data
stringlengths 358
232k
|
|---|
protocolSection identificationModule nctId: NCT06301646, orgStudyIdInfo id: IOE-psy, briefTitle: Oral Enteral Nutrition Tube Feeding on Stroke Survivors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Ahmadu Bello University Teaching Hospital, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to explore Clinical Effect of Intermittent Oro-esophageal Tube Feeding in Dysphagic Stroke Survivors. The main questions it aims to answer are:Can Intermittent Oro-esophageal Tube Feeding improve psychological status in Dysphagic Stroke Survivors? Can Intermittent Oro-esophageal Tube Feeding improve social interaction in Dysphagic Stroke Survivors? Patients will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Intermittent Oro-esophageal Tube Feeding as nutrition support and the control group will be given Nasogastric tube. The study lasts 15 days for each patient. Researchers will compare the Social Functioning Scale, Social Support Questionnaire, Patients Health Questionnaire-9, General Anxiety Disorder-7 to see if the Intermittent Oro-esophageal Tube Feeding can help improve the symptom., conditionsModule conditions: Cerebrovascular Accident, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Intermittent Oro-esophageal Tube Feeding, interventions name: Nasogastric Tube Feeding, interventions name: comprehensive rehabilitation therapy, outcomesModule primaryOutcomes measure: Social Functioning Scale, secondaryOutcomes measure: Social Support Questionnaire, secondaryOutcomes measure: Anxiety, secondaryOutcomes measure: Depression, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06301633, orgStudyIdInfo id: IOE-STROKE, briefTitle: Comparison of Oral and Nasal Tube Feeding on Stroke-related Dysphagia, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-01-31, primaryCompletionDateStruct date: 2023-12-10, completionDateStruct date: 2023-12-30, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Muhammad, class: OTHER, descriptionModule briefSummary: This was a prospective multicenter study. the patients after stroke with were randomly divided into the observation group and the control group. All patients were given comprehensive rehabilitation therapy. During the treatment, enteral nutrition support was provided for the two groups by Intermittent Oro-esophageal tube feeding and nasogastric tube feeding, respectively. Nutritional status, dysphagia, quality of life and depression before and after treatment were compared., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 126, type: ACTUAL, armsInterventionsModule interventions name: Intermittent Oro-esophageal Tube Feeding, interventions name: Nasogastric Tube Feeding, interventions name: comprehensive rehabilitation therapy, outcomesModule primaryOutcomes measure: Penetration-Aspiration Scale, secondaryOutcomes measure: Body weight, secondaryOutcomes measure: total protein, secondaryOutcomes measure: albumin, secondaryOutcomes measure: Yale pharyngeal residue severity rating scale, secondaryOutcomes measure: Patient health questionnaire-9, secondaryOutcomes measure: Swallowing Quality of Life questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The 1st afi. Hos., city: Zhenzhou, country: China, geoPoint lat: 32.28034, lon: 119.16999, hasResults: False
|
protocolSection identificationModule nctId: NCT06301620, orgStudyIdInfo id: GUANJIEQIANG, briefTitle: Intra-articular Injection: A Innovational Approach for Joint Disorder, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Muhammad, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to study about the clinical effect of Intra-articular Injection on Temporomandibular Joint DysfunctionThe main question it aims to answer is:• Can Intra-articular Injection help improve the Temporomandibular Joint Dysfunction Participants will be randomly assigned into the experimental group and the control group, all under comprehensive treatment. The experimental group will be given Intra-articular Injection additionally, The study lasts 15 days for each patient. Researchers will compare the assessments between the two groups to see if Intra-articular Injection can help improve the Temporomandibular Joint Dysfunction, conditionsModule conditions: Temporomandibular Joint Dysfunction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 88, type: ESTIMATED, armsInterventionsModule interventions name: Routine rehabilitation treatment, interventions name: Intra-articular Injection, outcomesModule primaryOutcomes measure: Friction Index, secondaryOutcomes measure: The Visual Analog Scale, secondaryOutcomes measure: The maximum mouth opening limit, secondaryOutcomes measure: Mann Assessment of Swallowing Ability, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06301607, orgStudyIdInfo id: Feedingamount, briefTitle: The Impact of Oral and Nasal Enteral Nutrition Feeding Quantity in Stroke Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Muhammad, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare the differences in feeding amount and nutritional status between ischemic stroke patients using Intermittent Oro-esophageal Tube and Nasogastric Tube. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the control group will use Nasogastric Tube. Researchers will compare changes in daily intake and nutritional status of two groups of patients before and after the study to see if Intermittent Oro-esophageal Tube can improve the feeding amount and nutritional status between ischemic stroke patients compared to Nasogastric Tube, conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Intermittent Oro-esophageal Tube Feeding, interventions name: Nasogastric Tube, interventions name: comprehensive rehabilitation therapy, outcomesModule primaryOutcomes measure: Feeding Amount, secondaryOutcomes measure: total protein level, secondaryOutcomes measure: hemoglobin level, secondaryOutcomes measure: albumin level, secondaryOutcomes measure: prealbumin level, secondaryOutcomes measure: Body weight, secondaryOutcomes measure: Functional Oral Intake Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06301594, orgStudyIdInfo id: Dys-prevent, briefTitle: Impact of Neck and Facial Exercises on Swallowing Function in Elderly Individuals, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-03, completionDateStruct date: 2024-03, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Muhammad, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to explore the impact of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of systematic simple swallowing training on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants are required to undergo a continuous three-week (21 days) systematic simple swallowing training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-30 minutes each., conditionsModule conditions: Dysphagia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Systematic simple swallowing training, outcomesModule primaryOutcomes measure: Swallowing-Related Quality of Life Questionnaire, secondaryOutcomes measure: Eating Assessment Tool-10, secondaryOutcomes measure: Time consumed in eating, secondaryOutcomes measure: Standardized Swallowing Assessment, secondaryOutcomes measure: Water Swallow Test, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06301581, orgStudyIdInfo id: ABIntl-23-42, briefTitle: Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-22, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Advanced Bionics AG, class: INDUSTRY, descriptionModule briefSummary: This is a retrospective study designed to collect speech perception results for HiRes Ultra CI and HiRes Ultra 3D CI users as measured in the clinical routine and to confirm the performance of these devices., conditionsModule conditions: Cochlear Hearing Loss, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Freiburger monosyllabic word recognition score in quiet in the implanted ear, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medizinische Hochschule Hannover, status: RECRUITING, city: Hannover, zip: D-30625, country: Germany, contacts name: Andreas Büchner, role: CONTACT, contacts name: Andreas Büchner, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.37052, lon: 9.73322, hasResults: False
|
protocolSection identificationModule nctId: NCT06301568, orgStudyIdInfo id: ABIntl-23-12, briefTitle: Retrospective Analysis of Long-term Speech Performance in Cochlear Implant Recipients Using Electro-acoustic Stimulation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-22, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Advanced Bionics AG, class: INDUSTRY, descriptionModule briefSummary: This is a retrospective study designed to collect long-term speech perception results for cochlear implants recipients using electro-acoustic-stimulation as measured in the clinical routine and to confirm the performance of sound processors associated with acoustic earhooks., conditionsModule conditions: Cochlear Hearing Loss, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, outcomesModule primaryOutcomes measure: Freiburger monosyllabic word recognition score in quiet, secondaryOutcomes measure: HSM sentence score or OlSa recognition score in quiet, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medizinische Hochschule Hannover, status: RECRUITING, city: Hannover, zip: D-30625, country: Germany, contacts name: Andreas Büchner, role: CONTACT, geoPoint lat: 52.37052, lon: 9.73322, hasResults: False
|
protocolSection identificationModule nctId: NCT06301555, orgStudyIdInfo id: db2023, briefTitle: Game-Based Digital Intervention for Relieving Depression and Anxiety Symptoms, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2024-01-01, completionDateStruct date: 2024-02-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Adai Technology (Beijing) Co., Ltd., class: OTHER, descriptionModule briefSummary: Objective: To collect preliminary data and assess the preliminary effectiveness of a game-based digital therapeutics (DTx) intervention for individuals with symptoms of anxiety and depression, and to investigate whether reinforcement learning (RL) can personalize the intervention and enhance effectiveness. Design: Randomized controlled trial with three arms. Setting: Internet-based recruitment and delivery of the intervention. Participants: 223 individuals with symptoms of anxiety and depression, aged between 18 and 50 years. Interventions: Participants were randomly assigned to one of three groups: game-based DTx with RL algorithm (RL algorithm group), game-based DTx without RL algorithm (no algorithm group), and a blank control group. Main Outcomes and Measures: The primary outcomes were reductions in symptoms of anxiety and depression, measured using the Patient Health Questionnaire-9 and Generalized Anxiety Disorder 7-item scales. Response rates and rates of recovery, as well as the impact of demographic variables, were also examined., conditionsModule conditions: Depression, conditions: Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 223, type: ACTUAL, armsInterventionsModule interventions name: Reinforcement learning algorithm powered cognitive and behavioral intervention, interventions name: cognitive and behavioral intervention, outcomesModule primaryOutcomes measure: PHQ9 Response, primaryOutcomes measure: GAD7 Response, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: the First Hospital of China Medical University, city: Shenyang, state: Liaoning, country: China, geoPoint lat: 41.79222, lon: 123.43278, hasResults: False
|
protocolSection identificationModule nctId: NCT06301542, orgStudyIdInfo id: 2020P003474, briefTitle: Multimodal, Task-Aware Movement Assessment and Control Using Functional Electrical Stimulation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-07, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-05-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Brigham and Women's Hospital, class: OTHER, collaborators name: Boston University, descriptionModule briefSummary: The study aims to investigate the relationship between post-stroke adults' movement patterns and disability levels. Utilizing the functional electrical stimulation (FES) system for individualized dorsiflexor and plantar flexor assistance during gait cycles. The investigators will analyze the cycles with and without the FES system. Initially, the context-aware motion assessment and neuroprosthetic control in a clinic will transition to in-home settings as the study progresses, broadening its application for safe and effective use at home., conditionsModule conditions: Post-stroke, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Functional electrical stimulation, outcomesModule primaryOutcomes measure: Apply functional electrical stimulation to the paretic limb of muscles of poststroke patients, secondaryOutcomes measure: Accurate motion assistance while using the functional electrical stimulation in the laboratory., secondaryOutcomes measure: Accurate motion assistance while using the functional electrical stimulation in the home., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Brigham and Women's Hospital, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: David M Levine, MD MPH MA, role: CONTACT, phone: 617-732-7063, email: dmlevine@partners.org, contacts name: David M Levine, MD MPH MA, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
|
protocolSection identificationModule nctId: NCT06301529, orgStudyIdInfo id: ALRx008, briefTitle: The Efficacy and Tolerability of Canagliflozin in Healthy Individual, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-02-12, primaryCompletionDateStruct date: 2024-04-29, completionDateStruct date: 2024-04-29, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: AgelessRx, class: INDUSTRY, descriptionModule briefSummary: The primary objective is to measure the effects that canagliflozin intervention has on reducing average glucose in healthy individuals.The secondary objective is to assess the tolerability and side effects and urinary glucose excretion following the pulsatile dosing protocol., conditionsModule conditions: Healthy Aging, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Invokana Pill, outcomesModule primaryOutcomes measure: Change in blood glucose values after taking Canagliflozin, secondaryOutcomes measure: Number of participants with treatment-related side effects through collected survey responses, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: AgelessRx, city: Ann Arbor, state: Michigan, zip: 48104, country: United States, geoPoint lat: 42.27756, lon: -83.74088, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP_ICF, hasProtocol: True, hasSap: True, hasIcf: True, label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form, date: 2024-01-24, uploadDate: 2024-02-21T09:47, filename: Prot_SAP_ICF_000.pdf, size: 1174837, hasResults: False
|
protocolSection identificationModule nctId: NCT06301516, orgStudyIdInfo id: HM20027823, secondaryIdInfos id: R41MH133540, type: NIH, link: https://reporter.nih.gov/quickSearch/R41MH133540, briefTitle: Impact VR: An Emotion Recognition and Regulation Training Program for Youth With CD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-16, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Virginia Commonwealth University, class: OTHER, collaborators name: National Institute of Mental Health (NIMH), descriptionModule briefSummary: Conduct disorder (CD) is one of the most prevalent childhood psychiatric disorders. Unfortunately, there are limited treatments available for CD. The present study aims to test an innovative virtual reality intervention called Impact VR for symptom reduction in a sample of 60 youth with CD., conditionsModule conditions: Conduct Disorder, conditions: Conduct Disorders in Children, conditions: Conduct Disorders in Adolescence, conditions: Callous-Unemotional Traits, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized clinical trial of psychological intervention. Once all assessments are completed, the treatment group allocation will be disclosed to the administrating researcher, youth, and caregiver. This blinded approach to block randomization prevents any bias from occurring during the assessment phase by the researcher., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Virtual Reality, interventions name: Comparative Control, outcomesModule primaryOutcomes measure: Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Callous-Unemotional traits, primaryOutcomes measure: Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Conduct disorder, primaryOutcomes measure: Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Conduct Problems, primaryOutcomes measure: Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Emotion regulation, primaryOutcomes measure: Assess the preliminary efficacy of Impact Virtual Reality (VR) in reducing Emotion recognition, eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Virginia Commonwealth University, status: RECRUITING, city: Richmond, state: Virginia, zip: 23298, country: United States, contacts name: Nicholas Johnson, role: CONTACT, phone: 804-828-6386, email: Nicholas.Thomson@VCUHealth.org, geoPoint lat: 37.55376, lon: -77.46026, hasResults: False
|
protocolSection identificationModule nctId: NCT06301503, orgStudyIdInfo id: 0103/UN14.2.2.VII.14/LT/2024, briefTitle: Postoperative Quality of Recovery After Combined Lumbar Plexus-Sciatic Nerve Block (LPB-SNB), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-08, primaryCompletionDateStruct date: 2024-04-20, completionDateStruct date: 2024-04-25, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Udayana University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the efficacy of lumbar plexus-sciatic nerve block (LPB-SNB) by comparing the postoperative quality of recovery as assessed by the Quality of Recovery-40 (QoR-40) questionnaire, in patients who received a combination of LPB-SNB versus patients who received the traditional intravenous opioid, after lower extremity orthopaedic surgeries with spinal anaesthesia.The main questions it aims to answer are:* Will there be a significant difference in QoR-40 scores between both groups?* Will the combined LPB-SNB significantly reduces opioid consumption within the first 24 hours?* Will the combined LPB-SNB significantly increases postoperative duration of analgesia?Participants will:* Receive a coded sealed opaque envelope containing their randomly allocated intervention group; first group receives a combination of lumbar plexus-sciatic nerve block, while the second group receives no block at all. This information would not be disclosed to the participants.* Receive an explanation on how to use the patient controlled analgesia (PCA) to deliver intravenous opioid, and instructions on filling in the QoR-40 questionnaire.Researchers will then compare the results between both groups to see if the combined lumbar plexus-sciatic nerve block successfully provides adequate analgesia and enhance postoperative quality of recovery after lower extremity orthopaedic surgeries., conditionsModule conditions: Lower Extremity Surgery, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: One hundred participants are to be randomly assigned by a computer-generated random number table into two parallel groups and 1:1 allocation to either receive a combination of LPB-SNB or no block at all., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Numbers were prepared in sealed envelopes prepared by a third party not involved in the study to ensure allocation concealment, and handed over to the anesthetist performing the block before surgery. Participants would be blinded to the group allocation., whoMasked: PARTICIPANT, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: USG Guided Combined LPB-SNB with Isobaric Bupivacaine, interventions name: Control, outcomesModule primaryOutcomes measure: Postoperative Quality of Recovery as assessed by the QoR-40 questionnaire, secondaryOutcomes measure: Postoperative Intravenous Opioid Consumption, secondaryOutcomes measure: Postoperative Analgesia Duration, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Prof. Dr. I.G.N.G. Ngoerah General Hospital, status: RECRUITING, city: Denpasar, state: Bali, zip: 80114, country: Indonesia, contacts name: Tjokorda GA Senapathi, Professor, role: CONTACT, phone: +6281337711220, email: tjoksenapathi@unud.ac.id, contacts name: Tjokorda GA Senapathi, Professor, role: SUB_INVESTIGATOR, contacts name: Pontisomaya Parami, Consultant, role: SUB_INVESTIGATOR, contacts name: Made Wiryana, Professor, role: SUB_INVESTIGATOR, contacts name: I Made G Widnyana, Doctorate, role: SUB_INVESTIGATOR, contacts name: I Putu P Suarjaya, Doctorate, role: SUB_INVESTIGATOR, contacts name: I Gusti NM Aribawa, Doctorate, role: SUB_INVESTIGATOR, contacts name: Ida Bagus KJ Sutawan, Consultant, role: SUB_INVESTIGATOR, contacts name: Georgina M Tiberias, MD, role: SUB_INVESTIGATOR, geoPoint lat: -8.65, lon: 115.21667, hasResults: False
|
protocolSection identificationModule nctId: NCT06301490, orgStudyIdInfo id: Taif university, briefTitle: The Effect of Myofascial Release in Patients With Subacromial Impingement Syndrome, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-01-11, primaryCompletionDateStruct date: 2024-02-15, completionDateStruct date: 2024-03-02, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Taif University, class: OTHER, descriptionModule briefSummary: BACKGROUND: Shoulder pain has been reported to be the third most common musculoskeletal presentation in primary care, after low back pain and knee pain. The prognosis for those presenting with musculoskeletal shoulder pain varies greatly amongst individuals, with 50% of people reporting symptoms 6 months after presenting in primary healthcare. Functional limitations, in addition to pain, are widespread and can interfere with job, hobbies, social, and sporting activities. They may also relate to psychological discomfort and a lower quality of life. Continuous computer uses without a break, awkward postures, and the duration and frequency of laptop use have all been identified as risk factors for musculoskeletal diseases. The most prevalent cause, accounting for 70% of cases, is rotator cuff dysfunction. Rotator cuff disorders are frequently associated with short and long-term impairment and discomfort, with approximately fifty percent of patients experiencing pain or functional restrictions for up to two years. The majority of shoulder pain concerns are treated in primary care by physiotherapists and general practitioners. Myofascial release is a common hands-on method manual therapy technique that uses carefully guided low load, long duration mechanical pressures to modify the myofascial complex with promising results in improving functional level.OBJECTIVE: The purpose of this study is to investigate the effect of myofascial release in patient with rotator cuff tendinopathy.METHOD: The design of this study is a double blinded Randomize control trail. Forty-two participants will be divided into one of two groups, group one will have strengthening exercises, range of motion exercise, and ice application, group two will perform the same exercises with ice application plus myofascial release. Patient will be followed for one month, two session per week and the session duration will be 30-45 mins. Assessment and re-assessment will be done by independent physical therapist. All patients will be assessed by using quick DASH, VAS, ROM, and Kessler psychological distress scale., conditionsModule conditions: Subacromial Impingement Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 36, type: ACTUAL, armsInterventionsModule interventions name: Myofascial Release, outcomesModule primaryOutcomes measure: pain intensity, primaryOutcomes measure: disability, secondaryOutcomes measure: rang of motion, secondaryOutcomes measure: psychological distress, and health-related quality of life (HRQoL), eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Taif University, city: Taif, state: Makkah, zip: 11099, country: Saudi Arabia, geoPoint lat: 21.27028, lon: 40.41583, hasResults: False
|
protocolSection identificationModule nctId: NCT06301477, orgStudyIdInfo id: 23/109X, briefTitle: PRecisiOn Microbiome Directed ExtensiOn of Anti-TNFα Crohn's Disease ThErapy in Children: The PROMOTE Trial, acronym: PROMOTE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-03-01, completionDateStruct date: 2027-03-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Children's Hospital of Eastern Ontario, class: OTHER, descriptionModule briefSummary: To determine whether a specific food-origin plant-derived resistant starch (RS) optimized for the individual will increase the abundance of known butyrate producing microbes., conditionsModule conditions: Inflammatory Bowel Diseases, conditions: Crohn Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A single-center, randomized, placebo-controlled, double-blinded, pilot trial, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: QUADRUPLE, maskingDescription: The treating physician, study participants, and research coordinators and lab researchers will not have knowledge of the randomization codes and will be blinded as to study product allocation. Unblinding will occur only if necessary to ensure study participants safety. Only Dr. Mack (Co-PI) will request to break the blind for safety reasons. Once the blind is broken by Dr. Mack the patient will be discontinued from study product., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Resistant Starch, interventions name: Placebo, outcomesModule primaryOutcomes measure: Measure of butyrate production by assessing expression of enzymes using metaproteomic/transcriptomic analysis, primaryOutcomes measure: Measure of butyrate production by assessing production of shorty-chain-fatty-acids including butyrates using metabolomics analysis, primaryOutcomes measure: Measure of butyrate production by assessing increases in butyrate producers using metagenomics/16S analysis, secondaryOutcomes measure: Change in intensification as measured by anti-TNFa dose escalation, secondaryOutcomes measure: Change in intensification as measured by anti-TNFa interval shortening, secondaryOutcomes measure: Change in disease activity, secondaryOutcomes measure: Changes in intestinal mucosal inflammation by measuring fecal calprotectin through stool samples, secondaryOutcomes measure: Changes in biomarkers of inflammation by measuring c-reactive protein through blood samples, secondaryOutcomes measure: Changes in patient reported disability outcomes as measured by the IBD Disability Index Questionnaire, secondaryOutcomes measure: Changes in patient reported quality of life outcomes as measured by the IMPACT III Questionnaire, secondaryOutcomes measure: Changes in parent/caregiver reported quality of life outcomes as measured by the IMPACT III-P, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: Children's Hospital of Eastern Ontario, city: Ottawa, state: Ontario, zip: K1H 8L1, country: Canada, contacts name: David Mack, MD, FRCPC, role: CONTACT, phone: (613)737-7600, phoneExt: 2516, email: dmack@cheo.on.ca, contacts name: Ruth Singleton, RN, CCRP, role: CONTACT, phone: (613)737-7600, phoneExt: 4123, email: rsingleton@cheo.on.ca, contacts name: David Mack, MD, FRCPC, role: PRINCIPAL_INVESTIGATOR, contacts name: Alain Stintzi, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.41117, lon: -75.69812, hasResults: False
|
protocolSection identificationModule nctId: NCT06301464, orgStudyIdInfo id: B-2003-603-103, briefTitle: Pepsinogen II and Helicobacter Pylori Test in Gastric Cancer, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2003-03-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Seoul National University Bundang Hospital, class: OTHER, descriptionModule briefSummary: The aim of this study to validate the role of pepsinogens in gastric cancer screening., conditionsModule conditions: Gastric Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 24000, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: The level of serum pepsinogens, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Seoul National University Bundang Hospital, city: Seongnam-si, state: Gyeonggi-do, zip: 463-707, country: Korea, Republic of, geoPoint lat: 37.43861, lon: 127.13778, hasResults: False
|
protocolSection identificationModule nctId: NCT06301451, orgStudyIdInfo id: XD2021-1, briefTitle: Efficacy and Safety of Portable Hydrogen Rich Water Machine is Used for Adjuvant Treatment of Patients With Hyperlipidemia, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-04-01, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Sun Jia, class: OTHER, descriptionModule briefSummary: In the past 30 years, the blood lipid level of the Chinese population has gradually increased, and the prevalence of dyslipidemia patients has increased significantly. Hyperlipidemia is a disease caused by abnormal blood lipid levels, also known as abnormal lipid metabolism. Common clinical indicators include total cholesterol (TC), triglyceride (TG), low-density lipoprotein (LDL) and high-density lipoprotein ( HDL).The number of patients with abnormal blood lipid levels in China accounts for as high as 40% of the total. It is estimated that between 2010 and 2030,cardiovascular disease events will increase by 9.2 million, which seriously endangers human health and becomes a high risk factor for various cardiovascular diseases, such as atherosclerosis. One of the pathological foundations of atherosclerosis is that abnormal lipid levels in the body cause a large amount of lipid to be deposited in the arterial endothelial matrix, which is phagocytosed by smooth muscle and macrophages to form foam cells.Hydrogen, the lightest and smallest molecular gas in the atmosphere, is considered a novel antioxidant that reduces oxidative stress. Accumulating evidence from various biomedical fields in clinical studies and experimental models of many diseases suggests that hydrogen inhalation or drinking hydrogen-containing solutions can be used as a therapeutic strategy. Due to the special physical properties of hydrogen gas that is easy to diffuse, hydrogen molecules can penetrate cell membranes to reach organelles and cell nuclei. Hydrogen's moderate reducing properties make it effective in reducing cytotoxicity, protecting nuclear DNA and mitochondria, and reducing the risk of lifestyle-related diseases and cancer.In addition, hydrogen intake can reduce oxidative stress, improve cellular function, and reduce chronic inflammation, which are associated with the pathology and etiology of hyperlipidemia and other related diseases. Molecular hydrogen can regulate important metabolic functions such as signal transduction, protein phosphorylation, miRNA expression, and autophagy. Studies have shown that intake of hydrogen water in APOE knockout mice can reduce serum total cholesterol and low-density lipoprotein levels and prevent the progression of atherosclerosis. A study by Song et al. in 2013 included 20 subjects who drank 0.9 to 1 L of hydrogen-rich water per day for 10 weeks, and the subjects' LDL-C levels decreased significantly before and after treatment. Another study showed that subjects with underlying lipid metabolism abnormalities were treated with high-concentration hydrogen water (5.5mmol/d) for up to 24 weeks, and serum total cholesterol and low-density lipoprotein levels were significantly reduced. Protein function and redox status (eg, increased serum superoxide dismutase and decreased malondialdehyde) were improved, markers of inflammation (eg, serum tumor necrosis factor-alpha) decreased and fasting blood glucose decreased. At present, the research on the treatment of hyperlipidemia with hydrogen water is very limited. The portable hydrogen water hydrogen machine used in this study has passed the registration test of the Guangdong Provincial Medical Device Quality Supervision and Inspection Institute. In order to evaluate the use of the portable hydrogen water hydrogen machine for hyperlipidemia The efficacy and safety of adjuvant therapy in patients, this clinical trial is specially carried out., conditionsModule conditions: Hyperlipidemias, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: It is estimated that 180 subjects will be enrolled and randomly divided into the experimental group and the control group according to 2:1. During the observation period, the experimental group drink the hydrogen water prepared by the experimental equipment on the basis of the general dietary guidance, while the control group adopted the general dietary guidance. Every subject's diet and lifestyle remains largely unchanged during the treatment period., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: General dietary guidance and hydrogen water prepared by portable hydrogen rich water machine, outcomesModule primaryOutcomes measure: Percent change from baseline in LDL-C at 3 months of intervention., secondaryOutcomes measure: Absolute change from baseline in LDL-C at 3 months of intervention., secondaryOutcomes measure: Percent change from baseline in LDL-C at 1 month of intervention., secondaryOutcomes measure: Absolute change from baseline in LDL-C at 1 month of intervention., secondaryOutcomes measure: Percent change from baseline in LDL-C at 6 months of intervention., secondaryOutcomes measure: Absolute change from baseline in LDL-C at 6 months of intervention., secondaryOutcomes measure: Percent change from baseline in triglycerides at 1 month of intervention., secondaryOutcomes measure: Absolute change from baseline in triglycerides at 1 month of intervention., secondaryOutcomes measure: Percent change from baseline in triglycerides at 3 months of intervention., secondaryOutcomes measure: Absolute change from baseline in triglycerides at 3 months of intervention., secondaryOutcomes measure: Percent change from baseline in triglycerides at 6 months of intervention., secondaryOutcomes measure: Absolute change from baseline in triglycerides at 6 months of intervention., secondaryOutcomes measure: Percent change from baseline in total cholesterol at 1 month of intervention., secondaryOutcomes measure: Absolute change from baseline in total cholesterol at 1 month of intervention., secondaryOutcomes measure: Percent change from baseline in total cholesterol at 3 months of intervention., secondaryOutcomes measure: Absolute change from baseline in total cholesterol at 3 months of intervention., secondaryOutcomes measure: Percent change from baseline in total cholesterol at 6 months of intervention., secondaryOutcomes measure: Absolute change from baseline in total cholesterol at 6 months of intervention., secondaryOutcomes measure: Percent change from baseline in HDL cholesterol at 1 month of intervention., secondaryOutcomes measure: Absolute change from baseline in HDL cholesterol at 1 month of intervention., secondaryOutcomes measure: Percent change from baseline in HDL cholesterol at 3 months of intervention., secondaryOutcomes measure: Absolute change from baseline in HDL cholesterol at 3 months of intervention., secondaryOutcomes measure: Percent change from baseline in HDL cholesterol at 6 months of intervention., secondaryOutcomes measure: Absolute change from baseline in HDL cholesterol at 6 months of intervention., secondaryOutcomes measure: Percent change from baseline in non-HDL cholesterol at 1 month of intervention., secondaryOutcomes measure: Absolute change from baseline in non-HDL cholesterol at 1 month of intervention., secondaryOutcomes measure: Percent change from baseline in non-HDL cholesterol at 3 months of intervention., secondaryOutcomes measure: Absolute change from baseline in non-HDL cholesterol at 3 months of intervention., secondaryOutcomes measure: Percent change from baseline in non-HDL cholesterol at 6 months of intervention., secondaryOutcomes measure: Absolute change from baseline in non-HDL cholesterol at 6 months of intervention., secondaryOutcomes measure: Percent change from baseline in small and dense LDL at 1 month of intervention., secondaryOutcomes measure: Absolute change from baseline in small and dense LDL at 1 month of intervention., secondaryOutcomes measure: Percent change from baseline in small and dense LDL at 3 months of intervention., secondaryOutcomes measure: Absolute change from baseline in small and dense LDL at 3 months of intervention., secondaryOutcomes measure: Percent change from baseline in small and dense LDL at 6 months of intervention., secondaryOutcomes measure: Absolute change from baseline in small and dense LDL at 6 months of intervention., secondaryOutcomes measure: Percent change from baseline in apolipoprotein B at 1 month of intervention., secondaryOutcomes measure: Absolute change from baseline in apolipoprotein B at 1 month of intervention., secondaryOutcomes measure: Percent change from baseline in apolipoprotein B at 3 months of intervention., secondaryOutcomes measure: Absolute change from baseline in apolipoprotein B at 3 months of intervention., secondaryOutcomes measure: Percent change from baseline in apolipoprotein B at 6 months of intervention., secondaryOutcomes measure: Absolute change from baseline in apolipoprotein B at 6 months of intervention., secondaryOutcomes measure: Percent change from baseline in TNF-alpha at 1 month of intervention., secondaryOutcomes measure: Absolute change from baseline in TNF-alpha at 1 month of intervention., secondaryOutcomes measure: Percent change from baseline in TNF-alpha at 3 months of intervention., secondaryOutcomes measure: Absolute change from baseline in TNF-alpha at 3 months of intervention., secondaryOutcomes measure: Percent change from baseline in TNF-alpha at 6 months of intervention., secondaryOutcomes measure: Absolute change from baseline in TNF-alpha at 6 months of intervention., secondaryOutcomes measure: Adverse Event (AE) Frequency, secondaryOutcomes measure: Severe Adverse Event (SAE) Frequency, secondaryOutcomes measure: Device deficiency rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhujiang Hospital of Southern Medical University, status: RECRUITING, city: Guangzhou, state: Guangdong, country: China, contacts name: Sun Jia, role: CONTACT, phone: 13751822925, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
|
protocolSection identificationModule nctId: NCT06301438, orgStudyIdInfo id: LY2024-022-A, briefTitle: Dalpiciclib in HR+/HER2- ABC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2028-12, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: RenJi Hospital, class: OTHER, descriptionModule briefSummary: To evaluate the efficacy and safety of dalpiciclib in patients with HR-positive/HER2-positive advanced breast cancer., conditionsModule conditions: Advanced Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 103, type: ESTIMATED, armsInterventionsModule interventions name: dalpiciclib, outcomesModule primaryOutcomes measure: Progression-Free Survival, secondaryOutcomes measure: Adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Renji Hospital, School of Medicine, Shanghai Jiaotong University, city: Shanghai, zip: 200127, country: China, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
|
protocolSection identificationModule nctId: NCT06301425, orgStudyIdInfo id: TROPHY-AML01, briefTitle: MRD Response-adapted Allo-HSCT for Adverse-risk AML, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2028-05-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Peking University People's Hospital, class: OTHER, collaborators name: Ruijin Hospital, collaborators name: Wuhan TongJi Hospital, collaborators name: Anhui Provincial Hospital, descriptionModule briefSummary: This TROPHY-AML01 regimen aims to identify the effectiveness and safety of MRD response-adapted allo-HSCT for adverse-risk acute myeloid leukemia in an open-label, randomized, controlled trial., conditionsModule conditions: Acute Myeloid Leukemia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 178, type: ESTIMATED, armsInterventionsModule interventions name: Intervention group, interventions name: Control group, outcomesModule primaryOutcomes measure: Event-free survival (EFS), secondaryOutcomes measure: Relapse, secondaryOutcomes measure: Leukemia-free survival (LFS), secondaryOutcomes measure: Non-relapse mortality (NRM), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Acute graft-versus-host disease (aGvHD), secondaryOutcomes measure: Chronic graft-versus-host disease (cGvHD), eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 65 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06301412, orgStudyIdInfo id: COTTIS-2_Version4.0-13Nov23, briefTitle: Combination of Hypothermia and Thrombectomy in Acute Stroke, acronym: COTTIS-2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2026-03-18, completionDateStruct date: 2026-06-18, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: University of Freiburg, class: OTHER, collaborators name: European Union, collaborators name: E+E CRO consulting, Vienna, Austria, collaborators name: Center for Medical data science, University of Vienna, Austria, descriptionModule briefSummary: The goal of this clinical trial is to test the combination of hypothermia and endovascular treatment in acute stroke patients with large vessel occlusion.The main question it aims to answer is: does an additional cooling to 35°C result in a benefit on clinical outcome ? Participants receive immediate cooling using a noninvasive transnasal cooling technique (RhonoChill) and are maintained at 35°C for 6 hours after reopening of the vessel using surface cooling, and then slowly rewarmed.Researchers will compare the intervention group (hypothermia and endovascular treatment and best medical treatment including iv thrombolysis) and control group (only endovascular treatment and best medical treatment including iv thrombolysis) to see if additional hypothermia leads to a better outcome after 3 months without relevant complications., conditionsModule conditions: Ischemic Stroke, conditions: Large Vessel Occlusion, conditions: Endovascular Treatment, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: hypothermia, outcomesModule primaryOutcomes measure: functional outcome, secondaryOutcomes measure: infarction volume, secondaryOutcomes measure: increase in infarction, secondaryOutcomes measure: recanalization result, secondaryOutcomes measure: neurological improvement, secondaryOutcomes measure: outcome at discharge, secondaryOutcomes measure: shift in functional outcome, secondaryOutcomes measure: very good clinical outcome, secondaryOutcomes measure: mortality, secondaryOutcomes measure: Length of ventilation, secondaryOutcomes measure: Length of stay, secondaryOutcomes measure: body temperature, secondaryOutcomes measure: time to groin puncture, secondaryOutcomes measure: time to recanalization, otherOutcomes measure: Occurrence of intracerebral haemorrhage (ICH), otherOutcomes measure: Complications associated with hypothermia, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06301399, orgStudyIdInfo id: Rituximab01, briefTitle: Rituximab Combined With Prior Therapy in Advanced Hepatocellular Carcinoma: Efficacy & Safety Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Tianjin Medical University Cancer Institute and Hospital, class: OTHER, descriptionModule briefSummary: Evaluation of the efficacy and safety of adding rituximab after failure of target immunotherapy in the Posterior treatment of advanced hepatocellular carcinoma, conditionsModule conditions: Advanced Hepatocellular Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Rituximab+PD-1 or PD-L1 inhibitors+targeted therapy, outcomesModule primaryOutcomes measure: ORR, secondaryOutcomes measure: PFS, secondaryOutcomes measure: OS, secondaryOutcomes measure: DoR, secondaryOutcomes measure: DCR, eligibilityModule sex: ALL, minimumAge: 17 Years, maximumAge: 79 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tianjin Medical University Cancer Institute & Hospital, city: Tianjin, state: Tianjin, zip: 300060, country: China, geoPoint lat: 39.14222, lon: 117.17667, hasResults: False
|
protocolSection identificationModule nctId: NCT06301386, orgStudyIdInfo id: EVOLUTION, briefTitle: Everolimus Combined With PD-1 in Advanced Colorectal Cancer Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-05-01, completionDateStruct date: 2026-12-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Fudan University, class: OTHER, collaborators name: Anyang Tumor Hospital, descriptionModule briefSummary: The goal of this clinical trial is to learn about efficacy of Everolimus in combination with PD-1 in patients with locally advanced and advanced colorectal cancer that cannot be R0 resected. The main question is to explore the survival time, safety and tolerability of the treatment. At the same time, the correlation between biomarkers (including PD-L1 expression, tumor mutation load, lymphocyte subpopulation, cytokines, TCR, intestinal microbes, and others) and the efficacy and drug resistance mechanism will be analyzed, so as to provide reference for the subsequent guidance of the screening of benefit groups., conditionsModule conditions: Colon Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Everolimus, interventions name: PD-1, outcomesModule primaryOutcomes measure: objective response rate (ORR), secondaryOutcomes measure: progression-free survival (PFS）, secondaryOutcomes measure: overall survival (OS), secondaryOutcomes measure: disease control rate (DCRs), secondaryOutcomes measure: advert events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anyang Tumor Hospital, city: Anyang, state: Henan, country: China, contacts name: Yanjun Wang, PhD, role: CONTACT, phone: +8613837266702, email: m13837266702@163.com, geoPoint lat: 36.096, lon: 114.38278, locations facility: Fudan University Shanghai Cancer Center, city: Shanghai, state: Shanghai, country: China, contacts name: Dawei Li, PhD, role: CONTACT, phone: +8613774201693, email: li_dawei@fudan.edu.cn, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
|
protocolSection identificationModule nctId: NCT06301373, orgStudyIdInfo id: SYSKY-2023-1185-02, briefTitle: Methotrexate Combined With Tofacitinib in Rheumatoid Arthritis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2030-04-01, completionDateStruct date: 2030-04-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, class: OTHER, descriptionModule briefSummary: Rheumatoid arthritis (RA) is the leading cause of disability in Chinese women. We established a synovial pathology queue in the early stage and proposed a new synovial immunopathology classification. We found that baseline myeloid stromal RA patients had severe conditions and poor outcome. Early identification of synovial myeloid stromal RA patients and intensified treatment are key to improving RA efficacy.This project aims to conduct a randomized, controlled, open label, multicenter clinical study on early intensified treatment of RA based on synovial pathology classification. 130 adult patients with synovial myeloid stromal type of primary treatment moderate to severe active RA were planned to be enrolled in three centers: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University; Shenshan Medical Center, Memorial Hospital of Sun Yat-Sen University, and Guangzhou Panyu Central Hospital. They were randomly divided into an intensive treatment group and a conventional treatment group in a 1:1 ratio. The intensive treatment group was treated with methotrexate combined with tofacitinib, while the conventional treatment group was treated with methotrexate monotherapy. The expected intervention period is 12 weeks, with a follow-up period of 48 weeks. The primary endpoint is the proportion of subjects who achieved ACR20 at week 12. Secondary endpoint indicators include improvement in disease activity and joint function among subjects at different follow-up points, safety, and the proportion of subjects who experienced joint destruction progression at week 48.This project proposes the concept of achieving precise diagnosis of RA based on synovial pathology classification, and explores the efficacy of early methotrexate combined with tofacitinib intensified treatment for patients with synovial medullary stromal RA who have poor conventional treatment efficacy, providing high-level clinical evidence for achieving precise initial treatment of RA treatment guidelines., conditionsModule conditions: Rheumatoid Arthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: Methotrexate Combined With Tofacitinib, interventions name: Methotrexate, outcomesModule primaryOutcomes measure: The proportion of subjects who achieved ACR20, secondaryOutcomes measure: Changes in disease activity scores (DAS28-CRP) relative to baseline, secondaryOutcomes measure: Changes in disease activity scores (DAS28-ESR) relative to baseline, secondaryOutcomes measure: Changes in disease activity scores (SDAI) relative to baseline, secondaryOutcomes measure: Changes in disease activity scores (CDAI) relative to baseline, secondaryOutcomes measure: Proportion of subjects with low disease activity and remission (SDAI standard) at weeks 4, 8, 12, 24, 36, and 48 after treatment, secondaryOutcomes measure: The proportion of subjects who met ACR50 criteria at weeks 4, 8, 12, 24, 36, and 48 after treatment, secondaryOutcomes measure: The proportion of subjects who met ACR70 criteria at weeks 4, 8, 12, 24, 36, and 48 after treatment, secondaryOutcomes measure: Changes in the Disability Index (HAQ-DI) of the Health Assessment Questionnaire relative to baseline, secondaryOutcomes measure: Changes in EQ-5D-5L relative to baseline, secondaryOutcomes measure: The proportion of subjects with joint destruction progression at 48 weeks after treatment, otherOutcomes measure: The proportion of adverse events (AE) in subjects at 4, 8, 12, 24, 36, and 48 weeks after treatment, otherOutcomes measure: The proportion of severe adverse events (SAE) in subjects at 4, 8, 12, 24, 36, and 48 weeks after treatment, otherOutcomes measure: Changes in serum MMP-3 levels relative to baseline, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06301360, orgStudyIdInfo id: KOSMOS2 2023-04956-01, briefTitle: Internet Based Emotional Awareness and Expression Therapy for Functional Somatic Disorder With and Without Therapist Support, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Daniel Maroti, class: OTHER, collaborators name: Wayne State University, descriptionModule briefSummary: Functional somatic syndromes (e.g. irritable bowel syndrome, fibromyalgia) and medically unexplained symptoms (e.g. chronic primary pain) are very common in primary care. These patients make 14 times more doctor visits than the general population, but describe themselves as less satisfied with the care they receive. Although Region Stockholm in Sweden recently developed care flows based on 'step up' care for the most common patient groups in primary care, patients with functional or medically unexplained symptoms are not mentioned.Short-term psychodynamic therapies such as Emotional Awareness and Expression Therapy (EAET) and Intensive Short Term Psychodynamic Therapy (ISTDP) have recently been evaluated in three systematic reviews and show good results for patients with medically unexplained symptoms. Short-term psychodynamic therapy considers that good treatment outcomes for patients with functional somatic syndromes can be achieved by increasing awareness of emotions and teaching patients to better experience, express and regulate emotions. In several randomized studies, short-term psychodynamic therapy has shown good effects even compared to other treatments, including cognitive behavioral therapy (CBT).The overall purpose of this research project is to to evaluate psychodynamic emotion-focused interventions (EAET and ISTDP) for patients with medically unexplained symptoms/functional somatic symptoms (MUS/FSD). The project includes several studies that will clarify effects and contribute to information on how care flows in primary care for the patient group can be created.The research question for this specific study is:Is internet-based Emotional Awareness and Expression Therapy (I-EAET) with therapist more effective than without therapist support for patients with FSD?, conditionsModule conditions: Functional Somatic Disorder, conditions: Somatic Symptom Disorder, conditions: Functional Somatic Syndromes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: RCT with two treatment arms, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Internet based Emotional Awareness and Expression Therapy (I-EAET), outcomesModule primaryOutcomes measure: Patient Health Questionnaire -15 (PHQ-15), primaryOutcomes measure: Numeric Rating Scales according to EURONET-SOMA, secondaryOutcomes measure: Generalized Anxiety Disorder-7 (GAD-7), secondaryOutcomes measure: Patient Health Questionnaire-9 (PHQ-9), secondaryOutcomes measure: Post traumatic stress disorder checklist-5 (PCL-5), secondaryOutcomes measure: Difficulties in Emotion Regulation Scale-16 (DERS-16), secondaryOutcomes measure: Sheehan Disability Scale (SDS), secondaryOutcomes measure: The revised illness perception questionnaire (IPQ-R), otherOutcomes measure: Mediational measure: DERS-16, otherOutcomes measure: Mediational measure: PHQ-15, otherOutcomes measure: Mediational measure: PHQ-4, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Stockholm University, status: RECRUITING, city: Stockholm, zip: 10691, country: Sweden, contacts name: Daniel Maroti, Med Dr, role: CONTACT, phone: +46738028474, email: daniel.maroti@su.se, geoPoint lat: 59.33258, lon: 18.0649, locations facility: Stockholm University, status: RECRUITING, city: Stockholm, zip: 11419, country: Sweden, contacts name: Daniel Maroti, role: CONTACT, phone: 0738028474, email: daniel.maroti@su.se, geoPoint lat: 59.33258, lon: 18.0649, hasResults: False
|
protocolSection identificationModule nctId: NCT06301347, orgStudyIdInfo id: LTP+P, briefTitle: Learning Through Play Plus for Psychosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-12-30, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Pakistan Institute of Living and Learning, class: OTHER, descriptionModule briefSummary: Evidence reports that parents with schizophrenia are particularly vulnerable to parenting difficulties and also experience problems in sensitively interacting with their children. This may cause insecure attachment in infants of mothers with psychosis. Children of parents with schizophrenia have poor developmental and clinical outcomes. However, there is no published trial, to the best of our knowledge, for children of parents with schizophrenia. Learning through Play (LTP) is a potentially low cost intervention to improve maternal mental health and child outcomes by promoting health child development. The proposed study will integrate LTP with existing culturally appropriate Cognitive Behaviour Theray (CBT) for psychosis (CaCBT-p) and test its feasibility and acceptability for parents with schizophrenia., conditionsModule conditions: Psychosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomized into one of the two treatment conditions (LTP Plus or TAU) through computer generated algorithm., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Learning through Play Plus, outcomesModule primaryOutcomes measure: Recruitment Rate, primaryOutcomes measure: Attrition Rate, primaryOutcomes measure: Intervention attendance log, secondaryOutcomes measure: Positive and Negative Syndrome Scale, secondaryOutcomes measure: Psychotic Rating Scale, secondaryOutcomes measure: Parenting Stress Index, secondaryOutcomes measure: Maternal Attachment Inventory, secondaryOutcomes measure: Knowledge attitude and practices of Child Development, secondaryOutcomes measure: Calgary Depression Scale, secondaryOutcomes measure: Social and Occupational Functioning Scale, secondaryOutcomes measure: Euro-Qol 5 Dimensions, secondaryOutcomes measure: Client Service Receipt Inventory, secondaryOutcomes measure: Ages and Stages Questionnaire, secondaryOutcomes measure: Manchester Assessment of Caregiver-Infant Interaction, secondaryOutcomes measure: Bayley Scale of infant development, secondaryOutcomes measure: Child Height, secondaryOutcomes measure: Child Weight, secondaryOutcomes measure: Child head circumference, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06301334, orgStudyIdInfo id: Soh-Med-24-01-11MS, briefTitle: Block and Erector Comparative Study Between Costotransverse Spinae Plane Block in Patients Undergoing Thoracotomy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-08-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: A thoracotomy requires a very painful incision, involving multiple muscle layers, rib resection and continuous motion as the patient breathes. Treatment of acute post thoracotomy pain is particularly important not only to keep the patient comfortable but also to minimize pulmonary complicationsThough epidural analgesia was once considered as the gold standard for post-thoracotomy pain management, it is not recommended for pain control after thoracotomy surgery because it is associated with high potential risks of dural puncture, nerve lesions, epidural hematoma and hypotension(4). Thoracic paravertebral block (TPVB) and intercostal nerve block are well described and recognized techniques for postoperative analgesia following thoracic surgeries, such as thoracotomy and mastectomy, conditionsModule conditions: Pain Mangement of Thoracotomy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Bupivacaine 0.25% Injectable Solution, outcomesModule primaryOutcomes measure: study aims to compare the analgesic efficacy of CTB and ESPB for post-operative analgesia in patients undergoing thoracotomy., secondaryOutcomes measure: The secondary outcome is the total postoperative morphine consumption, time of first analgesic,, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06301321, orgStudyIdInfo id: 461_2566, briefTitle: The Evaluation and Comparison of BCR-ABL p210 mRNA Transcripts (%IS Unit) Results Between Dr. PCR™ BCR-ABL1 Major IS Detection Kit (Optolane) and QXDx™ BCR-ABL %IS Kit (Bio-Rad) in Chronic Myeloid Leukemia Patients, acronym: BCR-ABL1, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-03-30, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Siriraj Hospital, class: OTHER, descriptionModule briefSummary: Today, there are many commercial kits for detecting BCR-ABL fusion transcripts. The QXDx™ BCR-ABL %IS kit (Bio-Rad, Hercules, CA, USA) is the first ddPCR-based in vitro diagnostics (IVD) product with the US Food and Drug Administration clearance and European Conformity (CE) mark which launched in 2017. Dr. PCR™ BCR-ABL1 Major IS Detection Kit (Optolane, South Korea) is one of CE-IVD commercial kits based on digital RT-PCR. Both commercial kits are digital PCR-based, also evaluated their correlation, pros and cons in order for users to select a reagents kit that are appropriate for themselves., conditionsModule conditions: Chronic Myelogenous Leukemia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, outcomesModule primaryOutcomes measure: Sensitivity, primaryOutcomes measure: Specificity, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Siriraj hospital, status: RECRUITING, city: Bangkok, zip: 10700, country: Thailand, contacts name: weerapat Owattanapanich, MD, role: CONTACT, phone: 0891081963, email: weerapato36733@gmail.com, contacts name: Wananchi Saisaard, MT, role: CONTACT, phone: 0817141717, email: wern.si12@gmail.com, contacts name: weerapat Owattanapanich, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 13.75398, lon: 100.50144, hasResults: False
|
protocolSection identificationModule nctId: NCT06301308, orgStudyIdInfo id: 2022021, briefTitle: A Novel Application of 2% Lidocaine Injection for Male Rigid cycstoscopy-a Patient-blinded Randomised Trial, statusModule overallStatus: WITHDRAWN, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2024-02-29, completionDateStruct date: 2024-02-29, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Second Xiangya Hospital of Central South University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to learn about a novel application of lidocaine injection in male patients who needs rigid cycstoscopy test. The main question it aims to answer is:Does New Application of Lidocaine Liquid Provide Pain Relief for Patients During Cystoscopy? Before the cycstoscopy,Participants will be randomly divided into three different anesthesia mode groups,namely are Group A (intraurethral lidocaine gel alone), Group B (intraurethral lidocaine gel + lidocaine 2% injection), and Group C (intraurethral lidocaine gel + liquid paraffinl).Patients only need to prepare and cooperate according to routine surgical operations，which is group B or group C., conditionsModule conditions: Bladder Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 0, type: ACTUAL, armsInterventionsModule interventions name: Intraurethral lidocaine gel alone, interventions name: Intraurethral lidocaine gel + lidocaine 2% injection, interventions name: intraurethral lidocaine gel + liquid paraffinl, outcomesModule primaryOutcomes measure: Access the pain score using the Visual Analogue Scale (VAS), secondaryOutcomes measure: Postoperative complications, eligibilityModule sex: MALE, maximumAge: 50 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: The second xiangya hospital, city: Changsha, state: Hunan, zip: 410000, country: China, geoPoint lat: 28.19874, lon: 112.97087, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP_ICF, hasProtocol: True, hasSap: True, hasIcf: True, label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form, date: 2024-01-01, uploadDate: 2024-03-03T08:40, filename: Prot_SAP_ICF_000.pdf, size: 387410, hasResults: False
|
protocolSection identificationModule nctId: NCT06301295, orgStudyIdInfo id: 2402-017-136, briefTitle: Feasibility of Targeted Bronchial Washing Fluid for Molecular Testing With Next Generation Sequencing in Patients Suspicious of Early-stage Lung Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Pusan National University Hospital, class: OTHER, descriptionModule briefSummary: This is a single center, clinical trial evaluating the relevance of intratumoral washing for detection of generic alteration with Next Generation Sequencing., conditionsModule conditions: Lung Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Ultarthin bronchoscopy with intratumoral washing, outcomesModule primaryOutcomes measure: Genetic alteration with Next Generation Sequencing detection rate in intratumoral washing fluid, secondaryOutcomes measure: Concordance rate of genetic alteration with Next Generation Sequencing detection rate among intratumoral washing fluid, plasma, and tissue, secondaryOutcomes measure: Turn-around time, secondaryOutcomes measure: Genetic alteration with Next Generation Sequencing sensitivity & specificity in intratumoral washing fluid, eligibilityModule sex: ALL, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06301282, orgStudyIdInfo id: 2021-02341, briefTitle: Electroencephalographic Signatures of Neuropsychiatric Fluctuations in Parkinson's Disease, acronym: Transition, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-03, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: University Hospital, Geneva, class: OTHER, descriptionModule briefSummary: Dopaminergic replacement therapy while efficient at reducing symptoms of Parkinson's disease is however often associated with motor and non-motor fluctuations which have a severe impact on patient quality of life. To date, the interplay between cortical activity linked to motor and non-motor symptoms and Parkinson's disease fluctuations linked to dopaminergic medication remain poorly understood.The aim of the study is to characterize the cortical electroencephalographic oscillatory correlates of Parkinson's disease motor and non-motor fluctuations and the temporal dynamics of their dopaminergic modulation.For this purpose, the investigators will apply an innovative approach using the differential non-linear temporal dynamics of motor and non-motor state during the transition from the dopaminergic withdrawal phase (i.e. OFF-levodopa state) to the dopaminergic effect phase (i.e. ON-levodopa state) following an acute levodopa administration.This research will allow to precisely disentangle the network dynamics subtending motor and non-motor symptoms of Parkinson's disease as well as precisely identify the electroencephalographic spectral modulations explaining the neuropsychiatric effects of levodopa. The identification of such biomarkers could pave the way toward innovative therapeutic approaches such as neurofeedback and transmagnetic stimulation., conditionsModule conditions: Parkinson Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: assessment during the transition between OFF-levodopa (i.e. withdrawal of levodopa phase) and ON-levodopa (i.e. effect of Levodopa phase)states, outcomesModule primaryOutcomes measure: Correlation of electroencephalographic resting-state oscillatory activity with neuropsychiatric clinical scores during the levodopa challenge, secondaryOutcomes measure: Correlation of electroencephalographic resting-state oscillatory activity with motor scores during the levodopa challenge, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital, Geneva, status: RECRUITING, city: Geneva, zip: 1204, country: Switzerland, contacts name: Vanessa Fleury, MD, role: CONTACT, phone: +41223728337, email: Vanessa.FleuryNissen@hcuge.ch, geoPoint lat: 46.20222, lon: 6.14569, hasResults: False
|
protocolSection identificationModule nctId: NCT06301269, orgStudyIdInfo id: 202312124RINA, briefTitle: A Study on Self-Compassion,Depression,and Quality of Life Among Primary Caregivers of People With Dementia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-10, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: National Taiwan University Hospital, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to investigate the correlation between self-compassion, depression, and quality of life among primary caregivers of persons with dementia.The main questions it aims to answer are:1. What is the current status of self-compassion, depression, and quality of life among primary caregivers of persons with dementia?2. Are there differences in self-compassion, depression, and quality of life among primary caregivers of persons with dementia based on different background variables?3. What is the correlation between self-compassion, depression, and quality of life among primary caregivers of persons with dementia?Participants will fill out the questionnaire to complete the study., conditionsModule conditions: Dementia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: FAMILY_BASED, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions, outcomesModule primaryOutcomes measure: Self-Compassion Scale, primaryOutcomes measure: PHQ-9 Scale, primaryOutcomes measure: Quality-of-Life Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Taiwan University Hospital, status: RECRUITING, city: Taipei, zip: 100, country: Taiwan, contacts name: wen lin YE, role: CONTACT, phone: +886-2312-3456, email: vovo951357@ntuh.gov.tw, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False
|
protocolSection identificationModule nctId: NCT06301256, orgStudyIdInfo id: I8F-NS-I002, briefTitle: Evaluate the Efficacy of TIRZEPATIDE for the Treatment of Moderate to Severe HS Hidradenitis Suppurativa, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2025-03-11, completionDateStruct date: 2025-03-11, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Florida Academic Centers Research and Education, LLC, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to determine the clinical efficacy and safety of tirzepatide in subjects with moderate to severe hidradenitis suppurativa. The study will be conducted over 24 weeks on active therapy followed by a eight-week observational follow-up visit. The total length of the study will be 32 weeks ., conditionsModule conditions: Hidradenitis Suppurativa, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: TIRZEPATIDE, outcomesModule primaryOutcomes measure: Hidradenitis Suppurativa Clinical Response (HiSCR) 50%, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06301243, orgStudyIdInfo id: FY24-62, briefTitle: Molecular Signature of Inactivity Induced Exercise Responsiveness, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Concordia University Wisconsin, class: OTHER, descriptionModule briefSummary: Fitness is one of the best predictors for heart and brain disease. To increase ones fitness, the American Heart Association (AHA) says to exercise at least 150 minutes per week or 75 minutes per week if really hard. These exercise guides are pretty effective, however not everyone will get the same results. What individuals do outside of the exercise bout can influence the effectiveness of exercise. One of these factors is our time sitting, which has caused the phrase "sitting is the new smoking". Other studies have said that the metabolic benefits of exercise are decreased when you exercise after a few days of low activity (less than 5,000 steps per day). This is important in that exercise may not be able to fully offset these times of inactivity. However, these studies were only looking at different fats in the blood. As exercise increases fat burn up to 10 times in the muscle, more research is needed to understand how inactivity affects the muscle during exercise and after exercise. This study will help answer two questions: 1) How does a day of sitting a lot affect the muscle's ability to respond to exercise? and 2) How does a day of sitting a lot affect carbohydrate and fat burn during and after a bout of exercise? The investigators will answer these questions by having people complete one day of inactivity (less than 5,000 steps) or normal activity (more than 8,500 steps). Subjects will then come in the next day to bike somewhat hard for 1 hour. The investigators will take blood samples before, during, and after exercise to measure energy sources. The investigators will also collect pieces of skeletal muscle before and after exercise to see how the muscle responded to exercise. This study is significant for the publication of exercise guidelines to minimize risk of heart and metabolic diseases., conditionsModule conditions: Metabolic Diseases, conditions: Aerobic Exercise, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Inactivity, outcomesModule primaryOutcomes measure: Circulating lipid and carbohydrate metabolism, primaryOutcomes measure: Basal and post-exercise gene expression with inactivity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Kevin J Gries, status: RECRUITING, city: Mequon, state: Wisconsin, zip: 53092, country: United States, contacts name: Kevin J Gries, PhD, role: CONTACT, phone: 262-243-4293, email: kevin.gries@cuw.edu, geoPoint lat: 43.21573, lon: -88.02962, hasResults: False
|
protocolSection identificationModule nctId: NCT06301230, orgStudyIdInfo id: PLET-2022, briefTitle: Home- vs. Hospital-based Surgical Training, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-09-01, primaryCompletionDateStruct date: 2021-12-31, completionDateStruct date: 2021-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Clarunis - Universitäres Bauchzentrum Basel, class: OTHER, collaborators name: University of Basel, descriptionModule briefSummary: The purpose of this study was to assess the effect of training with a personal, portable laparoscopic endo-trainer (PLET) on residents' laparoscopic skills. All participants were randomised to either a home- or hospital-based PLET training group and surgical skill performance was assessed using five laparoscopic exercises. Endpoints consisted ofsubjective and objective assessment ratings as well as exercise time and qualitative data up to 12 weeks. The primary outcome was the difference in exercise time and secondary outcomes included performance scores as well as qualitative data., conditionsModule conditions: Surgical Training, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ACTUAL, armsInterventionsModule interventions name: Portable Laparoscopic Trainer (PLET), outcomesModule primaryOutcomes measure: Exercise time, primaryOutcomes measure: Assessment rating, secondaryOutcomes measure: Qualitative feedback, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clarunis Universitäres Bauchzentrum Basel, city: Basel, zip: 4002, country: Switzerland, geoPoint lat: 47.55839, lon: 7.57327, hasResults: False
|
protocolSection identificationModule nctId: NCT06301217, orgStudyIdInfo id: NO: PT. BU. EC. 7, briefTitle: Are Axioscapular Muscles Activity and Cervical Curvature Associated With Disability in Neck Pain, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-12-17, primaryCompletionDateStruct date: 2024-03-10, completionDateStruct date: 2024-03-20, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Delta University for Science and Technology, class: OTHER, descriptionModule briefSummary: Despite the important role of axioscapular muscles electromyography and cervical posture as outcomes for the management of chronic neck non specific pain, there is gab of evidence that highlight their association to the commonly used neck disability index. The quest to improve outcomes for individuals suffering from chronic nonspecific neck pain is underscored by the need to identify key prognostic variables that can guide clinical decision-making and intervention strategies. This study seeks to bridge the gap in research by examining the association between neck disability index score, cervical sagittal curvature, and axioscapular muscles electromyography in forms of both trapezius and levator scapula root mean squares to indicate muscular activities and median frequencies to indicate muscular fatigue., conditionsModule conditions: Neck Pain, conditions: Electromyohgraph, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: There is no intervention, outcomesModule primaryOutcomes measure: Neck disability, primaryOutcomes measure: Curvature angle of the cervical spine, primaryOutcomes measure: root-mean-square value (RMS) of Surface electromyography for both upper trapezius and levator scapula, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Delta university for science and technology, city: Gamasa, state: Dakahleya, zip: 7731168, country: Egypt, geoPoint lat: 31.44112, lon: 31.53675, hasResults: False
|
protocolSection identificationModule nctId: NCT06301204, orgStudyIdInfo id: 21.06.2022-E.67046, briefTitle: Effectiveness Of Tranexamic Acıd Application Wıth Different Doses On Bleeding, Edema And Physician Comfort In Orthognathıc Surgery Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-03-01, primaryCompletionDateStruct date: 2023-11-01, completionDateStruct date: 2023-11-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Bezmialem Vakif University, class: OTHER, descriptionModule briefSummary: The aim of this clinical study conducted in accordance with the information in the literature is to compare the effects of administering tranexamic acid during orthognathic surgery, at different doses. Specifically, investigators aim to compare the effects of administering 1 ampoule IV (approximately 3 mg/kg) and 2 ampoules IV (approximately 6 mg/kg), and evaluate their impact on intraoperative bleeding (ml), surgical duration (min), postoperative swelling, and intraoperative surgical field evaluation (Fromme Scale), by comparing them with control group (applying no drug administration) patient data., conditionsModule conditions: Tranexamic Acid, conditions: Orthognathic Surgery, conditions: Edema, conditions: Bleeding, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Tranexamic acid injection, interventions name: Saline, outcomesModule primaryOutcomes measure: intraoperative bleeding during the surgery (ml), secondaryOutcomes measure: postoperative edema calculation for the first 1-3 and 7 day (cm), secondaryOutcomes measure: intraoperative surgical site evaluation (Fromme Scale), secondaryOutcomes measure: Hemoglobin (Hgb) and Hematocrit (Hct) values alteration preoperative and postoperative 2. day, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bezmialem Vakıf Universty, city: Istanbul, state: Fatih, zip: 34093, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
|
protocolSection identificationModule nctId: NCT06301191, orgStudyIdInfo id: 133/21-02-2022, briefTitle: The Effect of Semaglutide on Cardiovascular Markers and Liver Function, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-03-01, primaryCompletionDateStruct date: 2023-03-01, completionDateStruct date: 2024-05-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Attikon Hospital, class: OTHER, descriptionModule briefSummary: Fifty patients with diabetes mellitus type 2 and non-alcoholic fatty liver disease (NAFLD) will be enrolled in the study.25 patients will treated with semaglutide and 25 patients with dipeptidyl peptidase 4 (D-PP4) inhibitors.At baseline, at four and at 12 months will evaluate the endothelial, cardiovascular and liver function., conditionsModule conditions: Diabetes Type 2, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Semaglutide, 1.0 mg/mL, interventions name: Dipeptidyl Peptidase 4 inhibitor, outcomesModule primaryOutcomes measure: Comparison of arterial stiffness markers difference among treatment groups, primaryOutcomes measure: Comparison of endothelial glycocalyx thickness difference among treatment groups, primaryOutcomes measure: Comparison of liver stiffness difference among treatment groups, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Attikon University General Hospital, status: RECRUITING, city: Athens, zip: 12462, country: Greece, contacts name: Vaia Lambadiari, Professor, role: CONTACT, phone: 2105831148, email: vlambad@otenet.gr, geoPoint lat: 37.97945, lon: 23.71622, hasResults: False
|
protocolSection identificationModule nctId: NCT06301178, orgStudyIdInfo id: 12548, briefTitle: Effect of Vitamin D Injection on Hypertrophic Scars and Keloids, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-27, primaryCompletionDateStruct date: 2025-02-20, completionDateStruct date: 2026-02-20, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Mostafa Bahaa, class: OTHER, descriptionModule briefSummary: Scars and keloids cause patients severe morbidity and psychological distress. Hypertrophic scars rise above the skin but stay within the scar boundaries, while keloids expand.The development of keloids and hypertrophic scars is a consequence of insufficient wound healing. These lesions are distinguished by excessive ECM deposition. Excessive ECM deposition is caused by increased inflammatory and proliferative processes and decreased remodeling activities. These scarring lesions are also linked to genetic and systemic causes, conditionsModule conditions: Dermatologic Disease, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: Cholecalciferol, outcomesModule primaryOutcomes measure: Clinical scoring by Vancouver Scale Score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: faculty of medicine-Fayoum university, status: RECRUITING, city: Fayoum, zip: 63519, country: Egypt, contacts name: Marwa Kamal, PhD, role: CONTACT, phone: 01021365897, email: mka05@fayou.edu.eg, geoPoint lat: 29.30995, lon: 30.8418, hasResults: False
|
protocolSection identificationModule nctId: NCT06301165, orgStudyIdInfo id: 2023-FXY-129, briefTitle: TPC Versus GP Induction Chemotherapy for Nasopharyngeal Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-19, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: The NCCN guidelines recommend induction chemotherapy followed by concurrent chemoradiotherapy as the standard treatment for locoregionally advanced nasopharyngeal carcinoma (NPC). However, meta-analyses have shown significant survival differences between different induction chemotherapy regimens. How to choose an induction chemotherapy regimen and treatment course that ensures definitive therapeutic effects and low incidence of toxic side effects remains a hot spot in clinical research. Polymeric micellar paclitaxel are an innovative form of paclitaxel drugs, with high penetration and long retention effects, which can enter the vascularly disordered tumor microenvironment through passive targeting and form higher concentrations in tumor tissue. It remains to be investigated whether the TPC (paclitaxel, cisplatin and capecitabine) regimen based on polymeric micellar paclitaxel compared to the current standard first-line induction chemotherapy GP (gemcitabine, cisplatin) regimen can further improve therapeutic effects in high-risk patients with locally advanced disease. There is still a lack of head-to-head studies for comparison. This study aims to compare, through a prospective, parallel-controlled, randomized, open-label, multicenter phase II clinical trial, the TPC induction chemotherapy vs. the GP induction chemotherapy combined with concurrent chemoradiotherapy for the treatment of high-risk locoregionally advanced NPC (T4 or N2-3) in terms of 2-year progression-free survival, overall survival, overall response rate, toxic side effects, etc., conditionsModule conditions: Nasopharyngeal Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 162, type: ESTIMATED, armsInterventionsModule interventions name: TPC induction chemotherapy, interventions name: GP induction chemotherapy, outcomesModule primaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Distant progression, secondaryOutcomes measure: Locoregional progression, secondaryOutcomes measure: Short-term response rate, secondaryOutcomes measure: Incidence of acute and late toxicity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-sen University Cancer Center, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510060, country: China, contacts name: Hai-Qiang Mai, role: CONTACT, phone: 860-020-8734, phoneExt: 86-20-8734-364, email: maihq@sysucc.org.cn, contacts name: Hai-Qiang Mai, MD,PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, locations facility: Affiliated cancer hospital and institute of guangzhou medical university, status: NOT_YET_RECRUITING, city: Guangzhou, state: Please Select, zip: 510060, country: China, contacts name: Weijun Zhang, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: Sun Yat-Sen Memorial Hospital, status: NOT_YET_RECRUITING, city: Guangzhou, state: Please Select, zip: 510060, country: China, contacts name: Shoumin Bai, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: The First Affiliated Hospital of Guangzhou Medical University, status: NOT_YET_RECRUITING, city: Guangzhou, state: Please Select, zip: 510060, country: China, contacts name: Jiancong Sun, role: CONTACT, geoPoint lat: 23.11667, lon: 113.25, locations facility: Dongguan people's hospital, status: NOT_YET_RECRUITING, city: Dongguan, country: China, contacts name: Zhigang Liu, role: CONTACT, geoPoint lat: 23.01797, lon: 113.74866, locations facility: Foshan First People's Hospital, status: NOT_YET_RECRUITING, city: Foshan, country: China, contacts name: Ning Zhang, role: CONTACT, geoPoint lat: 23.02677, lon: 113.13148, locations facility: Peking university shenzhen hospital, status: NOT_YET_RECRUITING, city: Shenzhen, country: China, contacts name: Yajie Liu, MD, role: CONTACT, geoPoint lat: 22.54554, lon: 114.0683, locations facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, status: NOT_YET_RECRUITING, city: Wuhan, country: China, contacts name: Kunyu Yang, role: CONTACT, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False
|
protocolSection identificationModule nctId: NCT06301152, orgStudyIdInfo id: E2-22-1905, briefTitle: Lateral Epicondylitis Treatment High Intensive Laser Therapy and Extracorporeal Shock Wave Therapy, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-09-01, primaryCompletionDateStruct date: 2022-10-01, completionDateStruct date: 2023-05-30, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Ankara City Hospital Bilkent, class: OTHER, descriptionModule briefSummary: Objectives: This study aims to evaluate and compare the short-term efficacy of high-intensity laser therapy (HILT) and extra corporeal shock wave therapy(ESWT) on pain, sensitivity, handgrip strength, and functions in the treatment of lateral epicondylitis (LE).Material and methods: Forty five participants (age range, 18 to 65 years) with unilateral elbow pain were randomized into two groups. HILT group (n = 22) and the ESWT group (n = 23). The HILT and ESWT were administered three times a week for three weeks, and each treatment was combined with exercises. All patients in both groups were evaluated with ultrasonography for common extensor tendon(CET) thickness. A visual analog scale (VAS), Quick Disabilities of the Arm, Shoulder, and Hand (QDASH), and hand grip strength test were used to evaluate the patients before, one, and six weeks after treatment., conditionsModule conditions: Lateral Epicondylitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: two different treatment modalities were applied in two groups, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ACTUAL, armsInterventionsModule interventions name: high intensive laser, interventions name: extracorporeal shock wave therapy, outcomesModule primaryOutcomes measure: Visual analog scale, secondaryOutcomes measure: Quick Disability Arm, Shoulder and Hand questionary,, secondaryOutcomes measure: hand grip strength, secondaryOutcomes measure: musculoskeletal ultrasonography, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Emine Esra Bilir, city: Ankara, state: Çankaya, zip: 06800, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False
|
protocolSection identificationModule nctId: NCT06301139, orgStudyIdInfo id: P17-004, briefTitle: Goat Milk Infant Formula Comfort Study, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-05-01, primaryCompletionDateStruct date: 2021-04-01, completionDateStruct date: 2024-02-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Ausnutria Hyproca B.V., class: INDUSTRY, collaborators name: HM hospitales, descriptionModule briefSummary: In this study, the investigators aim to assess that infants with mild symptoms have significantly less (severe) symptoms after 14 days goat milk-based formula use compared to infants using cow's milk-based formula supplemented with probiotic drops., conditionsModule conditions: Gastrointestinal Diseases, conditions: Cow's Milk Intolerance, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized controlled pilot study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ACTUAL, armsInterventionsModule interventions name: Goat milk-based infant formula, interventions name: Cow's milk-based infant formula with probiotic drops, outcomesModule primaryOutcomes measure: Cow's Milk-related Symptoms, secondaryOutcomes measure: Cow's Milk-related Symptoms, secondaryOutcomes measure: Parental stress, secondaryOutcomes measure: Parental quality of life, secondaryOutcomes measure: Weight, secondaryOutcomes measure: Length, secondaryOutcomes measure: Weight-for-age, secondaryOutcomes measure: Length-for-age, secondaryOutcomes measure: Weight-for-length, eligibilityModule sex: ALL, minimumAge: 6 Weeks, maximumAge: 3 Months, stdAges: CHILD, contactsLocationsModule locations facility: HM hospitales, city: Madrid, zip: 28015, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False
|
protocolSection identificationModule nctId: NCT06301126, orgStudyIdInfo id: P.T.REC/012/004985, briefTitle: Virtual Reality on Pulmonary Function After Upper Abdominal Surgeries, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-02-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: After upper abdomen surgery, respiratory muscle dysfunction is well recognised. After laparotomy and even laparoscopy, maximum static inspiratory and expiratory pressures are lowered, and recovery can take several days. A variety of reasons have been implicated in such respiratory muscle dysfunction, including irritation and inflammation, as well as injuries near the diaphragm, resulting in local mechanical failure, reflex inhibition, and pain., conditionsModule conditions: Abdomen Hernia, conditions: Respiratory Complication, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Virtual reality, interventions name: conventional physical therapy exercise program, outcomesModule primaryOutcomes measure: Forced vital capacity (FVC), secondaryOutcomes measure: Forced expiratory volume in 1 second (FEV1), secondaryOutcomes measure: Peak expiratory flow (PEF), secondaryOutcomes measure: Respiratory muscle strength, secondaryOutcomes measure: diaphragmatic mobility, secondaryOutcomes measure: Functional capacity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Physical Therapy, status: RECRUITING, city: Giza, zip: 12111, country: Egypt, contacts name: Nesma M Allam, PhD, role: CONTACT, phone: +201281968332, email: dr.nesma2011@yahoo.com, geoPoint lat: 30.00808, lon: 31.21093, hasResults: False
|
protocolSection identificationModule nctId: NCT06301113, orgStudyIdInfo id: IRB#: 01202023_torabiDH_CBDloz, briefTitle: This Research Study Examines the Effects of Cannabidiol-infused Candy on Reducing the Bacteria Causing Tooth Decay, When Comparing it to a Sugar Free Candy on Adults., statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-27, primaryCompletionDateStruct date: 2023-02-11, completionDateStruct date: 2023-02-11, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: West Coast University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare the effect of CBD candy versus sugar free candy on reducing the number of bacteria causing tooth decay, in adults The main question is to see whether CBD have any effect on reducing the number of Streptococcus mutans, in the oral cavity the main bacteria causing tooth decay.Participants will be randomly placed in a group, and assigned to take either CBD-infused lozenge (if in the experimental group) or a sugar-free candy (if in the control group) once a day for 15 days.A sample of saliva will be collected and analyzed in a lab before and after consumption of the candy to see whether either product could reduce the harmful bacteria in the mouth., conditionsModule conditions: Tooth Decay, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 30 Participants were randomly assigned to groups A (experimental group)and B (Control group)., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: CBD infused candy, interventions name: Sugar free Candy, outcomesModule primaryOutcomes measure: To investigate the impact of CBD-infused lozenges on Streptococcus mutans, by employing quantitative polymerase chain reaction (qPCR) for bacterial analysis., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: West Coast University, city: Anaheim, state: California, zip: 92802, country: United States, geoPoint lat: 33.83529, lon: -117.9145, hasResults: False
|
protocolSection identificationModule nctId: NCT06301100, orgStudyIdInfo id: E20230371, briefTitle: Single-center, Prospective Study on the Identification and Delineation of Brain and Lung Tumors and At-Risk Organs, and Functional Testing of Surrounding Tissues Based on Dual-Energy CT, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-28, primaryCompletionDateStruct date: 2024-04-28, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Tianjin Medical University Cancer Institute and Hospital, class: OTHER, descriptionModule briefSummary: This study explored the feasibility of dual-energy CT in head and lung tumors. Dual-energy CT can achieve quantitative CT imaging based on traditional imaging by dual-energy spectral imaging, and enhance the clarity of head and lung tumors. In this study, we will prospectively explore the image accuracy and delineation accuracy of dual energy CT in radiotherapy to verify whether dual energy CT performs better with conventional CT., conditionsModule conditions: Image Quality and Contouring Accuracy of the Tumor in Radiotherapy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Dual energy CT after routine simulation, outcomesModule primaryOutcomes measure: DICE value, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Key laboratory of Cancer Prevention and Therapy, Tianjin's Clinical Research Center for Cancer, Huan-Hu-Xi, status: RECRUITING, city: Tianjin, state: Tianjin, zip: 300381, country: China, contacts name: Zhiyong Yuan, Doctor, role: CONTACT, phone: +86 186 2222 1199, email: zyuan@tmu.edu.cn, geoPoint lat: 39.14222, lon: 117.17667, hasResults: False
|
protocolSection identificationModule nctId: NCT06301087, orgStudyIdInfo id: WP-2024-01, briefTitle: Early Detection Neurodevelopmental Disorders of Children and Prevention of Postnatal Depression by Mobile Health App, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-05-01, primaryCompletionDateStruct date: 2024-02-08, completionDateStruct date: 2024-02-08, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Weprom, class: OTHER, collaborators name: Kelindi, descriptionModule briefSummary: The goal of this observational study is to confirm the impact of using this app adapted to be more specific for screening for 5 neurodevelopmental disorders and to evaluate the mothers' support program on the incidence of postpartum depression in of young parents with a minimum of 1 child under 10 years of age at the time of inclusion and using Malo on a regular basis. The main questions it aims to answer are :* the median age of possible neurodevelopmental disorders notification of infants* the median time of the mothers' postnatal depression notifications after childbirth subsequently to the support and prevention program Participants will agree with use of their data, conditionsModule conditions: Development, Child, conditions: Postnatal Depression, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 55618, type: ACTUAL, armsInterventionsModule interventions name: Web Application, outcomesModule primaryOutcomes measure: Time to neurodevelopment desorder diagnostic, secondaryOutcomes measure: User's satisfaction, secondaryOutcomes measure: Relevance of the neurodevelopmental desorder notification, secondaryOutcomes measure: Rate of mothers'postnal depression, secondaryOutcomes measure: Time of mothers'postnatal depression, eligibilityModule sex: ALL, maximumAge: 10 Years, stdAges: CHILD, contactsLocationsModule locations facility: ILC, city: Le Mans, country: France, geoPoint lat: 48.0, lon: 0.2, hasResults: False
|
protocolSection identificationModule nctId: NCT06301074, orgStudyIdInfo id: HS-10509-101, briefTitle: The Phase I Study of HS-10509 in Chinese Adult Subjects, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Jiangsu Hansoh Pharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The study is to evaluate the safety, tolerability, and PK characteristics following single administration of HS-10509 in healthy adults, and multiple administrations of HS-10509 in patients with schizophrenia.Participants will have HS-10509 tablets or placebo once in the single ascending dose (SAD) part or once daily for 28 days in the multiple ascending dose (MAD) part., conditionsModule conditions: Schizophrenia, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: For each cohort, participants will be assigned to receive HS-10509 or placebo in parallel, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: HS-10509, interventions name: Placebo, outcomesModule primaryOutcomes measure: Incidence and severity of adverse events(AE), serious AEs and AE leading to withdrawal from treatment., primaryOutcomes measure: Changes from baseline in lab tests, primaryOutcomes measure: Changes from baseline in vital signs, primaryOutcomes measure: Change from baseline in body weight, primaryOutcomes measure: Change from baseline in Electrocardiogram (ECG), primaryOutcomes measure: Change from Baseline in Columbia - Suicide Severity Rating Scale (C-SSRS), primaryOutcomes measure: Change from baseline in Abnormal Involuntary Movement Scale (AIMS), primaryOutcomes measure: Change from baseline in Barnes Akathisia Rating Scale (BARS), primaryOutcomes measure: Change from baseline in Simpson-Angus Scale (SAS), secondaryOutcomes measure: Cmax, secondaryOutcomes measure: Tmax, secondaryOutcomes measure: AUC0-t, secondaryOutcomes measure: AUC0-∞, secondaryOutcomes measure: λz, secondaryOutcomes measure: t½, secondaryOutcomes measure: CL/F, secondaryOutcomes measure: Vd/F, secondaryOutcomes measure: MRT, secondaryOutcomes measure: Css, max, secondaryOutcomes measure: Css, min, secondaryOutcomes measure: Css, av, secondaryOutcomes measure: Tss, max, secondaryOutcomes measure: AUCss, secondaryOutcomes measure: Change from Baseline in Positive and Negative Syndrome Scale (PANSS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Hospital of Jilin University, city: Changchun, state: Jilin, country: China, contacts name: Xiaojiao Li, Dr., role: CONTACT, phone: +86 13514314089, email: Xingxingsuo123456@126.com, geoPoint lat: 43.88, lon: 125.32278, hasResults: False
|
protocolSection identificationModule nctId: NCT06301061, orgStudyIdInfo id: PB001, briefTitle: Focal Microvibration and Chronic Lumbosacral Radicular Pain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-10-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Federico II University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to investigate the effectiveness of focal microvibration on patients affected by chronic lumbosacral radicular pain. The main question\[s\] it aims to answer are:* Can focal microvibration improve pain in this patient population?* Can focal microvibration improve quality of life in these patients? Participants will attach to their skin four little devices (10x20x0,5mm) delivering focal microvibration in the painful area according to researchers indications for 6 hours/day every day except Thursday and Sunday.Researchers will compare patients treated with focal microvibration to patients treated with a sham device and to patients treated with standard pharmacological therapy., conditionsModule conditions: Pain, Chronic, conditions: Lumbosacral Radiculopathy, conditions: Radicular; Neuropathic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Equistasi®, interventions name: Sham, interventions name: Gabapentin; Pregabalin; Duloxetine; Amitriptyline, outcomesModule primaryOutcomes measure: Pain intensity, secondaryOutcomes measure: Pain interference in daily life, secondaryOutcomes measure: Disability, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06301048, orgStudyIdInfo id: BFHHZS20230203, briefTitle: Effectiveness of Endoscopic Papillectomy With Stent for Treating Duodenal Papillary Adenoma, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-11-07, primaryCompletionDateStruct date: 2023-12-07, completionDateStruct date: 2023-12-07, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Beijing Friendship Hospital, class: OTHER, descriptionModule briefSummary: This is a retrospective study, including 79 patients with duodenal papillary adenoma, who treated with Endoscopic Papillectomy (EP) at Beijing friendship hospital. The cohort included patients who underwent EP with or without Pancreatic Duct (PD) and Common Bile Duct (CBD) stent placement. The investigators assessed the outcomes of EP and the impact of stent placement on complications and recurrence rates., conditionsModule conditions: Duodenal Adenoma, conditions: Complication of Treatment, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 79, type: ACTUAL, armsInterventionsModule interventions name: Stent Placement in Pancreatic and Bile Ducts, outcomesModule primaryOutcomes measure: Rate of complications, primaryOutcomes measure: Rate of complete resection, secondaryOutcomes measure: Rate of recurrence, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Friendship Hospital, city: Beijing, state: Beijing, zip: 100050, country: China, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
|
protocolSection identificationModule nctId: NCT06301035, orgStudyIdInfo id: 2024-01-012, briefTitle: Asymmetric High-flow Nasal Cannula (HFNC) vs Standard HFNC for Post Extubation High-risk Group, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Samsung Medical Center, class: OTHER, collaborators name: Fisher and Paykel Healthcare, descriptionModule briefSummary: Background The exacerbation of respiratory failure that occurs after endotracheal intubation often occurs in patients who have received mechanical ventilation therapy, and when it occurs, it emerges as an important issue to consider reintubation of endotracheal intubation. High-flow nasal cannula (HFNC) through nasal cannula is known to produce positive airway pressure and deliver a certain amount of oxygen, and recently reported clinical studies have demonstrated the effect of lowering the risk of reintubation after endotracheal intubation, which is recommended for use in recent clinical practice guidelines. However, in patients at high risk of intubation failure, the combination of high-flow oxygen therapy and non-invasive positive-pressure ventilation therapy rather than the application of high-flow oxygen therapy alone through nasal cannula is helpful in reducing the rate of reintubation of endotracheal intubation. However, an alternative to non-invasive positive-pressure ventilation therapy is needed as there is a possibility of complications such as aspiration pneumonia, maladaptation of the application device (mask), and discomfort, making it difficult to apply it in the field.Recently, it has been reported that high flow oxygen therapy through an asymmetric nasal cannula forms sufficient positive pressure in terms of respiratory dynamics, which makes the patient feel comfortable and reduces work of breath. However, no clinical studies have yet compared physiological effects using this method in patients at high risk of extubation failure.Goal The investigators would like to compare the physiological effects of high flow oxygen therapy through 'asymmetric nasal cannula' with high flow oxygen therapy through 'standard nasal cannula' in patients identified as high-risk groups for valvular failure.Hypothesis 'Asymmetric nasal cannula' reduces work of breath compared to 'standard nasal cannula' in high-risk patients with valvular failure., conditionsModule conditions: Acute Respiratory Failure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Asymmetric High flow nasal cannula, interventions name: Standard(symmetric) High flow nasal cannula, outcomesModule primaryOutcomes measure: Respiratory Rate Oxygenation (ROX) Index, secondaryOutcomes measure: The Lowest value of SpO2 within 24 hours after extubation, secondaryOutcomes measure: PaO2/FiO2, secondaryOutcomes measure: SpO2/FiO2, secondaryOutcomes measure: changes of end-expiratory lung impedance, at each flow rate measured through Electrical Impedance tomography (EIT), secondaryOutcomes measure: Changes in non-homogeneity indicators measured through EIT (changes in Global homeogeneity index), secondaryOutcomes measure: Respiratory rate, secondaryOutcomes measure: work of breath (Modified Borg Scale, MBS), secondaryOutcomes measure: systolic blood pressure, secondaryOutcomes measure: mean arterial pressure, secondaryOutcomes measure: heart rate, secondaryOutcomes measure: Rate of reintubation within 7 days, secondaryOutcomes measure: Length of ICU stay, secondaryOutcomes measure: Length of hospital stay, secondaryOutcomes measure: ICU Mortality, secondaryOutcomes measure: Hospital Mortality, secondaryOutcomes measure: 28 Day Mortality, secondaryOutcomes measure: 90 Day Mortality, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Samsung Medical Center, city: Seoul, country: Korea, Republic of, contacts name: Hye Rim Chung, role: CONTACT, phone: +82-2-3410-6399, email: hyerim37.jeong@samsung.com, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
|
protocolSection identificationModule nctId: NCT06301022, orgStudyIdInfo id: WXZ-Finerenone, briefTitle: Effectiveness and Safety of Finerenone in Chinese CKD Patients Without Diabetes Mellitus, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-12-15, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: First Affiliated Hospital of Harbin Medical University, class: OTHER, descriptionModule briefSummary: Background： This study aimed to evaluate the effectiveness and safety of Finerenone in patients with chronic kidney disease (CKD) without diabetes mellitus(DM), however, evidence based on both clinical trails and real-world data are limited.Methods:Patients with CKD without DM were enrolled in this study from December 2022 to December 2024. In conjunction with the established treatment regimen for chronic kidney disease (CKD), study participants were additionally administered Finerenone. To evaluate the therapeutic impact and safety profile of the intervention, three primary biomarkers were monitored: 24-hour urinary protein (UTP), estimated glomerular filtration rate (eGFR), and serum potassium (sK+). These parameters were closely measured on a monthly basis, starting from the point of enrollment and continuing for a duration of twelve months or possibly longer., conditionsModule conditions: Chronic Kidney Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 90, type: ESTIMATED, outcomesModule primaryOutcomes measure: 24 hours urinary total protein, primaryOutcomes measure: estimate Gromerular filtration rate, primaryOutcomes measure: serum potassium, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: First Aaffiliated Hospital of Harbin Medical University, status: RECRUITING, city: Harbin, state: Heilongjiang, zip: 150001, country: China, contacts name: XINGZHI WANG, PHD.,MD, role: CONTACT, phone: +8613904506176, email: WANG.XINGZHI@HRBMU.EDU.CN, geoPoint lat: 45.75, lon: 126.65, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-12-15, uploadDate: 2024-02-26T03:42, filename: Prot_SAP_000.pdf, size: 207441, hasResults: False
|
protocolSection identificationModule nctId: NCT06301009, orgStudyIdInfo id: AI-CAC-PVS, briefTitle: The AI-CAC Model for Subclinical Atherosclerosis Detection on Chest X-ray, acronym: AI-CAC-PVS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-10-01, completionDateStruct date: 2025-10-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Azienda Ospedaliera Città della Salute e della Scienza di Torino, class: OTHER, collaborators name: Compagnia di San Paolo, descriptionModule briefSummary: The AI-CAC model is an artificial intelligence system capable of assessing the presence of subclinical atherosclerosis on a simple chest radiograph. The present study will provide prospective validation of its diagnostic performance in a primary prevention population with a clinical indication for coronary artery calcium (CAC) testing., conditionsModule conditions: Cardiovascular Diseases, conditions: Atherosclerosis, conditions: Coronary Artery Calcification, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: AI-CAC score, outcomesModule primaryOutcomes measure: Diagnostic accuracy of the AI-CAC score to identify the presence of subclinical atherosclerosis on chest x-ray, secondaryOutcomes measure: Percentage of individuals with a therapeutic management change by the attending physician based on the CAC score, with concordant AI-CAC., secondaryOutcomes measure: Comparison of ASCVD events occurring in patients without (AI-CAC=0) vs. with subclinical atherosclerosis (AI-CAC >0) based on the AI-CAC score, as assessed by Kaplan Meier estimates of ASCVD events occurring until study completion., eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06300996, orgStudyIdInfo id: STUDY23110042, briefTitle: Spinal Cord Stimulation for the Treatment of Motor Deficits in People With Spinal Muscular Atrophy - Upper Limb, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2029-05, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Marco Capogrosso, class: OTHER, collaborators name: Roche-Genentech, descriptionModule briefSummary: Spinal cord stimulation (SCS) has shown remarkable efficacy in restoring motor function in people with spinal cord injury by recruiting afferent input to enhance the responsiveness of spared neural circuits to residual cortical inputs. This pilot will test if SCS can show evidence to improve motor deficits in people with Type 2, 3, or 4 spinal muscular atrophy (SMA). The investigators will enroll up to six subjects with Type 2, 3, or 4 SMA aged 16 or older that show quantifiable motor deficits of the upper body. The investigators will then implant the subjects with percutaneous, linear spinal leads near the cervical spinal cord for a period of up to 29 days. Although these leads are not optimized for motor function but rather for their clinically approved indication of treating pain, the investigators believe they provide a safe technology enabling our team to perform scientific measurement necessary to evaluate potential for effects of SCS in motor paralysis with SMA. After the end of the study, the leads will be explanted., conditionsModule conditions: Spinal Muscular Atrophy, conditions: Spinal Muscular Atrophy Type 3, conditions: Spinal Muscular Atrophy Type II, conditions: Spinal Muscular Atrophy 4, conditions: SMA, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single-arm, open-label study performed to quantify variables that are predictive of the efficacy of spinal cord stimulation to improve motor control., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Spinal Cord Stimulator (Octopolar Medtronic Vectris Leads), outcomesModule primaryOutcomes measure: Muscle Weakness Torque, primaryOutcomes measure: Number and Severity of Adverse Events, secondaryOutcomes measure: Muscle Weakness Muscle Activation, secondaryOutcomes measure: Motor Function ROM, secondaryOutcomes measure: Motor Function RULM, secondaryOutcomes measure: Motor Function Fatigue, secondaryOutcomes measure: Discomfort/Pain, secondaryOutcomes measure: Sensorimotor Network Structure Density, secondaryOutcomes measure: Impression, secondaryOutcomes measure: Sensorimotor Network Structure Integrity, secondaryOutcomes measure: Sensorimotor Network Function, secondaryOutcomes measure: Cortico-spinal Tract Integrity, secondaryOutcomes measure: Spinal Circuit Excitability, secondaryOutcomes measure: Motoneuron Firing Rates, secondaryOutcomes measure: Motor Firing Number, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 65 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Pittsburgh, city: Pittsburgh, state: Pennsylvania, zip: 15213, country: United States, contacts name: Sydney Bader, MS, role: CONTACT, email: syb17@pitt.edu, contacts name: Cierra Clark, MS, role: CONTACT, email: cic27@pitt.edu, geoPoint lat: 40.44062, lon: -79.99589, hasResults: False
|
protocolSection identificationModule nctId: NCT06300983, orgStudyIdInfo id: PR(AG)398/2022, briefTitle: Effectiveness of a Psychoeducational Intervention on Myositis Patients' Quality of Life and Well-Being, acronym: HRQoL, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-09-15, primaryCompletionDateStruct date: 2022-10-31, completionDateStruct date: 2022-10-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Hospital Universitari Vall d'Hebron Research Institute, class: OTHER, descriptionModule briefSummary: Purpose. Myositis is a rare disease associated with impaired health-related quality of life. A study evaluating the effectiveness of an intervention to improve the quality of life and well-being of myositis patients is presented.Materials and Methods. All myositis patients in a health district are contacted. Eligible patients are randomly assigned to the experimental or control group. A psychoeducational intervention of 5 100-min sessions focusing on the disease as related to daily life is conducted only in experimental patients. Several reliable tools to measure quality of life and well-being are administered twice, before and after the intervention, to both groups., conditionsModule conditions: Quality of Life, conditions: Myositis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 34, type: ACTUAL, armsInterventionsModule interventions name: Psychoeducative, interventions name: Placebo, outcomesModule primaryOutcomes measure: Health related quality of life, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona, city: Barcelona, zip: 08035, country: Spain, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False
|
protocolSection identificationModule nctId: NCT06300970, orgStudyIdInfo id: 0900f3eb81e634a9, briefTitle: Efficacy of Artesunate-amodiaquine and Artemether-lumefantrine for Treatment of Plasmodium Falciparum Malaria in Liberia, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-08-09, primaryCompletionDateStruct date: 2023-08-16, completionDateStruct date: 2023-08-16, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Centers for Disease Control and Prevention, class: FED, collaborators name: Ministry of Health, Liberia, descriptionModule briefSummary: To assess the efficacy of both first-line antimalarial medications used for the treatment of uncomplicated Plasmodium falciparum malaria infections in two geographic regions in Liberia., conditionsModule conditions: Plasmodium Falciparum, conditions: Malaria, conditions: Uncomplicated Malaria, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 352, type: ACTUAL, armsInterventionsModule interventions name: Amodiaquine-artesunate (ASAQ), interventions name: Artemether+Lumefantrine (AL), outcomesModule primaryOutcomes measure: Number of Participants with Early Treatment Failure (ETF), primaryOutcomes measure: Number of Participants with Late Treatment Failure (LTF), primaryOutcomes measure: Number of Participants with Adequate Clinical and Parasitological Response (APCR), secondaryOutcomes measure: Number of Patients with Adverse Events, otherOutcomes measure: Number of samples with confirmed Histidine-rich protein 2/3 (HRP2/3) gene deletions, otherOutcomes measure: Number of samples with molecular markers of anti-malarial resistance, eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 59 Months, stdAges: CHILD, contactsLocationsModule locations facility: Sinje Health Center, Garwula District, Sinje, Grand Cape Mount County, city: Sinje, state: Grand Cape Mount County, country: Liberia, locations facility: Saclepea-Mahn Comprehensive Health Center Saclepea-Mahn District, Nimba County, city: Saclepea, state: Nimba County, country: Liberia, geoPoint lat: 6.9625, lon: -8.84056, hasResults: False
|
protocolSection identificationModule nctId: NCT06300957, orgStudyIdInfo id: IRB00023124, secondaryIdInfos id: CE003310, type: OTHER_GRANT, domain: CDC, secondaryIdInfos id: OMB NO: 0920-1301, type: OTHER, domain: OMB, briefTitle: Help Wanted: Evaluating a Prevention Intervention for People With Sexual Interest in Children, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-24, primaryCompletionDateStruct date: 2026-05-31, completionDateStruct date: 2026-10-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins Bloomberg School of Public Health, class: OTHER, collaborators name: Barry University, collaborators name: University of Massachusetts, Lowell, descriptionModule briefSummary: This project aims to evaluate the Help Wanted Prevention Intervention, an online program to provide people with a sexual attraction to children the skills and resources to support their commitment to keep children safe and to improve the participants well-being. In phase one, ten men with a sexual attraction to children who have never had a contact offense with a child will be asked to go through an abbreviated version of the participant procedures that will be used in study phase two (described next). Specifically, the ten participants will complete one of the online surveys, review the Help Wanted program, and participate in a 30-60 minute anonymous audio call with a member of the study team to provide feedback on the study procedures and materials (e.g., consent form, recruitment form). Feedback from phase one will inform changes to study procedures for phase two. Phase two consists of a large-scale evaluation of the Help Wanted program. Three hundred men with a sexual attraction to children who have never had a contact offense with a child or accessed the Help Wanted Program will be randomly selected to be part of one of two groups: the program group (N = 200) or the control group (N = 100). Both groups will be asked to complete an online survey before reviewing the Help Wanted Program, provide feedback on the program over a one-month period, and complete another online survey immediately after reviewing the program and three months after reviewing the program. Participants in the control group will have a one month waiting period after the first online survey, during which the participants will receive alternative resources and supports for mental health and sexual attraction to children. After the one month waiting period, participants in the control group will complete one additional online survey before reviewing the Help Wanted program and completing the two final online surveys (one immediately after reviewing the program, one three months after reviewing the program). Survey questions will ask about participants thoughts, feelings, and behaviors, including questions about the participants overall well-being and sexual attraction to children. All study materials and resources are in English. Resources provided to participants are also in English, but provide services in over 30 countries to include participants who may reside in countries outside of the United States. Participation is anonymous and all data will be kept confidential., conditionsModule conditions: Program Evaluation, conditions: Child Sexual Abuse, conditions: Perpetration of Child Sexual Abuse, conditions: Prevention Intervention, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In Phase one investigators will recruit 10 participants to test out the study protocols. All 10 participants will go through the same study procedures.In Phase two, investigators will recruit 300 participants to take part in the RCT, 200 in the HW group and 100 in the WL group. After consenting to participate and completing the first online survey, participants will be randomized to either an intervention condition (N =200) or wait-list control condition (N =100) using a 2:1 allocation. The intervention group will gain access to Help Wanted for 1 month after which the participants will complete a post-intervention survey and then a three-month follow up survey. Participants in the control group will receive alternative resources for one month, then complete a one-month post-waitlist survey before being granted access to Help Wanted for a one-month period. The control group participants will then complete a one-month post-intervention survey and three-month follow-up survey., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 310, type: ESTIMATED, armsInterventionsModule interventions name: Help Wanted Prevention Intervention, interventions name: Waitlist Control, outcomesModule primaryOutcomes measure: Sexual Behavior Involving Minors Scale (SBIMS)., primaryOutcomes measure: Sexual Child Molestation Risk Assessment (SChiMRA) score, secondaryOutcomes measure: Depression, Anxiety and Stress Scale-21 (DASS-21), secondaryOutcomes measure: Suicidal Ideation Attributes Scale (SIDAS), secondaryOutcomes measure: General Self-Efficacy Scale - Short Form (GSE-6)., secondaryOutcomes measure: Revised University of California, Los Angeles (UCLA) Loneliness Scale, secondaryOutcomes measure: Self-Efficacy Scale Related to Minors (SESM), secondaryOutcomes measure: Hypersexual Behavior Inventory-19 score, secondaryOutcomes measure: Sexual Attraction to Children, secondaryOutcomes measure: Cognitions of internet sexual offending score, secondaryOutcomes measure: Cognitions that condone and support sexual offending against children scale - short form, secondaryOutcomes measure: Emotional Congruence with Children score, secondaryOutcomes measure: Brief Aggression Questionnaire score, secondaryOutcomes measure: Short Self-Regulation Questionnaire score, secondaryOutcomes measure: Alcohol Use Disorders Identification Test (AUDIT) score, secondaryOutcomes measure: Recent Alcohol & Cannabis Use score, otherOutcomes measure: Demographic characteristics as assessed by survey developed by study team, otherOutcomes measure: Number of Sexual Health Services Used, otherOutcomes measure: Sexual Offence Self-Report Risk Scale (SOSRS):, otherOutcomes measure: Minor Attraction Outness Scale, otherOutcomes measure: Revised Adverse Childhood Experiences Scale, otherOutcomes measure: Balanced Inventory of Desirable Responding - Impression Management Subscale (BIDR-Version 6-Form 40 - IMS)., otherOutcomes measure: Impact of Research Participation as assessed by survey, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Johns Hopkins Bloomberg School of Public Health, status: RECRUITING, city: Baltimore, state: Maryland, zip: 21231, country: United States, contacts name: Elizabeth J Letourneau, PhD, role: CONTACT, phone: 843-343-6865, email: elizabethletourneau@jhu.edu, contacts name: Amanda E Ruzicka, MA, role: CONTACT, phone: 7172699886, email: aruzicka@jhu.edu, geoPoint lat: 39.29038, lon: -76.61219, hasResults: False
|
protocolSection identificationModule nctId: NCT06300944, orgStudyIdInfo id: Ran Gao-2023-12, briefTitle: The Effect of Esketamine on Postoperative Pain Relief in Patients Undergoing Laparoscopic Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: General Hospital of Ningxia Medical University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to investigate whether continuous intraoperative infusion of esketamine combined with the addition of esketamine to postoperative PCIA can improve postoperative pain and sleep quality in patients undergoing laparoscopic uterine surgery under general anesthesia., conditionsModule conditions: Postoperative Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: parallel assignment, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 108, type: ESTIMATED, armsInterventionsModule interventions name: saline, interventions name: Esketamine, outcomesModule primaryOutcomes measure: Moderate to severe pain, primaryOutcomes measure: Incidence of adverse reactions including nausea, vomiting and dizziness, primaryOutcomes measure: Sleep quality, secondaryOutcomes measure: Remifentanil dosage, secondaryOutcomes measure: Additional post-operative analgesics, secondaryOutcomes measure: Postoperative exhaust time of patients, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: General Hospital of Ningxia Medical University, status: RECRUITING, city: Yinchuan, state: Ningxia, country: China, contacts name: Ma Hanxiang, role: CONTACT, phone: 86-13519591508, email: mahanxiang@hotmail.com, geoPoint lat: 38.46806, lon: 106.27306, hasResults: False
|
protocolSection identificationModule nctId: NCT06300931, orgStudyIdInfo id: KAPSDFE0948, briefTitle: KAP for Use of SDF Among Dental Interns Before vs After Educational Intervention, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: This study is a KAP questionnaire to assess Egyptian intern dentists' knowledge, attitudes and practices regarding use of SDF before and after an educational intervention., conditionsModule conditions: SDF, designModule studyType: OBSERVATIONAL, designInfo observationalModel: ECOLOGIC_OR_COMMUNITY, timePerspective: OTHER, enrollmentInfo count: 449, type: ESTIMATED, armsInterventionsModule interventions name: educational lecture, outcomesModule primaryOutcomes measure: Assessment of knowledge levels and attitude regarding SDF use before educational intervention, secondaryOutcomes measure: Assessment of knowledge levels and attitude regarding SDF use after educational intervention Correlation between demographic data and use of SDF., eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06300918, orgStudyIdInfo id: 2024-KY76, briefTitle: A Clinical Trial to Evaluate the Time Point of Anti-VEGF Pretreatment of PDR Based on Intraoperative FFA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-08, primaryCompletionDateStruct date: 2025-08-01, completionDateStruct date: 2025-08-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Jie Li, class: OTHER, descriptionModule briefSummary: The goal of this prospective randomized controlled study is to compare the therapeutic effect of injecting anti-VEGF drugs before surgery for patients with proliferative diabetic retinopathy at different time points. At present, studies have confirmed that anti-VEGF drugs are effective in inhibiting fundus neovascularization in proliferative diabetic retinopathy. The main question it aims to answer is which time point is better to injecting anti-VEGF drugs before surgery for patients with proliferative diabetic retinopathy.Participants will be randomly divided into three groups. And time points of injecting anti-VEGF drugs before surgery for each group will be 3 days, 7 days, 14 days. And we have a new technology that can have fluorescein fundus angiography during operation, so it can reflect the condition of fundus neovascularization immediately and precisely. In that case, we can compare the Inhibitory effect of anti-VEGF drugs on fundus neovascularization at different time points., conditionsModule conditions: The Condition of Fundus Neovascularization, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Time, outcomesModule primaryOutcomes measure: The number of fundus neovascularization seen in FFA., primaryOutcomes measure: The area of fundus neovascularization seen in FFA (using PD size as measurement)., primaryOutcomes measure: The intensity of neovascularization fluorescein leakage, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sichuan Academy of Medical Science Sichuan Provincial Hosptial, status: RECRUITING, city: Chendu, state: Sichuan, zip: 610014, country: China, contacts name: Jie Li, doctor, role: CONTACT, phone: +86 13908094675, email: lijieyk@med.uestc.edu.cn, hasResults: False
|
protocolSection identificationModule nctId: NCT06300905, orgStudyIdInfo id: CRO-2023-05-OMO-SNA-YPZ, briefTitle: Clinical Study on Malodor, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2023-07-02, completionDateStruct date: 2023-07-02, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Colgate Palmolive, class: INDUSTRY, descriptionModule briefSummary: This 3-week clinical study was designed to investigate the clinical efficacy on oral malodor of a 0.454% stannous fluoride toothpaste with nitrate and pyrophosphate (referred to as SNAP) compared to Colgate Cavity Protection Toothpaste containing 0.76% sodium monofluorophosphate 12 hours post-brushing after 3 weeks of product use., conditionsModule conditions: Oral Malodor, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 100, type: ACTUAL, armsInterventionsModule interventions name: test product, interventions name: Control product, outcomesModule primaryOutcomes measure: Organoleptic Oral Malodor Evaluations, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: West China Dental Institute of Chengdu, city: Chengdu, state: Sichuan, zip: 610041, country: China, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
|
protocolSection identificationModule nctId: NCT06300892, orgStudyIdInfo id: SURG-2023-31841, briefTitle: Surgical Site Infections and the Microbiome: Understanding the Pathogenesis of Surgical Site Infections, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: University of Minnesota, class: OTHER, descriptionModule briefSummary: This is a prospective, observational study of patients undergoing open GI surgery. At the time of operation, samples will be collected from the incision site and GI tract. The study will follow patients up to 30 days postoperatively, monitoring for signs of SSI. Samples will be taken from all patients who develop SSI. Sequencing will be performed on a subset of samples based on our specific aims.* Aim 1: conduct a case-control study of patients with SSI and age-, sex-, diagnosis-, and wound class-matched control patients without SSI, comparing microbiome alpha diversity and community composition with 16S RNA sequencing to determine the association with SSI.* Aim 2: identify the strain of bacteria isolated from SSIs using shotgun metagenomic sequencing and determine whether the specific strain was present in the skin and gut at the time of operation., conditionsModule conditions: Open GI Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: No intervention, outcomesModule primaryOutcomes measure: alpha diversity composition, primaryOutcomes measure: microbial community composition, primaryOutcomes measure: pathogenic strain of bacteria, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06300879, orgStudyIdInfo id: 2023-1058, briefTitle: A Prospective Study on Esophagogastrostomy by an Innovative Surgical Technique, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Huashan Hospital, class: OTHER, descriptionModule briefSummary: This is a single-center, open-label, Phase Ib/II study aiming to assess the perioperative safety and postoperative outcomes of a novel surgical technique in treating primary adenocarcinoma located in the upper 1/3 of the stomach or gastroesophageal junction (Siewert II or III).The study will enroll 30 patients who will undergo totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique. Clinical data will be collected to evaluate perioperative safety. Patients will be followed for at least 3 months, during which endoscopy will be performed to analyze occurrences and reasons for anastomotic-related complications. Additionally, the quality of life after surgery will be evaluated by QLQ-C30 and QLQ-STO22., conditionsModule conditions: Gastric Cancer, conditions: Adenocarcinoma of Esophagogastric Junction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Patients included in this group will receive totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique，which is an innovative surgery that investigators first began to apply in patients with proximal gastric cancer., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Performing totally laparoscopic proximal gastrectomy with esophagogastrostomy by fissure technique, outcomesModule primaryOutcomes measure: Assess intraoperative Perioperative Safety by Duration of surgery., primaryOutcomes measure: Assess intraoperative Perioperative Safety by Duration of anastomosis., primaryOutcomes measure: Assess intraoperative Perioperative Safety by blood loss ., primaryOutcomes measure: Postoperative recovery course, primaryOutcomes measure: Postoperative TNM staging by Pathological findings ., secondaryOutcomes measure: The incidence of postoperative reflux esophagitis, secondaryOutcomes measure: The incidence of postoperative anastomotic stenosis, secondaryOutcomes measure: Quality of Life at 3 Months Postoperatively will be assessed by EORTC QLQ-C30, secondaryOutcomes measure: Quality of Life at 3 Months Postoperatively will be assessed by EORTC QLQ-STO22 scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Huashan Hospital, Fudan University, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200040, country: China, contacts name: Hankun Hao, doctor, role: CONTACT, phone: +86 18121186328, email: haohankun@163.com, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
|
protocolSection identificationModule nctId: NCT06300866, orgStudyIdInfo id: CRO-2020-04-PGN-LLU-YPZ, briefTitle: Gingivitis Reduction After Use of 0.45% Stannous Fluoride Toothpaste, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-08-18, primaryCompletionDateStruct date: 2021-03-08, completionDateStruct date: 2021-03-08, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Colgate Palmolive, class: INDUSTRY, descriptionModule briefSummary: The 6-month clinical study was designed to investigate clinical efficacy on plaque and gingivitis for the stannous fluoride containing toothpaste (SNAP) compared to Colgate Cavity Protection Toothpaste after 3 and 6 months of product use., conditionsModule conditions: Gingivitis, conditions: Plaque, Dental, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 80, type: ACTUAL, armsInterventionsModule interventions name: Test, interventions name: Control, outcomesModule primaryOutcomes measure: Whole-Mouth Gingivitis Measurement, primaryOutcomes measure: Whole-Mouth Dental Plaque Measurement, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Loma Linda University School of Dentistry, city: Loma Linda, state: California, zip: 92350, country: United States, geoPoint lat: 34.04835, lon: -117.26115, hasResults: False
|
protocolSection identificationModule nctId: NCT06300853, orgStudyIdInfo id: 2023-07, briefTitle: Understanding Adaptive Immune Response After COVID-19 Vaccination Boosters to Improve Vaccination Strategies in Vulnerable Groups., acronym: COVaxFragile, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-14, primaryCompletionDateStruct date: 2025-11, completionDateStruct date: 2025-11, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: IRCCS Sacro Cuore Don Calabria di Negrar, class: OTHER, descriptionModule briefSummary: This is an experimental study without drug and device, non-profit, single-center.The general objective of the project is to study how the adaptive immune response evolves against SARS-CoV-2 with repeated vaccination boosters and infections also in relation to the evolution of variations. This study will be relevant to frail populations who are the main targets of repeated vaccinations. Our project will benefit from the availability of a highly cohort characterized of vaccinated people, including cancer patients and elderly people, with prospective collection of samples for an in-depth evaluation of the evolution of the immune response with repeated exposure to doses of infection or vaccine. As part of the study, analyzes will be carried out on samples of patients enrolled in a manner prospective at the oncology departments of the IRCCS (Medical Oncology, Department of Radiotherapy advanced oncology and nuclear medicine) and elderly patients residing in retirement homes of the IRCCS. Patients will also be asked for consent to store any residual samples in the Tropica DITM Biobank., conditionsModule conditions: COVID-19, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 350, type: ESTIMATED, armsInterventionsModule interventions name: Analisys of cellular response and humoral response to SARS-CoV-2 vaccine booster doses, outcomesModule primaryOutcomes measure: Cellular response evaluation: flow cytometry profiles (proportions of cells), primaryOutcomes measure: Cellular response evaluation: results of T and B cells stimulation with specific peptides (continuous variables, unity of measure: Optical Density OD), primaryOutcomes measure: Cellular response evaluation: ADCC assay (continuous variables, unity of measure: Optical Density OD), primaryOutcomes measure: Cellular response evaluation: anti-SARS-CoV-2 antibodies quantities (IgGs and IgM, BAU/ml), primaryOutcomes measure: Cellular response evaluation: neutralization assays against different SARS-CoV-2 variants (continuous variables, unity of measure: TCID50/ml), primaryOutcomes measure: Cellular response evaluation: avidity assays (continuous variables, unity of measure: BAU/ml)., primaryOutcomes measure: Humoral response evaluation: anti-SARS-CoV-2 antibodies quantities (IgGs and IgM, BAU/ml), primaryOutcomes measure: Humoral response evaluation: neutralization assays against different SARS-CoV-2 variants (continuous variables, unity of measure: TCID50/ml), primaryOutcomes measure: Humoral response evaluation: avidity assays (continuous variables, unity of measure: BAU/ml)., secondaryOutcomes measure: Neutralization assays against different human Coronavirus (hCoV)., secondaryOutcomes measure: Whole genome sequencing analysis results, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Sacro Cuore Don Calabria hospital, status: RECRUITING, city: Negrar, state: Verona, zip: 37024, country: Italy, contacts name: Chiara Piubelli, role: CONTACT, phone: +390456013706, email: chiara.piubelli@sacrocuore.it, contacts name: Chiara Piubelli, role: PRINCIPAL_INVESTIGATOR, contacts name: Stefania Gori, role: SUB_INVESTIGATOR, geoPoint lat: 45.52918, lon: 10.93899, hasResults: False
|
protocolSection identificationModule nctId: NCT06300840, orgStudyIdInfo id: 2023_49, secondaryIdInfos id: NL84562.075.23, type: OTHER, domain: METC ISALA, briefTitle: Vibrotactile Feedback Belt in Patients With Unilateral Vestibular Hypofunction (UVH), acronym: VIBE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Hanna van Eijsden, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to study the impact of a continuous vibrotactile feedback belt on balance, (fear of) falling, fatigue and overall functioning in participants with chronic disabling unilateral vestibular hypofunction.The main questions it aims to answer are: • does wearing a vibrotactile feedback belt during waking hours for a week improve sense of balance and mobility, fear of falling, fatigue and overall functioning • does wearing a vibrotactile feedback belt influence static and dynamic balance and gait performance during balance and gait testing.Participants will goes through different phases in an randomized order; a baseline phase, a sham phase (i.e., wearing the BalanceBelt while it is switched off) and an intervention phase (i.e., wearing the BalanceBelt while it is switched on).It is expected that, just as with patients with bilateral loss of the balance organ, patients with a unilateral loss will also benefit from the BalanceBelt., conditionsModule conditions: Vestibular Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Single-case-experiment (SCE) with a reversal design and with randomization of phases., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Data-analyst and test-observer are masked, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 8, type: ESTIMATED, armsInterventionsModule interventions name: BalanceBelt, outcomesModule primaryOutcomes measure: Mobility and Balance Score (MBS), secondaryOutcomes measure: General functioning, secondaryOutcomes measure: physical activity_NRS, secondaryOutcomes measure: physical activity_steps, secondaryOutcomes measure: Fear of falling, secondaryOutcomes measure: fatigue, secondaryOutcomes measure: falls, secondaryOutcomes measure: structured interview on compliance on wearing the Balancebelt(R), secondaryOutcomes measure: Questionnaire: vestibular activity avoiding instrument (VAAI), secondaryOutcomes measure: Questionnaire: Dizziness handicap inventory (DHI), secondaryOutcomes measure: modified Clinical Test of Sensory Interaction on Balance (mCTSIB), secondaryOutcomes measure: Dynamic Gait Index (DGI), secondaryOutcomes measure: Timed up and Go test (TUG), otherOutcomes measure: age, otherOutcomes measure: time since onset of the vestibular hypofunction, otherOutcomes measure: cause of vestibular hypofunction, otherOutcomes measure: Structured interview on vestibular rehabilitation, otherOutcomes measure: outcome of the vestibular function tests, otherOutcomes measure: Structured interview on participating in the research, otherOutcomes measure: Structured interview on the overall experience with the Balancebelt(R), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gelre Hospitals, city: Apeldoorn, state: Gelderland, zip: 7334 DZ, country: Netherlands, geoPoint lat: 52.21, lon: 5.96944, hasResults: False
|
protocolSection identificationModule nctId: NCT06300827, orgStudyIdInfo id: 2023 - 1302, briefTitle: The Effect of Structured Digital-Based Education Given to Nursing Students, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Gazi University, class: OTHER, collaborators name: The Scientific and Technological Research Council of Turkey, descriptionModule briefSummary: Turkey is a risky country in terms of disasters. Preparedness and awareness for all disasters affecting the whole world gain value. Disaster literacy is an important approach to evaluating disaster preparedness and awareness processes. Disaster literacy is defined as the ability of an individual to access, read, understand, and use the information necessary to make informed decisions and follow instructions in the context of mitigation, preparation, response, and recovery during a disaster Disaster literacy needs to be increased to raise awareness among individuals and minimize disaster risk. Along with the awareness studies, it is also important to identify the disaster preparedness belief in order to encourage individuals to change potentially harmful behavior. Belief in disaster preparedness; It may vary according to the perception of experiencing a disaster, the perceived severity of the disaster, the benefits of being prepared for a disaster, the perceived barriers to being prepared for a disaster, being prepared, and the individual's belief in his or her ability to cope with a disaster. It may be useful to determine both disaster preparedness beliefs and disaster literacy levels of individuals at the social level. It is predicted that when multiple interventions are brought together in the learning process, there will be a faster and more lasting effect. In this study, which aims to use education and information technology together, a structured digital-based educational intervention is planned. The intervention program was structured by taking advantage of both the advantages of the digital world and active learning methods in order to keep the student active. The program is eight weeks and consists of seven dimensions and the purpose of the program is based on accessing information, understanding, information, making decisions, and applying information. The planned study aimed to determine the effect of structured digital-based education given to university students studying in the nursing department on their disaster literacy and disaster preparedness belief levels., conditionsModule conditions: 18 Years and Over, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Experimental Group: Structured digital-based training will be implemented. Control Group: The nursing student will be expected to continue their daily life.Nursing students who meet the inclusion criteria will be randomly assigned to the experimental group by a statistician., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Research data/output measurements are made by a research assistant not involved in the research., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 76, type: ESTIMATED, armsInterventionsModule interventions name: Structured digital-based training, outcomesModule primaryOutcomes measure: Disaster Literacy Scale, primaryOutcomes measure: General Disaster Preparedness Belief Scale Using the Health Belief, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gazi University, status: RECRUITING, city: Ankara, country: Turkey, contacts name: Aysun Erdal, Ph. D. (c), role: CONTACT, phone: +905367655107, email: aysunmutlu25@gmail.com, geoPoint lat: 39.91987, lon: 32.85427, locations facility: Necmettin Erbakan University, status: RECRUITING, city: Konya, country: Turkey, contacts name: Fatma Zehra Genç, Ph. D., role: CONTACT, phone: +905063216816, email: fatmazehragnc@gmail.com, geoPoint lat: 37.87135, lon: 32.48464, locations facility: Tokat Gaziosmanpaşa University, status: RECRUITING, city: Tokat, country: Turkey, contacts name: Suzan Yıldız, Ph. D., role: CONTACT, phone: +905444794647, email: suzanmola@hotmail.com, geoPoint lat: 40.31389, lon: 36.55444, hasResults: False
|
protocolSection identificationModule nctId: NCT06300814, orgStudyIdInfo id: ERU-HEM-EU-01, briefTitle: The Effect of Exercise and Music on Sleep, Quality of Life and Emotional State in Children With Epilepsy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-03-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: TC Erciyes University, class: OTHER, descriptionModule briefSummary: This study was planned as a randomized controlled experimental study with a pretest-posttest design to determine the effect of parental supervision and video-guided progressive relaxation exercise (PRE) and music recital on sleep, quality of life and emotional states in children with epilepsy aged 9-16 years. The main questions it aims to answer are as follows:According to the evaluation of children with epilepsy, does the progressive relaxation exercise applied to children have an effect on sleep, quality of life and emotional states? According to the evaluation of children with epilepsy, does music recital applied to children have an effect on sleep quality of life and emotional states? The study consisted of 45 children (15 children in the progressive relaxation exercise group, 15 children in the music recital group and 15 children in the control group). Ethics committee approval, permission from the institutions and informed consent of the children were obtained for the conduct of the study. A value of p\<0.05 was considered statistically significant in data analysis., conditionsModule conditions: Epilepsy in Children, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 45, type: ESTIMATED, armsInterventionsModule interventions name: Progressive relaxation exercise group, interventions name: Music recital group, outcomesModule primaryOutcomes measure: The Children's Sleep Habits Questionnaire (CSHQ), secondaryOutcomes measure: The Pediatric Quality of Life Inventory (PedsQL), secondaryOutcomes measure: The Me and My School Questionnaire (M&MS), eligibilityModule sex: ALL, minimumAge: 9 Years, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: Erciyes University, status: RECRUITING, city: Kayseri, country: Turkey, geoPoint lat: 38.73222, lon: 35.48528, hasResults: False
|
protocolSection identificationModule nctId: NCT06300801, orgStudyIdInfo id: 2023-48, briefTitle: Postoperative Pancreatic Fistula in Patients Undergoing Pancreaticoduodenectomy, acronym: popf, statusModule overallStatus: NO_LONGER_AVAILABLE, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Erol Olcok Corum Training and Research Hospital, class: OTHER, descriptionModule briefSummary: Pancreaticoduodenectomy (PD) is a complex procedure performed in patients with malignant or benign tumors of the pancreatic head and periampullary region, associated with high morbidity and mortality. Postoperative pancreatic fistula (POPF) is the most common and clinically significant complication following PD. In this study, the investigators aim to predict pancreatic fistula using the C-reactive protein-albumin ratio (CAR). The total number of participants expected to be included in this research comprises patients who underwent PD between 2017 and 2023 and developed pancreatic fistula. The participants invitation is based on the detection of a pancreatic fistula. This study is conducted for research purposes and participation is voluntary. No interventions will be performed on the participants as part of this study; however, we have prepared this form to obtain participant permission to gather certain information. If the participants consent to the use of information for scientific purposes with the guarantee of confidentiality, they will be asked to sign a consent form., conditionsModule conditions: Pancreatic Fistula After Pancreaticoduodenectomy, conditions: C-Reactive Protein, conditions: Albumin, designModule studyType: EXPANDED_ACCESS, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06300788, orgStudyIdInfo id: 23-AOI-02, briefTitle: Inorganic Pyrophosphate Homeostasis (PPi) in Pediatric Chronic Kidney Disease, acronym: PPi-DIA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Nice, class: OTHER, descriptionModule briefSummary: The investigator aim to identify the role of inorganic pyrophosphate and other anti-calcifying molecules in vascular disease in children with chronic kidney disease, with a view to developing therapeutic approaches aimed at limiting the onset of vasculopathy., conditionsModule conditions: Pyrophosphate, Fetuin A, IL1, IL6, TNFalpha, Control, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: PPI and T50 dosing, outcomesModule primaryOutcomes measure: Plasma pyrophosphate concentration [PPi]pl in children with CKD, secondaryOutcomes measure: Plasma pyrophosphate [PPi]pl concentration in children with renal transplantation, secondaryOutcomes measure: Markers of phosphocalcic metabolism, secondaryOutcomes measure: Urinary PPi concentration, secondaryOutcomes measure: Markers of vascular damage in CKD, eligibilityModule sex: ALL, minimumAge: 0 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: CHU Nice - Hôpital de l'Archet 2, city: Nice, state: Alpes-Mritimes, zip: 06300, country: France, contacts name: Julie BERNARDOR, role: CONTACT, phone: 04.92.03.63.65, phoneExt: +33, email: bernardor.j@chu-nice.fr, geoPoint lat: 43.70313, lon: 7.26608, hasResults: False
|
protocolSection identificationModule nctId: NCT06300775, orgStudyIdInfo id: 123789, briefTitle: Evaluation of Modified Hyrax Versus Quad Helix in Treatment of Posterior Cross Bite, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: This study will be performed to evaluate the treatment of posterior cross-bite with modified hyrax \& Quad helix appliances and to compare which one will provide better results in relation to chewing difficulty in children with posterior cross- bite in mixed dentition, conditionsModule conditions: Posterior Cross Bite, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Modified Hyrax Versus Quad Helix, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: no Masking, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: modified hyrax, interventions name: quad helix, outcomesModule primaryOutcomes measure: Chewing difficulty, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Cairo univeristry, status: RECRUITING, city: Cairo, country: Egypt, contacts name: ola mostafa, prof, role: CONTACT, phone: 01006030036, email: ola.omar@dentistry.cu.edu.eg, contacts name: rasha adel, lecture, role: CONTACT, phone: 01007505888, email: rasha.adel@dentistry.cu.edu.com, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
|
protocolSection identificationModule nctId: NCT06300762, orgStudyIdInfo id: C3079, briefTitle: RCT Exudate Management Cutimed Sorbion Product Range, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: BSN Medical GmbH, class: INDUSTRY, descriptionModule briefSummary: The fluid handling capacity of superabsorbent dressings varies depending on the design and construction. The use of effective advanced wound dressings is a promising strategy to achieve adequate absorption of wound exudate and malodour promoting wound healing. The aim of the current study is to determine whether there is a difference in the clinical performance of exudate absorption with two commonly used CE-marked superabsorbent dressings when used on VLUs in routine wound care.As primary objective the dressing´s absorption performance and its ability to prevent skin maceration and leakage of the wound dressing will be investigated., conditionsModule conditions: Venous Leg Ulcer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Two assessors are blinded to evaluate some outcomes, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 152, type: ESTIMATED, armsInterventionsModule interventions name: Superabsorbent dressing application, outcomesModule primaryOutcomes measure: Exudate management performance, secondaryOutcomes measure: Dressing change frequency, secondaryOutcomes measure: Moisture-associated skin damages, secondaryOutcomes measure: Occurrence clinical relevant peri-wound skin changes, secondaryOutcomes measure: Changes in wound tissue and general wound pain, secondaryOutcomes measure: Need for debridement after product removal, secondaryOutcomes measure: Patient satisfaction with treatment and product, secondaryOutcomes measure: HCP satisfaction with treatment and product, secondaryOutcomes measure: Changes in quality of life using the "Wound-QoL 14" (short questionnaire measuring quality of life in patients with chronic wounds based on three established disease-specific instruments), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Niels Stensen Klinik, Christliches-Klinikum-Melle, city: Melle, state: Niedersachsten, zip: 49624, country: Germany, contacts name: Jan Heggemann, role: CONTACT, contacts name: Sabine Guth, role: CONTACT, geoPoint lat: 52.20197, lon: 8.33826, hasResults: False
|
protocolSection identificationModule nctId: NCT06300749, orgStudyIdInfo id: LE-CCM, briefTitle: Effectiveness of Chiropractic Cervical Manipulation in Lateral Epicondylitis, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-10-30, primaryCompletionDateStruct date: 2019-01-03, completionDateStruct date: 2019-01-03, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Mesut Arslan, class: OTHER, descriptionModule briefSummary: İt is aimed to examine the effect of chiropractic cervical manipulation on pain, functionality and grip strength in patients with lateral epicondylitis and whether it is preferable to placebo., conditionsModule conditions: Lateral Epicondylitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 50, type: ACTUAL, armsInterventionsModule interventions name: Chiropractic Cervical Manipulation, interventions name: Sham Technique Practice, outcomesModule primaryOutcomes measure: Numerical Pain Scale (NPS), primaryOutcomes measure: Grip Strength, primaryOutcomes measure: Patient Rated Tennis Elbow Evaluation (PRTEE), eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Bitlis Eren University, city: Bitlis, zip: 13000, country: Turkey, geoPoint lat: 38.40115, lon: 42.10784, hasResults: False
|
protocolSection identificationModule nctId: NCT06300736, orgStudyIdInfo id: 2023PI247, briefTitle: Design of a Predictive Score for Contamination of Pediatric Blood Cultures, acronym: HEPIC, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Central Hospital, Nancy, France, class: OTHER, descriptionModule briefSummary: The contamination rate for blood cultures is high in pediatrics, due to different sampling techniques and the difficulty of sampling small-weight children, thus favoring contamination of the devices at the time of sampling. It is also more difficult to distinguish contamination from true bacteremia in children at an early stage, notably due to the limited number of vials that can be taken at any one time.On a daily basis, clinicians are faced with the choice of whether or not to initiate probabilistic antibiotic therapy when faced with the result of a positive blood culture, particularly when identification is not yet available, but only direct examination.Contamination has major consequences for patient management. Studies in adults have shown that contamination increases hospital length of stay by 4 to 5 days, laboratory costs by +20% and recourse to intravenous antibiotic therapy by +39%. In children, studies came to the same conclusion, with greater prescription of antibiotics, particularly intravenous antibiotics, in patients with contaminated blood cultures than in patients with sterile blood cultures. It also showed that 26% of patients with contaminated blood cultures were initially hospitalized because of the positivity of this test.The aim of this research is to determine the factors associated with contamination, in order to create a predictive score that would help clinicians in their decision-making when receiving the blood culture result as "positive"., conditionsModule conditions: Bacteremia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, outcomesModule primaryOutcomes measure: Blood culture diagnosis, secondaryOutcomes measure: Score performance, eligibilityModule sex: ALL, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: CHRU Nancy, city: Nancy, zip: 54000, country: France, geoPoint lat: 48.68439, lon: 6.18496, hasResults: False
|
protocolSection identificationModule nctId: NCT06300723, orgStudyIdInfo id: 2024-BRL-101-SCD-01, briefTitle: Clinical Study of BRL-101 in Severe SCD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-25, primaryCompletionDateStruct date: 2026-03-20, completionDateStruct date: 2026-06-15, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Bioray Laboratories, class: INDUSTRY, collaborators name: First Affiliated Hospital of Guangxi Medical University, descriptionModule briefSummary: This is a single center, non-randomized, open label, single-dose study in subjects with Sickle Cell Disease (SCD). The study will evaluate the safety and efficacy of autologous CRISPR-Cas9 modified CD34+ human hematopoietic stem and progenitor cells (hHSPCs) (BRL-101)., conditionsModule conditions: Sickle Cell Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1, type: ESTIMATED, armsInterventionsModule interventions name: BRL-101, outcomesModule primaryOutcomes measure: Proportion of stem cell engrafted subjects, primaryOutcomes measure: Time to neutrophil engraftment, primaryOutcomes measure: Frequency, severity, and relationship to BRL-101 of adverse events over 12 months following BRL-101 infusion, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 35 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: First Affiliated Hospital of Guangxi Medical University, city: Nanning, state: Guangxi, zip: 530021, country: China, contacts name: Yongrong Lai, phD, role: CONTACT, email: laiyongrong@hotmail.com, geoPoint lat: 22.81667, lon: 108.31667, hasResults: False
|
protocolSection identificationModule nctId: NCT06300710, orgStudyIdInfo id: CPR in PICU, briefTitle: Outcomes and Risk Factors of CPR in PICU, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-02-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: 1. To detect the frequency and the underlying causes of cardiopulmonary arrest .2. To detect outcome of CPR3. To identify the associated risk factors for the different outcomes after CPR among those patients, conditionsModule conditions: Cardio Respiratory Arrest, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, outcomesModule primaryOutcomes measure: incidence of cardiac arrest and survival to discharge from the PICU (dead versus alive), secondaryOutcomes measure: Rate of risk factors associated with outcome of CPR, eligibilityModule sex: ALL, minimumAge: 1 Month, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06300697, orgStudyIdInfo id: HUM00235532, briefTitle: Michigan Food and Atopic Dermatitis (M-FAD) Program - Molecular Analytics Project, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: University of Michigan, class: OTHER, descriptionModule briefSummary: This study will explore potential links between atopic dermatitis and food allergy. This information will be useful to determine atopic dermatitis and food allergy share unique biochemical or genetic identifiers useful for diagnosing and treatments in the future.This is a mechanistic study consisting of obtaining blood and skin samples from participants at baseline. Individuals may also undergo a clinically indicated oral food challenge and have blood and skin samples collected at various times during the oral food challenge. This study will create a molecular map of the pathology of atopic dermatitis and food allergy. This information will be deployed to evaluate the hypothesis that atopic dermatitis and food allergy share unique genetic transcriptional signals in which the study team can then further analyze pathological pathways and cell types., conditionsModule conditions: Atopic Dermatitis, conditions: Food Allergy, conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Data and biospecimen collection, interventions name: Skin biopsies, interventions name: Oral Food Challenge (OFC) procedures, outcomesModule primaryOutcomes measure: Anaphylaxis occurrence rates in each group, secondaryOutcomes measure: Anaphylaxis severity in each group, secondaryOutcomes measure: Reaction rates in each group, secondaryOutcomes measure: Anaphylaxis likelihood in each group based on the Brighton score, eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 55 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: University of Michigan, status: RECRUITING, city: Ann Arbor, state: Michigan, zip: 48109, country: United States, contacts name: Bridgette Kaul, RN, role: CONTACT, phone: 734-963-5634, email: bbeaupre@umich.edu, contacts name: Chase Schuler, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.27756, lon: -83.74088, hasResults: False
|
protocolSection identificationModule nctId: NCT06300684, orgStudyIdInfo id: SBS-2022-0085, briefTitle: Exploring CBTi's Dual Effect on Sleep, Diet, & Chrononutrition, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-11-11, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: American University of Beirut Medical Center, class: OTHER, descriptionModule briefSummary: This study aims to investigate the effects of Cognitive Behavioral Therapy for Insomnia (CBTi) on both sleep patterns and dietary habits in Lebanese adults with insomnia. Sleep patterns and dietary habits are intricately linked, with dysregulated sleep associated with poor diet quality and increased snacking. Conversely, the types of nutrients consumed can affect hormonal balance and circadian rhythm. Insomnia and obesity are interrelated public health concerns, with CBTi showing efficacy in improving sleep. This study will recruit participants with insomnia and randomly assign them to receive either CBTi or basic sleep hygiene education. Baseline assessments will include validated questionnaires about insomnia, dietary habits, and physical activity and a 7-day 24-hour diet recall sheets, as well as actigraphy for sleep parameters, and physical activity assessments. The intervention will last for four weeks, with post-intervention assessments conducted similarly to baseline., conditionsModule conditions: Insomnia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This parallel-design interventional study randomly assigns participants to receive either Cognitive Behavioral Therapy for Insomnia (CBTi) or basic sleep hygiene education over four weeks. CBTi aims to enhance sleep quality, while the control group receives sleep hygiene education. Pre- and post-intervention assessments will measure sleep parameters and dietary habits, comparing outcomes between groups. Randomization ensures unbiased assignment. Statistical analysis evaluates CBTi's effectiveness in improving sleep patterns and diet, exploring the potential indirect impact of improved sleep on diet., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Participants will be blinded to the specific type of intervention they will receive, whether it is Cognitive Behavioral Therapy for Insomnia (CBTi) or basic sleep hygiene education., whoMasked: PARTICIPANT, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Cognitive Behavioral Therapy for Insomnia (CBT-i), outcomesModule primaryOutcomes measure: Change in Bed Time, primaryOutcomes measure: Change in Get Up Time, primaryOutcomes measure: Change in Time in Bed, primaryOutcomes measure: Change in Sleep Onset Latency (in minutes)., primaryOutcomes measure: Change in Sleep Efficiency, primaryOutcomes measure: Change in Wake After Sleep Onset, primaryOutcomes measure: Change in Late-Night Eating Occasions number, primaryOutcomes measure: Change in Eating Window Duration and Fasting Window Duration, primaryOutcomes measure: Change in Number of Meals, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lebanese American University, status: ACTIVE_NOT_RECRUITING, city: Jbaïl, state: Keserwan-Jbeil Governorate, zip: 1102-2801, country: Lebanon, geoPoint lat: 34.12111, lon: 35.64806, locations facility: American University of Beirut Medical Center, status: RECRUITING, city: Beirut, zip: 1100, country: Lebanon, contacts name: Chadi Antoun, MD, role: CONTACT, phone: +961 81 524 015, email: CA116@aub.edu.lb, contacts name: Farid Talih, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Chadi Antoun, MD, role: SUB_INVESTIGATOR, contacts name: Ismat Annan, MSc, role: SUB_INVESTIGATOR, geoPoint lat: 33.88894, lon: 35.49442, hasResults: False
|
protocolSection identificationModule nctId: NCT06300671, orgStudyIdInfo id: PNSÖ-Subtalar pronation, briefTitle: The Effect of Subtalar Joint Pronation Amount on Lower Extremity Alignment and Performance, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-15, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-05-30, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Bahçeşehir University, class: OTHER, descriptionModule briefSummary: The lower extremity consists of segments that can be affected by the relative position of each other. Deviation of one segment from its normal alignment in the lower extremity also affects the alignment of other segments. The hip joint can affect the frontal plane alignment from proximal to distal, while the foot and ankle complex can also affect it from distal to proximal. Increased subtalar joint pronation in the kinetic chain from distal to proximal; is associated with decreased dorsiflexion angle and increased frontal plane projection angle. It has been shown that ankle dorsiflexion limitation causes changes in the biomechanics and kinematics of landing after jumping, but no study examining the effect of foot pronation on jump tests has been found in the literature. Since the foot is located at the most distal point and acts as a support base for the kinematic chain, the smallest dynamic change in the foot affects the balance of the whole body. Due to foot pronation, changes in the sole contact surface may make it difficult for the foot to adapt to the ground, balance and postural stabilization may be adversely affected, and an increase in the workload of the muscles around the joint may be observed. In another study, it is mentioned that there is limited evidence about the effect of foot posture on postural stability. Although there are studies in the literature examining the effects of subtalar joint pronation on lower extremity alignment and postural stability, studies need to examine the effects of different subtalar joint pronation amounts on lower extremity alignment, jumping performance, and postural stability. Our study will contribute to the literature with this aspect., conditionsModule conditions: Balance Disorders, conditions: Foot Injury, conditions: Lower Extremity Problem, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 48 healthy individuals between the ages of 18-40 constitute the population of the study. Participants randomized into neutral, pronation, and hyperpronation groups., primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Foot Posture Index-6, outcomesModule primaryOutcomes measure: Postural Stability, secondaryOutcomes measure: Frontal Plane Projection Angle, secondaryOutcomes measure: Foot and Ankle Ability Measurement, secondaryOutcomes measure: Navicular Drop Test, secondaryOutcomes measure: Weight bearing lunge test, secondaryOutcomes measure: Countermovement jump test without arm swing, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Bahcesehir University, status: RECRUITING, city: Besiktas, state: Istanbul, zip: 34353, country: Turkey, contacts name: Pelin Pişirici, PT, PhD, role: CONTACT, phone: 05055016076, email: pelinpisirici@gmail.com, contacts name: Ozlem Feyzioglu, PT, PhD, role: CONTACT, phone: 05353529794, email: fztozlemfeyzioglu@gmail.com, hasResults: False
|
protocolSection identificationModule nctId: NCT06300658, orgStudyIdInfo id: 900/2/24, briefTitle: Stellate Ganglion Block for Preserving Arteriovenous Fistula in Hemodialysis Patients Undergoing Major Lower Limb Orthopedic Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-09, primaryCompletionDateStruct date: 2024-09-01, completionDateStruct date: 2024-09-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Aswan University, class: OTHER, descriptionModule briefSummary: The aim of this study is to evaluate the role of stellate ganglion blockade (SGB) for preserving arteriovenous fistula in hemodialysis patients undergoing major lower limb orthopedic surgery., conditionsModule conditions: Stellate Ganglion Block, conditions: Arteriovenous Fistula, conditions: Hemodialysis, conditions: Major Lower Limb Orthopedic Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Stellate ganglion block, outcomesModule primaryOutcomes measure: Fistula flow rate, secondaryOutcomes measure: Peak systolic velocity (PSV), secondaryOutcomes measure: End diastolic velocity (EDV), secondaryOutcomes measure: Incidence of failure, secondaryOutcomes measure: Adverse effects, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Aswan University, status: RECRUITING, city: Aswan, zip: 81528, country: Egypt, contacts name: Ayman M Eldemrdash, MD, role: CONTACT, phone: 00201001296116, email: ayman.mohamady@aswu.edu.eg, contacts name: Soudy S Hammad, MD, role: SUB_INVESTIGATOR, contacts name: Tarek S Hemaida, MD, role: SUB_INVESTIGATOR, contacts name: Taha T Dardeer, MD, role: SUB_INVESTIGATOR, contacts name: Ahmed A Mohsen, MD, role: SUB_INVESTIGATOR, contacts name: Ahmed K Fathy, MD, role: SUB_INVESTIGATOR, contacts name: Gamal H Shams, MD, role: SUB_INVESTIGATOR, geoPoint lat: 24.09082, lon: 32.89942, hasResults: False
|
protocolSection identificationModule nctId: NCT06300645, orgStudyIdInfo id: SPLATTvsTATT in recurrent CTEV, briefTitle: SPLATT to Peroneus Brevis vs TATT to Lateral Cuneiform, acronym: Recurrent CTEV, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-01-17, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Congenital talipes equinovarus, is a common congenital foot deformity involving hindfoot equinus and varus, along with mid-/forefoot adduction and cavus. Currently, the Ponseti method is the preferred initial treatment for idiopathic clubfoot1. Despite the initial phase's remarkable efficacy in correcting clubfeet, there remains a notable recurrence rate after Ponseti treatment2* Numerous studies demonstrate a very high success rate during early follow-ups, ranging from 92% to 100%3* Nonetheless, recurrence remains a challenge for orthopedic surgeons. A common trigger for recurrence is the dynamic supination of the foot, which results from excessive activation of the tibialis anterior muscle during ankle dorsiflexion4Multiple studies indicate that tibialis anterior tendon transfer (TATT) is an effective tool for management of clubfoot recurrence, particularly dynamic supination5* The widely used technique involves transferring the entire tendon through a drill hole in the lateral cuneiform and anchoring it on the plantar aspect of the foot using a sewing button and felt pad6* While effective, this procedure raises the risk of pressure sores due to button placement on the sole7Split anterior tibialis tendon transfer (SPLATT) to peroneus brevis is a well-described treatment strategy of varus foot deformities in patients with neuromuscular disorders8* The technique has been reported to achieve successful deformity correction while avoiding skin problems associated with external button placement on the sole of the foot in tendon-to-bone transfers8The present study aims to assess the outcome of utilizing SPLATT to peroneus brevis procedure in the treatment of recurrent CTEV in comparison to the original total TATT to the lateral cuneiform, conditionsModule conditions: Recurrent Congenital Talipes Equinovarus, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: SPLATT, outcomesModule primaryOutcomes measure: Correction of recurrent congenital talipes, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Assiut university hospital, city: Assiut, zip: 71515, country: Egypt, geoPoint lat: 27.18096, lon: 31.18368, hasResults: False
|
protocolSection identificationModule nctId: NCT06300632, orgStudyIdInfo id: Geriatric Locomotive Syndrome, briefTitle: Geriatric Locomotive Syndrome and Related Factors in Older Adults, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Kırıkkale University, class: OTHER, descriptionModule briefSummary: It has been stated that the results of physical function and physical performance affecting locomotive syndrome in elderly individuals are controversial and studies are still needed. However, no studies have been found examining its relationship with the decrease in physical activity level, decline in cognitive functions, kinesiophobia (fear of movement) and fatigue seen in old age. Early detection of locomotive syndrome risk factors in elderly individuals will help prevent this condition, detect the risk of falling in elderly individuals and increase their quality of life. Based on these deficiencies, it is aimed to examine the relationship between locomotive syndrome and kinesiophobia, physical activity level, physical performance, fatigue and cognitive functions in elderly individuals., conditionsModule conditions: Locomotive Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 97, type: ESTIMATED, armsInterventionsModule interventions name: geriatric locomotive syndrome, outcomesModule primaryOutcomes measure: Geriatric Locomotive Function Scale, primaryOutcomes measure: Two Step Test, primaryOutcomes measure: Stand Up Test, primaryOutcomes measure: Tampa Kinesiophobia Scale, primaryOutcomes measure: Physical Activity Scale for the Elderly (PASE), primaryOutcomes measure: Short Physical Performance Battery, primaryOutcomes measure: Fatigue Severity Scale, primaryOutcomes measure: Montreal Cognitive Assessment Scale (MoCA), eligibilityModule sex: ALL, minimumAge: 65 Years, maximumAge: 85 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ayşe Abit Kocaman, status: RECRUITING, city: Kırıkkale, country: Turkey, contacts name: Ayşe Abit Kocaman, Asst. Prof., role: CONTACT, phone: +90318-357 37 38 / 4700, email: ayseabit@gmail.com, geoPoint lat: 39.84528, lon: 33.50639, hasResults: False
|
protocolSection identificationModule nctId: NCT06300619, orgStudyIdInfo id: 2022-066, briefTitle: Pilates+4MS: Pilates Intervention for Multiple Sclerosis, acronym: P+4MS, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-04-05, primaryCompletionDateStruct date: 2022-08-25, completionDateStruct date: 2022-08-25, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: University of Colorado, Colorado Springs, class: OTHER, collaborators name: University of Illinois at Urbana-Champaign, descriptionModule briefSummary: The goal of this clinical trial is to test the physical health benefits of seated Pilates in the multiple sclerosis (MS) population. The main questions it aims to answer are: 1) is it feasible to deliver a seated Pilates class for 12 weeks, twice weekly over Zoom in a group format among participants with mild, moderate, and severe multiple sclerosis? 2) what are the mobility, balance, and symptom benefits of a 12-week seated Pilates class? 3) Does incorporating hip and shoulder stabilization augment the benefits compared to a standard seated Pilates protocol? 4) Are there benefits to physical activity participation? Participants will be screened over the phone for eligibility criteria and then scheduled for in-person data collection. In person data collection will involve: 1) completing the Timed 25-Foot Walk a total of 4 times, 2) the Timed Up and Go a total of 4 times, 3) the Berg Balance Scale a total of 2 times, and 4) a set of 8 questionnaires about multiple sclerosis symptoms and impact, and physical activity behavior. Participants will receive a FitBit and then will be randomized into the Pilates only group or the Pilates+4-Quadrant stability group for the intervention. The intervention is 12 weeks long, both groups meet twice weekly on Zoom for 60 minutes with 1 of 2 instructors and other class participants (12 per group). They wear the FitBit for all 12 weeks and then return for testing to repeat testing items 1-4 above. Researchers will compare the functional outcomes between the Pilates only group and the Pilates+4-Quadrant Stability group to see if there are differences in mobility, balance and physical activity outcomes., conditionsModule conditions: Multiple Sclerosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: Participants know that there are 2 Pilates groups, but not which group is under investigation vs. the comparison group., whoMasked: PARTICIPANT, enrollmentInfo count: 22, type: ACTUAL, armsInterventionsModule interventions name: Pilates+4, interventions name: Pilates, outcomesModule primaryOutcomes measure: Timed 25 Foot Walk, primaryOutcomes measure: Timed Up and Go, primaryOutcomes measure: Berg Balance Scale, secondaryOutcomes measure: Triaxial Accelerometer (FitBit) Physical Activity Data (minutes of wear time in sedentary time and light, moderate and vigorous physical activity), secondaryOutcomes measure: The Godin-Shepherd Leisure Time Exercise Questionnaire, secondaryOutcomes measure: Late-Life Function and Disability Instrument Short Form, secondaryOutcomes measure: Leeds Multiple Sclerosis Quality of Life Scale, secondaryOutcomes measure: Modified Fatigue Impact Scale, secondaryOutcomes measure: Multiple Sclerosis Impact Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hybl Sports Medicine and Performance Center, city: Colorado Springs, state: Colorado, zip: 80918, country: United States, geoPoint lat: 38.83388, lon: -104.82136, hasResults: False
|
protocolSection identificationModule nctId: NCT06300606, orgStudyIdInfo id: NOL1 and RA, briefTitle: Nociception Index Level (NOL) Perioperative Monitoring During Regional Anesthesia, acronym: NOL and LRA, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2024-04-15, completionDateStruct date: 2024-04-15, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: American Hospital of Paris, class: OTHER, collaborators name: Nataliya KARASHCHUK, collaborators name: Briana LUI, collaborators name: Thierry GUENOUN, collaborators name: Stephane ROMANO, descriptionModule briefSummary: This prospective observational study was conducted to assess pain using NOL index under locoregional anesthesia for orthopedic surgery of the upper limb. We included 50 consecutive adult patients scheduled for orthopedic surgery of the upper limb under locoregional anesthesia. The locoregional anesthesia was performed under ultrasound, with or without neurostimulation. Intraoperative pain is assessed using NOL index monitoring, ALGISCORE and Numerical Scale, and second point study is the midazolam and propofol requirement., conditionsModule conditions: Regional Anesthesia, conditions: Pain, conditions: Intraoperative Monitoring, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: NOL monitoring, outcomesModule primaryOutcomes measure: pain score, primaryOutcomes measure: pain score, secondaryOutcomes measure: sedative requirement, secondaryOutcomes measure: anxiolytic requirement, secondaryOutcomes measure: failure of regional anesthesia, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gilles BOCCARA, status: RECRUITING, city: Neuilly-sur-Seine, zip: 92200, country: France, contacts name: Gilles BOCCARA, role: CONTACT, phone: +33662382833, email: gilles.boccara@ahparis.org, contacts name: thierry GUENOUN, role: CONTACT, phone: +33146412691, email: thierry.guenoun@ahparis.org, geoPoint lat: 48.8846, lon: 2.26965, hasResults: False
|
protocolSection identificationModule nctId: NCT06300593, orgStudyIdInfo id: 1072.6120.292.2022-1, briefTitle: Activity of Chronic Inflammation in PCOS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-15, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Jagiellonian University, class: OTHER, descriptionModule briefSummary: Chronic inflammation in polycystic ovary syndrome (PCOS) may be the result of dysregulation of cytokine production (due to insulin resistance, excess visceral fat and hyperandrogenemia), i.e., overproduction of pro-inflammatory factors (e.g. TNF, IL-1, IL-6) in relation to anti-inflammatory ones (IL-10). This condition may be an important link between obesity and insulin resistance, which is crucial in the etiopathogenesis of the syndrome. However, it is not known whether it results from the tendency to accumulate adipose tissue or is a feature of the syndrome itself. There is no data indicating the relationship between chronic inflammation and the severity of metabolic disorders and the value of ovarian reserve in women with various PCOS phenotypes., conditionsModule conditions: Polycystic Ovary Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Measurement and comparison of leucocytosis and concentrations of C-reactive protein (CRP), interleukin-1 (IL-1), IL-6, IL-10, Tumor Necrosis Factor (TNF-alpha) in PCOS phenotypes A, B, C and D, interventions name: Evaluation of the correlation of serum concentrations of selected inflammatory markers (leucocytosis, CRP, IL-1, IL-6, IL-10, TNF-alpha) with metabolic and hormonal parameters, outcomesModule primaryOutcomes measure: Values of inflammation parameters - leukocytosis in peripheral blood in the four PCOS phenotypes, primaryOutcomes measure: Values of inflammation parameters - C-reactive protein (CRP) in peripheral blood in the four PCOS phenotypes, primaryOutcomes measure: Values of inflammation parameters - IL-1 in peripheral blood in the four PCOS phenotypes, primaryOutcomes measure: Values of inflammation parameters - IL-6 in peripheral blood in the four PCOS phenotypes, primaryOutcomes measure: Values of inflammation parameters - IL-10 in peripheral blood in the four PCOS phenotypes, primaryOutcomes measure: Values of inflammation parameters - TNF-alpha in peripheral blood in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the HOMA-IR value and the parameters of inflammation - leukocytosis in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the homeostatic model assessment for insulin resistance (HOMA-IR) value and the parameters of inflammation - CRP in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the HOMA-IR value and the parameters of inflammation - il-1 in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the HOMA-IR value and the parameters of inflammation - il-6 in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the concentration of HOMA-IR and the parameters of inflammation - il-10 in in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the HOMA-IR value and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the body mass index (BMI) value and the parameters of inflammation - leukocytosis in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the BMI value and the parameters of inflammation - CRP in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the BMI value and the parameters of inflammation - il-1 in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the BMI value and the parameters of inflammation - il-6 in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the concentration of BMI and the parameters of inflammation - il-10 in in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the BMI value and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of aspartate aminotransferase (AST) concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of AST concentration and the parameters of inflammation - CRP in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of AST concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of AST concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of AST concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of AST concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of alanine aminotransferase (ALT) concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of ALT concentration and the parameters of inflammation - CRP in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of ALT concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of ALT concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of ALT concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of ALT concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of total bilirubin concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of total bilirubin concentration and the parameters of inflammation - CRP in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of total bilirubin concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of total bilirubin concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of total bilirubin concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of total bilirubin concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of total cholesterol concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of total cholesterol concentration and the parameters of inflammation - CRP in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of total cholesterol concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of total cholesterol concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of total cholesterol concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of total cholesterol concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of triglycerides concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of triglycerides concentration and the parameters of inflammation - CRP in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of triglycerides concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of triglycerides concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of triglycerides concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of triglycerides concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of Anti-Müllerian hormone (AMH) concentration and the parameters of inflammation - leukocytosis in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of AMH concentration and the parameters of inflammation - CRP in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of AMH concentration and the parameters of inflammation - il-1 in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of AMH concentration and the parameters of inflammation - il-6 in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of AMH concentration and the parameters of inflammation - il-10 in in the four PCOS phenotypes, secondaryOutcomes measure: Correlation between the value of AMH concentration and the parameters of inflammation - TNF-alpha in the four PCOS phenotypes, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Jagiellonian University Medical College, status: RECRUITING, city: Krakow, zip: 31-501, country: Poland, contacts name: Iwona Gawron, PhD, MD, role: CONTACT, phone: +48 124248570, email: iwona.gawron@uj.edu.pl, contacts name: Robert Jach, Prof., role: CONTACT, phone: +48 124248571, email: jach@uj-cm.krakow.pl, geoPoint lat: 50.06143, lon: 19.93658, hasResults: False
|
protocolSection identificationModule nctId: NCT06300580, orgStudyIdInfo id: M23-991, briefTitle: Study of Oral ABBV-932 Capsules to Evaluate Dopamine D2 and D3 Receptor Occupancy in Brain in Adult Healthy Volunteers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-03, primaryCompletionDateStruct date: 2024-10-30, completionDateStruct date: 2024-10-30, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: AbbVie, class: INDUSTRY, descriptionModule briefSummary: The main objective of this study is to evaluate the dopamine D2 and D3 receptor occupancy in the brain as measured by PET with radiotracer \[11C\]-(+)-PHNO up to 14 days of once-daily oral doses of ABBV-932 in healthy subjects.ABBV-932 is a dopamine D3 receptor-preferring D3/D2 receptor partial agonist. Approximately 12 adult healthy volunteers will be enrolled in the United Kingdom.Participants will receive ABBV-932 oral capsules once daily for 2 weeks and followed for 60 days.Participants will be confined for approximately 15 days. Participants will receive 3 \[11C\]-(+)-PHNO PET scans during the study. Adverse Events and blood tests will be performed., conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: ABBV-932, outcomesModule primaryOutcomes measure: Change in Dopamine Receptor Occupancy in Brain Measured by Positron Emission Tomography (PET), primaryOutcomes measure: Number of Participants with Adverse Events (AEs), eligibilityModule sex: ALL, minimumAge: 23 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06300567, orgStudyIdInfo id: CFTR-RD misdiagnosis, briefTitle: Assessment of Patients Not Concluded After Neonatal Screening of Cystic Fibrosis., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-05-02, completionDateStruct date: 2026-11-02, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Hôpital Necker-Enfants Malades, class: OTHER, descriptionModule briefSummary: Assessment of the outcome of patients not concluded fir cystic fibrosis, either symptomatic patients or asymptomatic children detected by newborn screening for cystic fibrosis. The aim is to identify patients potentially at risk of progressing to the clinical spectrum of cystic fibrosis, conditionsModule conditions: CFTR-RD, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: data collection, outcomesModule primaryOutcomes measure: lung Imaging, secondaryOutcomes measure: lung infection, secondaryOutcomes measure: pancreatic function, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
|
protocolSection identificationModule nctId: NCT06300554, orgStudyIdInfo id: 2023-1653, secondaryIdInfos id: A171600, type: OTHER, domain: UW Madison, secondaryIdInfos id: Version 1/26/2024, type: OTHER, domain: UW Madison, briefTitle: 10th Mountain Healthy Minds Program App Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: University of Wisconsin, Madison, class: OTHER, descriptionModule briefSummary: The purpose of the study is to evaluate the acceptability, feasibility, and preliminary effects of the Healthy Minds Program (HMP) App in approximately 150 active duty military members., conditionsModule conditions: Well-Being, Psychological, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Healthy Minds Program App, outcomesModule primaryOutcomes measure: System Usability Scale Score, primaryOutcomes measure: Acceptability of Intervention Measure (AIM), primaryOutcomes measure: Intervention Appropriateness Measure (IAM), primaryOutcomes measure: Feasibility of Intervention Measure (FIM), primaryOutcomes measure: HMP App Usage: Did you use the Healthy Minds Program App (Yes or No), primaryOutcomes measure: HMP App Usage: Did you download the Healthy Minds Program App (Yes or No), secondaryOutcomes measure: Change in Perceived Stress Score, secondaryOutcomes measure: Change in WHO-5 Well-Being Score, secondaryOutcomes measure: Change in PROMIS Depression Score, secondaryOutcomes measure: Change in PROMIS Anxiety Score, secondaryOutcomes measure: Change in Meaning of Life Questionnaire - Presence Subscale Score, secondaryOutcomes measure: Change in NIH Toolbox Loneliness Score, secondaryOutcomes measure: Change in Suicide Cognitions Scale Score, secondaryOutcomes measure: HMP App Usage: How many times did you use the HMP App, otherOutcomes measure: HMP App Usage: Reasons for not downloading the HMP App, otherOutcomes measure: HMP App Usage: Reasons for not opening the HMP App, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Wisconsin, city: Madison, state: Wisconsin, zip: 53705, country: United States, geoPoint lat: 43.07305, lon: -89.40123, hasResults: False
|
protocolSection identificationModule nctId: NCT06300541, orgStudyIdInfo id: 940730, briefTitle: Prevalence and Impact of Sarcopenia in Patients With Inflammatory Bowel Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-04-01, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2027-12-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Sahlgrenska University Hospital, Sweden, class: OTHER, collaborators name: Ersta Hospital, Sweden, descriptionModule briefSummary: Sarcopenia is a condition characterized by significant muscle loss resulting in impaired muscle function. This condition is likely associated with a biological deviation leading to reduced reserves to withstand stressors, resulting in a poorer prognosis. The incidence of sarcopenia among patients with inflammatory bowel diseases (Ulcerative Colitis and Crohn's disease) is currently approximately 40-60%. This is likely a consequence of the preference for drug treatment over surgery, while many patients have continuous inflammation in their intestines leading to muscle loss and subsequently increased morbidity and mortality.The purpose of the study is to identify the prevalence of sarcopenia among patients experiencing a severe flare-up of their bowel disease and to evaluate whether the removal of the colon results in improved nutritional status. Furthermore, the investigators aim to investigate whether there is a specific microbiota composition related to an unfavorable course.The participants are longitudinally monitored with measurements taken at the flare-up/before surgery and one year afterward, including body composition, function, dietary recording, quality of life, blood tests, fecal samples, and intestinal biopsies that will be analyzed. The investigators plan to correlate body composition with a biological profile and then evaluate if there is an association. Additionally, the investigators aim to analyze if these markers are linked to different outcomes after colectomy. This study will contribute to an enhanced understanding of patients with advanced IBD and possibly change the perspective on how the clinicians should prioritize these patients for surgery. The investigators believe this study will lead to an improvement in healthcare quality and an enhanced understanding of how these disease processes function., conditionsModule conditions: Inflammatory Bowel Diseases, conditions: Sarcopenia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Colectomy, outcomesModule primaryOutcomes measure: Number of participants with increase in muscle mass as assessed by DEXA scan., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sahlgrenska University Hospital, status: RECRUITING, city: Gothenburg, zip: 41345, country: Sweden, contacts name: Jonas Varkey, MD, PhD, role: CONTACT, phone: 0046764030388, email: jonas.varkey@vgregion.se, geoPoint lat: 57.70716, lon: 11.96679, hasResults: False
|
protocolSection identificationModule nctId: NCT06300528, orgStudyIdInfo id: OSU-23423, secondaryIdInfos id: NCI-2024-01530, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), briefTitle: Pemigatinib for the Treatment of Patients With Relapsed or Refractory Mantle Cell Lymphoma or Marginal Zone Lymphoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-30, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Narendranath Epperla, class: OTHER, descriptionModule briefSummary: This phase II trial tests how well pemigatinib works in treating patients with mantle cell lymphoma (MCL) or marginal zone lymphoma (MZL) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Pemigatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth., conditionsModule conditions: Recurrent Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue, conditions: Recurrent Mantle Cell Lymphoma, conditions: Recurrent Marginal Zone Lymphoma, conditions: Recurrent Nodal Marginal Zone Lymphoma, conditions: Recurrent Splenic Marginal Zone Lymphoma, conditions: Refractory Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue, conditions: Refractory Mantle Cell Lymphoma, conditions: Refractory Marginal Zone Lymphoma, conditions: Refractory Nodal Marginal Zone Lymphoma, conditions: Refractory Splenic Marginal Zone Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Biospecimen Collection, interventions name: Bone Marrow Aspiration, interventions name: Bone Marrow Biopsy, interventions name: Computed Tomography, interventions name: Pemigatinib, interventions name: Positron Emission Tomography, outcomesModule primaryOutcomes measure: Overall response rate (ORR), secondaryOutcomes measure: Complete response (CR) rate, secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Incidence of adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ohio State University Comprehensive Cancer Center, city: Columbus, state: Ohio, zip: 43210, country: United States, contacts name: Narendranath Epperla, MD, MS, role: CONTACT, phone: 614-393-3196, contacts name: Narendranath Epperla, MD, MS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.96118, lon: -82.99879, hasResults: False
|
protocolSection identificationModule nctId: NCT06300515, orgStudyIdInfo id: PI23/00396, briefTitle: Exercise and Health Counseling in Pediatric Hematopoietic Stem Cell Transplantation, acronym: HENKO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-03-30, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Alejandro Lucia, class: OTHER, collaborators name: Hospital Infantil Universitario Niño Jesús, Madrid, Spain, collaborators name: Hospital General Universitario Gregorio Marañon, collaborators name: Hospital Universitario La Paz, collaborators name: Hospital Universitario 12 de Octubre, descriptionModule briefSummary: Thanks to medical advances, survival rates \>5 years in children/adolescents undergoing hematopoietic stem cell transplant (HSCT) exceed 70%. However, these patients are at high risk of suffering sequelae associated with the underlying disease and/or the HSCT itself, which negatively affects their physical capacity. These patients also tend to spend too much time inactive, which further accelerates functional decline in addition to producing fatigue and impairing quality of life. Therefore, new strategies are needed to minimize the morbidity associated with HSCT. In this effect, although physical exercise represents an interesting adjuvant treatment option for HSCT, scientific evidence in this area is still scarce. Implementation of physical exercise intervention in pediatric HSCT units is challenging due to the lack of research on the effectiveness, affordability and accessibility of this type of intervention. Therefore, establishing the effectiveness of physical exercise under controlled conditions is an important step. The investigators therefore aim to assess the impact of a physical exercise and health counseling program, compared to health counseling only (control group), in pediatric patients with cancer undergoing HSCT on physical-functional, behavioral, psycho-cognitive and clinical outcomes, and blood biomarkers. The investigators will also determine to what extent the benefits of this intervention are maintained over time. Additionally, the investigators will determine the feasibility of implementing the proposed intervention in a real clinical situation in 3 different pediatric HSCT units., conditionsModule conditions: Hematopoietic System--Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: The staff in charge of outcome assessment will be blinded to the group assigned to each participant., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Control Group (Active Comparator), interventions name: Intervention Group, outcomesModule primaryOutcomes measure: Change in objectively-assessed cardiorespiratory fitness (CRF) from baseline to follow-up, primaryOutcomes measure: Change in estimated cardiorespiratory fitness (CRF) from baseline to follow-up, secondaryOutcomes measure: Change in isometric leg muscle strength from baseline to follow-up, secondaryOutcomes measure: Change in dynamic lower-limb muscle strength from baseline to follow-up, secondaryOutcomes measure: Change in upper-limb muscle strength from baseline to follow-up, secondaryOutcomes measure: Change in respiratory muscle strength from baseline to follow-up, secondaryOutcomes measure: Change in the 'ventilatory threshold' (VT) from baseline to follow-up, secondaryOutcomes measure: Change in left ventricle (LV) ejection fraction from baseline to follow-up, secondaryOutcomes measure: Change in left ventricle (LV) fractional shortening from baseline to follow-up, secondaryOutcomes measure: Change in left ventricle (LV) global longitudinal strain (GLS) from baseline to follow-up, secondaryOutcomes measure: Change in total cardiac mass from baseline to follow-up, secondaryOutcomes measure: Change in functional mobility (stairs test) from baseline to follow-uo, secondaryOutcomes measure: Change in functional mobility (chair rising) from baseline to follow-up, secondaryOutcomes measure: Change in functional mobility (Quick Function test) from baseline to follow-up, secondaryOutcomes measure: Change in body mass index (BMI) from baseline to follow-up, secondaryOutcomes measure: Change in adiposity index from baseline to follow-up, secondaryOutcomes measure: Change in dual-energy X-ray absorptiometry (DXA) measures of total lean mass from baseline to follow-up, secondaryOutcomes measure: Change in dual-energy X-ray absorptiometry (DXA) measures of total fat mass from baseline to follow-up, secondaryOutcomes measure: Change in dual-energy X-ray absorptiometry (DXA) measures of bone health from baseline to follow-up, secondaryOutcomes measure: Change in physical activity (PA) from baseline to end of treatment, secondaryOutcomes measure: Change in ankle-dorsiflexion from baseline to end of treatment, secondaryOutcomes measure: Change in psychological status (health-related quality of life) from baseline to follow-up, secondaryOutcomes measure: Change in psychological status (fatigue) from baseline to follow-up, secondaryOutcomes measure: Change in lymphocyte subpopulations from baseline to follow-up, secondaryOutcomes measure: Change in immune phenotype from baseline to follow-up, secondaryOutcomes measure: Change in survival from baseline to follow-up, secondaryOutcomes measure: Change in treatment tolerability from baseline to follow-up, secondaryOutcomes measure: Change in treatment toxicities from baseline to follow-up, secondaryOutcomes measure: Change in the 'acute' molecular response to a single exercise session from baseline to 8 weeks after hospital discharge, secondaryOutcomes measure: Change in the 'chronic' (resting conditions) transcriptome from baseline to 8 weeks after hospital discharge, secondaryOutcomes measure: Change in the 'acute' transcriptome response to a single exercise session from baseline to 8 weeks after hospital discharge, secondaryOutcomes measure: Change in the 'acute' transcriptome response from baseline to 8 weeks after hospital discharge, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 21 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Hospital 12 de Octubre, city: Madrid, zip: 28041, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False
|
protocolSection identificationModule nctId: NCT06300502, orgStudyIdInfo id: 2023P003620, briefTitle: Assessing the Efficacy of Repeat, Monthly Treatments of Cutaneous Neurofibromas (cNFs), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Massachusetts General Hospital, class: OTHER, collaborators name: Johns Hopkins University, descriptionModule briefSummary: This study will evaluate the tolerability and effectiveness of four FDA-approved treatments in Neurofibromatosis Type 1 Cutaneous Neurofibromas. These treatments are: a 1064nm laser, a 755nm laser, and Kybella and Polidocanol injections. Each patient will have a treatment and a control site.This study is designed with the goal of improved efficacy/tumor reduction via multiple treatment visits. If there is minimal to no clinical improvement in tumor size with one treatment after three treatment visits, the subject will be given the option of crossover treatment with the most effective of the four treatments. Three treatment visits with the crossover treatment will then take place., conditionsModule conditions: Neurofibromas, Cutaneous, conditions: Neurofibromatosis 1, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Kybella, interventions name: Asclera, interventions name: 755nm Alexandrite Laser, interventions name: 1064nm Nd:YAG Laser, outcomesModule primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], secondaryOutcomes measure: Numeric Rating Scale (NRS-11)/Patient Satisfaction, secondaryOutcomes measure: Skindex 16, secondaryOutcomes measure: Patient Reported Outcomes, secondaryOutcomes measure: Clinician Reported Outcomes, otherOutcomes measure: Rate of healing, otherOutcomes measure: cNF appearance (volume), otherOutcomes measure: cNF appearance (height), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Wellman Center for Photomedicine, city: Boston, state: Massachusetts, zip: 02114, country: United States, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
|
protocolSection identificationModule nctId: NCT06300489, orgStudyIdInfo id: CARTOnG-2401, briefTitle: Genotype-driven Weekly Irinotecan Liposomes in Combination With Capecitabine-based Neoadjuvant Chemoradiation for Locally Advanced Rectal Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-03, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-10-31, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Zhejiang Cancer Hospital, class: OTHER, descriptionModule briefSummary: This study is a multicenter, open, and phase I dose increasing clinical study. Based on the UGT1A1 \* 28 and \* 6 genotypes of patients with locally advanced rectal cancer, determine the dose limiting toxicity (DLT) and maximum tolerable dose (MTD) of weekly irinotecan liposomes in concurrent chemoradiotherapy with capecitabine, investigate the tolerance of irinotecan liposome combined with capecitabine in concurrent chemoradiotherapy with locally advanced rectal cancer, and recommend the dosage for Phase II clinical study，and explore the pharmacokinetic characteristics of irinotecan liposomes combined with capecitabine.At the same time，Preliminary observe the efficacy and safety of irinotecan liposomes combined with capecitabine in chemoradiotherapy.The study plans to recruit 30 patients with advanced rectal cancer who have not received any therapy., conditionsModule conditions: Rectal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: irinotecan liposomes+capecitabine, outcomesModule primaryOutcomes measure: DLT（dose-limiting toxicity）, primaryOutcomes measure: MTD（maximum tolerable dose）, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhejiang Cancer Hospital, status: RECRUITING, city: Hangzhou, state: Zhejiang, country: China, contacts name: Ji Zhu, role: CONTACT, phone: 0571-88128152, email: leo.zhu@126.com, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
|
protocolSection identificationModule nctId: NCT06300476, orgStudyIdInfo id: 2023-1511, briefTitle: Safety and Efficacy of a Single Subretinal Injection of JWK006 Gene Therapy in Subjects With Stargardt Disease(STGD1), statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-11-20, primaryCompletionDateStruct date: 2026-12-30, completionDateStruct date: 2029-12-30, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: West China Hospital, class: OTHER, descriptionModule briefSummary: The purpose of the study is to assess the safety and efficacy of JWK006 in Stargardt Disease(STGD1).JWK006 is packed by adeno-associated virus vector that expressing ABCA4 gene., conditionsModule conditions: Stargardt Disease 1, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 9, type: ESTIMATED, armsInterventionsModule interventions name: JWK006, outcomesModule primaryOutcomes measure: Safety(Participants With Ocular and Non-ocular AEs (Adverse Events) and SAEs (Serious Adverse Events), secondaryOutcomes measure: Visual acuity, secondaryOutcomes measure: Ophthalmoscope Measurement, secondaryOutcomes measure: Qualitative and quantitative assessments of autofluorescence pattern (FAF), secondaryOutcomes measure: multifocal electroretinogram (mfERG), eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: West China Hospital, city: Chengdu, state: Sichuan, zip: 610044, country: China, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
|
protocolSection identificationModule nctId: NCT06300463, orgStudyIdInfo id: 23-06026214, briefTitle: Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Weill Medical College of Cornell University, class: OTHER, collaborators name: Agenus Inc., descriptionModule briefSummary: The goal of this clinical trial is to to learn about different combinations of immunotherapy in patients with colorectal cancer whose cancer has spread to their liver and are planning to have surgery to remove tumor metastases from their liver. The main questions it aims to answer are:* whether these combinations of immunotherapy change the tumor microenvironment in the liver* whether these combinations of immunotherapy are safe and effective when used in colorectal cancer with liver metastasesParticipants will be randomly assigned to one of the following:* Botensilimab and balstilimab* Botensilimab, balstilimab, and AGEN1423* Botensilimab, balstilimab, and radiationParticipants will be asked to come in to receive drug infusions (and radiation, if applicable) before and after their surgical resection. Participants will be followed for up to 2 years., conditionsModule conditions: Colorectal Cancer Metastatic, conditions: Liver Metastases, conditions: Colorectal Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Botensilimab, interventions name: Balstilimab, interventions name: AGEN1423, interventions name: Radiation, outcomesModule primaryOutcomes measure: Mean CD8:Treg ratio, as determined by flow cytometry of tumor tissue, at time of surgical resection in each treatment arm, secondaryOutcomes measure: Number of Treatment-Related Adverse Events (TRAEs) as assessed by CTCAE v5.0 per treatment arm, secondaryOutcomes measure: Pathological Response Rate Per Arm, secondaryOutcomes measure: Radiographic Response Rate Per Arm, secondaryOutcomes measure: Number of Participants Per Arm with ctDNA Clearance, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Weill Cornell Medicine/NewYork-Presbyterian Hospital, status: RECRUITING, city: New York, state: New York, zip: 10065, country: United States, contacts name: Casey Owens, role: CONTACT, phone: 646-962-8189, email: cdo4001@med.cornell.edu, contacts name: Myriam Elizaire-Williams, role: CONTACT, email: mye4001@med.cornell.edu, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
|
protocolSection identificationModule nctId: NCT06300450, orgStudyIdInfo id: 2022P002171, briefTitle: Randomized Controlled Trial of Alert-Based Computerized Decision Support for Patients With Peripheral Artery Disease Not Prescribed Lipid-Lowering Therapy, acronym: PAD-ALERT, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2025-02-28, completionDateStruct date: 2025-07-30, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Brigham and Women's Hospital, class: OTHER, collaborators name: Esperion Therapeutics, Inc., descriptionModule briefSummary: This single-center, 400-patient, randomized controlled trial assesses the impact of a patient- and provider-facing EPIC Best Practice Advisory (BPA; alert-based computerized decision support tool) to increase guideline-directed utilization of statin and statin-alternative oral LDL-C lowering therapies in patients with PAD who are not being prescribed LDL-C-lowering therapy., conditionsModule conditions: Peripheral Artery Disease, conditions: Peripheral Vascular Diseases, conditions: Dyslipidemias, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 400-patient U.S.-based single-center Quality Improvement Initiative in the form of a randomized controlled trial focused on the feasibility of implementation of this patient- and provider-facing alert-based CDS (EPIC BPA), primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Participants, investigators and outcomes assessors will be blinded to the assignment of the clinician to the computer alert or control (non-alert) group., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Computer Alert, outcomesModule primaryOutcomes measure: Frequency of prescription of oral LDL-C-lowering therapy, secondaryOutcomes measure: Change in LDL-C level, otherOutcomes measure: Frequency of all-cause mortality, otherOutcomes measure: Frequency of major adverse cardiovascular events, otherOutcomes measure: Frequency of major adverse limb events, otherOutcomes measure: Frequency of all-cause hospitalization, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Brigham and Women's Hospital, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: Gregory Piazza, MD, MS, role: CONTACT, phone: 617-732-6984, email: gpiazza@bwh.harvard.edu, contacts role: CONTACT, phoneExt: Piazza, email: gpiazza@bwh.harvard.edu, contacts name: Gregory Piazza, MD, MS, role: PRINCIPAL_INVESTIGATOR, contacts name: Samuel Goldhaber, MD, role: SUB_INVESTIGATOR, contacts name: Ron Blankstein, MD, role: SUB_INVESTIGATOR, contacts name: Jorge Plutzky, MD, role: SUB_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
|
protocolSection identificationModule nctId: NCT06300437, orgStudyIdInfo id: MS-372-2023, briefTitle: The Effects of Jaw Thrust on the Time to Successful Fiberoptic Pediatric Orotracheal Intubation During Residents Training Program, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-03, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-08-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Kasr El Aini Hospital, class: OTHER, descriptionModule briefSummary: In this study, the authors aim to investigate the effect of adding jaw thrust maneuver on time to successful orotracheal fiberoptic intubation of pediatrics during resident training program., conditionsModule conditions: Intubation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In this study, children undergoing elective surgery under general anesthesia will be randomized into 2 groups.* Group (J): will include the children who will receive jaw thrusting during fiberoptic intubation.* Group (C): will include the children who will not receive jaw thrusting (just sub laxed open mouth), primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: jaw thrust, interventions name: control (sub laxed jaw), outcomesModule primaryOutcomes measure: time to successful endotracheal tube insertion, secondaryOutcomes measure: Number of attempts to successful intubation, secondaryOutcomes measure: Complication, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 15 Years, stdAges: CHILD, contactsLocationsModule locations facility: Cairo university hospitals, status: RECRUITING, city: Cairo, country: Egypt, contacts name: Khaled Sarhan, role: CONTACT, phone: +201020067816, email: khaled.sarhan@kasralainy.edu.eg, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
|
protocolSection identificationModule nctId: NCT06300424, orgStudyIdInfo id: KY2024-162, briefTitle: Neoadjuvant Almonertinib Followed by Chemo-immunotherapy in II-IIIB EGFR-mutant NSCLC, acronym: NEOVADE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2027-09, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Guangdong Provincial People's Hospital, class: OTHER, descriptionModule briefSummary: Phase II, single-arm, open-label study that assess clinical feasibility and safety of neoadjuvant almonertinib followed by 3 cycles neoadjuvant adebrelimab plus chemotherapy in EGFR-mutant stage IIA-IIIB NSCLC followed by surgery, adjuvant treatment was upon investigators' decisions., conditionsModule conditions: Non Small Cell Lung Cancer, conditions: EGFR Gene Mutation, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: almonertinib, interventions name: Carboplatin, interventions name: Nab paclitaxel, outcomesModule primaryOutcomes measure: Major Pathological Response (MPR), secondaryOutcomes measure: Pathological Complete Response (pCR), secondaryOutcomes measure: Objective Response Rate (ORR), otherOutcomes measure: Overall Survival (OS), otherOutcomes measure: Event Free Survival (EFS), otherOutcomes measure: Incidence of Adverse Events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510080, country: China, contacts name: Wen-zhao Zhong, PhD, role: CONTACT, phone: +86 20 83827812, phoneExt: 51221, email: syzhongwenzhao@scut.edu.cn, contacts name: Jun-Tao Lin, PhD, role: CONTACT, email: 237801160@qq.com, contacts name: Wen-zhao Zhong, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Jun-Tao Lin, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
|
protocolSection identificationModule nctId: NCT06300411, orgStudyIdInfo id: SRG-514-01, briefTitle: SRG-514 Administered Intraoperatively to Patients Undergoing Breast-conserving Cancer Surgery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: SURGE Therapeutics, class: INDUSTRY, descriptionModule briefSummary: This is a multicenter, first-in-human (FIH), open label, Phase 1 dose escalation and recommended Phase 2 dose (RP2D) extension trial with a primary objective to define the RP2D of SRG-514 when administered intraoperatively to patients undergoing breast-conserving cancer surgery. SRG-514 will be investigated utilizing a 3+3 convention dose escalation cohorts., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 18, type: ESTIMATED, armsInterventionsModule interventions name: SRG-514, outcomesModule primaryOutcomes measure: Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability], primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability], secondaryOutcomes measure: Pharmacokinetics of SRG-514, secondaryOutcomes measure: Pharmacokinetics of SRG-514, secondaryOutcomes measure: Pharmacodynamics of SRG-514, secondaryOutcomes measure: Wound healing, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
|
protocolSection identificationModule nctId: NCT06300398, orgStudyIdInfo id: ECS_IAMA23_0101, briefTitle: IAMA-6 Oral Dose Study in Healthy Adults, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-08, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Iama Therapeutics S.r.l., class: INDUSTRY, descriptionModule briefSummary: The main purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of IAMA-6 administered orally to healthy adults., conditionsModule conditions: Neurodevelopmental Disorders, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: OTHER, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: IAMA-6, interventions name: Placebo, outcomesModule primaryOutcomes measure: Number of participants with adverse events (AEs), primaryOutcomes measure: Number of participants with serious adverse events (SAEs), primaryOutcomes measure: Number of participants with physical examination abnormalities, primaryOutcomes measure: Number of participants with vital sign abnormalities, primaryOutcomes measure: Number of participants with electrocardiogram (ECG) abnormalities, primaryOutcomes measure: Number of participants with clinical laboratory abnormalities, primaryOutcomes measure: Number of participants with hearing abnormalities, secondaryOutcomes measure: Cmax pharmacokinetic (PK) parameter of IAMA-6 following single and multiple oral doses, secondaryOutcomes measure: Tmax pharmacokinetic (PK) parameter of IAMA-6 following single and multiple oral doses, secondaryOutcomes measure: T1/2 pharmacokinetic (PK) parameter of IAMA-6 following single and multiple oral doses, secondaryOutcomes measure: AUC(0-t) and AUCτ pharmacokinetic (PK) parameters of IAMA-6 following single and multiple oral doses, secondaryOutcomes measure: Vd pharmacokinetic (PK) parameters of IAMA-6 following single and multiple oral doses, secondaryOutcomes measure: CL pharmacokinetic (PK) parameters of IAMA-6 following single and multiple oral doses, secondaryOutcomes measure: λz pharmacokinetic (PK) parameters of IAMA-6 following single and multiple oral doses, secondaryOutcomes measure: Urine volume, secondaryOutcomes measure: Na+ excretion, secondaryOutcomes measure: K+ excretion, secondaryOutcomes measure: Sleep assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Centro Ricerche Cliniche Di Verona S.r.l., status: RECRUITING, city: Verona, country: Italy, contacts name: Stefano Milleri, MD, role: CONTACT, phone: +39 0458126618, email: stefano.milleri@crc.vr.it, geoPoint lat: 45.4299, lon: 10.98444, hasResults: False
|
protocolSection identificationModule nctId: NCT06300385, orgStudyIdInfo id: IstanbulBUFC5, briefTitle: Effect of EMS and Strengthening Exercises on Pain, Fatigue and Physical Performance in Motocross Athletes, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Istanbul Bilgi University, class: OTHER, descriptionModule briefSummary: Motocross, a popular sport, involves riding motorized vehicles on rugged tracks with obstacles. It's physically demanding, with high speeds and a risk of accidents. Grip strength is crucial, especially in the arms and forearms, which are prone to injury. Physiotherapy often employs strength exercises, including electromyostimulation. However, there's little research on their effectiveness for motocross athletes. This study aims to compare electromyostimulation combined with strength training versus strength training alone in relieving pain, fatigue, and improving strength in motocross athletes., conditionsModule conditions: Sports Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 2 parallel groups randomized controlled study, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Electromyostimulation, interventions name: Strengthening exercises, outcomesModule primaryOutcomes measure: Visual analog scale, primaryOutcomes measure: Strength measurement, primaryOutcomes measure: Fatigue assessment, primaryOutcomes measure: Grip strength assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Istanbul Bilgi University, status: RECRUITING, city: Istanbul, zip: 34440, country: Turkey, contacts name: Hulya Sisli, PhD, role: CONTACT, phone: 2123115303, phoneExt: +90, email: hulya.sisli@bilgi.edu.tr, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
|
protocolSection identificationModule nctId: NCT06300372, orgStudyIdInfo id: Medipol Hospital 2, briefTitle: Modified Thoracoabdominal Nerve Plane Block In Living Liver Donors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-08-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Istanbul Medipol University Hospital, class: OTHER, descriptionModule briefSummary: Ultrasound-guided Modified Thoracoabdominal Nerve Plane Block (M-TAPA) is performed deep into the costochondral aspect at the 9th-10th costal level by injecting local anesthetics deep into the chondrium. It provides blockage of both the anterior and lateral cutaneous branches of the thoracoabdominal nerve. As there are studies showing M-TAPA block to be effective for postoperative analgesia for other abdominal surgeries, its effect on patients undergoing living liver donor surgery has not been studied yet. We hypothesize that M-TAPA block performed in living liver donors would reduce opioid consumption in the first 48 hours after surgery., conditionsModule conditions: Liver Failure, conditions: Acute Postoperative Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Fifty patients aged 18-65 years old with American Society of Anesthesiologists (ASA) classification I-II, scheduled for living liver donation surgery for liver transplantation will be included in the study. Patients will be randomly divided into two groups (Group A=M-TAPA block group, Group B = control group) including 25 patients each, before entering the operating room., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Outcomes assessor and participants will be blinded to the study, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: M-TAPA plane block, interventions name: Postoperative pain management, outcomesModule primaryOutcomes measure: Opioid consumption (Fentanyl PCA), secondaryOutcomes measure: Pain scores (Numerical rating scale-NRS, secondaryOutcomes measure: Need for rescue analgesia (meperidine), secondaryOutcomes measure: Adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istanbul Medipol University Mega Hospital Complex, status: RECRUITING, city: Istanbul, state: Bagcilar, country: Turkey, contacts name: Ayse Ince, Assist Prof, MD, role: CONTACT, phone: +905366774988, email: drayseince@gmail.com, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
|
protocolSection identificationModule nctId: NCT06300359, orgStudyIdInfo id: Prognostic indicators of GBS, briefTitle: Prognostic Indicators of Gullian-Barre Syndrome, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Prognostic indicators of Gullian-Barre syndrome and the predictive factors associated with worse prognosis in the Guillain-Barré syndrome (GBS), which can be helpful to fully evaluate the disease progression and provide proper treatments., conditionsModule conditions: Guillain-Barre Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 60, type: ESTIMATED, outcomesModule primaryOutcomes measure: Prognostic indicators of Gullian-Barre syndrome, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.