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protocolSection identificationModule nctId: NCT06327646, orgStudyIdInfo id: 66677, briefTitle: Maternal Adherence to MMS in Nepal, acronym: NAMASTE MMS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2024-07-20, completionDateStruct date: 2024-07-20, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Helen Keller International, class: OTHER, collaborators name: Eleanor Crook Foundation, descriptionModule briefSummary: Although clinical studies highlight the value of MMS for pregnant and lactating women, implementation research studies are necessary to understand adherence and acceptability to the product and to uncover potential obstacles to implementation in specific contexts. For Nepal, it is crucial to establish whether adherence to MMS supplementation is non-inferior to the existing IFA supplementation for 180 tablets, which has a high (65%) adherence rate. It is also important to investigate how whether providing MMS in bottles (containing a substantial quantity, such as 90 count bottles twice during pregnancy) might impact ANC utilization, particularly in terms of ensuring that pregnant women attend at least eight ANC visits. Furthermore, assessment of MMS acceptability, including pill taste, smell, size, swallowability, side effects, benefits as well as aspects such as product labeling and packaging, among end users in Nepal, is needed to understand acceptability of MMS vs. IFA. Finally, implementation issues within the health system, including the need of trainings for healthcare workers' and, female community health volunteers (FCHVs)' training needs; and government stakeholders' interest and barriers;; community s Social and behavioral change communication needs, and issues around supply chain issues should be well-understood and documented to inform prior to scale-up to support a smooth transition of MMS. Thus, Helen Keller International, in collaboration with Nepal's Ministry of Health and Population (MoHP) and the Eleanor Crook Foundation (ECF), will conduct a set of four mixed-methods studies to generate evidence and insights that inform the development of an MMS supplementation strategy. This trial in one province of Nepal is the first study that will be complemented by one additional quantitative study and two qualitative studies to generate evidence on the topics mentioned., conditionsModule conditions: Supplementation, conditions: Pregnancy Related, conditions: Postnatal Related, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 2640, type: ESTIMATED, armsInterventionsModule interventions name: Multiple Micronutrient Supplement Blister, interventions name: Multiple Micronutrient Supplement Bottle, interventions name: Iron Folic Acid Blister, outcomesModule primaryOutcomes measure: 180 days adherence: MMS (2 types) vs. IFA, secondaryOutcomes measure: 30, 90, and 225 days adherence, secondaryOutcomes measure: 180 adherence: MMS blister vs MMS bottle, secondaryOutcomes measure: MMS acceptability, secondaryOutcomes measure: Antenatal Care Utilization at 180 days, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06327633, orgStudyIdInfo id: ZZ2024, briefTitle: Effects of Olfactory Training on the Brain Function in T2DM Patients With Mild Cognitive Impairment, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-08-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, class: OTHER, descriptionModule briefSummary: This is a pilot, prospective, randomized, open label, parallel, 4-month study to explore and evaluate the therapeutic effects of olfactory training on the cognitive function, olfactory function, and odor-induced brain activation in T2DM patients with mild cognitive impairment (MCI)., conditionsModule conditions: Type 2 Diabetes Mellitus, conditions: Mild Cognitive Impairment, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Olfactory Training, outcomesModule primaryOutcomes measure: Change of olfactory brain activation by fMRI, secondaryOutcomes measure: Change of cognitive function, secondaryOutcomes measure: Olfactory threshold test, secondaryOutcomes measure: Change of metabolism, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University, status: RECRUITING, city: Nanjing, state: Jiangsu, zip: 210008, country: China, contacts name: Yan Bi, MD, PhD, role: CONTACT, phone: 86-25-83-105302, email: biyan@nju.edu.cn, contacts name: YAN BI, MD, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: ZHOU ZHANG, MD, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False
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protocolSection identificationModule nctId: NCT06327620, orgStudyIdInfo id: A002021015, briefTitle: Treatment Of Oral Lichen Planus, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-01-15, primaryCompletionDateStruct date: 2024-05-20, completionDateStruct date: 2024-05-20, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Mansoura University, class: OTHER, descriptionModule briefSummary: This novel project aims to explore an alternative treatment for oral lichen planus (OLP), a challenging condition with limited therapeutic options. The proposed treatment involves the topical application of Daivobet ointment, a combination of calcipotriol (vitamin D analog) and betamethasone (corticosteroid), which has shown promising results in the treatment of psoriasis Vulgaris.The study will involve 15 patients aged 30-60 years with clinically confirmed intra-oral erosive lichen planus, some of whom have not responded to current therapies. Participants will apply Daivobet ointment three times daily for four weeks, with clinical assessments conducted at the beginning, and at the end of the second and fourth weeks.Inclusion criteria require the presence of bilateral oral erosive lichen planus lesions, with clinical and histopathological confirmation based on the World Health Organization's modified definition. Exclusion criteria include histological signs of dysplasia, use of drugs possibly causing lichenoid reactions, recent treatment for OLP, and hypersensitivity to the study drug.Clinical evaluations will employ a scoring system based on lesion characteristics, including ulceration, erythema, and reticulation, measured with a calibrated grid. Subjective responses will be assessed through discomfort scores on a visual analog scale, and a questionnaire will capture any adverse effects. Digital photographs will document visual changes, and incisional biopsies will be performed to confirm the diagnosis.The project aims to provide valuable insights into the efficacy and safety of the Daivobet ointment as a potential alternative treatment for oral lichen planus, offering hope for improved outcomes for patients suffering from this challenging condition., conditionsModule conditions: Lichen Planus, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: Daivobet ointment, topical steroids, outcomesModule primaryOutcomes measure: Clinical Improvement of Oral Lichen Planus Lesions, secondaryOutcomes measure: Objective Response Score, secondaryOutcomes measure: Subjective Response Score, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Mansoura University, Faculty of Dentistry, status: RECRUITING, city: Mansoura, state: Dakahlia, zip: 35516, country: Egypt, contacts name: Mona Montaser, role: CONTACT, email: mmontaser@mans.edu.eg, geoPoint lat: 31.03637, lon: 31.38069, hasResults: False
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protocolSection identificationModule nctId: NCT06327607, orgStudyIdInfo id: IEO 1952, briefTitle: Psychosexuological Interventions to Support Sexual Function in Breast Cancer Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-09, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: Prospective pilot study on the feasibility and efficacy of a brief psychosexual support intervention in breast cancer patients undergoing hormonal therapies for at least 6 months.The study is randomized in the two following arms:Control arm (standard care pathway) Psychosexual intervention arm, conditionsModule conditions: Breast Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 82, type: ESTIMATED, armsInterventionsModule interventions name: Control Group, interventions name: Psychosexological intervention, outcomesModule primaryOutcomes measure: Evaluation of differences between two arms in female sexual satisfaction and functionality scores, secondaryOutcomes measure: Evaluation of differences between two arms in levels of quality of life, secondaryOutcomes measure: Evaluation of differences between two arms in levels of anxiety and depression, secondaryOutcomes measure: Evaluation of differences between two arms in levels of sleep quality, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: European Institute of Oncology, status: RECRUITING, city: Milan, country: Italy, contacts name: Gabriella Pravettoni, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06327594, orgStudyIdInfo id: XTang-0002, briefTitle: Assessment System of Sarcopenia in Lung Cancer Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2027-11, completionDateStruct date: 2028-11, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: West China Hospital, class: OTHER, descriptionModule briefSummary: 1. To explore the diagnostic value of musculoskeletal cross-modal imaging assessment system of ultrasound combined with abdominal CT/MRI for sarcopenia in patients with lung cancer.2. To explore the value of musculoskeletal cross-modal imaging assessment system of ultrasound combined with abdominal CT/MRI in evaluating the prognosis and the effect of nutritional support in patients with lung cancer during perioperative period.3. To explore the value of musculoskeletal cross-modal imaging assessment system of ultrasound combined with abdominal CT/MRI in evaluating the long-term prognosis of patients with lung cancer., conditionsModule conditions: Sarcopenia, conditions: Lung Cancer, conditions: Ultrasound, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 1500, type: ESTIMATED, armsInterventionsModule interventions name: ultrasound scan, interventions name: CT/MRI scan, outcomesModule primaryOutcomes measure: Death, primaryOutcomes measure: Perioperative complications, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xinyi Tang, status: RECRUITING, city: Chengdu, state: Sichuan, country: China, contacts name: Xinyi Tang, Dr., role: CONTACT, phone: +8615680819215, geoPoint lat: 30.66667, lon: 104.06667, hasResults: False
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protocolSection identificationModule nctId: NCT06327581, orgStudyIdInfo id: 101005, briefTitle: Combined Microneedling With Either 1% Lactic Acid Solution or Vitamin D3 or Triamcinolone Acetonide in The Treatment of Alopecia Areata, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-15, primaryCompletionDateStruct date: 2024-09-23, completionDateStruct date: 2024-12-22, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Zagazig University, class: OTHER_GOV, descriptionModule briefSummary: Alopecia areata (AA) is an immunologically mediated disease characterized by non-scarring hair loss (Madni and Shapiro, 2000). AA is presented by rapid and complete hair loss in one or more round or oval patches, usually on the scalp, beard area, eyebrows, eyelashes, and less commonly, on other hairy areas of the body (Berker et al., 2010 and James et al., 2011) Alopecia areata is a T-cell-mediated autoimmune disease. There is a complicated interplay between loss of immune privilege in the hair follicle, autoimmune-mediated hair follicle damage, and activation of inflammatory pathways that have been argued to explain the development of this disorder, but the exact pathophysiology of AA remains unknown. Hair follicles are infiltrated by autoreactive CD8 and CD4 T lymphocytes, which attack hair follicle-derived autoantigens while sparing the stem compartment (Rajabi et al., 2018).Alopecia areata can be treated with topical and/or intralesional corticosteroids, which are the treatment of choice. Anthralin, minoxidil, coal tar, and topical immunotherapy are examples of other topical treatments. Systemic immunosuppressants such as cyclosporine, systemic steroids, Janus kinase inhibitors, and methotrexate may be considered in severe resistant cases (lee and lee, 2017).Intralesional triamcinolone acetonide is preferred in cases of AA, as it is well known as anti-inflammatory and interferes with local immunity of the skin, which helps in the recovery of the disease, but if used in wrong technique or given in a high dose, it might cause all the side effects of corticosteroid, especially skin atrophy (Berker et al., 2010).Lactic acid is a member of alpha-hydroxy acids. It has been used in the treatment of many skin diseases, like AA and vitiligo. Lactic acid stimulates spontaneous secretion of vascular endothelial growth factor (VEGF) by human reconstructed epidermis. VEGF is an angiogenic cytokine involved in angiogenesis and wound healing and stimulates the growth of hair follicles resulting in recovery of AA. Other studies suggest that lactic acid may act through its irritant effect (Al-Tammimy, 2005).Vitamin D interacts with the innate and adaptive immune systems in a variety of ways, the majority of which contribute to its downregulation (Nancy and Yehuda, 2009). It has a powerful effect on T and B lymphocytes, influencing their activation responses (Arnson et al., 2007).All cells of the immune system express 1,25-dihydroxyvitamin D3 receptors (VDRs) and are therefore vulnerable to calcitriol-mediated modulation. Vitamin D3 has the ability to influence the migration and maturation of different dendritic cell subtypes and their production of chemokines and cytokines, giving them an immunoregulatory and tolerogenic role (Illescas-Montes et al., 2019) It has been shown that VDRs are highly expressed in the keratinocytes of human hair follicles and the absence of their expression is associated with reduced hair follicle growth and epidermal differentiation. Reduced VDR expression in the hair follicles of affected areas has also been observed in studies of AA patients' scalp (Çerman et al., 2015).Microneedling (MN) is a technique that comprises puncturing the skin repeatedly with sterile microneedles (Iriarte et al., 2017). It promotes hair regeneration by triggering stem cells in the hair bulge, which results in the generation of growth factors. It also improves blood circulation to the hair follicles and influences the local immune cells (Chandrashekar et al., 2014). Moreover, combining MN with applied topical drugs facilitates their absorption through the microchannels created within the epidermis (Fertig et al., 2018)., conditionsModule conditions: Alopecia Areata, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 44, type: ESTIMATED, armsInterventionsModule interventions name: Lactic Acid, interventions name: vit D, interventions name: Triamcinolone Acetonide, interventions name: Saline, outcomesModule primaryOutcomes measure: hair regrowth improvement assessed by 5-point semiquantitative regrowth score (RGS), eligibilityModule sex: ALL, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rana Ehab, status: RECRUITING, city: Zagazig, zip: 44519, country: Egypt, contacts name: rana ehab, md, role: CONTACT, phone: 01000896453, email: ranaehab015@gmail.com, geoPoint lat: 30.58768, lon: 31.502, hasResults: False
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protocolSection identificationModule nctId: NCT06327568, orgStudyIdInfo id: IEO 1663, briefTitle: Anal Cancer and/or Precancer Screening: Performance Analysis of the BD Onclarity™ HPV Assay on Anal Specimens, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-06-17, primaryCompletionDateStruct date: 2026-06-17, completionDateStruct date: 2029-06-17, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: Human papillomavirus (HPV) infection has been implicated as a necessary cause for the development of the majority of anogenital neoplasms which represent approximately 95% of anal tumors. Persistent high risk HR-HPV infection promotes progression from intraepithelial lesions high-grade squamous anal tumors (AIN) (H-SIL) to invasive anal tumors.The diagnosis of AIN is made by cytology or biopsy during routine examinations. To date, no HPV test has been clinically validated for anal specimens and none are available in the molecular diagnostics market for this purpose.The performance analysis of an HPV Test with simultaneous genotyping on anal samples could implement anal cancer screening without an invasive procedure and with one simple approach., conditionsModule conditions: Anal Intraepithelial Neoplasia 2, conditions: Anal Intraepithelial Neoplasia 1, conditions: Anal Cancer, conditions: High-Risk Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Sensitivity and specificity of BD Onclarity HPV assay for HPV detection and genotyping in case/control patients., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: European Institute of Oncology, status: RECRUITING, city: Milan, country: Italy, contacts name: Fabio Bottari, role: CONTACT, contacts name: Cristina Trovato, MD, role: SUB_INVESTIGATOR, contacts name: Anna Daniela Iacobone, MD, role: SUB_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06327555, orgStudyIdInfo id: M2023123, briefTitle: Study on the Effect of Telerehabilitation Using Wearable Devices After ACL Reconstruction, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Peking University Third Hospital, class: OTHER, descriptionModule briefSummary: Trial purpose: To evaluate the safety and effectiveness of using a new remote rehabilitation platform for postoperative rehabilitation in patients with anterior cruciate ligament rupture compared to conventional rehabilitation care through a randomized controlled trial.Test subjects: This study is a multicenter study that recruited 252 participants from three centers (aged ≥ 18 years) for cruciate ligament rupture reconstruction; Exclude patients who have undergone revision and bilateral surgery, and exclude patients with collateral ligament and posterior cruciate ligament injuries in the knee joint.Trial plan: The subjects were randomly enrolled and randomly divided into two groups: the remote rehabilitation group and the traditional rehabilitation group, using a mixed block randomization method. The probability of being divided into both groups was 50%. All subjects received routine outpatient diagnosis and treatment, with the same content. The remote rehabilitation group uses software and sensors to provide remote postoperative rehabilitation guidance. The traditional rehabilitation group receives routine rehabilitation diagnosis and treatment, with face-to-face rehabilitation twice a week. All subjects are required to undergo regular follow-up (1 day before surgery, 3 months after surgery, 6 months).Outcome measures: The main outcome measures were knee isokinetic muscle strength and Lysholm knee joint score . the secondary outcome measures were Y-balance test, Tegner activity scale, health survey summary table (SF-36),The other outcome measures were Anterior Cruciate Ligament Return to Sport After Injury (ACL-RSI) Scale, vas pain score., conditionsModule conditions: Anterior Cruciate Ligament Reconstruction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 252, type: ESTIMATED, armsInterventionsModule interventions name: the traditional rehabilitation group, interventions name: the remote rehabilitation group, outcomesModule primaryOutcomes measure: the Lysholm Knee Scoring Scale, primaryOutcomes measure: knee Isokinetic strength, secondaryOutcomes measure: Y-balance balance test, secondaryOutcomes measure: Tegner score, secondaryOutcomes measure: the 36-item Short Form Health Survey(SF-36), otherOutcomes measure: Anterior Cruciate Ligament Return to Sport After Injury (ACL-RSI) Scale, otherOutcomes measure: VAS pain score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: quan Jian Wang, status: RECRUITING, city: Beijing, state: Beijing, zip: 100191, country: China, contacts name: quan J Wang, M.D., role: CONTACT, phone: 13801076267, email: wjqsportsmed@163.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06327542, orgStudyIdInfo id: 22-37078B, secondaryIdInfos id: 1R61MD018333, type: NIH, link: https://reporter.nih.gov/quickSearch/1R61MD018333, briefTitle: Group-based Integrative Pain Management in Primary Care Safety Net Clinics, acronym: IPMP+, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-04-30, completionDateStruct date: 2027-04-30, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: University of California, San Francisco, class: OTHER, collaborators name: National Institute on Minority Health and Health Disparities (NIMHD), descriptionModule briefSummary: Socioeconomically disadvantaged populations have a high prevalence of chronic pain, exacerbated by social isolation, intersectional stigma, and disparities in pain assessment and treatment options. Effective interventions using a multilevel, biopsychosocial approach are needed to decrease the unequal burden of pain. The proposed study will test group-based integrative models of pain management in primary care safety net clinics to improve pain care for racially and ethnically diverse low-income patients., conditionsModule conditions: Chronic Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: 2x2 factorial trial, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: INVESTIGATOR, enrollmentInfo count: 360, type: ESTIMATED, armsInterventionsModule interventions name: Group Acupuncture, interventions name: Integrative Group Medical Visits, outcomesModule primaryOutcomes measure: Change in pain impact measured as a composite score of pain intensity, pain interference, and physical function., primaryOutcomes measure: Change in Social support and Pain Questionnaire (SPQ), secondaryOutcomes measure: Change in average pain intensity on the 0-10 numeric rating scale, secondaryOutcomes measure: Self-reported pain interference will be measured using the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) scale. Total t-scores range from 0 to 100, with higher scores indicating greater levels of pain interference., secondaryOutcomes measure: Change in physical function on the 6-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 6b, secondaryOutcomes measure: Change in Internalized Stigma of Chronic Pain (ISCP) survey, secondaryOutcomes measure: Change in social isolation on the 8-item NIH Patient Reported Outcomes Measurement Information System (PROMIS) Social Isolation Short Form 8a, secondaryOutcomes measure: Change in pain self efficacy on the Pain Self-Efficacy Questionnaire (PSEQ), secondaryOutcomes measure: Change in pain catastrophizing on the Pain Catastrophizing Scale (PCS) 6-item short form, secondaryOutcomes measure: Change in depressive symptoms on the Patient Health Questionnaire (PHQ-9), secondaryOutcomes measure: Change in anxiety on the Generalized Anxiety Disorder survey (GAD-2), secondaryOutcomes measure: Patient belief about treatment efficacy on the Patient Global Impression of Change (PGIC), secondaryOutcomes measure: Change in health-related quality of life on NIH Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale, secondaryOutcomes measure: Change in experiences of discrimination in healthcare, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tom Waddell Urban Health Clinic, city: San Francisco, state: California, zip: 94102, country: United States, contacts name: Jesse Wennik, NP, role: CONTACT, geoPoint lat: 37.77493, lon: -122.41942, hasResults: False
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protocolSection identificationModule nctId: NCT06327529, orgStudyIdInfo id: 2101814, briefTitle: Zinc and Iron Absorption From Common Beans in Young Adult Women, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: University of California, Davis, class: OTHER, descriptionModule briefSummary: Fifteen female study participants will be enrolled in a randomized crossover study to measure fractional and total zinc and iron absorption from four common bean (Phaseolus vulgaris) varieties with varying phytate and polyphenolic contents. Phytate, the storage form of phosphorus in plants, and polyphenols, which contribute to the varied colors of common beans, are natural components of the beans and can reduce zinc and iron bioavailability from these foods., conditionsModule conditions: Zinc Absorption, conditions: Iron Absorption, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: A four arm multi-tracer non-randomized crossover design, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, maskingDescription: Study participants will be masked to the type of bean that they will be receiving., whoMasked: PARTICIPANT, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: SER 118, interventions name: LMP 1001, interventions name: LPA 586, interventions name: KAT B1, outcomesModule primaryOutcomes measure: Fractional Zinc absorption, primaryOutcomes measure: Fractional Iron absorption, secondaryOutcomes measure: Total Zinc absorption, secondaryOutcomes measure: Total Iron absorption, eligibilityModule sex: FEMALE, minimumAge: 19 Years, maximumAge: 24 Years, stdAges: ADULT, contactsLocationsModule locations facility: Department of Nutrition, city: Davis, state: California, zip: 95616, country: United States, geoPoint lat: 38.54491, lon: -121.74052, hasResults: False
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protocolSection identificationModule nctId: NCT06327516, orgStudyIdInfo id: M2020023, briefTitle: Lysophosphatidylglycerol in Asthma Pathogenesis, statusModule overallStatus: RECRUITING, startDateStruct date: 2015-01-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Peking University Third Hospital, class: OTHER, descriptionModule briefSummary: The study aims to investigate the relationship between the small molecule metabolite lysophosphatidylglycerol and asthma clinical features and explore its involvement in asthma pathogenesis., conditionsModule conditions: Asthma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 250, type: ESTIMATED, outcomesModule primaryOutcomes measure: lipidomics, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking university third hospital, status: RECRUITING, city: Beijing, state: None Selected, zip: 100191, country: China, contacts name: Chun Chang, role: CONTACT, phone: 15810075362, email: doudou1977bysy@sina.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06327503, orgStudyIdInfo id: 36/7-2024, briefTitle: Salivary Signal Molecules for Neural and Vascular Homeostasis in T2DM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: University of Belgrade, class: OTHER, descriptionModule briefSummary: Various signal molecules are detected in blood and tissues of patients with T2DM, that are important for the function of neural tissue in diabetic setting. Among them, specifically important are neuroprotective and neurotrophic growth factors such as nerve growth factor (NGF), glial cells - derived neurotrophic factor (GDNF) and brain-derived neurotrophic factor (BDNF). Furthermore, several other signal molecules are discovered to affect vascular tissues homeostasis in T2DM, including soluble alpha-klotho (s-Klotho), vascular endothelial growth factor (VEGF) and interleukin-6 (IL-6). Most of these molecules are also detected in saliva in various states and diseases of orofacial system, but data about their levels in saliva of T2DM patients are lacking, although neural and vascular diabetic complications are present in orofacial tissues and organs. Also, there is no data about presence and levels of s-Klotho in saliva of healthy or T2DM patients, although it was reported that this molecule exerts protective effect on the salivary glands tissue. Salivary opiorphin is recently discovered pentapeptide, primarily isolated from saliva. It acts as an inhibitor of the enzymes that perform degradation of endogenous antinociceptive molecules enkephalins, affecting nociceptive signal transduction. This may be of special importance since some intraoral complications of T2DM (e.g. burning mouth) may have underlying peripheral neural changes as a pathophysiological mechanism. Against this background, the aim of the study is to detect the presence and levels of mentioned signal molecules in saliva of patients with and without T2DM., conditionsModule conditions: Type 2 Diabetes, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: saliva samples collecting, outcomesModule primaryOutcomes measure: NGF levels in saliva, primaryOutcomes measure: GDNF levels in saliva, primaryOutcomes measure: BDNF levels in saliva, primaryOutcomes measure: s-Klotho levels in saliva, primaryOutcomes measure: VEGF levels in saliva, primaryOutcomes measure: IL-6 levels in saliva, primaryOutcomes measure: opiorphin levels in saliva, secondaryOutcomes measure: unstimulated saliva flow, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Belgrade School of Dental Medicine, city: Belgrade, zip: 11000, country: Serbia, contacts name: Marija S Milic, DDS Ph.D, role: CONTACT, phone: +381112646280, phoneExt: 122, email: marija.milic@stomf.bg.ac.rs, geoPoint lat: 44.80401, lon: 20.46513, hasResults: False
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protocolSection identificationModule nctId: NCT06327490, orgStudyIdInfo id: UF-BRE-012, briefTitle: A Study Evaluating the Feasibility and Compliance of Manual Lymphatic Drainage Comparing Indocyanine-Green (ICG) Guided vs. Traditional Guided in Patients Undergoing Axillary Node Dissection for the Treatment of Breast Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2028-06, completionDateStruct date: 2028-06, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of Florida, class: OTHER, descriptionModule briefSummary: Breast cancer is estimated to affect approximately 300,000 women in the US in 2023. Studies demonstrate that 1 in 5 will develop breast cancer related lymphedema secondary to the treatments that they receive. BCRL at this time has no cure, however early detection can prevent the progression to late stage BCRL. At this time a technique of arm massage, manual lymphatic drainage (MLD), is used for treatment. This study investigates a new method of MLD, which is guided by the individual patients' lymphatic anatomy through use of ICG-lymphography., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: ICG-guided manual lymphatic drainage, interventions name: Traditional manual lymphatic drainage, outcomesModule primaryOutcomes measure: Subject compliance, secondaryOutcomes measure: Relative volume change, secondaryOutcomes measure: Bioimpedance, secondaryOutcomes measure: Breast cancer related lymphedema symptoms, secondaryOutcomes measure: Incidence of progression to late stage breast cancer related lymphedema, secondaryOutcomes measure: Health-related quality of life, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Florida, city: Gainesville, state: Florida, zip: 32610, country: United States, contacts name: Lisa Spiguel, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.65163, lon: -82.32483, hasResults: False
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protocolSection identificationModule nctId: NCT06327477, orgStudyIdInfo id: NU 23S01, secondaryIdInfos id: NCI-2024-01927, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: STU00220015, secondaryIdInfos id: NU 23S01, type: OTHER, domain: Northwestern University, secondaryIdInfos id: P30CA060553, type: NIH, link: https://reporter.nih.gov/quickSearch/P30CA060553, briefTitle: Proton-Spatially Fractionated Radiotherapy and Standard Radiation Therapy for the Treatment of Newly Diagnosed Retroperitoneal Soft Tissue Sarcoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2027-07-01, completionDateStruct date: 2028-07-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Northwestern University, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: This phase I/II trial studies the side effects and best dose of proton-spatially fractionated radiotherapy (P-SFRT) and to see how well it works with standard radiation therapy in treating patients with newly diagnosed retroperitoneal soft tissue sarcoma. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Standard spatially fractionated radiotherapy (SFRT) refers to how the radiation is delivered to the tumor. SFRT means that different parts of the tumor are receiving different doses of radiation (fractionation) through beams that allow areas of higher and lower (peaks and valleys) of doses of the radiation. This spatial fractionation allows an overall high-dose radiation to be given in the peaks and those areas of the tumor may release cells and substances that may help with killing tumor cells, reducing tumor symptoms and shrinking tumors. Proton therapy is a type of radiation therapy that can overcome some of the barriers of standard SFRT. Protons are tiny radioactive particles that can be controlled in a beam to travel up to the tumor and, compared to the particles used in standard radiotherapy, proton therapy can deliver higher doses to the tumor because smaller doses of radiation are delivered to tissues away from the tumor. This allows radiation therapy dose-escalated (continuously increasing the dose of radiation) treatment to tumors even though the tumor is near radiation sensitive organs like the colon. Giving P-SFRT with standard radiation therapy may work better in treating patients with newly diagnosed retroperitoneal soft tissue sarcoma., conditionsModule conditions: Retroperitoneal Sarcoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: Biopsy, interventions name: Biospecimen Collection, interventions name: Computed Tomography, interventions name: Intensity-Modulated Radiation Therapy, interventions name: Resection, interventions name: Spatially-fractionated Radiation Therapy, outcomesModule primaryOutcomes measure: Recommended phase II dose (Phase I), primaryOutcomes measure: Pathological complete response (Phase II), secondaryOutcomes measure: Incidence of adverse events (Phase I), secondaryOutcomes measure: Overall response rate (ORR) (Phase II), secondaryOutcomes measure: Progression-free survival (PFS) (Phase II), secondaryOutcomes measure: Overall survival (OS) ( (Phase II), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Northwestern University, status: RECRUITING, city: Chicago, state: Illinois, zip: 60611, country: United States, contacts name: Seth M. Pollack, role: CONTACT, phone: 312-695-6180, contacts name: Seth M. Pollack, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.85003, lon: -87.65005, hasResults: False
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protocolSection identificationModule nctId: NCT06327464, orgStudyIdInfo id: 23-03228, briefTitle: Exogenous Ketones and Appetite, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: University of British Columbia, class: OTHER, descriptionModule briefSummary: People with obesity have different appetitive responses to stimuli compared to people without obesity. For example, people with obesity have a blunted postprandial ghrelin ('hunger' hormone) response, lower glucagon-like peptide 1 (GLP-1) and peptide-YY (PYY; associated with satiety) compared to people without obesity. Given the favorable effects of exogenous ketones on appetite previously observed in healthy adults of normal body weight, it is possible that these supplements can alter appetite hormones in a manner that may closer match that observed in people without obesity. To explore this research question, investigators will conduct a randomized single-blind cross over study to characterize appetite and dietary intake after ingestion of an exogenous ketone supplement within adults with obesity (compared a control condition without exogenous ketones) and compared to adults without obesity. The research team will also explore differences in postprandial energy expenditure and fuel utilization. Twenty-two healthy young- and middle-aged adults will be included (up to n=26 enrolled). In addition to a baseline visit to measure body composition, participants will undergo two 4.5-hour study visits, one of which will include a ketone diol supplement and one will have a placebo. Participants will be given a 1-day run-in diet prior to each study day to support energy balance. On each study day visit, participants will undergo a resting metabolic rate test (indirect calorimetry) followed by a fasting appetite rating and blood sample collection. Participants will then be provided with a standard breakfast meal (one with the ketone supplement and one with placebo). Appetite ratings and blood sample collection will be repeated 60, 120, and 180 minutes after the meal. Indirect calorimetry will be completed after the 30, 90, and 150 minute assessments. After the 180-minute timepoint, participants will be provided with a buffet-like lunch meal with instructions to eat as much or as little as they would like to determine ad libitum dietary intake at a single meal. To assess free-living ad libitum dietary intake, participants will receive 1.5 days of food boxes tailored to their preferences, with uneaten food returned at the end of the 1.5-day period. This study will be the first to assess the impact of exogenous ketones on appetite in obesity and would help inform future weight loss intervention trials., conditionsModule conditions: Appetite, conditions: Obesity, conditions: Ketones, conditions: Appetitive Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 22, type: ESTIMATED, armsInterventionsModule interventions name: Exogenous ketones, outcomesModule primaryOutcomes measure: Acylated ghrelin area under the curve (AUC), secondaryOutcomes measure: Peptide-YY(3-36) area under the curve (AUC), secondaryOutcomes measure: Glucagon-like peptide 1 area under the curve (AUC), secondaryOutcomes measure: Insulin area under the curve (AUC), secondaryOutcomes measure: Glucose area under the curve (AUC), secondaryOutcomes measure: Leptin area under the curve (AUC), secondaryOutcomes measure: Hunger rating from visual analog scale, secondaryOutcomes measure: Satiety rating from visual analog scale, secondaryOutcomes measure: Prospective food consumption rating from visual analog scale, secondaryOutcomes measure: Desire to eat rating from visual analog scale, secondaryOutcomes measure: Dietary energy intake at a single meal, secondaryOutcomes measure: Free-living dietary energy intake, secondaryOutcomes measure: Postprandial energy expenditure, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of British Columbia - Okanagan, city: Kelowna, state: British Columbia, zip: V1V1V7, country: Canada, contacts name: Sarah Purcell, PhD, role: CONTACT, phone: 2508079827, email: sarah.purcell@ubc.ca, geoPoint lat: 49.88307, lon: -119.48568, hasResults: False
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protocolSection identificationModule nctId: NCT06327451, orgStudyIdInfo id: IRB2024-YX-037-01, briefTitle: Evaluate the Efficacy and Safety of Atorvastatin Combined With Temozolomide in the Treatment of Glioblastoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-02-28, completionDateStruct date: 2027-02-28, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Tianjin Medical University General Hospital, class: OTHER, descriptionModule briefSummary: Glioblastoma (GBM) is the primary intracranial malignant tumor with the highest morbidity and mortality, and the 5-year survival rate is less than 10%. The number of primary diagnostic patients and deaths of GBM in China ranks first in the world every year, which seriously threatens people's life and health. At present, the clinical treatment strategy of maximum surgical resection combined with concurrent chemo- and radio-therapy and TTF treatment is still not satisfactory, and the median survival time of GBM patients is only 14.4 months. Statins inhibit cholesterol production with few side effects and are widely used for cholesterol control in patients with hyperlipidemia. In recent years, statins have shown good anti-tumor effect. Our previous study found that statins can block the malignant progression of glioma mediated by EGFR pathway. Therefore, the investigators report a clinical study protocol designed to evaluate the clinical efficacy of a comprehensive treatment strategy of atorvastatin (ATO) combined with temozolomide (TMZ) in primary and recurrent glioblastomas with high EGFR expression.The investigators designed a multicenter, single-arm, double-blind, phase II clinical trial to evaluate the efficacy and safety of oral ATO combined with TMZ in EGFR-high expressing GBM. After informed consent was signed by the patient or authorized family members, the patients were treated with the current STUPP regimen and ATO (20mg, qn) orally. The patients were regularly followed up for 52 weeks after treatment. The primary endpoint was progression-free survival (PFS), which was defined as the time from the start of GBM surgery to tumor progression (recurrence) or death. The secondary end point was the rate of tumor control, which was defined as the proportion of patients with a complete response, a partial response, or a stable disease that had shrunk or remained stable for a given period of time. Safety will be assessed during the study by monitoring of regular MRI scans, laboratory tests (liver function, lipid profile, blood routine), electrocardiography, vital signs (blood pressure, pulse, temperature), and weight.The results of this clinical trial will provide key information on whether the oral combination of atorvastatin and temozolomide prolongs PFS in EGFR-high GBM patients with efficacy and safety., conditionsModule conditions: Glioblastoma, IDH-wildtype, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Atorvastatin 20mg, outcomesModule primaryOutcomes measure: progression-free survival, primaryOutcomes measure: Overall survival, primaryOutcomes measure: Tumor control rate, secondaryOutcomes measure: Hepatic burden of GBM patients after receiving atorvastatin administration, secondaryOutcomes measure: Percentage of participants with treatment-related adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Tianjin Medical University General Hospital, status: RECRUITING, city: Tianjin, zip: 300052, country: China, contacts name: Chunsheng Kang, role: CONTACT, phone: +8602260817499, email: kang97061@tmu.edu.cn, contacts name: Xiaoteng Cui, role: CONTACT, phone: +8602260817481, email: xiaotengcui@tmu.edu.cn, geoPoint lat: 39.14222, lon: 117.17667, hasResults: False
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protocolSection identificationModule nctId: NCT06327438, orgStudyIdInfo id: REC/211/MTI.PT/2401041, briefTitle: Effect of Complex Decongestive Therapy, Cryotherapy and Kinesio Taping in Patients With Post-mastectomy Lymphedema: A Randomized Control Trial, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-16, primaryCompletionDateStruct date: 2024-06-16, completionDateStruct date: 2024-07-16, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: South Valley University, class: OTHER, descriptionModule briefSummary: To examine the efficacy of complex decongestive therapy (CDT), cryotherapy and kinesio taping (KT) in patients with post-mastectomy lymphedema, conditionsModule conditions: Breast Neoplasms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized controlled study, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Complex decongestive therapy, interventions name: Cryotherapy, interventions name: Kinesio taping, outcomesModule primaryOutcomes measure: Arm girth measurement is measured by Circumferential measurements, primaryOutcomes measure: Pain severity is measured by VAS, secondaryOutcomes measure: The QOL is measured by SF-36, secondaryOutcomes measure: Range of motion (ROM) is measured by UG, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ragaee Saeed Mahmoud, status: RECRUITING, city: Giza, state: Faisal, country: Egypt, contacts name: Ragaee Mahmoud, role: CONTACT, phone: 00201223611112, email: ragaeesaeedpt10@gmail.com, contacts name: Reham Mahmoud, role: CONTACT, phone: 00201015447798, email: rsm_211pt@yahoo.com, geoPoint lat: 30.00808, lon: 31.21093, locations facility: Ragaee Saeed Mahmoud, status: RECRUITING, city: Faisal, state: Giza, zip: 002, country: Egypt, contacts name: Reham Saeed, Doctora, role: CONTACT, phone: 00201223611112, email: rsm_Pt211@yahoo.com, contacts name: Rabab Saeed, Doctora, role: CONTACT, phone: 00201017855222, email: rababSaeed10@yahoo.com, geoPoint lat: 30.01744, lon: 31.20376, hasResults: False
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protocolSection identificationModule nctId: NCT06327425, orgStudyIdInfo id: MCG-Tachyarrhythmia, briefTitle: MCG for Localization of Tachyarrhythmia's Origin, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-14, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Qilu Hospital of Shandong University, class: OTHER, descriptionModule briefSummary: This is an exploratory research aiming to accurately identify the site of origin of tachyarrhythmia using Magnetocardiography (MCG), which will have guiding significance for early diagnosis, the formulation of treatment plans and preoperative positioning for radiofrequency ablation., conditionsModule conditions: Tachyarrhythmia, conditions: Atrial Flutter, conditions: Paroxysmal Supraventricular Tachycardia, conditions: Atrial Tachycardia, conditions: Atrial Fibrillation, conditions: Premature Ventricular Contraction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Magnetocardiography, outcomesModule primaryOutcomes measure: Efficacy of MCG to detect the site of origin of Tachyarrhythmia using cardiac electrophysiology as a reference standard., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 79 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06327412, orgStudyIdInfo id: KayseriCHLYMP01, briefTitle: The Effects of Aerobic Exercise in Patients With Primary Lower Extremity Lymphedema, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Kayseri City Hospital, class: OTHER_GOV, descriptionModule briefSummary: Our aim in this study is to evaluate the effects of lymphedema on exercise capacity, body composition, functional level and quality of life in lymphedema patients with primary lower extremity involvement., conditionsModule conditions: Primary Lymphedema, conditions: Aerobic Exercise, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A total of 35 patients with primary stage 2 and 3 lower extremity lymphedema, aged 18-65, who apply to the lymphedema outpatient clinic and meet the criteria of the International Society of Lymphology, will be included. Patients participating in the study will be randomized into 2 groups: aerobic exercise group (Group 1) and home exercise group (Group 2). According to randomization, 18 patients will be included in one group and 17 patients in the other.Cardiopulmonary exercise test (CPET), 30-second-stand-sit test (30s-CST), 6-minute walk test (6MWT), Lymphedema Circumference and Volume Measurement, Bioimpedance Measurement, Lower Extremity Functional Scale (LEFS), Lymphedema Life Impact Scale ( LLIC), Hospital Depression and Anxiety Scale (HADS), Numerical Rating Scale (NRS) forms will be filled in the cardiopulmonary rehabilitation unit of Kayseri City Hospital in the 0th, 4th and 16th weeks., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 35, type: ESTIMATED, armsInterventionsModule interventions name: Aerobic exercise on the treadmill, interventions name: Walking between 12-13 RPE (The Borg Rating of Perceived Exertion) according to the Modified Borg Scale, outcomesModule primaryOutcomes measure: 30-second sit-stand test (30-s chair-stand test, 30s-CST), secondaryOutcomes measure: Cardiopulmonary exercise test (CPET), secondaryOutcomes measure: 6-minute walk test (6MWT), secondaryOutcomes measure: Circumference and volume measurement, secondaryOutcomes measure: Bioimpedance measurement, secondaryOutcomes measure: Lower Extremity Functional Scale (LEFS), secondaryOutcomes measure: Lymphedema Life Impact Scale (LLIC), secondaryOutcomes measure: Hospital Anxiety and Depression Scale (HADS), secondaryOutcomes measure: Numerical Rating Scale (NRS), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Health Sciences University, Kayseri Medicine Faculty, Kayseri City Hospital, city: Kayseri, zip: 38080, country: Turkey, geoPoint lat: 38.73222, lon: 35.48528, hasResults: False
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protocolSection identificationModule nctId: NCT06327399, orgStudyIdInfo id: MS-373-2023, briefTitle: Dexmedetomidine Infusion Dose Versus Rapid Bolus Dose Before Tracheal Intubation., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-21, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Kasr El Aini Hospital, class: OTHER, descriptionModule briefSummary: Dexmedetomidine bolus dose may provide similar or less hemodynamic changes (less bradycardia and less hypertension) than infusion dose during induction of anaesthesia and tracheal intubation., conditionsModule conditions: Dexmedetomidine, conditions: Intubation Complication, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Dexmedetomidine infusion, interventions name: Dexmedetomidine bolus, interventions name: Atropine Sulfate, interventions name: Ephedrine, interventions name: Propofol, outcomesModule primaryOutcomes measure: Mean blood pressure upon laryngoscopy, secondaryOutcomes measure: Blood pressure & Heart rate, secondaryOutcomes measure: Propfol, secondaryOutcomes measure: Bradycardia, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Cairo University Hospitals, status: RECRUITING, city: Giza, zip: 11562, country: Egypt, contacts name: Maher a Fawzy, MD, role: CONTACT, phone: 01201730249, email: kasralainirec@kasralainy.edu.eg, geoPoint lat: 30.00808, lon: 31.21093, hasResults: False
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protocolSection identificationModule nctId: NCT06327386, orgStudyIdInfo id: 202434, briefTitle: The Therapeutic Efficacy of 18F-FDG Combined With 18F-FAPI PET/MR in Neoadjuvant Therapy for Gastric Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2026-01-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, class: OTHER, descriptionModule briefSummary: Gastric cancer is the fifth most common cancer worldwide and the third leading cause of cancer-related deaths. Although surgical treatment can benefit the survival of the vast majority of patients, currently only early gastric cancer patients can be cured directly through endoscopic resection or surgery alone. Neoadjuvant therapy reduces tumor volume and improves tumor response rate through preoperative radiotherapy and chemotherapy, thereby increasing R0 resection rate and improving overall survival, without increasing postoperative complications and mortality. Timely imaging re staging during neoadjuvant therapy can allow patients to enter the surgical stage earlier, thereby reducing their preoperative burden. According to the different stages of neoadjuvant therapy, clinical staging can be divided into baseline stage (cBSstage) and clinical rest stage (cReStage) after neoadjuvant therapy.At present, the conventional imaging methods for diagnosing cBStage in gastric cancer include CT, endoscopic ultrasonography (EUS), and MRI. The NCCN guidelines recommend CT for cBStage, with a diagnostic accuracy of 77.1% to 88.9%. Similarly, EUS and MRI were also used for cBStage, with accuracy rates of 65.0% to 92.1% and 71.4% to 82.6%, respectively. The application of diffusion-weighted imaging (DWI) has improved the accuracy of MRI diagnosis of cBStage to 93%.However, due to the destruction of the gastric wall structure by neoadjuvant therapy, accurate imaging re staging is difficult. Currently, accurate tumor regression grading can only be obtained through surgical resection of pathological specimens. For cReT after neoadjuvant therapy, the diagnostic accuracy of EUS is only 63% (T2: 44%, T3: 68%, T4: 90%). Due to the presence of chronic inflammatory reactions, such as tumor cell apoptosis, necrosis, fibrosis, etc., in both the tumor and the critical normal gastric wall after neoadjuvant therapy, imaging cannot accurately identify the level of gastric wall, leading to the current low value of CT for cReT. Meanwhile, due to the fact that the pathological reactions of lymph nodes after neoadjuvant therapy are mainly subacute inflammatory reactions accompanied by scar tissue formation, and not all lymph node volumes that experience these pathological reactions will rapidly decrease, the accuracy of CT diagnosis of cReN is only 44%, while the sensitivity and specificity of EUS diagnosis of cReN are 50% and 56%, respectively.In addition, positron emission tomography (PET) can reflect the abnormal metabolism, protein synthesis, DNA repair, and cell proliferation of tumors at the molecular level, providing important information in tumor grading diagnosis, prognosis evaluation, treatment decision-making, and efficacy monitoring. The conventional positron tracer 18F-FDG can reflect the glucose metabolism ability of different tissues, while most types of malignant tumors exhibit high metabolism. Therefore, 18F-FDG can be used for the diagnosis, staging, and treatment monitoring of cancer. However, in gastric cancer patients, 18F-FDG has certain limitations, including 1) interference with physiological or inflammatory uptake of the gastric wall; 2) Low uptake of 18F-FDG is present in signet ring cell carcinoma, mucinous adenocarcinoma, or other poorly differentiated cancers with high mucus content; 3) There are cases of false positive FDG after immunotherapy. In the study of SUV changes in the tumor area before and after treatment, it was found that patients with postoperative pathological regression grades 1-5 Δ SUVs are between 0-70%.Tumor associated fibroblasts are closely related to tumor growth, invasion, and distant metastasis, and their activation requires the involvement of fibroblast activation protein (FAP). Therefore, radiolabeled fibroblast activation protein inhibitor (FAPI) can achieve in vivo FAP targeted tracing and quantification by specifically binding to FAP. Currently, a large number of studies have shown that 18F-FAPI is superior to 18F-FDG in the staging and re staging of gastric cancer. Furthermore, prospective studies have shown a certain relationship between tumor regression grade (TRG) and 18F-FAPI rate of change parameters (SUVmax, SUVavg, SUVR).Therefore, in the early stage of this study, 18F-FAPI combined with 18F-FDG PET/MRI imaging was used to evaluate the efficacy of neoadjuvant therapy for gastric cancer, preoperative assessment of tumor regression grade after treatment, and re staging to guide the development of further clinical treatment plans., conditionsModule conditions: Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: 18F-FAPI#18F-FDG, outcomesModule primaryOutcomes measure: Evaluation efficacy of tumor regression level, secondaryOutcomes measure: expression of FAP, secondaryOutcomes measure: expression of GLUT1, secondaryOutcomes measure: SUV, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Nuclear Medicine, Daping Hospital of Army Medical University, status: RECRUITING, city: Chongqing, state: Chongqing, zip: 400010, country: China, contacts name: Xiao Chen, Ph.D, role: CONTACT, phone: 15922970174, email: xiaochen229@foxmail.com, geoPoint lat: 29.56278, lon: 106.55278, hasResults: False
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protocolSection identificationModule nctId: NCT06327373, orgStudyIdInfo id: Pro00114903, briefTitle: A Feasibility Study of Supplemental Oxygen to Improve Pulmonary Hypertension in People With Intradialytic Hypoxemia, acronym: SOPHIE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Duke University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to assess the feasibility of supplemental oxygen delivery during hemodialysis in people with pulmonary hypertension and intradialytic hypoxemia., conditionsModule conditions: Pulmonary Hypertension, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Oxygen, interventions name: Room air, outcomesModule primaryOutcomes measure: Change daily hypoxemia burden, secondaryOutcomes measure: Change in six minute walk distance, secondaryOutcomes measure: Change in Montreal Cognitive Assessment (MoCA), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Davita Durham East, city: Durham, state: North Carolina, zip: 27701, country: United States, geoPoint lat: 35.99403, lon: -78.89862, locations facility: Davita Durham Downtown, city: Durham, state: North Carolina, zip: 27703, country: United States, contacts name: Rachel Cooper, role: CONTACT, phone: 720-261-8901, email: rachel.cooper@davita.com, geoPoint lat: 35.99403, lon: -78.89862, locations facility: Davita Research Triangle Park, city: Durham, state: North Carolina, zip: 27703, country: United States, contacts name: Rachel Cooper, role: CONTACT, phone: 720-261-8901, email: rachel.cooper@davita.com, geoPoint lat: 35.99403, lon: -78.89862, locations facility: Davita Durham Regional, city: Durham, state: North Carolina, zip: 27704, country: United States, contacts name: Rachel Cooper, role: CONTACT, phone: 720-261-8901, email: rachel.cooper@davita.com, geoPoint lat: 35.99403, lon: -78.89862, locations facility: Davita Durham West, city: Durham, state: North Carolina, zip: 27705, country: United States, contacts name: Rachel Cooper, role: CONTACT, phone: 720-261-8901, email: rachel.cooper@davita.com, geoPoint lat: 35.99403, lon: -78.89862, locations facility: Davita Bull City, city: Durham, state: North Carolina, zip: 27707, country: United States, contacts name: Rachel Cooper, role: CONTACT, phone: 720-261-8901, email: rachel.cooper@davita.com, geoPoint lat: 35.99403, lon: -78.89862, locations facility: Davita Durham Southpoint, city: Durham, state: North Carolina, zip: 27713, country: United States, contacts name: Rachel Cooper, role: CONTACT, phone: 720-261-8901, email: rachel.cooper@davita.com, geoPoint lat: 35.99403, lon: -78.89862, locations facility: Davita Hope Valley, city: Durham, state: North Carolina, zip: 27713, country: United States, contacts name: Rachel Cooper, role: CONTACT, phone: 720-261-8901, email: rachel.cooper@davita.com, geoPoint lat: 35.99403, lon: -78.89862, locations facility: Davita Vance County, city: Henderson, state: North Carolina, zip: 27536, country: United States, contacts name: Rachel Cooper, role: CONTACT, phone: 720-261-8901, email: rachel.cooper@davita.com, geoPoint lat: 36.32959, lon: -78.39916, locations facility: Davita Kerr Lake, city: Henderson, state: North Carolina, zip: 27537, country: United States, contacts name: Rachel Cooper, role: CONTACT, phone: 720-261-8901, email: rachel.cooper@davita.com, geoPoint lat: 36.32959, lon: -78.39916, locations facility: Davita Roxboro, city: Roxboro, state: North Carolina, zip: 27573, country: United States, contacts name: Rachel Cooper, role: CONTACT, phone: 720-261-8901, email: rachel.cooper@davita.com, geoPoint lat: 36.39375, lon: -78.98279, hasResults: False
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protocolSection identificationModule nctId: NCT06327360, orgStudyIdInfo id: FDG_ 88-16, briefTitle: Illness Expectations in Pulmonary Fibrosis, acronym: CAMFP, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-10-10, primaryCompletionDateStruct date: 2023-10-10, completionDateStruct date: 2025-10-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Fondazione Don Carlo Gnocchi Onlus, class: OTHER, collaborators name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, collaborators name: FIMARP ONLUS - FEDERAZIONE ITALIANA IPF E MALATTIE POLMONARI RARE, descriptionModule briefSummary: This study aims to delve into the constructs of illness beliefs and expectations among patients with Pulmonary Fibrosis, exploring how these beliefs and expectations may influence the treatment journey, including oxygen therapy, non-invasive ventilation therapy, and pharmacological treatments., conditionsModule conditions: Pulmonary Fibrosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 130, type: ESTIMATED, armsInterventionsModule interventions name: Psychological questionnaires, outcomesModule primaryOutcomes measure: Adherence to Pharmacological Treatment, primaryOutcomes measure: Adherence to Oxygen Therapy, primaryOutcomes measure: Adherence to Non invasive ventilation, primaryOutcomes measure: Illness beliefs, primaryOutcomes measure: Pharmacological treatment Beliefs, primaryOutcomes measure: Illness Expectations, primaryOutcomes measure: Illness Cognitions, secondaryOutcomes measure: Socio-demographic variables, secondaryOutcomes measure: Clinical and medical data, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano, city: Milano, zip: 20122, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Don Gnocchi Foundation, city: Milano, zip: 20148, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06327347, orgStudyIdInfo id: 2020-05_C2H, briefTitle: Comparative Study of 2 Multifocal Intraocular Lenses in Heidelberg, acronym: C2H, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-07-17, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2026-07-31, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Cristalens Industrie, class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to compare the performance of 2 intraocular lenses (IOLs): ARTIS SYMBIOSE (study lenses) vs PANOPTIX (comparator) through binocular Distance Corrected Intermediate Visual Acuity (DCIVA) assessed at 80 cm in photopic conditions at minimum 1-month post-operative by a blinded evaluator.This main objective will be to show superiority of the ARTIS SYMBIOSE system on the primary endpoint.The patient population to be included is patient suffering from cataract who requires cataract surgery procedure that meet the inclusion and non-inclusion criteria and provide written informed consent.Participants will attend a total of 5 study visits: 1 preoperative visit, 1 surgery visit and 3 postoperative visits., conditionsModule conditions: Cataract, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel Assignement, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) assessed at 80 cm in photopic conditions at minimum 1-month post-operative is perforemd by a blinded evaluator., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: intraocular lens implantation in cataract surgery, outcomesModule primaryOutcomes measure: Binocular Distance Corrected Intermediate Visual Acuity, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universitäts-Augenklinik Heidelberg International Vision Correction Research Centre (IVCRC), status: RECRUITING, city: Heidelberg, country: Germany, contacts name: Raquel Willrich Amroussi, role: CONTACT, phone: +49 6221 56-36849, email: raquel.willrichamroussi@med.uni-heidelberg.de, geoPoint lat: 49.40768, lon: 8.69079, hasResults: False
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protocolSection identificationModule nctId: NCT06327334, orgStudyIdInfo id: 2023/03, briefTitle: Brain Heart InterActioNs in Cardiac Arrest. Ancillary Study of the HEAVENwARd Trial, acronym: BHIANCA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2027-05-15, completionDateStruct date: 2027-05-15, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: CMC Ambroise Paré, class: OTHER, descriptionModule briefSummary: Despite advances in post-resuscitation care of patients with cardiac arrest (CA), the majority of survivors who are treated after restoration of spontaneous circulation (ROSC) will have sequelae of hypoxic-ischemic brain injury ranging from mild cognitive impairment to a vegetative state. Current recommendations suggest using a multimodal approach to predict poor prognosis, meaning combining markers together. Yet, a substantial proportion of patients do not have a clear prognostic evaluation even when applying the latest ESICM recommendations algorithm published in 2021. It is therefore important to identify new prognostic markers to predict both unfavorable and favorable outcomes. Data regarding the pathophysiological mechanisms of post-anoxic encephalopathy suggest a diffuse anoxo-ischemic injury. However, post-mortem neuropathology data suggest that these lesions do not uniformly affect neuroanatomical structures, with some regions (especially hippocampal and insular) appearing more sensitive to anoxia. Conversely, the brainstem appears less affected by anoxic lesions. Under physiological conditions, there are interactions between the heart and the brain, and between the brain and the heart mainly related to the autonomic nervous system, through interactions between central cortical control structures (especially insular) and brainstem structures (at the level of the bulb) and peripheral structures of the heart. Exploring the pathophysiological mechanisms of heart-brain interactions post-CA could thus help better understand the pathophysiology of anoxo-ischemic encephalopathy, before considering potential therapeutic targets. Furthermore, this heart-brain dysfunction could have prognostic value. Indeed, recent studies in healthy subjects and patients with consciousness disorders suggest that autonomic nervous system activity measured by brain-heart interactions could be a reliable marker of consciousness and cognitive processing. These coupled heart-brain interactions can be evaluated through synchronous electroencephalogram (EEG) and electrocardiogram (ECG) recordings, as there are coupled interactions between the signals of these two organs. The existence of abnormal brain-heart coupling could be associated, on the one hand, with the severity of post-anoxic encephalopathy, and on the other hand, with neurological prognosis in patients with persistent coma post-CA.This ancillary study of a multicentre prospective cohort "HEAVENwARd study" (NCT06044922) will assess the prevalence and prognostic value of bilateral brain-heart interactions in comatose patients after CA., conditionsModule conditions: Cardiac Arrest, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, outcomesModule primaryOutcomes measure: Bilateral brain-heart interactions, secondaryOutcomes measure: Poor neurological outcome evaluated using the CPC score, secondaryOutcomes measure: Mortality, secondaryOutcomes measure: Post-anoxic encephalopathy severity evaluated by composite prognostic markers combining EEG patterns, somatosensory evoked potentials (SEP) and neuron specific enolase (NSE)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Brest University Hospital, city: Brest, state: Bretagne, zip: 29609, country: France, contacts name: Pierre BAILLY, MD, role: CONTACT, email: pierre.bailly@chu-brest.fr, contacts name: Pierre BAILLY, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.3903, lon: -4.48628, locations facility: Ambroise Paré - Hartmann Private Hospital Group, city: Neuilly-sur-Seine, state: Ile-de-France, zip: 92200, country: France, contacts name: Guillaume GERI, MD, PhD, role: CONTACT, email: guillaume.geri@clinique-a-pare.fr, contacts name: Guillaume GERI, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.8846, lon: 2.26965, locations facility: Cochin Hospital, city: Paris, state: Ile-de-France, zip: 75014, country: France, contacts name: Alain CARIOU, MD, PhD, role: CONTACT, email: alain.cariou@aphp.fr, contacts name: Alain CARIOU, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Nantes University Hospital, city: Nantes, state: Pays De La Loire, zip: 44093, country: France, contacts name: Jean-Baptiste LASCARROU, MD, role: CONTACT, email: jeanbaptiste.lascarrou@chu-nantes.fr, contacts name: Jean-Baptiste LASCARROU, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.21725, lon: -1.55336, locations facility: Marseille University Hospital, city: Marseille, state: Provence-Alpes-Côte d'Azur, zip: 13005, country: France, contacts name: Jeremy BOURENNE, MD, role: CONTACT, email: jeremy.bourenne@ap-hm.fr, contacts name: Jeremy BOURENNE, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.29551, lon: 5.38958, hasResults: False
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protocolSection identificationModule nctId: NCT06327321, orgStudyIdInfo id: 23-PP-08, briefTitle: Vitiligo Treatment by Targeting TYK2 Mediated Responses, acronym: ViTYK, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-05, primaryCompletionDateStruct date: 2026-05-05, completionDateStruct date: 2026-11-05, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Nice, class: OTHER, descriptionModule briefSummary: Vitiligo affects approximately 1 to 2% of the global population and significantly impacts people's quality of life. Achieving the best treatment outcomes for vitiligo involves addressing the autoimmune inflammatory response to stop the depigmentation process and promoting the differentiation of melanocyte stem cells to induce repigmentation. The loss of melanocytes in vitiligo is a result of an autoimmune process. While the IFN gamma pathway plays a crucial role in the adaptive immune response in vitiligo, there is increasing evidence highlighting the importance of the innate immune response. Deucravacitinib, an allosteric TYK2 inhibitor, has shown effectiveness and safety in treating psoriasis. It inhibits the responses of IFN alpha (IFNα), IFN beta (IFNβ), and IL12, and may also have an impact on the Th1 response. The hypothesis is that by targeting the IFN type I response and IL12, deucravacitinib could effectively halt the depigmentation process and facilitate repigmentation of vitiligo lesions. When combined with NB-UVB, the process of repigmentation should be significantly enhanced. The primary objective is to compare the proportion of patients treated with deucravacitinib versus placebo achieving VITIL-IA 50 at week 24.Interventions Following central randomization, patients will be assigned to receive either deucravacitinib 12mg daily (QD) or a placebo daily (QD) for a duration of 24 weeks. At the end of this period, patients will be re-randomized to receive either deucravacitinib 12mg QD alone or deucravacitinib 12mg QD + twice weekly narrowband UVB treatment twice weekly for an additional 24 weeks.Throughout the study, there will be a total of six visits conducted: selection, inclusion, Week 12, Week 24, Week 36, and Week 48. In patients who volunteer, a skin biopsy will be performed on both the lesional and peri-lesional areas at baseline, Week 12 and Week 36. Serum and plasma samples will be collected at the screening visit, Week 12, Week 24, Week 36, and Week 48., conditionsModule conditions: Vitiligo, Generalized, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 128, type: ESTIMATED, armsInterventionsModule interventions name: Deucravacitinib, interventions name: Volunteer without treatment, outcomesModule primaryOutcomes measure: rate of depigmentation, secondaryOutcomes measure: number of patient with the T-VASI 50, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU de Nice - Hôpital de l'Archet, status: RECRUITING, city: Nice, state: Alpes-Maritimes, zip: 06200, country: France, contacts name: Passeron Thierry, PhD, role: CONTACT, phone: +33492036488, email: passeron.t@chu-nice.fr, contacts name: pradelli Emmanuelle, role: CONTACT, phone: +33492036488, email: pradelli.e@chu-nice.fr, contacts name: Thierry Passeron, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70313, lon: 7.26608, locations facility: APHP, Henri Mondor, status: NOT_YET_RECRUITING, city: Paris, state: Creteil, country: France, contacts name: Khaled EZZEDINE, PhD, role: CONTACT, email: khaled.ezzedine@aphp.fr, contacts name: Khaled EZZEDINE, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: CHU de Bordeaux, status: NOT_YET_RECRUITING, city: Bordeaux, state: Talence, zip: 33000, country: France, contacts name: Julien Seneschal, PhD, role: CONTACT, email: julien.seneschal@chu-bordeaux.fr, contacts name: Julien Seneschal, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 44.84044, lon: -0.5805, locations facility: CHU de Lille, status: NOT_YET_RECRUITING, city: Lille, country: France, contacts name: Laurent MORTIER, PhD, role: CONTACT, email: Laurent.MORTIER@chu-lille.fr, contacts name: Laurent MORTIER, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 50.63297, lon: 3.05858, locations facility: HCL, status: NOT_YET_RECRUITING, city: Lyon, country: France, contacts name: Cécile LESORT, PhD, role: CONTACT, email: cecile.lesort@chu-lyon.fr, contacts name: Cécile Lesort, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 45.74848, lon: 4.84669, hasResults: False
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protocolSection identificationModule nctId: NCT06327308, orgStudyIdInfo id: 2023/803, briefTitle: Evaluation of Cirrhotic Cardiomyopathy by Cardiac MRI in Patients Waiting for Liver Transplant., acronym: CARDIOFIBROCIR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-31, primaryCompletionDateStruct date: 2025-03-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Besancon, class: OTHER, descriptionModule briefSummary: The aim of this multicenter prospective observational pilot study is to describe the evolution of myocardial fibrosis in cirrhotic patients before and after liver transplantation (LT). Through multimodal analysis of myocardial function and architecture, and analysis of specific markers of inflammation, we aim to explore the following hypotheses: 1) systemic inflammation promotes myocardial fibrosis in cirrhotic patients and could be an early marker of cirrhotic cardiomyopathy; 2) LT allows resolution of myocardial fibrosis by preventing the bacterial translocation that favors the development of deleterious systemic inflammation., conditionsModule conditions: Cirrhosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: MRI, interventions name: Blood sampling, outcomesModule primaryOutcomes measure: Primary outcome measure, secondaryOutcomes measure: Prevalence of cirrhotic cardiomyopathy according to 2019 criteria [Izzy M, et al. Hepatology 2020;71:334-45], echocardiographic signs of left ventricular systolic and diastolic dysfunction :, secondaryOutcomes measure: Analysis of the association between myocardial extracellular volume (MECV) (explained variable) and plasma 3-HM concentration (explanatory variable)., secondaryOutcomes measure: Analysis of the association between myocardial extracellular volume (MECV) and the concentration of markers of inflammation (CRP, procalcitonin, copeptin, IL-6) and proteins modulating the degree of inflammation (LBP, PLTP, CETP)., secondaryOutcomes measure: Analysis of the association between the difference in MECV in transplant recipients between visit 2 and visit 3 according to the degree of immunosuppression, measured by mean residual tacrolemia in the 12 months post-LT., secondaryOutcomes measure: Number, type and cumulative incidence of cardiovascular events (heart failure, rhythm disorders, etc.) according to cirrhotic cardiomyopathy status occurring between inclusion and LT., secondaryOutcomes measure: Number, type and cumulative incidence of cardiovascular events (heart failure, rhythm disorders, etc.) occurring between inclusion and LT, according to cirrhotic cardiomyopathy status., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU Besancon - Hopital Minjoz, city: Besançon, zip: 25000, country: France, contacts name: Delphine WEIL, MD, PHD, role: CONTACT, geoPoint lat: 47.24878, lon: 6.01815, locations facility: CHU Dijon - Hopital François Mitterrand, city: Dijon, zip: 21000, country: France, contacts name: Marianne LATOURNERIE, MD, role: CONTACT, geoPoint lat: 47.31667, lon: 5.01667, locations facility: CHRU Nancy - Hôpital de Brabois, city: Nancy, zip: 54000, country: France, contacts name: Mouni BENSENANE -OUSSALAH, MD, role: CONTACT, geoPoint lat: 48.68439, lon: 6.18496, locations facility: CHU Strasbourg - Hopital de HautePierre, city: Strasbourg, zip: 67000, country: France, contacts name: Camille BESCH, MD, role: CONTACT, geoPoint lat: 48.58392, lon: 7.74553, hasResults: False
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protocolSection identificationModule nctId: NCT06327295, orgStudyIdInfo id: ATB1651-102, briefTitle: A Study of ATB1651 in Adults With Mild to Moderate Onchomycosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2026-01-30, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: AmtixBio Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The study is designed to evaluate the Safety, Tolerability and Pharmacokinetics of ATB1651 in participants with mild to moderate onychomycosis, conditionsModule conditions: Onychomycosis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: ATB1651-102- Cohort 1, interventions name: ATB1651-102- Cohort 2, interventions name: ATB1651-102- Cohort 3, interventions name: ATB1651-102- Cohort 4, interventions name: Placebo, outcomesModule primaryOutcomes measure: To evaluate the complete cure rate with topical ATB1651 3% and ATB1651 5% in participants with mild to moderate onychomycosis., secondaryOutcomes measure: To further evaluate the efficacy of topical ATB1651 3% and topical ATB1651 5% in participants with mild to moderate onychomycosis., secondaryOutcomes measure: To assess and collect the percentage and severity of adverse events (AEs)., secondaryOutcomes measure: Maximum plasma concentration (Cmax), secondaryOutcomes measure: Time to maximum plasma concentration (Tmax), secondaryOutcomes measure: Apparent terminal elimination rate constant (λz), secondaryOutcomes measure: Area under curve (AUC), secondaryOutcomes measure: Apparent terminal half-life (t 1/2), secondaryOutcomes measure: Apparent clearance (CL), secondaryOutcomes measure: Apparent terminal volume of distribution (VD), secondaryOutcomes measure: Plasma ATB1651 trough concentrations (Ctrough), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: New Zealand Clinical Research Christchurch, city: Christchurch, zip: 8011, country: New Zealand, contacts name: Corey Sellwood, Dr, role: CONTACT, phone: +64 800 862 278, contacts name: Corey Sellwood, Dr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -43.53333, lon: 172.63333, hasResults: False
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protocolSection identificationModule nctId: NCT06327282, orgStudyIdInfo id: ChinaPLAGHPAIN, briefTitle: the Effect of Preoperative Pain Education by Anesthesia Nurses on Postoperative Pain Among Adult Patients Undergoing Abdominal Surgery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-04-04, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Chinese PLA General Hospital, class: OTHER, descriptionModule briefSummary: To explore the effects of preoperative pain education on postoperative pain among patients undergoing abdominal surgery., conditionsModule conditions: Postoperative Pain, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 116, type: ESTIMATED, armsInterventionsModule interventions name: education on pain and related knowledge, outcomesModule primaryOutcomes measure: Occurrence of pain, secondaryOutcomes measure: Mastery of the use of patient-controlled analgesia pump, otherOutcomes measure: Patient satisfaction with postoperative analgesia, otherOutcomes measure: Adverse events of patients using analgesic pump were recorded, otherOutcomes measure: The number of times that the analgesic pump was pressed during each 24h and the amount of analgesic pump remaining at this time were recorded, otherOutcomes measure: The use of rescue analgesics after surgery, otherOutcomes measure: The postoperative sleep status of patients was evaluated, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06327269, orgStudyIdInfo id: MOHW111-TDU-B-221-114009, briefTitle: Innovative Diagnosis and Therapy in LDLT Patients With High-risk Hepatocellular Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-04-01, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Chang Gung Memorial Hospital, class: OTHER, collaborators name: Ministry of Health and Welfare, Taiwan, descriptionModule briefSummary: The challenge of LDLT to HCC is that tumors with a high risk of recurrence have a high rate of recurrence after liver transplantation, and there is no appropriate treatment to prevent HCC recurrence after transplantation in these patients. Using the advance proton therapy or yttrium 90 as a more aggressive down-staging therapy may contribute to change tumor behavior. It can be used to get a better treatment response and tumor necrosis before LDLT. As a result, it will improve recurrence-free survival and overall survival rate, especially in high-risk groups. In addition, lenvatinib is approved for using in patients with advanced liver cancer because its overall survival rate is not less than sorafenib in clinical trials. A new generation of targeted therapies will be applied to adjuvant therapy after LDLT., conditionsModule conditions: High Risk of Recurrence, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Lenvatinib 10 mg, outcomesModule primaryOutcomes measure: Recurrence-free survival with adjuvant therapy, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Surgery, status: RECRUITING, city: Kaohsiung, zip: 833, country: Taiwan, contacts name: Chih-Che Lin, Ph.D, role: CONTACT, phone: +88677317123, phoneExt: 8880, email: chihchelin@cgmh.org.tw, contacts name: I-Hsuan Chen, Ph.D, role: CONTACT, phone: +88677317123, phoneExt: 8582, email: ann0401@cgmh.org.tw, geoPoint lat: 22.61626, lon: 120.31333, hasResults: False
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protocolSection identificationModule nctId: NCT06327256, orgStudyIdInfo id: 1509-0002, secondaryIdInfos id: 2023-509293-29-00, type: REGISTRY, domain: CTIS, secondaryIdInfos id: U1111-1299-6907, type: REGISTRY, domain: WHO International Clinical Trials Registry Platform (ICTRP), briefTitle: A Study in Healthy People to Test How Well Different Doses of BI 3000202 Are Tolerated and How They Affect the Way the Body Handles Midazolam, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-28, primaryCompletionDateStruct date: 2024-09-27, completionDateStruct date: 2024-09-27, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Boehringer Ingelheim, class: INDUSTRY, descriptionModule briefSummary: The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) following multiple rising doses of BI 3000202 and to investigate the effect of BI 3000202 on the metabolism of midazolam., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: The multiple rising dose part of the trial will be conducted in a parallel group assignment. The effect of midazolam interaction will be assessed sequentially., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: The multiple rising dose part of the trial will be blinded to the participants and investigators . The effect of midazolam will be assessed open label., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: BI 3000202, interventions name: Placebo, interventions name: Midazolam, outcomesModule primaryOutcomes measure: Percentage of subjects with drug-related adverse events, secondaryOutcomes measure: Area under the concentration-time curve of BI 3000202 in plasma over the dosing interval 0 to 12 hours (AUC0-12), secondaryOutcomes measure: Maximum measured concentration BI 3000202 in plasma (Cmax), secondaryOutcomes measure: Area under the concentration-time curve of BI 3000202 in plasma over a uniform dosing interval τ (AUCτ,ss) at steady state, secondaryOutcomes measure: Maximum measured concentration of BI 3000202 in plasma (Cmax,ss) at steady state, secondaryOutcomes measure: Time from dosing to the maximum measured concentration of BI 3000202 in plasma (tmax,ss) at steady state, secondaryOutcomes measure: Area under the concentration-time curve of midazolam in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) after a single dose, secondaryOutcomes measure: Maximum measured concentration of midazolam in plasma (Cmax) after a single dose, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: SGS Life Science Services - Clinical Research, status: RECRUITING, city: Edegem, zip: 2650, country: Belgium, contacts name: Boehringer Ingelheim, role: CONTACT, phone: 080049616, email: belgique@bitrialsupport.com, geoPoint lat: 51.15662, lon: 4.44504, hasResults: False
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protocolSection identificationModule nctId: NCT06327243, orgStudyIdInfo id: TUMRHS, briefTitle: The Effects of Kinesio Taping on Pain, Range of Motion, and Functional Performance in People With Knee Osteoarthritis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Taibah University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the effectiveness of Kinesio Taping in individuals with knee osteoarthritis (KOA). KOA is a common condition that can lead to pain, stiffness, and decreased mobility. The main questions it aims to answer are:* Does Kinesio Taping reduce pain in individuals with KOA?* Can Kinesio Taping improve the range of motion and functional performance in those suffering from KOA?Participants will be asked to:Attend assessment sessions at the outpatient Physical Therapy clinic at Taibah University.Undergo Kinesio Taping three times over 12 days. Complete specific physical tests and questionnaires before and after the intervention period to measure their pain and mobility.Researchers will compare the group that receives Kinesio Taping with the group that receives sham (placebo) taping to see if there are significant differences in pain reduction and improvements in movement and daily function., conditionsModule conditions: Knee Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In a randomized and single-blinded approach, participants are divided into two groups. One group receives actual Kinesio taping, while the other undergoes a sham procedure, with neither group aware of their specific treatment type to ensure unbiased results., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Participants will not know if they are receiving the actual Kinesio Taping (KT) treatment or a sham taping. The KT will be applied following the correct standards for the rectus femoris muscle, including appropriate stretching. Conversely, the placebo taping will be applied horizontally across the muscle fibers without any stretching. The therapists applying the tape will know which treatment each participant is allocated to ensure that the application of either the real KT or the placebo taping aligns with the study's protocol., whoMasked: PARTICIPANT, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Elastic tape ( kinesio tape), interventions name: Sham Taping, outcomesModule primaryOutcomes measure: Pain (Visual analog scale), primaryOutcomes measure: Knee range of motion, primaryOutcomes measure: Timed up and go test, primaryOutcomes measure: The 50-foot Walk, primaryOutcomes measure: Knee Osteoarthritis Outcome Score (KOOS), eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Taibah University, status: RECRUITING, city: Medina, zip: 42353, country: Saudi Arabia, contacts name: President of the university, role: CONTACT, email: tawasul@taibahu.edu.sa, contacts name: Marwan MA Aljohani, Phd, role: CONTACT, email: mmjohani@taibahu.edu.sa, geoPoint lat: 24.46861, lon: 39.61417, hasResults: False
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protocolSection identificationModule nctId: NCT06327230, orgStudyIdInfo id: SRRSH2023-0627, briefTitle: The Application of Thoracic Epidural Analgesia in Patients With Acute Pancreatitis, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-04-30, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Sir Run Run Shaw Hospital, class: OTHER, descriptionModule briefSummary: Acute pancreatitis (AP) is one of the most common diseases of the digestive system, with its incidence increasing year by year. 15%-25% of patients will develop severe acute pancreatitis (SAP), characterized by necrosis and infection of the pancreas and surrounding tissues, as the investigators as multiple organ dysfunction syndrome (MODS), with a mortality rate as high as 17%. Currently, there is a lack of effective measures in clinical practice to regulate the early inflammation and immune response in acute pancreatitis. Animal experimental studies have confirmed that TEA, by blocking the abdominal sympathetic nerves, increases arterial blood flow and venous capacity, improves pancreatic perfusion insufficiency caused by AP, and alleviates metabolic acidosis. Simultaneously, TEA can suppress the secretion of catecholamines during the stress state of acute pancreatitis, reducing the release of inflammatory mediators and thereby inhibiting the inflammatory response. Our team's earlier animal experiments have further confirmed that TEA improves intestinal inflammation in mice with pancreatitis. This improvement is marked by a significant reduction in the concentrations of inflammatory cytokines such as IL-1β and TNF-α. Additionally, there is an observed alteration in the intestinal microbiota, characterized by an increase in the proportion of beneficial bacteria. Based on these findings, it is speculated that TEA, by reducing catecholamine release and downregulating sympathetic activity, effectively mitigates inflammation and stress responses in patients with pancreatitis. Furthermore, TEA dilates small arteries in blocked segments, thereby improving blood flow and microcirculation within the affected area. Indirectly, TEA increases vagal nerve activity, which in turn slows down the progression of intestinal ischemia, consequently reducing the impact of the "second hit" caused by the translocation of intestinal bacteria and endotoxins into the bloodstream, which exacerbates acute pancreatitis. Despite these promising results, clinical data on the efficacy of TEA in acute pancreatitis remains insufficient. Moreover, the precise mechanisms by which TEA influences the progression and severity of acute pancreatitis are yet to be fully elucidated. In order to further validate the clinical therapeutic effects of TEA and gain a deeper understanding of its mechanisms, the investigators have conducted this clinical study., conditionsModule conditions: Acute Pancreatitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 88, type: ESTIMATED, armsInterventionsModule interventions name: Thoracic Epidural Analgesia, outcomesModule primaryOutcomes measure: The change in systemic inflammatory response syndrome (SIRS) and organ dysfunction after inclusion., primaryOutcomes measure: The change in intra-abdominal pressure (measured via bladder pressure) after treatment., primaryOutcomes measure: The change in resting pain and movement pain after inclusion., secondaryOutcomes measure: Peripheral blood inflammation and immune markers., secondaryOutcomes measure: intestinal microbiota, secondaryOutcomes measure: total ICU treatment time, secondaryOutcomes measure: adverse event occurrence rate, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sir Run Run Shaw Hospital, city: Hangzhou, state: Zhejiang, zip: 310016, country: China, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False
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protocolSection identificationModule nctId: NCT06327217, orgStudyIdInfo id: OC-2023-009, briefTitle: Long Term Results After Hip Arthroscopy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Reinier Haga Orthopedisch Centrum, class: OTHER, descriptionModule briefSummary: A common cause of hip joint pain in the young and active population is femoroacetabular impingement (FAI) syndrome. if FAI is left untreated, the changed morphology will have a negative effect on the existing joint and will contribute to the development of osteoarthritis (OA). Hip arthroscopy is the first choice of operative treatment for FAI. While hip arthroscopy improves the patient reported outcome measures (PROMs), the influence of this treatment on the contribution to the development of osteoarthritis after FAI is to the best of our knowledge still unknown., conditionsModule conditions: Femoro Acetabular Impingement, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 451, type: ESTIMATED, armsInterventionsModule interventions name: Bilateral hip x-ray, interventions name: Questionnaires, outcomesModule primaryOutcomes measure: To evaluate the degree of osteoarthritis 5 to 10 years after a hip arthroscopy in comparison with the non-operative side., secondaryOutcomes measure: To evaluate the change in degree of osteoarthritis at 5 to 10 years after a hip arthroscopy in comparison with preoperative/perioperative., secondaryOutcomes measure: To report incidence of total hip replacement within 5 to 10 years after a hip arthroscopy., secondaryOutcomes measure: To determine the functional outcome of patients and, to determine what factors contribute to a good functional outcome 5/10 years after hip arthroscopy., secondaryOutcomes measure: To determine the inter-rater and intra-rater agreement of the Kellgren and Lawrence OA score., secondaryOutcomes measure: To determine patient satisfaction 5-10 years after hip arthroscopy., eligibilityModule sex: ALL, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Reinier Haga Orthopedic Center, city: Zoetermeer, zip: 2725 NA, country: Netherlands, geoPoint lat: 52.0575, lon: 4.49306, hasResults: False
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protocolSection identificationModule nctId: NCT06327204, orgStudyIdInfo id: Low Level laser 24, briefTitle: Efficacy of Different Low Level Laser Therapy Sessions, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2023-10-01, completionDateStruct date: 2023-12-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: October 6 University, class: OTHER, descriptionModule briefSummary: Myofascial pain dysfunction syndrome is one of the common causes of non-odontogenic pain in the head and neck region. It accounts for 40-60% of the adult population. Different treatment modalities had been reported to release the trigger point within the muscles of mastication in order to reduce pain and allow recovery of the function., conditionsModule conditions: Myofascial Pain Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ACTUAL, armsInterventionsModule interventions name: 940-nm diode laser / one session, interventions name: 940-nm diode laser / two session, interventions name: 940-nm diode laser/ three session, outcomesModule primaryOutcomes measure: pain score, secondaryOutcomes measure: maximum mouth opening, secondaryOutcomes measure: quality of life questioner, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Dentistry, October 6 University, city: Cairo, zip: 21523, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06327191, orgStudyIdInfo id: 23-CRFG-21, secondaryIdInfos id: 23-CRFG-21, type: OTHER, domain: Clinical Research Facility Galway (CRFG) study number, briefTitle: EMERGE Mothers and Kids, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: National University of Ireland, Galway, Ireland, class: OTHER, descriptionModule briefSummary: The EMERGE Mothers and Kids study is a follow-up to the EMERGE trial of women with GDM (N=535) that aimed to determine the effect of the addition of metformin compared to placebo on insulin initiation rates, maternal weight gain and perinatal morbidity and mortality.The primary objectives of the EMERGE Mothers and Kids follow up study are:1. to determine whether treatment with metformin leads to a reduction in maternal disorders of glucose, metabolic syndrome, obesity, hypertension and lipids at up to 6 years post the index pregnancy;2. to examine the impact of metformin on maternal anxiety, depression, quality of life and breast feeding duration;3. to examine whether exposure to metformin leads to a reduction in obesity in the offspring at follow up;4. to determine whether treatment with metformin during pregnancy, in women with GDM, leads to a reduction in adiposity in the offspring at follow up as measured by anthropometric measurements and sum of skinfolds., conditionsModule conditions: Gestational Diabetes, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 321, type: ESTIMATED, armsInterventionsModule interventions name: No intervention as the study is observational., outcomesModule primaryOutcomes measure: To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces the risk of disorders of glucose metabolism at follow up.., primaryOutcomes measure: To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces the risk of metabolic syndrome., primaryOutcomes measure: To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces rates of OW and OB at follow up., primaryOutcomes measure: To assess if treatment of GDM with metformin during pregnancy compared to placebo reduces the risk of hypertension., primaryOutcomes measure: To examine the associations of GDM diagnosis, sum of fasting, 1-hour, and 2-hour glucose z-scores after 75-g load, insulin sensitivity, and lipid levels at 24-32 weeks' gestation with lipid levels 3-6 years postpartum., primaryOutcomes measure: To determine whether treatment with metformin during pregnancy, in women with GDM, leads to a reduction in adiposity in the offspring at follow up as measured by anthropometric measurements and sum of skinfolds., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06327178, orgStudyIdInfo id: NFEC-2023-520, briefTitle: Abscopal Effects of Stereotactic Body Radiotherapy in Metastatic Clear Renal Cell Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2024-01-31, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Nanfang Hospital, Southern Medical University, class: OTHER, descriptionModule briefSummary: Prior research has indicated that stereotactic body radiotherapy (SBRT) can effectively trigger systemic anti-tumor immune response. The goal of this observational study is to learn about abscopal effects of stereotactic body radiotherapy in patients of metastatic clear renal cell carcinoma. The primary objective was to assess the objective response rate (ORR) and complete response (CR) in non-irradiated lesions, and incidence of adverse events (AEs)., conditionsModule conditions: Abscopal Effects of Stereotactic Body Radiotherapy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, outcomesModule primaryOutcomes measure: Objective Response Rate, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Nanfang Hospital, Southern Medical University, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510515, country: China, contacts name: Guozhu Xie, role: CONTACT, email: xieguozhu@126.com, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
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protocolSection identificationModule nctId: NCT06327165, orgStudyIdInfo id: 1-2023-0072, briefTitle: Predictability of ANI (Analgesia Nociception Index) for Spinal Hypotension, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Yonsei University, class: OTHER, descriptionModule briefSummary: Spinal anesthesia is widely accepted as the anesthetic method of choice for Cesarean section. However, the incidence of spinal hypotension is 50-70%, and the decrease in blood pressure is often rapid and severe. Heart rate variability is influenced by various factors such as the sympathetic nervous system, parasympathetic nervous system, temperature regulation, baroreflex, and endocrine regulation, but high frequency heart rate variability above 0.15 Hz very specifically reflects the parasympathetic nervous system. The ANI monitor calculates heart rate variability mediated by changes in the parasympathetic nervous system. This study aims to determine whether ANI monitor can predict hypotension in patients undergoing a caesarean section under spinal anaesthesia while applying the preemptive vasopressor phenylephrine infusion protocol., conditionsModule conditions: Cesarean Section, conditions: Spinal Anesthesia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: observation, outcomesModule primaryOutcomes measure: predictive value of ANI monitor for spinal hypotension during cesarean delivery, secondaryOutcomes measure: Optimal cutoff value of ANI level for predicting occurrence of hypotension, eligibilityModule sex: FEMALE, minimumAge: 20 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yonsei University Health system, Severance Hospital, status: RECRUITING, city: Seoul, country: Korea, Republic of, contacts name: Seung Hyun Kim, Associate Professor, role: CONTACT, phone: 82-2-2224-1055, email: anesshkim@yuhs.ac, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
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protocolSection identificationModule nctId: NCT06327152, orgStudyIdInfo id: 2659, briefTitle: Caffeine Use in the Management of Preterm Infants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-22, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: University of California, Irvine, class: OTHER, descriptionModule briefSummary: This study aims to assess whether extending the duration of caffeine therapy will help preterm infants achieve full oral feeding faster., conditionsModule conditions: Apnea of Prematurity, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a randomized, double-blinded, placebo-controlled trial of 40 preterm infants born at less than or equal to 32 weeks and 0 days gestation. Infants will be randomized to receive either caffeine or placebo for up to maximum of additional four (4) weeks after meeting clinical criteria to come off caffeine., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Families, nurses, therapists, and doctors will be blinded. Only pharmacy will be unblinded and know which subjects are in each treatment arm., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Caffeine, interventions name: Sterile Water Placebo, outcomesModule primaryOutcomes measure: Time to full feeds, secondaryOutcomes measure: Time to discharge, secondaryOutcomes measure: Post menstrual age (PMA) at time of discharge, secondaryOutcomes measure: Number of significant cardiopulmonary events, secondaryOutcomes measure: Weight change, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 40 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: UC Irvine Medical Center, status: RECRUITING, city: Orange, state: California, zip: 92868, country: United States, contacts name: Cherry Uy, MD, role: CONTACT, phone: 714-456-6933, email: ccuy@hs.uci.edu, contacts name: Cherry Uy, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Ernest Lai, MD, role: SUB_INVESTIGATOR, contacts name: Muhammad Aslam, MD, role: SUB_INVESTIGATOR, geoPoint lat: 33.78779, lon: -117.85311, hasResults: False
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protocolSection identificationModule nctId: NCT06327139, orgStudyIdInfo id: CTRIAL 23-24, briefTitle: Optimising Patient Experience in Head and Neck Radiotherapy, acronym: OPEN, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-02, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-07, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Irish Research Radiation Oncology Group, class: NETWORK, descriptionModule briefSummary: This study is a phase III, randomized, single-centre, multiple arm trial examining the set-up accuracy of three different types of immobilization methods for head and neck cancer patients receiving radical radiation therapy. The methods of immobilization under investigation in this study are two types of open faced head and neck masks compared with the convention closed faced head and neck mask. Patients receiving treatment using an open faced mask will have their intra fraction motion monitored through the use of intra fraction surface guided monitoring. The study aims to determine the set-up accuracy of the three types of immobilization through measuring the magnitude of the translational corrections on the daily cone beam computed tomography (CBCT). To be eligible for the study a patient must be planned to receive a minimum of 30 fractions of head and neck radiation therapy.Patients distress levels associated with each type of immobilization device will be measured using the psychological measure General Health Questionnaire-12 (GHQ-12) which will be collected at the beginning and end of their course of radiation therapy treatment., conditionsModule conditions: Head and Neck Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This study is a phase III, randomized, single-centre, multiple arm trial of immobilization methods for head and neck cancer patients receiving radical radiation therapy. A faceless three point head and neck mask in conjunction with intra fraction surface guided monitoring, a faceless five point mask in conjunction with intra fraction surface guided monitoring and a conventional closed face five point mask without the use of intra fraction surface guided monitoring are being investigated in this study. The set-up accuracy will be based on the magnitude of the translational corrections measured prior to delivery of each radiation therapy fraction., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 201, type: ESTIMATED, armsInterventionsModule interventions name: Conventional 5 point closed face immobilisation mask., interventions name: 5 point open face immobilization mask, interventions name: 3 point open face immobilization mask, outcomesModule primaryOutcomes measure: The setup accuracy of each immobilization device will be measured based on the magnitude of the translational corrections measured in millimeters prior to delivery of each radiation therapy fraction., secondaryOutcomes measure: Estimate of distress levels during the first week and during the final week of the participants course of radiation therapy using the psychological measure General Health Questionnaire-12 (GHQ-12)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: St. Luke's Radiation Oncology Network, status: RECRUITING, city: Dublin, zip: D06 HH36, country: Ireland, contacts name: Roisin O Maolalai, BSc, role: CONTACT, phone: 0035314065458, email: Roisin.OMaolalai@slh.ie, contacts name: Emma Noone, BSc MA, role: CONTACT, phone: 003534065467, email: Emma.Noone@slh.ie, contacts name: Sinead Brennan, FFR RCSI, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.33306, lon: -6.24889, hasResults: False
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protocolSection identificationModule nctId: NCT06327126, orgStudyIdInfo id: BFHHZS20240001, briefTitle: Efficacy and Safety of Single-session Endoscopic Stone Extraction, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-05-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Beijing Friendship Hospital, class: OTHER, descriptionModule briefSummary: This is a retrospective study, including approximately 600 patients with acute cholangitis accompanied with choledocholithiasis, who treated with single-session or two-session endoscopic stone extraction at Beijing friendship hospital. The investigators assessed the outcomes of single-stage and two-stage endoscopic stone extraction., conditionsModule conditions: Choledocholithiasis With Acute Cholangitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: two-session ERCP, interventions name: single-session ERCP, outcomesModule primaryOutcomes measure: Success rate of complete stone removal, primaryOutcomes measure: ERCP-related complication rate, secondaryOutcomes measure: Length of stay, secondaryOutcomes measure: Hospital expenses, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Friendship Hospital, status: RECRUITING, city: Beijing, state: Beijing, zip: 100050, country: China, contacts name: Wei Jiang, role: CONTACT, phone: 18663186116, email: jfw899w@outlook.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False
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protocolSection identificationModule nctId: NCT06327113, orgStudyIdInfo id: IRB#23-001248, briefTitle: Antibiotic Tumescent For Chronic Wounds, acronym: TAI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2027-03-25, completionDateStruct date: 2028-03-25, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: University of California, Los Angeles, class: OTHER, descriptionModule briefSummary: Chronic non-healing wounds are becoming an increasingly more common problem. Eligible, consenting patients with chronic leg wounds will either continue to the standard of care or will be randomized to the treatment cohort where antibiotic solution will be injected in the area around the wound. All patients will continue standard wound care as dictated by the wound care clinic. Subjects of both the control and treatment will have approximately 6 study specific visits that may or may not coincide with previously schedule wound care clinic visits. As these specified visits wound size and healing will be documented and patients will complete surveys. The study will conclude for the subject after approximately 6 months. Again, these patients may continue standard wound care but will no longer have study obligations., conditionsModule conditions: Non-healing Wound, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a single center, prospective, comparative interventional, two-arm parallel group, randomized, clinical safety and efficacy trial comparing a group receiving standard wound care with tumescent antibiotic injection (TAI) with a control group receiving standard wound care, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: CeFAZolin Injectable Solution, outcomesModule primaryOutcomes measure: Primary Objective - Assess the rate of occurrence and severity of adverse events and their relationship to TAI, secondaryOutcomes measure: Secondary Objective - To evaluate wound size and closure., secondaryOutcomes measure: Secondary Objective - Chronic-wound-related pain, secondaryOutcomes measure: Secondary Objective - Rating Quality of life, otherOutcomes measure: Exploratory Objectives - Assess the number of chronic wound-related complications (increased wound sizes, infections, dermatitis)., otherOutcomes measure: Exploratory Objectives - Assess the number of clinical signs of infection in participants., otherOutcomes measure: Exploratory Objectives - Determine the species of pathogenic bacteria present in wound., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06327100, orgStudyIdInfo id: 2023-0934, secondaryIdInfos id: NCI-2024-02551, type: OTHER, domain: NCI-CTRP Clinical Registry, briefTitle: Open Label Phase 2 Study of Tasquinimod in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), or Post-Essential Thrombocytosis Myelofibrosis (Post-ET MF), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-30, primaryCompletionDateStruct date: 2029-05-01, completionDateStruct date: 2031-05-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: M.D. Anderson Cancer Center, class: OTHER, collaborators name: Active Biotech AB, descriptionModule briefSummary: To learn if tasquinimod either alone or in combination with ruxolitinib can help to control PMF, post-PV MF, or post-ET MF., conditionsModule conditions: Primary Myelofibrosis, conditions: Post-polycythemia Vera Myelofibrosis, conditions: Post-Essential Thrombocytosis Myelofibrosis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 33, type: ESTIMATED, armsInterventionsModule interventions name: Ruxolitinib, interventions name: Tasquinimod, outcomesModule primaryOutcomes measure: Safety and adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MD Anderson Cancer Center, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Lucia Masarova, MD, role: CONTACT, phone: 832-750-4211, email: lmasarova@mdanderson.org, contacts name: Lucia Masarova, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False
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protocolSection identificationModule nctId: NCT06327087, orgStudyIdInfo id: 22-00874, briefTitle: Appetite and Dietary Intake Across the Menstrual Cycle, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-06-01, primaryCompletionDateStruct date: 2025-05-31, completionDateStruct date: 2025-05-31, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: University of British Columbia, class: OTHER, descriptionModule briefSummary: Lay language summary: Women are younger and menstruating about monthly ("pre-menopausal") often have fluctuations in the food they eat ("dietary intake") across the menstrual cycle. However, relationships between food intake and appetite, metabolism, body composition (i.e., the proportion of muscle and fat), physical activity and premenstrual symptoms have not been reported. This study will measure appetite and food intake in laboratory and usual life settings in healthy pre-menopausal women in two hormonally different parts of the menstrual cycle. Data on ovarian hormones, metabolism, body composition, physical activity and premenstrual symptoms will also be collected to assess their potential relationship with food intake., conditionsModule conditions: Appetitive Behavior, conditions: Healthy, conditions: Dietary Habits, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 23, type: ESTIMATED, armsInterventionsModule interventions name: No intervention, outcomesModule primaryOutcomes measure: Energy intake, primaryOutcomes measure: Hunger area under the curve, primaryOutcomes measure: Satiety area under the curve, primaryOutcomes measure: Prospective food consumption area under the curve, secondaryOutcomes measure: Free-living ad libitum energy intake, secondaryOutcomes measure: Resting metabolic rate, secondaryOutcomes measure: Body composition, secondaryOutcomes measure: Estradiol, secondaryOutcomes measure: Progesterone, secondaryOutcomes measure: Physical activity patterns, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of British Columbia - Okanagan, status: RECRUITING, city: Kelowna, state: British Columbia, zip: V1V1V7, country: Canada, contacts name: Sarah Purcell, PhD, role: CONTACT, phone: 2508079827, email: sarah.purcell@ubc.ca, geoPoint lat: 49.88307, lon: -119.48568, hasResults: False
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protocolSection identificationModule nctId: NCT06327074, orgStudyIdInfo id: 21-3063.cc, briefTitle: Testing the Engaged Approach to Lung Cancer Screening, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: University of Colorado, Denver, class: OTHER, collaborators name: Bristol-Myers Squibb, descriptionModule briefSummary: The goal of this study is to assess feasibility and acceptability of the Engaged Approach to Lung Cancer Screening (EA-LCS) in diverse lung cancer screening (LCS) programs operating in a variety of geographic regions across Colorado and the US., conditionsModule conditions: Lung Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Engaged Approach to Lung Cancer Screening, outcomesModule primaryOutcomes measure: Percentage of the intervention group who would like to continue the EA-LCS framework, primaryOutcomes measure: Percentage of the intervention group who would recommend the EA-LCS framework to other programs, primaryOutcomes measure: Percentage of participants who would describe the framework as workable, secondaryOutcomes measure: Evaluate the intervention acceptability by Acceptability of Intervention Measure (AIM), secondaryOutcomes measure: Evaluate the intervention appropriateness by Intervention Appropriateness Measure (IAM), secondaryOutcomes measure: Evaluate the intervention feasibility by Feasibility of Intervention Measure (FIM), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Colorado Hospital, status: RECRUITING, city: Denver, state: Colorado, zip: 80045, country: United States, contacts name: Jamie Studts, role: CONTACT, email: Jamie.Studts@CUANSCHUTZ.EDU, contacts name: Jamie Studts, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Erin Hirsch, role: SUB_INVESTIGATOR, geoPoint lat: 39.73915, lon: -104.9847, hasResults: False
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protocolSection identificationModule nctId: NCT06327061, orgStudyIdInfo id: R01DA058659, type: NIH, link: https://reporter.nih.gov/quickSearch/R01DA058659, secondaryIdInfos id: IRB00026607, type: OTHER, domain: JHSPH IRB, briefTitle: Social Network Overdose Prevention and Education Intervention, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2027-06-01, completionDateStruct date: 2027-12-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins Bloomberg School of Public Health, class: OTHER, collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: The purpose of this study is to test a social intervention focused on overdose prevention and care. In the investigators prior work, the investigators have shown that people who use opioids (PWUO) can be effective peer educators (PEs)., conditionsModule conditions: Drug Overdose, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: a standard two-group clinical trial, one group is the experimental, the other the control, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Both groups receive overdose prevention training, whoMasked: PARTICIPANT, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: Network overdose prevention, interventions name: Standard of care health education, outcomesModule primaryOutcomes measure: Number of drug overdoses, primaryOutcomes measure: Participant drug use, secondaryOutcomes measure: Number of Network member contacts, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Johns Hopkins Bloomberg School of Public Health, city: Baltimore, state: Maryland, zip: 21205, country: United States, geoPoint lat: 39.29038, lon: -76.61219, hasResults: False
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protocolSection identificationModule nctId: NCT06327048, orgStudyIdInfo id: School of Nursing, briefTitle: Application of Cognitive Training Based on Remind Strategy in Glioma Patients With Cognitive Impairment, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-06, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: YuanYuan Ma, class: OTHER, descriptionModule briefSummary: The purpose of this study is to form an interdisciplinary team to dynamically evaluate patient cognitive outcomes and develop an individualized cognitive training program for Chinese brain tumor patients, conditionsModule conditions: Glioma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Non-randomized intervention study, primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: Blind the evaluator, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: Individual cognitive rehabilitation training based on Remind strategy was given, outcomesModule primaryOutcomes measure: Montreal Cognitive Assessment(MoCA), secondaryOutcomes measure: The European Organization for Research and Treatment of Cancer core Quality of Life Questionnaire (EORTC QLQ-C30), secondaryOutcomes measure: The EORTC QLQ-Brain Neoplasms 20(EORTC QLQ-BN20), secondaryOutcomes measure: Self-Rating Anxiety Scale(SAS), secondaryOutcomes measure: Self-Rating Depression Scale(SDS), secondaryOutcomes measure: Modified Barthel Index(MBI), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yuanyuanma, status: RECRUITING, city: Lanzhou, state: Gansu, country: China, contacts name: yuanyuan ma, Bachelor, role: CONTACT, phone: 15294126094, email: 1657107645@qq.com, geoPoint lat: 36.05701, lon: 103.83987, hasResults: False
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protocolSection identificationModule nctId: NCT06327035, orgStudyIdInfo id: 2023-A02660-45, briefTitle: Evolution of Walking Abilities in Subacute Stroke Patients Hospitalized in Neurorehabilitation Center, acronym: PROWALK, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Clinique Les Trois Soleils, class: OTHER, collaborators name: Le Normandy, descriptionModule briefSummary: The goal of this observational study is to describe the evolution of gait recovery during the subacute phase of stroke up to six months after stroke, in patients hospitalized in medical and neurological rehabilitation units., conditionsModule conditions: Stroke, conditions: Gait, Hemiplegic, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Gait rehabilitation, outcomesModule primaryOutcomes measure: Functional Ambulation Classification, secondaryOutcomes measure: Postural Assesment Scale for Stroke Patient, secondaryOutcomes measure: Timed Up and Go, secondaryOutcomes measure: 10-Meter Walk Test, secondaryOutcomes measure: 6Minute-Walk Test, secondaryOutcomes measure: Motricity Index, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06327022, orgStudyIdInfo id: P0038444, briefTitle: Social Media-based Electronic Bibliotherapy for Dementia Caregivers, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-07-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: The Hong Kong Polytechnic University, class: OTHER, descriptionModule briefSummary: This study aims to assess the efficacy of social media-based electronic bibliotherapy in improving the well-being of informal caregivers of people with dementia compared to a control group., conditionsModule conditions: Mental Health, conditions: Quality of Life, conditions: Dementia Caregivers, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Social media-based electronic bibliotherapy, interventions name: Usual care, outcomesModule primaryOutcomes measure: Changes in mental health, secondaryOutcomes measure: Changes in health related quality of life, secondaryOutcomes measure: Changes in caregiving appraisal, secondaryOutcomes measure: Changes in psychological wellbeing, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Hong Kong Polytechnic University, city: Kowloon, country: Hong Kong, geoPoint lat: 22.31667, lon: 114.18333, hasResults: False
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protocolSection identificationModule nctId: NCT06327009, orgStudyIdInfo id: fasting ramadan in GN patients, briefTitle: Effect of Ramadan Fasting on Kidney Function and Proteinuria in Patients With Glomerulonephritis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-22, primaryCompletionDateStruct date: 2024-04-22, completionDateStruct date: 2024-05-22, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Alexandria University, class: OTHER, descriptionModule briefSummary: This research aims to assess effects of ramadan fasting on kidney function and proteinuria in patients with glomerulonephritis., conditionsModule conditions: Fasting Ramadan, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: fasting month of ramadan, outcomesModule primaryOutcomes measure: Change in kidney function, primaryOutcomes measure: Change in proteinuria, eligibilityModule sex: ALL, minimumAge: 18 Months, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Faculty of Medicine, Aexandria University, city: Alexandria, zip: 21526, country: Egypt, contacts name: Mohamed Mamdouh Elsayed, MD, role: CONTACT, email: dr_mohamedmamdouh87@yahoo.com, geoPoint lat: 31.21564, lon: 29.95527, hasResults: False
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protocolSection identificationModule nctId: NCT06326996, orgStudyIdInfo id: 23-001185, briefTitle: Thiamine Intervention and Coronary Artery Bypass Grafting, acronym: B1&CABG, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-01, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: University of California, Los Angeles, class: OTHER, descriptionModule briefSummary: The purpose of this study is to gain a better understanding of the association between brain changes and cognitive deficits in coronary heart disease (CHD) patients undergoing coronary artery bypass grafting (CABG) and whether a low-cost thiamine intervention can be used to reduce post-CABG cognitive issues in CHD subjects., conditionsModule conditions: Coronary Heart Disease, conditions: Coronary Artery Bypass Grafting, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Post-CABG patients with and without thiamine treatment., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Participants will be assigned a random number, double-blind randomized, \& longitudinal study design., whoMasked: PARTICIPANT, enrollmentInfo count: 52, type: ESTIMATED, armsInterventionsModule interventions name: Thiamine, interventions name: Placebo, outcomesModule primaryOutcomes measure: Effects of thiamine treatment intervention on blood lactate levels., primaryOutcomes measure: Effects of thiamine treatment intervention on blood thiamine levels., primaryOutcomes measure: Effects of thiamine treatment intervention on blood inflammatory levels., primaryOutcomes measure: Evaluate cognitive function in CABG patients with thiamine treatment., primaryOutcomes measure: Evaluate long term effects of thiamine treatment intervention on cognitive function in CABG patients with thiamine treatment., primaryOutcomes measure: Examine cognition in CABG patients with thiamine treatment., primaryOutcomes measure: Examine long term effects of thiamine treatment intervention on cognition in CABG patients with thiamine treatment., primaryOutcomes measure: Cognition assessment in CABG patients after thiamine treatment., primaryOutcomes measure: Assessment of long term effects of thiamine treatment intervention on cognition in CABG patients after thiamine treatment., primaryOutcomes measure: Long term effect of thiamine treatment intervention on quality of life., primaryOutcomes measure: Long term effect of thiamine treatment intervention on daily activities using PASE., primaryOutcomes measure: Long term effect of thiamine treatment intervention on daily activities using PPA., eligibilityModule sex: ALL, minimumAge: 60 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UCLA, city: Los Angeles, state: California, zip: 90095, country: United States, geoPoint lat: 34.05223, lon: -118.24368, hasResults: False
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protocolSection identificationModule nctId: NCT06326983, orgStudyIdInfo id: IRB-P00047028, briefTitle: Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Boston Children's Hospital, class: OTHER, descriptionModule briefSummary: This is a prospective, randomized, controlled, non-inferiority study of patients undergoing tonsil surgeries at Boston Children's Hospital Waltham. The overall aim is to evaluate the efficacy of an opioid anesthetic plan (morphine, ketorolac, and acetaminophen versus an opioid sparing anesthetic plan (dexmedetomidine, ketorolac and acetaminophen) for perioperative analgesia and recovery time in patients undergoing tonsillectomies and tonsillotomies at Boston Children's Hospital Waltham. Secondary measures include rescue opioids administered in post-anesthesia care unit (PACU), re-operation secondary to bleeding, emergence delirium, post-operative nausea and vomiting, intraoperative hemodynamics, intraoperative vasopressor administration, and length of procedure., conditionsModule conditions: Tonsillitis, conditions: Post-operative Nausea and Vomiting (PONV), conditions: Emergence Delirium, conditions: Opioid Analgesic Adverse Reaction, conditions: Anesthesia, conditions: Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 58, type: ESTIMATED, armsInterventionsModule interventions name: Dexmedetomidine, interventions name: Acetaminophen, interventions name: Ketorolac, interventions name: Morphine, outcomesModule primaryOutcomes measure: Median Pain Scores in the Post-Anesthesia Care Unit, primaryOutcomes measure: Post-operative pain at 12-24 hours, primaryOutcomes measure: Post Operative Anesthesia Unit Length of Stay (hours), secondaryOutcomes measure: Opioid rescue medication administration, secondaryOutcomes measure: Emergence Delirium, secondaryOutcomes measure: Post-operative nausea and vomiting, secondaryOutcomes measure: Procedure length (minutes), secondaryOutcomes measure: Intraoperative Blood pressure (mmHg), secondaryOutcomes measure: Intraoperative Heart rate (beats per second), secondaryOutcomes measure: Vasopressor administration, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06326970, orgStudyIdInfo id: HenanICE202401, briefTitle: SPECT Fibroblast Activation Protein Imaging in Patients With Cardiac Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Henan Institute of Cardiovascular Epidemiology, class: OTHER, descriptionModule briefSummary: This observational study aims to learn about the preliminary exploration of 99mTc-FAPI imaging in heart diseases and its potential application.Participant involves patients with myocarditis, pulmonary hypertension, arrhythmia, myocardial infarction, dilated cardiomyopathy, and cardiac tumors, health conditions may also studied as control.The main questions it aims to answer are 1, radionuclide 99mTc labeled fibroblast-activated protein inhibitors (99mTc-FAPI) imaging in the use of cardiac diseases and its limitations. 2, the performance in subjects with different control of hypertension to evaluate myocardial injury and fibrosis for providing a molecular biological basis for the study of diseases and mechanisms.Participants will undergo 99mTc-FAPI imaging by Single-photon emission computed tomography (SPECT) and record their cardiac disease characterization and treatment., conditionsModule conditions: Myocardial Fibrosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: 99mTc-FAPI SPECT imaging, outcomesModule primaryOutcomes measure: positive uptake, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06326957, orgStudyIdInfo id: 334979 V1 15/01/2024, secondaryIdInfos id: NIHR302904, type: OTHER_GRANT, domain: National Institute for Health & Care Research (NIHR), secondaryIdInfos id: 24/LO/0142, type: OTHER, domain: Research Ethics Committee (REC), briefTitle: Reducing Chronic Breathlessness in Adults by Following a Self-guided, Internet Based Supportive Intervention (SELF-BREATHE), acronym: SELF-BREATHE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2028-02, completionDateStruct date: 2028-07, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: King's College Hospital NHS Trust, class: OTHER, descriptionModule briefSummary: Background:Some health conditions make breathing difficult and uncomfortable. When this happens every day, it is called chronic breathlessness. Over 3 million people living with heart and lung disease have chronic breathlessness in the UK.Breathlessness is very difficult for patients themselves and their families, resulting in disability and feelings of fear, distress, and isolation. Due a to lack of supportive breathlessness services many patients frequently attend hospital Accident and Emergency (A\&E) departments seeking help.Given the on-going challenges faced by the National Health Service (NHS) in the United Kingdom, such as long waiting times, staff shortages, increased demand for services because of the COVID-19 pandemic, there is an urgent need to develop new ways to support those living with chronic breathlessness. One potential solution is to offer support online, as it is estimated that in the UK, 7 out of every 10 people with chronic breathlessness are internet users.With the help of patients and NIHR funding the research team lead by Dr Charles Reilly, developed an online breathlessness supportive website called SELF-BREATHE. SELF-BREATHE provides information and self-management tools such as breathing exercises, that patients can do at home themselves.SELF-BREATHE has been tested as part of its development. SELF-BREATHE is acceptable and valued by patients. But what is unknown is whether SELF-BREATHE improves patients' breathlessness and their life? This is the question this research seeks to answer.Aims1. To test if using SELF-BREATHE for six-weeks improves patients' breathlessness, their quality of life and whether SELF-BREATHE should be offered within the NHS2. To see if patients opt to continue to use SELF-BREATHE after six-weeks and what benefits this may have for patients.MethodsThe research team are undertaking a randomised controlled trial. For this, 246 people living with chronic breathlessness will be recruited in to this study. Each person will be randomly chosen by a computer to continue with their usual care or their usual care plus access to SELF-BREATHE. All study participants will complete questionnaires at the start of the study, thereafter at seven and twelve weeks after randomisation.These questionnaires will ask patients about 1) their breathlessness and its effect on their life and 2) planned and unplanned hospital visits. At the end of the study, we will compare answers to these questionnaires between the two groups at seven and 12 weeks.This will tell if SELF-BREATHE improved patients' breathlessness and reduced their need for unplanned hospital visits e.g., A\&E attendances due to breathlessness., conditionsModule conditions: Chronic Obstructive Pulmonary Disease, conditions: Bronchiectasis, conditions: Interstitial Lung Disease, conditions: Lung Cancer, conditions: Asthma, conditions: Dyspnea, conditions: Fibrotic Lung Disease, conditions: Chronic Lung Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: A statistician blind, whoMasked: INVESTIGATOR, enrollmentInfo count: 246, type: ESTIMATED, armsInterventionsModule interventions name: SELF-BREATHE, outcomesModule primaryOutcomes measure: Numerical Rating Scale (NRS) Worst Breathlessness, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 110 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: King's College Hospital NHS Foundation Trust, city: London, zip: MK40 4DG, country: United Kingdom, contacts name: Charles C Reilly, role: CONTACT, phone: 00442032998062, email: charles.reilly@nhs.net, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False
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protocolSection identificationModule nctId: NCT06326944, orgStudyIdInfo id: MS-527-2023, briefTitle: Fascia Transversalis Versus Transversus Abdominis Plane Block for Children Undergoing Inguinal Hernia Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-18, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Kasr El Aini Hospital, class: OTHER, descriptionModule briefSummary: Fascia transversalis block in pediatrics undergoing inguinal surgical repair may be simple technique and may give longer effect in reduction of post-operative pain in comparison to transversus abdominis plane block., conditionsModule conditions: Fascia Transversalis Plane Block, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Ultrasound- guided Fascia Transversalis plane block, interventions name: Ultrasound-guided Transversus abdominus plane block, interventions name: Fentanyl, interventions name: Pethidine, interventions name: Acetaminophen, outcomesModule primaryOutcomes measure: Time to First need of analgesia, secondaryOutcomes measure: Total Pethidine Consumption, secondaryOutcomes measure: Postoperative pain assessment FLACC, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 6 Years, stdAges: CHILD, contactsLocationsModule locations facility: Cairo University Hospitals, status: RECRUITING, city: Giza, zip: 11562, country: Egypt, contacts name: Maher a Fawzy, MD, role: CONTACT, phone: 01201730249, email: kasralainirec@kasralainy.edu.eg, geoPoint lat: 30.00808, lon: 31.21093, hasResults: False
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protocolSection identificationModule nctId: NCT06326931, orgStudyIdInfo id: JE001, briefTitle: Thermal Pulsation Versus Warm Compress Treatment for Meibomian Gland Dysfunction, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-06-24, primaryCompletionDateStruct date: 2023-06-22, completionDateStruct date: 2023-06-22, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Jacksoneye, class: OTHER, descriptionModule briefSummary: This study aimed to assess the treatment outcome differences between a single, in-office bilateral treatment with the thermal pulsation system and twice-daily, 10-minute applications of the warm compress mask at home for 8 weeks., conditionsModule conditions: Meibomian Gland Dysfunction, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Prospective, randomized, controlled clinical trial, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The clinician evaluating MGS score was masked to subject treatment assignment, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 68, type: ACTUAL, armsInterventionsModule interventions name: thermal pulsation, interventions name: warm compress, outcomesModule primaryOutcomes measure: Change in MGS score for the worse eye, secondaryOutcomes measure: Change in MGS score for the worse eye, secondaryOutcomes measure: Change in OSDI score, secondaryOutcomes measure: Change in OSDI score, secondaryOutcomes measure: Incidence of adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jacksoneye, city: Lake Villa, state: Illinois, zip: 60046, country: United States, geoPoint lat: 42.41697, lon: -88.07397, hasResults: False
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protocolSection identificationModule nctId: NCT06326918, orgStudyIdInfo id: RP026, briefTitle: Duodenal Microbiota in Functional Dyspepsia, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-12, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: King Chulalongkorn Memorial Hospital, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to assess the type of duodenal microbiota and duodenal microbiome in in FD patients compared to control group. The main questions it aims to answer are:* What are the differences in the type of duodenal microbiota and is there a difference in duodenal microbiome diversity between patients diagnosed with functional dyspepsia (FD) and the control group?* Are there any significant variations in the composition and diversity of gut microbiota between patients with FD and the control group, considering the method of sample collection (duodenal brushing vs. duodenal biopsy)?, conditionsModule conditions: Functional Dyspepsia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Duodenal mucosal brushing, interventions name: Duodenal mucosal biopsy, outcomesModule primaryOutcomes measure: Specific microbial genus using mucosal brushing, primaryOutcomes measure: Microbiome diversity using mucosal brushing, secondaryOutcomes measure: Specific microbial genus using mucosal biopsy, secondaryOutcomes measure: Microbiome diversity using mucosal biopsy, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: King Chulalongkorn Memorial Hospital, status: RECRUITING, city: Bangkok, zip: 10330, country: Thailand, contacts name: Rapat Pittayanon, MD, role: CONTACT, phone: +66813132112, email: rapat125@gmail.com, contacts name: Chatpol Samuthpongtorn, MD, role: CONTACT, phone: +66813462108, email: csamuthpongtorn@gmail.com, geoPoint lat: 13.75398, lon: 100.50144, hasResults: False
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protocolSection identificationModule nctId: NCT06326905, orgStudyIdInfo id: IRB00437750, secondaryIdInfos id: K23DK133677-01A1, type: NIH, link: https://reporter.nih.gov/quickSearch/K23DK133677-01A1, briefTitle: CAPABLE Transplant, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-09-01, completionDateStruct date: 2026-05-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Johns Hopkins University, class: OTHER, collaborators name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), descriptionModule briefSummary: The purpose of this mixed methods study is to adapt CAPABLE as CAPABLE Transplant to accomplish two things: 1) To resolve barriers to being classified as active on the Kidney Transplant (KT) waitlist and 2) as a surgical prehabilitation intervention targeting the pre-frail/ frail KT waitlist population. It consists of two phases- an open label pilot and a randomized waitlist control trial., conditionsModule conditions: Quality of Life, conditions: Depression, conditions: End Stage Renal Disease, conditions: Disability Physical, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Waitlist Control Trial, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: The assessment collector will be blinded as to whether a participant is in the intervention or waitlist group, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 33, type: ESTIMATED, armsInterventionsModule interventions name: CAPABLE Transplant- Open Label Pilot, interventions name: CAPABLE Transplant- Randomized Control Trial, outcomesModule primaryOutcomes measure: Waitlist-status as assessed by data obtained by the National Kidney Registry, secondaryOutcomes measure: Change in self-efficacy as assessed by the Coping Self-Efficacy Instrument, secondaryOutcomes measure: Change in self-efficacy as assessed by the Self-Efficacy of Chronic Disease Management Instrument, secondaryOutcomes measure: Change in Pain as assessed by the Brief Pain Inventory, secondaryOutcomes measure: Change in Depression as assessed by the Patient Health Questionnaire Depression Scale (PHQ-8), secondaryOutcomes measure: Change in Social engagement as assessed by the Lubben Social Network Scale, secondaryOutcomes measure: Change in Social engagement as assessed by the Krause-Borawski-Clark Support Interactions Scale, secondaryOutcomes measure: Change in Fatigue/Quality of Life as assessed by the Kidney disease Quality of Life Scale, secondaryOutcomes measure: Change in Frailty as assessed by the Fried Frailty Phenotype, secondaryOutcomes measure: Change in Health Team Communication as assessed by the CollaboRATE Scale Measure, secondaryOutcomes measure: Change in Function as assessed by Lawton & Brody's assessment of Instrumental Activities of Daily Living Scale, secondaryOutcomes measure: Change in Function as assessed by the Katz Index of Independence in Activities of Daily Living, otherOutcomes measure: Acceptability at endpoint of intervention assessed by survey, otherOutcomes measure: Feasibility as assessed by qualitative questions, otherOutcomes measure: Fidelity as assessed by percent completion of intervention items, eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Johns Hopkins School of Nursing, city: Baltimore, state: Maryland, zip: 21205, country: United States, contacts name: Samantha Curriero, MPH, role: CONTACT, phone: 443-699-1220, geoPoint lat: 39.29038, lon: -76.61219, hasResults: False
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protocolSection identificationModule nctId: NCT06326892, orgStudyIdInfo id: CHR1-101-2024, briefTitle: Natural Orifice Specimen Extraction in Low Rectal Cancer Surgery, acronym: NOSES, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-31, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-10-15, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Istituto Clinico Humanitas, class: OTHER, descriptionModule briefSummary: This study aims to compare the postoperative outcomes of low rectal cancer patients who underwent surgery with Natural Orifice Specimen Extraction (NOSE) versus traditional Pfannenstiel extraction., conditionsModule conditions: Rectal Cancer, conditions: Surgery, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 350, type: ESTIMATED, armsInterventionsModule interventions name: Natural Orifice Specimen Extraction (NOSE), interventions name: Traditional specimen extraction, outcomesModule primaryOutcomes measure: Surgical Site Infections (SSI), secondaryOutcomes measure: Opioid rescue, secondaryOutcomes measure: Postoperative pain, secondaryOutcomes measure: Postoperative ileus, secondaryOutcomes measure: Incisional hernia, secondaryOutcomes measure: Overall postoperative complications, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Humanitas Research Hospital, status: RECRUITING, city: Rozzano, state: MI, zip: 20089, country: Italy, contacts name: Annalisa Maroli, PhD, role: CONTACT, phone: 02 8224 7776, phoneExt: 0039, email: colorapp@humanitas.it, contacts name: Stefano De Zanet, MS, role: CONTACT, phone: 02 8224 4623, phoneExt: 0039, email: colorapp@humanitas.it, geoPoint lat: 45.38193, lon: 9.1559, hasResults: False
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protocolSection identificationModule nctId: NCT06326879, orgStudyIdInfo id: 3527, briefTitle: A Comparative Study Between Early Onset Colorectal Cancer and Late Onset Colorectal Cancer Patients, acronym: EOrOS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-30, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-10-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Istituto Clinico Humanitas, class: OTHER, descriptionModule briefSummary: This study aims to investigate the clinical, socioeconomic, behavioral, genetic, and molecular factors characterizing Early Onset Colorectal Cancer (EOCRC) patients compared with Late Onset Colorectal Cancer (LOCRC) patients, conditionsModule conditions: Colorectal Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 340, type: ESTIMATED, armsInterventionsModule interventions name: No intervention, outcomesModule primaryOutcomes measure: Incidence rate ratio of colorectal cancer recurrence, secondaryOutcomes measure: Correlation between lifestyle and incidence rate of colorectal cancer recurrence, secondaryOutcomes measure: Correlation between genetic profile and incidence rate of colorectal cancer recurrence, secondaryOutcomes measure: Correlation between molecular profile and incidence rate of colorectal cancer recurrence, secondaryOutcomes measure: Correlation between socioeconomic characteristics and incidence rate of colorectal cancer recurrence, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Humanitas Research Hospital, status: RECRUITING, city: Rozzano, state: MI, zip: 20089, country: Italy, contacts name: Annalisa Maroli, PhD, role: CONTACT, phone: 02 8224 7776, phoneExt: 0039, email: colorapp@humanitas.it, contacts name: Stefano De Zanet, MS, role: CONTACT, phone: 02 8224 4623, phoneExt: 0039, email: colorapp@humanitas.it, geoPoint lat: 45.38193, lon: 9.1559, hasResults: False
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protocolSection identificationModule nctId: NCT06326866, orgStudyIdInfo id: E-74555795-050.04-941208, briefTitle: Otoacoustic Emissions in Different Blood Types, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-02-07, primaryCompletionDateStruct date: 2024-03-12, completionDateStruct date: 2024-03-18, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Istanbul University - Cerrahpasa (IUC), class: OTHER, descriptionModule briefSummary: The objective of this study is to examine whether ABO and Rhesus (Rh) blood group systems have an association with distortion product otoacoustic emission (DPOAE) and transient otoacoustic emission (TEOAE) amplitudes with the hypothesis of blood groups may affect hearing thresholds., conditionsModule conditions: Hearing Loss, Cochlear, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 70, type: ACTUAL, armsInterventionsModule interventions name: Otoacoustic emissions (non-invasive), outcomesModule primaryOutcomes measure: Signal to noise ratios, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 26 Years, stdAges: ADULT, contactsLocationsModule locations facility: Eyyup KARA, city: İstanbul, zip: 34107, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06326853, orgStudyIdInfo id: Adipofisi, briefTitle: Neuroendocrine Mechanisms in Adiposity: An Integrated Approach to the Characterization of Potential Pharmacological Novel Targets Based on Experimental and Clinical Models, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-03, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: IRCCS San Raffaele, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to evaluate, retrospectively and prospectively, the effect of different hormonal and neuropeptide dysfunctions on the body composition of patients suffering from hypothalamic-pituitary pathologies, and to evaluate the potential beneficial effect of surgical and medical treatments with agonists and antagonists of hypothalamic neuropeptides, currently available, on the development and treatment of adiposity and negative cross-talk between adiposity and muscle/bone tissue, conditionsModule conditions: Endocrine Disorders, conditions: Adiposity, conditions: Pituitary Adenoma, conditions: Cushing Syndrome, conditions: Acromegaly, conditions: Hypopituitarism, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 200, type: ESTIMATED, outcomesModule primaryOutcomes measure: Rate of patients with BMI greater than 30 with hypothalamic-pituitary pathologies, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06326840, orgStudyIdInfo id: 98107, briefTitle: Clinical Efficacy and Adverse Reactions of Antipsychotic Treatment, statusModule overallStatus: COMPLETED, startDateStruct date: 2010-05-31, primaryCompletionDateStruct date: 2011-06-10, completionDateStruct date: 2011-06-10, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Taipei Medical University Hospital, class: OTHER, collaborators name: Taipei Medical University, descriptionModule briefSummary: The goal of this clinical trial is to explore the potential of metformin in managing olanzapine-induced metabolic disturbance and hyperprolactinemia in patients with schizophrenia. The main questions it aims to answer are:1. The effect of metformin on olanzapine-induced metabolic disturbance2. The effect of metformin on olanzapine-induced hyperprolactinemiaParticipants will receive metformin 1500 mg/day for 8 weeks and assessments every 2 weeks., conditionsModule conditions: Metabolic Disturbance, conditions: Hyperprolactinemia, conditions: Schizophrenia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 42, type: ACTUAL, armsInterventionsModule interventions name: Metformin, outcomesModule primaryOutcomes measure: Glucose level, primaryOutcomes measure: prolactin level, primaryOutcomes measure: Insulin level, primaryOutcomes measure: low-density lipoprotein cholesterol (LDL-C) level, primaryOutcomes measure: high-density lipoprotein cholesterol (HDL-C) level, primaryOutcomes measure: cholesterol level, primaryOutcomes measure: triglycerides level, primaryOutcomes measure: leptin level, secondaryOutcomes measure: Clinical Global Impression scale, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Taipei Medical University-Wan Fang Hospital, city: Taipei, zip: 116, country: Taiwan, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False
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protocolSection identificationModule nctId: NCT06326827, orgStudyIdInfo id: P231127IBSORTHO, briefTitle: In'Oss™ (MBCP® Putty) Ortho, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2026-05, completionDateStruct date: 2026-08, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Advanced Medical Solutions Ltd., class: INDUSTRY, descriptionModule briefSummary: Study of the osteoconductive potential of the injectable bone substitute In'Oss™ (MBCP® Putty) in the filling of orthopaedic bone defects to collect Post-Market Clinical Follow-up (PMCF) data for the CE-marked In'Oss™ (MBCP® Putty) device in the orthopaedic trauma surgery, conditionsModule conditions: Orthopedic Disorder, conditions: Trauma Injury, conditions: Extremity Injury, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: In'Oss™ (MBCP® Putty), outcomesModule primaryOutcomes measure: Successful bone defect reconstruction in the extremities, secondaryOutcomes measure: Evaluation of functional mobility restoration in the extremities with PRO measures, secondaryOutcomes measure: Evaluation of patient's pain intensity with VAS pain scale, secondaryOutcomes measure: Evaluation of safety of In'Oss, secondaryOutcomes measure: Evaluation of device usability, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06326814, orgStudyIdInfo id: TDU16837, secondaryIdInfos id: U1111-1298-7281, type: REGISTRY, domain: ICTRP, briefTitle: A Study to Test if SAR443809 is Tolerated and Safe When Taken as a Single Dose in Healthy Adults, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-10-11, primaryCompletionDateStruct date: 2023-05-05, completionDateStruct date: 2023-05-05, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Sanofi, class: INDUSTRY, descriptionModule briefSummary: Primary objective* The tolerability and safety of SAR443809 Secondary* The PK parameters of SAR443809* The PD activity of SAR443809* The immunogenicity of SAR443809, conditionsModule conditions: Paroxysmal Nocturnal Hemoglobinuria, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 54, type: ACTUAL, armsInterventionsModule interventions name: Humanized anti-Factor Bb monoclonal antibody, interventions name: Placebo, outcomesModule primaryOutcomes measure: Number of participants with adverse events (AEs)/treatment-emergent adverse events (TEAEs), primaryOutcomes measure: Incidence of potentially Clinical laboratory abnormalities, secondaryOutcomes measure: PK parameters of SAR443809 for IV and SC administrations: Maximum plasma concentration observed (Cmax, secondaryOutcomes measure: PK parameters of SAR443809 for IV and SC administrations: First time to reach Cmax (tmax, secondaryOutcomes measure: PK parameters of SAR443809 for IV and SC administrations: Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to tlast (AUClast), secondaryOutcomes measure: PK parameters of SAR443809 for IV and SC administrations: Area under the plasma concentration versus time curve extrapolated to infinity (AUC0-∞), secondaryOutcomes measure: PK parameters of SAR443809 for IV and SC administrations: Terminal half-life associated with the terminal slope (λz) (t1/2z), secondaryOutcomes measure: PK parameters of SAR443809 for IV and SC administrations: Time corresponding to the last concentration above the limit of quantification (Clast tlast), secondaryOutcomes measure: PK parameters of SAR443809 for IV and SC administrations: total body clearance of a drug from the plasma calculated by dividing dose by AUC (CL), secondaryOutcomes measure: PK parameters of SAR443809 for SC administrations: apparent total body clearance of the SC formulation (CL/F), secondaryOutcomes measure: PK parameters of SAR443809 for IV and SC administrations: volume of distribution at steady-state (Vss), secondaryOutcomes measure: PK parameters of SAR443809 for SC administrations: apparent volume of distribution at steady-state (Vss/F), secondaryOutcomes measure: PK parameters of SAR443809 for SC administrations: absolute bioavailability (F), secondaryOutcomes measure: Complement alternative pathway activity (Wieslab AP and alternative pathway hemolytic activity [AH50]), secondaryOutcomes measure: Complement classical pathway activity (Wieslab CP), secondaryOutcomes measure: Incidence of treatment -emergent Anti-SAR443809 antibodies, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Parexel International Site Number : 8400002, city: Glendale, state: California, zip: 91206, country: United States, geoPoint lat: 34.14251, lon: -118.25508, locations facility: Parexel International Site Number : 8400003, city: Baltimore, state: Maryland, zip: 21255, country: United States, geoPoint lat: 39.29038, lon: -76.61219, hasResults: False
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protocolSection identificationModule nctId: NCT06326801, orgStudyIdInfo id: REC/014220 Muhammad Iqbal, briefTitle: Resistive Diaphragmatic Breathing Exercise With Pursed Lips Breathing Exercise in Sub-acute Stroke Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2024-01-15, completionDateStruct date: 2024-01-18, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Riphah International University, class: OTHER, descriptionModule briefSummary: To determine whether resistive diaphragmatic breathing exercise with pursed lips breathing exercise improve pulmonary function in sub-acute ischemic stroke, To determine whether resistive diaphragmatic breathing exercise with pursed lips breathing exercise improve Trunk Control in sub-acute ischemic stroke, To determine whether resistive diaphragmatic breathing exercise with pursed lips breathing exercise improve Functional Capacity in sub-acute ischemic stroke, conditionsModule conditions: Stroke, Ischemic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 27, type: ACTUAL, armsInterventionsModule interventions name: Resistive Diaphragmatic breathing exercise, interventions name: Diaphragmatic breathing exercise, interventions name: Conventional stroke physiotherapy, outcomesModule primaryOutcomes measure: pulmonary function, primaryOutcomes measure: Trunk Control, primaryOutcomes measure: Functional Capacity, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Northwest General Hospital, Peshawar;, city: Peshawar, state: Punjab, zip: 44000, country: Pakistan, geoPoint lat: 34.008, lon: 71.57849, hasResults: False
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protocolSection identificationModule nctId: NCT06326788, orgStudyIdInfo id: 3912 Mehnoor Butt, briefTitle: Effects of Moderate Intensity Soleus Push-ups vs Sustained Soleus Push-ups on Lipid Profile Among Young Population, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2024-07-28, completionDateStruct date: 2024-07-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Riphah International University, class: OTHER, descriptionModule briefSummary: To determine the effects of Short duration moderate intensity soleus push- ups VS Sustained Soleus Push-ups on lipid profile among Young Population., conditionsModule conditions: Health Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 33, type: ESTIMATED, armsInterventionsModule interventions name: Short Duration Moderate Intensity Soleus Push-ups, interventions name: SUSTAINED SOLEUS PUSH-UPS, outcomesModule primaryOutcomes measure: Change in Lipid Profile, otherOutcomes measure: Adherence to Exercise Protocol, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 26 Years, stdAges: ADULT, contactsLocationsModule locations facility: Riphah Rehabilitation Center, status: RECRUITING, city: Islamabad, zip: 46600, country: Pakistan, contacts name: Mehnoor Butt, MSPT, role: CONTACT, phone: 335 5400831, email: mehnoorarshad1109@gmail.com, contacts name: Waqar Ahmed Awan, PHD, role: CONTACT, phone: 333 5348846, email: waqar.ahmed@riphah.edu.pk, geoPoint lat: 33.72148, lon: 73.04329, hasResults: False
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protocolSection identificationModule nctId: NCT06326775, orgStudyIdInfo id: KY20240311-KS-02, briefTitle: Research on Precision Pharmaceutical Care for Heart Transplant Recipients, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-12, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Nanjing First Hospital, Nanjing Medical University, class: OTHER, collaborators name: Wuhan Union Hospital, China, collaborators name: Changhai Hospital, collaborators name: Shanghai Zhongshan Hospital, descriptionModule briefSummary: Establishing personalized dose prediction and related adverse drug reaction prediction models for immunosuppressive drugs after heart transplantation using multiple methods to construct a precise pharmaceutical service system for heart transplant patients has important research value and clinical significance in improving the safety and effectiveness of medication for patients., conditionsModule conditions: Heart Transplant Patients, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, outcomesModule primaryOutcomes measure: Steady state whole blood trough concentration of tacrolimus, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pharmacy Department of Nanjing First Hospital, city: Nanjing, state: Jiangsu, zip: 210006, country: China, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False
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protocolSection identificationModule nctId: NCT06326762, orgStudyIdInfo id: younes, briefTitle: Gap CO2 in Septic Patient to Predict Cardiomyopathy Septic, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2023-10-30, completionDateStruct date: 2023-10-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Mohammed VI University Hospital, class: OTHER, descriptionModule briefSummary: the investigators included 98 patients admitted for sepsis and septic shock (68.4% men, 31.6% women) with an average age of 60.42 years ± 15.13, ranging from 21 to 96 years. The average length of hospital stay was 7.53 days. The most noted medical histories were diabetes (38.8%), hypertension (28.6%), and renal insufficiency (17.1%). Regarding laboratory findings: the mean white blood cell count was 15,985.16 cells/mm³, the mean C-reactive protein (CRP) level was 227.69 mg/L, and the mean procalcitonin level was 50.43 µg/L. In terms of blood gas analysis: the mean lactate level was 3.67 mmol/L, and the mean PCO2 gap (DELTAPCO2) was 4.85. All our patients were continuously monitored by pulse wave analysis: the mean cardiac output was 5.69 L/min, and the mean cardiac index was 4.14 L/s/m² All our patients underwent an echocardiogram, which is a routine examination in our department and is performed at the patient's bedside. The average left ventricular ejection fraction (LVEF) was 51.73%, and the average subaortic peak velocity (ITV) was 14.66 cm.Subsequently. the investigators examined the clinical and paraclinical profile of patients with septic cardiomyopathy. the investigators identified 19 patients with this condition, while 79 patients did not exhibit cardiac involvement. The percentage was significantly higher in the population with cardiac involvement, accounting for 28.3%. Among the patients with cardiac involvement, 76.5% had a PCO2 gap (DELTAPCO2) ≥ 6 mmHg, a significantly reduced cardiac output with an average of 3.3 L/min, and a predominantly low cardiac index, with 64.3% having an index \< 2.2 L/min/m². The mortality rate was significantly increased at 73.7%., conditionsModule conditions: Gap co2, conditions: Cardiac Output, Low, conditions: Cardiac Defect, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 98, type: ACTUAL, armsInterventionsModule interventions name: comparaison, outcomesModule primaryOutcomes measure: gapCO2, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: younes Oujidi, city: Berkane, zip: 9999, country: Morocco, geoPoint lat: 34.92, lon: -2.32, hasResults: False
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protocolSection identificationModule nctId: NCT06326749, orgStudyIdInfo id: 2024/19, briefTitle: Effectiveness of Modified Graded Motor Imagery Training in Stroke Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-11-15, completionDateStruct date: 2025-03-15, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Inonu University, class: OTHER, descriptionModule briefSummary: In the study, movement observation training, Modified Graded Motor Imaging Training, which includes upper extremity functional exercises, and Graded Motor Imaging Training, where the standard protocol is applied, will be used in stroke patients to improve their upper extremity motor functions and daily lives. It is aimed to present it on an evidence-based basis by investigating its effects on Daily Living Activity, quality of life, upper extremity-specific right/left lateralization performance, mental stopwatch performance and motor imagery skills., conditionsModule conditions: Graded Motor Imagery, conditions: Stroke, conditions: Action Observation Training, conditions: Motor Imagery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 21, type: ESTIMATED, armsInterventionsModule interventions name: Modified Graded Motor Imagery and Conventional Treatment Group, interventions name: Graded Motor Imagery and Conventional Treatment Group, interventions name: Conventional Treatment Group, outcomesModule primaryOutcomes measure: Fugl-Meyer Upper Extremity Motor Rating Scale, primaryOutcomes measure: Wolf Motor Function Test (WMFT), primaryOutcomes measure: Modified Barthel Index, primaryOutcomes measure: Stroke-Specific Quality of Life Scale, secondaryOutcomes measure: Lateralization Assessment, secondaryOutcomes measure: Mental Chronometry Time, secondaryOutcomes measure: Kinesthetic and Visual Imagery Questionnaire (KGIA), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Inonu University, city: Malatya, zip: 44280, country: Turkey, contacts name: Havva ADLI, role: CONTACT, phone: 05369831133, email: h.adli@hotmail.com, contacts name: Kezban BAYRAMLAR, Prof. Dr., role: SUB_INVESTIGATOR, geoPoint lat: 38.35018, lon: 38.31667, hasResults: False
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protocolSection identificationModule nctId: NCT06326736, orgStudyIdInfo id: 2024NZKY-014-02, briefTitle: Study of Neoantigen mRNA Vaccines in Patients With Resectable Pancreatic Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Jinling Hospital, China, class: OTHER, collaborators name: Jiangsu Synthgene Biotechnology Co.Ltd., descriptionModule briefSummary: The purpose of this study is to evaluate the safety and efficacy of treating pancreatic cancer with surgery to remove cancerour tissue, followed by camrelizumab and a personalized cancer mRNA vaccines., conditionsModule conditions: Pancreatic Cancer, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Surgery, interventions name: Camrelizumab, interventions name: SJ-Neo006, interventions name: Gemcitabine+Abraxane, outcomesModule primaryOutcomes measure: Incidence of Treatment Emergent Adverse Events (TEAEs), secondaryOutcomes measure: Disease control rate (DCR), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Wang Sizhen, status: RECRUITING, city: Nanjing, state: Jiangsu, country: China, contacts name: wu qiong, role: CONTACT, phone: 02580863234, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False
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protocolSection identificationModule nctId: NCT06326723, orgStudyIdInfo id: SIM0808-101, briefTitle: Investigate the PK, Safety, and Tolerability After Single and Multiple Dose Daridorexant in Chinese Healthy Subjects, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-09-04, primaryCompletionDateStruct date: 2023-12-24, completionDateStruct date: 2024-02-05, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Jiangsu Simcere Pharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: This clinical study is a single-center, randomized, double-blind, placebo-controlled Phase 1 clinical study to assess the PK characteristics and safety and tolerability of single and multiple dose daridorexant in 32 healthy adult Chinese subjects., conditionsModule conditions: Healthy Volunteer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 32, type: ACTUAL, armsInterventionsModule interventions name: Daridorexant, outcomesModule primaryOutcomes measure: Pharmacokinetic Endpoints1, primaryOutcomes measure: Pharmacokinetic Endpoints2, primaryOutcomes measure: Pharmacokinetic Endpoints3, primaryOutcomes measure: Pharmacokinetic Endpoints4, primaryOutcomes measure: Pharmacokinetic Endpoints5, primaryOutcomes measure: Pharmacokinetic Endpoints6, primaryOutcomes measure: Pharmacokinetic Endpoints7, secondaryOutcomes measure: Safety Endpoints1, secondaryOutcomes measure: Safety Endpoints2, secondaryOutcomes measure: Safety Endpoints3, secondaryOutcomes measure: Safety Endpoints4, secondaryOutcomes measure: Safety Endpoints5, secondaryOutcomes measure: Safety Endpoints6, secondaryOutcomes measure: Safety Endpoints7, secondaryOutcomes measure: Safety Endpoints8, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Nanjing Drum Tower hospital, city: Nanjing, state: Jiangsu, zip: 210000, country: China, geoPoint lat: 32.06167, lon: 118.77778, hasResults: False
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protocolSection identificationModule nctId: NCT06326710, orgStudyIdInfo id: P0045122, briefTitle: The 'Outdoor Rehab-Fit' App-based Physical Activity Education Intervention for Frail Older Adults in Hong Kong, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: The Hong Kong Polytechnic University, class: OTHER, descriptionModule briefSummary: In recent years, research teams around the world have developed interventions to educate older adults to use outdoor exercise facilities (OEFs) to improve health outcomes like strength, balance, mobility, PA level, and weight. These interventions employed trainers or therapists to instruct, and monitor exercise training for older adults using the public accessible OEFs. Apart from therapist or trainer-led intervention, an Australian research team developed a mobile application, and social support strategies to help participants to use OEFs to enhance their aerobic and resistance-based PA.A recent local in-depth qualitative study discovered that OEFs in Hong Kong attracted frailer older adults (i.e., those who recovered from a major illness or who has chronic diseases), and their caregivers to use OEFs to support and maintain their daily PA behavior. Some used OEFs to complement their formal rehabilitation sessions. It appears that OEFs in Hong Kong serves as an important health maintenance space for frailer older adults in the city to "age in place", yet educational training related to OEFs has been lacking over the years. Signage besides the exercise equipment has been the only education material for users over the years.A mobile app-based physical activity education intervention will be developed for frail old adults in Hong Kong. The intervention has two components: (1) mobile app; and (2) face-to-face group session that teaches the how to use correctly and safely use OEF in public parks to maintain PA habits.The main objective of this study is to evaluate the feasibility, acceptability, and pilot effectiveness of the 'Outdoor Rehab-Fit' App-based physical activity education intervention. Primary outcomes include recruitment rate, retention rate, attrition rate, attendance, perceived usefulness of the app. Secondary outcomes include exercise self-efficacy, mental well-being, physical activity level.This study adopts a mixed-method design with quantitative and qualitative method. This study is a pilot randomized controlled trial, running for 4 months evaluating of the effectiveness of the mHealth intervention. 40 frail older adults will be randomized into (i) mHealth group or (ii) control group.Quantitative analysis will be adopted to investigate the effectiveness of the 'Outdoor Rehab-Fit' App-based physical activity education intervention on the health outcomes of frail older adults. The qualitative component will consist of semi-structure interviews with the frail older adults to understand the acceptability of the intervention., conditionsModule conditions: Physical Inactivity, conditions: Frailty, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: mHealth, interventions name: Health Talk, outcomesModule primaryOutcomes measure: Feasibility outcome: Recruitment rate, primaryOutcomes measure: Feasibility outcome: Intervention completion rate, primaryOutcomes measure: Feasibility outcome: Attrition rate, primaryOutcomes measure: Feasibility outcome: Attendance, primaryOutcomes measure: Acceptability outcome: Perceived Usefulness on Outdoor Rehab-Fit App, primaryOutcomes measure: Acceptability outcome: Participants' views about the barriers and facilitation of the mHealth program, secondaryOutcomes measure: Change in Physical activity level (Objective) at 1 month and 3 months, secondaryOutcomes measure: Change in Physical activity level (Subjective) at 1 month and 3 months, secondaryOutcomes measure: Change in Exercise self-efficacy at 1 month and 3 months, secondaryOutcomes measure: Change in Mental well-being at 1 month and 3 months, secondaryOutcomes measure: Change in usage of outdoor exercise facilities, eligibilityModule sex: ALL, minimumAge: 55 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Janet Lok Chun Lee, PhD, role: CONTACT, email: lcjlee@polyu.edu.hk, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False
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protocolSection identificationModule nctId: NCT06326697, orgStudyIdInfo id: HIK-AZA-2023-01, briefTitle: Bioequivalence of Azacitidine 300 mg Film-Coated Tablets in Adult Patients With Acute Myeloid Leukaemia (AML), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Hikma Pharmaceuticals LLC, class: INDUSTRY, descriptionModule briefSummary: A Randomized, Single Oral Dose, Open Label, Two Treatment, Crossover study to investigate the bioequivalence of the Test Product Azacitidine 300 mg Film coated tablets relative to Reference Product Onureg® 300 mg Film Coated Tablets in adult patients with AML under fasting conditions, conditionsModule conditions: Acute Myeloid Leukaemia, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Azacitidine, interventions name: Onureg, outcomesModule primaryOutcomes measure: Cmax, primaryOutcomes measure: AUC0-t, secondaryOutcomes measure: AUC0-∞, secondaryOutcomes measure: Kel, secondaryOutcomes measure: Tmax, secondaryOutcomes measure: T1/2el, secondaryOutcomes measure: Adverse Events (AEs), secondaryOutcomes measure: Change in clinical safety labs, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06326684, orgStudyIdInfo id: 88524, briefTitle: Suvorexant and Alcohol, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-15, primaryCompletionDateStruct date: 2027-03-15, completionDateStruct date: 2027-03-15, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: University of Kentucky, class: OTHER, collaborators name: National Institute on Alcohol Abuse and Alcoholism (NIAAA), descriptionModule briefSummary: This research will translate findings from preclinical research and provide the initial clinical evidence that orexin antagonism reduces motivation for alcohol, as well as other alcohol-associated maladaptive behaviors in people with Alcohol Use Disorder. This study will also provide basic science information about the orexinergic mechanisms underlying the pharmacodynamic effects of alcohol in humans. As such, the outcomes will contribute to our understanding of the clinical neurobiology of Alcohol Use Disorder. Overall, the proposed work seeks to expand the scope of current clinical neuroscience research on alcohol addiction by focusing on orexin, which has strong preclinical evidence supporting its critical role in addiction but remains unstudied in humans., conditionsModule conditions: Alcohol Use Disorder, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Alcohol, interventions name: Placebo, interventions name: Suvorexant, interventions name: Suvorexant, outcomesModule primaryOutcomes measure: Reinforcing Effects of Alcohol, secondaryOutcomes measure: Craving, secondaryOutcomes measure: Mood, secondaryOutcomes measure: Alcohol Response, secondaryOutcomes measure: Heart rate, secondaryOutcomes measure: Blood pressure, secondaryOutcomes measure: Breath Alcohol Level, secondaryOutcomes measure: Temperature, secondaryOutcomes measure: Side Effects, secondaryOutcomes measure: Delay Discounting, secondaryOutcomes measure: n-back Task, secondaryOutcomes measure: Stop-Signal Task Inhibitory Failures, secondaryOutcomes measure: Sleep, eligibilityModule sex: ALL, minimumAge: 21 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Psychopharmacology of Addiction Laboratory, city: Lexington, state: Kentucky, zip: 40507, country: United States, contacts name: William Walton Stoops, role: CONTACT, phone: 8592575388, email: william.stoops@uky.edu, contacts name: William W Stoops, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.98869, lon: -84.47772, hasResults: False
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protocolSection identificationModule nctId: NCT06326671, orgStudyIdInfo id: STXA-BE-03, briefTitle: A Trial to Assess the Bioequivalence of Generic Tiotropium Bromide Inhalation Powder and Reference Product in Healthy Adult Participants Under Fasting Conditions (Pilot), statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2024-03, completionDateStruct date: 2024-04, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: Primary Objective: To evaluate the pharmacokinetics of Tiotropium Bromide Inhalation Powder (Strength:18 mcg; manufactured by Chia Tai Tianqing Pharmaceutical Group Co. Ltd) and reference products Tiotropium Bromide Inhalation Powder (Spiriva®, Handihaler®, Strength: 18mcg, manufactured by Boehringer Ingelheim Pharmaceuticals, Inc) by oral inhalation of single dose in healthy participants under fasting conditions., conditionsModule conditions: Chronic Obstructive Pulmonary Disease, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 39, type: ACTUAL, armsInterventionsModule interventions name: Tiotropium Bromide Inhalation Powder, interventions name: Spiriva HandiHaler, outcomesModule primaryOutcomes measure: Peak concentration (Cmax), primaryOutcomes measure: Area under the plasma concentration versus time curve (AUC) 0-t, primaryOutcomes measure: Area under the plasma concentration versus time curve (AUC) 0-∞, secondaryOutcomes measure: The time to maximum plasma concentration (Tmax), secondaryOutcomes measure: The elimination half-life (t1/2), secondaryOutcomes measure: Terminal elimination rate constant (Kel), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Henan (Zhengzhou) Zhonghui Cardiovascular Hospital, city: Zhengzhou, state: Henan, zip: 450003, country: China, geoPoint lat: 34.75778, lon: 113.64861, hasResults: False
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protocolSection identificationModule nctId: NCT06326658, orgStudyIdInfo id: TCM for Frequent AECOPD, briefTitle: Bufei Yishen Prescription on Patients With Frequent AECOPD in Stable Stage, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-05-01, completionDateStruct date: 2026-10-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Henan University of Traditional Chinese Medicine, class: OTHER, collaborators name: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, collaborators name: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, descriptionModule briefSummary: To evaluate the clinical efficacy and health economic advantages of Lung Replenishing and Kidney Enhancing Formula for the treatment of patients with frequent acute exacerbations in the stabilized phase., conditionsModule conditions: Chronic Obstructive Pulmonary Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 848, type: ESTIMATED, armsInterventionsModule interventions name: Bufei Yishen Prescription Granule, outcomesModule primaryOutcomes measure: The number of acute exacerbations, secondaryOutcomes measure: The number of AECOPD leading to hospitalization and death, secondaryOutcomes measure: Time of onset of the first AECOPD, secondaryOutcomes measure: Severity of AECOPD, secondaryOutcomes measure: Duration of AECOPD, secondaryOutcomes measure: Case fatality rate, secondaryOutcomes measure: Lung function, secondaryOutcomes measure: Score for clinical signs and symptoms, secondaryOutcomes measure: 6-minute walking distance (6MWD), secondaryOutcomes measure: The Chronic Obstructive Pulmonary Patient Self-Assessment Test (CAT), secondaryOutcomes measure: The MOS item short fromhealth survey（SF-36）, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06326645, orgStudyIdInfo id: IRB23-891, briefTitle: Open-Label Pilot Study With Crofelemer in Patients With Short Bowel Syndrome, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-12-01, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Lindsey Russell, MD, class: OTHER, collaborators name: Napo Pharmaceuticals, Inc., descriptionModule briefSummary: The objectives of this study are to evaluate the efficacy and safety of crofelemer treatment in adults affected by Short Bowel Syndrome (SBS) with an ileostomy on parenteral support (PS) in reducing output or PS needs. Crofelemer will be provided as a powder three times daily for 12 weeks and a 4 week follow up. ., conditionsModule conditions: Short Bowel Syndrome, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Small exploratory study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 6, type: ESTIMATED, armsInterventionsModule interventions name: Crofelemer Oral Product, outcomesModule primaryOutcomes measure: Ostomy output reduction, secondaryOutcomes measure: Change in average weekly Parenteral Support (PS) volume, secondaryOutcomes measure: Change in SBS-QoL (Short bowel syndrome quality of life), secondaryOutcomes measure: Change in GSRS (Gastrointestinal Symptom Rating Scale), secondaryOutcomes measure: Change in intestinal absorption of fluids and macronutrients with consequent reduction of macronutrient requirements in patients with SBS, secondaryOutcomes measure: Change in weekly need for parenteral electrolytes, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Cleveland Clinic Main Campus, city: Cleveland, state: Ohio, zip: 44106, country: United States, contacts name: Lindsey A Russell, MD, role: CONTACT, geoPoint lat: 41.4995, lon: -81.69541, hasResults: False
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protocolSection identificationModule nctId: NCT06326632, orgStudyIdInfo id: RHPT/0022/023, briefTitle: Comparative Effectiveness Study of Constant-Load Versus Graded Aerobic Exercise in Obese Children With Bronchial Asthma, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-10-30, primaryCompletionDateStruct date: 2023-12-07, completionDateStruct date: 2023-12-07, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: This study aimed to compare the effect of constant-load aerobic exercise (CL-AE) and graded aerobic exercise (G-AE) on cardiopulmonary fitness, and functional capacity in a cohort of obese children with bronchial asthma (BA).A total of 78 children with BA were randomly assigned to the CL-AE group (n = 26, who underwent moderate-intensity aerobic training with the training load maintained at the same level throughout the entire program, besides the respiratory re-training program), the G-AE group (n = 26, received an intensity- and duration-graded aerobic training in addition to the respiratory re-training program), or the control group (n = 29, who only engaged in a respiratory re-training program). Interventions were administered three times/week for 12 successive weeks.The cardiopulmonary fitness and functional capacity were evaluated in the three groups before and after the completion of the assigned interventions., conditionsModule conditions: Bronchial Asthma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A prospective, three-arm, randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: A single-blind protocol was adopted. The researcher who collected the data was blind to the allocation of treatment, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 78, type: ACTUAL, armsInterventionsModule interventions name: Constant-load Aerobic Exercise, interventions name: Graded Aerobic exercise, interventions name: Respiratory Re-training, outcomesModule primaryOutcomes measure: Peak oxygen uptake, secondaryOutcomes measure: Six-minute walk test, secondaryOutcomes measure: Dyspnea, secondaryOutcomes measure: Fatigue, eligibilityModule sex: ALL, minimumAge: 8 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Ragab K. Elnaggar, city: Al Kharj, state: Riyadh, country: Saudi Arabia, geoPoint lat: 24.15541, lon: 47.33457, hasResults: False
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protocolSection identificationModule nctId: NCT06326619, orgStudyIdInfo id: SurvSysT, briefTitle: Survival Benefit of Primary Tumour Resection Compared to Systemic Therapy Alone in Stage IV Colorectal Cancer Patients, acronym: SurvSysT, statusModule overallStatus: COMPLETED, startDateStruct date: 2012-01-01, primaryCompletionDateStruct date: 2020-12-31, completionDateStruct date: 2020-12-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Medizinische Hochschule Brandenburg Theodor Fontane, class: OTHER, collaborators name: Clinical-Epidemiological Cancer Registry Brandenburg-Berlin, descriptionModule briefSummary: About 20-25 percent of all colorectal cancer patients are diagnosed with International Union Against Cancer (UICC) stage IV disease. The benefit of primary tumor resection in the palliative context is therefore of high concern. However, empirical evidence from randomized and observational studies is inconsistent.The objective of the present study is to compare the survival of palliative stage IV colorectal cancer patients selected for primary tumor resection and systemic treatment (PTR+SYST) to patients with systemic treatment only (SYST)., conditionsModule conditions: Colorectal Cancer, conditions: Neoadjuvant Systemic Therapy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 480, type: ACTUAL, armsInterventionsModule interventions name: Primary tumor resection, interventions name: Systemic Therapy, outcomesModule primaryOutcomes measure: Survival, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06326606, orgStudyIdInfo id: 23-MLS101-101, briefTitle: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MLS101 in Healthy Participants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: MycoMedica Life Sciences PBC, class: INDUSTRY, descriptionModule briefSummary: MLS101 is being developed as a low dose psilocybin, that can be administered to treat various neurological and psychiatric conditions.The purpose of this clinical trial is to assess how safe and tolerated MLS101 is; to see how MLS101 is distributed and cleared by the body (pharmacokinetics); and to assess the psychedelic effects of MLS101 in healthy adult participants., conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a randomized, double-blind, placebo-controlled, single ascending and multiple dose study to assess the safety, tolerability, and pharmacokinetics of MLS101 in healthy participants. The study consists of 2 parts:Part 1 - Single Ascending Dose (SAD): 24 participants will be enrolled in 3 sequential dose cohorts and will be randomized to receive a single dose of MLS101 or placebo. Additional cohorts (comprising 8 participants in each cohort) may be enrolled to explore more doses.Part 2: Multiple Dose study, doses and administration regimens are pending the results from Part 1, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Psilocybin, interventions name: Placebo, outcomesModule primaryOutcomes measure: Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs), primaryOutcomes measure: Occurrence of clinically significant changes in physical examination, vital signs, ECGs, clinical laboratory tests, the Columbia-Suicide Severity Rating Scale (C-SSRS)., secondaryOutcomes measure: Pharmacokinetics of MLS101: maximum observed serum concentration (Cmax), secondaryOutcomes measure: Pharmacokinetics of MLS10: area under the plasma concentration-time curve (AUC), secondaryOutcomes measure: Pharmacokinetics of MLS101: time corresponding to the occurrence of Cmax (tmax), secondaryOutcomes measure: Pharmacokinetics of MLS101: apparent terminal elimination half-life (t½), secondaryOutcomes measure: Pharmacokinetics of MLS101: apparent total systemic clearance after oral administration (CL/F), secondaryOutcomes measure: Pharmacokinetics of MLS101: apparent volume of distribution during the terminal phase (Vz/F), secondaryOutcomes measure: Sensorial effects of MLS101, secondaryOutcomes measure: Cognitive function, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CMAX Clinical Research Pty Ltd, status: RECRUITING, city: Adelaide, state: South Australia, zip: 5000, country: Australia, contacts name: Eloise Spooner, role: CONTACT, phone: +61 8 7088 7900, email: eloise.spooner@cmax.com.au, contacts name: Sepehr Shakib, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.92866, lon: 138.59863, hasResults: False
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protocolSection identificationModule nctId: NCT06326593, orgStudyIdInfo id: P.T.REC/012/005049, briefTitle: Wii Aerobic Training in Inhalation-injury Children Post-thermal Burn, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-22, primaryCompletionDateStruct date: 2024-05-25, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: MTI University, class: OTHER, descriptionModule briefSummary: Inhalation injury is a composite of multiple insults including: supra glottic thermal injury, subglottic airway and alveolar poisoning, and systemic poisoning from absorbed small molecule toxins. These contaminant insults independently affect each of the pulmonary functions as well as having a direct effect on systemic physiology. Further, anatomic characteristics can predispose patients to inhalation injury. For example, an infant will develop airway obstructions much faster than an adult due to reduced airway diameter. Understanding the contributions of each of these pathologies to the patient's disease is critical to managing inhalation injury.Wii fit aerobic training gives similar results with traditional rehabilitation practices, it causes less energy costs. This suggests that it can be a suitable rehabilitation tool for adult and elderly people with low energy levels. A review showed that video games are safe and feasible in the children with lung complications. Children' balance, aerobic and cognitive functions, quality of life improved and depressive mood decreased. WII aerobic games also make children to communicate better with other family members., conditionsModule conditions: Inhalation Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Wii aerobic training, interventions name: conservative chest care, outcomesModule primaryOutcomes measure: Forced vital capacity (FVC), primaryOutcomes measure: forced expiratory volume in 1 second (FEV1), primaryOutcomes measure: peak expiratory flow (PEF), secondaryOutcomes measure: Upper and lower chest expansion (2nd intercostal space, xiphoid)]), secondaryOutcomes measure: Functional capacity 6-Minute Walk Test (6-MWT), secondaryOutcomes measure: Timed Up and Go test (TUG), eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Heba Elfeky, status: RECRUITING, city: Cairo, zip: 6347113, country: Egypt, contacts name: ahmed m el fahl, phd, role: CONTACT, phone: 00201097782441, email: nn_ee_mm_oo@yahoo.com, geoPoint lat: 30.06263, lon: 31.24967, locations facility: Ahmed Mohamed Ahmed Abdelhady, status: RECRUITING, city: Cairo, country: Egypt, contacts name: Ahmed El Fahl, ph.d, role: CONTACT, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06326580, orgStudyIdInfo id: MS.22.09.2144, briefTitle: Clinical Prediction Model of Obstructive Sleep Apnea at Mansoura University Hospitals, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-10-20, primaryCompletionDateStruct date: 2023-10-20, completionDateStruct date: 2024-02-20, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Mansoura University, class: OTHER, descriptionModule briefSummary: Obstructive sleep apnea syndrome (OSAS)is a sleep breathing disorder manifested by complete apnea or partial hypopnea obstruction of the upper airway, which often remains undiagnosed and untreated (Kuczynski, W., 2019). These episodes, which should be more than 5 per hour and last at least 10 s, can lead to a sleep fragmentation and hypoxia (Huon, L.-K.A., 2017). OSAS predominantly affects 26% of individuals between 30 and 70 years in the U.S (apnea hypopnea index ≥5 events per hour) (Schwartz, M., 2018).Obstructive sleep apnea it is increasingly recognized as an independent risk factor for cardiac, neurologic, and perioperative morbidities. Yet this disorder remains undiagnosed in a substantial portion of our population. It is imperative for all physicians to remain vigilant in identifying patients with signs and symptoms consistent with OSA (Park, J. G., 2011).The test of hypothesis is to design a clinical prediction model of obstructive sleep apnea from collected data of the patients having symptoms of obstructive sleep apnea and the results of their sleep study, conditionsModule conditions: Osa Syndrome, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: OTHER, enrollmentInfo count: 1129, type: ACTUAL, outcomesModule primaryOutcomes measure: The recorded data of all patients which include all their symptoms and comorbidities as well as their use of any regular medications will be collected., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mansoura University, city: Mansoura, state: Dakhlia, zip: 050, country: Egypt, geoPoint lat: 31.03637, lon: 31.38069, hasResults: False
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protocolSection identificationModule nctId: NCT06326567, orgStudyIdInfo id: 84032, briefTitle: Comprehensive Connected Cancer Care (C4): Intervention Evaluation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Timothy Mullett, class: OTHER, collaborators name: Merck Sharp & Dohme LLC, descriptionModule briefSummary: The C4 program aims to provide a multi-level intervention program (Patient Level, Healthcare Team and Healthcare System Level) that improves the coordination of care with supportive/ancillary care providers and community services through the use of patient navigation and a digital needs assessment and a closed-loop referral system and improves patient-centered communication and engagement in care through skills training for the healthcare team and provision of culturally appropriate patient educational tools and resources. The program components incorporate three areas that are critical to improving patient-centered care: coordination of care, patient-centered communication and engagement, and psychosocial care and other supportive services., conditionsModule conditions: Cancer, conditions: Health Care Utilization, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: C4 Program, outcomesModule primaryOutcomes measure: Change in Health Related Quality of Life (FACT-G7), secondaryOutcomes measure: Overall Survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Kentucky, status: RECRUITING, city: Lexington, state: Kentucky, zip: 40506, country: United States, contacts name: Yvonne Taul, RN, role: CONTACT, phone: 859-323-2354, email: Yvonne.Taul@uky.edu, geoPoint lat: 37.98869, lon: -84.47772, hasResults: False
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protocolSection identificationModule nctId: NCT06326554, orgStudyIdInfo id: 22-5933, briefTitle: Single Arm Pilot Trial of Virtual and In-person STEP2, acronym: STEP2, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: University Health Network, Toronto, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to assess the feasibility of offering oncology patients a referral to the outpatient palliative care clinic based on virtual symptom screening before oncology clinic appointments, and to qualitatively explore factors patients consider when deciding to accept or defer a visit to this clinic.Participants will be asked to complete questionnaires assessing quality of life, symptom burden, depression, anxiety, and satisfaction with care at baseline, 2, 4, and 6 months., conditionsModule conditions: Oncology, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single arm intervention, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Virtual and in-person Symptom screening with Targeted Early Palliative care (STEP2), outcomesModule primaryOutcomes measure: FACIT-PAL 14, secondaryOutcomes measure: FACIT-PAL 14, secondaryOutcomes measure: ESAS-r-CS, secondaryOutcomes measure: PHQ-9, secondaryOutcomes measure: FAMCARE-P16, secondaryOutcomes measure: Generalized Anxiety Disorder-7, secondaryOutcomes measure: Patient Global Impression of Change, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06326541, orgStudyIdInfo id: okutan, briefTitle: The Effect of Listening to the Holy Quran on Vital Signs in Coma Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-05, primaryCompletionDateStruct date: 2023-12-10, completionDateStruct date: 2023-12-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Bitlis Eren University, class: OTHER, descriptionModule briefSummary: The aim of this study is to examine the effect of the Holy Quran listened to to coma patients on their vital signs.Does listening to the Holy Quran have a positive effect on the life values of coma patients?, conditionsModule conditions: Sequelae of; Complications Surgical and Medical Care, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: single group pretest-posttest, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 72, type: ACTUAL, armsInterventionsModule interventions name: music therapy, outcomesModule primaryOutcomes measure: systolic blood pressure- (mmHg), primaryOutcomes measure: diastolic blood pressure- (mmHg), primaryOutcomes measure: pulse (number of beats/min), primaryOutcomes measure: body temperature (degrees Celsius), primaryOutcomes measure: saturation (%-oxygen saturation), eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bitlis Eren University, city: Bitlis, zip: 13100, country: Turkey, geoPoint lat: 38.40115, lon: 42.10784, hasResults: False
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protocolSection identificationModule nctId: NCT06326528, orgStudyIdInfo id: SGLT2 inhibitors, briefTitle: SGLT2 Inhibitors and Perioperative Period, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-10-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: The expanded use of SGLT2 inhibitors motivates us to assess the role of SGLT2 inhibitors in perioperative period on patients who will undergo cardiac surgery in Assiut University., conditionsModule conditions: Perioperative Complication, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: SGLT2 inhibitor, outcomesModule primaryOutcomes measure: Difference of cardiac function by speckle tracing between patients who will receive SGLT2 and patients who not., eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06326515, orgStudyIdInfo id: Government College University, briefTitle: Cognitive Behavior Therapy for Depression, Stigmatization, Criminogenic Cognition, and Quality of Life Among Patients With Opioid Use Disorder (OUD): A Randomized Control Trial., acronym: CBT with OUD, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-07-20, completionDateStruct date: 2024-09-10, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Government College University Faisalabad, class: OTHER, descriptionModule briefSummary: to investigate the impact of cognitive behavior therapy for psychiatric problems among patients with opioid use disorder with relapse condition.In this randomize control trail (RCT), N=120 patients with relapse condition would be taken. After enrolment patients' eligibility assessment would be completed and then n=60 patients would be allocated to experimental (n=30) and waitlist control (n=30) through random assignment. Patient's age range would be between 20 to 30 years., conditionsModule conditions: Psychoeducation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized control trial design would be used in this study. It would be two arm study and there would be two groups an experimental and wait-list control group. Experimental group will receive intervention and another group would be placed in waitlist. In this research, parallel group design would be used. We will give treatment to all participants in a parallel way. Allocation ratio and framework would be equivalence i.e., treatment group and control group would be equal number of participants, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: psychoeducation, interventions name: Stigma Reduction and Relapse Management, outcomesModule primaryOutcomes measure: The Alcohol, Smoking and Substance Involvement Screening Test (ASSIST; Henry-Edwards et al., 2003; Hussain et al., 2022)., primaryOutcomes measure: Criminogenic Cognition Scale (CCS;Tangney, at el, 2012; Jamil & Fatima, 2018):, primaryOutcomes measure: Patient Health Questionnaire (PHQ-9; Robert et al. 1999; Ahmad et al, 2018)., primaryOutcomes measure: Relapse Risk Scale (RRS; Marlatt & Gordon, 1985; Hussain et al., 2016):, primaryOutcomes measure: Perceived Stigma of Addiction Scale, primaryOutcomes measure: Brief Cope Inventory (BCI), secondaryOutcomes measure: World Health Organization Quality-of-Life Scale, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Dr Khalid Mahmood, city: Faisalābad, state: Punjab, country: Pakistan, geoPoint lat: 31.41554, lon: 73.08969, hasResults: False
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protocolSection identificationModule nctId: NCT06326502, orgStudyIdInfo id: 22ETN101-2IND001, briefTitle: A Safety and Efficacy Study of Multiple Tyrosine Kinase Inhibitor Drug (ETN101) in Advanced Hepatocellular Carcinoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-07, primaryCompletionDateStruct date: 2027-03-07, completionDateStruct date: 2027-06-07, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Etnova Therapeutics Corp., class: INDUSTRY, descriptionModule briefSummary: ETN101 is a multiple tyrosine kinase inhibitor (mTKI) targeting fms-like tyrosine kinase 3 (FLT3), receptor tyrosine kinase (KIT), vascular endothelial growth factor receptor 2 (VEGFR2), and platelet-derived growth factor receptor beta. Both in vitro and in vivo studies showed that ETN101 treatment/administration inhibited cancer cell survival and proliferation. In animal models, ETN101 had antitumor activity when administered to animals that did not respond to conventional targeted anticancer agents., conditionsModule conditions: Hepatocellular Carcinoma, conditions: Advanced Hepatocellular Carcinoma, conditions: Liver Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: ETN101, outcomesModule primaryOutcomes measure: Dose-limiting Toxicity (DLT), eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Seoul National University Hospital, status: RECRUITING, city: Seoul, zip: 03080, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, locations facility: Severance Hospital, status: RECRUITING, city: Seoul, zip: 03722, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
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protocolSection identificationModule nctId: NCT06326489, orgStudyIdInfo id: 105122023-1/05.12.2023, secondaryIdInfos id: ERP-2023-13520, type: OTHER_GRANT, domain: Medtronic, briefTitle: Evaluating the Efficacy and Quality of Life Impact of Transitioning to Advanced Hybrid Closed-Loop Insulin Pump Therapy in Romanian Children With Type 1 Diabetes Mellitus, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2024-08-30, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: ELIAS Emergency University Hospital, class: OTHER, descriptionModule briefSummary: The proposed study aims to demonstrate the potential benefits of transitioning T1DM children from predictive low glucose suspend insulin pump therapy to advanced hybrid closed-loop insulin pump therapy in Romania. Primary Outcome: Variations in HbA1c between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G).Secondary Outcomes: changes in insulin requirements, time in range (TIR) levels, time below range (TBR), coefficient of variation (CV), frequency of severe hypoglycemic and hyperglycemic events requiring hospitalization, and PedsQL SF15 questionnaire scores., conditionsModule conditions: Diabetes Mellitus, Type 1, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: The study will include 30 children with type 1 diabetes aged seven years and older who use a predictive low glucose suspend insulin pump (740G). Patients eligible for the study will receive a 780G insulin pump for three months., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Switching to the Medtronic 780G insulin pump, outcomesModule primaryOutcomes measure: Variations in HbA1c, secondaryOutcomes measure: changes in insulin requirements, secondaryOutcomes measure: changes in time in range (TIR) levels, secondaryOutcomes measure: changes in time below range (TBR), secondaryOutcomes measure: changes in coefficient of variation (CV), secondaryOutcomes measure: changes in frequency of severe hypoglycemic and hyperglycemic events requiring hospitalization, secondaryOutcomes measure: changes in The Pediatric Quality of Life Inventory™ 4.0 Short Form 15 Generic Core Scales questionnaire scores, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Elias University Emergency Hospital, status: RECRUITING, city: Bucharest, state: Sector 1, zip: 011461, country: Romania, contacts name: Sorin Ioacara, MD, PhD, role: CONTACT, phone: 0040213161600, email: drsorin@yahoo.com, geoPoint lat: 44.43225, lon: 26.10626, hasResults: False
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protocolSection identificationModule nctId: NCT06326476, orgStudyIdInfo id: IRB-300012699, secondaryIdInfos id: 000544067, type: OTHER, domain: University of Alabama at Birmingham, briefTitle: A Study to Demonstrate the Safety and Efficacy of Siplizumab in the Treatment of Hidradenitis Suppurativa, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-01, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: University of Alabama at Birmingham, class: OTHER, collaborators name: ITB-Med LLC, descriptionModule briefSummary: This study is to investigate the efficacy of siplizumab in the treatment of Hidradenitis Suppurativa., conditionsModule conditions: Hidradenitis Suppurativa, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Siplizumab, outcomesModule primaryOutcomes measure: Change in inflammatory lesion counts, secondaryOutcomes measure: Change in Hidradenitis Suppurativa Clinical Response (HiSCR), secondaryOutcomes measure: Change in Hurley Stage, secondaryOutcomes measure: Change in Dermatology Life Quality Index (DLQI) scores, secondaryOutcomes measure: Improvement in Visual Analogue Scale (VAS) pain scores, secondaryOutcomes measure: Change in Lesion Counts, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06326463, orgStudyIdInfo id: DIRECT70, secondaryIdInfos id: NCI-2024-03240, type: OTHER, domain: NCI Clinical Trial Registration Program, briefTitle: CAR T-cell Therapy Directed to CD70 for Pediatric Patients With Hematological Malignancies, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2030-07-01, completionDateStruct date: 2031-07-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: St. Jude Children's Research Hospital, class: OTHER, descriptionModule briefSummary: The study participant has one of the following blood cancers: acute myelogenous leukemia (AML)/myelodysplastic syndrome (MDS), acute lymphoblastic leukemia (B-ALL, T-ALL) or Lymphoma. Your cancer has been difficult to treat (refractory) or has come back after treatment (relapse).Primary ObjectiveTo determine the safety and maximum tolerated dose of intravenous infusions of escalating doses of CD70-CAR T cells in patients (≤21 years) with recurrent/refractory CD70+ hematological malignancies after lymphodepleting chemotherapy.Secondary ObjectivesTo evaluate the antileukemic activity of CD70-CAR T cells. We will determine the anti- leukemic activity of the CD70-CAR T cells in the bone marrow and in the treatment of extramedullary disease., conditionsModule conditions: Hematologic Malignancy, conditions: ALL, Childhood, conditions: AML, Childhood, conditions: Lymphoma, conditions: MDS, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Fludarabine, interventions name: Cyclophosphamide, interventions name: CD70-CAR T cell infusion (Autologous), interventions name: Mesna, outcomesModule primaryOutcomes measure: Maximum tolerated dose of CD70-CAR T cells, eligibilityModule sex: ALL, maximumAge: 21 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: St. Jude Children's Research Hospital, city: Memphis, state: Tennessee, zip: 38105, country: United States, contacts name: Swati Naik, MD, role: CONTACT, phone: 866-278-5833, email: referralinfo@stjude.org, geoPoint lat: 35.14953, lon: -90.04898, hasResults: False
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protocolSection identificationModule nctId: NCT06326450, orgStudyIdInfo id: 74626, briefTitle: Traditional In-Person Vs. Remote AR Clinical Simulation, acronym: AR Brazil, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-05-31, completionDateStruct date: 2025-05-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Stanford University, class: OTHER, descriptionModule briefSummary: This is a non-inferiority, international, controlled trial that aims to evaluate the progression of physicians and residents through an Advanced Cardiac Life Support (ACLS) clinical simulated scenario. The study's primary objective is to compare the performance outcomes between two groups: participants in the traditional in-person simulation and those immersed in the Augmented Reality (AR) scenario, conditionsModule conditions: Educational Problems, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Augmented Reality Headset, outcomesModule primaryOutcomes measure: Progression through the ACLS clinical simulation demonstrated by NTS and TS, secondaryOutcomes measure: Demonstration of NTS during ACLS scenario, secondaryOutcomes measure: Evaluation of the AR system's usability, secondaryOutcomes measure: Exploration of perceptions, attitudes, and opinions of the AR simulation participants, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06326437, orgStudyIdInfo id: 1223, briefTitle: Dyadic Intervention for Psychological Distress of Patients With Colorectal Cancer and Their Spouses, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Sun Yat-sen University, class: OTHER, descriptionModule briefSummary: The overall aim of the study is to evaluate the preliminary effect and feasibility of a dyadic intervention on mutuality, psychological strengths (i.e., illness cognition and dyadic coping), psychological distress, and QoL outcomes of patients with colorectal cancer and spouses. The colorectal cancer couples will be randomly allocated to the intervention group to receive a 6-week dyadic intervention, or to the control group to receive the usual care provided by the clinical team in the hospital., conditionsModule conditions: Colorectal Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: 6-week dyadic intervention, outcomesModule primaryOutcomes measure: the Kessler psychological distress scale-10, secondaryOutcomes measure: The Illness Cognition Questionnaire, secondaryOutcomes measure: Dyadic Coping Inventory, secondaryOutcomes measure: European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Core 30, secondaryOutcomes measure: Locke-Wallace Marital Adjustment Scale, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 59 Years, stdAges: ADULT, contactsLocationsModule locations facility: The Sixth Affiliated Hospital of Sun Yat-sen University, city: Guangzhou, state: Guangdong, zip: 510000, country: China, contacts name: Qian Sun, role: CONTACT, phone: +86 15616167998, email: sunq68@mail2.sysu.edu.cn, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
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protocolSection identificationModule nctId: NCT06326424, orgStudyIdInfo id: 2023H0085, briefTitle: Delirium Identification in Older Patients With Alzheimer's and Other Related Dementias In the Emergency Department, acronym: DELIRIUM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Ohio State University, class: OTHER, descriptionModule briefSummary: Delirium is highly prevalent and very bad for patients with dementia. Delirium is a dangerous medical condition that occurs in 6-38% of older Emergency Department patients and 70% of ICU patients. A person who develops delirium in the ED or hospital has a 12 times higher odds of being newly diagnosed with dementia in the next year compared to a similar patient who does not become delirious. Delirium is especially dangerous for persons living with Alzheimer Disease and Related Dementias (AD/ADRD). Persons living with ADRD have an almost 50% chance of developing delirium in the hospital.Clinicians are bad at recognizing delirium. A recent systematic review led by the Geriatric Emergency Care Applied Research network (NIH funded) found that current delirium screening tools are at most 64% sensitive, meaning that physicians can identify some phenotypes of delirium well, but cannot easily rule out delirium in acutely ill older patients.The investigators propose integrating wrist biosensors into the emergency management of older adults with dementia. The investigators will monitor heart rate variability, movement, and electrodermal activity (electrical activity of at the level of the skin) to determine if an array of biosensors more sensitive to delirium than current verbal screening tools., conditionsModule conditions: Delirium, conditions: Dementia, conditions: Hospital Acquired Condition, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Empatica EmbracePlus, outcomesModule primaryOutcomes measure: Proportion of participants who develop delirium, secondaryOutcomes measure: Intervention Acceptability, secondaryOutcomes measure: Biosensor data usability, secondaryOutcomes measure: Correlation of biosensor array data with clinical delirium, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Ohio State University Wexner Medical Center, city: Columbus, state: Ohio, zip: 43210, country: United States, geoPoint lat: 39.96118, lon: -82.99879, hasResults: False
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protocolSection identificationModule nctId: NCT06326411, orgStudyIdInfo id: NST-628-001, briefTitle: A Study to Investigate the Safety and Efficacy of NST-628 Oral Tablets in Subjects With Solid Tumors, acronym: NST-628, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2028-11, completionDateStruct date: 2029-11, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Nested Therapeutics, Inc, class: INDUSTRY, descriptionModule briefSummary: This is a two-part Phase 1, open label, multi-center, single arm, non-randomized, multiple dose, safety, pharmacokinetic (PK) and preliminary efficacy study of single agent NST-628 in adult patients with MAPK pathway mutated/dependent advanced solid tumors who have exhausted standard treatment options., conditionsModule conditions: Oncology, conditions: MEK Mutation, conditions: RAF Gene Mutation, conditions: Ras (KRAS or NRAS) Gene Mutation, conditions: Melanoma, conditions: NSCLC, conditions: Glioma, conditions: Solid Tumor, Adult, conditions: MAPK Pathway Gene Mutation, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 230, type: ESTIMATED, armsInterventionsModule interventions name: NST-628, outcomesModule primaryOutcomes measure: Part A and B: Evaluate the safety of NST-628 in patients with advanced solid tumors, primaryOutcomes measure: Part A: Determine the recommended dose for expansion of NST-628, primaryOutcomes measure: Part B: Evaluate objective tumor response rate, secondaryOutcomes measure: Part A: Evaluate objective tumor response rate, secondaryOutcomes measure: Part A and B: Evaluate progression free survival (PFS), secondaryOutcomes measure: Part A and B: Evaluate overall survival (OS), secondaryOutcomes measure: Part A and B: Characterize the pharmacokinetics of NST-628, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Scientia Clinical Research, Ltd, status: RECRUITING, city: Rand, state: New South Wales, zip: 2031, country: Australia, contacts name: Shiena Lemin, role: CONTACT, phone: +61 2 9382 5800, email: ethics@scientiaclinicalresearch.com.au, contacts name: Charlotte Lemech, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -35.60079, lon: 146.62354, locations facility: Southern Oncology Research Unit, status: NOT_YET_RECRUITING, city: Adelaide, zip: 5042, country: Australia, contacts name: Meggan O'Riley, role: CONTACT, email: Meggan.ORiley@socru.org.au, contacts name: Ganessan Kichenadasse, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.92866, lon: 138.59863, hasResults: False
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protocolSection identificationModule nctId: NCT06326398, orgStudyIdInfo id: 3D moulage, briefTitle: The Effect of Using 3D Printers and Moulage on Improving Stoma Care, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-10-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Namik Kemal University, class: OTHER, collaborators name: TÜBİTAK, descriptionModule briefSummary: When studies in the literature are examined, there are studies in which various methods are applied to students' stoma care knowledge and skills. Additionally, it is seen that there are studies using moulage or 3D printers as simulation applications in nursing education. However, there is no study on high-reality simulation application using 3D printer and moulage technique together.nIn this research, the effect of the stoma created with a 3D printer in a high-reality simulation on the stoma care knowledge and skills, satisfaction and self-confidence of nursing students will be examined by using the moulage technique. In addition, this application will be compared with nursing students' stoma care practices in the stoma model, which is classified as low-reality simulation. We think that our project will be unique in this field, as it uses current technological methods together in this planned research and is different from similar studies., conditionsModule conditions: Stoma Colostomy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 76, type: ESTIMATED, armsInterventionsModule interventions name: Stoma Care, outcomesModule primaryOutcomes measure: Knowledge Level Evaluation Form Regarding Stoma Care, primaryOutcomes measure: Stoma Care Skill Grading Key, primaryOutcomes measure: Student Satisfaction and Self-Confidence Scale in Learning, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 22 Years, stdAges: ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06326385, orgStudyIdInfo id: 53244021, briefTitle: Machine Learning Predictive Models for Sepsis Risk in ICU Patients With Intracerebral Hemorrhage, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-30, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-05-30, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: Xiangya Hospital of Central South University, class: OTHER, descriptionModule briefSummary: Patients with intracerebral hemorrhage (ICH) in the intensive care unit (ICU) are at heightened risk of developing sepsis, significantly increasing mortality and healthcare burden. Currently, there is a lack of effective tools for the early prediction of sepsis in ICH patients within the ICU. This study aims to develop a reliable predictive model using machine learning techniques to assist clinicians in the early identification of patients at high risk and to facilitate timely intervention.The Medical Information Mart for Intensive Care (MIMIC) IV database (version 2.2) is an international online repository for critical care expertise. This database contains patient-related information collected from the ICUs of Beth Israel Deaconess Medical Center between 2008 and 2019. It includes a vast dataset of 299,712 hospital admissions and 73,181 intensive care unit patients.The eICU Collaborative Research Database (eICU-CRD) comprises data from over 200,000 ICU admissions for 139,367 unique patients across 208 US hospitals between 2014 and 2015, providing a valuable resource for critical care research.This study aims to establish and validate multiple machine learning models to predict the onset of sepsis in ICU patients with ICH and to identify the model with the optimal predictive performance., conditionsModule conditions: Intracerebral Hemorrhage, conditions: Sepsis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1800, type: ESTIMATED, armsInterventionsModule interventions name: no intervention, outcomesModule primaryOutcomes measure: Occurrence of sepsis, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 89 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Le Zhang, city: Changsha, state: Hunan, zip: 410008, country: China, contacts name: Le Zhang, role: CONTACT, phone: 13973187150, email: zlzdzlzd@csu.edu.cn, contacts name: Ye Li, role: CONTACT, phone: 19967131289, email: 17670516318@163.com, geoPoint lat: 28.19874, lon: 112.97087, hasResults: False
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protocolSection identificationModule nctId: NCT06326372, orgStudyIdInfo id: Delirium, briefTitle: The Effect of Intraoperative Hyperoxemia on Postoperative Delirium in Geriatric Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-06-20, completionDateStruct date: 2024-07-01, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Tepecik Training and Research Hospital, class: OTHER, descriptionModule briefSummary: Oxygen therapy is the most common treatment modality for patients with hypoxemia, but target values for normoxemia are not clearly defined. Therefore, iatrogenic hyperoxemia is a very common situation. Even though there are many side effects reported related to hyperoxemia and hyperoxemia is shown to be related to worse outcome than expected; clinicians still observe hyperoxemia frequently.Oxygen reserve index (ORi™) (Masimo Corp., Irvine, USA) can guide clinicians in detection of hyperoxia. ORi is a parameter which can evaluate partial pressure of oxygen (PaO2) rating from 0 to 1. There are growing evidences in ORi that it might be helpful to reduce hyperoxia in general anesthesia. Continuous ORi monitoring can be used for detecting and preventing hyperoxia. The ability to perform FiO2 titration with ORi may be an appropriate monitoring management to prevent the harmful effects of hyperoxia.In this study, in patients who underwent major abdominal surgery; It was aimed to investigate the effectiveness of ORi-guided FiO2 titration in preventing hyperoxia., conditionsModule conditions: Hyperoxia, conditions: Delirium in Old Age, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: control, interventions name: ORi+SpO2, outcomesModule primaryOutcomes measure: Correlation of FiO2 and ORi value, primaryOutcomes measure: Correlation of ORi and Delirium, secondaryOutcomes measure: Correlation of FiO2 and delirium, eligibilityModule sex: ALL, minimumAge: 65 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Aykut Saritaş, city: İ̇zmi̇r, zip: 35640, country: Turkey, geoPoint lat: 38.41273, lon: 27.13838, hasResults: False
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protocolSection identificationModule nctId: NCT06326359, orgStudyIdInfo id: Soh-Med-24-02-03MD, briefTitle: Autologous Stromal Vascular Fraction in Treatment of Male Androgenic Alopecia, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2026-10, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: Evaluation of Safety and efficacy of autologous stromal vascular fraction derived from denovo versus platelet rich plasma enhanced donner site in treatment of male androgenic alopecia, conditionsModule conditions: Androgenic Alopecia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: autologous stromal vascular fraction, outcomesModule primaryOutcomes measure: hair density, primaryOutcomes measure: hair shaft thickness, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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