data
stringlengths 358
232k
|
|---|
protocolSection identificationModule nctId: NCT06352359, orgStudyIdInfo id: ONC-841-002, briefTitle: Safety, Pharmacokinetics (PK), and Efficacy of ONC 841 in Advanced Solid Tumors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-30, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2027-06-30, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: OncoC4, Inc., class: INDUSTRY, descriptionModule briefSummary: This is a Phase I open label, dose-escalation study of intravenous (IV) infusion of ONC-841 as a single agent in patients with advanced/metastatic solid tumors. The study will evaluate seven dose levels of ONC-841 starting from 0.03 mg/kg to 30 mg/kg., conditionsModule conditions: Advanced Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: ONC-841, outcomesModule primaryOutcomes measure: Dose Limiting Toxicity (DLT), primaryOutcomes measure: Maximum Toxicity Dose (MTD), secondaryOutcomes measure: Cmax of ONC-841, secondaryOutcomes measure: The serum half-life of ONC-841, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of California at Davis Cancer Center, city: Sacramento, state: California, zip: 95817, country: United States, contacts name: Tianhong Li, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.58157, lon: -121.4944, locations facility: Norton Cancer Center, city: Louisville, state: Kentucky, zip: 40202, country: United States, contacts name: John Hamm, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.25424, lon: -85.75941, locations facility: Tranquil Clinical Research, city: Houston, state: Texas, zip: 77598, country: United States, contacts name: John Knecht, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False
|
protocolSection identificationModule nctId: NCT06352346, orgStudyIdInfo id: Plan Game_ABI&Psychiatry, briefTitle: A Single-case Design to Investigate a Compensatory Brain Game Supporting Goal Management Training Intervention in a Psychiatric Brain Injury Population, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: ProPersona, class: OTHER, descriptionModule briefSummary: The main cognitive complaint in brain-injured patients is often the everyday disorganization caused by Executive Function (EF) deficits. EF deficits are often seen in patients with psychiatric disorders i.e. depression or anxiety. In order to minimize everyday disorganization, effective EF interventions are required. Interventions using compensatory strategies have the potential to enable patients to minimize disabilities, minimize participation problems and to function more independently in daily life. A well-known evidence-based intervention that uses compensatory strategies is Goal Management Training (GMT), a training that has been found to alleviate depressive symptoms in a depressed population. GMT entails learning and applying an algorithm, in which a daily task is subdivided into multiple steps to handle executive difficulties of planning, and problem solving. To adopt the GMT strategy and ensure maximal profitability for patients, they have to learn to use the algorithm in different situations and tasks. Therefore, GMT is comprehensive, time-consuming and thus labour-intensive. Along with this, brain games become increasingly attractive as an (add-on) intervention, most notably in an effort to develop home-based personalized care. Until now, however, the rationale behind brain games is based on what can be considered the restorative approach (i.e. strengthening of executive problems) rather than practicing compensatory strategies, with little or no transfer to improvements in daily life functioning. This study therefore aims to assess the potential of a newly developed Brain Game, based on compensatory strategies, as an add-on to GMT to develop a shortened and partly self-paced GMT intervention. The primary objective of this study is to assess whether the use of a compensatory brain game supported GMT treatment could be of interest in people with EF deficits after ABI that also suffer from depression or anxiety, to improve goal achievement, their executive function performance during goal-related tasks, and their executive performance during an ecological valid shopping task. Also we assess whether psychological symptoms alleviate following the GMT intervention and at 6-weeks follow-up. The study will be a multiple-baseline across individuals single-case experimental design (SCED). The study population consists of brain-injured patients, between 18 and 75 years old that receive in-patient mental neuropsychiatric healthcare. Participants eligible for the study must have EF deficits due to (nonprogressive) Acquired Brain Injury (ABI), minumum time post-onset of 3 months and depressive or anxiety symptoms. EF deficits will be assessed by extensive neuropsychological examination. Participants will be recruited from an inpatient clinic. In the course of one and a half year four participants will be recruited., conditionsModule conditions: Acquired Brain Injury, conditions: Depressive Symptoms, conditions: Anxiety, conditions: Executive Dysfunction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: A randomized Single-case Experimental Design (SCED) with a follow-up period of 6 weeks. Participants will be first assigned to a baseline phase (phase A). The start of the treatment phase (phase B) is determined randomly for each participant, given the restriction that the baseline phase (phase A) should last for at least three weeks (21 days) and at most five weeks (30 days). This means that the treatment phase can start on any day between the 21th and the 30th days. So, in the first three weeks, all participants are in the baseline condition. The duration of baseline will thus be different for each subject. Nonspecific effects, such as linear trends, retesting or non-specific recovery, can be controlled by this approach, since expected changes in level of performance due to treatment should parallel this stepwise onset of therapy procedure.Phase A acts as a control and is therefore compared with phase B., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The target behavior (i.e. performance on an untrained shopping task) will be measured repeatedly, on a minimum of six occasions in each phase where possible, in accordance with the recommendations of the What Works Clearinghouse and RoBiNT criteria. Repeated measures of target behavior will be assessed via the OxMET-NL task and is scored automatically: no assessor input is required to either save or score the main outcome data. The secondary outcome measure(s) are scored by an outcome assessor who is blind to the order in which the secondary outcome measure(s) were taken., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 4, type: ESTIMATED, armsInterventionsModule interventions name: Compensatory brain game supporting Goal Management Training intervention, outcomesModule primaryOutcomes measure: Change in performance on the Oxford Multiple Errands Test- Dutch version (OxMET-NL) from phase A to phase B, secondaryOutcomes measure: Change on the Visual Analogue Scale (VAS) from phase A to phase B to follow-up, secondaryOutcomes measure: Change in performance on treatment goals as measured with the Goal Attainment Scale (GAS), secondaryOutcomes measure: Change in performance on two trained IADL task (treatment goals), secondaryOutcomes measure: Change in everyday difficulties in activities/participation as measured on the Daily Living Questionnaire (DLQ-R-NL), secondaryOutcomes measure: Change in strategy use during the performance of trained and untrained IADL tasks, secondaryOutcomes measure: Change in subjective experience of strategy use in daily life, secondaryOutcomes measure: Change in subjectively experienced psychological symptoms such as depressive, anxiety and stress symptoms., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ProPersona, city: Wolfheze, state: Gelderland, zip: 6874 BE Wolfheze, country: Netherlands, contacts name: Bea Tiemens, PhD, role: CONTACT, email: [email protected], contacts name: Floor Poerschke, MSc, role: SUB_INVESTIGATOR, contacts name: Emily Vink, MSc, role: SUB_INVESTIGATOR, geoPoint lat: 52.00333, lon: 5.79028, hasResults: False
|
protocolSection identificationModule nctId: NCT06352333, orgStudyIdInfo id: Parasagittal Vs Cornerpocket, briefTitle: Parasagittal Vs Cornerpocket Approaches, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2024-11-01, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: Brachial plexus blocks are widely used to provide anesthesia for upper limb surgery.Although many different approaches to the brachial plexus block have been described, there is widespread acceptance that injecting at the supraclavicular level is the most reliable method in terms of spread of local anesthetic agent.Each approach of ultrasound guided supraclavicular brachial plexus block (US -SCBPB ) has a different success rate and complications. .A supraclavicular block can provide effective surgical anesthesia of the forearm and hand.The most commonly performed US- SCBPB is the corner pocket approach which was described by Chan et al with probe resting posterior to the clavicle, with postero latero-anteromedial orientation provides a very stable location, but has the disadvantage of "looking" across the first rib, with the apex of the lung visualized close to thePlexus .A new Parasagittal approach for brachial plexus block at the supraclavicular level was studied by Adrian Searle where the arc of the first rib was used to provide a deep limit to needle transit in order to minimize the risk of pneumothorax ;the aim of our study is to further evaluate the parasagittal approach for brachial plexus block and compare it with the popular corner pocket approach, conditionsModule conditions: Supraclavicular Brachial Plexus Block, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Inclusion criteria:* 18to60 yearsold* ASA grade I to II* Elective upper limb surgery, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: supraclavicular ultrasound guided brachial plexus block, outcomesModule primaryOutcomes measure: Needle visibility in both approaches, secondaryOutcomes measure: Duration of sensory and motor block, otherOutcomes measure: Success rate, otherOutcomes measure: Complications, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Sohag university Hospital, city: Sohag, country: Egypt, contacts name: Magdy M Amin, professor, role: CONTACT, geoPoint lat: 26.55695, lon: 31.69478, hasResults: False
|
protocolSection identificationModule nctId: NCT06352320, orgStudyIdInfo id: XJTU1AF2023LSK-533, briefTitle: Risk Stratification and New Early Prevention and Treatment Strategies for Patients With Cardiomyopathy (STRENGTH）, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-12-31, primaryCompletionDateStruct date: 2030-08-31, completionDateStruct date: 2032-08-31, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: First Affiliated Hospital Xi'an Jiaotong University, class: OTHER, descriptionModule briefSummary: This study will include patients with different types of cardiomyopathy from multiple centers were prospectively enrolled in a retrospective study to establish a natural population cohort of cardiomyopathy patients. By collecting clinical data and biological samples from surgical patients, we will construct a prognostic system for cardiomyopathy, optimize risk stratification, explore new strategies for the early prevention and treatment of cardiomyopathy, and improve the efficiency of clinical cardiomyopathy patients' diagnosis and treatment., conditionsModule conditions: Cardiomyopathies, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Diagnosis of HCM, interventions name: Diagnosis of DCM, interventions name: Diagnosis of ARVC, interventions name: Diagnosis of NDLVC, interventions name: Diagnosis of RCM, interventions name: Diagnosis of LVNC, outcomesModule primaryOutcomes measure: Change in the incidence of mortality rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: First Affiliated Hospital of Xi'an Jiantong University, city: Xi'an, state: Shaanxi, zip: 710061, country: China, geoPoint lat: 34.25833, lon: 108.92861, hasResults: False
|
protocolSection identificationModule nctId: NCT06352307, orgStudyIdInfo id: XJTU1AF2023LSK-532, briefTitle: Risk Stratification, Early Prevention and Treatment Strategies for Arrhythmogenic Cardiomyopathy, acronym: STARTER, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-12-31, primaryCompletionDateStruct date: 2030-08-31, completionDateStruct date: 2032-08-31, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: First Affiliated Hospital Xi'an Jiaotong University, class: OTHER, descriptionModule briefSummary: This study will include patients diagnosed with Arrhythmogenic cardiomyopathy (ACM) in the First Affiliated Hospital of Xi 'an Jiaotong University and other centers, and collect clinical data and biological samples of patients with different ACM phenotypes. Through the establishment of disease cohort and long-term follow-up, to explore the disease characteristics, development law, clinical characteristics, natural course of disease and long-term prognosis of ACM., conditionsModule conditions: Arrhythmogenic Cardiomyopathy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 1500, type: ESTIMATED, armsInterventionsModule interventions name: Diagnosis of ACM, outcomesModule primaryOutcomes measure: Change in the incidence of mortality rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: First Affiliated Hospital of Xi'an Jiantong University, city: Xi'an, state: Shaanxi, zip: 710061, country: China, contacts name: Guoliang Li, role: CONTACT, phone: 008613759982523, email: [email protected], contacts name: Yang Yan, role: CONTACT, phone: +86.29.85323869, email: [email protected], geoPoint lat: 34.25833, lon: 108.92861, hasResults: False
|
protocolSection identificationModule nctId: NCT06352294, orgStudyIdInfo id: MSDALAKCI, briefTitle: The Effects of Myofascial Relaxation Technique Applied Together With Core Stabilization Trainings on Balance, Pain, Joint Range of Motion and Functionality in Individuals With Chronic Neck Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-29, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Kirsehir Ahi Evran Universitesi, class: OTHER, descriptionModule briefSummary: Chronic neck pain is a musculoskeletal disorder that affects people frequently in life. Nov.Postural control is based on the process of correctly identifying and selectively focusing the incoming afferent input of the Central Nervous System (CNS).The main treatment options for people with neck pain include soft tissue and joint mobilizations, stabilization exercises for the neck, trunk and shoulder muscles, cervical Deckings, relaxation training, strengthening exercises and body awareness and posture training Nov.In this study, it was aimed to investigate the effects of myofascial relaxation on balance, pain, joint range of motion and functionality in individuals with chronic neck pain by dividing them into two groups in the form of core stabilization and core stabilization and myofascial relaxation.The study included 45 people between the ages of 18 and 65 Dec. In two groups, the core stabilization group will be 22 people, and the core stabilization and myofascial relaxation group will be 23 people. The study period is planned as 6 weeks and 3 sessions per week., conditionsModule conditions: Neck Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Core stability training, interventions name: Core stability training and myofascial relase, outcomesModule primaryOutcomes measure: Pain severity, primaryOutcomes measure: Pressure pain threshold (PPT), secondaryOutcomes measure: Balance, secondaryOutcomes measure: Range of motion, secondaryOutcomes measure: Neck Disability İndex, secondaryOutcomes measure: DASH, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kırşehir Ahi Evran Üniversitesi, status: RECRUITING, city: Merkez, state: Kırşehir, country: Turkey, contacts name: Muhammed Samed Dalakçı, role: CONTACT, phone: 905445325572, email: [email protected], hasResults: False
|
protocolSection identificationModule nctId: NCT06352281, orgStudyIdInfo id: KM-007, briefTitle: Efficacy and Safety of CAR-T Cells Therepy for Chronic or Refractory Primary Immune Thrombocytopenia (ITP), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2026-01-01, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China, class: OTHER, descriptionModule briefSummary: It is a single-center, single-arm, open-labeled clinical trial to evaluate the efficacy and safety of CAR-T cells therapy for Chronic or Refractory Primary Immune Thrombocytopenia (ITP)., conditionsModule conditions: ITP - Immune Thrombocytopenia, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: CAR-T cells, outcomesModule primaryOutcomes measure: Portion of patients with response (R), secondaryOutcomes measure: Portion of patients with complete response (CR), secondaryOutcomes measure: Portion of patients with relapse, secondaryOutcomes measure: Time (in days) from treatment start to response (R), secondaryOutcomes measure: Time (in days) from treatment to complete response (CR), secondaryOutcomes measure: Duration (in days) of response (R), secondaryOutcomes measure: Incidence of adverse events(AE) after infusion, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 75 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China, status: RECRUITING, city: Kunming, state: Yunnan, zip: 650000, country: China, contacts name: Wang Sanbin, Doctor, role: CONTACT, phone: 13187424131, phoneExt: +86, email: [email protected], geoPoint lat: 25.03889, lon: 102.71833, hasResults: False
|
protocolSection identificationModule nctId: NCT06352268, orgStudyIdInfo id: IEC-368/17.07.2023, briefTitle: Lesioning Procedures for Movement Disorders, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: All India Institute of Medical Sciences, New Delhi, class: OTHER, descriptionModule briefSummary: Dystonia is a rare syndrome with varying etiologies. Similarly, tremor conditions refractory to medical management and disabling that they need surgical interventions are rare in our setting. So far there are no randomized controlled trials of pallidotomy for management of dystonia. There is scant literature on the long term efficacy and safety of Pallidotomy, thalamotomy and other such lesioning procedures in the management of movement disorders. The current literature is significantly plagued by publication bias as case reports with successful outcomes are likely to be selectively published in journals or conference abstracts. Lesioning procedures though seem to be effective are often considered to be risky, especially bilateral pallidotomy is not preferred by several centres. However, our center routinely performs simultaneous bilateral pallidotomy. To generate long term data on the efficacy and safety of lesioning procedures in rare diseases like dystonias especially the effect of functional neurosurgery on varying etiologies of the disease, robust registries are required which collect data on all consecutive patients who undergo the procedure., conditionsModule conditions: Dystonia, conditions: Parkinson Disease, conditions: Essential Tremor, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Pallidal, subthalamic or thalamic lesioning, outcomesModule primaryOutcomes measure: Long term functional outcomes, primaryOutcomes measure: Long term functional outcomes, secondaryOutcomes measure: Predictors of outcomes, secondaryOutcomes measure: Demography, secondaryOutcomes measure: Clinical features, secondaryOutcomes measure: Laboratory findings, secondaryOutcomes measure: Imaging features, secondaryOutcomes measure: Treatment trends, secondaryOutcomes measure: Clinical features, secondaryOutcomes measure: Treatment trends, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: All India Institute of Medical Sciences, New Delhi, city: New Delhi, state: Delhi, zip: 110029, country: India, contacts name: Arunmozhimaran Elavarasi, MD DM, role: CONTACT, phone: +919013844274, email: [email protected], geoPoint lat: 28.63576, lon: 77.22445, hasResults: False
|
protocolSection identificationModule nctId: NCT06352255, orgStudyIdInfo id: AR1937, briefTitle: Pain and Anxiety During Local Block, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: University of Seville, class: OTHER, descriptionModule briefSummary: INTRODUCTION: Currently, there is no scientific evidence about pain in the anesthetic blockage of the first finger according to the application method. However, clinical evidence has valued the use of carpule, due to the low pain it generates in the patient to the application of anesthetic. Most studies on anesthesia and pain, especially with the use of carpule and distracting methods, belong to the field of dentistry.OBJECTIVES: It is intended to determine the pain after an anesthetic block in H of Frost in the first finger with different application methods, such as syringe and carpule. As secondary objectives, it is intended to establish the difference in pain according to the sex and age of the patients.METHODOLOGY: Experimental, transverse and random clinical trial type analytical study, in which a sample of 200 individuals will be selected, 100 per group, which would require digital anesthesia of the first finger and that would fulfill the inclusion criteria.Result: after the completion of the study CONCLUSIONS: After the completion of the study, conditionsModule conditions: Anesthesia, Local, conditions: Pain, conditions: Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Digital block, outcomesModule primaryOutcomes measure: Grade of Pain postinyection, secondaryOutcomes measure: Anxiety before the intervention, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06352242, orgStudyIdInfo id: RECHMPL24-0076 UF 9572, briefTitle: Is Trogocytosis a Predictive Marker of CAR-T Cell Response in Diffuse Large B-cell Lymphoma?, acronym: CARTROG, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-08, primaryCompletionDateStruct date: 2026-04-08, completionDateStruct date: 2026-04-08, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: University Hospital, Montpellier, class: OTHER, descriptionModule briefSummary: CAR-T cell therapy has improved survival in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL R/R). However, only 65% of patients achieve a complete metabolic response after this treatment. To date, there is no predictive test for therapeutic response after injection of CAR-T cells. Recent studies have shown that the level of trogocytosis by immune cells correlates with the persistence of tumor cells in patients with hematological malignancies. Our main objective is to identify a phenotypic "signature" of trogocytosis predictive of therapeutic response 6 months after injection of CAR-T cells for DLBCL., conditionsModule conditions: Diffuse Large B Cell Lymphoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 85, type: ESTIMATED, armsInterventionsModule interventions name: Flow cytometry analysis to determine the level of trogocytosis by effector immune cells in patients, interventions name: Flow cytometry analysis to determine the level of trogocytosis by effector immune cells in volunteers, outcomesModule primaryOutcomes measure: Identification of a phenotypic "signature" of trogocytosis predictive of failure to achieve a complete metabolic response for patients with diffuse large B-cell lymphoma., secondaryOutcomes measure: Identification of a phenotypic "signature" of trogocytosis predictive of the occurrence of grade II or more immunological adverse events, secondaryOutcomes measure: Identification of a phenotypic "signature" of trogocytosis predictive of the occurrence of serious hematological side effects., secondaryOutcomes measure: Determination of the trogocytosis level of normal lymphocytes and NK cells in healthy subjects, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06352229, orgStudyIdInfo id: 514-0335/23-2000, briefTitle: The Playful Learning in Infancy Program, acronym: PLIP, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2026-11-30, completionDateStruct date: 2026-11-30, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: University of Copenhagen, class: OTHER, collaborators name: LEGO Foundation, descriptionModule briefSummary: In the Playful Learning in Infancy Program, parents receive research-based educational guidance on playful interactions with their infants aged 0-1 year. They learn to recognize their infants' cues indicating readiness to engage in play and they are introduced to specific, developmentally appropriate activities for interactive engagement. The guidance is delivered to parents during routine home visits by public health visitors.The aims of the Playful Learning in Infancy Program are to 1) promote playful interactions between infants and parents, parental attitudes towards play, and infant socioemotional development; 2) enhance the language and knowledge of playful learning in infancy among frontline staff; and 3) evaluate the Playful Learning in Infancy Program for potential testing in a future large-scale RCT study.Evaluation is based on a parallel group study design, with half of the participants receiving care as usual and half of the participants receiving care as usual along with the Playful Learning in Infancy Program., conditionsModule conditions: Parent-Child Relations, conditions: Infant Development, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Evaluation is based on a parallel group study, with half of the participants receiving care as usual and half of the participants receiving care as usual along with the Playful Learning in Infancy Program., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 2327, type: ESTIMATED, armsInterventionsModule interventions name: Playful Learning in Infancy Program, interventions name: Postnatal care as usual, outcomesModule primaryOutcomes measure: Parental Playful interactions, secondaryOutcomes measure: Parental Stress, secondaryOutcomes measure: Infant Socio-emotional Development, secondaryOutcomes measure: Infant Level of Play, secondaryOutcomes measure: Parental Mind-Mindedness, secondaryOutcomes measure: Parental Attachment Style, secondaryOutcomes measure: Parental Mental Well-Being, secondaryOutcomes measure: Infant Screen Time, secondaryOutcomes measure: Questions developed for the study regarding Parental Involvement, secondaryOutcomes measure: Questions developed for the study regarding Parental Knowledge of Play, secondaryOutcomes measure: Parental Experience of the PLIP, secondaryOutcomes measure: Health Visitors' Experience of the PLIP, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Center for Early Interventions and Family Studies, Department of Psychology, University of Copenhagen, status: RECRUITING, city: Copenhagen, zip: 1353, country: Denmark, contacts name: Mette S. Væver, PhD, role: CONTACT, phone: +45 35324906, email: [email protected], contacts name: Maja Nyström-Hansen, PhD, role: CONTACT, phone: +4535336499, email: [email protected], geoPoint lat: 55.67594, lon: 12.56553, hasResults: False
|
protocolSection identificationModule nctId: NCT06352216, orgStudyIdInfo id: Elo-Ger-2023-1642, briefTitle: Prevalence of Synovitis in Patients With Haemophilia A, acronym: SynoPrev, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2027-02, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: University Hospital, Bonn, class: OTHER, collaborators name: Swedish Orphan Biovitrum, descriptionModule briefSummary: The aim of this study is to evaluate the prevalence of synovitis in adult patients with haemophilia A., conditionsModule conditions: Haemophilia A, conditions: Synovitis, conditions: Hemophilia Arthropathy, conditions: Sonography, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US); Haemophilia joint health score (HJHS), outcomesModule primaryOutcomes measure: Haemophilia early arthropathy detection with ultrasound (HEAD-US), secondaryOutcomes measure: The Hemophilia Joint Health Score version 2.1 (HJHS), secondaryOutcomes measure: PROMIS-29 Questionaire, secondaryOutcomes measure: Haemophilia Activities List (HAL), otherOutcomes measure: Baseline Characteristics, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Bonn, status: RECRUITING, city: Bonn, state: NRW, zip: 53113, country: Germany, contacts name: Andreas C. Strauss, PD Dr. med., role: CONTACT, phone: 004922828714176, email: [email protected], contacts name: Andreas C. Strauss, PD Dr. med., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.73438, lon: 7.09549, hasResults: False
|
protocolSection identificationModule nctId: NCT06352203, orgStudyIdInfo id: AUT/23.02, briefTitle: Effect of Probiotics on the Intestinal Microbiota of Pediatric Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-11, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: ProbiSearch SL, class: INDUSTRY, descriptionModule briefSummary: Numerous studies have described an altered gut microbiota composition (dysbiosis) in patients with neurodevelopmental disorders that can be correlated with their symptoms, especially gastrointestinal symptoms.An interventional, randomised, double-blind, placebo-controlled study will be conducted to investigate the effect of a probiotic supplement on the microbiota composition of children aged 3-7 years with neurodevelopmental issues.The duration of the study will be of 6 months approximately, including 6 months of product intake.Participants will be randomly assigned to one of the two study groups: control group with placebo administration or probiotic administration group., conditionsModule conditions: Neurodevelopmental Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Probiotic, interventions name: Placebo, outcomesModule primaryOutcomes measure: Number of children with intestinal dysbiosis after 6 months of treatment., eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 7 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06352190, orgStudyIdInfo id: SY-5007-I-04, briefTitle: A Study to Evaluate the Mass Balance of [14C] SY-5007 in Healthy Adult Male Subjects in China, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Shouyao Holdings (Beijing) Co. LTD, class: OTHER, descriptionModule briefSummary: This is a single-center, open-label, non-randomized, single dose study in healthy male subjects designed to assess mass balance recovery, metabolite profile and metabolite identification of radio-labeled SY-5007 administered orally., conditionsModule conditions: Healthy Subjects, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 8, type: ESTIMATED, armsInterventionsModule interventions name: [14C] SY-5007, outcomesModule primaryOutcomes measure: Total radioactivity in plasma PK: Cmax, primaryOutcomes measure: Total radioactivity in plasma PK: Tmax, primaryOutcomes measure: Total radioactivity in plasma PK: AUC0-t, primaryOutcomes measure: Total radioactivity in plasma PK: t½, primaryOutcomes measure: Total radioactivity in plasma PK: CL/F, primaryOutcomes measure: Whole blood to plasma total radioactivity ratio, primaryOutcomes measure: Cumulative total radioactivity in urine and faeces, primaryOutcomes measure: Metabolic profiling in plasma, urinary and fecal excretion, secondaryOutcomes measure: Cmax of SY-5007 and its metabolites, secondaryOutcomes measure: Tmax of SY-5007 and its metabolites, secondaryOutcomes measure: AUC0-t of SY-5007 and its metabolites, secondaryOutcomes measure: t½ of SY-5007 and its metabolites, secondaryOutcomes measure: CL/F of SY-5007 and its metabolites, secondaryOutcomes measure: Incidence of adverse events, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Beijing Friendship Hospital, Capital Medical University, city: Beijing, zip: 100050, country: China, contacts name: Ruihua Dong, MD, role: CONTACT, phone: 86-010-63139033, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
|
protocolSection identificationModule nctId: NCT06352177, orgStudyIdInfo id: protocol-1, briefTitle: Digital Therapeutic Lifestyle Intervention Program for Patients With MASLD, acronym: ENLIGHTEN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-04-01, primaryCompletionDateStruct date: 2029-12-31, completionDateStruct date: 2030-08-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Milton S. Hershey Medical Center, class: OTHER, descriptionModule briefSummary: The ENLIGHTEN study that will evaluate the efficacy of a novel DTx lifestyle intervention in participants with non-cirrhotic MASH. People who have MASH, the progressive subtype of MASLD, have the highest risk for liver disease progression and poor outcomes, including cirrhosis and hepatocellular carcinoma, and greater overall mortality. Thus, these participants are expected to experience the greatest benefit from treatment.This is a randomized, controlled trial comparing DTx lifestyle intervention in participants with non-cirrhotic MASH to standard clinical care. The study includes a screening period (up to 2 wks.) followed by randomization, 48-wk treatment period and 12-wk follow-up period (total duration up to 62 wks.)., conditionsModule conditions: NASH, conditions: NASH - Nonalcoholic Steatohepatitis, conditions: Liver Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 50/50 randomization, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Noom Weight Application, outcomesModule primaryOutcomes measure: Clinically significant liver fat loss, secondaryOutcomes measure: Sustained clinically significant body weight loss, secondaryOutcomes measure: Sustained clinically significant body weight loss, secondaryOutcomes measure: Liver fat and liver stiffness using imaging analysis, secondaryOutcomes measure: Liver fat and liver stiffness using imaging analysis, secondaryOutcomes measure: Liver fat and liver stiffness using imaging analysis, secondaryOutcomes measure: Liver fat and liver stiffness using imaging analysis, secondaryOutcomes measure: Liver fat and liver stiffness using imaging analysis, secondaryOutcomes measure: Liver fat and liver stiffness using imaging analysis, secondaryOutcomes measure: Clinically meaningful improvement in liver fat and stiffness, secondaryOutcomes measure: Clinically meaningful improvement in liver fat and stiffness, secondaryOutcomes measure: Clinically meaningful improvement in liver fat and stiffness, secondaryOutcomes measure: Clinically meaningful improvement in liver fat and stiffness, secondaryOutcomes measure: Clinically meaningful improvement in liver fat and stiffness, secondaryOutcomes measure: Clinically meaningful improvement in liver fat and stiffness, secondaryOutcomes measure: Circulating biomarkers of hepatic injury, secondaryOutcomes measure: Circulating biomarkers of hepatic injury, secondaryOutcomes measure: Circulating biomarkers of hepatic injury, secondaryOutcomes measure: Circulating biomarkers of hepatic injury, secondaryOutcomes measure: Circulating biomarkers of hepatic injury, secondaryOutcomes measure: Circulating biomarkers of hepatic injury, secondaryOutcomes measure: Circulating biomarkers of hepatic injury, secondaryOutcomes measure: Circulating biomarkers of hepatic injury, secondaryOutcomes measure: Circulating biomarkers of hepatic injury, secondaryOutcomes measure: Circulating biomarkers of hepatic injury, secondaryOutcomes measure: Circulating biomarkers of hepatic injury, secondaryOutcomes measure: Circulating biomarkers of hepatic injury, secondaryOutcomes measure: Circulating biomarkers of hepatic injury, secondaryOutcomes measure: Circulating biomarkers of liver fibrosis and fibrogenesis, secondaryOutcomes measure: Circulating biomarkers of liver fibrosis and fibrogenesis, secondaryOutcomes measure: Circulating biomarkers of liver fibrosis and fibrogenesis, secondaryOutcomes measure: Circulating biomarkers of liver fibrosis and fibrogenesis, secondaryOutcomes measure: Circulating biomarkers of liver fibrosis and fibrogenesis, secondaryOutcomes measure: Circulating biomarkers of liver fibrosis and fibrogenesis, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06352164, orgStudyIdInfo id: ZYS2024-03, briefTitle: Efficacy Classification Prediction of the Effects of Acupuncture on Abdominal Pain in Patients With Crohn's Disease, statusModule overallStatus: COMPLETED, startDateStruct date: 2015-03-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2024-03-31, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Shanghai Institute of Acupuncture, Moxibustion and Meridian, class: OTHER, descriptionModule briefSummary: Machine learning algorithms are applied to discover gut flora markers that predict the clinical efficacy of acupuncture, so as to screen the appropriate population for acupuncture and optimise the allocation of healthcare resources., conditionsModule conditions: Crohn Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 55, type: ACTUAL, armsInterventionsModule interventions name: Acupuncture treatment, outcomesModule primaryOutcomes measure: Characterisation of gut microflora strains predictive of acupuncture efficacy, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Institute of Acupuncture, Moxibustion and Meridian, city: Shanghai, zip: 200000, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
|
protocolSection identificationModule nctId: NCT06352151, orgStudyIdInfo id: 2022-041, briefTitle: Effects of Orofacial Therapy and Therapeutic Yoga in Children With Down Syndrome, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2024-09-28, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Hasan Kalyoncu University, class: OTHER, descriptionModule briefSummary: The study aims to compare the effects of orofacial therapy and therapeutic yoga on swallowing, sleep habits, and quality of life in children with Down syndrome., conditionsModule conditions: Down Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Routine Physiotherapy Group, interventions name: Orofacial Treatment Group, interventions name: Therapeutic Yoga Group, outcomesModule primaryOutcomes measure: The Pediatric Functional Independence Measure, primaryOutcomes measure: Pediatric Eating Assessment Tool-10, primaryOutcomes measure: Children's Sleep Habits Questionnaire, primaryOutcomes measure: The Health-Related Quality of Life Scale-KIDSCREEN-27, eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Hasan Kalyoncu University, status: RECRUITING, city: Gaziantep, zip: 27410, country: Turkey, contacts name: Aysenur Tuncer, PhD, role: CONTACT, phone: +903422118080, contacts name: Yasemin Kotevoglu, MSc, role: CONTACT, geoPoint lat: 37.05944, lon: 37.3825, hasResults: False
|
protocolSection identificationModule nctId: NCT06352138, orgStudyIdInfo id: ENCASE, briefTitle: Comparative Study of Two Recombinant Human Erythropoietin Products on Chronic Kidney Disease Patients, acronym: ENCASE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Megalabs, class: INDUSTRY, collaborators name: Azidus Laboratories, descriptionModule briefSummary: Phase III, multicentre, double-blind, randomised, parallel, equivalence clinical trial to determine the efficacy, safety and immunogenicity of Megalabs® recombinant human alfa epoetin for subcutaneous use, compared to Eprex® (Janssen-Cilag Farmacêutica Ltda.), in the treatment of anaemia in participants with chronic renal disease, dependent on haemodialysis, conditionsModule conditions: Anemia of Chronic Kidney Disease, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: multicentre, double-blind, randomised, parallel, equivalence trial, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 280, type: ESTIMATED, armsInterventionsModule interventions name: Experimental: Epoetin alfa Megalabs® Erythropoietin injectable in intravenous administration., interventions name: Active comparator: European Union licenced epoetin alfa, outcomesModule primaryOutcomes measure: Mean Absolute Change in Hemoglobin Levels, primaryOutcomes measure: Change in Mean Hb Level, secondaryOutcomes measure: immunogenicity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Megalabs, city: Colonia Nicolich, state: Canelones, zip: 15000, country: Uruguay, contacts name: Victoria Rodriguez, MD, role: CONTACT, phone: 26836300, phoneExt: 3110, email: [email protected], geoPoint lat: -34.81516, lon: -56.02435, hasResults: False
|
protocolSection identificationModule nctId: NCT06352125, orgStudyIdInfo id: TP-CLN-100503, briefTitle: An Observational Trial to Assess the Performance of the TEG® 6s Diagnostic System With the Citrated K, KH, RTH, FFH Cartridge, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-12-09, primaryCompletionDateStruct date: 2023-01-31, completionDateStruct date: 2023-01-31, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Haemonetics Corporation, class: INDUSTRY, collaborators name: ClinStatDevice, collaborators name: Boston Healthcare Technologies Consultants, LLC, descriptionModule briefSummary: This clinical trial is designed to assess the agreement of the TEG® 6s system using the Citrated K, KH, RTH, FFH, cartridge (hereafter referred to as the Heparin Neutralization (HN) Cartridge) with its comparators., conditionsModule conditions: Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 338, type: ACTUAL, armsInterventionsModule interventions name: TEG 6s Citrated K, KH, RTH, FFH Cartridge, interventions name: Clauss Fibrinogen, outcomesModule primaryOutcomes measure: Primary Method Comparison, primaryOutcomes measure: Primary Method Comparison, primaryOutcomes measure: Primary Method Comparison, primaryOutcomes measure: Primary Method Comparison, primaryOutcomes measure: Primary Method Comparison, primaryOutcomes measure: Primary Method Comparison, primaryOutcomes measure: Primary Method Comparison, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of California - San Francisco, city: San Francisco, state: California, zip: 94143, country: United States, geoPoint lat: 37.77493, lon: -122.41942, locations facility: University of Colorado, city: Aurora, state: Colorado, zip: 80045, country: United States, geoPoint lat: 39.72943, lon: -104.83192, locations facility: Ochsner Clinic, city: New Orleans, state: Louisiana, zip: 70121, country: United States, geoPoint lat: 29.95465, lon: -90.07507, locations facility: Lifebridge Health (Sinai Hospital), city: Baltimore, state: Maryland, zip: 21215, country: United States, geoPoint lat: 39.29038, lon: -76.61219, locations facility: Massachusetts General Hospital, city: Boston, state: Massachusetts, zip: 02114, country: United States, geoPoint lat: 42.35843, lon: -71.05977, locations facility: University of Pittsburgh Medical Center, city: Pittsburgh, state: Pennsylvania, zip: 15213, country: United States, geoPoint lat: 40.44062, lon: -79.99589, locations facility: University of Texas Health Science Center - San Antonio, city: San Antonio, state: Texas, zip: 78229, country: United States, geoPoint lat: 29.42412, lon: -98.49363, hasResults: False
|
protocolSection identificationModule nctId: NCT06352112, orgStudyIdInfo id: 02.04.2024 - POP, briefTitle: Effects of the Hypopressive Exercises in Women With Pelvic Organ Prolapse, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-15, primaryCompletionDateStruct date: 2024-01-15, completionDateStruct date: 2024-02-15, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Hacettepe University, class: OTHER, collaborators name: Istanbul Training and Research Hospital, descriptionModule briefSummary: The aim of this study was compare home-based pelvic floor muscle training (PFMT) alone and home-based PFMT combined with hypopressive exercise (HE) in terms of pelvic floor muscle (PFM) activation and severity of pelvic floor dysfunction (PFD) in women with pelvic organ prolapse (POP) for eight weeks. For this purpose, the participants were randomly divided into two groups: \[PFMT alone (n:15) and PFMT combined with HE(n:17)\]. DuoBravo EMG device for evaluation of PFM activation and "Pelvic Floor Distress Inventory-20" was used to evaluate the severity of PFD. All evaluations were performed twice in total, at baseline and at week 8., conditionsModule conditions: Pelvic Floor Disorders, conditions: Prolapse; Female, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 32, type: ACTUAL, armsInterventionsModule interventions name: Pelvic Floor Muscle Training, interventions name: Hypopressive Exercises, outcomesModule primaryOutcomes measure: Pelvic Floor Muscle Activation, secondaryOutcomes measure: Severity of pelvic floor dysfunction, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Istanbul Research and Training Hospital, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
|
protocolSection identificationModule nctId: NCT06352099, orgStudyIdInfo id: 6315, briefTitle: Dietary Supplementation and Cognitive Functions in the Elderly, acronym: ESPINS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: In recent years, globally, there has been a growth in both the size and the proportion of older adults in the world population. The World Health Organization (WHO) has estimated that by 2030, 1 in 6 people will be 60 years of age or older, and that by 2050, the population of older adults will reach 2.1 billion. The population of older adults (over 80 years) will triple to 426 million by 2050. In particular, Italy represents the second country with the oldest population in the world.Age-related evolution is a gradual and continuous process involving a series of physical and cognitive changes, which, however, has no real 'onset' age. In fact, rather than chronological age, the concept of 'elderly' is based on the individual's degree of self-sufficiency and independence. From a biological point of view, ageing is the set of changes at the molecular and cellular level that occur over time and lead to multi-system functional impairment. It is a process directly related to frailty, falls, and disability.An important factor in counteracting frailty is nutritional intake. Humans ingest approximately 500 g of chemical compounds daily through their diet, most of which are components of plants or vegetables in general. In addition to the well-known macronutrients (proteins, fats, and carbohydrates) and micronutrients (minerals and vitamins), the plant world provides other elements, such as phenols, terpenes, terpenoids, alkaloids, purines, pyrimidines, nucleic acids, and steroids, that exert powerful biological activities. These components are generically called phytochemicals. Epidemiological studies have established that diets rich in plant-based foods help prevent many diseases, such as cardiovascular, metabolic, neurovegetative, and inflammatory diseases.Phytochemical compounds are an extremely diverse set of elements that, when taken at significant levels, have a protective effect on human health. These substances exert various biological functions, such as antioxidant activity, modulation of detoxifying enzymes, stimulation of the immune system, reduction of platelet aggregation, modulation of hormone metabolism, reduction of blood pressure, and antibacterial and antiviral activity.Among the phytochemical compounds, flavonoids represent a category of polyfunctional substances with high bioactivity, comprising more than 5000 compounds. They possess biochemical properties of functional interest in the nutritional and therapeutic fields; for example, rutin, diosmin, and hesperidin are present in some pharmaceutical specialties; flavonoids from ginkgo biloba, hawthorn, and red vine are the main components of many phytotherapeutic extracts. Flavonoids have been shown to play an important role in cardioprotection. Furthermore, in neuroprotection, anthocyanin-rich fruits play a protective role against age-related decline in cognitive functions.However, few studies have evaluated the effect of hesperidin and proanthocyanidins on motor, cognitive, and functional aspects in the elderly.Altemor® is a food supplement based on micronized diosmin, hesperidin, and herbal extracts that has an important integrative supporting action in optimising blood microcirculation.The aim of the study is to evaluate the contribution of dietary supplementation with Altemor® on cognitive function, balance, fatigue, and some domains of quality of life in elderly subjects., conditionsModule conditions: Cognitive Impairment, conditions: Old Age; Debility, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Dietary supplement with micronised diosmin, hesperidin and herbal extracts, outcomesModule primaryOutcomes measure: Trial Making Test (TMT), secondaryOutcomes measure: Short Physical Performance Battery (SPPB), secondaryOutcomes measure: HandGrip Strenght Test (HGST), secondaryOutcomes measure: Silver Index (SI), secondaryOutcomes measure: Mental Deterioration battery (MDB), secondaryOutcomes measure: Hospital Anxiety and Depression Scale (HADS), secondaryOutcomes measure: EuroQol- 5 Dimension (EQ-5D), secondaryOutcomes measure: Modified Fatigue Impact Scale (MFIS), eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione Policlinico Universitario A. Gemelli IRCCS, city: Roma, state: RM, zip: 00168, country: Italy, contacts name: Silvia Giovannini, MD, PhD, role: CONTACT, phone: +390630154382, email: [email protected], contacts name: Letizia Castelli, PhD, role: CONTACT, phone: +390630154382, email: [email protected], geoPoint lat: 41.89193, lon: 12.51133, hasResults: False
|
protocolSection identificationModule nctId: NCT06352086, orgStudyIdInfo id: STUDY00009227, briefTitle: Understanding Visual Processing After Occipital Stroke, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2028-09, completionDateStruct date: 2029-09, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: University of Rochester, class: OTHER, descriptionModule briefSummary: The purpose of this study is to investigate how visual orientation discrimination and metacognition (i.e., perceptual confidence) are affected by occipital stroke that causes hemianopia and quadrantanopia in adults. This research will provide insight as to how the residual visual system, which not directly damaged by the occipital stroke, processes orientation (assayed in terms of orientation discrimination) and metacognition (by measuring perceptual confidence for orientation discrimination). These measures will be used to refine computational models that attempt to explain how the brain copes with loss of primary visual cortex (V1) as a result of stroke. This knowledge is essential to devise more effective visual rehabilitation therapies for patients suffering from occipital strokes., conditionsModule conditions: Vision Loss Partial, conditions: Vision; Loss, Both Eyes, conditions: Hemianopia, Homonymous, conditions: Hemianopia, conditions: Quadrantanopia, conditions: Stroke, Ischemic, conditions: Stroke - Occipital Infarction, conditions: Cortical Blindness, conditions: Occipital Lobe Infarct, conditions: Peripheral Visual Field Defect of Both Eyes, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 20, type: ESTIMATED, outcomesModule primaryOutcomes measure: Orientation discrimination threshold, primaryOutcomes measure: Perceptual Confidence in Orientation Discrimination, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06352073, orgStudyIdInfo id: 23-2625, secondaryIdInfos id: R668-EE-2380, type: OTHER, domain: Regeneron, briefTitle: Dupilumab for Eosinophilic Esophagitis With Severe Strictures, acronym: DESTRICT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-11, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: University of North Carolina, Chapel Hill, class: OTHER, collaborators name: Regeneron Pharmaceuticals, collaborators name: Sanofi, descriptionModule briefSummary: The purpose of this research study is to determine how well an FDA-approved drug, dupilumab, works to treat patients with severe strictures and active Eosinophilic Esophagitis (EoE). This is an open-label study, meaning everyone in the study will receive dupilumab.Participants will have a screening visit where they will complete surveys and undergo an endoscopy (EGD). Blood and biopsies (small tissue samples) will also be collected. If eligible and enrolled into the study, participants will receive weekly subcutaneous (under the skin) injections of dupilumab for 52 weeks (one year). The first dose of dupilumab will be administered at the week 1 visit by a clinician and participants will receive training on how to self-administer the remaining doses.Participants will return for study visits every at weeks 4, 8, 12, 18, 24, 30, 36, 44, and 52. During these visits, vital signs (temperature, heart rate, etc.) will be collected and participants will complete surveys. During visits at week 12, 24, and 52, blood will be collected and an endoscopy with biopsy will be performed.At 64 weeks (12 weeks after the last dose of dupilumab), participants assigned male at birth (AMAB) will be contacted about their / their partner's pregnancy status and participants assigned female at birth (AFAB) may be asked to come for an in-person visit to complete a urine pregnancy test., conditionsModule conditions: Eosinophilic Esophagitis, conditions: EoE, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Dupilumab, outcomesModule primaryOutcomes measure: Histologic Response to Dupilumab, secondaryOutcomes measure: Change in Minimum Esophageal Caliber, secondaryOutcomes measure: Decrease in Number of Dilations, secondaryOutcomes measure: Change in Endoscopic Severity, secondaryOutcomes measure: Change in Histologic Severity, eligibilityModule sex: ALL, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of North Carolina at Chapel Hill, city: Chapel Hill, state: North Carolina, zip: 27599, country: United States, contacts name: Julia Phillips, role: CONTACT, phone: 919-843-4453, email: [email protected], contacts name: Hiwot Ekuban, role: CONTACT, email: [email protected], geoPoint lat: 35.9132, lon: -79.05584, hasResults: False
|
protocolSection identificationModule nctId: NCT06352060, orgStudyIdInfo id: KCHRRF_MONITOR AF_030, briefTitle: Dynamic Data-Driven Management of Atrial Fibrillation Using Implantable Cardiac Monitors: The MONITOR-AF Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Kansas City Heart Rhythm Research Foundation, class: OTHER, descriptionModule briefSummary: Observational, multi-center, retrospective study to evaluate the use of ICM (implantable cardiac monitor) versus traditional, non-ICM (non-implantable cardiac monitor) methods such as ECGs (electrocardiogram), Holter, and mobile cardiac outpatient telemetry (MCOT) units., conditionsModule conditions: Atrial Fibrillation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 2500, type: ESTIMATED, armsInterventionsModule interventions name: No intervention or administration will be performed due to the observational nature of the study, outcomesModule primaryOutcomes measure: No.of patients with arrhythmia recurrence, primaryOutcomes measure: No.of patients with redo ablation, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Menorah Medical Center, status: RECRUITING, city: Overland Park, state: Kansas, zip: 66209, country: United States, contacts name: Donita Atkins, role: CONTACT, geoPoint lat: 38.98223, lon: -94.67079, locations facility: Kansas City Heart Rhythm Institute - Roe Clinic, status: RECRUITING, city: Overland Park, state: Kansas, zip: 66211, country: United States, contacts name: Donita Atkins, role: CONTACT, phone: 816-651-1969, email: [email protected], contacts name: Naga Venkata K. Pothineni, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.98223, lon: -94.67079, locations facility: Overland Park Regional Medical Center, status: RECRUITING, city: Overland Park, state: Kansas, zip: 66215, country: United States, contacts name: Donita Atkins, role: CONTACT, phone: 816-651-1969, email: [email protected], contacts name: Naga Venkata K. Pothineni, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.98223, lon: -94.67079, locations facility: Centerpoint Medical Center Clinic, status: RECRUITING, city: Independence, state: Missouri, zip: 64057, country: United States, contacts name: Donita Atkins, role: CONTACT, geoPoint lat: 39.09112, lon: -94.41551, locations facility: Centerpoint Medical Center, status: RECRUITING, city: Independence, state: Missouri, zip: 64057, country: United States, contacts name: Donita Atkins, role: CONTACT, geoPoint lat: 39.09112, lon: -94.41551, locations facility: Research Medical Center Clinic, status: RECRUITING, city: Kansas City, state: Missouri, zip: 64032, country: United States, contacts name: Donita Atkins, role: CONTACT, phone: 816-651-1969, email: [email protected], contacts name: Naga Venkata K. Pothineni, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.09973, lon: -94.57857, locations facility: Research Medical Center, status: RECRUITING, city: Kansas City, state: Missouri, zip: 64032, country: United States, contacts name: Donita Atkins, role: CONTACT, phone: 816-651-1969, email: [email protected], contacts name: Naga Venkata K. Pothineni, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.09973, lon: -94.57857, hasResults: False
|
protocolSection identificationModule nctId: NCT06352047, orgStudyIdInfo id: Karadeniz Tech. University, briefTitle: The Effects of Positioning After Extubation of Preterm Infants on the Respiratory Functions, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-11-01, primaryCompletionDateStruct date: 2019-06-01, completionDateStruct date: 2019-06-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Karadeniz Technical University, class: OTHER, descriptionModule briefSummary: The aim of this study was to examine the effect of positioning on respiratory functions of preterm infants after extubation.Hypothesis 0a (H0a): There is no difference between the oxygen saturation (SpO2) levels of preterm infants in supine and prone positions after extubation.Hypothesis 0b (H0b): There is no difference between the respiratory rate of preterm infants in supine and prone positions after extubation.Hypothesis 0c (H0c): There is no difference between the respiratory rhythms of preterm infants in supine and prone positions after extubation.Hypothesis 0d (H0d): There is no difference between respiratory distress in preterm infants in supine and prone positions after extubation., conditionsModule conditions: Premature Infants, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Simple randomization method was used in the sample of the study. In previous studies, there were no published data on the effect of supine and prone positioning after extubation on the pulmonary functions of premature infants. Therefore, the sample size was calculated using the G-power 3.1.3 program according to the SpO2 level and standard deviation values of 4 infants who were mechanically ventilated in the neonatal intensive care unit. The study was conducted with a total of 42 premature babies, two groups of 21 premature babies, each of whom had the characteristics of the research groups. Premature infants were divided into two groups, the supine position and the prone group, by randomization using a computer-based random number generator (www.randomizer.org)., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 42, type: ACTUAL, armsInterventionsModule interventions name: The effect of positioning on respiratory functions of preterm infants after extubation., outcomesModule primaryOutcomes measure: Newborn Evaluation Form, eligibilityModule sex: ALL, minimumAge: 37 Weeks, maximumAge: 37 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: İlknur Kahriman, city: Trabzon, zip: 61080, country: Turkey, geoPoint lat: 41.005, lon: 39.72694, locations facility: Karadeniz Technical University Health Application and Research Center Farabi Hospital, city: Trabzon, zip: 61080, country: Turkey, geoPoint lat: 41.005, lon: 39.72694, hasResults: False
|
protocolSection identificationModule nctId: NCT06352034, orgStudyIdInfo id: Empathy Training for Students, briefTitle: Empathy Training for Future Mental Health Practitioners in University Students, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Peking University, class: OTHER, descriptionModule briefSummary: This study aims to investigate the efficacy of empathy training for future psychological counselors in university students. The training contains 5 sessions of psychoeducation, three-role group exercises, and Q\&A. Self-reported, listener-reported, and observer-reported measurements will be applied for empathy assessment., conditionsModule conditions: Empathy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Empathy Training, outcomesModule primaryOutcomes measure: Change from counseling duration, primaryOutcomes measure: Change from Baseline of 12-Item Version of the Barrett-Lennard Relationship Inventory, primaryOutcomes measure: Change from consultation willingness question inquiry, primaryOutcomes measure: Change from morphed emotion perception task, primaryOutcomes measure: Change from Baseline of the Measure of Empathy Scale, primaryOutcomes measure: Change from Baseline of the Emotion Perception Scale, primaryOutcomes measure: Change from Baseline of the Peking Alexithymia Scale, secondaryOutcomes measure: Change from Baseline of the Patient Health Questionnaire, secondaryOutcomes measure: Change from Baseline of the Generalized Anxiety Disorder Scale, secondaryOutcomes measure: Change from Baseline of the Peking Irritability Scale, secondaryOutcomes measure: Change from Baseline of the the Fatigue Assessment Scale, secondaryOutcomes measure: Change from Baseline of the the Patient Health Questionnaire, secondaryOutcomes measure: Change from Baseline of the Cognitive-Emotion Regulation Questionnaire, secondaryOutcomes measure: Change from Baseline of the Difficulties in Emotion Regulation Scale, secondaryOutcomes measure: Change from Baseline of the the Satisfaction with Life Scale, secondaryOutcomes measure: Change from Baseline of the the Subjective Happiness Scale, secondaryOutcomes measure: Change from Baseline of the Connor-Davidson Resilience Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking University, city: Peking, state: Beijing, zip: 100871, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
|
protocolSection identificationModule nctId: NCT06352021, orgStudyIdInfo id: KAHRİMAN İlknur, briefTitle: The Effect of Distraction With a Kaleidoscope on the Level of Perceived Pain During Blood Sampling in Children, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-05-30, primaryCompletionDateStruct date: 2019-06-30, completionDateStruct date: 2019-06-30, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: İlknur KAHRİMAN, class: OTHER, descriptionModule briefSummary: This experimental study aimed to determine the effect of distracting children with a kaleidoscope during blood sampling on their perception of pain during the procedure and to increase and improve the quality of evidence for the effectiveness of these methods across different populations and cultures.Hypothesis 0 (H0): There is no difference between the pain scores of the kaleidoscope group and the control group during blood sampling.Hypothesis 1 (H1): There is a difference between the pain scores of the kaleidoscope group and the control group during blood sampling., conditionsModule conditions: Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: kaleidoscope, outcomesModule primaryOutcomes measure: The Wong-Baker Pain Scale, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Karadeniz Technical University Health Application and Research Center Farabi Hospital, city: Trabzon, zip: 61080, country: Turkey, geoPoint lat: 41.005, lon: 39.72694, hasResults: False
|
protocolSection identificationModule nctId: NCT06352008, orgStudyIdInfo id: Zhansheng Jiang, briefTitle: To Evaluate the Efficacy and Safety of Anrotinib Hydrochloride Capsule in Postoperative Non-pCR Patients With Non-small Cell Lung Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2026-06-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Tianjin Medical University Cancer Institute and Hospital, class: OTHER, descriptionModule briefSummary: To explore the effectiveness of anrotinib hydrochloride capsule in postoperative non-pCR non-small cell lung cancer patients with adjuvant intensive therapy, conditionsModule conditions: Event-free Lifetime, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: Anlotinib, outcomesModule primaryOutcomes measure: EFS, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tianiin Medical University Cancer Institute & Hospital, city: Tianjin, country: China, contacts role: CONTACT, phone: +008618526812877, geoPoint lat: 39.14222, lon: 117.17667, hasResults: False
|
protocolSection identificationModule nctId: NCT06351995, orgStudyIdInfo id: KOR-19-22, briefTitle: Neostigmine and Glycopyrrolate by Iontophoresis, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2020-11-06, primaryCompletionDateStruct date: 2022-10-25, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: James J. Peters Veterans Affairs Medical Center, class: FED, descriptionModule briefSummary: To determine a lower effective dose of neostigmine to induce bowel evacuation by transcutaneous administration by iontophoresis., conditionsModule conditions: Spinal Cord Injuries, conditions: Constipation, conditions: Fecal Incontinence, conditions: Neurogenic Bowel, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 6, type: ACTUAL, armsInterventionsModule interventions name: Combination of Neostigmine and Glycopyrrolate, interventions name: I-Box by Dynatronics, outcomesModule primaryOutcomes measure: Presence or absence of bowel evacuation, primaryOutcomes measure: Time to bowel evacuation, primaryOutcomes measure: Stool Consistency, primaryOutcomes measure: Stool Quantity, secondaryOutcomes measure: Presence or absence of headache, dry mouth, muscle twitching and abdominal cramps., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 89 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: James J. Peters Veterans Affairs Medical Center, city: Bronx, state: New York, zip: 10468, country: United States, geoPoint lat: 40.84985, lon: -73.86641, hasResults: False
|
protocolSection identificationModule nctId: NCT06351982, orgStudyIdInfo id: 211123PER3-3-2, briefTitle: Treatment Of Shallow Periodontal Pockets 4-6mm Using AIRFLOW Prophylaxis Master Device With Erythritol vs Manual Scalers, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: Periodontitis is a chronic condition associated with the inflammatory destruction of the periodontal tissues ultimately leading to tooth loss. Clinically, it is identified by key features such as clinical attachment loss (CAL), bleeding upon probing (BOP), and an increase in probing pocket depth (PPD), and/or gingival recession. Periodontitis is mediated by polymicrobial dysbiosis with keystone pathogens affecting the virulence of the entire biofilm community. The removal of this biofilm and its retention factors is the ultimate goal of clinical treatment and oral measures applied. The elimination of the biofilm has traditionally been achieved with the use of either hand instruments or power driven devices. Promoting periodontal health or diminishing bacterial presence and calculus buildup on teeth can be accomplished with the same efficacy whether using manual scalers and curettes or ultrasonic scaling instruments.Both hand and ultrasonic instruments are characterized by being time-consuming and requiring technical skill, often causing patient discomfort and post-treatment pain, including hypersensitivity resulting from the loss of hard tissue when scaling the tooth surface. Ultrasonic instruments tend to leave a rougher surface behind compared to hand instruments. While effective the current techniques all have their disadvantages.The aim of this study is to evaluate changes in probing depth clinically, Bleeding on probing, Clinical attachment level, Plaque index, Calculus index, Patient pain/discomfort, Patient satisfaction, Cost effectiveness, Treatment time and Number of pockets closed after using AIRFLOW® Prophylaxis Master device with erythritol powder., conditionsModule conditions: Periodontal Pocket, conditions: Periodontitis, conditions: Gingival Diseases, conditions: Gingival Bleeding, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 46, type: ESTIMATED, armsInterventionsModule interventions name: Electro Medical Systems AIRFLOW® Prophylaxis Master Device, interventions name: Hand and ultrasonic scalers and curettes, outcomesModule primaryOutcomes measure: Change in probing pocket depth, secondaryOutcomes measure: Bleeding On Probing, secondaryOutcomes measure: Clinical Attachment Level, secondaryOutcomes measure: Plaque index, secondaryOutcomes measure: Calculus index, secondaryOutcomes measure: Patient pain/discomfort, secondaryOutcomes measure: Patient satisfaction, secondaryOutcomes measure: Cost effectiveness, secondaryOutcomes measure: Treatment time, secondaryOutcomes measure: Number of healed pockets, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 80 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Dentistry, Cairo University, status: RECRUITING, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
|
protocolSection identificationModule nctId: NCT06351969, orgStudyIdInfo id: Ms 9-12-2023, briefTitle: Evaluating Placental Thickness and Thickness of Uterine Muscle at Placenta Attachment in Prediction of Postpartum Blood Loss, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-21, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Benha University, class: OTHER, descriptionModule briefSummary: Aim of the Work is To determine the significance of the placental thickness and the thickness of the uterine muscle layer at placenta attachment in the prediction of postpartum hemorrhage and to evaluate both of them as as parameters for identifying high-risk patients., conditionsModule conditions: Post Partum Hemorrhage, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, outcomesModule primaryOutcomes measure: Evaluating Placental Thickness in cm and Thickness of Uterine Muscle in cm at Placenta Attachment in Prediction of Postpartum Blood Loss, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Benha Univeristy, status: RECRUITING, city: Banhā, country: Egypt, contacts name: Ashraf Ismail mohamed, professor, role: CONTACT, phone: +201119709696, geoPoint lat: 30.45906, lon: 31.17858, hasResults: False
|
protocolSection identificationModule nctId: NCT06351956, orgStudyIdInfo id: Arrhythmias in Septic Patients, briefTitle: New Onset Cardiac Arrhythmias in Septic Patients in Critical Care Setting, Predictors and Outcomes., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2026-04-20, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: New Onset Cardiac Arrhythmias in Septic Patients in Critical Care Setting, Predictors and Outcomes, conditionsModule conditions: Cardiac Arrhythmia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 72, type: ESTIMATED, outcomesModule primaryOutcomes measure: Risk Factors of cardiac arrhythmias in septic patients in CU., primaryOutcomes measure: Fates of cardiac arrhythmia., secondaryOutcomes measure: The frequent type of arrhythmias., secondaryOutcomes measure: Mortality rate due to new onset arrhythmia., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06351943, orgStudyIdInfo id: ImageDB pilot, briefTitle: Proximal Femur Image Database Validation, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2021-05-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: AO Innovation Translation Center, class: OTHER, collaborators name: University of Turin, Italy, descriptionModule briefSummary: The AO@AI Turin project is a collaborative project with a Turin group and the AO (Arbeitsgemeinschaft für Osteosynthesefragen, or in English, Association for the Study of Internal Fixation) foundation. An Image database (DB) has been built to host AP pelvic radiographs ready for artificial intelligence (AI) development.The goal of this project is to determine the agreement between the Turin annotation of fracture status and the annotation from an external group of AO expert surgeons for a random subset of the Turin images., conditionsModule conditions: Proximal Femoral Fracture, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 2932, type: ESTIMATED, armsInterventionsModule interventions name: Fracture classification annotations provided by the Turin group, interventions name: Fracture classification annotations provided by the AO expert surgeon group, outcomesModule primaryOutcomes measure: Annotations of fracture status of the image, primaryOutcomes measure: In case of fracture, Arbeitsgemeinschaft für Osteosynthesefragen (AO, in English, Association for the Study of Internal Fixation)/Orthopedic Trauma Association (OTA) classification: Type, primaryOutcomes measure: In case of fracture, AO/OTA classification: Group, primaryOutcomes measure: In case of fracture, AO/OTA classification: Subgroup, primaryOutcomes measure: In case of fracture, AO/OTA classification: Qualifier for 31A1.1, primaryOutcomes measure: In case of fracture, AO/OTA classification: Qualifier for 31B2, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: AO Foundation, city: Dübendorf, zip: 8600, country: Switzerland, geoPoint lat: 47.39721, lon: 8.61871, hasResults: False
|
protocolSection identificationModule nctId: NCT06351930, orgStudyIdInfo id: EA210473, briefTitle: CBT for Insomnia in Adolescents With ADHD, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: The University of Hong Kong, class: OTHER, collaborators name: Kwai Chung Hospital, Hong Kong, descriptionModule briefSummary: Insomnia and attention deficit hyperactivity disorder (ADHD) are highly comorbid conditions with an intricate, bidirectional relationship. In particular, insomnia and ADHD often co-occur, with 22.9-34.6% of adolescents with insomnia having clinically significant ADHD, and 22-33.5% of adolescents with ADHD experiencing comorbid insomnia symptoms. Insomnia is not only associated with increased ADHD severity, but also linked to an increased risk for other mental health problems and poorer treatment response in young people with ADHD. Behavioural sleep interventions have shown promise in improving sleep in young children with comorbid ADHD and insomnia. Nonetheless, when treating adolescent insomnia, especially those with ADHD, there is a need to consider the unique sleep and circadian features as well as psychosocial factors associated with not only ADHD but also adolescence, a challenging developmental stage. To date, there is a paucity of research to test the efficacy of cognitive behavioural therapy for insomnia (CBT-I) in adolescents with comorbid ADHD and insomnia. To address the limitations in the existing literature, this study aims to conduct a randomised controlled trial (RCT) to examine the effects of CBT-I relative to a usual care (UC) condition in adolescents with ADHD, on improving sleep and ADHD symptoms, and other clinical and daytime symptoms as well as overall functional improvement., conditionsModule conditions: Insomnia, conditions: ADHD, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A randomised, assessor-blind, parallel group controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 84, type: ESTIMATED, armsInterventionsModule interventions name: CBT-I + UC group, outcomesModule primaryOutcomes measure: Change in Insomnia Symptoms, secondaryOutcomes measure: Change in ADHD Symptoms (Self-report), secondaryOutcomes measure: Change in Internalising and Externalising Symptoms (Parent-rated), secondaryOutcomes measure: Change in depressive symptoms (Self-report), secondaryOutcomes measure: Change in anxiety symptoms (Self-report), secondaryOutcomes measure: Change in Sleep Diary Measure - Time in Bed (TIB), secondaryOutcomes measure: Change in Sleep Diary Measure - Total Sleep Time (TST), secondaryOutcomes measure: Change in Sleep Diary Measure - Sleep Onset Latency (SOL), secondaryOutcomes measure: Change in Sleep Diary Measure - Wake After Sleep Onset (WASO), secondaryOutcomes measure: Change in Sleep Diary Measure - Sleep Efficiency (SE), secondaryOutcomes measure: Change in Objective Sleep Measures - Time in Bed (TIB), secondaryOutcomes measure: Change in Objective Sleep Measures - Total Sleep Time (TST), secondaryOutcomes measure: Change in Objective Sleep Measures - Sleep Onset Latency (SOL), secondaryOutcomes measure: Change in Objective Sleep Measures - Wake After Sleep Onset (WASO), secondaryOutcomes measure: Change in Objective Sleep Measures - Sleep Efficiency (SE), secondaryOutcomes measure: Change in Individual Beliefs and Attitude about Sleep, secondaryOutcomes measure: Change in Adolescent Sleep Hygiene, secondaryOutcomes measure: Change in Quality of Life, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Child and adolescent outpatient psychiatric clinic of Kwai Chung Hospital, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Waiyan Vivian CHIU, Clinical Psychologist, role: CONTACT, geoPoint lat: 22.27832, lon: 114.17469, locations facility: Sleep Research Clinic and Laboratory, Department of Psychology, The University of Hong Kong, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Shirley X Li, PhD, DClinPsy, role: CONTACT, phone: 852-39177035, email: [email protected], geoPoint lat: 22.27832, lon: 114.17469, hasResults: False
|
protocolSection identificationModule nctId: NCT06351917, orgStudyIdInfo id: LEVEXE, briefTitle: Effect of Topical PlexoZome® Levagen® Spray on Relief of Post Exercise Knee Joint Pain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: RDC Clinical Pty Ltd, class: INDUSTRY, descriptionModule briefSummary: This is a randomised, double-blind, placebo controlled, 2 arm parallel clinical trial to evaluate the effect of topical PlexoZome® Levagen® spray on relief of post exercise knee joint pain in healthy adults compared to placebo over 4 weeks duration., conditionsModule conditions: Knee Joint Pain, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: PlexoZome® Levagen® topical spray solution, interventions name: Placebo topical spray solution, outcomesModule primaryOutcomes measure: Joint pain, secondaryOutcomes measure: Time to pain relief, secondaryOutcomes measure: Number of Adverse Events, secondaryOutcomes measure: Severity of Adverse Events, secondaryOutcomes measure: Rescue medication use, eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: RDC Clinical Pty Ltd, city: Brisbane, state: Queensland, zip: 4006, country: Australia, contacts name: Amanda Rao, PhD, role: CONTACT, phone: +61 414 488 559, email: [email protected], contacts name: David Briskey, PhD, role: CONTACT, phone: +61 421 784 077, email: [email protected], contacts name: Amanda Rao, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -27.46794, lon: 153.02809, hasResults: False
|
protocolSection identificationModule nctId: NCT06351904, orgStudyIdInfo id: RAG-01-01, briefTitle: A Study of RAG-01 in Patients With Non-muscle-invasive Bladder Cancer (NMIBC) Who Have Failed Bacillus Calmette Guérin (BCG) Therapy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-03, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-08-31, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Ractigen Therapeutics., class: OTHER, descriptionModule briefSummary: This is an open label, multi-center study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of RAG-01 in patients with NMIBC who have failed BCG therapy., conditionsModule conditions: Non-Muscle-Invasive Bladder Cancer (NMIBC), designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: RAG-01, outcomesModule primaryOutcomes measure: Safety and tolerability of RAG-01 in patients with non-muscle-invasive bladder cancer (NMIBC), primaryOutcomes measure: Maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of RAG-01, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: GenesisCare North Shore, status: RECRUITING, city: St Leonards, state: New South Wales, zip: 2065, country: Australia, contacts name: Laurence Krieger, MBCHB, role: CONTACT, phone: +61 2 8037 4100, email: [email protected], geoPoint lat: -33.82344, lon: 151.19836, hasResults: False
|
protocolSection identificationModule nctId: NCT06351891, orgStudyIdInfo id: SHARE2402, briefTitle: Efficacy and Safety of Bismuth Quadruple Therapy Containing Cefuroxime and Tetracycline as First-line Therapy for Eradicating Helicobacter Pylori in Patients Allergic to Penicillin, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Qilu Hospital of Shandong University, class: OTHER, descriptionModule briefSummary: The researchers collected untreated H. pylori positive patients from outpatient clinics. Subjects were randomly assigned to receive either 14 days of bismuth quadruple therapy with cefuroxime and tetracycline or 14 days of bismuth quadruple therapy with cefuroxime and levofloxacin for Helicobacter pylori eradication. After 6 weeks of treatment, subjects underwent another 13C urea breath test. Eradication rates, adverse reaction rates and patient compliance were calculated., conditionsModule conditions: Helicobacter Pylori Infection, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 248, type: ESTIMATED, armsInterventionsModule interventions name: 14-day bismuth quadruple regimen containing cefuroxime and tetracycline, interventions name: 14-day bismuth quadruple regimen containing cefuroxime and levofloxacin, outcomesModule primaryOutcomes measure: Eradication rate, secondaryOutcomes measure: Rate of adverse reactions, secondaryOutcomes measure: Patient compliance, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Qilu Hospital of Shandong University, city: Jinan, state: Shandong, zip: 250012, country: China, contacts name: Yueyue Li, MD,PhD, role: CONTACT, phone: 86-18560089751, email: [email protected], geoPoint lat: 36.66833, lon: 116.99722, hasResults: False
|
protocolSection identificationModule nctId: NCT06351878, orgStudyIdInfo id: Pro00113559, briefTitle: TipTraQ Home Sleep Test Validation Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2024-08-23, completionDateStruct date: 2024-08-23, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: PranaQ Pte. Ltd., class: INDUSTRY, descriptionModule briefSummary: A validation study has been designed to assess the performance of a home sleep test device, TipTraQ, for screening sleep apnea. The study involves participants wearing the TipTraQ device on their fingertip during a traditional sleep test, known as polysomnography (PSG), conducted in a sleep center. The performance of the device will then be evaluated by comparing the results from the TipTraQ system with those from the traditional sleep test., conditionsModule conditions: Obstructive Sleep Apnea, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 125, type: ESTIMATED, outcomesModule primaryOutcomes measure: Apnea Hypopnea Index(AHI), primaryOutcomes measure: Oxygen Desaturation Index(ODI), primaryOutcomes measure: Total Sleep Time(TST), eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Duke University, status: RECRUITING, city: Durham, state: North Carolina, zip: 27705, country: United States, contacts name: Alexis Schuettke, role: CONTACT, phone: 919-668-2842, email: [email protected], geoPoint lat: 35.99403, lon: -78.89862, hasResults: False
|
protocolSection identificationModule nctId: NCT06351865, orgStudyIdInfo id: PHU/2023/21, briefTitle: Feasibility Study to Evaluate the Use of Patient Reported Complications After Digital Consent, acronym: PRC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-07, primaryCompletionDateStruct date: 2024-09-19, completionDateStruct date: 2024-10-31, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Portsmouth Hospitals NHS Trust, class: OTHER_GOV, collaborators name: University of East Anglia, descriptionModule briefSummary: Patient report complication data to our best knowledge has not been studied yet in electronic consent. This study is a feasibility study to assess whether patients will reliably report their complications, the quality of this reporting and whether the information provided in the consent form matches up to their experience. This data will then be used to improve the consent process and evaluate whether the Patient Initiated Follow Up (PIFU) model is effective or if it leads to underreporting of problems., conditionsModule conditions: Breast Cancer, conditions: Complication of Surgical Procedure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, outcomesModule primaryOutcomes measure: Proportion of patients who respond to the feedback questionnaire, primaryOutcomes measure: Final attrition rate, secondaryOutcomes measure: Quoted risks in the consent to the incidence of complications, secondaryOutcomes measure: Frequency of PRC and CRCs (Consent Form Reported Complications), secondaryOutcomes measure: Understanding of consent, secondaryOutcomes measure: Language used in patient reported complications, secondaryOutcomes measure: Accuracy of potential complications, secondaryOutcomes measure: Participant preparation for surgery, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Queen Alexandra Hospital, status: RECRUITING, city: Portsmouth, state: Hampshire, zip: PO6 3LY, country: United Kingdom, contacts name: Edward St John, role: CONTACT, phone: 02392286000, email: [email protected], geoPoint lat: 50.79899, lon: -1.09125, hasResults: False
|
protocolSection identificationModule nctId: NCT06351852, orgStudyIdInfo id: 1678243, briefTitle: Transdermal Administration by a Novel Wireless Iontophoresis Device, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-03-22, primaryCompletionDateStruct date: 2025-02-15, completionDateStruct date: 2025-02-15, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: James J. Peters Veterans Affairs Medical Center, class: FED, descriptionModule briefSummary: Persons with spinal cord injury (SCI) have neurogenic bowel disorders which is associated with significant morbidity. The negative impact of bowel complications is often at the top of the list of problems reported by persons with SCI. Despite the magnitude of the problem of bowel dysfunction in persons with SCI, and the associated reduction in quality of life, this condition has yet to be effectively treated. The investigators have developed a novel dual drug combination to elicit a safe and predictable bowel evacuation (BE).The ability to move the bowel contents along to the rectum was severely impaired primary because of poor gut contractions on the left side of the colon, as shown by our team of investigators. To address this problem, a dual medication combination (neostigmine and glycopyrrolate) was developed that safely and predictably caused the bowel to empty after delivering these drugs into a vein (intravenously) or into the muscle bed (intramuscularly). Because no one likes needles, and because of the practical limits of administering medications on a routine basis by the use of needles, especially in persons with SCI because of their other health considerations, the investigators have devised a new approach: driving these medications across the skin and into the circulation of the body by applying an electrical current that is too small to feel (iontophoresis).The proposed research project to determine the safety of positively charged compounds (e.g., vitamin B12, NEO, and GLY) administered transcutaneously by the prototype wireless ION device and to compare the pharmacokinetic profiles of transcutaneous administration of NEO and GLY by the wireless ION device to a commercially available wired ION device. The potential administration of any number of other positively charged agents by this wireless prototype may be a clinically relevant outcome of this work. The ability to use a wireless ION device is far more practical for patients to use, especially those with SCI, which will permit the self-administration of these agents in the home setting to induce a bowel evacuation., conditionsModule conditions: Spinal Cord Injuries, conditions: Constipation, conditions: Fecal Incontinence, conditions: Neurogenic Bowel, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 6, type: ESTIMATED, armsInterventionsModule interventions name: Combination of Neostigmine and Glycopyrrolate, interventions name: I-Box by Dynatronics, outcomesModule primaryOutcomes measure: Presence or absence of bowel evacuation, primaryOutcomes measure: Time to bowel evacuation, primaryOutcomes measure: Stool Consistency, primaryOutcomes measure: Stool Quantity, secondaryOutcomes measure: Presence or absence of headache, dry mouth, muscle twitching and abdominal cramps, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 89 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: James J. Peters Veterans Affairs Medical Center, status: RECRUITING, city: Bronx, state: New York, zip: 10468, country: United States, contacts name: Christopher P Cardozo, MD, role: CONTACT, phone: 718-584-9000, phoneExt: 1828, email: [email protected], geoPoint lat: 40.84985, lon: -73.86641, hasResults: False
|
protocolSection identificationModule nctId: NCT06351839, orgStudyIdInfo id: 2024/500457(REK), briefTitle: Sleep Well Despite Persistent Pain Symptoms, acronym: Sleep-Well, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-10, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: University of Tromso, class: OTHER, collaborators name: University Hospital of North Norway, collaborators name: Diakonhjemmet Hospital, descriptionModule briefSummary: Background: The prevalence of comorbid insomnia is 8-10 times higher in patients with chronic pain than in the general population. Insomnia adds a considerable burden as it worsens the quality of life, restoration and repair, mental health and pain symptoms. Since pain and sleep problems are mutually reinforcing, improvements in sleep may have beneficial effects on pain. Unfortunately, the customary use of sleep medication (TAU: treatment-as-usual) often yields short-lived plus side effects. The "Sleep-Well" intervention examines if a group-based intervention program focusing on sleep literacy, sleep restriction, stimulus control and metacognitive therapy modules may perform better than TAU in improving patients' insomnia and sleep quality.Eligible patients: Investigators target adult patients referred to the University Hospital of North Norway (Tromsø) for a diagnostic evaluation of their pain condition. Patients eligible for the Sleep-Well study are those who satisfy diagnostic criteria for a non-malign pain disorder plus a comorbid insomnia sleep disorder. Patients are not eligible if they use drugs or large doses of morphine (\>100 equivalents), are engaged in an insurance case due to their diagnosis, or participate in other ongoing group programs at the hospital.Aims: This trial uses a randomized semi-crossover design to examine if the Sleep-Well group does better regarding insomnia and sleep quality than the control patients (TAU). The primary outcome measures are reductions in diagnostic criteria for insomnia, self-reported insomnia symptoms, quality of life, and actigraphy-measured insomnia indicators (long sleep onset latency, frequent nightly awakenings and early morning awakening). The secondary outcome measures include a simplified polysomnography measurement of brain activity during sleep to assess if proportions or durations of slow-wave versus light-wave sleep and EEG-based arousal indices improve. In addition, it is examined if the Sleep-Well intervention incurs benefits concerning pain complaints, dysfunctional sleep and pain cognitions, anxiety and depression.The intervention: The Sleep-Well program schedules group sessions that cover four topics (sleep literacy, behavioural and mental strategies, maintenance and relapse prevention). All sessions are led by two therapists. Those randomized to the active control group (TAU) cross over to the Sleep-Well intervention three months later., conditionsModule conditions: Insomnia Chronic, conditions: Insomnia Due to Medical Condition, conditions: Pain, Chronic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: We randomize patients to receive either the Sleep-Well intervention or to the TAU condition (active waiting-list group). After 3 months, the TAU patients cross over and receive the Sleep-Well intervention; hence, the design is semi-crossover., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 106, type: ESTIMATED, armsInterventionsModule interventions name: Sleep-Well despite persistent pain, interventions name: TAU (treatment-as-usual), outcomesModule primaryOutcomes measure: Insomnia symptoms, primaryOutcomes measure: Insomnia diagnosis, primaryOutcomes measure: Actigraphy insomnia indicators (SOL, WASO and EMA in minutes), primaryOutcomes measure: Actigraphy insomnia indicators (SE %), primaryOutcomes measure: Sleep diary insomnia indicators (SOL, WASO and EMA in minutes), secondaryOutcomes measure: Sleep brain activity as measured by a simplified polysomnography device, i.e., a Home Sleep Test (HST), secondaryOutcomes measure: Anxiety and depression (HADS), secondaryOutcomes measure: Quality of Life (EQ-5Q-5L), secondaryOutcomes measure: Fatigue (Chalder Fatigue Scale), secondaryOutcomes measure: Pain intensity, interference and locations (BPI), secondaryOutcomes measure: Tolerance and Acceptance of chronic pain (CPAQ-R), otherOutcomes measure: Mediator: Sleep hygiene (SHI), otherOutcomes measure: Hyperactivity (HAS), otherOutcomes measure: Mediator: Dysfunctional beliefs and attitudes about sleep (DBAS), otherOutcomes measure: Mediator: Metacognitions about insomnia (MCQ-i), otherOutcomes measure: Mediator: Insomnia catastrophizing Scale (ISC), otherOutcomes measure: Mediator: Pain Catastrophizing Scale (PCS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UiT The Arctic University of Norway, city: Tromsø, state: Troms County, zip: 9037, country: Norway, contacts name: Oddgeir Friborg, ph.d., role: CONTACT, phone: 4777646772, email: [email protected], contacts name: Svein Bergvik, ph.d., role: CONTACT, phone: 4777646323, email: [email protected], contacts name: Oddgeir Friborg, ph.d., role: PRINCIPAL_INVESTIGATOR, contacts name: Jan H Rosenvinge, ph.d., role: SUB_INVESTIGATOR, contacts name: Svein Bergvik, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 69.6489, lon: 18.95508, hasResults: False
|
protocolSection identificationModule nctId: NCT06351826, orgStudyIdInfo id: 22070876, briefTitle: Effectiveness of ELLASI Intervention Towards Polytrauma Patients in the Emergency Department, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-03, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Indonesia University, class: OTHER, descriptionModule briefSummary: This clinical trial aims to test the effectiveness of ELLASI intervention in response time, deterioration score, and metabolic status of polytrauma patients in the emergency department. The main questions it aims to answer are:1. Is the response time of polytrauma patients who receive ELLASI in the intervention group faster than the control group?2. Is the deterioration score of polytrauma patients who receive ELLASI in the intervention group better than the control group?3. Is the metabolic status of polytrauma patients who receive ELLASI in the intervention group better than the control group?Polytrauma patients in the intervention group will receive ELLASI, a structured intervention consisting of the six following:1. Evaluation of airway and cervical control, remove the foreign body, fluid, etc., from the airway,2. Patient positioning and giving oxygen, head-up,3. Stabilisation, including IV insertion, applying pressure and bandage, place monitor, and haemodynamic monitoring4. Assessment: re-assessment of pain and other main complaints5. Make sure informed consents are documented6. Inform patient and family for further interventionPolytrauma patients in the control group will receive the usual/standard intervention.Response time, early warning score, and arterial blood gas of polytrauma patients from both groups will be obtained and documented before and after the intervention., conditionsModule conditions: Polytrauma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: ELLASI, interventions name: Standard, outcomesModule primaryOutcomes measure: Response time, primaryOutcomes measure: Deterioration score, primaryOutcomes measure: Acidic Level (pH), primaryOutcomes measure: Base Excess (BE), primaryOutcomes measure: Bicarbonate level (HCO3), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: RSCM, status: RECRUITING, city: Jakarta Pusat, state: Jawa Barat, zip: 10430, country: Indonesia, contacts name: RSCM, role: CONTACT, phone: 062211500135, email: [email protected], geoPoint lat: -6.1818, lon: 106.8223, hasResults: False
|
protocolSection identificationModule nctId: NCT06351813, orgStudyIdInfo id: B2024-029R, briefTitle: Predicting Adverse Kidney Events of Cardiac Surgery-Associated Acute Kidney Injury Using Novel Biomarkers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Shanghai Zhongshan Hospital, class: OTHER, collaborators name: Zhongshan Hospital (Xiamen), Fudan University, collaborators name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, descriptionModule briefSummary: The aim of this study was to identify and validate novel biomarkers for predict acute kidney injury (AKI) subphenotype, major adverse kidney events and other poor outcomes., conditionsModule conditions: Acute Kidney Injury, conditions: Critical Illness, conditions: Kidney Failure, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 358, type: ESTIMATED, outcomesModule primaryOutcomes measure: AKI nonresolving subphenotype, secondaryOutcomes measure: Major adverse kidney events at 30 days, secondaryOutcomes measure: Major adverse kidney events at 90 days, secondaryOutcomes measure: Major adverse kidney events at 365 days, secondaryOutcomes measure: Mortality, secondaryOutcomes measure: Receipt of renal replacement treatment, secondaryOutcomes measure: Moderate and severe AKI, secondaryOutcomes measure: AKI progression, secondaryOutcomes measure: Composite Outcome, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shanghai Zhongshan Hospital, city: Shanghai, state: Shanghai, zip: 200032, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
|
protocolSection identificationModule nctId: NCT06351800, orgStudyIdInfo id: PE-0280-2018, briefTitle: The PredictPlusPrevent Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-15, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-04-30, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: The Mediterranean Institute for the Advance of Biotechnology and Health Research, class: OTHER, descriptionModule briefSummary: Objective: To design, develop, and evaluate a personalized intervention for the universal prevention of depression and anxiety in the general population based on risk algorithms, ICTs, and decision support systems (DSS).Methods: A double-blind, parallel-group, randomized controlled trial with a twelve-month follow-up. The entire process of recruitment, random allocation, intervention, and follow-up will be conducted through the 'PredictPlusPrevent' platform and its associated apps. Following a media campaign, at least 9,000 Spanish participants aged 18 to 55 years without depression and/or anxiety at baseline will be randomly assigned to the intervention or active control group "PredictPlusPrevent". The "PredictPlusPrevent" intervention will be self-guided and implemented through participants' smartphones via an app; it will have a biopsychosocial and multi-component approach (8 modules: physical exercise, improving sleep, expanding relationships, problem-solving, improving communication, assertiveness, decision-making, and managing thoughts). The "PredictPlusPrevent" intervention is based on validated risk algorithms for depression and anxiety and a DSS that will help participants develop their own personalized depression prevention plans, which they will implement themselves while the platform monitors and provides feedback. The active control "PredictPlusPrevent" will include information from the risk algorithms and 24 self-help booklets. The primary outcome will be the incidence of new cases of depression and/or anxiety assessed using the PRIME-MD questionnaire, and secondary outcomes will include reductions in depression (PHQ-9) and anxiety symptoms (GAD-7), probability of depression and anxiety risk (predictD and predictA algorithms), and physical and mental quality of life (SF-12)., conditionsModule conditions: Depression, conditions: Anxiety Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 9000, type: ESTIMATED, armsInterventionsModule interventions name: Predictplusprevent intervention, interventions name: Psychoeducational intervention, outcomesModule primaryOutcomes measure: Incidence of depression and/or anxiety disorders., secondaryOutcomes measure: Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9)., secondaryOutcomes measure: Anxious symptoms measured by the General Anxiety Questionnaire (GAD-7)., secondaryOutcomes measure: Probability of depression measured by the Spanish predictD risk algorithm., secondaryOutcomes measure: Probability of anxiety measured by the Spanish predictA risk algorithm., secondaryOutcomes measure: Quality of life measured by the 12-item Short Form (SF-12)., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06351787, orgStudyIdInfo id: 22-X-97, briefTitle: Project Soma: Cortical Activity of a Body Scan Meditation and Yoga Practice in Healthy Yogis, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-10-31, primaryCompletionDateStruct date: 2023-06-28, completionDateStruct date: 2023-06-28, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Ohio University, class: OTHER, descriptionModule briefSummary: In this 2-armed randomized cross-sectional experimental study of healthy participants with yoga experience, we will examine the relationship between 4 self-reported enhancing psychological factors, cortical activity captured with functional near-infrared spectroscopy (fNIRS), and pain sensitivity (mechanical pressure pain tolerance) captured with algometry.Specifically, we will examine the correlates of interoceptive awareness and mindful awareness with cortical activity (Aim 1a) and pain tolerance (Aim 1b); determine cortical activity responsiveness of two brief awareness-focused meditations - a resting-based body scan practice and yoga practice (Aim 2a); characterize cortical activity profiles with sequentially delivered body scan and yoga practices (Aim 2b); and elucidate the relationship between interoceptive awareness with healthy emotionality and psychological wellbeing (Aim 3).Our central hypotheses are that (Aim 1a) higher interoceptive awareness and mindful awareness will moderately correlate with higher cortical activity for both awareness-focused meditation practices; (Aim 1b) individuals sub-grouped into the 'acceptance in action cluster' based on 2 self-report measures will exhibit higher pain tolerance; (Aim 2a) cortical activity will be higher in the yoga practice compared to the body scan practice; and (Aim 2b) higher cortical activity will be observed in the body scan-\>yoga intervention sequence compared to the yoga-\>body scan intervention sequence. Furthermore, (Aim 3) we predict that interoceptive awareness will moderately correlate with healthy emotionality and psychological well-being., conditionsModule conditions: Well-Being, Psychological, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: A 2-armed randomized cross-sectional experimental study with 20 healthy participants who hold yoga experience., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 14, type: ACTUAL, armsInterventionsModule interventions name: Resting and movement-based focused awareness meditations, outcomesModule primaryOutcomes measure: Cortical activity, primaryOutcomes measure: Interoceptive awareness, primaryOutcomes measure: Mindful awareness, primaryOutcomes measure: Pressure pain threshold and tolerance, secondaryOutcomes measure: Healthy emotionality, secondaryOutcomes measure: Well-being, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ohio University, city: Athens, state: Ohio, zip: 45701, country: United States, geoPoint lat: 39.32924, lon: -82.10126, hasResults: False
|
protocolSection identificationModule nctId: NCT06351774, orgStudyIdInfo id: 21-F-45, briefTitle: Project AdaPT: An Adaptive Physiotherapy Intervention Augmented With a Healthy Mind Training Program for People With Chronic Low Back Pain, acronym: AdaPT, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-05-24, primaryCompletionDateStruct date: 2024-02-08, completionDateStruct date: 2024-03-25, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Ohio University, class: OTHER, collaborators name: University of Wisconsin, Madison, descriptionModule briefSummary: In the proposed research, we will elucidate the comparative effectiveness of standalone physiotherapy (PT) vs. PT augmented with a self-guided, app-based Healthy Minds Innovation wellbeing program (PT+HMI) aimed at cultivating awareness, connection, insight, and purpose for people with chronic low back pain (CLBP)., conditionsModule conditions: Back Pain Lower Back Chronic, conditions: Disability Physical, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: A 2 armed sequential, multiple-assignment randomized trial design, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The investigator was masked to the initial treatment assignment. The outcome assessor was not masked to treatment assignment and monitored treatment response at the mid-intervention in order to recommend continuation of current treatment or to augment treatment with the Healthy Mind Innovations training program for individuals who did not favorably respond to standalone PT., whoMasked: INVESTIGATOR, enrollmentInfo count: 13, type: ACTUAL, armsInterventionsModule interventions name: Physical therapy, outcomesModule primaryOutcomes measure: Oswestry Disability Index, primaryOutcomes measure: PROMIS Pain Interference, secondaryOutcomes measure: Actigraphy, secondaryOutcomes measure: 3D Motion Capture, secondaryOutcomes measure: Pain acceptance, secondaryOutcomes measure: Committed action, secondaryOutcomes measure: Healthy emotionality, secondaryOutcomes measure: Exercise behavior, secondaryOutcomes measure: Back pain screening tool 1, secondaryOutcomes measure: Back pain screening tool 1, secondaryOutcomes measure: Kinesiophobia, secondaryOutcomes measure: Attitudes towards complementary and alternative medicine, secondaryOutcomes measure: Treatment expectancy, secondaryOutcomes measure: Lumbar pressure pain threshold, secondaryOutcomes measure: Thermal method of limits, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ohio University, city: Athens, state: Ohio, zip: 45701, country: United States, geoPoint lat: 39.32924, lon: -82.10126, hasResults: False
|
protocolSection identificationModule nctId: NCT06351761, orgStudyIdInfo id: SCT02-ECG, briefTitle: WIBOFA - Validation of SCT02 With ECG-App for Detection of AF, acronym: WIBOFA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Withings, class: INDUSTRY, descriptionModule briefSummary: The aim of the study is to evaluate the performance of Withings SCT02 with embedded Withings ECG-app in the automatic detection of atrial fibrillation, conditionsModule conditions: Atrial Fibrillation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 270, type: ESTIMATED, armsInterventionsModule interventions name: Investigational Device (Withings SCT02) 30 second Electrocardiogram recording, interventions name: Reference Device (Schiller Cardiovit FT-1) 30 second Electrocardiogram recording, outcomesModule primaryOutcomes measure: Co-primary outcome 1 - Sensitivity of Investigational Device, primaryOutcomes measure: Co-primary outcome 2 - Specificity of Investigational Device, secondaryOutcomes measure: Rhythm classification by ranges of heart rate, secondaryOutcomes measure: Quality of plots measured by the IMD - ECG Waveform Visibility, secondaryOutcomes measure: Quality of plots measured by the IMD - ECG Waveforms Polarity, secondaryOutcomes measure: Quality of plots measured by the IMD - ECG Waveforms Intervals, secondaryOutcomes measure: Quality of plots measured by the IMD - Heart Rate calculation, eligibilityModule sex: ALL, minimumAge: 22 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: FWD Clinical Research, city: Boca Raton, state: Florida, zip: 33486, country: United States, geoPoint lat: 26.3669, lon: -80.13033, locations facility: Diverse Clinical Research, city: Miami, state: Florida, zip: 33175, country: United States, geoPoint lat: 25.77427, lon: -80.19366, locations facility: Henri Mondor University Hospital, city: Créteil, state: Val De Marne, zip: 94000, country: France, geoPoint lat: 48.78333, lon: 2.46667, hasResults: False
|
protocolSection identificationModule nctId: NCT06351748, orgStudyIdInfo id: NN9535-7877, secondaryIdInfos id: U1111-1296-3151, type: OTHER, domain: World Health Organization (WHO), briefTitle: Real-world Study of CHina Ozempic cLinicAl pRactice in Patients With Type 2 Diabetes (SCHOLAR), acronym: SCHOLAR, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-04-05, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Novo Nordisk A/S, class: INDUSTRY, descriptionModule briefSummary: This study is to describe the real-world use and impact of semaglutide once-weekly (OW) among participants with type 2 diabetes mellitus (T2DM) in China. Participants diagnosed with T2DM who initiated semaglutide OW for the first time between 1 Jan 2022 (the date when semaglutide OW was listed in the National Reimbursement Drug List \[NRDL\] in China\] and 28 Feb 2023 (9 months prior to the data extraction cut-off date of 30 Nov 2023) will be included in this study. The study period will be 36 months prior to the first date of participants identification period., conditionsModule conditions: Diabetes Mellitus, Type 2, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 27000, type: ESTIMATED, armsInterventionsModule interventions name: Semaglutide, outcomesModule primaryOutcomes measure: Change in Haemoglobin A1c (HbA1c) level, primaryOutcomes measure: Change in HbA1c level, primaryOutcomes measure: Proportion of participants achieving HbA1c less than (<) 7.0%, secondaryOutcomes measure: Change in HbA1c level, secondaryOutcomes measure: Change in HbA1c level, secondaryOutcomes measure: Proportion of participants achieving HbA1c <7.0%, secondaryOutcomes measure: Change in body weight, secondaryOutcomes measure: Change in body weight, secondaryOutcomes measure: Description of participants with different demographic characteristics, secondaryOutcomes measure: Description of participants with different clinical characteristics, secondaryOutcomes measure: Proportion of participants with different antidiabetic medications, secondaryOutcomes measure: Proportion of participants with different non-antidiabetic medications, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tianjin Medical University Chu Hsien-I Memorial Hospital, city: Tianjin, country: China, geoPoint lat: 39.14222, lon: 117.17667, hasResults: False
|
protocolSection identificationModule nctId: NCT06351735, orgStudyIdInfo id: 2024-0336, briefTitle: Efficacy and Safety of Deep Cervical Lymph Node-vein Bypass Surgery in ALS Amyotrophic Lateral Sclerosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-05-01, completionDateStruct date: 2027-05-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Second Affiliated Hospital, School of Medicine, Zhejiang University, class: OTHER, descriptionModule briefSummary: Amyotrophic lateral sclerosis (ALS), a fatal neurodegenerative disease, affects motor neurons, causing progressive muscle atrophy and weakness. Current treatments are ineffective, with most patients dying within 3-5 years of diagnosis. The disease's exact cause is unclear, but factors such as oxidative stress and protein abnormalities are implicated. Abnormal protein deposits and neurotoxic factors in the brain and spinal cord contribute to ALS pathology. Recent research on the brain's glymphatic-lymphatic system suggests impaired waste clearance may exacerbate ALS. Restoring drainage connections between cervical lymphatic vessels and veins could potentially alleviate neurodegenerative disease progression., conditionsModule conditions: Evaluation of the Efficacy and Safety of Deep Cervical Lymph Node-vein Bypass Surgery in Patients With Amyotrophic Lateral Sclerosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CROSSOVER, timePerspective: PROSPECTIVE, enrollmentInfo count: 3, type: ESTIMATED, armsInterventionsModule interventions name: Deep cervical lymph node-vein bypass surgery, outcomesModule primaryOutcomes measure: ALSFRS-R scale, primaryOutcomes measure: Cognitive and Behavioral Scale (CAS), secondaryOutcomes measure: Baseline of slow vital capacity (SVC), secondaryOutcomes measure: Evaluation of glymphatic and meningeal lymphatic drainage, secondaryOutcomes measure: Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-5), eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06351722, orgStudyIdInfo id: smokingnlrp3inflasome, briefTitle: Non-surgical Periodontal Treatment in Smokers on SIRT-1, NLRP3 Inflammasome and LncRNAs, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2024-12-15, completionDateStruct date: 2025-03-15, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Necmettin Erbakan University, class: OTHER, descriptionModule briefSummary: The goal of this observational is to analyze the relationship between levels of interleukin-18 (IL-18), interleukin (IL-1β), Tumor Necrosis Factor-alpha (TNF-α), interleukin-10 (IL-10), transforming growth factor beta (TGF-β), Nucleotide-binding oligomerization domain -like receptor protein 3 (NLRP3), apoptosis-associated speck-like protein (ASC), caspase-1, Sirtuin 1 (SIRT-1), Long noncoding RNA (lncRNA) small nucleolar RNA host gene 5 (SNHG5), and maternally expressed gene 3 (MEG3) in saliva, serum, and peripheral mononuclear blood cell (PMBC)in patients with periodontitis and smokers, to examine the changes in these biomarkers after non surgical periodontal treatment (NSPT), and to evaluate potential confounders that may mediate this relationship.The main questions it aims to answer are:question 1: Is there a relationship between the biomarkers mentioned above and periodontitis and smoking? question 2:How do the above-mentioned biomarkers change after NSPT in smokers and non-smokers?, conditionsModule conditions: Periodontitis, Adult, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Before non-surgical periodontal treatment, interventions name: non-surgical periodontal treatment, interventions name: 3rd month after non-surgical periodontal treatment, outcomesModule primaryOutcomes measure: Pre-treatment clinical and laboratory evaluation, primaryOutcomes measure: Comparison of clinical measurements and laboratory measurements at 3 months post-treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06351709, orgStudyIdInfo id: UmutPaksoy, briefTitle: Acute Effects of Heat, Cold and Stretching on Knee Proprioception and Vertical Jump, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-11-02, primaryCompletionDateStruct date: 2021-02-20, completionDateStruct date: 2021-02-20, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Istanbul Bilgi University, class: OTHER, descriptionModule briefSummary: The aim of our study is to investigate the effects of heat, cold and stretching on knee proprioception and vertical jump. 60 healthy individuals were randomized into hot, cold, stretching and control groups of 15 each. Pre-test and post-test measurements were made immediately after the application. Knee proprioception was measured with a digital goniometer using the EPD (joint position sense) test. Vertical jump heights were measured with contact mat by countermovement (CMJ) and squat splash (SQS) tests., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Stretching, interventions name: Hot pack application, interventions name: Cold pack application, outcomesModule primaryOutcomes measure: Vertical Jump Distance Measurement, primaryOutcomes measure: Joint Position Sense Measurement, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: İstanbul Medipan Tıp Merkezi, city: Istanbul, zip: 34218, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
|
protocolSection identificationModule nctId: NCT06351696, orgStudyIdInfo id: 43008563, briefTitle: The Effects of Bromelain Supplement in Patients With Ulcerative Colitis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2024-07-20, completionDateStruct date: 2024-08-10, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: National Nutrition and Food Technology Institute, class: OTHER, descriptionModule briefSummary: In this study, patients with active mild to moderate UC with or without PSC will be randomized to receive either bromlein or placebo along with low FODMAP diet for 8 weeks.IBDQ, SCCAIQ, CRP, TAC, TNF-a will be measured before and after the intervention., conditionsModule conditions: Ulcerative Colitis, conditions: Primary Sclerosing Cholangitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 84, type: ESTIMATED, armsInterventionsModule interventions name: Bromlein, interventions name: Placebo, outcomesModule primaryOutcomes measure: SCCAIQ, secondaryOutcomes measure: IBDQ, secondaryOutcomes measure: Serum TAC, secondaryOutcomes measure: Serum hsCRP, secondaryOutcomes measure: Serum TNF-a, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Azita Hekmatdoost, status: RECRUITING, city: Tehran, state: Middle East, zip: 19835, country: Iran, Islamic Republic of, contacts name: Azita Hekmatdoost, MD, PhD, role: CONTACT, phone: +989123065084, email: [email protected], geoPoint lat: 35.69439, lon: 51.42151, hasResults: False
|
protocolSection identificationModule nctId: NCT06351683, orgStudyIdInfo id: 24-066-2, secondaryIdInfos id: P30AG067988, type: NIH, link: https://reporter.nih.gov/quickSearch/P30AG067988, briefTitle: Testing MitoQ on Lower Urinary Tract Symptoms in Older Women With Metabolic Syndrome, acronym: Mito-LUTS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-03, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Iman Al-Naggar, PhD, class: OTHER, collaborators name: National Institute on Aging (NIA), collaborators name: American Urological Association, collaborators name: Urology Care Foundation, collaborators name: Claude D. Pepper Older Americans Independence Center (OAIC), descriptionModule briefSummary: The goal of this clinical trial is to test the effect of a supplement called MitoQ (mitoquinol mesylate) on bladder symptoms such as urgency and frequency in women aged 50-75 years old who have the metabolic syndrome. The main questions it aims to answer are:* Is the study design feasible and acceptable to participants?* Do participants taking the study drug get any improvement to their bladder symptoms compared to participants taking a placebo (a look-alike substance that contains no drug)?Participants will take 2 capsules of the study drug every morning for 4 months, answer many questions about their health including questions about their bladder health, perform physical and cognitive testing, give blood and urine samples, collect urine over 24 hour periods 3 times over the 4 months of the study, complete 3 day bladder diaries about how much they drink and void, undergo electrocardiograms, have their vitals and measurements (weight, height, waist circumference) taken, participate in 4 visits to the clinical research area and participate in many phone calls of varying length. Researchers will compare participants who were taking capsules containing MitoQ and participants taking capsules not containing MitoQ to see if MitoQ improves their bladder symptoms (urgency, frequency, nocturia, incontinence, etc.), conditionsModule conditions: Lower Urinary Tract Symptoms, conditions: Overactive Bladder Syndrome, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Double-blinded. Pharmacy will randomize and dispense capsules., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: MitoQ (mitoquinol mesylate), interventions name: Placebo, outcomesModule primaryOutcomes measure: Overactive Bladder Symptom Score (OABSS), secondaryOutcomes measure: Three-day bladder voiding diary, eligibilityModule sex: FEMALE, minimumAge: 50 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UConn Health, status: RECRUITING, city: Farmington, state: Connecticut, zip: 06030, country: United States, contacts name: Lisa Kenyon-Pesce, role: CONTACT, phone: 860-679-2305, email: [email protected], contacts name: Peter C Albertsen, MD, role: SUB_INVESTIGATOR, contacts name: George A Kuchel, MD, role: SUB_INVESTIGATOR, contacts name: Jenna M Bartley, PhD, role: SUB_INVESTIGATOR, contacts name: Oh Sung Kwon, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 41.71982, lon: -72.83204, hasResults: False
|
protocolSection identificationModule nctId: NCT06351670, orgStudyIdInfo id: 1109/2024, briefTitle: Personalised Monitoring of Early and Intermediate Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression, acronym: SUDETES, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2027-07, completionDateStruct date: 2027-07, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Medical University of Vienna, class: OTHER, collaborators name: University Medical Centre Ljubljana, collaborators name: Centre Hospitalier Universitaire Dijon, collaborators name: Queen's University, Belfast, collaborators name: University of Zurich, collaborators name: Vista Klinik, collaborators name: Fundacion Clinic per a la Recerca Biomédica, descriptionModule briefSummary: The goal of this prospective, multinational, multicenter observational study is to to predict conversion of early and intermediate AMD with functional vision to advanced AMD with irreversible loss of vision on an individual-based level over 2 years. The main objectives of this study are:* Identify and quantify focal and global alterations in the retina in regard to disease progression.* Assess the individual risk of disease progression in intermediate AMD patients converting to advanced AMD based on imaging.* Specify the course of disease in regard to the sequence of events that lead to the conversion to advanced AMD* Enhance the ability to classify AMD using artificial intelligence in addition to traditional models.All patients will be followed for 24 months with 6 month intervals to assess clinical changes. Monitoring of disease progression will be performed using the following routine in-vivo imaging procedures:* Scanning Laser Fundus Photography* Color Fundus Photography (CFP)* Optical Coherence Tomography (OCT)* Optical Coherence Tomography Angiography (OCTA) Patients will be asked for their medical history. Standard ophthalmic examination, as well as a questionnaire on visual function will be carried out.No intervention will be performed during the study since no treatment is yet available within Europe. As soon as treatment is approved in the EU, patients in this cohort might receive treatment according to availability in their respective country and standard of care. If treatment will be performed, it will be as standard of care outside the study according to each country's standard of care and by EMA label., conditionsModule conditions: Age-Related Macular Degeneration, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, outcomesModule primaryOutcomes measure: To characterise and quantify focal and global changes of the retina by retinal imaging to identify patients at risk for conversion to advanced AMD., secondaryOutcomes measure: To identify and quantify disease progression-related biomarkers, secondaryOutcomes measure: To evaluate monitoring of AMD progression assisted by AI algorithms, eligibilityModule sex: ALL, minimumAge: 55 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06351657, orgStudyIdInfo id: 1088/2024, briefTitle: Personalized Monitoring of Non-foveal, Non-vision Compromising Atrophic Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression, acronym: APENNINES, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2027-07, completionDateStruct date: 2027-07, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Medical University of Vienna, class: OTHER, collaborators name: University Medical Centre Ljubljana, collaborators name: Centre Hospitalier Universitaire Dijon, collaborators name: University of Zurich, collaborators name: Vista Klinik, collaborators name: Queen's University, Belfast, collaborators name: Fundacion Clinic per a la Recerca Biomédica, descriptionModule briefSummary: The goal of this prospective, multinational, multicenter observational study is to assess and predict progression in non-foveal, non-vision compromising atrophic AMD on an individual-based level over two years. The main objectives of this study are:* Assess the individual progression rate of a patient in non-foveal, non-vision compromising atrophic AMD and assess personalized risk of progression based on imaging.* Identify and quantify focal and global alterations in the retina in regard to disease progression.* Evaluate the monitoring of AMD progression using approved AI algorithms.All patients will be followed for 24 months with 6 month intervals to assess clinical changes. Monitoring of disease progression will be performed using the following routine in-vivo imaging procedures:* Scanning Laser Fundus Photography* Color Fundus Photography (CFP)* Optical Coherence Tomography (OCT)* Optical Coherence Tomography Angiography (OCTA)Patients will be asked for their medical history. Standard ophthalmic examination, as well as a questionnaire on visual function will be carried out.No intervention will be performed during the study since no treatment is yet available within Europe. As soon as treatment is approved in the EU, patients in this cohort might receive treatment according to availability in their respective country and standard of care. If treatment will be performed, it will be as standard of care outside the study according to each country's standard of care and by EMA label., conditionsModule conditions: Age-Related Macular Degeneration, conditions: Geographic Atrophy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, outcomesModule primaryOutcomes measure: To characterise and quantify focal and global changes of the retina by retinal imaging to identify patients at risk for fast geographic atrophy (GA) progression, secondaryOutcomes measure: To identify and quantify disease progression-related biomarkers, secondaryOutcomes measure: To evaluate monitoring AMD progression using approved AI algorithms., eligibilityModule sex: ALL, minimumAge: 55 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06351644, orgStudyIdInfo id: STUDY-24-00244, briefTitle: ON 123300 (Narazaciclib) and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-03, primaryCompletionDateStruct date: 2028-06-05, completionDateStruct date: 2028-06-05, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Adriana Rossi, class: OTHER, descriptionModule briefSummary: Multiple myeloma (MM) is a malignancy characterized by uncontrolled proliferation of plasma cells for which there is an urgent and unmet need to develop new, effective therapeutics. Onconova Therapeutics has developed a first-in-class oral inhibitor of CDK4 and ARK5 ON 123300 (NARAZACICLIB) which shows potent anti-myeloma activity in vitro and in vivo in preclinical models, and is undergoing evaluation in Phase 1-2 trials worldwide.In this study, the researchers will test the safety and preliminary efficacy of inhibition of CDK4 and ARK5 by ON 123300 (NARAZACICLIB) in combination with dexamethasone in myeloma patients in a Phase I/II clinical trial., conditionsModule conditions: Relapsed and/or Refractory Multiple Myeloma, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This is a single arm optimal biologic dose finding phase I/II clinical trial., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: ON 123300, interventions name: Dexamethasone, outcomesModule primaryOutcomes measure: Phase I: The optimal biological dose (OBD) of the combination of ON 123300 (NARAZACICLIB) and dexamethasone, primaryOutcomes measure: Phase I: Dose-Limiting Toxicity (DLT) rate, primaryOutcomes measure: Phase II: Overall response rates (ORR), secondaryOutcomes measure: Number of Adverse events of Special Interest (AESI), secondaryOutcomes measure: HbA1c, secondaryOutcomes measure: Fasting insulin levels, secondaryOutcomes measure: Lipid profiles, secondaryOutcomes measure: Free fatty acids, secondaryOutcomes measure: Best overall response (BOR), secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Time to Progression (TTP), secondaryOutcomes measure: Progression-Free Survival (PFS), secondaryOutcomes measure: Disease Control Rate (DCR), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mount Sinai Health System, city: New York, state: New York, zip: 10029, country: United States, contacts name: Adriana Rossi, MD, role: CONTACT, contacts name: Katherine Vandris, role: CONTACT, email: [email protected], contacts name: Adriana Rossi, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
|
protocolSection identificationModule nctId: NCT06351631, orgStudyIdInfo id: 3543-017, secondaryIdInfos id: 2023-506996-89, type: OTHER, domain: EU CT, secondaryIdInfos id: U1111-1294-8621, type: OTHER, domain: UTN, secondaryIdInfos id: MK-3543-017, type: OTHER, domain: Merck ID, briefTitle: A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-21, primaryCompletionDateStruct date: 2034-12-04, completionDateStruct date: 2034-12-04, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Merck Sharp & Dohme LLC, class: INDUSTRY, descriptionModule briefSummary: The primary purpose of the study is to transition participants into an extension study to collect long-term safety and efficacy data. The study will include participants who are safely tolerating bomedemstat, receiving clinical benefit from its use in estimation of the investigator, and have shown the following criteria:* Participants from the IMG-7289-202/MK-3543-005 (NCT05223920) study must have received at least 6 months of treatment with bomedemstat;* Essential thrombocythemia (ET) and polycythemia vera (PV) participants from studies other than IMG-7289-202/MK-3543-005 must have achieved confirmed hematologic remission.No hypothesis testing will be conducted in this study., conditionsModule conditions: Thrombocythemia, Essential, conditions: Primary Myelofibrosis, conditions: Myelofibrosis, conditions: Post-polycythemia Vera Myelofibrosis, conditions: Post-essential Thrombocythemia Myelofibrosis, conditions: Polycythemia Vera, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Bomedemstat, outcomesModule primaryOutcomes measure: Percentage of participants with one or more adverse events (AEs), primaryOutcomes measure: Percentage of participants who discontinued study treatment due to an AE, secondaryOutcomes measure: For participants with ET or PV: Duration of clinicohematologic response, secondaryOutcomes measure: For participants with ET or PV: Duration of hematologic remission, secondaryOutcomes measure: For participants with ET or PV: Percentage of participants with transformation to MF or MDS/AML, secondaryOutcomes measure: For participants with MF: Percentage of participants with worsening of splenomegaly or transformation to MDS/AML, secondaryOutcomes measure: For participants with MF, ET, or PV: Percentage of participants with thrombotic events, secondaryOutcomes measure: For participants with MF, ET, or PV: Percentage of participants with major hemorrhagic events, secondaryOutcomes measure: For participants with MF, ET, or PV: Event-Free Survival (EFS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06351618, orgStudyIdInfo id: 2023-06114-01, briefTitle: Epidemiology of Injuries in the Professional Women's Swedish National IceHockey League Permitted to Body-Checking, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2024-03-26, completionDateStruct date: 2028-01-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Lund University, class: OTHER, descriptionModule briefSummary: This research project can contribute to a deeper understanding of injury patterns among professional female ice-hockey players allowed to body check. An understanding of common injury types and mechanisms aids the clinician in diagnosis and management. This information can guide preventative strategies in the areas of education, coaching, rule enforcement, rule modifications, equipment improvement, and sportsmanship. Today, ice hockey is a sport associated with many severe injuries that not only causes suffering and lower quality of life for the athlete, but also costs society a lot of money. Reducing the number and severity of sport-related injuries is therefore of importance. Knowledge of the injury epidemiology of women's hockey could also contribute to better preventive training programs and other injury preventive actions in the sport. Currently, only a minority of all sports medicine research is made on female study participants (26). This research project has the possibility to gain more knowledge about the female athlete, not only applicable for elite hockey-players, but also for female athletes in different disciplines and in youth teams. Knowledge of factors associated with injury could also contribute to better injury preventive actions and highlight subgroups in extra need of future preventive interventions., conditionsModule conditions: Sport Injury, conditions: Ice-Skates Accident, conditions: Sports Accident, conditions: Female Athlete Triad, conditions: Female, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 225, type: ESTIMATED, armsInterventionsModule interventions name: No intervention will be conducted., outcomesModule primaryOutcomes measure: Injuries per 1000 training hours, primaryOutcomes measure: Injuries per 1000 game hours, eligibilityModule sex: FEMALE, minimumAge: 16 Years, maximumAge: 110 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Faculty of Medicine at Lund University, status: RECRUITING, city: Malmö, zip: 20213, country: Sweden, contacts name: Amanda Lahti, role: CONTACT, phone: 0704854798, email: [email protected], geoPoint lat: 55.60587, lon: 13.00073, hasResults: False
|
protocolSection identificationModule nctId: NCT06351605, orgStudyIdInfo id: CSP006, briefTitle: A Registry Study to Assess Photobiomodulation in Dry Age-Related Macular Degeneration (EUROLIGHT) (EUROLIGHT), statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: LumiThera, Inc., class: INDUSTRY, descriptionModule briefSummary: The EUROLIGHT study is being conducted to collect real life data for the safety and effectiveness of PBM in dry AMD, in routine clinical practice both retrospectively and prospectively., conditionsModule conditions: Dry Age-related Macular Degeneration, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: OTHER, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Valeda Light Delivery System, outcomesModule primaryOutcomes measure: Best-Corrected Visual Acuity (BCVA), secondaryOutcomes measure: OCT Imaging, secondaryOutcomes measure: FAF Imaging, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Oslo University Hospital, status: RECRUITING, city: Oslo, country: Norway, contacts name: Øygunn Utheim, MD, role: CONTACT, phone: +47 93692578, email: [email protected], geoPoint lat: 59.91273, lon: 10.74609, hasResults: False
|
protocolSection identificationModule nctId: NCT06351592, orgStudyIdInfo id: ALN-SOD-ALS-2351, secondaryIdInfos id: 2023-510344-20-00, type: REGISTRY, domain: EU CT Number, briefTitle: First in Human (FIH) Study of ALN-SOD in Adult Participants With Amyotrophic Lateral Sclerosis Associated With Mutation in the SOD1 Gene (SOD1-ALS), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-28, primaryCompletionDateStruct date: 2029-04-28, completionDateStruct date: 2029-04-28, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Regeneron Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: This study is researching an experimental drug called ALN-SOD (called "study drug"). This study is focused on people with amyotrophic lateral sclerosis (ALS) who have a mutation in a gene called the superoxide dismutase-1 (SOD1) gene. This type of ALS is known as "SOD1-ALS". This is the first time that ALN-SOD will be given to people. The aim of the study is to see how safe and tolerable the study drug is.The study is looking at several other research questions, including:* The effect the study drug has on specific biomarkers, which are molecules in the blood or in the fluid that surrounds the brain and spinal cord, known as cerebrospinal fluid (CSF)* How much study drug is in the blood and in the CSF, at different times* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)* What effects the study drug has on ALS symptoms, conditionsModule conditions: Amyotrophic Lateral Sclerosis (ALS), conditions: Mutation in the Superoxide Dismutase-1 (SOD1) Gene, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: No masking during Open-Label Treatment Period after 4-week Double-Blind Treatment Period. This part of the study consists of a crossover design., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: ALN-SOD, interventions name: Diluent, interventions name: Placebo (PB), outcomesModule primaryOutcomes measure: Incidence of treatment-emergent adverse event (TEAEs) in participants treated with ALN-SOD, primaryOutcomes measure: Severity of TEAEs in participants treated with ALN-SOD, secondaryOutcomes measure: Concentration of SOD1 protein in cerebrospinal fluid (CSF) over time, secondaryOutcomes measure: Change in concentration of SOD1 protein in CSF over time, secondaryOutcomes measure: Concentration of neurofilament light chain (NfL) in plasma over time, secondaryOutcomes measure: Change in concentration of NfL in plasma over time, secondaryOutcomes measure: Concentration of NfL in CSF over time, secondaryOutcomes measure: Change in concentration of NfL in CSF over time, secondaryOutcomes measure: Concentration of ALN-SOD in plasma over time, secondaryOutcomes measure: Concentration of ALN-SOD in CSF over time, secondaryOutcomes measure: Incidence of anti-drug antibodies (ADAs) to ALN-SOD in serum over time, secondaryOutcomes measure: Titer of ADAs to ALN-SOD in serum over time, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06351579, orgStudyIdInfo id: 1010159, briefTitle: Data Collection Post Radical Prostatectomy, acronym: ALTO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-15, primaryCompletionDateStruct date: 2025-12-30, completionDateStruct date: 2026-03-15, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Levee Medical, Inc., class: INDUSTRY, collaborators name: RQMplus, descriptionModule briefSummary: The study is to collect information on patients undergoing radical prostatectomy (RP), with a primary focus on the occurrence, duration, and severity of post-prostatectomy incontinence. Data will be collected at multiple time points, allowing for a dynamic understanding of urinary incontinence patterns at post RP., conditionsModule conditions: Stress Urinary Incontinence, conditions: Radical Prostatectomy, conditions: BPH, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Control, outcomesModule primaryOutcomes measure: The change in average 24-hour pad weight over time, secondaryOutcomes measure: Change in pad weight during a 1-hour provocative pad weight test, otherOutcomes measure: Expanded Prostate Index Composite (EPIC-26) score., eligibilityModule sex: MALE, minimumAge: 45 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06351566, orgStudyIdInfo id: VD3, Prebiotics in Diabetes, briefTitle: Effects of Vitamin D3 and Prebiotics Supplementation on Cardiovascular Risk Factors in Patients With Type 2 Diabetes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-24, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Huazhong University of Science and Technology, class: OTHER, descriptionModule briefSummary: The goal of this randomized, double-blind, placebo-controlled, 6-month supplementation study in individuals with type 2 diabetes is to investigate whether taking daily dietary supplements of vitamin D3 (1600 IU) or prebiotics (inulin, 10 gram) has beneficial effects on cardiovascular disease risk factors., conditionsModule conditions: Diabetes Mellitus, Type 2, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Vitamin D3, interventions name: Prebiotics, interventions name: Vitamin D3 placebo, interventions name: Prebiotics placebo, outcomesModule primaryOutcomes measure: Glycated hemoglobin (HbA1c), primaryOutcomes measure: Concentration of blood lipids, primaryOutcomes measure: Metagenomic analysis of the gut microbiota, secondaryOutcomes measure: Concentration of fasting glucose, secondaryOutcomes measure: Concentration of fasting insulin, secondaryOutcomes measure: Systolic and diastolic blood pressure, secondaryOutcomes measure: Estimated glomerular filtration rate (eGFR), secondaryOutcomes measure: Concentration of C-reactive protein (CRP), secondaryOutcomes measure: Concentration of procalcitonin, secondaryOutcomes measure: Concentration of interleukin-6 (IL-6), secondaryOutcomes measure: Concentration of serum 25(OH)D, secondaryOutcomes measure: Body weight, secondaryOutcomes measure: Waist circumference, secondaryOutcomes measure: Hip circumference, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 69 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06351553, orgStudyIdInfo id: 2023-169, briefTitle: Effect of the Autonomic Nervous System on the Outcomes of PULSEd Field Ablation to Treat Atrial Fibrillation, acronym: EASy-PULSE AF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Hospital General Universitario de Alicante, class: OTHER, descriptionModule briefSummary: Pulmonary vein (PV) isolation is considered the therapeutic strategy of choice to maintain sinus rhythm (SR) in symptomatic patients with atrial fibrillation (AF). The most commonly used energy modality is radiofrequency (RF). However, this type of energy presents notable challenges, such as its lack of selectivity for myocardial tissue, which increases the risk of serious complications such as atrioesophageal fistula, PV stenosis, and vagus nerve injuries. In this context, PV isolation using pulsed field ablation (PFA) emerges as a promising alternative due to its greater myocardial selectivity. However, this selectivity presents additional challenges. Preliminary studies indicate that PFA may not damage the autonomic nervous system (ANS) involved in the initiation and maintenance of AF in certain patients, although stronger evidence is needed to support this claim.The investigators propose to carry out a single-center clinical trial, although with the possibility in the future of including other centers. Patients will be randomized to three research groups: PV isolation with RF, PV isolation with PFA, and PV isolation combining PFA and RF (using RF on the anterior wall and PFA on the posterior wall). This assignment will be open to the operator who performs the procedure, but blind for the researcher responsible for monitoring and for the data analyst. The objective is to compare the impact of different energy sources during PV isolation on the ability to produce a permanent alteration in the ANS. The hypothesis is that combined PF isolation will be capable of producing a permanent alteration of autonomic function parameters superior to ablation using exclusive PFA., conditionsModule conditions: Atrial Fibrillation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 156, type: ESTIMATED, armsInterventionsModule interventions name: Pulmonary vein isolation exclusively with radiofrequency, interventions name: Pulmonary vein isolation exclusively with pulsed field ablation, interventions name: Combined pulmonary vein isolation, outcomesModule primaryOutcomes measure: Efficacy primary outcome: Alteration of autonomic function parameters, secondaryOutcomes measure: Efficacy secondary outcome: Alteration of autonomic function parameters, secondaryOutcomes measure: Efficacy secondary outcome: Alteration of autonomic function parameters, secondaryOutcomes measure: Efficacy secondary outcome: Alteration of autonomic function parameters, secondaryOutcomes measure: Efficacy secondary outcome: Procedure duration., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Laura García Cano, city: Alicante, zip: 03010, country: Spain, geoPoint lat: 38.34517, lon: -0.48149, hasResults: False
|
protocolSection identificationModule nctId: NCT06351540, orgStudyIdInfo id: IRB00332797, secondaryIdInfos id: R21DA056687, type: NIH, link: https://reporter.nih.gov/quickSearch/R21DA056687, briefTitle: Examining the Role of Tolerance on Dose-dependent Effects of Acute THC on Oculomotor and Cognitive Performance, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-01, primaryCompletionDateStruct date: 2025-08-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins University, class: OTHER, collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: The purpose of this research is to determine the extent to which oculomotor function accurately detects THC-impairment, if cannabis use experience impacts this detection threshold, and to examine how the oculomotor index corresponds to a measure of sustained attention. A double-blind, placebo-controlled, within-subjects crossover design will be used to examine the dose-effects of THC (0, 5mg, 30mg) on oculomotor performance tasks and a sustained attention task in frequent and infrequent cannabis users. Results from the study will advance the investigators' understanding of the effect of THC and cannabis use frequency on oculomotor function and sustained attention, and will directly inform the validity of the investigators' oculomotor platform for identifying acute THC- induced impairment in frequent and infrequent users., conditionsModule conditions: Cannabis Use, conditions: Impaired Driving, conditions: Cognitive Impairment, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: double-blind, placebo-controlled, within-subjects crossover design, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, maskingDescription: placebo controlled, double-blind, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Cannabis, outcomesModule primaryOutcomes measure: Commission Errors, primaryOutcomes measure: Omission Errors, primaryOutcomes measure: Reaction Time, primaryOutcomes measure: Reaction Time Standard Error, primaryOutcomes measure: Visuomotor Index, secondaryOutcomes measure: Saccade Speed, secondaryOutcomes measure: Visually Guided Oculomotor Performance, secondaryOutcomes measure: Antisaccade, secondaryOutcomes measure: Memory-Guided, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Johns Hopkins Behavioral Pharmacology Research Unit, city: Baltimore, state: Maryland, zip: 21224, country: United States, geoPoint lat: 39.29038, lon: -76.61219, hasResults: False
|
protocolSection identificationModule nctId: NCT06351527, orgStudyIdInfo id: ICP-CL-01202, briefTitle: Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ICP-248 in Mature B-cell Malignancies, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2027-06-25, completionDateStruct date: 2027-10-25, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: InnoCare Pharma Inc., class: INDUSTRY, descriptionModule briefSummary: Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ICP-248 in Mature B-cell Malignancies, conditionsModule conditions: Mature B-cell Malignancies, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: ICP-248, outcomesModule primaryOutcomes measure: Maximum tolerated dose and/or recommended Phase 2 dose, primaryOutcomes measure: To investigate the incidence, nature and severity of adverse events (AE) according to NCI-CTCAE V5.0 evaluation criteria., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06351514, orgStudyIdInfo id: 2023/00745, briefTitle: An Open-Label, Single Arm Study of the Efficacy of Accelerated Intermittent Theta Burst Stimulation in Schizophrenia Patients With Persistent Negative Symptoms, acronym: NOBLE-TMS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2026-09, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Institute of Mental Health, Singapore, class: OTHER, descriptionModule briefSummary: Schizophrenia patients commonly present with persistent negative symptoms which remain the main reason for dysfunction after recovery from an acute episode of psychotic symptoms. Negative symptoms in schizophrenia exact significant burden with no effective pharmacological or behavior treatment options thus far. Neuromodulatory modalities present a novel and alternative treatment approach and recent trials have shown preliminary evidence for the efficacy of intermittent Theta Burst Stimulation (iTBS) to treat negative symptoms in schizophrenia. In this study, we aim to examine the effectiveness of an accelerated iTBS treatment protocol as an augmentation treatment regime for patient in rehabilitation care with persistent negative symptoms.We propose a pragmatic, open label and single arm clinical trial. Forty patients with diagnosis of schizophrenia, who had been stabilized from psychotic symptoms and currently suffering from dominant negative symptoms will be recruited and undergo accelerated iTBS treatment for 5 consecutive sessions each day for 5 working days. Participants will be followed up immediately, 1 month and 3 months after the end of treatment. Clinical assessment includes, BNSS, The Brief Negative Symptom Scale; SANS, Scale for the assessment of negative symptoms; SAPS, Scale for the assessment of positive symptoms; PANSS, Positive and Negative Symptoms Scale; MoCA, Montreal Cognitive Assessment scale; CDSS, Calgary Depression Scale for Schizophrenia: SDS, Sheehans' disability scale and EQ-5D. The primary endpoint of the trial is the change of negative symptoms as assessed by PANSS, negative symptoms subscale immediately after the treatment.This study will determine whether accelerated iTBS is effective to be delivered as an augmentation therapy for patients with persistent negative symptoms. The optimal treatment system for this population can be immediately translated to clinical practice and benefit patients in need., conditionsModule conditions: Schizophrenia; Negative Type, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Accelerated iTBS, outcomesModule primaryOutcomes measure: Change of Negative symptoms, secondaryOutcomes measure: Trend of Negative symptoms, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institute of Mental Health, status: RECRUITING, city: Singapore, zip: 539747, country: Singapore, contacts name: Jenny Tay, role: CONTACT, email: [email protected], geoPoint lat: 1.28967, lon: 103.85007, hasResults: False
|
protocolSection identificationModule nctId: NCT06351501, orgStudyIdInfo id: P170923J, secondaryIdInfos id: 2019-000300-16, type: EUDRACT_NUMBER, briefTitle: Evaluation of the Effectiveness of Hormonal Treatment in Adolescents Suffering From Gender Dysphoria, acronym: TRANSADO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-06, primaryCompletionDateStruct date: 2029-06-06, completionDateStruct date: 2031-06-06, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: Gender dysphoria (GD) is a significant suffering lasting more than 6 months in a subject, regarding the gap felt between gender identity of someone and birth sex. From the start of puberty, most of these adolescents who identify as transgender will persist in this sense and will engage in hormonal-surgical reassignment at some stage. For these adolescents, International recommendations for good practice recommend early treatment at the beginning of pubertal development (Tanner 2) to block pubertal progression, with the possibility of hormonal transition by administration of sex hormones of the desired sex at the age of 16. However, in order to reduce the psychosocial consequences of GD, more and more reference teams are practicing this hormonal transition from the age of 14 without any randomized study showing its benefit compared to a transition at the age of 16 years old. Indeed, in the absence of treatment, comorbidities among adolescents suffering from gender dysphoria is very high, with anxiety and depression, suicidal risk and school dropout.Our hypothesis is that when hormonal transition is started at an age closer to what physiological puberty would be, it will reduce comorbidities and improve quality of life of these adolescents. This is the first therapeutic randomized study in France on this transgender adolescent population, a field where international recommendations based on "Evidence Based Medicine" principles are scared. We hope that results of this study will guide transgender youth health care allowing them, if the study is positive, to access hormonal treatments earlier and improve their overall functioning, their anxious and depressive symptoms, their quality of life., conditionsModule conditions: Cross Sex Hormonal Treatment in Adolescents With Gender Dysphoria, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: multicentric, controlled, randomized, open trial with blinded assessment of the primary outcome measure (Prospective Open Blinding Endpoint PROBE study), primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The evaluation of the main criterion by the CGAS will be administered by a psychologist trained on this scale who will not have knowledge of the adolescent's attribution group and will not have participated in their care, based on elements keys to the patient's file which will be provided to him without any element that could indicate his group to which he belongs or his original sex, and a telephone interview with the adolescent and with his parents where they will have been previously informed not to not reveal the group to which they belong or the sex of origin., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: hormonal treatment with cross sex hormones (testosterone or oestrogenes) started at 14 years old +/- 6 months, interventions name: Cross sex hormones ( œstrogenes or testosterone) started at 16 years old +/- 6 months, outcomesModule primaryOutcomes measure: Global functionning using the Children's Global Assessment Scale (CGAS), secondaryOutcomes measure: DEP-ADO, secondaryOutcomes measure: WISC-V (weschler Test), secondaryOutcomes measure: UGDS (Utrecht Gender Dysphoria Scale ), secondaryOutcomes measure: Beck Depression Inventory (BDI), secondaryOutcomes measure: Body Image Scale (BIS), secondaryOutcomes measure: State and Anxiety Inventory for Children (STAI-C), secondaryOutcomes measure: CBCL (Youth Self Report YSR) Child Behaviour Chekcklist, secondaryOutcomes measure: World Health Organization Quality Of Life (WHO QOL), secondaryOutcomes measure: Satisfaction With Life Scale (SWLS), secondaryOutcomes measure: Adolescent Depression Rating Scale (ADRS), secondaryOutcomes measure: Mini International Neuropsychiatric Interview (MINI), secondaryOutcomes measure: Inventory of Parents and Peers Attachment (IPPA), eligibilityModule sex: ALL, minimumAge: 14 Years, maximumAge: 14 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06351488, orgStudyIdInfo id: APHP231661, briefTitle: Detection of Circulating Kidney DNA in Kidney Transplant Patients Facing an Episode of Graft Rejection, acronym: DART-RREGREF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-10, primaryCompletionDateStruct date: 2026-02-11, completionDateStruct date: 2026-02-11, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, collaborators name: CGenetix, collaborators name: Institut National de la Santé Et de la Recherche Médicale, France, descriptionModule briefSummary: In France, 3,500 kidney transplants are carried out per year; and 40,000 people succeed in 2019 with a kidney transplant. Despite regular medical monitoring, nearly 30% of transplant patients will develop rejection. Currently, only solid biopsy of the graft makes it possible to establish the diagnosis of graft rejection, and to characterize its cellular origin based on the Banff classification.Several studies have shown the possibility of identifying the tissue origin of DNA circulating in the blood, in healthy subjects, on the basis of the epigenetic properties of circulating DNA. In addition, in kidney transplant subjects, an increase in the quantity of circulating DNA originating from the graft in the blood and urine has been shown as well as an increase in urinary chemokine levels during renal dysfunction (notably dismiss). Thus, the company CGenetix in partnership with INSERM units 1155 and 1151 is developing a method to identify and characterize kidney transplant rejection early, through the detection of epigenetic biomarkers on circulating DNA targeting different fractions of the kidney (glomerular, tubular, peritubular capillary and vascular). The main objective is to study the diagnostic performance of the quantity of DNA of renal origin in kidney transplant patients in the blood and in the urine (expressed in copies/ml) for the diagnosis of type Rejection mediated by kidneys. antibody (ABMR) established by kidney graft biopsy (gold standard) and according to the Banff 2022 classification., conditionsModule conditions: Kidney Transplant Patients Eligible for a Solid Biopsy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 319, type: ESTIMATED, outcomesModule primaryOutcomes measure: The area under the ROC curve of ABMR rejection prediction models according to kidney biopsy and with renal circulating DNA quantities as variables of interest, secondaryOutcomes measure: The area under the ROC curve of TCMR rejection prediction models according to kidney biopsy and with renal circulating DNA quantities as variables of interest, secondaryOutcomes measure: The area under the ROC curve of mixed rejection prediction models according to kidney biopsy and with renal circulating DNA quantities as variables of interest, secondaryOutcomes measure: The area under the ROC curve of glomerulitis-type rejection prediction models (≥g1) according to kidney biopsy and with renal circulating DNA quantities as variables of interest, secondaryOutcomes measure: The area under the ROC curve of tubulitis-type rejection prediction models (≥t1) according to kidney biopsy and with renal circulating DNA quantities as variables of interest, secondaryOutcomes measure: The area under the ROC curve of vascularitis-type rejection prediction models (≥v1) according to kidney biopsy and with renal circulating DNA quantities as variables of interest, secondaryOutcomes measure: The area under the ROC curve of capillaritis-type rejection prediction models (≥ptc1) according to kidney biopsy and with renal circulating DNA quantities as variables of interest, secondaryOutcomes measure: Areas under the ROC curve of rejection prediction models according to renal biopsy and with as covariates of interest the quantities of urinary chemokines (CXCL9 and CXCL10) determined by ELISA and expressed in pg/mL in urine, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06351475, orgStudyIdInfo id: APHP230864, briefTitle: Efficacy of Intraoperative Use of 20% Albumin Combined With Ringer Lactate Versus Ringer Lactate During Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy, acronym: ALBUCHIP, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2026-10, completionDateStruct date: 2026-10, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: Introduction Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) is considered as the standard of care for the treatment of peritoneal metastases. Cytoreductive surgery with HIPEC is characterized by large intra operative fluid shift secondary to surgical resection, peritoneal inflammation and capillary shifts, requesting high volume of intra operative fluid therapy. Previous studies found a strong association between intra operative hypovolemia or volume overload with post operative outcomes. Albumin as an intravenous fluid has been widely studied in critical ill patients, but evaluation of its efficacy during major surgery on post operative clinical outcomes are lacking. We hypothesize that a reduction of intra operative crystalloid volume infusion by using 20% albumin during CRS with HIPEC could improve patients' prognosis. The aim of this study will be to assess the efficacy of 20% albumin combined with Ringer Lactate versus Ringer Lactate for fluid therapy during CRS with HIPEC on post operative outcome at 28 day.Methods and analysis The study protocol has been designed and written in accordance with the Prospective randomised, comparative, controlled, prospective, open-label, with parallel group and multicentre clinical trial.Recruitment, randomisation and allocation Information on the study and screening of patients will be conducted during the consultation of anaesthesia (= selection visit), 2 months at 3 days before the surgery. Information notice and consent form will be delivered. The day before the surgery, anaesthesiologist who will conduct the pre anaesthetic visit will be able to include patients in the study (=inclusion visit). Randomisation will be done at the inclusion visit after information and signature of consent form of voluntary patients. A randomization number will be assigned. The 1:1 randomisation will be centralized via an online interface ensuring secret group assignment, and based on predefined randomisation lists with variable-size permutation blocks, stratified by center. Randomisation will be accomplished using a computer-generated random sequence.Randomized Open, Blinded endpoint (PROBE) design. This study is a randomised, comparative, controlled, prospective, open-label, with parallel group and multicentre clinical trial.Intervention* 20% Albumin + Ringer Lactate group (intervention group) Per-operative fluid therapy consisting in Ringer Lactate combined with 20% albumin. Patients will receive a bolus of 3 mL/kg on one hour of 20% albumin from anaesthetic induction. Then, infusion of 20% albumin (100 mL, 20g) will be administered for each 1200 mL of vascular filling by Ringer Lactate. Dosage of intra operative albuminemia will be realized 2 hours after the end of the bolus or infusion to ensure albuminemia is within the target concentrations (35-45 g/L). Use of 20% albumin will be realized for the entire duration of the surgery and stopped at the end of the surgery.* Control group Ringer Lactate for intra operative fluid management based on the latest scientific recommendations. As the the study is an open labelled randomized clinical trial, placebo use is not planned.Outcome measures The primary outcome will be the Comprehensive Complication Index (CCI score) at day 28 after CRS with HIPEC. Secondary outcomes are mortality at day 28, CCI score at day 7, volume of intra operative and post operative (48h) post operative fluid therapy, cumulated incidence of surgical post operative complications, cumulated incidence of medical post operative complications, need for mechanical ventilation, renal replacement therapy between surgery and day 28, SOFA score variation between pre operative period and 48h after surgery, number of days alive out of intensive care unit and out of hospital until day 28Sample size calculation To ensure a power of 80%, a number of patients 130 (65 patients by group) will be necessary with a reduction of 13.6 (SD 24) points of the CCI score at day 28 in the intervention group. Because of a risk of neoplastic evolution between anaesthetic consultation and randomisation (10% of early cancellation), a total of 146 patients (73 by group) will be included in the study.Discussion In summary, ALBUCHIP study will be the first randomized clinical trial assessing efficacy of intraoperative use of 20% albumin combined with Ringer Lactate versus Ringer Lactate during CRS with HIPEC. Results yielded from this study will be helpful for vascular filling during CRS with HIPEC but, thanks to ancillary studies, to improve pathophysiological understanding of this surgery., conditionsModule conditions: Peritoneal Neoplasms, conditions: Hyperthermic Intraperitoneal Chemotherapy, conditions: Intraoperative Care, conditions: Fluid Therapy, conditions: Postoperative Complications, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 146, type: ESTIMATED, armsInterventionsModule interventions name: Intra-operative albumin administration, interventions name: Control, outcomesModule primaryOutcomes measure: Comprehensive Complication Index score, secondaryOutcomes measure: Mortality, secondaryOutcomes measure: Comprehensive Complication Index score, secondaryOutcomes measure: Volume of intra operative and post operative fluid therapy, secondaryOutcomes measure: Cumulative incidence of surgical post operative complications, secondaryOutcomes measure: Cumulative incidence of medical post operative complications, secondaryOutcomes measure: Need for mechanical ventilation, secondaryOutcomes measure: Need for renal replacement therapy, secondaryOutcomes measure: Sequential organ failure assessment (SOFA) score variation, secondaryOutcomes measure: Number of days alive out of intensive care unit, secondaryOutcomes measure: Number of days alive out of hospital, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06351462, orgStudyIdInfo id: APHP200008, briefTitle: Comparative Health Status and Quality of Life of Patients With Sickle Cell Disease (SCD) Who Underwent Matched-sibling Hematopoietic Stem Cell Transplantation Versus Non Transplanted SCD Case-control Patients, acronym: TRANSPLANTORN2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2027-05-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: The long term burden of morbidity and mortality in the natural history of sickle cell disease has not been compared up to date to the risks and mortality of a curative option like bone marrow transplantation in severe sickle-cell disease patients. Given this lack of data, primary-care Sickle Cell Disease (SCD) physicians and transplant physicians are prevented from a factual debate over the benefit/risk ratio for each patient and refining indications of transplant in patients. Therefore, the present study seeks to describe and compare the very long-term outcomes after either Human Leukocyte Antigen (HLA) -matched sibling transplantation (study arm) and "non-transplant care" for severe sickle cell disease SCA patients in order to yield robust comparative data regarding both arms.The main objective is to assess the benefit of Hematopoietic stem cell transplantation (HSCT) regarding quality of life compared to standard care after 10 years, in patients with severe Sickle Cell Disease (SCD)., conditionsModule conditions: Sickle Cell Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 220, type: ESTIMATED, armsInterventionsModule interventions name: Spermogram, interventions name: Hospital Anxiety and Depression Scale (HADS), interventions name: SF36 Quality of life questionnaire, interventions name: Psychologist interview, interventions name: Optional sera banking, interventions name: Optional DNA banking, outcomesModule primaryOutcomes measure: Evaluation of quality of life assessed by SF36, secondaryOutcomes measure: Evaluation of gonadal function, secondaryOutcomes measure: Evaluation of quality of life, secondaryOutcomes measure: Proportion of patients with anxiety and depression, eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 80 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06351449, orgStudyIdInfo id: 69HCL22_0489, briefTitle: Characterization of Visual Characteristics in Allergic Contact Dermatitis Using the Skincam® Tool, acronym: PatchCam, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2027-04-15, completionDateStruct date: 2027-04-30, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Hospices Civils de Lyon, class: OTHER, descriptionModule briefSummary: Contact dermatitis (CD) is a common inflammatory skin disease, affecting approximately 15-20% of the general population in industrialized countries and ranking first among occupational diseases in many European countries.The patch test method aims at reproducing the eczematous lesions by applying occlusive patches containing the suspected allergens to the patient's healthy skin. It requires experienced medical staff to read the reaction.Newtones Technologies society has developed a new tool, the SkinCam®, able to capture high resolution cross and parallel images, allowing a quantification of color and relief of skin.This study aims to illustrate patch test results, describing skin appearance (color, roughness, shine), using photographs taken by the SkinCam®., conditionsModule conditions: Allergic Contact Dermatitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: The patch under study is photographed using the SkinCam®, outcomesModule primaryOutcomes measure: To highlight characteristics of allergic contact dermatitis (ACD), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06351436, orgStudyIdInfo id: TBC20240402, briefTitle: Virtual Reality Cave Experience With Mindfulness for Mental Wellbeing, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: The Hong Kong Polytechnic University, class: OTHER, descriptionModule briefSummary: The aim of this study is to investigate the effectiveness of a mindfulness-based intervention using a virtual reality cave system for promoting mental wellbeing in youths. The mindfulness-based intervention will last for three months, with 6-8 weekly sessions lasting 1.5 hours each. Participants will attend the sessions in a group format, and the sessions will be administered by registered social worker who are specialized in counselling. The intervention content is designed by a registered clinical psychologist accredited for delivering mindfulness-based intervention and nurses who are experienced in mindfulness training.A single-group pre-post uncontrolled design will be employed. Evaluations will be conducted at baseline (0 weeks) and post-intervention (3 months)., conditionsModule conditions: Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single-group non-randomized uncontrolled trial, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Mindfulness, outcomesModule primaryOutcomes measure: Mental Well-Being in Youths, secondaryOutcomes measure: Stress Level in Youths, secondaryOutcomes measure: Feasibility of Eligibility and Enrollment, secondaryOutcomes measure: Feasibility of Attendance Rate, secondaryOutcomes measure: Feasibility of Retention Rate, eligibilityModule sex: ALL, minimumAge: 11 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06351423, orgStudyIdInfo id: HE-NHS2023/03, briefTitle: The Effectiveness of MIND Diet and Forest Bathing on Stress Reduction, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-29, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Hong Kong Metropolitan University, class: OTHER, descriptionModule briefSummary: This clinical trial aims to explore the effectiveness of the Mediterranean DASH Intervention for Neurodegenerative Delay (MIND) diet and Forest Bathing (FB) in reducing psychological stress among older Chinese individuals. The main questions it aims to answer are:1. what is the effect of FB on stress reduction2. what is the effect of MIND on stress reductionParticipants of the MIND-FB group will participate will receive1. FB: a two-hour FB session on four consecutive weekends in a country park,2. MIND: four nutrition sessions, and adhere to the MIND diet for 12 weeksResearchers will compare the FB and routine care groups to compare the effectiveness of MIND and FB in reducing psychological stress., conditionsModule conditions: Anxiety, conditions: Depression, conditions: Stress, conditions: Psychological Stress, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: a 3-arm randomized controlled study in a parallel design. Eligible participants will be randomly assigned into 3 interventions: (1) FB-MIND, (2) FB and (3) routine care-control., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Forest Bathing (FB), interventions name: MIND diet, outcomesModule primaryOutcomes measure: Emotional states, secondaryOutcomes measure: Systolic Blood Pressure (SBP), secondaryOutcomes measure: Salivary Cortisol, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hong Kong Metropolitan University, city: Hong Kong, country: Hong Kong, contacts name: Fabian Ling Ngai Tung, PhD, role: CONTACT, phone: 85239708732, email: [email protected], contacts name: Fabian Ling Ngai Tung, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Queenie Pui Sze Law, PhD, role: SUB_INVESTIGATOR, contacts name: Katherine Ka Yin Yau, DHsC, role: SUB_INVESTIGATOR, contacts name: Sam Kit San Yuen, role: SUB_INVESTIGATOR, contacts name: Eric Tsz Fai Chan, role: SUB_INVESTIGATOR, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False
|
protocolSection identificationModule nctId: NCT06351410, orgStudyIdInfo id: JEP 2023-679, briefTitle: Assessment of Tear Production, Corneal Staining, and Comfort Level Wearing Different Types of Contact Lenses, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-02, primaryCompletionDateStruct date: 2024-07-30, completionDateStruct date: 2025-02-28, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: National University of Malaysia, class: OTHER, descriptionModule briefSummary: This research assesses the tear performance of five distinct types of soft contact lenses commonly found in the market. The study involves contact lens participants, all of whom are students enrolled at UKM. Before the study, participants were instructed to discontinue wearing their usual contact lenses for two weeks. The lenses utilized in this clinical trial all possess current refractive power. Participants are required to wear the lenses for an entire day only. Upon completion of the study, participants will be requested to complete a brief questionnaire., conditionsModule conditions: Dry Eye, conditions: Dry Eye Syndromes, conditions: Contact Lens-induced Corneal Fluorescein Staining, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: 18 participants will be fitted with 2 types of lenses on either eye at one time. There will be a 2-week wash-off period before another 2 set of fittings with another 4 types of lenses., primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, maskingDescription: The 6 types of Contact Lenses used will be labeled as A, B, C, D, E, and F by a co-investigator and will be fitted on the participant's eye randomly., enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: Eye Wearing Contact Lens, outcomesModule primaryOutcomes measure: To assess the quantity of tears in eyes wearing contact lenses, primaryOutcomes measure: To asess the quality of tears in eyes wearing contact lenses, primaryOutcomes measure: To assess corneal staining in eyes wearing contact lenses, primaryOutcomes measure: To assess comfort level of participants using CL Discomfort Index Questionaire, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 29 Years, stdAges: ADULT, contactsLocationsModule locations facility: Optometry Clinic, city: Kuala Lumpur, zip: 50300, country: Malaysia, geoPoint lat: 3.1412, lon: 101.68653, documentSection largeDocumentModule largeDocs typeAbbrev: Prot, hasProtocol: True, hasSap: False, hasIcf: False, label: Study Protocol, date: 2024-04-02, uploadDate: 2024-04-01T23:49, filename: Prot_000.pdf, size: 837117, hasResults: False
|
protocolSection identificationModule nctId: NCT06351397, orgStudyIdInfo id: 75021, briefTitle: Immersive Mixed Reality Simulation to Evoke Empathy, acronym: Empathy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Stanford University, class: OTHER, descriptionModule briefSummary: This is a quantifiable study evaluating the ability of a mixed reality (MR), immersive simulation experience to evoke empathy in anesthesiology trainees. Quantitative methodologies will be employed using standardized questionnaires including the The Jefferson Scale of Physician Empathy for Health Professions Students, (HP-version). Trainees will assess their preliminary, baseline empathy using the Jefferson Scale and after the simulation and debrief, will reassess empathy scores, once again using the Jefferson Scale. A satisfaction survey to assess simulated patient embodiment as a valuable exercise and contributor to empathy education curriculum., conditionsModule conditions: Educational Problems, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Mixed Reality (MR), outcomesModule primaryOutcomes measure: Changes in self-reported empathy from before and after the simulation, secondaryOutcomes measure: Satisfaction of Design Features of the Simulation, secondaryOutcomes measure: Evaluation of the CHARM system's usability, secondaryOutcomes measure: Evaluation of the CHARM system's ergonomics, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lucile Packard Children's Hospital Stanford, city: Palo Alto, state: California, zip: 94303, country: United States, contacts name: Astrid Suen, MMedSc, role: CONTACT, email: [email protected], contacts name: Thomas Caruso, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.44188, lon: -122.14302, hasResults: False
|
protocolSection identificationModule nctId: NCT06351384, orgStudyIdInfo id: 20230744, briefTitle: Early Detection and Risk Stratification of Colorectal Cancer Based on miRNA Platform, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-10-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Sir Run Run Shaw Hospital, class: OTHER, descriptionModule briefSummary: This is a prospective, observational cohort study to establish the minimal residual disease (MRD) model for predicting relapse risk and identifying disease recurrence in patients with colorectal adenocarcinoma based on the miRNA platform.Blood miRNA markers will be evaluated. The study will enroll approximately 600 participants, including participants with malignancies or benign diseases, and healthy participants., conditionsModule conditions: Colorectal Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: miRNA detection test, outcomesModule primaryOutcomes measure: Correlation between post-surgery 1 month MRD status and recurrence-free survival (RFS) in colorectal patients, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06351371, orgStudyIdInfo id: NCI-2024-01153, secondaryIdInfos id: NCI-2024-01153, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: EAY131-K2, type: OTHER, domain: ECOG-ACRIN Cancer Research Group, secondaryIdInfos id: EAY131-K2, type: OTHER, domain: CTEP, secondaryIdInfos id: U10CA180820, type: NIH, link: https://reporter.nih.gov/quickSearch/U10CA180820, briefTitle: Testing JNJ-42756493 (Erdafitinib) as Potentially Targeting Treatment in Cancers With FGFR Mutations or Fusions (MATCH - Subprotocol K2), statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2018-06-19, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: National Cancer Institute (NCI), class: NIH, descriptionModule briefSummary: This phase II MATCH treatment trial tests how well erdafitinib (JNJ-42756493) works in treating patients with tumors that have FGFR mutations or fusions. Erdafitinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal FGFR protein that signals cancer cells to multiply. This may help keep cancer cells from growing and may kill them., conditionsModule conditions: Malignant Solid Neoplasm, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: Biopsy, interventions name: Biospecimen Collection, interventions name: Computed Tomography, interventions name: Erdafitinib, interventions name: Magnetic Resonance Imaging, outcomesModule primaryOutcomes measure: Objective response rate (ORR), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: 6-month progression-free survival (PFS) rate, secondaryOutcomes measure: Progression free survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: ECOG-ACRIN Cancer Research Group, city: Philadelphia, state: Pennsylvania, zip: 19103, country: United States, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False
|
protocolSection identificationModule nctId: NCT06351358, orgStudyIdInfo id: GLI.04.US.SL.036, briefTitle: Evaluation of the Effects of a Biostimulator and Dermal Fillers for Cheek Augmentation and Contour Deficiencies, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-10-31, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Galderma R&D, class: INDUSTRY, descriptionModule briefSummary: Adult subjects with a history of or currently taking glucagon-like peptide-1 (GLP-1) receptor agonist medication and moderate-to-severe cheek wrinkles and midface contour deficiencies will be treated with Sculptra correction of fine lines and wrinkles in the cheek area and Restylane Lyft or Restylane Contour for cheek augmentation and correction of midface contour deficiencies., conditionsModule conditions: Photoaging, conditions: Weight Loss, conditions: Skin Laxity, conditions: Photodamaged Skin, conditions: Volume Deficiency of the Midface, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Sculptra treatment, interventions name: Restylane Treatment, outcomesModule primaryOutcomes measure: Change in skin hydration from baseline, primaryOutcomes measure: Change in skin radiance from baseline, primaryOutcomes measure: Change in skin elasticity from baseline, primaryOutcomes measure: Change in skin thickness from baseline, secondaryOutcomes measure: Subject Treatment Satisfaction, eligibilityModule sex: ALL, minimumAge: 22 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Somenek + Pittman MD: Advanced Plastic Surgery, status: ENROLLING_BY_INVITATION, city: Washington, state: District of Columbia, zip: 20037, country: United States, geoPoint lat: 38.89511, lon: -77.03637, locations facility: Lorenc Aesthetic Plastic Surgery Center, status: RECRUITING, city: New York, state: New York, zip: 10028, country: United States, contacts name: Paul Lorenc, MD, role: CONTACT, phone: 212-472-2900, email: [email protected], contacts name: Allison Bonugli, role: CONTACT, email: [email protected], contacts name: Paul Z Lorenc, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
|
protocolSection identificationModule nctId: NCT06351345, orgStudyIdInfo id: Pro00115215, briefTitle: 129 Xenon Imaging in Patients Treated With Sotatercept, acronym: Sox-PH, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-08-01, completionDateStruct date: 2025-08-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Bastiaan Driehuys, class: OTHER, collaborators name: Merck Sharp & Dohme LLC, descriptionModule briefSummary: Determine the ability of 129Xe MRI/MRS biomarker signatures to non-invasively monitor pulmonary vascular reverse remodeling induced by sotatercept in pulmonary arterial hypertension (PAH)., conditionsModule conditions: Pulmonary Hypertension, conditions: Pulmonary Arterial Hypertension, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 14, type: ESTIMATED, armsInterventionsModule interventions name: 129Xe Hyperpolarized, outcomesModule primaryOutcomes measure: Change in Xenon MRI Red Blood Cell (RBC) percentage, primaryOutcomes measure: Change in cardiogenic oscillation amplitudes, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Duke University Medical Center, city: Durham, state: North Carolina, zip: 27710, country: United States, geoPoint lat: 35.99403, lon: -78.89862, hasResults: False
|
protocolSection identificationModule nctId: NCT06351332, orgStudyIdInfo id: 24-005, briefTitle: A Phase I/II Single-arm Trial of Azenosertib (ZN-c3) Combined With Carboplatin and Pembrolizumab in Patients With Metastatic Triple-negative Breast Cancer (ZAP-IT), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2027-03-01, completionDateStruct date: 2029-09-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Filipa Lynce, MD, class: OTHER, collaborators name: Merck Sharp & Dohme LLC, collaborators name: Zentalis Pharmaceuticals, descriptionModule briefSummary: This research is being done to evaluate the safety and effectiveness of a drug currently known as Azenosertib (ZN-C3) in combination with the drugs carboplatin and pembrolizumab in metastatic triple-negative breast cancer.The names of the study drugs involved in this study are:* Azenosertib (a type of WEE1 inhibitor)* Carboplatin (a type of platinum compound)* Pembrolizumab (a type of monoclonal antibody), conditionsModule conditions: Breast Cancer, conditions: Breast Cancer Female, conditions: Triple Negative Breast Cancer, conditions: Hormone Receptor Negative Malignant Tumor Breast Triple, conditions: HER2-negative Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 78, type: ESTIMATED, armsInterventionsModule interventions name: Azenosertib, interventions name: Carboplatin, interventions name: Pembrolizumab, outcomesModule primaryOutcomes measure: Number of Participants Experiencing Dose Limiting Toxicity (DLT), primaryOutcomes measure: Maximum Tolerated Dose (MTD), primaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Clinical Beneficial Rate (CBR), secondaryOutcomes measure: Median Progression Free Survival (PFS), secondaryOutcomes measure: Median Overall Survival (OS), secondaryOutcomes measure: Duration of Response (DOR), secondaryOutcomes measure: Grade 3-5 Treatment-Related Toxicity Rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dana-Farber Cancer Institute, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Filipa Lynce, MD, role: CONTACT, phone: 617-632-3800, email: [email protected], contacts name: Filipa Lynce, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
|
protocolSection identificationModule nctId: NCT06351319, orgStudyIdInfo id: HenanPPH-zhangquncheng, briefTitle: Endobronchial Ultrasound-based SVM Model for Differentiating Benign and Malignant Mediastinal and Hilar Lymph Nodes, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-01-01, primaryCompletionDateStruct date: 2023-12-01, completionDateStruct date: 2024-04-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Quncheng Zhang, class: OTHER, descriptionModule briefSummary: ABSTRACT Background and objective: To establish a ultrasound radiomics machine learning model based on endobronchial ultrasound (EBUS)to assistdoctors in distinguishing between benign and malignant diagnoses ofmediastinal and hilar lymph nodes.Methods: The clinical and ultrasonic image data of 197 patients wereretrospectively analyzed. The radiomics features were extracted by EBUS.based radiomics and dimensionality reduction was performed on thesefeatures by the least absolute shrinkage and selection operator (LASSO)EBUS-based radiomics model was established by support vector machine(SVM).205 lesions were randomly divided into a training group (n=143)and a validation group (n=62). The diagnostic efficiency was evaluated byreceiver operating characteristic (ROC).Results: A total of 13 stable features with non-zero coefficients wereselected. The support vector machine (SV) model exhibited promisingperformance in both the training and verification groups. In the traininggroup, the SVM model achieved an area under the curve (AUC) of 0.892(95% CI: 0.885-0.899), with an accuracy of 85.3%, sensitivity of 93.2%and specificity of 79.8%.In the verification group, the SVM modeldemonstrated an AUC of 0.906 (95% C: 0.890-0.923),along with anaccuracy of 74.2%,sensitivity of 70.3%, and specificity of 74.1% Conclusion:EBUS-based radiomics model can be used to differentiatemediastinal and hilar benign and malignant lymph nodes. The SVM modeldemonstrates superiority and holds potential as a diagnostic tool in clinical practice, conditionsModule conditions: Benign and Malignant Lymph Nodes, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 197, type: ACTUAL, armsInterventionsModule interventions name: SVM model, outcomesModule primaryOutcomes measure: AUC, primaryOutcomes measure: accuracy, primaryOutcomes measure: sensitivity, primaryOutcomes measure: specificity, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Respiratory and Critical Care Medicine, city: Zhengzhou, state: Henan, zip: 450000, country: China, geoPoint lat: 34.75778, lon: 113.64861, hasResults: False
|
protocolSection identificationModule nctId: NCT06351306, orgStudyIdInfo id: AAAU5915, briefTitle: DEC-C and Thioguanine for R/R AML, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-30, primaryCompletionDateStruct date: 2027-12, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Joseph Jurcic, class: OTHER, descriptionModule briefSummary: The purpose of this study is to find out if oral decitabine-cedazuridine (Inqovi®) is effective, safe, and able to be tolerated without severe side effects when given with thioguanine (Tabloid®) in patients with acute myeloid leukemia (AML) whose disease has returned or did not respond to treatment (relapsed or refractory).This is a "phase II trial with a safety lead-in." The goal of the lead-in portion of the study is to make sure participants are getting the highest dose of medications that are safe. If too many serious side effects are seen with the dose previously studied, some additional patients may be treated with a lower dose to make sure that this dose is safe., conditionsModule conditions: Acute Myeloid Leukemia, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Thioguanine (Tabloid ®), interventions name: DecitabineCedazuridine (Inqovi ®), outcomesModule primaryOutcomes measure: Composite Complete Remission (CRc) Rate, secondaryOutcomes measure: Duration of Remission, secondaryOutcomes measure: Time to Complete Remission (CR), secondaryOutcomes measure: Overall Survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Columbia University, status: RECRUITING, city: New York, state: New York, zip: 10032, country: United States, contacts name: Research Nurse Navigator, role: CONTACT, phone: 212-342-5162, email: [email protected], contacts name: Joseph G. Jurcic, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
|
protocolSection identificationModule nctId: NCT06351293, orgStudyIdInfo id: GLI.04.US.SL.034, briefTitle: A Comparative Analysis of Two Hyaluronic Acid Fillers for Nasolabial Fold Correction, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-02-21, primaryCompletionDateStruct date: 2025-02-28, completionDateStruct date: 2025-02-28, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Galderma R&D, class: INDUSTRY, descriptionModule briefSummary: This is a randomized, split-face, subject-blinded, comparative study. Subjects will receive initial treatment with Defyne on one of the NLFs and with RHA3 on the other based on the pre-determined randomization.4 weeks after the initial treatment, subjects will receive optional touch-up on one side or both sides at the Investigator's discretion for optimal correction.Subjects to return to the site at Month 3, 6, and 12 for follow-ups., conditionsModule conditions: Wrinkle, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Subjects will be blinded to the treatment assignment, in which randomization and treatment side will be concealed in order to avoid bias in subjective assessment. The clinic staff will mask the product identity by covering the packaging and product name (e.g., using tape, marker, wipe-out, etc.) so that it is not visible to the subjects. The Investigator will not be blinded., whoMasked: PARTICIPANT, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Defyne Treatment in Nasolabial Fold, interventions name: RHA3 Treatment in Nasolabial Fold, outcomesModule primaryOutcomes measure: Visual Comparison of Nasolabial Fold Ultrasounds, secondaryOutcomes measure: Volume Change Imaging Analysis, eligibilityModule sex: ALL, minimumAge: 22 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Aesthetic Clinique, city: Santa Rosa Beach, state: Florida, zip: 32459, country: United States, geoPoint lat: 30.39603, lon: -86.22883, hasResults: False
|
protocolSection identificationModule nctId: NCT06351280, orgStudyIdInfo id: Sana Nasir Zaidi, briefTitle: Evaluation of Performance-based Functional Outcome Measures After Open Abdominal Surgery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Riphah International University, class: OTHER, descriptionModule briefSummary: A laparotomy is a surgical technique, the increasing rate of this surgical interventions and the subsequent need to evaluate the post-surgical recovery and rehabilitation process comprehensively. This study aims to provide essential insights into the reliability, validity, and responsiveness of such tests, enabling healthcare professionals to make informed decisions about patient recovery progress and the optimization of rehabilitation protocols., conditionsModule conditions: Laparotomy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Standardised Physiotherapy Plan, outcomesModule primaryOutcomes measure: 6MWT (Six-Minute Walk Test), primaryOutcomes measure: 5 Times Sit to Stand, primaryOutcomes measure: 2MWT (Two-Minute Walk Test), primaryOutcomes measure: Timed Up and GO (TUG), eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Fauji Foundation Hospital, city: Rawalpindi, state: Punjab, zip: 00666, country: Pakistan, contacts name: Suman Sheraz, PhD*, role: CONTACT, phone: 03335646361, email: [email protected], contacts name: Sana Nasir, MS-CPPT*, role: SUB_INVESTIGATOR, contacts name: Suman Sheraz, PhD*, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.6007, lon: 73.0679, hasResults: False
|
protocolSection identificationModule nctId: NCT06351267, orgStudyIdInfo id: REC/RCR & AHS/23/0568, briefTitle: Combined Effects of Core Stability Exercises and Back Strengthening Exercises on Pregnancy-Induced Back Pain., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-05, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-10-15, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Riphah International University, class: OTHER, descriptionModule briefSummary: The study will be a Randomized controlled trial to check the combined effects of Core Stability Exercises with and without Back strengthening exercises in females with pregnancy-induced back pain, disability, and function so that we can examine the effect of the above techniques on pain, disability and function in pregnant females Non-probability convenience sampling technique will be used, subject following eligibility criteria from Society Hospital Nabipura Lahore will be randomly allocated in two groups. Group A participants will be given core stability exercises with back strengthening exercises, Group B participants will be given core stability exercises for 4 weeks. Assessment will be done via, Numeric Pain Rating Scale, Oswestry disability index questionnaire and Back pain Functional Scale., conditionsModule conditions: Low Back Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 34, type: ESTIMATED, armsInterventionsModule interventions name: Core Stability Exercises, interventions name: Back Strengthening exercises, outcomesModule primaryOutcomes measure: Numeric Pain Rating Scale, primaryOutcomes measure: Oswestry Disability Index Questionnaire, primaryOutcomes measure: Back Pain Functional Scale (BPFS):, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Society Hospital Nabipura, city: Lahore, state: Punjab, zip: 54700, country: Pakistan, contacts name: Ghulam Fatima, PhD*, role: CONTACT, phone: +923034073057, email: [email protected], geoPoint lat: 31.558, lon: 74.35071, hasResults: False
|
protocolSection identificationModule nctId: NCT06351254, orgStudyIdInfo id: REC/RCR & AHS/23/01101nayab, briefTitle: Kinesthetic Exercises and Sine Sound Waves in Cervical Spondylosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-20, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Riphah International University, class: OTHER, descriptionModule briefSummary: The goal of this Randomized control trial is to determine the Effect of kinesthetic exercises and sound waves on pain, ROM, shoulder alignment and disability in cervical spondylosis. The main question it aims to answer is:Weather sine sound and kinesthetic exercise are effective in management of pain, rom, alignment, and disability in patients that are suffering from cervical spondylosis, conditionsModule conditions: Cervical Spondylosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Sine sound waves, interventions name: Kinesthetic exercises, interventions name: Sine sound waves plus kinesthetic exercises, outcomesModule primaryOutcomes measure: NPRS, primaryOutcomes measure: Inclinometer, primaryOutcomes measure: Goniometer, primaryOutcomes measure: NDI, eligibilityModule sex: ALL, minimumAge: 45 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Riphah international university, status: RECRUITING, city: Lahore, state: Punjab, zip: 54000, country: Pakistan, contacts name: Muhammad Sanaullah, role: CONTACT, phone: 03224819253, email: [email protected], geoPoint lat: 31.558, lon: 74.35071, hasResults: False
|
protocolSection identificationModule nctId: NCT06351241, orgStudyIdInfo id: E.222840/280, briefTitle: Hemodynamic Effects of Steep Trendelenburg Position and Pneumoperitoneum, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-11-29, primaryCompletionDateStruct date: 2023-04-14, completionDateStruct date: 2023-04-14, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Ege University, class: OTHER, descriptionModule briefSummary: BACKGROUND: The steep Trendelenburg position and pneumoperitoneum are used to improve surgical visibility in robot-assisted laparoscopic radical prostatectomy (RALRP). However, these procedures can lead to hemodynamic changes. This study aimed to investigate the effects of these interventions on the perfusion index (PI) and the Pleth variability index (PVI) in patients undergoing RALRP under general anesthesia.METHODS: Fifty-three patients scheduled for RALRP underwent standard monitoring; PI and PVI values were monitored using a finger probe. PI, PVI, hemodynamic and respiratory parameters, and intraabdominal pressure were recorded before and after anesthesia induction, after adopting the Trendelenburg position, after pneumoperitoneum, after pneumoperitoneum and the Trendelenburg position, at 15 min, 30 min, in the supine position, after carbon dioxide (CO2) desufflation, and after extubation., conditionsModule conditions: Perfusion Index, conditions: Pleth Variability Index, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 53, type: ACTUAL, outcomesModule primaryOutcomes measure: Hemodynamic effects of steep trendelenburg position and pneumoperitoneum in urologic robotic surgery, eligibilityModule sex: MALE, minimumAge: 25 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nursen Karaca, city: Bornova, state: İzmir, zip: 35040, country: Turkey, geoPoint lat: 38.47921, lon: 27.2399, hasResults: False
|
protocolSection identificationModule nctId: NCT06351228, orgStudyIdInfo id: 5720, briefTitle: Fertility-sparing in Early-stage Cervcial Cancer: The ETERNITY Project, acronym: Eternity, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, class: OTHER, descriptionModule briefSummary: The ETERNITY project is a retrospective analysis of outcomes of patients undergoing fertility-sparing treatment for cervcial cancer.The primary aim is to report outcomes of those patients.Other aims included:1. Evaluation about the effectiveness of different treatment modalities;2. Evaluation of outcomes according to different stages of disease;3. Evaluation of the impactof neoadjuvant chemotherapy in patients undergoing conservative surgery, conditionsModule conditions: Cervical Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Conization plus nodal evaluation, outcomesModule primaryOutcomes measure: oncological outcomes, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, city: Milano, state: Lombardia, zip: 20133, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
|
protocolSection identificationModule nctId: NCT06351215, orgStudyIdInfo id: APP-24-00554, briefTitle: PO Methadone Ortho Outpatient, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2024-12-15, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Keck School of Medicine of USC, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn if oral methadone given before surgery works to minimize post-operative pain and opioid usage. The main questions it aims to answer are:Does oral methadone improve post-operative pain scores as compared to standard treatment? Does oral methadone lead to reduced use of post-operative and post-discharge opioid usage as compared to the current standard treatment?Researchers will compare oral methadone to a placebo (a look-alike substance that contains no drug) to assess the questions above.Participants will:Receive either oral methadone or a look-alike placebo before surgery Receive standard intraoperative and immediate post-operative pain control at the anesthesiologist's discretion Be asked about their pain levels in the recovery area Keep a diary of pain and opioid usage over the first 2 days after surgery, conditionsModule conditions: Arthroscopic Knee Repair, conditions: Arthroscopic Hip Repair, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Methadone group, interventions name: Placebo, outcomesModule primaryOutcomes measure: Post-op opioid usage, secondaryOutcomes measure: Post-op Pain Score, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: USC Healthcare Consultation 3, city: Los Angeles, state: California, zip: 90033, country: United States, contacts name: Alexander Chen, M.D., role: CONTACT, phone: 323-442-7400, email: [email protected], contacts name: Abigail Song, B.S., role: SUB_INVESTIGATOR, contacts name: Benjamin Liu, M.D., role: SUB_INVESTIGATOR, contacts name: Paul Lee, M.D., M.S., role: SUB_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, hasResults: False
|
protocolSection identificationModule nctId: NCT06351202, orgStudyIdInfo id: RBGP 2023 COLNE, secondaryIdInfos id: 2023-A02256-39, type: OTHER, domain: ANSM, briefTitle: Impact Assessment of Abdominal Massage on Feeding Tolerance of Preterms, acronym: PREMABDO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: University Hospital, Clermont-Ferrand, class: OTHER, descriptionModule briefSummary: Every year in France, 60,000 children are born prematurely (before 37 weeks of amenorrhea - WA), and present an immaturity of their various systems, in particular the digestive system. This can result in feeding intolerance, expressed by abdominal distension, regurgitation, irregular transit and abdominal discomfort. It can influence the length of hospitalization and lead to necrotising enterocolitis, a major complication.At the Clermont-Ferrand University Hospital Center, abdominal massages have been performed by physiotherapist for several years in order to improve the state of the digestive system of preterm infants. The indication for abdominal massages are very dependent on the caregivers in charge of the newborns because the evaluation of feeding intolerance remains subjective.In this context, the investigators carried out a first study to validate a scale that they created (ECAP scale : Clinical Assessment Scale for Abdominal state of Preterm infant) to assess in a rapid, reliable and reproductible manner the abdominal state of preterm infant - data currently being published). This scale can pose the indications for abdominal massage more objectively.The hypothesis is that abdominal massage improves feeding tolerance (decrease ECAP score), allows faster weight gain and reaching the full ration and therefore reduces the length of hospitalization of preterm infants.The aim of the study is to assess the effectiveness of abdominal massage, over a period of 14 days, on the feeding tolerance of preterm infants (under 34 weeks of amenorrhea), defined by the achievement and maintenance of an ECAP score less than 4 during 3 days., conditionsModule conditions: Preterm Birth Complication, conditions: Digestive System Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Abdominal massage, outcomesModule primaryOutcomes measure: Clinical Abdominal assessment scale for Preterm infants score (ECAP score), secondaryOutcomes measure: Variation of the ECAP score (Clinical Abdominal assessement scale for preterms score) between t0 minute and t10 minutes, secondaryOutcomes measure: Weight gain of preterm infants with feeding intolerance, secondaryOutcomes measure: Duration to reach the full ration, secondaryOutcomes measure: Duration of hospitalization in level 3, secondaryOutcomes measure: 6-hour fasting windows, secondaryOutcomes measure: Incidence of occurrence of necrotizing enterocolitis, secondaryOutcomes measure: Evolution of digestive tolerance over time, eligibilityModule sex: ALL, minimumAge: 3 Days, maximumAge: 60 Days, stdAges: CHILD, contactsLocationsModule locations facility: CHU clermont-ferrand, city: Clermont-Ferrand, country: France, geoPoint lat: 45.77966, lon: 3.08628, hasResults: False
|
protocolSection identificationModule nctId: NCT06351189, orgStudyIdInfo id: CIVI/2022/AD-01, briefTitle: NETTI Wheelchair: Does Dynamic Mode or Static Mode Affect the Sitting Position in Patients With Involuntary Movements ?, acronym: DYNAMIC SYSTEM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2026-08-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Nīmes, class: OTHER, descriptionModule briefSummary: This study compares two modes of the NETTI wheelchair (dynamic or sitting) for patients with hyperkinetic syndromes, to discover which mode is the most comfortable and best suited to these patients.It is a prospective, single-center pilot study comparing two medical devices evaluated using SCED (Single Case Experimental Design) ABAB methodology: NETTI DYNAMIC chair in dynamic mode (intervention group; phase B) versus the same chair in static mode (control group; phase A). The subject will be his/her own control, conditionsModule conditions: Hyperextension Spasms, conditions: Involuntary Movements, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 5, type: ESTIMATED, armsInterventionsModule interventions name: Observation, outcomesModule primaryOutcomes measure: Forward slippage in static mode (PHASE A), primaryOutcomes measure: Forward slippage in static mode (PHASE A), primaryOutcomes measure: Forward slippage in static mode (PHASE A), primaryOutcomes measure: Forward slippage in static mode (PHASE A), primaryOutcomes measure: Forward slippage in dynamic mode (PHASE B), primaryOutcomes measure: Forward slippage in dynamic mode (PHASE B), primaryOutcomes measure: Forward slippage in dynamic mode (PHASE B), primaryOutcomes measure: Forward slippage in dynamic mode (PHASE B), secondaryOutcomes measure: Peak force in static mode (PHASE A), secondaryOutcomes measure: Peak force in static mode (PHASE A), secondaryOutcomes measure: Peak force in static mode (PHASE A), secondaryOutcomes measure: Peak force in static mode (PHASE A), secondaryOutcomes measure: Peak force in dynamic mode (PHASE B), secondaryOutcomes measure: Peak force in dynamic mode (PHASE B), secondaryOutcomes measure: Peak force in dynamic mode (PHASE B), secondaryOutcomes measure: Peak force in dynamic mode (PHASE B), secondaryOutcomes measure: Maximum downward force in static mode (PHASE A), secondaryOutcomes measure: Maximum downward force in static mode (PHASE A), secondaryOutcomes measure: Maximum downward force in static mode (PHASE A), secondaryOutcomes measure: Maximum downward force in static mode (PHASE A), secondaryOutcomes measure: Maximum downward force in dynamic mode (PHASE B), secondaryOutcomes measure: Maximum downward force in dynamic mode (PHASE B), secondaryOutcomes measure: Maximum downward force in dynamic mode (PHASE B), secondaryOutcomes measure: Maximum downward force in dynamic mode (PHASE B), secondaryOutcomes measure: Patient's comfort in static mode (PHASE A), secondaryOutcomes measure: Patient's comfort in static mode (PHASE A), secondaryOutcomes measure: Patient's comfort in static mode (PHASE A), secondaryOutcomes measure: Patient's comfort in static mode (PHASE A), secondaryOutcomes measure: Patient's comfort in dynamic mode (PHASE B), secondaryOutcomes measure: Patient's comfort in dynamic mode (PHASE B), secondaryOutcomes measure: Patient's comfort in dynamic mode (PHASE B), secondaryOutcomes measure: Patient's comfort in dynamic mode (PHASE B), secondaryOutcomes measure: Caregiver's comfort in static mode (PHASE A), secondaryOutcomes measure: Caregiver's comfort in dynamic mode (PHASE B), secondaryOutcomes measure: Caregiver's comfort in dynamic mode (PHASE B), secondaryOutcomes measure: Caregiver's comfort in dynamic mode (PHASE B), secondaryOutcomes measure: Number of repositionings required in static mode (PHASE A), secondaryOutcomes measure: Number of repositionings required in static mode (PHASE A), secondaryOutcomes measure: Number of repositionings required in static mode (PHASE A), secondaryOutcomes measure: Number of repositionings required in static mode (PHASE A), secondaryOutcomes measure: Number of repositionings required in dynamic mode (PHASE B), secondaryOutcomes measure: Number of repositionings required in dynamic mode (PHASE B), secondaryOutcomes measure: Number of repositionings required in dynamic mode (PHASE B), secondaryOutcomes measure: Number of repositionings required in dynamic mode (PHASE B), secondaryOutcomes measure: Discomfort perceived by the caregiver in static mode (PHASE A), secondaryOutcomes measure: Discomfort perceived by the caregiver in static mode (PHASE A), secondaryOutcomes measure: Discomfort perceived by the caregiver in static mode (PHASE A), secondaryOutcomes measure: Discomfort perceived by the caregiver in static mode (PHASE A), secondaryOutcomes measure: Discomfort perceived by the caregiver in dynamic mode (PHASE B), secondaryOutcomes measure: Discomfort perceived by the caregiver in dynamic mode (PHASE B), secondaryOutcomes measure: Discomfort perceived by the caregiver in dynamic mode (PHASE B), secondaryOutcomes measure: Discomfort perceived by the caregiver in dynamic mode (PHASE B), secondaryOutcomes measure: Safety as perceived by the caregiver/carer in static mode (PHASE A), secondaryOutcomes measure: Safety as perceived by the caregiver/carer in static mode (PHASE A), secondaryOutcomes measure: Safety as perceived by the caregiver/carer in static mode (PHASE A), secondaryOutcomes measure: Safety as perceived by the caregiver/carer in static mode (PHASE A), secondaryOutcomes measure: Safety as perceived by the caregiver/carer in dynamic mode (PHASE B), secondaryOutcomes measure: Safety as perceived by the caregiver/carer in dynamic mode (PHASE B), secondaryOutcomes measure: Safety as perceived by the caregiver/carer in dynamic mode (PHASE B), secondaryOutcomes measure: Safety as perceived by the caregiver/carer in dynamic mode (PHASE B), secondaryOutcomes measure: Average of peak forces exerted on the wheelchair's backrest in static mode (PHASE A), secondaryOutcomes measure: Average of peak forces exerted on the wheelchair's backrest in static mode (PHASE A), secondaryOutcomes measure: Average of peak forces exerted on the wheelchair's backrest in static mode (PHASE A), secondaryOutcomes measure: Average of peak forces exerted on the wheelchair's backrest in static mode (PHASE A), secondaryOutcomes measure: Average of peak forces exerted on the wheelchair's backrest in dynamic mode (PHASE B), secondaryOutcomes measure: Average of peak forces exerted on the wheelchair's backrest in dynamic mode (PHASE B), secondaryOutcomes measure: Average of peak forces exerted on the wheelchair's backrest in dynamic mode (PHASE B), secondaryOutcomes measure: Average of peak forces exerted on the wheelchair's backrest in dynamic mode (PHASE B), secondaryOutcomes measure: Average of peak forces exerted on the wheelchair's seat in static mode (PHASE A), secondaryOutcomes measure: Average of peak forces exerted on the wheelchair's seat in static mode (PHASE A), secondaryOutcomes measure: Average of peak forces exerted on the wheelchair's seat in static mode (PHASE A), secondaryOutcomes measure: Average of peak forces exerted on the wheelchair's seat in static mode (PHASE A), secondaryOutcomes measure: Average of peak forces exerted on the wheelchair's seat in dynamic mode (PHASE B), secondaryOutcomes measure: Average of peak forces exerted on the wheelchair's seat in dynamic mode (PHASE B), secondaryOutcomes measure: Average of peak forces exerted on the wheelchair's seat in dynamic mode (PHASE B), secondaryOutcomes measure: Average of peak forces exerted on the wheelchair's seat in dynamic mode (PHASE B), otherOutcomes measure: Sex, otherOutcomes measure: Age, otherOutcomes measure: Height, otherOutcomes measure: Weight, otherOutcomes measure: Body mass index, eligibilityModule sex: ALL, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06351176, orgStudyIdInfo id: 2024-6819, briefTitle: Impact of Glycemic Control on Skeletal Outcomes in Adults With Type 1 Diabetes, acronym: DenSiFy cohort, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-07-04, primaryCompletionDateStruct date: 2024-12-22, completionDateStruct date: 2025-08-29, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: CHU de Quebec-Universite Laval, class: OTHER, collaborators name: Diabetes Canada, descriptionModule briefSummary: Background : Type 1 diabetes (T1D) is associated with an increased risk of fractures. The mechanisms accounting for this bone fragility are not yet fully understood. As T1D is often diagnosed in childhood or early adulthood, the lower bone mineral density (BMD) and deteriorated bone microarchitecture observed in T1D may reflect changes in the bone that occurred before or at the time of peak bone mass achievement. There is a lack of high-quality prospective studies to determine whether adults with T1D continue to lose BMD or deteriorate bone quality compared with controls. Moreover, while chronic hyperglycemia is a risk factor for fracture in T1D, it is unknown if better glycemic control affects bone outcomes.This prospective multicenter cohort study aims: (1) To compare the changes in the following outcomes over 4 years in adults with T1D and controls without diabetes of similar age, sex and body-mass index distribution: BMD by dual-energy X-ray absorptiometry (DXA) at the femoral neck, hip, spine, and radius, trabecular bone score (TBS) by DXA, and serum biochemical markers of bone turnover (BTMs); (2) To evaluate whether long-term glycemic control or the presence of a microvascular complication are independent predictors of the changes in BMD and TBS in people with T1D., conditionsModule conditions: Diabetes Mellitus, Type 1, conditions: Bone Health, conditions: Bone Loss, conditions: Bone Diseases, Metabolic, conditions: Hyperglycaemia Due to Type 1 Diabetes Mellitus, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 163, type: ESTIMATED, armsInterventionsModule interventions name: Clinical tests, interventions name: Biochemical tests, interventions name: DXA scan with TBS and VFA, interventions name: AGEReader, outcomesModule primaryOutcomes measure: Change in areal bone mineral density (aBMD) at the femoral neck in g/cm2, secondaryOutcomes measure: Change in areal bone mineral density (aBMD) at the spine in g/cm2, secondaryOutcomes measure: Change in areal bone mineral density (aBMD) at the total hip in g/cm2, secondaryOutcomes measure: Change in areal bone mineral density (aBMD) at the distal third of radius in g/cm2, secondaryOutcomes measure: Change in Trabecular bone score (TBS) (unitless), secondaryOutcomes measure: Glycemic control, assessed with mean glycated hemoglobin (HbA1c) of the past 7 years, secondaryOutcomes measure: Glycemic control, assessed with skin advanced glycation end products (AGEs), secondaryOutcomes measure: Presence of a microvascular complication (neuropathy, nephropathy, retinopathy), otherOutcomes measure: Areal bone mineral density at the femoral neck, g/cm2, otherOutcomes measure: Areal bone mineral density at the femoral neck, T-Score, otherOutcomes measure: Areal bone mineral density at the femoral neck, Z-Score, otherOutcomes measure: Areal bone mineral density at the total hip, g/cm2, otherOutcomes measure: Areal bone mineral density at the total hip, T-score, otherOutcomes measure: Areal bone mineral density at the total hip, Z-score, otherOutcomes measure: Areal bone mineral density at the spine, g/cm2, otherOutcomes measure: Areal bone mineral density at the spine, T-Score, otherOutcomes measure: Areal bone mineral density at the spine, Z-score, otherOutcomes measure: Areal bone mineral density at the distal third of radius, g/cm2, otherOutcomes measure: Areal bone mineral density at the distal third of radius, T-score, otherOutcomes measure: Areal bone mineral density at the distal third of radius, Z-score, otherOutcomes measure: Trabecular bone score (TBS) at the lumbar spine (L1-L4) (unitless), otherOutcomes measure: Vertebral Fracture Assessment (VFA) from the T4 to L5 vertebrae to detect the presence of vertebral fracture, otherOutcomes measure: Lean mass (arm, leg, trunk, android, gynoid and total) (g), otherOutcomes measure: Fat mass (arm, leg, trunk, android, gynoid and total) (g), otherOutcomes measure: C-terminal cross-linking telopeptide of type I collagen (C-telopeptide, CTX) (ng/mL), otherOutcomes measure: Procollagen type 1 N-terminal propeptide (P1NP) (ng/mL), otherOutcomes measure: Osteocalcin (ng/mL), otherOutcomes measure: Sclerostin (pmol/mL), otherOutcomes measure: Change in C-terminal cross-linking telopeptide of type I collagen (C-telopeptide, CTX) (ng/mL), otherOutcomes measure: Change in osteocalcin (ng/mL), otherOutcomes measure: Change in procollagen type 1 N-terminal propeptide (P1NP) (ng/mL), otherOutcomes measure: Change in sclerostin (pmol/mL), otherOutcomes measure: Skin advanced glycation end-products (AGEs) (arbitrary units), otherOutcomes measure: Glycated hemoglobin (HbA1c, %), otherOutcomes measure: Fasting glucose (mmol/L), otherOutcomes measure: Complete blood count, otherOutcomes measure: Thyroid-stimulating hormone (TSH) (mU/L), otherOutcomes measure: Lipid panel (total cholesterol, LDL-cholesterol, HDL-cholesterol, non-HDL-cholesterol, total cholesterol/HDL-cholesterol ratio, triglycerides, in mmol/L), otherOutcomes measure: Creatinine (umol/L), otherOutcomes measure: Microalbuminuria (mg/mmol), otherOutcomes measure: Liver enzymes (AST, ALT) (U/L), otherOutcomes measure: Calcium (mmol/L), otherOutcomes measure: Albumine (g/L), otherOutcomes measure: Phosphate (mmol/L), otherOutcomes measure: 25-hydroxyvitamin D3 (nmol/L), otherOutcomes measure: Parathormone (PTH) (ng/L), otherOutcomes measure: Antitransglutaminase antibodies (U/mL), otherOutcomes measure: Immunoglobulin A (IgA) (g/L), otherOutcomes measure: Insulin like growth factor-1 (IGF-1) (ng/mL), otherOutcomes measure: Follicle stimulating hormone (FSH, women) (U/L), otherOutcomes measure: Total testosterone (men) (nmol/L), otherOutcomes measure: Sex hormone-binding globulin (SHBG, men) (nmol/L), eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institut de recherches cliniques de Montréal (IRCM), city: Montréal, state: Quebec, zip: H2W 1R7, country: Canada, geoPoint lat: 45.50884, lon: -73.58781, locations facility: Centre de recherche du CHU de Québec-Université Laval, city: Quebec City, state: Quebec, zip: G1V 4G2, country: Canada, geoPoint lat: 46.81228, lon: -71.21454, hasResults: False
|
protocolSection identificationModule nctId: NCT06351163, orgStudyIdInfo id: 1451_03/BVNTW-VNCSKTE, briefTitle: Minimally Invasive Surgical Management for Pediatric Intussusception: A Retrospective Cohort Study, statusModule overallStatus: COMPLETED, startDateStruct date: 2016-01, primaryCompletionDateStruct date: 2020-12, completionDateStruct date: 2024-03, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: National Children's Hospital, Vietnam, class: OTHER, collaborators name: Vinmec Research Institute of Stem Cell and Gene Technology, descriptionModule briefSummary: Intussusception is the primary cause of intestinal obstruction in children aged 3 months to 5 years, leading to significant morbidity and mortality rates. Most cases involve the ileocolic region and can often be resolved through air enema, with a success rate of up to 95%. Surgical intervention becomes necessary if pneumatic reduction fails or is not recommended. Traditionally, manual reduction required a large incision on the right side of the abdomen. However, the advancement of minimally invasive techniques, such as the laparoscopic approach (LAP), has become increasingly popular for managing intussusception. LAP offers benefits such as reduced surgical trauma and shorter operative times compared to open procedures. Nevertheless, the adoption of LAP remains controversial due to challenges like limited working space in children and variability in the affected bowel segment. This study aims to investigate the safety and feasibility of LAP and mini-open reduction (MOR) techniques in treating idiopathic intussusception in pediatric patients., conditionsModule conditions: Intussusception, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 181, type: ACTUAL, armsInterventionsModule interventions name: Laparoscopic reduction, interventions name: Transumbilical mini-open reduction, outcomesModule primaryOutcomes measure: Operating time, primaryOutcomes measure: Intraoperative complications, primaryOutcomes measure: Immediate postoperative complications, primaryOutcomes measure: Time to feed, primaryOutcomes measure: Hospital stays, primaryOutcomes measure: Recurrence rate, primaryOutcomes measure: Long-term complication rate, eligibilityModule sex: ALL, minimumAge: 2 Months, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: The National Hospital of Pediatrics, city: Hanoi, country: Vietnam, geoPoint lat: 21.0245, lon: 105.84117, locations facility: Vinmec Research Institute of Stem Cell and Gene Technology, city: Hanoi, country: Vietnam, geoPoint lat: 21.0245, lon: 105.84117, hasResults: False
|
protocolSection identificationModule nctId: NCT06351150, orgStudyIdInfo id: TQG3902-III-01, briefTitle: Efficacy and Safety of Angiotensin II Injection Versus Placebo in Patients With Refractory Distributed Shock, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-06, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: A randomized, double-blind, placebo-controlled study on the treatment of refractory distributed shock with angiotensin II injection, with a random ratio of 1:1. Assuming a success rate of 25% for the main therapeutic endpoint in the control group and 50% for the experimental group, a total of 214 subjects will be enrolled, including 107 in the experimental group and 107 in the control group., conditionsModule conditions: Vasodilatory Shock, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 214, type: ESTIMATED, armsInterventionsModule interventions name: Angiotensin II Injection, interventions name: 0.9% sodium chloride injection, outcomesModule primaryOutcomes measure: Proportion of subjects with blood pressure response at 3 hours after administration of study drug, secondaryOutcomes measure: Sequential Organ Failure Assessment (SOFA) total score, secondaryOutcomes measure: Cardiovascular SOFA subscore, secondaryOutcomes measure: Mortality at Day 7, secondaryOutcomes measure: Mortality at Day 28, secondaryOutcomes measure: Proportion of subjects with blood pressure response at 1 hour after administration, secondaryOutcomes measure: Proportion of subjects with blood pressure response at 2 hours after administration, secondaryOutcomes measure: Change in background vasoactive agent dose from 0 to 48 hours, secondaryOutcomes measure: Absolute change in blood lactate from 0 to 3 hours, secondaryOutcomes measure: Absolute change in blood lactate from 3 to 48 hours, secondaryOutcomes measure: Absolute change in heart rate from 0 to 3 hours, secondaryOutcomes measure: Absolute change in heart rate from 3 to 48 hours, secondaryOutcomes measure: Adverse events (AE), secondaryOutcomes measure: Serious adverse events (SAE), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking Union Medical College Hospital, city: Beijing, state: Beijing, zip: 100730, country: China, contacts name: Yun Long, M.D., role: CONTACT, phone: 13911608699, email: [email protected], geoPoint lat: 39.9075, lon: 116.39723, locations facility: The First Affiliated Hospital of Sun Yat sen University, city: Guangzhou, state: Guangdong, zip: 510062, country: China, contacts name: Xiangdong Guan, M.D., role: CONTACT, phone: 13802925067, email: [email protected], geoPoint lat: 23.11667, lon: 113.25, locations facility: Zhujiang Hospital of Southern Medical University, city: Guangzhou, state: Guangdong, zip: 510260, country: China, contacts name: Zhanguo Liu, M.D., role: CONTACT, phone: 18520711669, email: [email protected], geoPoint lat: 23.11667, lon: 113.25, locations facility: Qingyuan Hospital Affiliated to Guangzhou Medical University, city: Qingyuan, state: Guangdong, zip: 511518, country: China, contacts name: Jingwen Yang, M.D., role: CONTACT, phone: 13542498765, email: [email protected], geoPoint lat: 23.7, lon: 113.03333, locations facility: The First Affiliated Hospital of Shantou University Medical College, city: Shantou, state: Guangdong, zip: 515041, country: China, contacts name: Yongru Chen, M.D., role: CONTACT, phone: 13411969797, email: [email protected], geoPoint lat: 23.36814, lon: 116.71479, locations facility: Liuzhou General Hospital, city: Liuzhou, state: Guangxi, zip: 545026, country: China, contacts name: Guangyu Lv, M.D., role: CONTACT, phone: 13977210130, email: [email protected], locations facility: The Affiliated Hospital of Hebei University, city: Baoding, state: Hebei, zip: 050031, country: China, contacts name: Zhanbiao Yu, M.D., role: CONTACT, phone: 15188655821, email: [email protected], geoPoint lat: 38.85111, lon: 115.49028, locations facility: The First Affiliated Hospital of Harbin Medical University, city: Harbin, state: Heilongjiang, zip: 150007, country: China, geoPoint lat: 45.75, lon: 126.65, locations facility: The First Affiliated Hospital of Bengbu Medical College, city: Bengbu, state: Henan, zip: 233099, country: China, contacts name: Yongsheng Zheng, M.D., role: CONTACT, phone: 13955252796, email: [email protected], geoPoint lat: 32.94083, lon: 117.36083, locations facility: The First Affiliated Hospital of Henan University of Science and Technology, city: Luoyang, state: Henan, zip: 450052, country: China, contacts name: Qizhi Fu, M.D., role: CONTACT, phone: 13837944687, email: [email protected], geoPoint lat: 34.68361, lon: 112.45361, locations facility: The First Affiliated Hospital of Zhengzhou University, city: Zhengzhou, state: Henan, zip: 450052, country: China, contacts name: Tongwen Sun, M.D., role: CONTACT, phone: 13838516916, email: [email protected], geoPoint lat: 34.75778, lon: 113.64861, locations facility: Union Hospital, Tongji Medical College of huazhong university of science and technology, city: Wuhan, state: Hubei, zip: 430022, country: China, contacts name: You Shang, M.D., role: CONTACT, phone: 15972127819, email: [email protected], geoPoint lat: 30.58333, lon: 114.26667, locations facility: Xiangya Hospital Central South University, city: Changsha, state: Hunan, zip: 140008, country: China, contacts name: Lina Zhang, M.D., role: CONTACT, phone: 15874875763, email: [email protected], geoPoint lat: 28.19874, lon: 112.97087, locations facility: Jiangsu Province Hospital, city: Nanjing, state: Jiangsu, zip: 210029, country: China, contacts name: Quan Cao, M.D., role: CONTACT, phone: 13851992695, email: [email protected], geoPoint lat: 32.06167, lon: 118.77778, locations facility: The Second Affiliated Hospital of Xi'an Jiaotong University, city: Xi'an, state: Shaanxi, zip: 710004, country: China, contacts name: Xiaochuang Wang, M.D., role: CONTACT, phone: 13772152935, email: [email protected], geoPoint lat: 34.25833, lon: 108.92861, locations facility: The First Hospital of Shanxi Medical University, city: Taiyuan, state: Shanxi, zip: 030001, country: China, contacts name: Jing Cao, M.D., role: CONTACT, phone: 13834691242, email: [email protected], geoPoint lat: 37.86944, lon: 112.56028, locations facility: West China Hospital of Sichuan University, city: Chengdu, state: Sichuan, zip: 610044, country: China, contacts name: Yan Kang, M.D., role: CONTACT, phone: 13808041931, email: [email protected], geoPoint lat: 30.66667, lon: 104.06667, locations facility: Sichuan Provincial People's Hospital, city: Chengdu, state: Sichuan, zip: 610072, country: China, contacts name: Xiaobo Huang, M.D., role: CONTACT, phone: 18140049936, email: [email protected], geoPoint lat: 30.66667, lon: 104.06667, locations facility: The First Affiliated Hospital of Xinjiang Medical University, city: Ürümqi, state: Xinjiang, zip: 830054, country: China, contacts name: Xiangyou Yu, M.D., role: CONTACT, phone: 13009681003, email: [email protected], geoPoint lat: 43.80096, lon: 87.60046, hasResults: False
|
protocolSection identificationModule nctId: NCT06351137, orgStudyIdInfo id: INIV2023, briefTitle: Timecost of Intranasal Versus Intravenous Analgesia in Traumatic Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), class: OTHER, descriptionModule briefSummary: Prehospital treatment of acute traumatic pain is common in military practice. Analgesics are usually administered intravenously (IV). Research from the civil prehospital environment shows that obtaining IV access can be difficult and time consuming, delaying onset of treatment. The challenges for obtaining IV access in the military prehospital setting are even bigger, for example in combat environments. However, this has not been assessed.Current guidelines also offer alternative routes of administration for analgesics, for example intranasal (IN) administration. IN administration is a fast, easy and effective route of administration. This study determines whether IN administration of analgesia is faster and leads to increased healthcare provider satisfaction compared to IV administration in patients with acute traumatic pain in a simulated military prehospital environment., conditionsModule conditions: Acute Pain Due to Trauma, conditions: Analgesia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: Intravenous administration, interventions name: Intranasal administration, outcomesModule primaryOutcomes measure: Time required for administration of analgesic (minutes), secondaryOutcomes measure: Total time spent on scene (minutes), secondaryOutcomes measure: Time required for obtaining IV access, secondaryOutcomes measure: Time required preparing IN administration, secondaryOutcomes measure: Satisfaction of the navy nurse regarding the used route of administration., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Amsterdam UMC, status: RECRUITING, city: Amsterdam, state: Noord-Holland, zip: 1105AZ, country: Netherlands, contacts name: Midas N de Grunt, MD, role: CONTACT, phone: +31205669111, email: [email protected], contacts name: Markus W Hollmann, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.37403, lon: 4.88969, hasResults: False
|
protocolSection identificationModule nctId: NCT06351124, orgStudyIdInfo id: 00005294, briefTitle: Beta-Hydroxybutyrate Feasibility Treating IBS, acronym: BHB, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: University of Texas at Austin, class: OTHER, descriptionModule briefSummary: This clinical trial aims to understand the feasibility of patients taking ketone body supplement beta-hydroxybutyrate (BHB) for 4 weeks with a confirmed diagnosis of Crohn's disease and starting new therapy for active disease.The main questions it aims to answer are:* BHB supplementation will be feasible and acceptable to patients.* BHB supplementation will be associated with a reduction in systemic inflammation.* BHB supplementation will be associated with a reduction in pro-inflammatory bacterial colonies.Participants will:* Take 3 capsules x 3 times per day for 4 weeks.* Document food consumption using a 24-hour food recall questionnaire.* Provide blood and fecal samples twice, at the beginning of the study and the 4-week mark.Researchers will compare the group taking the ketone body supplement and the group not taking the supplement to see if the supplement provides relief of symptoms suffered from Crohn's disease., conditionsModule conditions: Crohn's Disease, conditions: Irritable Bowel Syndrome, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This will be a prospective, open-label, randomized, two-arm pilot trial of adults, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, maskingDescription: Eligible consenting patients will be randomized to either standard of care therapy (control) vs standard of care therapy plus BHB supplementation (intervention). BHB will be supplemented as a capsule taken orally three times daily for four weeks for those randomized to the intervention arm., enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Feasibility of beta-hydroxybutyrate supplementation to reduce inflammation in patients with Inflammatory Bowel Disease, outcomesModule primaryOutcomes measure: Ability to enroll patients who meet the inclusion criteria within the target time frame, primaryOutcomes measure: Adherence to proposed study timelines and anticipated study costs, primaryOutcomes measure: Patient adherence to the intervention, secondaryOutcomes measure: Microbial Diversity, secondaryOutcomes measure: BHB Blood Levels, secondaryOutcomes measure: Gastrointestinal Symptoms, secondaryOutcomes measure: Quality of Life, secondaryOutcomes measure: Clinical Response, secondaryOutcomes measure: Systemic Inflammation, secondaryOutcomes measure: Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Texas at Austin, city: Austin, state: Texas, zip: 78712, country: United States, contacts name: Michelle Stickler, Associate Vice President, DEd, role: CONTACT, phone: 512-475-6323, email: [email protected], contacts name: Thomas Street, Executive Director, role: CONTACT, phone: 512 495 5142, email: [email protected], geoPoint lat: 30.26715, lon: -97.74306, hasResults: False
|
protocolSection identificationModule nctId: NCT06351111, orgStudyIdInfo id: IRB-24-240, briefTitle: [Trial of device that is not approved or cleared by the U.S. FDA], statusModule overallStatus: WITHHELD, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: [Redacted], hasResults: False
|
protocolSection identificationModule nctId: NCT06351098, orgStudyIdInfo id: 2024579, briefTitle: Longitudinal Investigation of Sleep, Memory, and Brain Development Across the Nap Transition, acronym: HSR, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-05, primaryCompletionDateStruct date: 2028-06, completionDateStruct date: 2028-06, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: University of Maryland, College Park, class: OTHER, collaborators name: University of Massachusetts, Amherst, descriptionModule briefSummary: To examine the relations between sleep (nap transitions, sleep physiology), memory, and brain development longitudinally, the researchers will assess n=180 children (in order to acquire n=152 usable data sets) who are 36-54 months of age and habitual nappers at enrollment. In each wave, the researchers will assess memory, memory change over a nap and equivalent waking interval, sleep physiology of the nap, and brain structure and function (using Magnetic Resonance Imagining or MRI). Additionally, overnight sleep physiology will be assessed in all participants. Waves will take place approximately every 6 months. For all children, three waves will be collected. With these data, the researchers will address the following aims:* Examine neural markers that predict the sleep transition (Aim 1);* Examine changes in sleep-dependent memory processing (mnemonic discrimination) over both nap and overnight sleep intervals, across the sleep transition (Aim 2);* Examine changes in sleep microstructure in both nap and overnight sleep across the sleep transition (Aim 3)* Examine interrelations among brain, memory and sleep microstructure across the sleep transition (Aim 4), conditionsModule conditions: Memory, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: nap, outcomesModule primaryOutcomes measure: Memory, eligibilityModule sex: ALL, minimumAge: 36 Months, maximumAge: 60 Months, stdAges: CHILD, contactsLocationsModule locations facility: University of Maryland, status: RECRUITING, city: College Park, state: Maryland, zip: 20742, country: United States, contacts name: Tracy Riggins, Ph.D., role: CONTACT, phone: 301-405-5905, email: [email protected], contacts name: Postdoctoral Fellow, role: CONTACT, phone: 301-405-5922, email: [email protected], geoPoint lat: 38.98067, lon: -76.93692, locations facility: University of Massachusetts, status: RECRUITING, city: Amherst, state: Massachusetts, zip: 01003, country: United States, contacts name: Rebecca MC Spencer, PhD, role: CONTACT, phone: 413-577-6128, email: [email protected], contacts name: Postdoctoral Fellow, role: CONTACT, phone: 413-545-4831, email: [email protected], geoPoint lat: 42.36723, lon: -72.51852, hasResults: False
|
protocolSection identificationModule nctId: NCT06351085, orgStudyIdInfo id: 1937769-1, briefTitle: Enhancing Lung Cancer Screening Through Human-Centered Intervention, acronym: ELFE, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-11-10, primaryCompletionDateStruct date: 2025-04-14, completionDateStruct date: 2025-04-14, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: University of California, Davis, class: OTHER, descriptionModule briefSummary: The purpose of this study is to further understand the factors involved in increasing lung cancer screening., conditionsModule conditions: Lung Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients of the intervention clinics will be assigned one of two interventions: 1) Pre Visit Planner (PVP) or 2) PVP + patient education delivered via the MyUCDHealth patient web portal., primaryPurpose: SCREENING, maskingInfo masking: SINGLE, maskingDescription: Biostatistician created a randomized table to allocate patient in either intervention 1 or 2., whoMasked: PARTICIPANT, enrollmentInfo count: 2869, type: ESTIMATED, armsInterventionsModule interventions name: Pre-Visit Planner, interventions name: Pre-Visit Planner + MyChart, outcomesModule primaryOutcomes measure: Lung Cancer Screening, secondaryOutcomes measure: Completion of Interviews with Staff and Patients, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of California, Davis, status: RECRUITING, city: Sacramento, state: California, zip: 95817, country: United States, contacts name: Moon Chen, M.P.H, Ph.D, role: CONTACT, phone: 916-548-3928, email: [email protected], contacts name: Moon Chen, M.P.H, Ph.D, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.58157, lon: -121.4944, hasResults: False
|
protocolSection identificationModule nctId: NCT06351072, orgStudyIdInfo id: NOXANI, briefTitle: Correlation Between qNOX and Analgesia Nociception Index (ANI) Values During General Anesthesia, acronym: ANI, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University of Padova, class: OTHER, descriptionModule briefSummary: qNOX and ANI are two indexes evaluting the analgesia conduction during general anesthesia.No trials have compared them, so with this trial authors want to explore the correlations between them., conditionsModule conditions: Analgesia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, outcomesModule primaryOutcomes measure: Correlation between qNOX and ANI values, secondaryOutcomes measure: Correlation between qNOX from CONOX and Analgesia nocicpetion index (ANI) values and postoperative pain, secondaryOutcomes measure: Correlation between qNOX from CONOX and analgesia nocicpetion index (ANI) values and postoperative delirium, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Treviso Regional Hospital, status: RECRUITING, city: Treviso, state: TV, zip: 31100, country: Italy, contacts name: Federico Linassi, role: CONTACT, email: [email protected], geoPoint lat: 45.66673, lon: 12.2416, hasResults: False
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.