId: NCT06337331, orgStudyIdInfo id: NSH 1401, briefTitle: Adding Venetoclax to the High-dose Chemotherapy Regimen Prior to Mismatche Allogeneic Stem Cell Transplant, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-31, primaryCompletionDateStruct date: 2026-08-31, completionDateStruct date: 2027-08-31, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Northside Hospital, Inc., class: OTHER, descriptionModule briefSummary: Patients eligible for a mismatch allogeneic stem cell transplant will receive Venetoclax daily for 7 days prior to transplant in addition to the following chemotherapy regimen: Decitabine daily for 5 days, Fludarabine daily for 5 days, and Busulfan daily for 2 days followed by 1 day of total body irradiation. Stem cell transplant will occur thereafter., conditionsModule conditions: Acute Myeloid Leukemia, conditions: Myelodysplastic Syndromes, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 23, type: ESTIMATED, armsInterventionsModule interventions name: Venetoclax, interventions name: Decitabine, interventions name: Fludarabine, interventions name: Busulfan, interventions name: Total Body Irradiation, outcomesModule primaryOutcomes measure: Incidence of relapse/progression by conducting blood and bone marrow biopsy evaluations at one-year post-transplant, secondaryOutcomes measure: Number of patients alive at one-year post transplant, secondaryOutcomes measure: Number of patients alive without recurrence of disease at one-year post transplant by conducting blood and bone marrow biopsy procedures, secondaryOutcomes measure: Number of patients who died one year post-transplant not related to recurrence of disease, secondaryOutcomes measure: Number of patients who fully engrafted (blood counts fully recovered) by conducting chimerism studies at 30-, 60-, 90-, 180-, and 365-days post transplant, secondaryOutcomes measure: Number of patients who developed acute graft-versus-host disease by recording signs and symptoms of acute GVHD according to MAGIC standards at one-year post-transplant, secondaryOutcomes measure: Number of patients who developed chronic graft-versus-host disease by recording signs and symptoms of chronic GVHD according to NIH standards at one-year post-transplant, secondaryOutcomes measure: Number of patients who are alive at one-year post transplant who also did not develop GVHD, secondaryOutcomes measure: Number of patients with treatment-related adverse events to venetoclax as assessed by CTCAE v5.0, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Caitlin Guzowski, city: Atlanta, state: Georgia, zip: 30342, country: United States, geoPoint lat: 33.749, lon: -84.38798, hasResults: False
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protocolSection identificationModule nctId: NCT06337318, orgStudyIdInfo id: NCI-2024-02361, secondaryIdInfos id: NCI-2024-02361, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: S2308, type: OTHER, domain: SWOG, secondaryIdInfos id: S2308, type: OTHER, domain: CTEP, secondaryIdInfos id: U10CA180888, type: NIH, link: https://reporter.nih.gov/quickSearch/U10CA180888, briefTitle: Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-31, primaryCompletionDateStruct date: 2032-03-31, completionDateStruct date: 2032-03-31, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: National Cancer Institute (NCI), class: NIH, descriptionModule briefSummary: This phase III trial compares the effectiveness of rituximab to mosunetuzumab in treating patients with follicular lymphoma with a low tumor burden. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. It is not yet known if giving rituximab or mosunetuzumab works better in treating patients with follicular lymphoma with a low tumor burden., conditionsModule conditions: Classic Follicular Lymphoma, conditions: Follicular Lymphoma With Unusual Cytological Features, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: Biospecimen Collection, interventions name: Computed Tomography, interventions name: Mosunetuzumab, interventions name: Positron Emission Tomography, interventions name: Rituximab, interventions name: Rituximab and Hyaluronidase Human, outcomesModule primaryOutcomes measure: 3-year milestone progression free survival (PFS), primaryOutcomes measure: PFS, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Overall response rate, secondaryOutcomes measure: Event free survival (EFS), secondaryOutcomes measure: Incidence of adverse events, secondaryOutcomes measure: Restricted chance of longer PFS, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06337305, orgStudyIdInfo id: STUDY00146138, briefTitle: Resiliency in Patients Undergoing Radical Cystectomy for Bladder Cancer, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-08-19, primaryCompletionDateStruct date: 2022-08-19, completionDateStruct date: 2023-08-19, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: University of Kansas Medical Center, class: OTHER, descriptionModule briefSummary: This is a prospective cross-sectional survey-based study composed of both a retrospective chart review and 3-series patient survey. This study will help elicit potential areas throughout the perioperative course of radical cystectomy to improve patient resilience and quality of life, providing opportunity for future interventional studies., conditionsModule conditions: Bladder Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 74, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Change in resiliency as measured by the Connor-Davidson Resilience Scale (CD-RISC-25)., primaryOutcomes measure: Change in quality of life in patients undergoing radical cystectomy as measured by the Functional Assessment of Cancer Therapy-Bladder-Cystectomy (FACT-Bl-Cys)., primaryOutcomes measure: Change in quality of life in patients undergoing radical cystectomy as measured by the PROMIS-29., secondaryOutcomes measure: Identification of clinical and demographic factors in bladder cancer patients, secondaryOutcomes measure: Demographics, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Kansas Medical Center, city: Kansas City, state: Kansas, zip: 66160, country: United States, geoPoint lat: 39.11417, lon: -94.62746, hasResults: False
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protocolSection identificationModule nctId: NCT06337292, orgStudyIdInfo id: IRB00440042, briefTitle: Incisional Negative Pressure Wound Therapy to Reduce Infection and Complications in High-Risk Fractures: A Multicenter Randomized Controlled Trial, acronym: iVAC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2028-09-30, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Major Extremity Trauma Research Consortium, class: OTHER, descriptionModule briefSummary: This is a multi-center, pragmatic, parallel arm randomized controlled trial (RCT) of 352 patients with high-risk open or closed tibial plateau fracture, high-risk open or closed tibial pilon fracture, or open tibial shaft fracture with incision \>3cm. Eligible participants will be randomized to receive either incisional negative pressure wound therapy (NPWT) or a non-suction standard-of-care wound dressing for their definitive wound management. The primary outcome will be a composite outcome to evaluate clinical status 3 months after randomization. The secondary outcomes will independently assess the components of the primary outcome., conditionsModule conditions: Fracture of Tibia, conditions: Wound Heal, conditions: Infected Wound, conditions: Wound Complication, conditions: Wound Dehiscence, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomization into study treatment arms (incisional NPWT or non-suction standard of care) will occur in variable permuted blocks, stratified by clinical center, in a 1:1 ratio. Patients will be randomized electronically by an online Data Management System maintained by the Coordinating Center at Johns Hopkins School of Public Health., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 352, type: ESTIMATED, armsInterventionsModule interventions name: Incisional Negative Pressure Wound Therapy (NPWT), outcomesModule primaryOutcomes measure: Complication composite outcome, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06337279, orgStudyIdInfo id: FMUUH-0322, briefTitle: Systemic Oxidative Stress Score as a Predictor of Gastric Cancer Survival and Recurrence Risk, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-12-10, primaryCompletionDateStruct date: 2023-08-20, completionDateStruct date: 2024-03-20, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Fujian Medical University, class: OTHER, collaborators name: Fujian Medical University Union Hospital, descriptionModule briefSummary: The Systemic Oxidative Stress Score (SOSS), a comprehensive score reflecting the oxidative stress conditions in the microenvironment, can independently and effectively predict tumor burden and long-term prognosis in GC patients. Nomograms based on SOSS provide a potential and promising model for risk stratification and guiding the implementation of treatment decisions., conditionsModule conditions: Gastric Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 3820, type: ACTUAL, outcomesModule primaryOutcomes measure: 5-year OS, primaryOutcomes measure: 5-year DFS, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fujian Medical University Union Hospital, city: Fuzhou, state: Fujian, zip: 350000, country: China, geoPoint lat: 26.06139, lon: 119.30611, hasResults: False
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protocolSection identificationModule nctId: NCT06337266, orgStudyIdInfo id: 2024KY246, briefTitle: A Novel Online Calculator to Predict Long-term Survival and Recurrence Risk of Patients With Gastric Adenocarcinoma, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2023-08-20, completionDateStruct date: 2024-03-19, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Fujian Medical University, class: OTHER, collaborators name: Fujian Medical University Union Hospital, descriptionModule briefSummary: This study aimed to develop a novel Prognostic Oxidative Stress-Immune-Inflammatory Score (POSII Score) and introduce an innovative online calculator designed to predict long-term survival and assess the recurrence risk of gastric cancer (GC)., conditionsModule conditions: Gastric Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 3622, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: 5-year OS, primaryOutcomes measure: 5-year DFS, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fujian Medical University Union Hospital, city: Fuzhou, state: Fujian, zip: 350000, country: China, geoPoint lat: 26.06139, lon: 119.30611, hasResults: False
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protocolSection identificationModule nctId: NCT06337253, orgStudyIdInfo id: MOZ202401, briefTitle: Seasonal Malaria Chemoprevention Rapid Assessment Study Mozambique, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2024-05-26, completionDateStruct date: 2024-11-26, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Malaria Consortium, class: OTHER, descriptionModule briefSummary: Seasonal malaria chemoprevention (SMC) is a highly effective community-based intervention to prevent malaria infections caused by Plasmodium falciparum in areas where the burden of malaria is high and malaria transmission is seasonal. SMC is commonly seen as a success story in the Sahel region, however, there are regions in east and southern Africa where malaria transmission is seasonal, and the burden is high. However, the same decision-making frameworks that was used in the Sahel are unlikely to be applicable to east and southern Africa due to higher pre-existing resistance to the drugs used, seasonality heterogeneity, contextual difference, and unknown cost-effectiveness, amongst others. This study aims to estimate the chemoprevention efficacy, potential upscale impact, acceptability, and feasibility of SMC with sulfadoxine-pyrimenthamine + amodiaquine (SP+AQ) medicines in Niassa Province in Mozambique.The study is divided into two separate components with different objectives which outputs feed into each other: a non-randomized controlled trial to estimate the chemoprevention efficacy of SP+AQ; and a qualitative study that will evaluate the feasibility and acceptability of the intervention.These will be the first studies analysing the chemoprevention efficacy, feasibility, acceptability, and potential scale-up impact of SMC in Niassa Province, Mozambique The outcomes of these studies aim to guide future policy changes at local, national, and international levels and potentially allow for a historically successful program to expand in a sustained and cost-effective way beyond the Sahel region., conditionsModule conditions: Malaria,Falciparum, conditions: Chemoprevention, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: The intervention in this study is the administration of one cycle of SPAQ medicines. SPAQ medicines procured by Malaria Consortium are from one of the 3 manufacturers with WHO prequalification, with whom Malaria Consortium has framework agreements: Tridem Pharma, S Kant Healthcare Ltd, or MacLeods Pharmaceuticals Ltd.Each monthly SMC cycle consists of one dispersible tablet of SP and three daily dispersible tablets of AQ. There are two doses of SPAQ: a lower dose for children aged three to \<12 months, and a higher dose for children aged 12 to 59 months. For children aged 12 to 59 months, the dosage comprises a single dose of a full tablet of SP 500/25mg and three daily doses of a full tablet of AQ 153mg. Those aged three to \<12 months are administered half the dose given to those aged 12 to 59 months, given as full dispersible tablets., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Sulfadoxine/pyrimethamine plus amodiaquine, outcomesModule primaryOutcomes measure: Chemoprevention failure, secondaryOutcomes measure: Uncomplicated malaria within 28 days, eligibilityModule sex: ALL, minimumAge: 3 Months, maximumAge: 59 Months, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06337240, orgStudyIdInfo id: pelvic floor exercise, briefTitle: Pelvic Floor Exercises Versus Pilates on Urinary Incontinance in Chronic Obstructive Pulmonary Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-29, primaryCompletionDateStruct date: 2024-07-02, completionDateStruct date: 2024-07-02, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: The aim of the study is To compare between the effect of both pelvic floor and Pilates exercises on urinary incontinences in COPD patients., conditionsModule conditions: Urinary Incontinence, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Pelvic floor on COPD patients, interventions name: Pilates exercises on COPD patients, outcomesModule primaryOutcomes measure: Urinary incontinence (1 Hour and 24- Hour pad test), primaryOutcomes measure: Incontinence severity index:, secondaryOutcomes measure: Urinary incontinence quality of life questionnaire (I-QOL), secondaryOutcomes measure: Cough symptoms score, secondaryOutcomes measure: Cough symptoms questionnaire, secondaryOutcomes measure: The COPD Assessment Tool (CAT), eligibilityModule sex: FEMALE, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Physical Therapy, status: RECRUITING, city: Cairo, country: Egypt, contacts name: Donia El masry, doctorate, role: CONTACT, phone: 01005587119, email: donia.elmasry@cu.edu.eg, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06337227, orgStudyIdInfo id: 2/22, briefTitle: Potential Role of Sirtuins as Epigenetic Biomarkers of the Patient With Atherosclerosis or Calcific Aortic Stenosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-19, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2026-10, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: IRCCS SYNLAB SDN, class: OTHER, collaborators name: Federico II University, descriptionModule briefSummary: The project aims to shed light on the role of Sirtuins, enzymes belonging to the third class of histone deacetylases (class III) involved in epigenetic modifications (deacetylation), focusing mainly on Sirtuin 6 (SIRT6), as a regulator of atherosclerosis and severe aortic valve stenosis through molecular-based and epigenetic studies in human VSMC cells., conditionsModule conditions: Atherosclerosis and Calcific Aortic Stenosis With and Without Diabetes, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 3, type: ESTIMATED, armsInterventionsModule interventions name: lncRNA signature analyses, outcomesModule primaryOutcomes measure: To evaluate by analysis of data obtained from NGS techniques whether and which proteins belonging to the Sirtuin family may be deregulated in patients with atherosclerosis or calcific aortic stenosis, secondaryOutcomes measure: To evaluate the experimental results achieved in the clinical-diagnostic context, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Irccs Synlab Sdn, status: RECRUITING, city: Naples, zip: 80143, country: Italy, contacts name: Monica Franzese, PhD, role: CONTACT, phone: +393334041413, email: direzionescientifica.irccssdn@synlab.it, geoPoint lat: 40.85216, lon: 14.26811, hasResults: False
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protocolSection identificationModule nctId: NCT06337214, orgStudyIdInfo id: TCHIRB-11301014-E, briefTitle: TCM Therapy Program Impact on Breast Cancer Patients' Vital Energy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2025-02-28, completionDateStruct date: 2025-02-28, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Taipei City Hospital, class: OTHER_GOV, descriptionModule briefSummary: The goal of this study is to evaluate the impact of the "Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy" on patients with breast cancer who are currently undergoing conventional Western medical treatments in Taiwan. The main questions it aims to answer are:Can the "Traditional Chinese Medicine Therapy Program" alleviate symptoms experienced by breast cancer patients? Does the program improve the quality of life for breast cancer patients receiving Western medical treatments? How does the program contribute to the management of side effects associated with Western oncological therapies?Participants will:Engage in the "Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy" provided by the Taiwan Compassionate Cancer Care Association.Receive supportive and educational services, including auxiliary Chinese medicine treatment courses, lifestyle and health education, and psychological counseling.This study seeks to integrate the concept of holistic healthcare, emphasizing coordinated care that encompasses physical, mental, and social aspects, into the treatment of breast cancer., conditionsModule conditions: Breast Cancer, conditions: Neoplasm, Breast, conditions: Patient Participation, conditions: Mental Health Issue, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy, outcomesModule primaryOutcomes measure: Questionnaire: Constitution in Chinese Medicine Questionnaire, primaryOutcomes measure: Questionnaire: Functional Assessment of Cancer Therapy-General Scale, FACT-G)(Version 4), primaryOutcomes measure: Questionnaire: European Organisation for Research and Treatment of Cancer, EORTC QLQ-BR23), secondaryOutcomes measure: Additional questions regarding the "Traditional Chinese Medicine Program for Reinforcing Vital Energy", eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Taipei City Hospital, status: RECRUITING, city: Taipei, zip: 10845, country: Taiwan, contacts name: Yu-Hsuan Tai, MD, role: CONTACT, phone: +886918130891, email: daidayangisele@gmail.com,dbb02@tpech.gov.tw, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False
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protocolSection identificationModule nctId: NCT06337201, orgStudyIdInfo id: BTH-6.1.1-0138-2023, briefTitle: A Digital Life Story to Support Person-centred Care for Older Adults With Dementia Perspectives, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-08-15, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2027-06, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Blekinge Institute of Technology, class: OTHER, descriptionModule briefSummary: Person-centred care can be supported when healthcare professionals access and actively use the information recorded in a life story. Active use of the life story can create security for a person with dementia and their carers. The written life story describes the person and their life experiences, which can define the person's identity. National guidelines for care and nursing in dementia and Blekinge's regional guidelines emphasise the importance of care and nursing for people with dementia, which should be given with a person-centred approach, where the life story becomes a tool for healthcare professionals. Research shows that a life story can be designed in several ways. For example, in book form, as a brochure, collage, memory box or electronically. The life story is also intended as a tool for healthcare professionals to create security and facilitate communication with the individual. As more and more older adults are using computers and tablets as assistive devices, and it is also becoming more common for healthcare professionals to use, for example, tablets as assistive devices in nursing care, the life story could be shared in digital form as an application and become a living document.Overall aim: To test an application for the life story with the intention of supporting person-centred care for older adults with dementia and to test whether the application can replace the written completion document. Study I: Exploring the research area of the life story in digital form. Study II: Focus group interviews with healthcare professionals. Study III: Test the application, Min Memoria. Study IV: Observations on the use of the application., conditionsModule conditions: Cognitive Impairment, conditions: Dementia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Test of the application Min Memoria, outcomesModule primaryOutcomes measure: Healthcare professionals' experiences using a written life story in the daily care of older adults with dementia, primaryOutcomes measure: Data on the use of a digital life story tool., primaryOutcomes measure: Observation when using a digital life story, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Blekinge Institute of Technology, status: RECRUITING, city: Karlskrona, state: Blekinge, zip: 37179, country: Sweden, contacts name: Johan Sanmartin Berglund, MD, PhD, role: CONTACT, phone: +46455385471, email: johan.sanmartin.berglund@bth.se, contacts name: Peter Anderberg, PhD, role: CONTACT, phone: +46455385436, email: peter.anderberg@bth.se, geoPoint lat: 56.16156, lon: 15.58661, hasResults: False
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protocolSection identificationModule nctId: NCT06337188, orgStudyIdInfo id: AAC PhII, briefTitle: Adaptive and Individualized AAC Phase II, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Altec Inc., class: INDUSTRY, collaborators name: University of Nebraska, descriptionModule briefSummary: The overall objective of this study is to develop an Augmentative and Alternative Communication (AAC) system that is effective in delivering a person-centric communication device that will provide a versatile access method that can automatically learn and adapt to the user's physical abilities by creating a personalized, comprehensive keyboard interface for communication, not otherwise available to people in need of alternative communication., conditionsModule conditions: Communication Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Experimental AAC, interventions name: Generic AAC, outcomesModule primaryOutcomes measure: Tele-healthcare Satisfaction Questionnaire - Wearable Technology (TSQ-WT), primaryOutcomes measure: Information Transfer Rate, primaryOutcomes measure: National Aeronautics and Space Administration (NASA) Task Load Index, secondaryOutcomes measure: Character-to-character Movement Time, secondaryOutcomes measure: Path Efficiency, secondaryOutcomes measure: Frequency of Selecting Word Completion Options, secondaryOutcomes measure: Number of Written Disfluencies, eligibilityModule sex: ALL, minimumAge: 6 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06337175, orgStudyIdInfo id: 000000230988, briefTitle: Predictors of Post-alteplase Hemorrhagic Transformation of Brain Infarction, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-06-01, primaryCompletionDateStruct date: 2023-10-30, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Kafrelsheikh University, class: OTHER, descriptionModule briefSummary: The investigators evaluated whether the characteristics of ischemic stroke patients, door-to-needle time, and stroke risk factors were predictive variables for different subtypes of post-alteplase hemorrhagic transformation of brain infarction., conditionsModule conditions: Ischemic Stroke, conditions: Alteplase Adverse Reaction, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study consisted of two distinct groups. The first group comprised 464 patients who did not experience hemorrhagic infarction, while the second group comprised 152 patients who experienced hemorrhagic infarction., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: Alteplase, interventions name: Alteplase, outcomesModule primaryOutcomes measure: predictors of the hemorrhagic infarction type 1, secondaryOutcomes measure: predictors of the hemorrhagic infarction type 2, secondaryOutcomes measure: predictors of the parenchymal hematoma type 1, secondaryOutcomes measure: predictors of the parenchymal hematoma type 2, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kafr Elsheikh University Hospital, status: RECRUITING, city: Kafr Ash Shaykh, zip: 33155, country: Egypt, contacts name: mohamed G. Zeinhom, MD, role: CONTACT, phone: 2001009606828, email: mohamed_gomaa@med.kfs.edu.eg, contacts name: sherihan R ahmed, MD, role: CONTACT, phone: 2001007481842, email: sherihanrezk2016@gmail.com, geoPoint lat: 31.11174, lon: 30.93991, hasResults: False
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protocolSection identificationModule nctId: NCT06337162, orgStudyIdInfo id: UPCC 20223, secondaryIdInfos id: IRB#855195, type: OTHER, domain: University of Pennsylvania IRB, briefTitle: Pre-Transplant INCBB099280 for Hepatocellular Carcinoma (HCC), acronym: HCC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2028-09-01, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Abramson Cancer Center at Penn Medicine, class: OTHER, collaborators name: Incyte Corporation, descriptionModule briefSummary: This is a pilot safety study of the oral PD-L1 inhibitor INCB099280 in patients with HCC awaiting liver transplant., conditionsModule conditions: Hepatocellular Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: INCB099280, outcomesModule primaryOutcomes measure: Acute Cellular Rejection of Liver Transplant Attributed to Study Therapy, secondaryOutcomes measure: Acute Cellular Rejection of Liver Transplant Within 3 Months, secondaryOutcomes measure: Acute Cellular Rejection of Liver Transplant Within 1 Year, secondaryOutcomes measure: Toxicity Rates by Category and Grade, secondaryOutcomes measure: Proportion of Patients Downstaged, secondaryOutcomes measure: Pathologic Complete Response Rate, secondaryOutcomes measure: Recurrence-Free Survival at 1 Year After Transplant, secondaryOutcomes measure: Overall Survival at 1 Year After Transplant, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Abramson Cancer Center at University of Pennsylvania, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, contacts name: Jennifer Walsh, role: CONTACT, phone: 215-615-5858, email: Jennifer.Walsh4@pennmedicine.upenn.edu, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False
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protocolSection identificationModule nctId: NCT06337149, orgStudyIdInfo id: APHP230348, secondaryIdInfos id: IDRCB: 2023-A00006-39, type: REGISTRY, domain: IDRCB ANSM, briefTitle: Relationship Between Breathing and Attention in Children With Ondine Syndrome, acronym: OndineCo, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2026-09-01, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: Congenital central hypoventilation syndrome (CCHS) is a rare disorder of autonomic and respiratory regulation that alters oxygen delivery to the brain. CCHS patients are at risk for broad neurocognitive deficits. Patients retain ventilatory activity when awake through a respiratory-related cortical network but the need to mobilise cortical resources to breathe lead to breathing-cognition interferences during cognitive tasks. The purpose of this study is to assess the relationship between breathing pattern and attention in CCHS children, conditionsModule conditions: Ondine Syndrome, conditions: Congenital Central Hypoventilation Syndrome (CCHS), designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: neuropsychological tests used usually in clinical practice (TEA-ch, NEPSY, BRIEF) and research (Conners 3, K-CPT II or CPT III, Flankers Task), outcomesModule primaryOutcomes measure: Wechsler scale, primaryOutcomes measure: Nepsy II test, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: Robert Debre Hospital, status: RECRUITING, city: Paris, zip: 75019, country: France, contacts name: Christophe DELCLAUX, MD, PhD, role: CONTACT, phone: +331 40 03 41 90, email: christophe.delclaux@aphp.fr, contacts name: Benjamin DUDOIGNON, MD, role: CONTACT, phone: +331 40 03 41 90, email: benjamin.dudoignon@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False
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protocolSection identificationModule nctId: NCT06337136, orgStudyIdInfo id: 2022-A01837-36, briefTitle: neonAtal motoR paTtErn autoMatIc analySis, acronym: AIMOTHERNeo, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: This project consists in developing a computerized clinical assessment system for newborns that takes into account the four major criteria of the various clinical scales: facial mimicry, cry, posture and movement. Classification of motor patterns according to gestational age at birth The aim of this work is the automated identification of pathological motor patterns related to anoxo-ischemic encephalopathy/brachial plexus paralysis/early neonatal bacterial infection/stroke/etc ..., conditionsModule conditions: Automated Computer Analysis, conditions: Neonatal Motor Pattern, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, outcomesModule primaryOutcomes measure: comparison of the computer score with the clinical examination, secondaryOutcomes measure: Comparison of the evolution of neurological examination and posture based on the day of life for each patient and each group of patients, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 15 Days, stdAges: CHILD, contactsLocationsModule locations facility: Department of paediatric neurological care and intentive care unity (PICU), Raymond Poincaré hospital - APHP, city: Garches, zip: 92380, country: France, geoPoint lat: 48.84226, lon: 2.18232, hasResults: False
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protocolSection identificationModule nctId: NCT06337123, orgStudyIdInfo id: K-38, briefTitle: Physica TT Tibial Plate Follow up Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Limacorporate S.p.a, class: INDUSTRY, descriptionModule briefSummary: This clinical study aims at evaluating clinical, radiographic, patient-reported outcomes of total knee arthroplasty with Physica TT Tibial Plate in combination with Physica Porous KR or Physica Porous PS up to 2 years after surgery, in order to assess the performance of the devices. Furthermore, ithe objective is to collect short-term survivorship of the implant and the incidence of early complications., conditionsModule conditions: Knee Arthropathy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: Device: Physica TT TIbial Plate and Physica Porous KR, interventions name: Device: Physica TT TIbial Plate and Physica Porous PS, outcomesModule primaryOutcomes measure: Percentage of Knee Society Score (KSS) equal or greater than "Good" (score ≥ 70) 2 years after surgery, secondaryOutcomes measure: Changes in Range of Motion over time up to 2 years after surgery, secondaryOutcomes measure: Changes in Oxford Knee Score (OKS) over time up to 2 years after surgery., secondaryOutcomes measure: Changes in Forgotten Joint Score (FJS) over time up to 2 years after surgery., secondaryOutcomes measure: Changes in Visual Analogue Scale (VAS) Pain over time up to 2 years after surgery., secondaryOutcomes measure: Radiographic implant evaluation and stability assessment from postoperative (baseline) over time up to 2 years after surgery, secondaryOutcomes measure: Survival rate (Kaplan-Meier) at 2 years after surgery, secondaryOutcomes measure: Incidence, type and severity of Adverse Device Effects (ADE) and Serious Adverse Device Effects (SADE) up to 2 years follow up, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Casa di Cura San Camillo Hopital, city: Forte Dei Marmi, state: Lucca, zip: 55042, country: Italy, contacts name: Alessandro Tripodo, role: CONTACT, contacts name: Alessandro Tripodo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.96388, lon: 10.17478, locations facility: Ospedale Privato Accreditato Sol et Salus, city: Torre Pedrera, state: Rimini, zip: 47922, country: Italy, contacts name: Marco Fravisini, role: CONTACT, contacts name: Marco Fravisini, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.10694, lon: 12.51274, locations facility: Casa di Cura Carmona, city: Messina, zip: 98100, country: Italy, contacts name: Marcello La Bruna, role: CONTACT, contacts name: Marcello La Bruna, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.19394, lon: 15.55256, locations facility: Istituto Clinico Porta Sole, city: Perugia, zip: 06100, country: Italy, geoPoint lat: 43.1122, lon: 12.38878, hasResults: False
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protocolSection identificationModule nctId: NCT06337110, orgStudyIdInfo id: 20436A, briefTitle: A Study Investigating the Movement of Lu AF28996 Into, Through, and Out of the Body of Healthy Men, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-05, primaryCompletionDateStruct date: 2024-05-25, completionDateStruct date: 2024-05-25, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: H. Lundbeck A/S, class: INDUSTRY, descriptionModule briefSummary: The main goal of this study is to learn about how Lu AF28996 moves into, through, and out of the body after a single dose is given to healthy male participants., conditionsModule conditions: Healthy Participants, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 8, type: ESTIMATED, armsInterventionsModule interventions name: Lu AF28996, outcomesModule primaryOutcomes measure: Total Recovery of the Administered Radiolabelled Drug-related Material (Percentage of Dose in Urine and Faeces), primaryOutcomes measure: AUC0-infinity: Area Under the Plasma Concentration Curve of Radiolabelled Drug-related Material from Zero to Infinity, primaryOutcomes measure: Cmax: Maximum Observed Plasma Concentration of Radiolabelled Drug-related Material, primaryOutcomes measure: Tmax: Nominal Time Corresponding to the Occurrence of Cmax of Radiolabelled Drug-related Material, primaryOutcomes measure: T½: Apparent Elimination Half-life of Radiolabelled Drug-related Material, primaryOutcomes measure: AUC0-infinity of Lu AF28996, primaryOutcomes measure: Cmax of Lu AF28996, primaryOutcomes measure: Tmax of Lu AF28996, primaryOutcomes measure: T½ of Lu AF28996, eligibilityModule sex: MALE, minimumAge: 35 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Fortrea Clinical Research Unit Ltd, city: Holbeck, state: Leeds, zip: LS11 9EH, country: United Kingdom, geoPoint lat: 53.25, lon: -1.18333, hasResults: False
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protocolSection identificationModule nctId: NCT06337097, orgStudyIdInfo id: 2023-1021, secondaryIdInfos id: NCI-2024-02687, type: OTHER, domain: NCI-CTRP Clinical Registry, briefTitle: STRICT - Surveillance With TRoponin During Immune Checkpoint Therapy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-02, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: M.D. Anderson Cancer Center, class: OTHER, descriptionModule briefSummary: To learn if monitoring blood levels of heart injury (troponin levels) in cancer participants treated with immune checkpoint inhibitors will lead to decreased heart-related side effects., conditionsModule conditions: Immune Checkpoint Therapy, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 880, type: ESTIMATED, armsInterventionsModule interventions name: Troponin surveillance, interventions name: Standard of care, outcomesModule primaryOutcomes measure: Safety and adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MD Anderson Cancer Center, status: RECRUITING, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Nicolas Palaskas, MD, role: CONTACT, phone: 713-606-3957, email: nlpalaskas@mdanderson.org, contacts name: Nicolas Palaskas, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False
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protocolSection identificationModule nctId: NCT06337084, orgStudyIdInfo id: MNPR-101-D001, briefTitle: Diagnostic Efficacy and Dosimetry of MNPR-101-DFO*-89Zr in Patients With Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Monopar Therapeutics, class: INDUSTRY, descriptionModule briefSummary: The goal of this study is to test a new PET imaging agent in patients with solid tumors. This tracer is made of a radioactively-labeled monoclonal antibody MNPR-101, and can show where tumors are present in the body using a PET-scan. The investigators will investigate if the new imaging agent correctly shows all tumor lesions. In the future, this method may be useful to help predict who will benefit from certain therapies.Participants will be injected with the radioactive tracer once. After injection, participants will undergo 3 PET-scans. Each PET-scan will take a maximum of 30 minutes. The PET-scans are on separate days within 10 days after injection of the tracer (e.g., 2 hours after injection plus 3-5 days and 7-10 days after injection). Furthermore, the investigators will take blood samples 6 times (5 mL each). Blood pharmacokinetics (PK) will be measured on Day 1 at 10 min, 1h, 2h, once on Days 3-5, and once on Days 7-10.The amount of radioactivity injected will range between 37-74 MBq (±10%)., conditionsModule conditions: Solid Tumor, Adult, conditions: Bladder Cancer, conditions: Urothelial Carcinoma, conditions: Triple-negative Breast Cancer, conditions: Lung Cancer, conditions: Colorectal Cancer, conditions: Gastric Cancer, conditions: Ovarian Cancer, conditions: Pancreatic Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Diagnostic Test: MNPR-101-DFO*-89Zr PET Scan, outcomesModule primaryOutcomes measure: assess dosimetry and biodistribution of product, primaryOutcomes measure: assess tumor Standard Uptake Values (SUV) of product, secondaryOutcomes measure: assess pharmacokinetics (PK) levels of product, otherOutcomes measure: assess tumor uptake to background and tumor uptake to liver ratios of product, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Melbourne Theranostic Innovation Centre (MTIC), status: RECRUITING, city: North Melbourne, state: Victoria, zip: 3051, country: Australia, contacts name: Referral Coordinator, role: CONTACT, phone: 03 9454 5800, geoPoint lat: -37.80132, lon: 144.95822, hasResults: False
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protocolSection identificationModule nctId: NCT06337071, orgStudyIdInfo id: AM2023MCV4Ⅱ, briefTitle: A Study of the ACYW135 Meningococcal Polysaccharide Conjugate Vaccine, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Aimei Vacin BioPharm (Zhejiang) Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study was to explore the safety and immunogenicity of the experimental vaccine compared with the control vaccines. It is planed to enroll a total of 1,200 subjects, including 300 subjects in each of the 3-5 months old, 6-11 months old, 12-23 months old and 2-15 years old groups, who will be randomly assigned to the trial in a 1:1 ratio to study group or control group. The 3-5 month-old group will have three doses vaccination at 0, 1 and 2 month, and a booster dose at 12 months of age; the 6-11month-old and 12-23 month-old groups will each have total two doses vaccination; the 2-15 year-old group will have one dose vaccination., conditionsModule conditions: Meningococcal Meningitis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 1200, type: ESTIMATED, armsInterventionsModule interventions name: ACYW135 Meningococcal Polysaccharide Conjugate Vaccine, interventions name: ACYW135 Meningococcal Polysaccharide Vaccine, outcomesModule primaryOutcomes measure: Immunogenicity 1, primaryOutcomes measure: Immunogenicity 2, primaryOutcomes measure: Immunogenicity 3, primaryOutcomes measure: Safety 1, secondaryOutcomes measure: Immunogenicity 4, secondaryOutcomes measure: Immunogenicity 5, secondaryOutcomes measure: Immunogenicity 6, secondaryOutcomes measure: Immunogenicity 7, secondaryOutcomes measure: Immunogenicity 8, secondaryOutcomes measure: Immune persistence 1, secondaryOutcomes measure: Immune persistence 2, secondaryOutcomes measure: Safety 2, secondaryOutcomes measure: Safety 3, secondaryOutcomes measure: Safety 4, eligibilityModule sex: ALL, minimumAge: 3 Months, maximumAge: 15 Years, stdAges: CHILD, contactsLocationsModule locations facility: Yunnan Center For Disease Control and Prevention, city: Kunming, state: Yunnan, zip: 650022, country: China, contacts name: ZHENG Yan, role: CONTACT, phone: +8687163627796, email: yaqueer_zy@163.com, geoPoint lat: 25.03889, lon: 102.71833, hasResults: False
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protocolSection identificationModule nctId: NCT06337058, orgStudyIdInfo id: KSUHULYAKAMALAK001, briefTitle: Motivational Interviews With Women Experiencing Sexual Dysfunction During Menopause Period, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-06-15, primaryCompletionDateStruct date: 2021-06-15, completionDateStruct date: 2022-12-15, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Hülya KAMALAK, class: OTHER, descriptionModule briefSummary: The aim of this study is to evaluate the effect of motivational interviews with women who experience sexual dysfunction during menopause on sexual quality of life and self-efficacy.The population of the study consisted of menopausal women who applied to the gynecology outpatient clinic of Kahramanmaraş Sütçü İmam University Health Practice and Research Hospital. It was calculated as 164 women (82 experimental, 82 control).In data collection, 'Personal Information Form (EK- )', 'Arizona Sexual Experiences Scale (ACYÖ) (EK- )', 'Sexual Quality of Life Scale-Female (SIQQ-F) (EK-)' and 'Sexual Self-Efficacy Scale' (Annex- )' was used., conditionsModule conditions: Sexual Dysfunction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 164, type: ACTUAL, armsInterventionsModule interventions name: Experimental group (motivational interview), outcomesModule primaryOutcomes measure: Arizona Sexual Experiences Scale - Female Version Questionnaire (ASEX-F), primaryOutcomes measure: Arizona Sexual Experiences Scale - Female Version Questionnaire (ASEX-F), primaryOutcomes measure: Sexual Quality of Life-Female Questionnaire (SQOL-F), primaryOutcomes measure: Sexual Quality of Life-Female Questionnaire (SQOL-F), primaryOutcomes measure: Sexual Self-Efficacy Scale (SSES), primaryOutcomes measure: Sexual Self-Efficacy Scale (SSES), eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kahramanmaras Sutçu Imam University, city: Kahramanmaraş, country: Turkey, geoPoint lat: 37.5847, lon: 36.92641, hasResults: False
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protocolSection identificationModule nctId: NCT06337045, orgStudyIdInfo id: AF-rehab, briefTitle: Atrial Fibrillation, Prevention and Rehabilitation, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-02-01, primaryCompletionDateStruct date: 2020-06-30, completionDateStruct date: 2020-06-30, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Odense University Hospital, class: OTHER, collaborators name: Department of Cardiology, Odense University Hospital, Odense, Denmark., collaborators name: Health Center, Municipality of Svendborg, Svendborg, Denmark., collaborators name: Department of Internal Medicine & Emergency Department, Svendborg Hospital, Odense University Hospital, Svendborg, Denmark., collaborators name: The Danish Heart Association, Funen, and local committee in Svendborg, Denmark, descriptionModule briefSummary: Evidence shows that people with atrial fibrillation (AF) can benefit from prevention and rehabilitation interventions related to quality of life, lowered anxiety, etc. In this study, a complex prevention and rehabilitation intervention for people with AF was carried out in a Health Center at a Danish municipality in cooperation with the cardiology department at Svendborg Hospital. The study was designed as a feasibility study, with data gathered systematically including focus group interviews and quantitative patient reported outcomes. People with AF were included at the hospital. Eligible participants were offered intervention in the Health Center. Interventions, in accordance with present international guidelines, consisted of physical exercise, patient education, psychosocial support and consultations with health professionals as well as risk factor management. Also, medicinal yoga (MediYoga) were chosen to be part of the intervention due to promising research results within AF. All interventions were optional and based on needs assessment and preferences.The primary objective was to investigate the feasibility of delivering a complex prevention and rehabilitation intervention for people with AF in a municipal Health Center.There were the following four secondary objectives:1. To explore the participant's experiences of participating in the municipality-based complex prevention and rehabilitation intervention.2. To explore the participant's needs and preferences of the interventions.3. To explore changes in HRQoL, anxiety and depression.4. To explore the feasibility of collecting patient reported outcome measures as part of the intervention.The hypothesis was that the complex prevention and rehabilitation intervention was feasible in a municipality-based set-up, and was well received by people with AF and may contribute to better outcomes in terms of HRQoL, anxiety and depression., conditionsModule conditions: Atrial Fibrillation, conditions: Prevention, conditions: Rehabilitation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Eligible participants were diagnosed with AF at the hospital and had symptomatic AF rated by the modified European Heart Rhythm Association (mEHRA) score ≥2B. If the patient was eligible based on the mEHRA-score, at least one of the following risk factors had to be present: hypertension, diabetes, obesity, smoking, excessive alcohol consumption, physical inactivity, sleep apnoea, anxiety, depression, or mental vulnerability., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ACTUAL, armsInterventionsModule interventions name: Complex prevention and rehabilitation intervention, outcomesModule primaryOutcomes measure: HeartQoL, primaryOutcomes measure: The hospital anxiety and depression scale (HADS), primaryOutcomes measure: Experience of participating, experiences needs and preferences of interventions, primaryOutcomes measure: Feasibility of collecting patient reported outcomes (PROMs). The PROMs was the HeartQoL and the hospital anxiety and depression scale., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Cardiology, Odense University Hospital, city: Odense, state: Region Of Southern Denmark, zip: 5000, country: Denmark, geoPoint lat: 55.39594, lon: 10.38831, locations facility: Health Center, Municipality Svendborg, city: Svendborg, state: Region Of Southern Denmark, zip: 5700, country: Denmark, geoPoint lat: 55.05982, lon: 10.60677, hasResults: False
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protocolSection identificationModule nctId: NCT06337032, orgStudyIdInfo id: GS-US-380-6684, briefTitle: A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2034-03, completionDateStruct date: 2034-03, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Gilead Sciences, class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical study is to provide continued access to the study drug(s) to children and adolescents with human immunodeficiency virus type 1 (HIV-1) who completed their participation in an applicable parent study and to monitor for adverse events.The primary objectives of this study are as follows:* To provide continued access to the study drug received in the parent protocol or switch to bictegravir/emtricitabine/tenofovir (B/F/TAF) for participants who completed a Gilead parent study evaluating drugs for HIV treatment.* To evaluate the safety of the study drug(s) in participants with HIV-1., conditionsModule conditions: HIV-1-infection, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 350, type: ESTIMATED, armsInterventionsModule interventions name: F/TAF (High Dose Tablet), interventions name: F/TAF (Low Dose Tablet), interventions name: F/TAF (Lowest Dose Tablet), interventions name: F/TAF (High Dose TOS), interventions name: F/TAF (Low Dose TOS), interventions name: F/TAF (Lowest Dose TOS), interventions name: E/C/F/TAF, interventions name: E/C/F/TAF (Low Dose), interventions name: Cobicistat (High Dose), interventions name: Cobicistat (Low Dose), interventions name: Cobicistat (TOS), interventions name: B/F/TAF (High Dose), interventions name: B/F/TAF (Low Dose), interventions name: B/F/TAF (High Dose TOS), interventions name: B/F/TAF (Low Dose TOS), interventions name: B/F/TAF (Lowest Dose TOS), interventions name: 3rd ARV Agent, interventions name: Nucleos(t)ide reverse transcriptase inhibitors (NRTI), interventions name: ATV, interventions name: DRV, interventions name: Lopinavir Boosted with ritonavir (LPV/r), outcomesModule primaryOutcomes measure: Number of Eligible Participants Who Have Received Access to the Study Drug(s) in the Study, secondaryOutcomes measure: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs), eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06337019, orgStudyIdInfo id: IRMO, briefTitle: The Italian Registry of Malnutrition in Oncology, acronym: IRMO, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-10-25, primaryCompletionDateStruct date: 2027-10, completionDateStruct date: 2027-10, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Policlinico San Matteo di Pavia, class: OTHER, collaborators name: Istituto di Ricerche Farmacologiche Mario Negri IRCCS, descriptionModule briefSummary: The aim of the Italian Registry of Malnutrition in Oncology (IRMO) is to set up a digital register of newly diagnosed or treated oncologic patients to monitor their nutritional status, early identify malnutrition and investigate the implications of nutritional support management. In particular, this project aims to establish a prospective cohort of cancer patients in order to investigate the effects of nutritional status and management on overall survival (OS) and progression free survival (PFS), and analyse the effects of the nutritional management and support on patients' symptoms and QoL., conditionsModule conditions: Cancer, conditions: Cancer Metastatic, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 1500, type: ESTIMATED, armsInterventionsModule interventions name: Cohort observational, outcomesModule primaryOutcomes measure: Overall survival, secondaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Treatment toxicity, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Istituto Tumori Giovanni Paolo II,, status: NOT_YET_RECRUITING, city: Bari, state: BA, country: Italy, contacts name: Antonella Daniele, role: CONTACT, geoPoint lat: 41.11148, lon: 16.8554, locations facility: IRCCS Saverio De Bellis, status: RECRUITING, city: Castellana Grotte, state: BA, country: Italy, contacts name: Giovanni de Pergola, role: CONTACT, contacts name: Rosalisa Cici, role: CONTACT, geoPoint lat: 40.88643, lon: 17.16549, locations facility: Istituto Ortopedico Rizzoli, status: RECRUITING, city: Bologna, state: BO, country: Italy, contacts name: Alessandra Longhi, role: CONTACT, contacts name: Toni Ibrahim, role: CONTACT, geoPoint lat: 44.49381, lon: 11.33875, locations facility: Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" IRCCS, status: RECRUITING, city: Meldola, state: FC, country: Italy, contacts name: Patrizia Serra, role: CONTACT, geoPoint lat: 44.12775, lon: 12.0626, locations facility: IRCCS Ospedale Policlinico San Martino, status: NOT_YET_RECRUITING, city: Genova, state: GE, country: Italy, contacts name: Samir Guseppe Sukkar, role: CONTACT, geoPoint lat: 44.40478, lon: 8.94438, locations facility: IRCCS Ospedale San Raffaele, Milano, status: RECRUITING, city: Milano, state: MI, country: Italy, contacts name: Roberto Mele, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Centro di Riferimento Oncologico, status: RECRUITING, city: Aviano, state: PN, country: Italy, contacts name: Renato Cannizzaro, role: CONTACT, geoPoint lat: 46.07056, lon: 12.59472, locations facility: IOV Istituto Oncologico Veneto, status: RECRUITING, city: Padova, state: PV, country: Italy, contacts name: Maria Teresa Nardi, role: CONTACT, contacts name: Marco Tonello, role: CONTACT, geoPoint lat: 45.40797, lon: 11.88586, locations facility: AUSL IRCCS Reggio-Emilia, status: RECRUITING, city: Reggio Emilia, state: RE, country: Italy, contacts name: Debora Pezzuolo, role: CONTACT, geoPoint lat: 44.69825, lon: 10.63125, locations facility: IDI IRCCS - Istituto Dermopatico dell'Immacolata, status: RECRUITING, city: Roma, state: RM, country: Italy, contacts name: Cristina Fortes, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Istituto Nazionale Tumori Regina Elena, status: RECRUITING, city: Roma, state: RM, country: Italy, contacts name: Lupe Sanchez Mete, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Policlinico Universitario Agostino Gemelli, status: RECRUITING, city: Roma, state: RM, country: Italy, contacts name: Carmelo Pozzo, role: CONTACT, contacts name: Maria Cristina Mele, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Istituto di Candiolo - Fondazione del Piemonte per l'Oncologia - IRCCS, status: RECRUITING, city: Candiolo, state: TO, country: Italy, contacts name: Filippo Montemurro, role: CONTACT, contacts name: Valentina Casalone, role: CONTACT, geoPoint lat: 44.95858, lon: 7.59812, locations facility: IRCCS Sacro Cuore Don Calabria, status: RECRUITING, city: Negrar, state: VR, country: Italy, contacts name: Stefania Gori, role: CONTACT, geoPoint lat: 45.52918, lon: 10.93899, locations facility: Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, status: NOT_YET_RECRUITING, city: Napoli, country: Italy, contacts name: Vincenzo Quagliariello, role: CONTACT, geoPoint lat: 40.85216, lon: 14.26811, locations facility: Fondazione IRCCS Policlinico San Matteo, Pavia, status: RECRUITING, city: Pavia, country: Italy, contacts name: Riccardo Caccialanza, role: CONTACT, contacts name: Paolo Pedrazzoli, role: CONTACT, geoPoint lat: 45.19205, lon: 9.15917, hasResults: False
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protocolSection identificationModule nctId: NCT06337006, orgStudyIdInfo id: SÜKAEK 2023/14/1, briefTitle: Laryngeal Mask Airway Failure in Pediatric Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-15, primaryCompletionDateStruct date: 2024-04-15, completionDateStruct date: 2024-05-15, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Samsun University, class: OTHER, descriptionModule briefSummary: There are a significant number of studies identifying risk factors for misplacement of LMAs. However, despite objective data indicating that tracheal intubation is performed inappropriately, such as air leaks, high air pressures, insufficient lung ventilation and single lung ventilation, which are easily identified after tracheal intubation, there are no objective data to define the misplacement of LMAs, which are increasingly used especially in short surgical procedures.The aim of the study was to describe unsuccessful LMA placement in pediatric patients with objective data., conditionsModule conditions: Airway Management, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Placement of the laryngeal mask airway, outcomesModule primaryOutcomes measure: Evaluation of the success of placement of the laryngeal mask airway, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Samsun University, status: RECRUITING, city: Samsun, state: Canik, zip: 55090, country: Turkey, contacts name: OZGUR KOMURCU, 1, role: CONTACT, phone: 90 505 5273180, email: zgrkom@gmail.com, contacts name: Hatice SELCUK KUSDERCİ, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.27976, lon: 36.3361, hasResults: False
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protocolSection identificationModule nctId: NCT06336993, orgStudyIdInfo id: liuxianguiji, briefTitle: Evaluation of Clinical Efficacy of Herbal Compound in the Treatment of NSLBP, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2023-06-16, completionDateStruct date: 2023-12-15, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Zhejiang Provincial Tongde Hospital, class: OTHER, descriptionModule briefSummary: The aim of this randomized controlled trial was to explore the clinical efficacy and safety of HXTL in the treatment of NSLBP based on TCM principles and to compare the clinical outcomes of different syndromes of NSLBP with celecoxib.In this study, 80 patients with NSLBP were recruited and randomly grouped to use TCM compound and celeoxib respectively for intervention. The pain status and lumbar function use scale of patients were scored before intervention, 1 week, 2 weeks and 3 weeks after intervention, and the adverse reactions of patients after medication were recorded, and the clinical efficacy of the two groups of patients was compared finally., conditionsModule conditions: Low Back Pain, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 71, type: ACTUAL, armsInterventionsModule interventions name: herbal compound, interventions name: Celecoxib, outcomesModule primaryOutcomes measure: Visual Analogue Scale, primaryOutcomes measure: Oswestry disability index, primaryOutcomes measure: Japanese Orthopaedic Association Scores, otherOutcomes measure: the adverse reactions of digestive or other system, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tongde Hospital, city: Hangzhou, state: Zhejiang, zip: 310000, country: China, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
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protocolSection identificationModule nctId: NCT06336980, orgStudyIdInfo id: 31021, briefTitle: Creating Welcoming Faith Communities for People With Serious Mental Illnesses, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-22, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Temple University, class: OTHER, collaborators name: National Institute on Disability, Independent Living, and Rehabilitation Research, descriptionModule briefSummary: The goal of this intervention study is to test a behavioral intervention to increase inclusionary practices toward individuals with serious mental illness in faith communities. The main questions it aims to answer are:1. To determine if the behavior-based intervention leads to an increase in inclusionary practices (e.g., conducting outreach with mental health agencies).2. To determine if the behavior-based intervention is effective in increasing inclusive practices by members and leaders of faith communities.3. To determine if the intervention leads to a greater understand of mental illness and a decrease in stigmatizing beliefs by congregation members.4. To determine if the intervention results in individuals with serious mental illness and their family members reporting less discrimination and increased inclusion.Congregations will be asked to create an inclusion committee that will then work on developing systems and changing congregational practices to become more inclusive. All congregation members will be invited to a half-day training that will provide information on mental illness and inclusion, and will provide tips and strategies when they encounter situations or behaviors that are less familiar to them. All congregation members will be given the opportunity to participate in a survey about congregational practices., conditionsModule conditions: Other, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 700, type: ESTIMATED, armsInterventionsModule interventions name: Increasing Inclusionary Practices in Faith Communities, outcomesModule primaryOutcomes measure: Inclusionary practices, primaryOutcomes measure: Indicators of Welcome, primaryOutcomes measure: Mental Health Knowledge Questionnaire, primaryOutcomes measure: Social Distance Scale, primaryOutcomes measure: Community Attitudes Toward the Mentally Ill, primaryOutcomes measure: Reported and Intended Behavior Scale, primaryOutcomes measure: Sense of Belonging Scale, secondaryOutcomes measure: University of California Los Angeles Loneliness Scale, secondaryOutcomes measure: Lerman Quality of Life Interview, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Temple Univeristy, status: RECRUITING, city: Philadelphia, state: Pennsylvania, zip: 19121, country: United States, contacts name: Crystal Slanzi, PhD, role: CONTACT, email: crystal.slanzi@temple.edu, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False
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protocolSection identificationModule nctId: NCT06336967, orgStudyIdInfo id: 855282, briefTitle: Testing a Wellness App for First Responders, Military Personnel and Veterans, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: University of Pennsylvania, class: OTHER, collaborators name: Nlyten Corp, descriptionModule briefSummary: The purpose of the research study is to trial a smart phone application, the GUIDE App, to better understand its impact on social connectedness, personal growth and mental health/wellness among first responders, soldiers, and veterans. The research team will also investigate workplace metrics (e.g., engagement and burnout), implementation outcomes and technical merit. The investigators plan to run a three-armed randomized waitlist pilot feasibility trial with up to 150 participants., conditionsModule conditions: Mental Health Wellness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: GUIDE, outcomesModule primaryOutcomes measure: PERMA-Profiler Overall Wellbeing Score, primaryOutcomes measure: Patient Health Questionnaire for depression symptoms (PHQ-8), primaryOutcomes measure: Generalized Anxiety Disorder (GAD-7), primaryOutcomes measure: WHO Well-being Index (WHO-5), primaryOutcomes measure: Personal Wellbeing Score (PWS), primaryOutcomes measure: Difficulties in Emotion Regulation Scale Short Form (DERS-SF), secondaryOutcomes measure: Positive Emotion (Positive emotion subscale of the PERMA-Profiler), secondaryOutcomes measure: Social Connectedness (Engagement and Relationship subscales of PERMA-Profiler), secondaryOutcomes measure: Social Connectedness (Number of posts/comments in the app), secondaryOutcomes measure: Personal Growth (Meaning and Accomplishment subscales of the PERMA-Profiler), secondaryOutcomes measure: Personal Growth (Total GUIDE lessons and courses completed), secondaryOutcomes measure: Utrecht Work Engagement Scale (UWES-17), secondaryOutcomes measure: Maslach Burnout Inventory (MBI), secondaryOutcomes measure: Job Retention (Employment status), otherOutcomes measure: Feasibility of Intervention Measure (FIM), otherOutcomes measure: Acceptability of Intervention Measure (AIM), otherOutcomes measure: Intervention Appropriateness Measure (IAM), otherOutcomes measure: System Usability Scale (SUS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Pennsylvania, city: Philadelphia, state: Pennsylvania, zip: 19146, country: United States, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False
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protocolSection identificationModule nctId: NCT06336954, orgStudyIdInfo id: MA-NSCLC-#-037, briefTitle: Adibelimab, Famitinib and Chemotherapy for Advanced NSCLC After PD-1 Inhibitor Failure, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Second Affiliated Hospital of Xi'an Jiaotong University, class: OTHER, descriptionModule briefSummary: This prospective, single-arm trial explores the efficacy of Adibelimab monoclonal antibody combined with Famitinib and chemotherapy in treating locally advanced or metastatic NSCLC patients with negative driver genes who have progressed after PD-1 monoclonal antibody and chemotherapy treatment. The study focuses on assessing progression-free survival (PFS) in 40 participants. Key objectives include evaluating PFS and understanding the progression patterns post-first-line immunotherapy, with an interest in whether switching from PD-1 to PD-L1 inhibitors can overcome immune resistance., conditionsModule conditions: Non Small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Adibelimab, outcomesModule primaryOutcomes measure: Progression-free survival time (PFS), secondaryOutcomes measure: Objective Response Rate, secondaryOutcomes measure: Duration of Response, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Treatment-Related Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06336941, orgStudyIdInfo id: 32822, briefTitle: "Ultra-High Frequency intraOral UltraSonography of the TONgue" (HOUSTON), acronym: HOUSTON, statusModule overallStatus: RECRUITING, startDateStruct date: 2018-06-07, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2030-12-31, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: University of Pisa, class: OTHER, descriptionModule briefSummary: Oral diseases are currently diagnosed by means of clinical examination and supported by surgical biopsy procedures. In particular, daily oral medicine practice is lacking the use of a routine diagnostic support to the visualization of anatomical structures located beyond the mucosal surface. Considering the growing interest in minimally invasive diagnosis, the possibility of having an imaging technique dedicated to the investigation of oral soft tissues and their alterations may be instrumental to support the clinical diagnosis. Therefore, attempts to introduce conventional ultrasonography (US) to the diagnostic work-up of pathological conditions of the head and neck have been done, exploiting the unique features of this technique in terms of limited invasive- ness, repeatability, and cost efficiency.In the literature, both extraoral and intraoral applications of US have been reported. Extraoral applications mainly focus on the characterization of oral and maxillofacial swellings of various origin, while intraoral applications mostly involve the study of malignant lesions in terms of tumor thickness and depth of invasion. The aim of the present protocol is to evaluate the role of intraoral ultra-high frequency ultrasonography in the study of oral mucosal lesions., conditionsModule conditions: Oral Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Ultrasound, outcomesModule primaryOutcomes measure: Depth of invasion, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Università di Pisa, status: RECRUITING, city: Pisa, zip: 56126, country: Italy, contacts name: Rossana Izzetti, DS, PhD, role: CONTACT, phone: +39050993037, email: rossana.izzetti@unipi.it, geoPoint lat: 43.70853, lon: 10.4036, hasResults: False
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protocolSection identificationModule nctId: NCT06336928, orgStudyIdInfo id: 1B-23-6, secondaryIdInfos id: NCI-2024-01332, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 1B-23-6, type: OTHER, domain: USC / Norris Comprehensive Cancer Center, secondaryIdInfos id: P30CA014089, type: NIH, link: https://reporter.nih.gov/quickSearch/P30CA014089, briefTitle: A Validation Study to Determine Concordance of Liquid Biopsy and Breast Cancer Diagnosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2029-04-01, completionDateStruct date: 2030-04-01, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: University of Southern California, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: This study evaluates whether a special type of blood analysis, called liquid biopsy (LBx), correlates with mammography results and/or diagnosis of breast cancer., conditionsModule conditions: Breast Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 490, type: ESTIMATED, armsInterventionsModule interventions name: Non-Interventional Study, outcomesModule primaryOutcomes measure: Assess the sensitivity and specificity of LBx as a screening method for breast cancer, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Keck Medicine of USC Koreatown, city: Los Angeles, state: California, zip: 90020, country: United States, contacts name: Bomi Choi, role: CONTACT, phone: 323-865-0451, email: Bomi.Choi@med.usc.edu, contacts name: Anastasia Martynova, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, locations facility: Los Angeles General Medical Center, city: Los Angeles, state: California, zip: 90033, country: United States, contacts name: Kimberly Arieli, RN, role: CONTACT, phone: 323-865-0451, email: Kimberly.Arieli@med.usc.edu, contacts name: Anastasia Martynova, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, locations facility: USC / Norris Comprehensive Cancer Center, city: Los Angeles, state: California, zip: 90033, country: United States, contacts name: Kimberly Arieli, RN, role: CONTACT, phone: 323-865-0451, email: Kimberly.Arieli@med.usc.edu, contacts name: Anastasia Martynova, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, locations facility: USC Norris Oncology/Hematology-Newport Beach, city: Newport Beach, state: California, zip: 92663, country: United States, contacts name: Kristy Massopust, role: CONTACT, phone: 949-474-5733, email: Massopust_K@med.usc.edu, contacts name: Anastasia Martynova, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.61891, lon: -117.92895, hasResults: False
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protocolSection identificationModule nctId: NCT06336915, orgStudyIdInfo id: 121.NUR.2022.D, briefTitle: Physician-Nurse Dyad Rounding: A Collaborative Approach to Improve Unit-Level Metrics, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-03, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Methodist Health System, class: OTHER, descriptionModule briefSummary: The project will be implemented on one unit at a time until the co-rounding process has been implemented on each Medical-Surgical unit. This study will involve the geo-localized hospitalist on the designated unit and the nursing staff involved in clinical patient care, conditionsModule conditions: Wellness, Psychological, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Physician-Nurse Dyad Rounding, outcomesModule primaryOutcomes measure: Difference in percentage of discharged patients before 1400 (Mon-Fri) after project implementation compared to before implementation, secondaryOutcomes measure: Difference in Top Box Patient Satisfaction Scores and Doctor Domain, secondaryOutcomes measure: Difference in LOS of private hospitalist patients after project implementation compared to before implementation, secondaryOutcomes measure: Difference in collaboration and build positive relationships scores after project implementation compared to before implementation, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinical Research Institute at Methodist Health System, status: RECRUITING, city: Dallas, state: Texas, zip: 75203, country: United States, contacts name: Colette N Ndjom, MS, role: CONTACT, phone: 410-947-4681, phoneExt: 74681, email: ColetteNgoNdjom@mhd.com, contacts name: Loretta W Bedell, MPH, role: CONTACT, phone: 214-947-4680, phoneExt: 74680, email: lorettabedell@mhd.com, contacts name: Lauren Hoffman, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Methodist Dallas Medical Center, status: NOT_YET_RECRUITING, city: Dallas, state: Texas, zip: 75203, country: United States, contacts name: Colette N Ndjom, MS, role: CONTACT, phone: 214-947-4681, email: mhsirb@mhd.com, contacts name: Loretta W Bedell, MPH, role: CONTACT, phone: 217-947-4680, email: mhsirb@mhd.com, contacts name: Lauren Hoffman, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.78306, lon: -96.80667, hasResults: False
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protocolSection identificationModule nctId: NCT06336902, orgStudyIdInfo id: 3C-23-11, secondaryIdInfos id: NCI-2024-01368, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 3C-23-11, type: OTHER, domain: USC / Norris Comprehensive Cancer Center, secondaryIdInfos id: P30CA014089, type: NIH, link: https://reporter.nih.gov/quickSearch/P30CA014089, briefTitle: Botensilimab Plus Balstilimab and Fasting Mimicking Diet Plus Vitamin C for Patients With KRAS-Mutant Metastatic Colorectal Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2027-04-01, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: University of Southern California, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: This phase Ib trial tests the safety, side effects, and effectiveness of botensilimab, and balstilimab in combination with a fasting mimicking diet and high dose vitamin C in treating patients with KRAS-mutant metastatic colorectal cancer. Botensilimab and balstilimab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. KRAS is protein found on some tumor cells that is involved in the growth of tumor cells. KRAS mutant cells have been found to be more sensitive to vitamin C induced growth suppression in the presence of low-sugar (glucose). A fasting mimicking diet, a plant-based, calorie reduced, low-sugar diet alternating with refeeding periods, may positively change the way the body responds to cancer treatment. Vitamin C is a nutrient that the body needs in small amounts to function and stay healthy. It is an antioxidant that that can help prevent cell damage and may block growth and spread of tumor cells. Botensilimab and balstilimab in combination with a fasting mimicking diet and high dose vitamin C may be safe, tolerable and effective in treating patients with KRAS-mutant metastatic colorectal cancer., conditionsModule conditions: Metastatic Colorectal Adenocarcinoma, conditions: Stage IV Colorectal Cancer AJCC v8, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Balstilimab, interventions name: Biospecimen Collection, interventions name: Botensilimab, interventions name: Computed Tomography, interventions name: Dietary Intervention, interventions name: Magnetic Resonance Imaging, interventions name: Vitamin C, outcomesModule primaryOutcomes measure: Proportion of patients who adhere to the fast mimicking diet, primaryOutcomes measure: Incidence of adverse events (AEs), secondaryOutcomes measure: Overall response rate (ORR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Los Angeles General Medical Center, city: Los Angeles, state: California, zip: 90033, country: United States, contacts name: Charlean Ketchens, RN, role: CONTACT, phone: 323-865-0451, email: Charlean.Ketchens@med.usc.edu, contacts name: Rabia Rehman, role: CONTACT, phone: 323-865-0451, email: Rabia.Rehman@med.usc.edu, contacts name: Diana Hanna, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, locations facility: USC / Norris Comprehensive Cancer Center, city: Los Angeles, state: California, zip: 90033, country: United States, contacts name: Charlean Ketchens, RN, role: CONTACT, phone: 323-865-0451, email: Charlean.Ketchens@med.usc.edu, contacts name: Rabia Rehman, role: CONTACT, phone: 323-865-0451, email: Rabia.Rehman@med.usc.edu, contacts name: Diana Hanna, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, hasResults: False
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protocolSection identificationModule nctId: NCT06336889, orgStudyIdInfo id: 092.TRA.2018.D, briefTitle: Pelvic Angioembolization: A Prospective Multi-Institutional Study (Data From All Campuses Will be Used), statusModule overallStatus: RECRUITING, startDateStruct date: 2017-10-26, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Methodist Health System, class: OTHER, descriptionModule briefSummary: The investigator's propose a multicenter prospective observational study to investigate the use of embolization in patients with negative angiogram and to ascertain the optimal level of treatment when the angiogram is positive; non-selective vs. selective embolization., conditionsModule conditions: Pelvic Hemorrhage, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Pelvic Angioembolization, outcomesModule primaryOutcomes measure: Mortality outcome, primaryOutcomes measure: transfusion requirements, primaryOutcomes measure: thromboembolic events, secondaryOutcomes measure: Patient demographics(age, sex), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Methodist Dallas Medical Center, status: RECRUITING, city: Dallas, state: Texas, zip: 75201, country: United States, contacts name: Jennifer Burris, MD, role: CONTACT, phone: 214-947-1280, email: clinicalresearch@mhd.com, geoPoint lat: 32.78306, lon: -96.80667, hasResults: False
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protocolSection identificationModule nctId: NCT06336876, orgStudyIdInfo id: 080.EDU.2019.R, briefTitle: Perceived Coping, Meaning, and Joy at Work, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-06-30, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Methodist Health System, class: OTHER, descriptionModule briefSummary: The aim of this study is to assess and describe employee characteristics associated with perceived horizontal inter-collegial workplace uncivil behavior within nursing services, and identify any relationships with meaning and joy in work (MJW), and assess job satisfaction., conditionsModule conditions: Undefined, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 84, type: ESTIMATED, armsInterventionsModule interventions name: Survey, outcomesModule primaryOutcomes measure: Workplace Incivil Behavior, primaryOutcomes measure: Meaning, Joy in Work, primaryOutcomes measure: Occupational Coping Self-Efficacy, primaryOutcomes measure: Demographic, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Methodist Richardson Medical Center, status: RECRUITING, city: Richardson, state: Texas, zip: 75082, country: United States, contacts name: Maxine Adegbola, RN, role: CONTACT, phone: 214-876-9767, email: maxineadegbola@mhd.com, contacts name: Maxine Adegbola, RN, role: PRINCIPAL_INVESTIGATOR, contacts name: David Irvan, RN, role: SUB_INVESTIGATOR, contacts name: Terri Daugherty, RN, role: SUB_INVESTIGATOR, contacts name: Joanna Bender, RN, role: SUB_INVESTIGATOR, contacts name: Tabitha Moore, RN, role: SUB_INVESTIGATOR, contacts name: Sharon Blackerby, RN, role: SUB_INVESTIGATOR, contacts name: Katherine Hartdegen, RN, role: SUB_INVESTIGATOR, contacts name: Melissa Miller, RN, role: SUB_INVESTIGATOR, contacts name: Shannon Jackson, RN, role: SUB_INVESTIGATOR, contacts name: Obed Thomas, RN, role: SUB_INVESTIGATOR, geoPoint lat: 32.94818, lon: -96.72972, hasResults: False
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protocolSection identificationModule nctId: NCT06336863, orgStudyIdInfo id: STU-2023-1151, briefTitle: Use of DNA Testing and Gene Expression Profiling to Help Transition Kidney Transplant Recipients to Belatacept-only Immunosuppression, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-08, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: University of Texas Southwestern Medical Center, class: OTHER, descriptionModule briefSummary: The purpose of the study is to provide immunosuppression weaning and/or monitoring for an additional 12-months to evaluate the safety and efficacy of belatacept monotherapy in patients previously enrolled in the clinical trial: "Use of donor derived-cell free DNA (AlloSure) and gene expression profiling (AlloMap Kidney) to facilitate Belatacept monotherapy in kidney transplant patients.", conditionsModule conditions: Kidney Transplant Immunosuppression, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Allosure and TruGraf, interventions name: Immunosuppression Taper, outcomesModule primaryOutcomes measure: Incidence of acute kidney graft rejection, primaryOutcomes measure: Incidence of facilitation to Belatacept monotherapy, secondaryOutcomes measure: Patient Survival after Immunosuppression Wean, secondaryOutcomes measure: Kidney Graft Failure after Immunosuppression Wean, secondaryOutcomes measure: Mean change in Estimated Glomerular Filtration Rate (eGFR) after Immunosuppression Wean, secondaryOutcomes measure: Incidence of Proteinuria after Immunosuppression Wean, secondaryOutcomes measure: Incidence of de-novo donor specific antibodies (dnDSA), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Texas Southwestern Medical Center, city: Dallas, state: Texas, zip: 75390, country: United States, contacts name: David Wojciechowski, DO, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.78306, lon: -96.80667, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2024-03-06, uploadDate: 2024-03-28T09:25, filename: Prot_SAP_000.pdf, size: 293395, hasResults: False
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protocolSection identificationModule nctId: NCT06336850, orgStudyIdInfo id: 069.GID.2020.D, briefTitle: Safety and Efficacy of Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-12-23, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Methodist Health System, class: OTHER, descriptionModule briefSummary: The purpose of this study is to evaluate the efficacy, safety, and adequacy of Endoscopic Ultrasound (EUS) Portal Pressure Gradient Measurement (PPGM) in patients undergoing EUS-guided liver biopsies., conditionsModule conditions: Liver Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement, outcomesModule primaryOutcomes measure: Portal Pressure Gradient Measurements from Hepatic and Portal Veins, secondaryOutcomes measure: Correlation between Portal Pressure Gradient Measurements and the presence or absence of portal hypertension, secondaryOutcomes measure: Clinical significance between portal pressure gradient measurement and portal hypertension, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Methodist Dallas Medical Center, status: RECRUITING, city: Dallas, state: Texas, zip: 75203, country: United States, contacts name: Prashant Kedia, MD, role: CONTACT, geoPoint lat: 32.78306, lon: -96.80667, hasResults: False
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protocolSection identificationModule nctId: NCT06336837, orgStudyIdInfo id: 24-3T/48, briefTitle: False Positive Peripheral Blood Culture in Children With Leukaemia: A Prevalence Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Ege University, class: OTHER, descriptionModule briefSummary: Chemotherapy, the main treatment for childhood leukemia, has side effects on healthy cells. One of the most important of these side effects is the risk of infection due to neutropenia. In clinics, blood culture is the gold standard for the detection of possible infection risk (bacteremia, fungemia, etc.). During the diagnosis and treatment process in children with leukemia, a large number of peripheral or catheter blood cultures are performed. When the culture results are positive, it is accepted that the infection has grown. In some cases, a positive peripheral blood culture result may not be clinically significant. An agent belonging to the skin flora of the patient or the healthcare professional taking the field culture may also cause the blood culture result to be positive. This is called contamination or false positive blood culture. Contaminated cultures may cause prolonged hospitalization, additional medical interventions, unnecessary initiation of antibiotic treatment and related antibiotic resistance, toxicity due to additional drugs and an increase in hospital costs. The peripheral blood culture contamination rate, which is accepted as a quality indicator in some countries, should be below 3%.In this context, this study aimed to determine the prevalence of false positive peripheral blood cultures by examining the peripheral blood culture results obtained during routine follow-ups from children hospitalized with leukemia in the pediatric hematology clinic. The data will be collected retrospectively covering three years before March 2024 when the ethics committee approval was obtained. Since the relevant clinic cares for approximately 25 new children diagnosed with leukemia annually, the study sample is planned as 75 cases., conditionsModule conditions: Nurse's Role, conditions: Leukemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: blood culture contamination rate, eligibilityModule sex: ALL, minimumAge: 0 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Ege University, status: RECRUITING, city: İzmir, zip: 35100, country: Turkey, contacts name: Seda ARDAHAN SEVGILI, PhD, role: CONTACT, phone: 00905544318390, email: sedardahan@gmail.com, contacts name: Figen YARDIMCI, PhD, role: CONTACT, email: figenyardimci@gmail.com, geoPoint lat: 38.41273, lon: 27.13838, hasResults: False
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protocolSection identificationModule nctId: NCT06336824, orgStudyIdInfo id: EVOS 1.2 dated 25/10/2023, briefTitle: Early Intravenous to Oral Antibiotic Switch in Uncomplicated Staphylococcus Aureus Bacteraemia, acronym: EVOS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Clinical Research Centre, Malaysia, class: OTHER, descriptionModule briefSummary: The Early Intravenous to Oral Antibiotic Switch in Uncomplicated Staphylococcus aureus Bacteraemia (EVOS) study is a multicentre, randomized, open-label, parallel group, phase 3, non-inferiority trial of early intravenous to oral antibiotic switch in comparison with standard intravenous antibiotic regime among patients with uncomplicated Staphylococcus aureus bacteraemia (SAB). The study is based on the hypothesis that an early switch from IV to oral antimicrobial therapy is non-inferior and safe compared to conventional minimum 14-day course of IV therapy in patients with low-risk uncomplicated SAB., conditionsModule conditions: Staphylococcus Aureus Bacteremia, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 290, type: ESTIMATED, armsInterventionsModule interventions name: Tab. Trimethoprim-sulfamethoxazole, Tab. Clindamycin, Tab. Cephalexin, or Tab. Linezolid, interventions name: IV Cloxacillin, IV Cefazolin, IV Vancomycin, or IV Ceftaroline, outcomesModule primaryOutcomes measure: Rate of SAB-relapse, secondaryOutcomes measure: Number of days of hospitalization, secondaryOutcomes measure: Rate of all-cause mortality, secondaryOutcomes measure: Rate of complications related to IV therapy, secondaryOutcomes measure: Rate of Clostridium difficile diarrhoea, secondaryOutcomes measure: Rate of adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Sultanah Aminah, city: Johor Bahru, state: Johor, zip: 80100, country: Malaysia, contacts name: Wei Xuan Tuang, role: CONTACT, email: weixuan0706@gmail.com, geoPoint lat: 1.4655, lon: 103.7578, locations facility: Hospital Sultanah Bahiyah, city: Alor Setar, state: Kedah, zip: 05460, country: Malaysia, contacts name: Sharifah Baizura Syed Alwi, role: CONTACT, email: baizura1973@hotmail.my, geoPoint lat: 6.12104, lon: 100.36014, locations facility: Hospital Sultan Abdul Halim, city: Sungai Petani, state: Kedah, zip: 08000, country: Malaysia, contacts name: Noralfazita An, role: CONTACT, email: noralfazitaa@moh.gov.my, geoPoint lat: 5.647, lon: 100.48772, locations facility: Hospital Tuanku Ja'afar, city: Seremban, state: Negeri Sembilan, zip: 70300, country: Malaysia, contacts name: Tiang Koi Ng, role: CONTACT, email: tiangkoi79@yahoo.com, geoPoint lat: 2.7297, lon: 101.9381, locations facility: Hospital Pulau Pinang, city: George Town, state: Penang, zip: 10450, country: Malaysia, contacts name: Chuan Huan Chuah, role: CONTACT, email: chchuah7@yahoo.com, geoPoint lat: 5.41123, lon: 100.33543, locations facility: Hospital Seberang Jaya, city: Seberang Jaya, state: Penang, zip: 13700, country: Malaysia, contacts name: Peng Peng Ang, role: CONTACT, email: angpp2209@gmail.com, geoPoint lat: 5.39085, lon: 100.41044, locations facility: Hospital Raja Permaisuri Bainun, city: Ipoh, state: Perak, zip: 30450, country: Malaysia, contacts name: Steven Lim, role: CONTACT, email: stevenlimcl@gmail.com, geoPoint lat: 4.5841, lon: 101.0829, locations facility: Hospital Ampang, city: Ampang, state: Selangor, zip: 68000, country: Malaysia, contacts name: Suraya Hanim Abdullah Hashim, role: CONTACT, email: surayahanim.abdullahhashim@gmail.com, locations facility: Hospital Sultan Idris Shah Serdang, city: Kajang, state: Selangor, zip: 43000, country: Malaysia, contacts name: Kah Chuan Lim, role: CONTACT, email: ck7902@gmail.com, geoPoint lat: 2.99424, lon: 101.78875, locations facility: Hospital Tengku Ampuan Rahimah, city: Klang, state: Selangor, zip: 41200, country: Malaysia, contacts name: Azureen Azmel, role: CONTACT, email: aazmel@gmail.com, geoPoint lat: 3.03333, lon: 101.45, locations facility: Hospital Selayang, city: Selayang Baru Utara, state: Selangor, zip: 68100, country: Malaysia, contacts name: Anuradha P. Radhakrisnan, role: CONTACT, email: anurapr70@gmail.com, geoPoint lat: 3.2549, lon: 101.6668, locations facility: Hospital Melaka, city: Melaka, zip: 75400, country: Malaysia, contacts name: Wee Fu Gan, role: CONTACT, email: ganweefu@gmail.com, geoPoint lat: 2.196, lon: 102.2405, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-10-25, uploadDate: 2024-03-28T09:13, filename: Prot_SAP_001.pdf, size: 749936, hasResults: False
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protocolSection identificationModule nctId: NCT06336811, orgStudyIdInfo id: DEU active-pasive VR, briefTitle: Virtual Reality Distraction During Phlebotomy in Children, acronym: activeVR, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-05-30, primaryCompletionDateStruct date: 2023-12-30, completionDateStruct date: 2023-12-30, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Dokuz Eylul University, class: OTHER, descriptionModule briefSummary: This randomized controlled study was conducted to evaluate the effect of distraction methods using virtual reality on the emotional appearance, pain, fear, and anxiety associated with the procedure during phlebotomy in children aged 6-12 in a private blood collection unit., conditionsModule conditions: Pain, Acute, conditions: Child, Only, conditions: Anxiety and Fear, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: Before blood collection, the "Emotional Appreance Scale for Children" was evaluated by a non-researcher nurse. Pediatric patients between the ages of 6 and 12, from whom blood would be collected, were distributed to groups according to the randomization scheme., whoMasked: INVESTIGATOR, enrollmentInfo count: 150, type: ACTUAL, armsInterventionsModule interventions name: passive virtual reality distraction, interventions name: active virtual reality distraction, outcomesModule primaryOutcomes measure: procedure related pain, primaryOutcomes measure: anxiety, primaryOutcomes measure: fear, primaryOutcomes measure: emotional apperance, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Gülçin Özalp Gerçeker, city: İzmir, zip: 35100, country: Turkey, geoPoint lat: 38.41273, lon: 27.13838, hasResults: False
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protocolSection identificationModule nctId: NCT06336798, orgStudyIdInfo id: STUDY00005871, secondaryIdInfos id: K23HL166775, type: NIH, link: https://reporter.nih.gov/quickSearch/K23HL166775, briefTitle: Bioenergetic Effect of Pioglitazone in CLD-PH, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2028-08, completionDateStruct date: 2028-08, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Emory University, class: OTHER, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule briefSummary: The goal of this clinical trial is to learn about the safety and efficacy of Pioglitazone in people with Pulmonary Hypertension (PH) due to Chronic Lung Disease (CLD). The main question it aims to answer is:• Whether pioglitazone affects mitochondrial oxygen utilization in patients with PH due to CLD.Participants will be asked to take pioglitazone or placebo once daily for 28 days followed by a washout period of 2 weeks followed by 28 days of the other study drug (participants randomized to placebo followed by pioglitazone or pioglitazone followed by placebo)., conditionsModule conditions: Pulmonary Hypertension, conditions: Pulmonary Hypertension Due to Lung Diseases, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Pioglitazone 30mg, interventions name: Placebo, interventions name: Labs, outcomesModule primaryOutcomes measure: Change in Mitochondrial metabolism parameters: Spare respiratory capacity, primaryOutcomes measure: Change in Mitochondrial metabolism parameters: Maximal respiration, primaryOutcomes measure: Change in Mitochondrial metabolism parameters: Basal respiration, secondaryOutcomes measure: Number of hypoglycemia incidences, secondaryOutcomes measure: Number of participants with leg edema, secondaryOutcomes measure: Change in BNP levels, secondaryOutcomes measure: Change in Six minute walk distance (6MWT), secondaryOutcomes measure: Change in Borg dyspnea score, secondaryOutcomes measure: Change in NYHA/WHO Functional Classification, secondaryOutcomes measure: Change in University of California San Diego Shortness of Breath Questionnaire score, secondaryOutcomes measure: Change in emPHasis-10 Questionnaire score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06336785, orgStudyIdInfo id: 04-2023-HIT-K&S, briefTitle: Kiss and Smile HIT, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-02, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2025-11-30, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Erevna Innovations Inc., class: OTHER, descriptionModule briefSummary: The "Holistic Individualized Treatment" (HIT) approach is used to identify treatment priorities, focus areas, and appropriate products for soft tissue filler treatments.The "Kiss and Smile HIT" considers lip volume, lip framing and expression to improve patients appearance. This trial will assess the effectiveness of the Kiss and Smile HIT algorithm in treating patients with different kiss and smile related issues (e.g. volume loss, lips lack proper framing, lack of a confident smile due to issues with expression)., conditionsModule conditions: Aesthetic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Restylane line of dermal fillers and Dysport neuromodulator, outcomesModule primaryOutcomes measure: Global Aesthetic Improvement Scale (GAIS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Erevna Innovations Inc., status: RECRUITING, city: Montréal, state: Quebec, zip: H3R3A1, country: Canada, contacts name: Andreas Nikolis, MD, role: CONTACT, phone: 514-488-0163, email: research@vicpark.com, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False
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protocolSection identificationModule nctId: NCT06336772, orgStudyIdInfo id: 10-2023-GAL-SHYP, briefTitle: Restylane Shaype Versus Juvederm Volux for Chin Augmentation, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-10-23, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-11-01, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Erevna Innovations Inc., class: OTHER, descriptionModule briefSummary: This study aims to compare two injectable products (Restylane Shaype and Juvéderm Volux) for aesthetic augmentation of the chin, conditionsModule conditions: Chin Retrusion, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: Restylane Shaype, interventions name: Juvéderm Volux, outcomesModule primaryOutcomes measure: Statistically significant group differences in the average three-dimensional volumetric increase since baseline, secondaryOutcomes measure: Treatment group differences assessed by blinded evaluations on a validated chin retrusion scale (Galderma Chin Retrusion Scale), secondaryOutcomes measure: Treatment group differences assessed by blinded evaluations of aesthetic improvement (Global Aesthetic Improvement Scale), secondaryOutcomes measure: Assessment of product integration by means of ultrasound (the radius or surface area of in vivo product placed within tissues, integration [or lack thereof] of the product into the surrounding tissues), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Erevna Innovations Inc., city: Montréal, state: Quebec, zip: H3R3A1, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False
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