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protocolSection identificationModule nctId: NCT06319846, orgStudyIdInfo id: ZLRK202312, briefTitle: Tirofiban for Patients With intraCranial Artery Stenosis and High-risk Acute Non-disabling Cerebrovascular Events(CHANCE-4）, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Beijing Tiantan Hospital, class: OTHER, descriptionModule briefSummary: The CHANCE-4 study is a multicenter, double-blind, double-simulation, randomized controlled study. In patients at high-risk for mild ischemic stroke or transient ischemic attack with symptomatic intracranial artery stenosis within 24 hours of onset, we will examine whether treatment with tirofiban for 48 hours reduce the risk of ischemic stroke recurrence within 90 days compared with placebo., conditionsModule conditions: Ischemic Stroke, Acute, conditions: TIA, conditions: Symptomatic Intracranial Artery Stenosis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 4674, type: ESTIMATED, armsInterventionsModule interventions name: Tirofiban, interventions name: Tirofiban placebo, outcomesModule primaryOutcomes measure: New ischemic stroke, primaryOutcomes measure: BARC type 3 or type 5 bleeding, secondaryOutcomes measure: New ischemic stroke, secondaryOutcomes measure: Any new vascular events, secondaryOutcomes measure: Proportion of patients with disabling stroke, secondaryOutcomes measure: Occurrence and severity of stroke or transient ischemic attack, secondaryOutcomes measure: Proportion of patients with aggravated neurological impairment, otherOutcomes measure: BARC type 3 or type 5 bleeding, otherOutcomes measure: All bleeding events, otherOutcomes measure: Death, otherOutcomes measure: Adverse events or serious adverse events, otherOutcomes measure: BARC type 2 or type 3 or 5 bleeding, eligibilityModule sex: ALL, minimumAge: 40 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The 2nd Affiliated Hospital of Harbin Medical University, city: Harbin, state: Heilongjiang, zip: 150086, country: China, contacts name: Lihua Wang, role: CONTACT, phone: 13100881600, email: wanglh211@163.com, geoPoint lat: 45.75, lon: 126.65, locations facility: People's Hospital of Qihe County, city: Dezhou, state: Shandong, zip: 251199, country: China, contacts name: Haitao Li, role: CONTACT, phone: 13869215737, email: userfiled@126.com, geoPoint lat: 37.45127, lon: 116.31046, locations facility: Liaocheng People's Hospital（Liaocheng Brain Hospital）, city: Liaocheng, state: Shandong, zip: 252001, country: China, contacts name: Xiafeng Yang, role: CONTACT, phone: 13326356005, email: Cranialnerves@163.com, geoPoint lat: 36.45596, lon: 115.97766, locations facility: Third People's Hospital of Liaocheng, city: Liaocheng, state: Shandong, zip: 252004, country: China, contacts name: Liguo Chang, role: CONTACT, phone: 17763559299, email: chliguo@163.com, geoPoint lat: 36.45596, lon: 115.97766, locations facility: Yantai Penglai traditional Chinese medicine hospital, city: Yantai, state: Shandong, zip: 265699, country: China, geoPoint lat: 37.47649, lon: 121.44081, hasResults: False
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protocolSection identificationModule nctId: NCT06319833, orgStudyIdInfo id: 348CER23, briefTitle: Effects of Brain Breaks on Educational Achievement in School Settings: The Break4Brain Project, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-01-08, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: University of the Balearic Islands, class: OTHER, collaborators name: Ministry of Science and Innovation, collaborators name: European Regional Development Fund, collaborators name: Spanish State Research Agency, descriptionModule briefSummary: A total of 600 children between 10 and 12 years of age will be randomized among two experimental conditions: physical activity interacting with a video (n = 300), and sedentary activity (n = 300). The experimental condition will take place in the school settings during the school day through a between-subject design with a total of two measurements, pre, and post-test. Using the latest advances, the transient effects of the experimental conditions on cognitive and academic performance will be measured. The experimental condition was crafted through a qualitative design involving semi-structured interviews with teachers (n = 41) and members of the management team (n = 16), along with questionnaires administered to students (n = 600). To enhance and ensure its sustainability, the same process will be replicated after the intervention. Interviews and questionnaires were meticulously crafted by the RE-AIM framework, and subsequently validated through a rigorous process involving an expert panel (n = 30) utilizing the Delphi methodology. This project has the potential to substantially contribute to the field of acute physical activity and could have a meaningful transference on the educational system. This method might be prescribed as an effective teaching strategy., conditionsModule conditions: Physical Activity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 600, type: ESTIMATED, armsInterventionsModule interventions name: Physical activity interacting with a video, outcomesModule primaryOutcomes measure: Academic achievement, primaryOutcomes measure: Inhibition-attention and cognitive flexibility, primaryOutcomes measure: Working memory, primaryOutcomes measure: Selective attention, primaryOutcomes measure: Design of active breaks: semi-structured questionnaires, primaryOutcomes measure: Design of active breaks: semi-structured interviews, secondaryOutcomes measure: Physical activity patterns, secondaryOutcomes measure: Self-report physical activity patterns, secondaryOutcomes measure: Self-report sedentary patterns, secondaryOutcomes measure: Self-report physical fitness, secondaryOutcomes measure: Socioeconomic level, secondaryOutcomes measure: Student's behavior, secondaryOutcomes measure: Body composition, secondaryOutcomes measure: Creativity, eligibilityModule sex: ALL, minimumAge: 10 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: University of the Balearic Islands, city: Palma, state: Balearic Islands, zip: 07122, country: Spain, geoPoint lat: 39.56939, lon: 2.65024, hasResults: False
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protocolSection identificationModule nctId: NCT06319820, orgStudyIdInfo id: 42756493BLC3004, secondaryIdInfos id: 2023-507684-19, type: EUDRACT_NUMBER, briefTitle: A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer, acronym: MoonRISe-1, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-18, primaryCompletionDateStruct date: 2028-06-28, completionDateStruct date: 2028-06-28, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Janssen Research & Development, LLC, class: INDUSTRY, descriptionModule briefSummary: The main purpose of this study is to compare the disease-free survival between participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of intermediate-risk NMIBC., conditionsModule conditions: Non-Muscle Invasive Bladder Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 540, type: ESTIMATED, armsInterventionsModule interventions name: TAR-210, interventions name: Gemcitabine, interventions name: MMC, outcomesModule primaryOutcomes measure: Disease Free Survival (DFS), secondaryOutcomes measure: Time to next Treatment (TTNT), secondaryOutcomes measure: High Grade Recurrence-free Survival (HG RFS), secondaryOutcomes measure: Progression Free Survival (PFS), secondaryOutcomes measure: Rate of Diagnostic and Therapeutic Invasive Urological Interventions after Study Treatment, secondaryOutcomes measure: Number of Participants With Adverse Events (Including Physical Examination, Vital Signs and Laboratory Abnormalities), secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire Core-30 items (EORTC-QLQ-C30) Scores, secondaryOutcomes measure: European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire for Non muscle Invasive Bladder Cancer (EORTC-QLQ-NMIBC24) Scores, secondaryOutcomes measure: Percentage of Participants With Significant Change From Baseline in EORTC-QLQ-C30 Scores, secondaryOutcomes measure: Percentage of Participants With Significant Change From Baseline in EORTC-QLQ-NMIBC24 Scores, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Arkansas Urology, status: RECRUITING, city: Little Rock, state: Arkansas, zip: 72211, country: United States, geoPoint lat: 34.74648, lon: -92.28959, locations facility: Genesis Research LLC, status: RECRUITING, city: Los Alamitos, state: California, zip: 90720, country: United States, geoPoint lat: 33.80307, lon: -118.07256, locations facility: Genesis Research LLC, status: RECRUITING, city: Sherman Oaks, state: California, zip: 91411, country: United States, geoPoint lat: 34.15112, lon: -118.44925, locations facility: MidLantic Urology, status: RECRUITING, city: Bala-Cynwyd, state: Pennsylvania, zip: 19004, country: United States, geoPoint lat: 40.00761, lon: -75.23407, locations facility: Urology Associates, status: RECRUITING, city: Nashville, state: Tennessee, zip: 37209, country: United States, geoPoint lat: 36.16589, lon: -86.78444, locations facility: Urology Austin, status: RECRUITING, city: Austin, state: Texas, zip: 78745, country: United States, geoPoint lat: 30.26715, lon: -97.74306, locations facility: Hadassah University Hospita - Ein Kerem, status: RECRUITING, city: Jerusalem, zip: 9112001, country: Israel, geoPoint lat: 31.76904, lon: 35.21633, hasResults: False
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protocolSection identificationModule nctId: NCT06319807, orgStudyIdInfo id: IRB00110194, briefTitle: GrowWell - Responsive Bottle Feeding, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Wake Forest University Health Sciences, class: OTHER, descriptionModule briefSummary: The overall goal of this research is use digital health to augment the clinical encounter with Women, Infants, and Children (WIC) clinicians and prevent rapid infant weight gain among children living in low-income households. Intervening on weight gain during infancy offers an opportunity to influence lifelong obesity risk. Using personalized motivational messages and targeted skills-training resources, the intervention will support parents and caregivers in adopting responsive feeding strategies. Knowledge gained from this project will be used to develop a future, larger grant submission focused on developing healthy feeding and eating habits among mother-infant dyads., conditionsModule conditions: Bottle Feeding, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Digital Health Intervention, interventions name: Safety Control, outcomesModule primaryOutcomes measure: Engagement - average text message completion rate, secondaryOutcomes measure: Satisfaction Scores - Acceptability, secondaryOutcomes measure: Satisfaction Scores - Frequency, secondaryOutcomes measure: Satisfaction Scores - Timing, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Wake Forest University Health Sciences, city: Winston-Salem, state: North Carolina, zip: 27157, country: United States, contacts name: Melissa C Kay, PhD, role: CONTACT, phone: 781-249-3062, email: mekay@wakehealth.edu, geoPoint lat: 36.09986, lon: -80.24422, hasResults: False
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protocolSection identificationModule nctId: NCT06319794, orgStudyIdInfo id: TQR-BTOP-101, briefTitle: Study on the Safety and Efficacy of Bimiralisib Gel in Participants Suffering From Actinic Keratosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: TORQUR, class: INDUSTRY, descriptionModule briefSummary: The aim of the study is to evaluate efficacy and safety of bimiralisib gel treatment for treatment of actinic keratosis (AK) on the face and/or scalp and/or back of hands, conditionsModule conditions: Actinic Keratosis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Bimiralisib, interventions name: Bimiralisib, outcomesModule primaryOutcomes measure: Change from baseline in AK lesions as measured by achieving an Investigator Global Assessment (IGA) score of 0 or 1, secondaryOutcomes measure: Proportion of participants with partial or complete clearance of AK lesions at the End of Treatment Visit (Week 2 or 4 depending on treatment arms), secondaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events, secondaryOutcomes measure: Incidence of local skin reactions, eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Hospital Basel / Department of Dermatology, city: Basel, country: Switzerland, contacts name: Alexander Navarini, role: CONTACT, geoPoint lat: 47.55839, lon: 7.57327, locations facility: CHUV centre hospitalier universitaire vaudois / Department of Dermatology and Venereology, city: Lausanne, country: Switzerland, contacts name: Olivier Gaide, role: CONTACT, geoPoint lat: 46.516, lon: 6.63282, hasResults: False
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protocolSection identificationModule nctId: NCT06319781, orgStudyIdInfo id: H-23038433, briefTitle: A Pilot Cohort Study of Risk Factors and Novel Methods of Skin Lesion Assessments in Adults With Atopic Dermatitis, Alopecia Areata, Psoriasis or Vitiligo, acronym: Derma-001, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-15, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2025-05, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Blueskin AS, class: INDUSTRY, descriptionModule briefSummary: The objective of the study is to explore various clinical and biochemical parameters and their potential associations with disease severity, activity, and prognosis in atopic dermatitis, psoriasis, alopecia areata, and vitiligo. Further, the study aims at validating remote assessments of skin lesions, using smartphone-acquired photos. The study will also assess the feasibility and compliance with weekly remote-assessments and patient-reported data collection over the full study period of one year. The study will observe patients through a period of one year and will provide detailed information concerning the type and dose of medication used, as well as data to evaluate the disease activity with high resolution during this period. The study will involve collection of serum samples for exploratory biomarkers, and punch biopsies. A total of approximately 370 patients, divided into the four disease areas of atopic dermatitis, alopecia areata, psoriasis, and vitiligo, will be enrolled in the study. Using a combination of self-reported and on-site assessments and procedures, the intent is to observe the natural history of patients with select dermatological conditions, investigate tissue characteristics associated with disease activity and symptoms, and evaluate the validity of remote assessment of lesions, and feasibility of weekly self-acquired smart-phone images of skin lesions for remote assessment., conditionsModule conditions: Alopecia Areata, conditions: Vitiligo, conditions: Atopic Dermatitis, conditions: Psoriasis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 370, type: ESTIMATED, armsInterventionsModule interventions name: Observational, outcomesModule primaryOutcomes measure: Severity of the disease., primaryOutcomes measure: Clinical characteristics and disease activity., primaryOutcomes measure: Tissue profiling and disease activity., primaryOutcomes measure: Disease activity and biomarkers., primaryOutcomes measure: Quality of life., primaryOutcomes measure: Compliance of remote tasks., primaryOutcomes measure: Quality of smartphone collected photos., primaryOutcomes measure: Level of agreement between the in-person and remote scoring, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sanos Clinic, Gandrup, status: RECRUITING, city: Gandrup, zip: 9362, country: Denmark, contacts name: Cecilie Rovsing, MD, role: CONTACT, phone: +45 7370 8220, email: info.nordjylland@sanosclinic.com, geoPoint lat: 56.74249, lon: 9.82298, locations facility: Sanos Clinic, Herlev, status: RECRUITING, city: Herlev, zip: 2730, country: Denmark, contacts name: Zarqa Ali, PhD, role: CONTACT, phone: +45 7370 8200, email: info@sanosclinic.com, geoPoint lat: 55.72366, lon: 12.43998, locations facility: Sanos Clinic, Vejle, status: RECRUITING, city: Vejle, zip: 7100, country: Denmark, contacts name: Randi Kviesgaard Bechmann, MD, role: CONTACT, phone: +45 7370 8210, email: info.syddanmark@sanosclinic.com, geoPoint lat: 55.70927, lon: 9.5357, hasResults: False
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protocolSection identificationModule nctId: NCT06319768, orgStudyIdInfo id: soh-med-24-01-04ms, briefTitle: Efficacy of Intralesional Injection of Pentoxifylline, Platelet-Rich Plasma, and Combined Pentoxifylline With Platelet-Rich Plasma in Patients With Atrophic Acne Scars, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2024-06-15, completionDateStruct date: 2024-06-15, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: Platelet-rich plasma (PRP) is an Acne vulgaris is a common chronic inflammatory skin disorder. It is the eighth most prevalent disease worldwide with a prevalence of 9.4%. Acne scar is one of the most persistent complications of acne, causes marked psychological stress to the patient . The process of acne scar formation can be broadly divided into two stages: increased tissue formation and loss or damage of tissue, corresponding to keloid or hypertrophic scar and atrophic scar, respectively.The ultimate severity of acne scars is correlated with acne grade and the delay in treatment of active disease. The atrophic scars include three subtypes: icepick or V-shaped, rolling or M-shaped, and boxcar or U-shaped scars. Among atrophic scars, the ice pick type represents 60%-70%; the boxcar type represents 20%-30%; and the rolling type represents 15%-25% (Salameh and Shumaker, 2022). According to the qualitative scarring grading system, a macular acne scar type also exists, which clinically shows erythematous, hyperpigmented, or hypopigmented flat marks.autologous blood product containing high concentrations of platelets in a small volume of plasma. PRP has been utilized in the treatment of orthopedic, musculoskeletal, and maxillofacial conditions for many years, it has only recently gained popularity in dermatology. PRP contains various growth factors, including platelet-derived growth factor (PDGF), transforming growth factor (TFG), vascular endothelial growth factor (VEGF), and insulin-like growth factor (IGF). These growth factors stimulate tissue remodeling and are associated with enhanced healing through the attraction of macrophages, upregulation of collagen synthesis, and promotion of tissue regeneration. Moreover, platelet-derived growth factor (PDGF) was shown to promote wound healing, angiogenesis, and tissue remodeling., conditionsModule conditions: Atrophic Acne Scar, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: Pentoxifylline, interventions name: platelet rich plasma, interventions name: combined pentoxifylline and platelet rich plasma, outcomesModule primaryOutcomes measure: goodman and baron qualitative grading system of postacne scarring, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sohag university Hospital, status: RECRUITING, city: Sohag, country: Egypt, contacts name: Magdy M Amin, professor, role: CONTACT, geoPoint lat: 26.55695, lon: 31.69478, hasResults: False
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protocolSection identificationModule nctId: NCT06319755, orgStudyIdInfo id: X23-0230, briefTitle: Characteristics of Intestinal Microbiome Following Pancreatic Surgery, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Royal Prince Alfred Hospital, Sydney, Australia, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to learn about intestinal microbiome structure and function in individuals who have undergone a pancreatoduodenectomy and compare to healthy matched controls.The primary objectives of the study are:1. To explore and describe any differences in the gut microbiota especially Shannon diversity index2. To conduct functional profiling by exploring and describing any differences in functional metabolites produced in the gut in people having had pancreatoduodenectomy greater than 6 months ago compared to healthy matched controls.Participants will be asked to complete the following:* Three-day food, bowel and medication diary (see Protocol appendix 5)* Gastrointestinal Symptom Rating Scale (see Protocol appendix 6)* Quality of life questionnaire (see Protocol appendix 7)* Stool sample test using Microba Insight TradeMark (a small swab is taken from soiled toilet paper, sealed in a room-temperature storage capsule and mailed to the testing laboratory), conditionsModule conditions: Pancreatic Cancer, conditions: Microbiota, conditions: Pancreatoduodenectomy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Comparison of microbiota profile between post-surgical participants and healthy controls., secondaryOutcomes measure: Compliance with 3-day food dairies, secondaryOutcomes measure: Pre-paid return rates, secondaryOutcomes measure: Ease of matching, secondaryOutcomes measure: Shannon diversity index, secondaryOutcomes measure: Gastrointestinal symptoms, secondaryOutcomes measure: Protein:fibre ratio of diet, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06319742, orgStudyIdInfo id: NSISTRCR_2201, briefTitle: Extracellular Vesicle Surface Markers In Acute Cerebrovascular Syndromes., acronym: ElViS-ACS, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-11-18, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-01-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Ospedale Civico, Lugano, class: OTHER_GOV, descriptionModule briefSummary: Clinical implication of eventual blood biomarkers for stroke diagnosis and prognosis would be limited, mainly because clinical evaluation and scales (providing stroke severity) or neuroimaging (providing accurate size of the lesion) are more reliable predictors for clinical outcome prediction. In clinical practice, it would be more useful to find a biomarker, which can help to orientate the physician in conditions in which the clinical picture and imaging provide a limited support.Transient Ischemic Attacks (TIAs) represent a classical example for which a biomarker would be of interest to confirm and distinguish a brain ischemic process from a stroke mimic. Diagnostic biomarkers of TIA have been investigated, but none of the potential candidates reached enough accuracy for TIA diagnosis. Our group has found that Extracellular Vesicles (EVs) could be useful as biomarkers for detecting brain ischemia in patients with TIA because the EV-surface antigen profile appears to be different in patients with transient symptoms, adjudicated to be very likely caused by brain ischemia, compared to patients whose symptoms were less likely to due to brain ischemia. Our study has raised interest in the scientific community recognizing the promising role of of blood-derived EVs analysis in expanding the possibilities to correctly diagnose and classify TIA and stroke events, discriminate them from TIA or stroke mimics, with important future implications in management and therapy of the patients with acute ischemic cerebrovascular syndrome. the validity of our approach needs to be tested in a larger, prospective, multicenter study., conditionsModule conditions: Stroke, TIA, Stroke-mimics, Stroke Biomarkers, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Extracellular vescicles (EV) analysis, outcomesModule primaryOutcomes measure: TIA differentiation from TIA mimics, secondaryOutcomes measure: TIA differentiation from Stroke, secondaryOutcomes measure: Stroke etiology, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Neurocenter of Southern Switzerland, Ospedale Civico, status: RECRUITING, city: Lugano, state: Ticino, zip: CH-6900, country: Switzerland, contacts name: Carlo Cereda, MD, role: CONTACT, phone: +41 91 811 6691, email: carlo.cereda@eoc.ch, contacts name: Carlo Cereda, role: PRINCIPAL_INVESTIGATOR, contacts name: Giovanni Bianco, role: SUB_INVESTIGATOR, contacts name: Lucio Barile, role: SUB_INVESTIGATOR, geoPoint lat: 46.01008, lon: 8.96004, hasResults: False
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protocolSection identificationModule nctId: NCT06319729, orgStudyIdInfo id: REC/22-23/0659, briefTitle: A Chinese Herbal Medicine for IBS-C, acronym: CDD2105RCT1, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Hong Kong Baptist University, class: OTHER, descriptionModule briefSummary: This double-blind, placebo-controlled randomized pilot clinical trial will test the hypothesis that granules of CDD-2105, a Chinese herbal medicine formula, will have efficacy in alleviating constipation and abdominal pain in individuals with IBS-C. Participants (n=78) will be randomly assigned to the treatment or placebo group in a 1:1 ratio, followed by 4 weeks of intervention and 4 weeks of follow-up., conditionsModule conditions: Constipation-predominant Irritable Bowel Syndrome, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A double-blind, placebo-controlled randomized clinical trial, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: All the study drugs and placebo should be in the same package with the same drug appearance and blinded according to the randomized numbers of the subgroups. The specific blinding method is set as follows: the study drugs and placebo are uniformly packaged and numbered according to the corresponding randomized group results. One copy of the blinding letter in duplicate is sent with the test drug to the project leader of the test center for storage, and the other copy is kept by the pharmacy until the end of the trial., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 78, type: ESTIMATED, armsInterventionsModule interventions name: CDD-2105, interventions name: Placebo, outcomesModule primaryOutcomes measure: Abdominal Pain Responder Rate, primaryOutcomes measure: Complete Spontaneous Bowel Movement (CSBM) Responder Rate, secondaryOutcomes measure: Change in the weekly average self-assessed daily maximum abdominal pain scores (0-10), secondaryOutcomes measure: Change in the number of days of abdominal pain per week, secondaryOutcomes measure: Change in the average weekly Complete Spontaneous Bowel Movement (CSBM) frequency, secondaryOutcomes measure: Change in the average weekly Spontaneous Bowel Movement (SBM) frequency, secondaryOutcomes measure: Change in the score of Irritable Bowel Syndrome-Severity of Symptoms (IBS-SSS) questionnaire, secondaryOutcomes measure: Change in the score of Patient Assessment of Constipation-Symptoms (PAC-SYM), secondaryOutcomes measure: Change in the score of Patient Assessment of Constipation Quality of Life (PAC-QoL) questionnaire, secondaryOutcomes measure: Safety: number of adverse events, secondaryOutcomes measure: Safety: the level of liver function (ALT, AST, AKP, GGT, TBIL, DBIL) and renal function (blood urea nitrogen, creatinine), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06319716, orgStudyIdInfo id: 23-01274, briefTitle: Leveraging Videos and Community Health Workers to Address Social Determinants of Health in Immigrants, acronym: LINK-IT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2028-06-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: NYU Langone Health, class: OTHER, collaborators name: National Institute on Minority Health and Health Disparities (NIMHD), descriptionModule briefSummary: The overall goal of this study is to examine the efficacy of the video-based Diabetes Self-Management Education and Support (DSMES) (hereafter VIDEO), or the video-based DSMES+community health worker (CHW) intervention (hereafter VIDEO+CHW), compared with a wait-list control group (hereafter CONTROL) to improve glycemic control among Chinese immigrants with uncontrolled Type 2 diabetes in NYC., conditionsModule conditions: Type 2 Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 324, type: ESTIMATED, armsInterventionsModule interventions name: Video-Based Diabetes Self-Management Education and Support (DSMES), interventions name: Community Health Worker (CHW) Support, outcomesModule primaryOutcomes measure: Hemoglobin A1c (HbA1c) Levels, primaryOutcomes measure: Hemoglobin A1c (HbA1c) Levels, primaryOutcomes measure: Hemoglobin A1c (HbA1c) Levels, secondaryOutcomes measure: Stanford Self-Efficacy for Diabetes Scale Score, secondaryOutcomes measure: Stanford Self-Efficacy for Diabetes Scale Score, secondaryOutcomes measure: Stanford Self-Efficacy for Diabetes Scale Score, secondaryOutcomes measure: Summary of Diabetes Self-Care Activities (SDSCA) Score, secondaryOutcomes measure: Summary of Diabetes Self-Care Activities (SDSCA) Score, secondaryOutcomes measure: Summary of Diabetes Self-Care Activities (SDSCA) Score, secondaryOutcomes measure: Starting the Conversation (STC) Diet Scale Score, secondaryOutcomes measure: Starting the Conversation (STC) Diet Scale Score, secondaryOutcomes measure: Starting the Conversation (STC) Diet Scale Score, secondaryOutcomes measure: International Physical Activity Questionnaire (IPAQ) Short-Version Score, secondaryOutcomes measure: International Physical Activity Questionnaire (IPAQ) Short-Version Score, secondaryOutcomes measure: International Physical Activity Questionnaire (IPAQ) Short-Version Score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NYU Langone Health, city: New York, state: New York, zip: 10016, country: United States, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
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protocolSection identificationModule nctId: NCT06319703, orgStudyIdInfo id: 22-00634, briefTitle: Implementing an Effective Diabetes Intervention Among Low-Income Immigrants, acronym: IDEAL, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-10-31, completionDateStruct date: 2028-03-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: NYU Langone Health, class: OTHER, collaborators name: Agency for Healthcare Research and Quality (AHRQ), descriptionModule briefSummary: The goal of this IDEAL project is to examine the effectiveness and implementation process of the video-based Diabetes Self-Management Education and Support (DSMES) + community health worker (CHW) (hereafter: "IDEAL") intervention compared with a wait-list control group (hereafter: "CONTROL") to improve glycemic control among Chinese immigrants with Type 2 diabetes (T2D) in New York City (NYC). Participants will be randomized with equal allocation to one of the 2 groups. The IDEAL group will receive 1 DSMES brief video/week for 24 weeks delivered via text message. The CHW will assess participants' SDOH barriers to T2D care and link them to available resources in the community. The CONTROL group will continue to receive their usual care and at the end of the study, they will receive DSMES videos., conditionsModule conditions: Type 2 Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, enrollmentInfo count: 270, type: ESTIMATED, armsInterventionsModule interventions name: Diabetes Self-Management Education and Support (DSMES) Videos, interventions name: Community Health Worker Support (CHW), outcomesModule primaryOutcomes measure: Change in Hemoglobin A1C (HbA1c) Test Scores, primaryOutcomes measure: Change in Hemoglobin A1C (HbA1c) Test Scores, secondaryOutcomes measure: Stanford Self-Efficacy for Diabetes Scale Score, secondaryOutcomes measure: Stanford Self-Efficacy for Diabetes Scale Score, secondaryOutcomes measure: Stanford Self-Efficacy for Diabetes Scale Score, secondaryOutcomes measure: Summary of Diabetes Self-Care Activities (SDSCA) Score, secondaryOutcomes measure: Summary of Diabetes Self-Care Activities (SDSCA) Score, secondaryOutcomes measure: Summary of Diabetes Self-Care Activities (SDSCA) Score, secondaryOutcomes measure: Starting the Conversation (STC) Diet Scale Score, secondaryOutcomes measure: Starting the Conversation (STC) Diet Scale Score, secondaryOutcomes measure: Starting the Conversation (STC) Diet Scale Score, secondaryOutcomes measure: National Cancer Institute Dietary Screener Questionnaire Score, secondaryOutcomes measure: National Cancer Institute Dietary Screener Questionnaire Score, secondaryOutcomes measure: National Cancer Institute Dietary Screener Questionnaire Score, secondaryOutcomes measure: International Physical Activity Questionnaire (IPAQ) Short-Version Score, secondaryOutcomes measure: International Physical Activity Questionnaire (IPAQ) Short-Version Score, secondaryOutcomes measure: International Physical Activity Questionnaire (IPAQ) Short-Version Score, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NYU Langone Health, city: New York, state: New York, zip: 10016, country: United States, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False
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protocolSection identificationModule nctId: NCT06319690, orgStudyIdInfo id: REC/RCR&AHS/23/0362, briefTitle: Combined Effects of Lion's Breath Technique With Chest Percussion Therapy in Pneumonia Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-06-05, completionDateStruct date: 2024-06-15, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Riphah International University, class: OTHER, descriptionModule briefSummary: This study will be randomized controlled trial with non-probability convenient sampling. Sample size will be 90,45 in each group. Outcome will be measured by using 6 minute walk test, Spirometry (FVC, FEV1/FVC and PEF), Functional Independence Measure., conditionsModule conditions: Pneumonia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized Control Trial (RCT), primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Lion's Breath Technique, interventions name: Chest Percussion Therapy, outcomesModule primaryOutcomes measure: George respiratory questionnaire, primaryOutcomes measure: Forced vital capacity (FVC), primaryOutcomes measure: Borg Dyspnea Scale, primaryOutcomes measure: Forced expiratory volume (FEV1), primaryOutcomes measure: FEV1/FVC Ratio, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jinnah Hospital, status: RECRUITING, city: Lahore, state: Punjab, zip: 42000, country: Pakistan, contacts name: Muhammad Ashraf Jamal, MBBS, role: CONTACT, phone: 03009685981, email: drmajamal@hotmail.com, contacts name: Tania Amjad, DPT, role: SUB_INVESTIGATOR, geoPoint lat: 31.558, lon: 74.35071, hasResults: False
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protocolSection identificationModule nctId: NCT06319677, orgStudyIdInfo id: Ivljingjing, briefTitle: PK/PD Study of Anti-Infective Drugs in Critically Ill Patients Receiving Extracorporeal Membrane Oxygenation Treatment, acronym: ECMO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-05-01, completionDateStruct date: 2027-05-01, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: The Third Xiangya Hospital of Central South University, class: OTHER, descriptionModule briefSummary: Extracorporeal membrane pulmonary oxygenation (ECMO) may provide partial or complete support for organ replacement in patients with severe cardiopulmonary failure, buying time for further management of the primary disease. However, ECMO may significantly alter the pharmacokinetic and pharmacodynamic profiles of critically ill patients, affecting the safety and efficacy of drug therapy. This prospective observational study aims to investigate the impact of ECMO treatment on the pharmacokinetics and pharmacodynamics of antimicrobial drugs in critically ill adult patients. Investigators intend to establish a Population Pharmacokinetic (POP PK) and Pharmacokinetic/Pharmacodynamic (PK/PD) model by prospectively collecting blood samples from patients and relevant treatment data. The primary objective is to quantitatively characterize the pharmacokinetic profiles of critically ill patients undergoing ECMO support and provide model-based recommendations for drug regimens tailored to critically ill patients., conditionsModule conditions: Critical Illness, conditions: Extracorporeal Membrane Oxygenation Complication, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: ECMO treatment, outcomesModule primaryOutcomes measure: Blood drug concentration, primaryOutcomes measure: Pharmacokinetic parameter, primaryOutcomes measure: Pharmacokinetic parameter, secondaryOutcomes measure: Mortality at 14 and 28 days, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xiangya Third Hospital, Central South University, city: Changsha, state: Hunan, country: China, contacts name: Jingjing Liu, Doctor, role: CONTACT, phone: +86 0731-88618170, email: ivljingjing@126.com, geoPoint lat: 28.19874, lon: 112.97087, hasResults: False
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protocolSection identificationModule nctId: NCT06319664, orgStudyIdInfo id: sjnkzzj, briefTitle: Clinical Outcomes and Decision-making Choice of Skull Base Approaches for Petroclival Meningiomas, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-05-27, primaryCompletionDateStruct date: 2021-08-10, completionDateStruct date: 2021-09-10, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Xiangya Hospital of Central South University, class: OTHER, descriptionModule briefSummary: Petroclival meningioma (PCM) is a technically challenging lesion. We aimed to analyze the role of various skull base approaches and evaluate the therapeutic outcomes guided by the modified classification. We retrospectively analyzed the clinical characteristics, surgical approaches, outcomes and follow-up data from 179 cases of PCM from January 2011 to December 2020. We modified the previous classification into updated five types with two subtypes: clivus type (CV), petroclival type (PC), petroclivosphenoidal type (PC-S), sphenopetroclival type (S-PC) with two subtypes of S-PC I and S-PC II and central skull base type (CSB). Statistical analysis was performed using IBM SPSS Statistical Package 21.0. The t-test was performed to clinical data comparisons between the two groups and the ANOVA test was used to compare the difference between multiple groups. P \< 0.05 was considered statistically significant., conditionsModule conditions: Skull Base Meningioma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 179, type: ACTUAL, armsInterventionsModule interventions name: retrosigmoid approach (RSA), interventions name: subtemporal transtentorial transpetrosal approach (STTA), interventions name: extended pterional transtentorial approach (EPTA), interventions name: pretemporal trancavernous anterior transpetrosal approach (PTCA), interventions name: presigmoid combined supra-infratentorial approach (PCA), interventions name: inoperable, outcomesModule primaryOutcomes measure: QOL were assessed and measured using the Karnofsky Performance Scale (KPS) score, eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 73 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xiangya Hospital, Central South University, city: Changsha, state: Hunan, zip: 410000, country: China, geoPoint lat: 28.19874, lon: 112.97087, hasResults: False
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protocolSection identificationModule nctId: NCT06319651, orgStudyIdInfo id: REC/RCR&AHS/23/0360, briefTitle: Effects of Lower Limb Resistance Band Exercises in Phase 1 Cardiac Rehabilitation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-06-05, completionDateStruct date: 2024-06-15, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Riphah International University, class: OTHER, descriptionModule briefSummary: This study will be randomized controlled trial with non-probability purposive sampling. Study conducted among post CABG patients. Sample size will be 56, 28 in each group. Outcome will be measured by using 6 minute walk test, Spirometry (FVC, FEV1/FVC and PEF), Functional Independence Measure., conditionsModule conditions: Cardiovascular Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized controlled trial (RCT). Pre \& Post data collection, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule interventions name: Lower Limb Resistance Band Exercises, interventions name: Routine Phase 1 cardiac rehabilitation, outcomesModule primaryOutcomes measure: Functional Independence Measure, primaryOutcomes measure: 6 Minute Walk Test, primaryOutcomes measure: Forced expiratory volume (FEV1), primaryOutcomes measure: Forced vital capacity (FVC), primaryOutcomes measure: FEV1/FVC ratio, eligibilityModule sex: ALL, minimumAge: 35 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Rehmatul lil Alameen Institute of cardiology, status: RECRUITING, city: Lahore, state: Punjab, zip: 42000, country: Pakistan, contacts name: Dr. Fareed Ahmad, MBBS, role: CONTACT, phone: 04299330101, email: ms.raic@pessi.punjab.gov.pk, contacts name: Afifa Shoaib, DPT, role: SUB_INVESTIGATOR, geoPoint lat: 31.558, lon: 74.35071, hasResults: False
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protocolSection identificationModule nctId: NCT06319638, orgStudyIdInfo id: SGB TBI, briefTitle: Efficacy of Stellate Ganglion Block in Traumatic Brain Injury Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in Traumatic Brain Injury Patients. The main question it aims to answer are:Can stellate ganglion block improve the dysphagia and activities of daily living in Traumatic Brain Injury Patients.Traumatic Brain Injury Patients will be divided into the the control group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. The swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated., conditionsModule conditions: Traumatic Brain Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Rehabilitation therapy, interventions name: Stellate ganglion block, interventions name: Placebo block, interventions name: Lidocaine Hydrochloride, outcomesModule primaryOutcomes measure: Penetration-Aspiration Scale, secondaryOutcomes measure: Modified Barthel Index, secondaryOutcomes measure: Swallowing duration, secondaryOutcomes measure: Functional Oral Intake Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06319625, orgStudyIdInfo id: SGB PARKINSON, briefTitle: Effectiveness of Stellate Ganglion Block in Patients Diagnosed With Parkinson's Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in patients with Parkinson's disease. The main question it aims to answer are:• Can stellate ganglion block improve the dysphagia and activities of daily living in patients with Parkinson's disease.Participants will be divided into the the control group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. The swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated., conditionsModule conditions: Parkinson Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Rehabilitation therapy, interventions name: Stellate ganglion block, interventions name: Lidocaine hydrochloride, interventions name: Placebo injection, outcomesModule primaryOutcomes measure: Penetration-Aspiration Scale, secondaryOutcomes measure: Modified Barthel Index, secondaryOutcomes measure: Functional Oral Intake Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06319612, orgStudyIdInfo id: SGB OSA DOUBLE BLIND, briefTitle: Effectiveness of Stellate Ganglion Block for the Treatment of Obstructive Sleep Apnea, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: The goal of this clinical trial is to test the efficacy of stellate ganglion block in Obstructive Sleep Apnea. The main question it aims to answer are:• Can stellate ganglion block improve Obstructive Sleep Apnea? Patients were randomly divided into two groups, all provided with routine therapy. Based on this, the experimental group was given stellate ganglion block. The video fluoroscopic swallowing study was done to test the swallowing function before and after the study., conditionsModule conditions: Obstructive Sleep Apnea, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: routine rehabilitation treatment, interventions name: Stellate ganglion block, interventions name: Lidocaine Hydrochloride, interventions name: Placebo injection, outcomesModule primaryOutcomes measure: Epworth Sleepiness Scale, secondaryOutcomes measure: Apnea-Hypopnea Index, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06319599, orgStudyIdInfo id: SGB GUDU, briefTitle: Stellate Ganglion Block in Children With Autistic Disorder, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: The goal of this clinical trial is to explore efficacy of stellate ganglion block Children with Autistic Disorder. The main question it aims to answer is:Can stellate ganglion block improve the Autistic Disorder in children? Children with Autistic Disorder will be divided into the control group and experimental group evenly. All the patients were provided with routine therapy, while the patients in the experimental group were given stellate ganglion block. The Childhood Autism Rating Scale of the two groups of patients before and after treatment are evaluated., conditionsModule conditions: Autistic Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Routine therapy, interventions name: Stellate ganglion block, interventions name: Lidocaine hydrochloride, interventions name: placebo injection, outcomesModule primaryOutcomes measure: Childhood Autism Rating Scale, secondaryOutcomes measure: Children's Communication Checklist, secondaryOutcomes measure: Social Interaction Assessment Scale, secondaryOutcomes measure: Children's Depression Inventory, secondaryOutcomes measure: Childhood Anxiety Sensitivity Index, eligibilityModule sex: ALL, minimumAge: 4 Months, maximumAge: 8 Years, stdAges: CHILD, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06319586, orgStudyIdInfo id: Soh-Med-24-02-08MS, briefTitle: The Radial Forearm Flap In Reconstruction Of Upper Limb Injuries, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-02-07, primaryCompletionDateStruct date: 2024-02-07, completionDateStruct date: 2024-02-07, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: The radial forearm flap is a very useful and versatile flap with a long vascular pedicle and a thin, pliable skin. It's used in reconstruction of the mutilated hand as a reverse pedicled flap. The dominant pedicle is the radial artery, with venous outflow through the dual system of the venae comitantes and cephalic vein. Sensory innervation may be derived from the medial and lateral antebrachial cutaneous nerves. The radial forearm flap offers the advantage of a large area of donor tissue from the involved extremity with the potential for inclusion of bone, nerve, and tendon grafts. Sacrifice of the radial artery has not been associated with significant patient symptoms However, the donor defect can be troublesome, frequently requiring skin grafting directly over the paratenon of the flexor tendons, producing an undesirable donor site appearance, conditionsModule conditions: for Upper Limb Soft Tissue Coverage, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ACTUAL, armsInterventionsModule interventions name: Radial Forearm Flap, outcomesModule primaryOutcomes measure: Viability of the flap, eligibilityModule sex: ALL, minimumAge: 5 Years, maximumAge: 80 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sohag University hospitals, city: Sohag, country: Egypt, geoPoint lat: 26.55695, lon: 31.69478, hasResults: False
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protocolSection identificationModule nctId: NCT06319573, orgStudyIdInfo id: 2305-UNIVF-070-DC, briefTitle: The Impact of Personalized Prognostic Counseling on IVF Patient's Experience and Treatment Utilization, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-19, primaryCompletionDateStruct date: 2025-08-31, completionDateStruct date: 2026-02-28, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Ginefiv, class: OTHER, collaborators name: Univfy Inc., descriptionModule briefSummary: This study will be conducted in two phases. In the first phase, research subjects will be assigned to receive standard counseling. In the second phase, research subjects will receive Univfy counseling., conditionsModule conditions: Infertility, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 366, type: ESTIMATED, armsInterventionsModule interventions name: Counseling Supported by Univfy® Report, interventions name: Standard Counseling, outcomesModule primaryOutcomes measure: Treatment utilization (conversion) rate in the two groups, primaryOutcomes measure: Patient experience responses, primaryOutcomes measure: Validation of Univfy prediction upon CLBdR, primaryOutcomes measure: Retention Rate, primaryOutcomes measure: Time to Pregnancy, secondaryOutcomes measure: Self-reported satisfaction related to psychological support and cost of treatment, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 39 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ginefiv S.L, status: RECRUITING, city: Barcelona, zip: 08015, country: Spain, contacts name: Xinxin Lin Miao, role: CONTACT, phone: +34930400200, email: x.lin@ginefiv.com, contacts name: Xinxin Lin Miao, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Ginefiv S.L, status: RECRUITING, city: Madrid, zip: 28018, country: Spain, contacts name: Joaquin Llacer, role: CONTACT, phone: +34900908988, email: j.llacer@ginefiv.com, contacts name: Joaquin Llacer, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False
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protocolSection identificationModule nctId: NCT06319560, orgStudyIdInfo id: JEP-2023-866, briefTitle: Hydroxychloroquine in Type 2 Diabetes During Pregnancy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-02, primaryCompletionDateStruct date: 2026-01-01, completionDateStruct date: 2027-01-01, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: National University of Malaysia, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare the use of hydroxychloroquine as an adjunct to the current treatment of pregnant women with Type 2 diabetes mellitus.The main questions it aims to answer are:* Does hydroxychloroquine improve the pregnancy outcomes in women with type 2 diabetes during pregnancy?* Does hydroxychloroquine improve the inflammatory markers in women with type 2 diabetes during pregnancy? Participants will be randomised into the intervention and control group. The control group will be on standard treatment where as the intervention group will receive hydroxychloroquine as an adjunct of standard treatment, conditionsModule conditions: Diabetes in Pregnancy, conditions: Type 2 Diabetes, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 56, type: ESTIMATED, armsInterventionsModule interventions name: Hydroxychloroquine Oral Tablet, outcomesModule primaryOutcomes measure: To compare the serum glycated haemoglobin between the two groups, primaryOutcomes measure: To compare the serum fructosamine between the two groups, primaryOutcomes measure: To compare the serum interleukin-6 between the two groups, primaryOutcomes measure: To compare the serum interleukin-10 between the two groups, primaryOutcomes measure: To compare the serum tumour necrosis factor alpha between the two groups, primaryOutcomes measure: To compare the shearwave elastography of the placenta between the two groups, secondaryOutcomes measure: To compare the gestational age at delivery between the two groups, secondaryOutcomes measure: Type of labour, secondaryOutcomes measure: Mode of delivery, secondaryOutcomes measure: Postpartum haemorrhage, secondaryOutcomes measure: Third or fourth degree perineal tear, secondaryOutcomes measure: Neonatal birth weight at delivery, secondaryOutcomes measure: Large for gestational age or macrosomia, secondaryOutcomes measure: Shoulder dystocia, secondaryOutcomes measure: Appearance, pulse, grimace, activity and respiration score of neonate at 5 minutes, secondaryOutcomes measure: Arterial cord pH at birth, secondaryOutcomes measure: Number of neonates needing admission into neonatal intensive care unit, secondaryOutcomes measure: Height or length of neonates, secondaryOutcomes measure: Weight of the neonates, secondaryOutcomes measure: Hospital admission, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Antenatal clinic, UKM Medical Centre, status: RECRUITING, city: Cheras, state: Kuala Lumpur, zip: 56000, country: Malaysia, contacts name: Rahana Abd Rahman, role: CONTACT, geoPoint lat: 3.05, lon: 101.76667, hasResults: False
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protocolSection identificationModule nctId: NCT06319547, orgStudyIdInfo id: Soh-Med-24-02-07MS, briefTitle: Comparing Outcome of Thoracocentesis and Pigtail Catheter Drainage in Treatment of Patients With Hepatic Hydrothorax, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: Hepatic hydrothorax (HH) is a pleural effusion that develops in a patient with cirrhosis and portal hypertension in the absence of cardiopulmonary disease (Lv et al., 2018). Several factors are known to contribute to the development of effusion; the most accepted mechanism of which is the direct delivery of ascitic fluid from the peritoneal cavity to the pleural cavity by "positive" intra-abdominal pressure and a "negative" intrathoracic pressure of the pleural cavity through microscopic congenital diaphragmatic defects (Han et al., 2022)., conditionsModule conditions: Hepatic Hydrothorax, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Thoracocentasis, outcomesModule primaryOutcomes measure: percentage of empyema in patients with hepatic hydrothorax after thoracocentesis, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sohag University hospitals, status: RECRUITING, city: Sohag, country: Egypt, contacts name: Magdy M Amin, Professor, role: CONTACT, geoPoint lat: 26.55695, lon: 31.69478, hasResults: False
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protocolSection identificationModule nctId: NCT06319534, orgStudyIdInfo id: SGB-ZHENQIU, briefTitle: Stellate Ganglion Block in Bulbar Palsy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: This is a randomized controlled study, including dysphagic patients with bulbar palsy after ischemic stroke who were received in the department of rehabilitation medicine in 3 hospitals in China. All patients are randomly allocated to the observation group or the control group. Both groups are provided with comprehensive rehabilitation. Besides, the observation group additionally undergoes the stellate ganglion block. At admission and after 10-day treatment, video fluoroscopic swallowing study, and penetration-aspiration scale, Functional Oral Intake Scale, Flexible laryngoscope are used to assess swallowing function., conditionsModule conditions: Bulbar Palsy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Comprehensive rehabilitation, interventions name: Stellate ganglion block, interventions name: Lidocaine Hydrochloride, interventions name: placebo injection, outcomesModule primaryOutcomes measure: Penetration-Aspiration Scale, secondaryOutcomes measure: Functional Oral Intake Scale, secondaryOutcomes measure: Murray secretion severity scale, secondaryOutcomes measure: Yale pharyngeal residue severity rating scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06319521, orgStudyIdInfo id: SGB-REFLUX, briefTitle: Stellate Ganglion Block on Gastroesophageal Reflux Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: The goal of this clinical trial is to explore Clinical Effect of Stellate Ganglion Block on Gastroesophageal Reflux Disease. The main question it aims to answer is:• Can stellate ganglion block improve gastroesophageal reflux symptoms better on the basis of rehabilitation training? Participants will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Stellate Ganglion Block once a day additionally. The study lasts 20 days for each participant. Researchers will compare the Gastroesophageal Reflux Disease Questionnaire, Pressure pain threshold, Self-Evaluation Questionnaire for Gastroesophageal Reflux Disease, to see if the Stellate Ganglion Block can help improve the symptom., conditionsModule conditions: Gastroesophageal Reflux Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Rehabilitation therapy, interventions name: Stellate ganglion block, interventions name: Lidocaine hydrochloride, interventions name: Placebo injection, outcomesModule primaryOutcomes measure: Gastroesophageal Reflux Disease Questionnaire, secondaryOutcomes measure: Pressure pain threshold, secondaryOutcomes measure: Modified Mayo Clinic Dysphagia-30 questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06319508, orgStudyIdInfo id: SGB-NT, briefTitle: Stellate Ganglion Block in Cerebral Palsy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: The goal of this clinical trial is to test the efficacy of stellate ganglion block in children with cerebral palsy and dysphagia. The main question it aims to answer are:• Can stellate ganglion block improve the dysphagia of children with cerebral palsy? Participants were randomly divided into two groups, all provided with routine therapy. Based on this, the experimental group was given stellate ganglion block. The video fluoroscopic swallowing study was done to test the swallowing function before and after the study., conditionsModule conditions: Cerebral Palsy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: routine rehabilitation treatment, interventions name: Stellate ganglion block, interventions name: Lidocaine hydrochloride, interventions name: Placebo injection, outcomesModule primaryOutcomes measure: Penetration-Aspiration Scale, secondaryOutcomes measure: Swallowing duration, secondaryOutcomes measure: Functional Oral Intake Scale, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 7 Years, stdAges: CHILD, hasResults: False
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protocolSection identificationModule nctId: NCT06319495, orgStudyIdInfo id: SGB-CSVD, briefTitle: Stellate Ganglion Block in Patients With Cerebral Small Vessel Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Copka Sonpashan, class: OTHER_GOV, descriptionModule briefSummary: This is a prospective study conducted on patients with Cerebral Small Vessel Disease, dysphagia and cognitive impairment. They were divided into the comparison group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given Stellate Ganglion Block. The swallowing function, cognitive function and activities of daily living of the two groups of patients before and after treatment were evaluated by Penetration-Aspiration Scale, Mini-mental state examination and modified Barthel index., conditionsModule conditions: Cerebral Small Vessel Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Rehabilitation therapy, interventions name: Stellate ganglion block, interventions name: Lidocaine Hydrochloride, interventions name: placebo injection, outcomesModule primaryOutcomes measure: Penetration-Aspiration Scale, secondaryOutcomes measure: Modified Barthel Index, secondaryOutcomes measure: Mini-Mental State Examination, secondaryOutcomes measure: Functional Oral Intake Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06319482, orgStudyIdInfo id: Adherence Study, briefTitle: The Adherence of Proactive Sleep Apnea Therapy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-08-01, completionDateStruct date: 2025-08-01, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: NovaResp Technologies Inc, class: INDUSTRY, descriptionModule briefSummary: The goal of this clinical trial is to compare the adherence to Positive Airway Pressure (PAP) therapy for newly diagnosed Obstructive Sleep Apnea (OSA) patients. The main question(s) it aims to answer are:1. To compare the adherence of proactive therapy and conventional Automatic-PAP (APAP) therapy short-term (3 months) and long-term (12 months) for newly diagnosed OSA patients.2. To compare health outcomes (AHI, nightly pressure, and patient-reported outcomes) between proactive therapy and conventional APAP therapy., conditionsModule conditions: Obstructive Sleep Apnea, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Proactive CPAP Therapy, interventions name: Conventional APAP Therapy, outcomesModule primaryOutcomes measure: Adherence, secondaryOutcomes measure: Apnea-Hypopnea Index, secondaryOutcomes measure: Pressure, secondaryOutcomes measure: Self-assessed sleep outcomes, secondaryOutcomes measure: Self-assessed functional outcomes, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06319469, orgStudyIdInfo id: FMBSUREC/06122022/Mohamed, briefTitle: The Additive Value of Pyridostigmine to Silodosin in Acute Urinary Retention, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-02-01, primaryCompletionDateStruct date: 2024-01-30, completionDateStruct date: 2024-01-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Beni-Suef University, class: OTHER, descriptionModule briefSummary: Acute urine retention, AUR, is often considered the most serious consequence of aging men with progressive benign prostatic hyperplasia (BPH). AUR is defined as the sudden and painful inability to void freely. This study aims to evaluate whether pyridostigmine bromide added to silodosin is beneficial in treating acute urine retention caused by BPH., conditionsModule conditions: Prostatic Hyperplasia, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 140, type: ACTUAL, armsInterventionsModule interventions name: silodosin 8 mg capsule and the pyridostigmine bromide 60 mg tablet, interventions name: silodosin 8 mg capsule, outcomesModule primaryOutcomes measure: International Prostate Symptom Score (IPSS), eligibilityModule sex: MALE, minimumAge: 50 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beni-Seuf University Hospital, city: Banī Suwayf, country: Egypt, geoPoint lat: 29.07441, lon: 31.09785, hasResults: False
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protocolSection identificationModule nctId: NCT06319456, orgStudyIdInfo id: APG2575CC301, briefTitle: A Global Study of Lisaftoclax (APG-2575) Combined With Acalabrutinib Versus Immunochemotherapy for Newly Diagnosed CLL/SLL., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-08, completionDateStruct date: 2028-08, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Ascentage Pharma Group Inc., class: INDUSTRY, descriptionModule briefSummary: This is a global, multicenter, randomized, open-label, Phase III confirmatory study to investigate the efficacy and safety of Lisaftoclax (APG-2575) in combination with Acalabrutinib in patients with newly diagnosed CLL/SLL., conditionsModule conditions: CLL/SLL, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 344, type: ESTIMATED, armsInterventionsModule interventions name: Lisaftoclax (APG-2575), interventions name: Acalabrutinib, interventions name: Fludarabine, interventions name: Cyclophosphamide，CTX, interventions name: Rituximab, interventions name: Chlorambucil, outcomesModule primaryOutcomes measure: Progress Free Survival (PFS), secondaryOutcomes measure: Objective Response Rate (ORR), secondaryOutcomes measure: Minimal Residual Disease (MRD) negativity rate, secondaryOutcomes measure: Safety evaluation based on the adverse event concurrence, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Bengbu Medical College, status: NOT_YET_RECRUITING, city: Bengbu, state: Anhui, zip: 233004, country: China, contacts name: Yinghua Geng, Ph.D., role: CONTACT, contacts name: Yinghua Geng, Ph.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.94083, lon: 117.36083, locations facility: Guangdong Provincial People's Hospital, status: NOT_YET_RECRUITING, city: Guangzhou, state: Guangdong, zip: 510080, country: China, contacts name: Wenyu Li, Ph.D., role: CONTACT, contacts name: Wenyu Li, Ph.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, locations facility: Nanfang Hospital of Southern Medical University, status: NOT_YET_RECRUITING, city: Guangzhou, state: Guangdong, zip: 510515, country: China, contacts name: Xutao Guo, Ph.D., role: CONTACT, contacts name: Xutao Guo, Ph.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, locations facility: Henan Provincial Cancer Hospital, status: RECRUITING, city: Zhengzhou, state: Henan, zip: 450003, country: China, contacts name: Keshu Zhou, M.D., Ph.D., role: CONTACT, phone: 13674902391, email: drzhouks77@163.com, contacts name: Keshu Zhou, M.D., Ph.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.75778, lon: 113.64861, locations facility: Hematology Hospital of the Chinese Academy of Medical Sciences, status: RECRUITING, city: Tianjin, state: Tianjin, zip: 300020, country: China, contacts name: Lugui Qiu, M.D., Ph.D., role: CONTACT, phone: 022-23909272, email: qiulg@ihcams.ac.cn, contacts name: Lugui Qiu, M.D., Ph.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.14222, lon: 117.17667, hasResults: False
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protocolSection identificationModule nctId: NCT06319443, orgStudyIdInfo id: STUDY00019235, briefTitle: Daily Vinegar Ingestion and 24-Hour Blood Glucose Control, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Arizona State University, class: OTHER, descriptionModule briefSummary: When linking dietary interventions and blood glucose management, much of the existing research - particularly studies exploring the effects of vinegar - has relied on discrete readings from the conventional testing methods: blood samples or glucometers. These methods lack the capacity to provide insights into blood glucose dynamics 24/7.Recognizing this gap, the current study aims to utilize continuous glucose monitoring to examine the impact of daily vinegar ingestion on glucose variability in adults identified as glucose intolerant., conditionsModule conditions: Glucose Intolerance, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: This is a 9-day trial. Participants will be fitted with a continuous glucose monitor and follow their typical diet and activity patterns. Participants will be randomized to ingest 2 tablespoons of vinegar twice daily (diluted in water) or a vinegar pill for the first 4 days on the trial. On day 5 of the trial participants will consume the alternate treatment for trial days 5-8. Dietary intake will be recorded daily using a fitness app. Physical activity will be assessed at baseline and on study day 4 and 8. On day 9, participants will return to the test site for device removal., primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: Liquid and pill vinegar will be the treatments. The pill is the 'control' as the level of acetic acid is below the amount needed for an antiglycemic effect (a fact not realized by the participant)., whoMasked: PARTICIPANT, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Liquid vinegar, interventions name: vinegar pill, outcomesModule primaryOutcomes measure: Average glucose, primaryOutcomes measure: Glucose: time in range, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: 850 PBC, status: RECRUITING, city: Phoenix, state: Arizona, zip: 85004, country: United States, contacts name: Carol S Johnston, PhD, role: CONTACT, phone: 602-965-2539, email: carol.johnston@asu.edu, geoPoint lat: 33.44838, lon: -112.07404, hasResults: False
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protocolSection identificationModule nctId: NCT06319430, orgStudyIdInfo id: HS26236(H2023:343), briefTitle: Technology in Play for Children With Physical Disabilities: the Dice Model of Play, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-05-28, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: University of Manitoba, class: OTHER, collaborators name: Rehabilitation Centre for Children, Canada, descriptionModule briefSummary: Play is an important activity for children. Almost all children play, but what is play? It is not easy to define play. In the past, people believed that children played to burn their energy. Now, it is known that play is important for children's growth. Some kids with disabilities cannot play. Many experts use play to teach children specific skills. People often forget that play is a child's right. It is important to help all children play. The first step is to define play and find what features are important in helping a child with a disability play.There are some models of play. But they are not complete. They do not look at play as a whole. Some models are just about playfulness, and some are about playing with others. Having a model that defines play helps researchers and clinicians think about play and the different parts of it. Then, when a child cannot play, experts can fix the part that is not working. Investigators want to introduce a model of play in this project. Investigators want to edit and complete it in three steps. First, Investigators will ask parents and children with disabilities about things that help or do not help them play; then, investigators will give Lego robots to kids that they will build with help and play with them for a few weeks. And at the end, investigators will ask therapists and other experts about our model of play. This model will be edited during the study., conditionsModule conditions: Physical Disability, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: The primary purpose is validation of.........., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: robots, interventions name: conventional, outcomesModule primaryOutcomes measure: Test of Playfulness, primaryOutcomes measure: The Child Initiated Pretend Play Assessment (ChIPPA-2), primaryOutcomes measure: The Pretend Play Enjoyment-Developmental Checklist (PPE-DC), eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 8 Years, stdAges: CHILD, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP_ICF, hasProtocol: True, hasSap: True, hasIcf: True, label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form, date: 2024-01-22, uploadDate: 2024-03-04T16:47, filename: Prot_SAP_ICF_000.pdf, size: 1962440, hasResults: False
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protocolSection identificationModule nctId: NCT06319417, orgStudyIdInfo id: HT-UCAM, briefTitle: Hydroxytyrosol Caramel Treatment on Cardiovascular Risk Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-04-15, primaryCompletionDateStruct date: 2023-03-23, completionDateStruct date: 2023-03-23, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Universidad Católica San Antonio de Murcia, class: OTHER, descriptionModule briefSummary: The goal of this double-blind crossover randomized clinical trial is to evaluate the impact of a phenolic natural compound called hydroxytyrosol (HT) on patients at cardiovascular risk (CVR). The main questions it aims to answer are:* Evaluating the effect of HT caramels on CVR biomarkers.* Assessing the impact of HT caramels on cellular phenotype.Participants will take 4 caramels/day, each containing 15 mg of HT, consuming a daily intake of 60 mg for 28 days. One group will begin with HT caramel consumption for 28 days, while the other group will start with a placebo treatment. Following a 2-week washout period, the treatments will be switched between the groups. Those who initially consumed HT will then switch to the placebo treatment, and vice-versa, each for a duration of 28 days., conditionsModule conditions: Cardiovascular Pathology, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: 28 days of treatment: one group with HT treatment and the other with placebo treatment.2-weeks washout period. The treatment will be switched between groups for another 28 days: those who initially consumed HT will the switch to the placebo treatment, and vice versa., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Nor participant and care provider knew the treatment given., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 26, type: ACTUAL, armsInterventionsModule interventions name: HT treatment, interventions name: Placebo treatment, outcomesModule primaryOutcomes measure: Change of cardiovascular biomarkers, primaryOutcomes measure: Change of cellular phenotype of platelets, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Catholic University of Murcia (UCAM), city: Murcia, zip: 30107, country: Spain, geoPoint lat: 37.98704, lon: -1.13004, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2022-03-01, uploadDate: 2024-03-12T10:59, filename: ICF_000.pdf, size: 995478, hasResults: False
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protocolSection identificationModule nctId: NCT06319404, orgStudyIdInfo id: 2022YFC2505700, briefTitle: Immune Function of Colorectal Cancer Lymph Nodes, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Shanxi Province Cancer Hospital, class: OTHER, collaborators name: The Second Affiliated Hospital of Harbin Medical University, collaborators name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences, descriptionModule briefSummary: Lymph nodes are very important immune organs in the human body and play an important role in the physiological and pathological activities of the body, especially in anti-tumor immunity. The role of regional draining lymph nodes in the development of colorectal cancer is still unknown. In this study, the role of lymph nodes in the development of colorectal cancer was investigated through multicenter and multi-omics data., conditionsModule conditions: Colorectal Cancer, conditions: Lymph Node, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions, outcomesModule primaryOutcomes measure: To investigate the difference of immune pathway activation in tumor-draining lymph node based on genomics, primaryOutcomes measure: To investigate the relationship between the type and number of immune cells in tumor draining lymph nodes and the activation of immune pathways is based on pathomics, primaryOutcomes measure: The immune function of tumor draining lymph nodes of colorectal cancer patients was previously identified based on radiomics, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06319391, orgStudyIdInfo id: JSZ007, briefTitle: Analysis of the Effect of Donor CYP3A5 Gene Polymorphism on Early Tacrolimus Concentration and Postoperative Acute Renal Injury After Liver Transplantation, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-04-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2025-10-01, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Ziqiang Li, class: OTHER, descriptionModule briefSummary: Tacrolimus is the most commonly used immunosuppressant for preventing and treating rejection after liver transplantation. However, its treatment window is narrow, the pharmacokinetic individual differences are large, routine dose according to body weight, sometimes low dose will cause graft rejection of patients, or high dose will lead to infection and liver and kidney toxicity and other adverse reactions. Moreover, the conventional drug testing can not fully reflect the efficacy of tacrolimus, and there are shortcomings of lag, experience and passivity. FK506 is metabolized primarily by cytochrome P450 member 3A5 in the liver and intestines. CYP3A5\*3 is the most important factor determining the expression level of CYP3A5. This mutation can cause variable shear and produce unstable protein, so that patients carrying CYP3A5\*3/\*3 gene do not express CYP3A5. Acute kidney injury is a common and important complication after liver transplantation. Despite recent advances in organ preservation, surgical techniques, and immunosuppressive protocols, the incidence of AKI after orthotopic liver transplantation remains high. AKI has a significant impact on both short - and long-term prognosis of orthotopic liver transplantation recipients. Studies have shown that orthotopic liver transplantation recipients with AKI have significantly higher mortality rates in hospital, at 28 days and at 1 year after surgery than those without AKI. In this study, the relationship between donor and recipient CYP3A5 gene polymorphism and tacrolimus concentration was investigated, and the effect of donor and recipient CYP3A5 gene polymorphism and tacrolimus concentration on acute kidney injury after liver transplantation was investigated. To provide guidance for individual administration of gene-directed tacrolimus in patients, and provide basis for prevention and reduction of postoperative acute kidney injury in liver transplantation patients., conditionsModule conditions: Complete and Accurate Statistical Data of 60 Patients, conditions: CYP3A5*3 Genotypes of 60 Donors and Recipients Were Analyzed Accurately, conditions: Postoperative Tacrolimus Concentrations Were Accurately Recorded in 60 Patients, conditions: According to the Diagnosis and Grading Criteria of Acute Kidney Injury, the Cases and Grading of Postoperative Acute Kidney Injury in 60 Patients Were Counted, conditions: Scientific and Rigorous Statistical Analysis of Data, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: CYP3A5*1*、CYP3A5*1*3, interventions name: CYP3A5*3*3, outcomesModule primaryOutcomes measure: Fk506, primaryOutcomes measure: Scr, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital), city: Jinan, state: Shandong, zip: 250013, country: China, geoPoint lat: 36.66833, lon: 116.99722, hasResults: False
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protocolSection identificationModule nctId: NCT06319378, orgStudyIdInfo id: CAPSI no 2 date 231024, secondaryIdInfos id: 2023-505532-35-00, type: OTHER, domain: CTIS, briefTitle: Cancer Related Major Depression Treated With a Single Dose of Psilocybin, acronym: CAPSI, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-17, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Section for Affective Disorders; Northern Stockholm Psychiatry, class: OTHER, collaborators name: Uppsala University Hospital, collaborators name: Region Örebro County, collaborators name: Vastra Gotaland Region, collaborators name: Karolinska Institutet, descriptionModule briefSummary: The goal of this randomized placebo controlled trial is to compare the antidepressant effect of a single oral dose of psilocybin 25 mg compared to 1 mg in 100 patients with cancer related major depressive disorder. The main question it aims to answer is:The primary objective of this study is to evaluate the efficacy of a single 25 mg oral dose of psilocybin for major depressive disorder (MDD) compared to an active placebo (psilocybin 1 mg) assessed as the difference between groups in changes in depressive symptoms, in the following Population: 20-80 (inclusive) years old, current depressive episode (according to Patient Health Questionnaire (PHQ-9)≥10), \>1 month after cancer diagnosis, with at least 12 months of life expectancy, willingness to abstain from other psychotherapeutic or antidepressant treatments during the study (wash out time 5 half-lives)., conditionsModule conditions: MDD, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized Controlled Trial, active placebo, randomization ratio 2:1, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: psilocybin 25 mg sod, interventions name: psilocybin 1 mg sod, outcomesModule primaryOutcomes measure: MADRS at day 42, secondaryOutcomes measure: MADRS day 8, secondaryOutcomes measure: MADRS-S at all evaluations between Day 0 and Day 42 (Mixed Models for Repeated Measures (MMRM) x1), secondaryOutcomes measure: SDS at Day 42, secondaryOutcomes measure: CGI at Day 8 and Day 42 (analysis of covariance (ANCOVA) x6), secondaryOutcomes measure: EQ-5D-5L at Day 8 and Day 42 (ANCOVA x6), secondaryOutcomes measure: AQOL-6D at Day 42 (ANCOVA x1), secondaryOutcomes measure: MADRS at Day 90 and Day 180 (ANCOVA x2), secondaryOutcomes measure: MADRS-S at all evaluations between Day 43 and Day 180 (MMRM x1), secondaryOutcomes measure: SDS at Day 180 (ANCOVA x3), secondaryOutcomes measure: GAD-7 at Day 180 (ANCOVA x3), secondaryOutcomes measure: HADS at Day 180 (ANCOVA x3), secondaryOutcomes measure: CGI at Day 90 and Day 180 (ANCOVA x6), secondaryOutcomes measure: EQ-5D-5L at Day 90 and Day 180 (ANCOVA x6), secondaryOutcomes measure: AQOL-6D at Day 90 and Day 180 (ANCOVA x2), secondaryOutcomes measure: GAD-7 at Day 42, secondaryOutcomes measure: HADS at Day 42, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: region Västra Götaland, status: RECRUITING, city: Göteborg, country: Sweden, contacts name: Helena Werin Sjögren, MD, role: CONTACT, email: helena.werin.sjogren@vgregion.se, contacts name: Mikael Landén, MD PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 57.70716, lon: 11.96679, locations facility: Norra Stockholms Psykiatri, status: RECRUITING, city: Stockholm, country: Sweden, contacts name: Evana Lopez, MD, role: CONTACT, email: evana.lopez@ki.se, contacts name: Carl-Johan Ekman, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.33258, lon: 18.0649, locations facility: Psykiatriska Kliniken, Akademiska Sjukhuset, status: RECRUITING, city: Uppsala, country: Sweden, contacts name: Evana Lopez, role: CONTACT, email: evana.lopez@ki.se, contacts name: robert Bodén, MD PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.85882, lon: 17.63889, locations facility: Örebro sjukhus, status: RECRUITING, city: Örebro, country: Sweden, contacts name: Axel Nordenskjöld, MD PhD, role: CONTACT, contacts name: Evana Lopez, MD, role: CONTACT, email: evana.lopez@ki.se, contacts name: axel Nordenskjöld, MD PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 59.27412, lon: 15.2066, hasResults: False
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protocolSection identificationModule nctId: NCT06319365, orgStudyIdInfo id: gurcansolmaz, briefTitle: Yoga on Women's Blood Pressure, Sexual Life, And Marital Compliance, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-01, primaryCompletionDateStruct date: 2024-03-22, completionDateStruct date: 2024-03-22, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-25, sponsorCollaboratorsModule leadSponsor name: University of Yalova, class: OTHER, descriptionModule briefSummary: Introduction This study will examine the effects of a 12-week yoga program consisting of one-hour sessions three times a week on blood pressure, sexual life and marital adjustment among hypertensive women. Hypertension can adversely affect vascular health and affect marital relationships by contributing to sexual dysfunction.Method. The study will be a pre-post test randomized controlled study in accordance with CONSORT rules. Personal Information Form, Bloood pressure measurement, Arizona Sexual Experience Scale and Marital Adjustment Test will be used for data collection., conditionsModule conditions: Hypertension, conditions: Sexuality, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: yoga, outcomesModule primaryOutcomes measure: blood presure, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yalova University, status: RECRUITING, city: Yalova, country: Turkey, contacts name: GÜRCAN SOLMAZ, role: CONTACT, email: gurcansolmaz@hotmail.com, geoPoint lat: 40.65501, lon: 29.27693, hasResults: False
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protocolSection identificationModule nctId: NCT06319352, orgStudyIdInfo id: HUM00243293, briefTitle: Evaluation of Quality-of-Life Improvements Using UroShield Device, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-31, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University of Michigan, class: OTHER, collaborators name: Nanovibronix, descriptionModule briefSummary: The goal of this pilot study is to test key elements of the full study that will follow, including recruitment and retention strategies, intervention delivery, laboratory testing, data collection methods, and adherence to study protocol.The main questions the investigators aim to answer focus on implementation and practicality:* Recruitment feasibility and time to recruit* How well do participants adhere to device protocol?* How often do device components (i.e., actuators and drivers) have to be replaced?* How much time is required for data collection and what sources or methods for data collection are used?Results of this pilot study will inform the investigators as to necessary protocol modifications and overall feasibility for the larger randomized clinical trial to follow., conditionsModule conditions: Quality of Life, conditions: Catheter-Associated Urinary Tract Infection, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: Active UroShield, interventions name: Sham UroShield, outcomesModule primaryOutcomes measure: Recruitment rate, secondaryOutcomes measure: Device use adherence, secondaryOutcomes measure: Device accountability, secondaryOutcomes measure: Efficiency of data collection, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06319339, orgStudyIdInfo id: 0419-23-FB, briefTitle: Impact of Nrf2 Activation on Macrovascular, Microvascular & Leg Function & Walking Capacity in Peripheral Artery Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: University of Nebraska, class: OTHER, descriptionModule briefSummary: Purpose: Peripheral artery disease (PAD) is associated with elevated oxidative stress, and oxidative stress has been implicated as the cause of reduced endothelial reactivity in individuals with PAD. Endothelial function is important because the endothelium contributes to the dilation of arteries during exercise, thereby implicating impaired endothelial function as a mechanism contributing to exacerbated exercise-induced ischemia. Therefore, the purpose of this study is to test the hypothesis that acute exogenous diroximel fumarate (Vumerity) intake will improve antioxidant capacity, thereby reducing oxidative stress and improving vascular function and walking capacity in those with PAD. Eligibility: Individuals with PAD will be deemed eligible for this study if they 1) are 50-75 years old and postmenopausal, 2) have a positive history of exercise-limiting claudication (Fontaine II or III), 3) do not have renal impairments, 4) do not have Fontaine stage IV PAD, and 5) are not currently pregnant or nursing. Age-matched controls will be deemed eligible for this study if they 1) are 50-75 years old and postmenopausal, 2) have an ABI greater than 0.9 (no PAD), 3) do not have exercise-limiting diseases or injuries, 4) do not have renal impairments, and 5) are not currently pregnant or nursing. Intervention and Evaluation: During this study, participants will be administered diroximel fumarate or a placebo, and the acute effects of diroximel fumarate on vascular function and walking capacity will be assessed. Vascular function and walking capacity will be assessed with flow-mediated dilation, arterial stiffness, head-up tilt test, blood biomarkers, near-infrared spectroscopy, and a treadmill test. Follow-up: There will be a follow-up visit to assess blood work after diroximel fumarate., conditionsModule conditions: Peripheral Artery Disease, conditions: Peripheral Vascular Diseases, conditions: Peripheral Arterial Disease, conditions: Peripheral Arterial Occlusive Disease, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: There will be a peripheral artery disease (PAD) group and an age-matched healthy control group. Within each of these groups will be a 1:1 randomized, crossover, double-blinded study., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Double-blinded study, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Vumerity, interventions name: Placebo, outcomesModule primaryOutcomes measure: Macrovascular Endothelial Function, primaryOutcomes measure: Oxygen Transfer and Utilization, primaryOutcomes measure: Femoral and Popliteal Artery Blood Flow, primaryOutcomes measure: Walking capacity, secondaryOutcomes measure: Autonomic Nervous Activity, secondaryOutcomes measure: Arterial Stiffness, secondaryOutcomes measure: Circulating blood markers of Oxidative Stress and Antioxidants, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Nebraska - Omaha, city: Omaha, state: Nebraska, zip: 68182, country: United States, contacts name: Song-Young Park, PhD, role: CONTACT, phone: 402-554-3374, email: song-youngpark@unomaha.edu, geoPoint lat: 41.25626, lon: -95.94043, hasResults: False
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protocolSection identificationModule nctId: NCT06319326, orgStudyIdInfo id: Postfeed Intestinal Perfusion, briefTitle: Intestinal Perfusion After Feeding in Preterm and Term Infants, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-02, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-08-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: The Hospital for Sick Children, class: OTHER, collaborators name: Xiamen Children's Hospital, descriptionModule briefSummary: This is a pilot exploratory observational prospective cohort phase I study. In this study, we will gather preliminary data to evaluate (i) the magnitude of changes in blood flow in the bowel before and after feeding and (ii) the differences between preterm and term infants., conditionsModule conditions: Premature, conditions: Necrotizing Enterocolitis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Evaluation of intestinal perfusion with color Doppler abdominal ultrasound before and after feeding., outcomesModule primaryOutcomes measure: Time-averaged mean velocity of the superior mesenteric artery, secondaryOutcomes measure: Bowel wall perfusion, eligibilityModule sex: ALL, maximumAge: 4 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: Children's Hospital of Fudan University (Xiamen Branch), city: Xiamen, state: Fujian, zip: 361000, country: China, contacts name: Haitao Zhu, MD, role: CONTACT, phone: +86-592-2529586, email: haitao_zhu@fudan.edu.cn, contacts name: Haitao Zhu, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 24.47979, lon: 118.08187, hasResults: False
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protocolSection identificationModule nctId: NCT06319313, orgStudyIdInfo id: JMT101-013, briefTitle: Efficacy and Safety of JMT101 Combined Wth Docetaxel / HB1801 in Patients With Squamous Cell Non-Small Cell Lung Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-07-01, completionDateStruct date: 2027-12-01, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Shanghai JMT-Bio Inc., class: INDUSTRY, descriptionModule briefSummary: This study is a phase II/III, randomized, controlled, open-label, multi-center study with safety run-in to evaluate the efficacy and safety of JMT101 combined with docetaxel/ HB1801 in Patients with Squamous cell non-small cell lung cancer （sqNSCLC）., conditionsModule conditions: Squamous Cell Non-small Cell Lung Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 534, type: ESTIMATED, armsInterventionsModule interventions name: JMT101, interventions name: docetaxel, interventions name: HB1801, outcomesModule primaryOutcomes measure: Overall response rate (ORR), primaryOutcomes measure: Overall Survival (OS), primaryOutcomes measure: Incidence and severity of adverse events (AE) and serious adverse events (SAE), secondaryOutcomes measure: Progression-free Survival (PFS), secondaryOutcomes measure: Disease Control Rate (DCR), secondaryOutcomes measure: Duration of response（DOR）, secondaryOutcomes measure: JMT101 Concentrations in Plasma, secondaryOutcomes measure: Total and Free Docetaxel Concentrations in Plasma, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06319300, orgStudyIdInfo id: 20240115023245436, briefTitle: Artificial Intelligence-assisted Insulin System in Type 2 Diabetes in General Wards, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-19, primaryCompletionDateStruct date: 2026-03-20, completionDateStruct date: 2026-05-20, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Shanghai Zhongshan Hospital, class: OTHER, collaborators name: Shanghai Fifth People's Hospital,Fudan University, descriptionModule briefSummary: Our study was a single-blind, randomised, controlled, multicentre study. The study was planned to include 140 patients admitted to the general ward for subcutaneous insulin therapy, who were randomly divided into two groups in the ratio of 1:1, one group with an artificial intelligence assisted insulin dosimetry system to adjust the insulin dose to control their blood glucose, and the other group with a physician instituted insulin dosimetry adjustments to control their blood glucose. The effectiveness and safety of the system was confirmed by comparing the glycaemic control and risk of adverse events between the two groups., conditionsModule conditions: Diabetes Type 2, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: AI-assisted insulin dose adjustment model, interventions name: doctor's insulin dose adjustment, outcomesModule primaryOutcomes measure: time in target range (3.9-10.0 mmol/L ), secondaryOutcomes measure: sensor glucose, secondaryOutcomes measure: capillary blood sugar, secondaryOutcomes measure: hypoglycaemic event, secondaryOutcomes measure: hyperglycaemic event, secondaryOutcomes measure: insulin dosage, secondaryOutcomes measure: satisfaction score of doctors, secondaryOutcomes measure: Length of hospitalisation, secondaryOutcomes measure: Other/Serious Adverse Events, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zhongshan Hospital, Fudan University, status: RECRUITING, city: Shanghai, state: Shanghai, zip: 200032, country: China, contacts name: Xiaoying Li, role: CONTACT, phone: +862164041990, email: li.xiaoying@zs-hospital.sh.cn, geoPoint lat: 31.22222, lon: 121.45806, hasResults: False
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protocolSection identificationModule nctId: NCT06319287, orgStudyIdInfo id: PRO-00125, briefTitle: Phase 2a Multi-Center Prospective, Randomized Trial to Evaluate the Safety & Efficacy of Topical PEP-TISSEEL for Diabetic Foot Ulcers (DFU), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-27, primaryCompletionDateStruct date: 2025-04-05, completionDateStruct date: 2025-07-12, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Rion Inc., class: INDUSTRY, collaborators name: Professional Education and Research Institute, descriptionModule briefSummary: A Phase 2a Multi-Center, Prospective, Randomized, Controlled Study to Evaluate the Safety and Efficacy of Topically Applied PEP-TISSEEL in Subjects with Diabetic Foot Ulcers (DFU), conditionsModule conditions: Diabetic Foot Ulcer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Multi-center, Open Label, Randomized Controlled Clinical Trial Evaluating the Effect of PEP/TISSEEL in the Treatment of Diabetic Foot Ulcers, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Open Label, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: PEP (Purified Exosome Product) / TISSEEL, outcomesModule primaryOutcomes measure: Wound Closure, primaryOutcomes measure: Safety, secondaryOutcomes measure: Percent Area Reduction of Wound at 12 Weeks, otherOutcomes measure: Visual Analogue Scale (VAS) for Pain over 12 weeks, otherOutcomes measure: Semmes-Weinstein Score, otherOutcomes measure: Wound-Q Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Professional Education & Research Institute (PERI), status: RECRUITING, city: Blue Ash, state: Ohio, zip: 45242, country: United States, contacts name: Charles Zelen, M.D., role: CONTACT, phone: 540-344-3668, email: cmzelen@mriedu.com, contacts name: Morgan Zelen, role: CONTACT, phone: 203-671-5915, email: mzelen@periedu.com, geoPoint lat: 39.232, lon: -84.37827, hasResults: False
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protocolSection identificationModule nctId: NCT06319274, orgStudyIdInfo id: COMBAT-ARF, briefTitle: Infusion of Prostacyclin vs Placebo for 72-hours in Mechanically Ventilated Patients With Acute Respiratory Failure, acronym: COMBAT-ARF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-12-30, completionDateStruct date: 2026-12-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Pär Johansson, class: OTHER, descriptionModule briefSummary: The purpose of this clinical trial is to investigate the efficacy and safety of continuous intravenous administration of low dose iloprost versus placebo for 72-hours, in 450 mechanically ventilated patients with infectious respiratory failure. The study hypothesis is that iloprost may be beneficial as an endothelial rescue treatment as it is anticipated to deactivate the endothelium and restore vascular integrity in patients suffering from respiratory failure caused by endothelial breakdown, ultimately improving survival., conditionsModule conditions: Acute Respiratory Failure, conditions: Endothelial Dysfunction, conditions: Pulmonary Infection, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomization active/placebo (1:1) parallel arms, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) The preparation will be done by an unblinded study nurse independent of the including ICU´s, who will be responsible for preparing the investigational drug to be administered in a blinded fashion. Iloprost is a colorless fluid that is to be diluted in 0.9% saline. The infusion pump containing diluted active drug and placebo will be identical in both looks and behavior., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 450, type: ESTIMATED, armsInterventionsModule interventions name: Iloprost, interventions name: Isotonic saline, outcomesModule primaryOutcomes measure: 28-day mortality, secondaryOutcomes measure: 90-day mortality, secondaryOutcomes measure: Vasopressor-free days, secondaryOutcomes measure: Renal replacement-free days, secondaryOutcomes measure: Mechanical ventilation free days, secondaryOutcomes measure: Serious adverse reactions (SARs), secondaryOutcomes measure: Serious adverse events (SAEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dept. of Anaesthesia and Intensive Care, Bispebjerg Hospital, city: Copenhagen, zip: 2400, country: Denmark, contacts name: Niels E Clausen, MD, role: CONTACT, contacts name: Niels E Clausen, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.67594, lon: 12.56553, locations facility: Dept. of Intensive Care, Copenhagen University Hospital Herlev, city: Herlev, zip: 2730, country: Denmark, contacts name: Peter Soee-Jensen, MD, role: CONTACT, contacts name: Peter Soee-Jensen, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.72366, lon: 12.43998, locations facility: Dept. of Anaesthesia and Intensive Care, Nordsjaelands Hospital, city: Hillerød, zip: 3400, country: Denmark, contacts name: Morten Bestle, MD, role: CONTACT, contacts name: Morten Bestle, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.92791, lon: 12.30081, locations facility: Department of Anesthesia and Intensive Care Medicine, Zealand University Hospital, city: Køge, zip: 4600, country: Denmark, contacts name: Lars Peter K Andersen, MD, PhD, role: CONTACT, contacts name: Lars Peter K Andersen, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.45802, lon: 12.18214, hasResults: False
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protocolSection identificationModule nctId: NCT06319261, orgStudyIdInfo id: 858623, briefTitle: Efficacy of Guided Biofilm Therapy (GBT) for Treatment of Deep Periodontal Pockets., statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-10, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: University of Baghdad, class: OTHER, descriptionModule briefSummary: the aim of the study is to evaluate the efficacy of guided biofilm therapy (GBT) for treatment of deep periodontal pockets.the objectives are1- To compare the change in the clinical periodontal parameters and microbiological parameters by using real time PCR for P. gingivalis, Aggregatibacter actinomycetemcomitans and Filifactor alocis among sites treated by GBT and conventional hand instrumentation after a period of 3 months and to assess the level of the selected periodontal pathogens in deep periodontal pockets and to estimate and compare deep periodontal pockets which need surgery after 3 months of non-surgical treatment by GBT and conventional hand instrumentation.the hypothesis is whether there are no differences in in the clinical and microbiological parameters among sites treated by GBT and conventional hand instrumentation after a period of 3 months or there are differences in in the clinical and microbiological parameters among sites treated by GBT and conventional hand instrumentation after a period of 3 months.The participants will be selected on a consecutive basis from patients referred to the Department of Periodontics, College of Dentistry, University of Baghdad.For each patient, each site will be randomly assigned to either treatment protocol:1. Sites treated with GBT.2. Sites treated with conventional manual instrumentation only., conditionsModule conditions: Periodontitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: guided biofilm therapy, interventions name: root surface debridement, outcomesModule primaryOutcomes measure: Periodontal pocket depth (PPD), secondaryOutcomes measure: Plaque index, secondaryOutcomes measure: Bleeding on probing, secondaryOutcomes measure: Relative attachment level, secondaryOutcomes measure: Changes in the bacterial load, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06319248, orgStudyIdInfo id: 24-000121, briefTitle: Use of Midodrine in Septic Shock Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2029-05-30, completionDateStruct date: 2029-07-30, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, descriptionModule briefSummary: This study is being done to determine if early administration of Midodrine can improve outcomes by maintaining a higher mean blood pressure off of intravenous medications. Researchers want to see if Midodrine can help people with sepsis need fewer vasopressors, which could mean shorter hospital stays, less time with uncomfortable tubes, and a smoother recovery overall., conditionsModule conditions: Sepsis, conditions: Low Blood Pressure, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 270, type: ESTIMATED, armsInterventionsModule interventions name: Midodrine, interventions name: Placebo, outcomesModule primaryOutcomes measure: Time alive and without vasopressor support, secondaryOutcomes measure: Total vasopressor requirements, secondaryOutcomes measure: Central venous access duration, secondaryOutcomes measure: Cumulative fluid balance over the first 48 hours, secondaryOutcomes measure: Cumulative fluid balance up to 7 days of ICU stay, secondaryOutcomes measure: ICU Length of Stay, secondaryOutcomes measure: Hospital Length of Stay, secondaryOutcomes measure: ICU, hospital, and organ support-free days, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic Minnesota, city: Rochester, state: Minnesota, zip: 55905, country: United States, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False
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protocolSection identificationModule nctId: NCT06319235, orgStudyIdInfo id: DUO2022_01, secondaryIdInfos id: 2022-002412-23, type: EUDRACT_NUMBER, briefTitle: Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG®, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-27, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: MB PHARMA s.r.o., class: INDUSTRY, descriptionModule briefSummary: DUOFAG® is a phage cocktail containing bacteriophages active against Staphylococcus aureus and Pseudomonas aeruginosa. It is an investigational medicinal product for the treatment of surgical site infections caused by S. aureus and P. aeruginosa.The primary objective of the study is to demonstrate the safety of DUOFAG® and the clinical and microbiological change within 10 weeks after the start of treatment or until healing., conditionsModule conditions: Surgical Site Infection, conditions: Staphylococcus Aureus Infection, conditions: Pseudomonas Aeruginosa Infection, conditions: Bacterial Infections, conditions: Surgical Wound Infection, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 52, type: ESTIMATED, armsInterventionsModule interventions name: IMP, interventions name: Placebo, outcomesModule primaryOutcomes measure: Primary endpoint - Cohort 1, primaryOutcomes measure: Primary endpoint - pooled Cohorts 1 & 2, secondaryOutcomes measure: Safety endpoints (assessed in pooled Cohorts 1 & 2), secondaryOutcomes measure: Microbiological endpoints (assessed in pooled Cohort 1 and Cohort 2), secondaryOutcomes measure: Clinical efficacy endpoints, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: St. Anne's University Hospital Brno, status: RECRUITING, city: Brno, state: Czech Republic, zip: 602 00, country: Czechia, contacts name: Dominik Maduda, MUDr., role: CONTACT, phone: +420 543 182 432, email: dominik.maduda@fnusa.cz, contacts name: Kateřina Bílá, MUDr., role: CONTACT, phone: +420 543 182 451, email: katerina.bila@fnusa.cz, geoPoint lat: 49.19522, lon: 16.60796, hasResults: False
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protocolSection identificationModule nctId: NCT06319222, orgStudyIdInfo id: 23-007870, briefTitle: Implementation of a Digital Clinic for Alcohol-associated Liver Disease and Alcohol Use Disorder (DALC), acronym: DALC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-12, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-04-01, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, collaborators name: Ria Health, descriptionModule briefSummary: The purpose of this study is to determine whether a multidisciplinary digital clinic will improve health outcomes, reduce costs, increase access, and improve provider satisfaction.The primary aim of this study is to improve clinical outcomes in patients with ALD through the implementation of a novel digital health platform for personalized multi-disciplinary treatment of patients with ALD and AUD. Secondary aims include improvement in provider and patient-reported outcomes including satisfaction with AUD treatment., conditionsModule conditions: Alcohol Use Disorder, conditions: Liver Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: DALC Digital Clinic, outcomesModule primaryOutcomes measure: Median delta MELD-3.0 from baseline to end of study., secondaryOutcomes measure: Sustained alcohol abstinence, secondaryOutcomes measure: Reduction of Number of hospitalizations, secondaryOutcomes measure: Greater provider satisfaction in DALC arm, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic Arizona, status: RECRUITING, city: Scottsdale, state: Arizona, zip: 85259, country: United States, contacts name: Blanca C Lizaola-Mayo, MD, role: CONTACT, phone: 480-342-1094, email: dalc@mayo.edu, geoPoint lat: 33.50921, lon: -111.89903, locations facility: Mayo Clinic, status: RECRUITING, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Douglas Simonetto, MD, role: CONTACT, phone: 507-284-1649, email: dalc@mayo.edu, contacts name: Camille Kezer, MD, role: CONTACT, phone: 507-284-2687, email: dalc@mayo.edu, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False
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protocolSection identificationModule nctId: NCT06319209, orgStudyIdInfo id: 2024KY023, briefTitle: Timing of Surgery and the Evolution of Postoperative Outcomes in Breast Cancer Patients Undergoing Surgical Intervention Following Recovery From SARS-CoV-2 Infection, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2023-03-31, completionDateStruct date: 2024-03-31, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Fujian Medical University Union Hospital, class: OTHER, descriptionModule briefSummary: Perioperative SARS-CoV-2 infection significantly increases the risk of postoperative complications and mortality, while also exerting long-lasting impacts on multiple organs and systems. Due to the curtailment or cessation of non-emergency surgeries during the initial phase of the pandemic, there is a lack of evidence regarding the optimal timing and medium- to long-term postoperative outcomes of surgical intervention in breast cancer patients with prior SARS-CoV-2 infection, particularly after vaccination. We aim to investigate whether prior SARS-CoV-2 infection increases the risk of postoperative adverse outcomes in breast cancer patients and determine the optimal timing for surgical intervention during the pandemic, as well as to longitudinally assess the evolution of postoperative adverse outcomes within one year after COVID-19 and identify associated risk factors., conditionsModule conditions: Breast Cancer, conditions: COVID-19, conditions: Postoperative Complications, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 392, type: ACTUAL, armsInterventionsModule interventions name: Preoperative resolved COVID-19, outcomesModule primaryOutcomes measure: 30-day postoperative outcomes, secondaryOutcomes measure: Postoperative outcomes at the time of the initial tumor assessment after surgery, secondaryOutcomes measure: 12-month postoperative outcomes, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fujian Medical University Union Hospital, city: Fuzhou, state: Fujian, country: China, geoPoint lat: 26.06139, lon: 119.30611, hasResults: False
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protocolSection identificationModule nctId: NCT06319196, orgStudyIdInfo id: Clear Me, briefTitle: Clear Me: Interception Trial to Detect and Clear Molecular Residual Disease in Patients With High-risk Melanoma, acronym: ClearMe, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-02-15, completionDateStruct date: 2030-02-15, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University Health Network, Toronto, class: OTHER, descriptionModule briefSummary: Clear-Me is a biomarker-driven phase II study that tests whether the combination anti- lymphocyte-activation gene-3 (LAG3)/anti-programmed cell death protein 1(PD-1) inhibition Bristol-Myers Squibb (BMS986213) is superior to anti-PD-1 inhibition in patients with detectable circulating tumor deoxyribonucleic acid (ctDNA) following definitive surgery for high risk melanoma. Patients will be allocated to either Arm A or Arm B via the process of randomization. The randomization process will be stratified according to stage (Stage 2A/2B/3A/3B/3C/3D or 4), to ensure absolute balance between stage groups. The investigators are choosing only 1 stratification factor, disease stage, as the investigators consider stage being the most significant prognosticating variable. Each stage represents a biologically distinct entity with varying recurrence rate outcomes. Block randomization will be performed to ensure equal sample sizes in the combination and monotherapy arms. At least 54 patients will be included in the randomized part of the study. The investigators are expecting approximately 20% of the patients to have detectable ctDNA after definite surgery. Therefore, approximately 270 patients are expected to be enrolled and tested for ctDNA in the entire study., conditionsModule conditions: Cutaneous Melanoma, conditions: Melanoma Stage IV, conditions: Mucosal Melanoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: Opdualag, interventions name: Nivolumab, outcomesModule primaryOutcomes measure: Clearance of ctDNA at 12 months after starting adjuvant treatment. ctDNA clearance is defined as no detection of plasma ctDNA, secondaryOutcomes measure: Recurrence-free survival (RFS), secondaryOutcomes measure: Number and severity of treatment related adverse events according to CTCAE v5.0., otherOutcomes measure: Clearance of ctDNA, otherOutcomes measure: Measured changes of biomarker ctDNA, otherOutcomes measure: Methylation patterns of biomarker ctDNA using circulating free methylated DNA immunoprecipitation and sequencing (cfMeDIPseq) assay and correlation with ctDNA total variant allele frequency (VAF) detection., otherOutcomes measure: Quality of life assessment using Quality of Life Questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UHN- Princess Margaret Cancer Center, status: RECRUITING, city: Toronto, state: Ontario, zip: M5G 1Z5, country: Canada, contacts name: Anna Spreafico, MD, role: CONTACT, phone: 416-946-2263, email: anna.spreafico@uhn.ca, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False
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protocolSection identificationModule nctId: NCT06319183, orgStudyIdInfo id: 2023tjdxsy045, briefTitle: The Regulatory Function of Inhaled Asthma Medication Salbutamol on Thermogenesis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Tongji University, class: OTHER, descriptionModule briefSummary: In recent years, obesity and its complications have severely threatened human health. Given the limited options for obesity treatment currently available, there is an urgent need to develop new drugs and therapeutic methods to alleviate patient suffering.Mammalian adipose tissue is primarily divided into energy-storing white fat and energy-consuming brown fat. Physical activity, exposure to cold, and other factors induce the transformation of white fat into energy-consuming brown fat, a process known as adipose tissue browning. The occurrence of adipose tissue browning increases the body's energy expenditure and dissipates it in the form of heat, effectively mitigating the onset of obesity. Therefore, the regulatory mechanism of adipose tissue browning has become an important potential target for obesity treatment.The main component of asthma medication is the β2 adrenergic receptor agonist, which can act on GPCR receptors on the surface of the tracheal smooth muscle through inhalation, causing bronchial dilation and thereby alleviating asthma symptoms. Preliminary experimental results have shown that pulmonary epithelial cells can secrete protein factors that regulate the browning process of adipose tissue, and the expression of these secretory factors is regulated by the cell surface GPCR receptor signaling pathway. Therefore, our goal is to validate the regulatory effect of the asthma medication salbutamol on adipose tissue browning through inhalation administration in humans, establishing a new function for asthma medication in obesity treatment., conditionsModule conditions: Effect of Asthma Medication Salbutamol on Obesity, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Salbutamol, outcomesModule primaryOutcomes measure: Temperature of Scapular Region, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06319170, orgStudyIdInfo id: TV44749-NPC-10205, briefTitle: Open-label Trial Characterizing the PK of 3 SC Olanzapine Extended-release Formulations in Participants With Schizophrenia/Schizoaffective Disorder, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-28, primaryCompletionDateStruct date: 2024-12-11, completionDateStruct date: 2024-12-11, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Teva Branded Pharmaceutical Products R&D, Inc., class: INDUSTRY, descriptionModule briefSummary: The primary objective of the study is to characterize the pharmacokinetics of 3 formulations of olanzapine.A secondary objective is to evaluate the safety and tolerability of 3 formulations of olanzapine.Another secondary objective is to characterize the pharmacokinetics of ZYPREXA.The planned duration of the study for each participant is 19 weeks., conditionsModule conditions: Schizophrenia, Schizoaffective Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 95, type: ESTIMATED, armsInterventionsModule interventions name: Olanzapine Extended Release, interventions name: Olanzapine, outcomesModule primaryOutcomes measure: Maximum observed plasma drug concentration (Cmax), primaryOutcomes measure: Area under the plasma drug concentration-time curve (AUC), primaryOutcomes measure: AUC extrapolated to infinity (AUC0-∞), secondaryOutcomes measure: Number of participants with at least 1 treatment-emergent adverse event (TEAE), secondaryOutcomes measure: Number of participants with at least 1 serious adverse event (SAE), secondaryOutcomes measure: Cmax of ZYPREXA, secondaryOutcomes measure: AUC of ZYPREXA, secondaryOutcomes measure: Apparent plasma terminal elimination rate constant (λz) of ZYPREXA, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 64 Years, stdAges: ADULT, contactsLocationsModule locations facility: Teva Investigational Site 15727, status: RECRUITING, city: Hollywood, state: Florida, zip: 33024, country: United States, geoPoint lat: 26.0112, lon: -80.14949, locations facility: Teva Investigational Site 15726, status: RECRUITING, city: Marlton, state: New Jersey, zip: 08053, country: United States, geoPoint lat: 39.89122, lon: -74.92183, hasResults: False
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protocolSection identificationModule nctId: NCT06319157, orgStudyIdInfo id: SYSKY-2023-1263-02, briefTitle: Minimal Access Versus Conventional Latissimus Dorsi Flap Harvest for Breast Reconstruction, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2028-11, completionDateStruct date: 2028-11, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, class: OTHER, descriptionModule briefSummary: For patients refusing implants for breast reconstruction after cancer surgery, autologous tissue flap reconstruction using the latissimus dorsi muscle is an alternative. Conventional surgery leaves a long incision on the back, affecting aesthetics and quality of life. Minimal access techniques result in a smaller, more concealable scar. While previous studies suggest its safety and effectiveness, most are retrospective. To further validate patient satisfaction and short-term outcomes, a prospective, randomized controlled trial comparing minimal access with conventional surgery is planned. The primary endpoint is Breast Q-satisfaction with back score at 6 months. Secondary outcomes include other Breast Q subscales, surgical metrics, and complications. The study aims to enroll 94 patients in total, providing evidence for surgical decision-making in breast cancer reconstruction., conditionsModule conditions: Breast Neoplasms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 94, type: ESTIMATED, armsInterventionsModule interventions name: minimal access breast reconstruction with a latissimus dorsi muscle flap, interventions name: conventional breast reconstruction with a latissimus dorsi muscle flap, outcomesModule primaryOutcomes measure: Breast Q-satisfaction with back, secondaryOutcomes measure: Patient satisfaction, secondaryOutcomes measure: Latissimus dorsi acquisition time, secondaryOutcomes measure: Intraoperative blood loss, secondaryOutcomes measure: Postoperative pain, secondaryOutcomes measure: Postoperative complications, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510120, country: China, contacts name: Shicheng Su, M.D., Ph.D., role: CONTACT, phone: +86 13632394954, email: lnl_trial@126.com, contacts name: Erwei Song, M.D., Ph.D., role: CONTACT, phone: +86 13719237746, email: lnl_trial@126.com, geoPoint lat: 23.11667, lon: 113.25, hasResults: False
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protocolSection identificationModule nctId: NCT06319144, orgStudyIdInfo id: KYLL20240306-1, briefTitle: Effect of Intravenous 5% Dextrose Infusion During Recovery From Anesthesia on the Quality of Early Postoperative Recovery in Patients Undergoing Painless Gastrointestinal Endoscopy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-14, primaryCompletionDateStruct date: 2024-03-14, completionDateStruct date: 2024-05-05, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Weifang Medical University, class: OTHER, descriptionModule briefSummary: The aim of this study was to determine the effect of intravenous infusion of 5% dextrose injection during the recovery period of anesthesia for painless gastroenteroscopy on the patient's blood glucose level, incidence of hypoglycemia and time of awakening from anesthesia, postoperative vertigo, postoperative nausea and vomiting, and quality of recovery in the early postoperative period., conditionsModule conditions: Insulin Resistance, conditions: Postoperative Nausea and Vomiting, conditions: Quality of Recovery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: 5% glucose, interventions name: 0.9% Normal Saline, outcomesModule primaryOutcomes measure: Preoperative blood glucose 30min, primaryOutcomes measure: Postoperative blood glucose 30min, primaryOutcomes measure: Postoperative nausea and vomiting, primaryOutcomes measure: Postoperative nausea and vomiting, primaryOutcomes measure: Postoperative nausea and vomiting, primaryOutcomes measure: Postoperative nausea and vomiting, secondaryOutcomes measure: Anesthesia awakening time, secondaryOutcomes measure: Dizziness level, secondaryOutcomes measure: Dizziness level, secondaryOutcomes measure: Dizziness level, secondaryOutcomes measure: Quality of postoperative recovery (QoR40), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lin Cheng, status: RECRUITING, city: Weifang, state: Shandong, zip: 261041, country: China, contacts name: Lin Cheng, B.S, role: CONTACT, phone: 17667404256, email: 1318216353@qq.com, geoPoint lat: 36.71, lon: 119.10194, hasResults: False
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protocolSection identificationModule nctId: NCT06319131, orgStudyIdInfo id: Tipharosis, briefTitle: Nadroparin Versus TIPS in Cirrhotic Patients With Refractory Asymptomatic PVT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-30, completionDateStruct date: 2026-05-30, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Shanghai Zhongshan Hospital, class: OTHER, collaborators name: Shanghai 6th People's Hospital, collaborators name: ShuGuang Hospital, collaborators name: Tongji Hospital, collaborators name: Renmin Hospital of Wuhan University, descriptionModule briefSummary: The purpose of this study is to evaluate the comparative effectiveness of nadroparin versus transjugular intrahepatic portosystemic shunt in cirrhotic patients with refractory asymptomatic portal vein thrombosis using a design of a multicenter, randomized controlled trial, conditionsModule conditions: Portal Vein Thrombosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 84, type: ESTIMATED, armsInterventionsModule interventions name: TIPS, interventions name: Nadroparin, outcomesModule primaryOutcomes measure: complete recanalization rate of PVT, secondaryOutcomes measure: partial recanalization rate of PVT, secondaryOutcomes measure: Bleeding rate, secondaryOutcomes measure: Mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06319118, orgStudyIdInfo id: JD-LK2023091-I01, briefTitle: A Clinical Study of Dihydroergotine Mesylate Extended-release Tablets for the Treatment of Drooling in Parkinson's Disease., statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-10-01, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Second Affiliated Hospital of Soochow University, class: OTHER, descriptionModule briefSummary: Objective: To evaluate the efficacy and safety of dihydroergotine mesylate extended-release tablets for salivation in Parkinson\'s disease Study content: Using a randomized, double-blind, placebo-controlled study design, 120 patients with Parkinson\'s disease and cognitive impairment were enrolled, and the treatment was followed up for 12 weeks: dihydroergotine mesylate sustained-release tablets + conventional treatment (treatment group patients, 80 cases), placebo + conventional treatment (control group patients, 40 cases), and the main indicators were observed: the improvement effect of dihydroergotine mesylate sustained-release tablets on PD salivation was observed, and the secondary indicators were observed: the effect of dihydroergotine mesylate sustained-release tablets on the cognitive function of PD patients was observed.Expected results: The improvement effect of dihydroergotine mesylate sustained-release tablets on PD salivation was significantly different from that of the placebo control group. The dihydroergotine mesylate sustained-release tablet group had a significant effect on the cognitive function of PD patients., conditionsModule conditions: Salivation in Parkinson's Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Placebo, interventions name: dihydroergotine mesylate sustained-release tablets, outcomesModule primaryOutcomes measure: the objective weight of saliva in patients with Parkinson's disease changed from baseline, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Second Arilliated Hospital of Soochow University, city: Suzhou, state: Jiangsu, zip: 215004, country: China, geoPoint lat: 31.30408, lon: 120.59538, hasResults: False
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protocolSection identificationModule nctId: NCT06319105, orgStudyIdInfo id: 775736, briefTitle: PathToScale: An Implementation Evaluation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-26, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Georgetown University, class: OTHER, collaborators name: AIDS Vaccine Advocacy Coalition, collaborators name: Centers for Disease Control and Prevention, collaborators name: Center for the Development of People, collaborators name: Cooper/Smith, collaborators name: Elizabeth Glaser Pediatric AIDS Foundation, collaborators name: Family Health Services, collaborators name: Healthqual, collaborators name: Johns Hopkins Research Project, Malawi, collaborators name: Johns Hopkins Bloomberg School of Public Health, collaborators name: Kamuzu University of Health Sciences, collaborators name: Blantyre District Health Office, Malawi, collaborators name: Lilongwe District Health Office, Malawi, collaborators name: Lighthouse Trust, collaborators name: Ministry of Health, Malawi, collaborators name: National AIDS Commission, Malawi, collaborators name: Pakachere Institute of Health and Development Communication, collaborators name: Partners in Hope, collaborators name: Population Services International, collaborators name: University of North Carolina, collaborators name: United States Agency for International Development (USAID), collaborators name: United States President's Emergency Plan for AIDS Relief, collaborators name: Quantitative Engineering Design, collaborators name: Clinton Health Access Initiative-Malawi, descriptionModule briefSummary: The purpose of this study is to evaluate the implementation and clinical outcomes of expanded pre-exposure prophylaxis delivery modalities and service delivery points offering long-acting injectable cabotegravir and oral pre-exposure prophylaxis to high-priority groups through diverse delivery channels., conditionsModule conditions: Oral Pre-exposure Prophylaxis (PrEP), conditions: Long-acting Injectable Cabotegravir for PrEP, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 9900, type: ESTIMATED, armsInterventionsModule interventions name: Standard intervention: Offer PrEP choice, outcomesModule primaryOutcomes measure: Pre-exposure prophylaxis uptake by modality, primaryOutcomes measure: Pre-exposure prophylaxis uptake by delivery channel, primaryOutcomes measure: Pre-exposure prophylaxis uptake by population, primaryOutcomes measure: Pre-exposure prophylaxis continuation by modality, primaryOutcomes measure: Pre-exposure prophylaxis continuation by delivery channel, primaryOutcomes measure: Pre-exposure prophylaxis continuation by population, primaryOutcomes measure: Rates of switching between oral and injectable pre-exposure prophylaxis, secondaryOutcomes measure: Implementation readiness, secondaryOutcomes measure: Pregnancy rates among long-acting injectable cabotegravir for pre-exposure prophylaxis users, secondaryOutcomes measure: Pregnancy outcomes among long-acting injectable cabotegravir for pre-exposure prophylaxis users, eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 110 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Community Health Science Unit, status: RECRUITING, city: Lilongwe, country: Malawi, contacts name: W Ozituosauka, role: CONTACT, geoPoint lat: -13.96692, lon: 33.78725, hasResults: False
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protocolSection identificationModule nctId: NCT06319092, orgStudyIdInfo id: 2023/175, briefTitle: Immersive Virtual Reality Version of the 6 Minute Pegboard and Ring Test, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-06-01, primaryCompletionDateStruct date: 2023-10-01, completionDateStruct date: 2023-12-01, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Gaziantep Islam Science and Technology University, class: OTHER, descriptionModule briefSummary: The 6 Minute Pegboard and Ring Test is a test applicable to the upper extremities. The upper extremity plays an important role in activities of daily living, especially in tasks related to reaching, grasping and holding objects. Various activities of daily living, such as combing hair, brushing teeth and picking up objects, require supported or unsupported upper limb activity. Therefore, evaluation of upper extremity function is important. In addition, it is a simple test, it is also seen as a game, its application is functional, and there is no need for expensive equipment. Its validity and reliability have been demonstrated only for patients with Chronic Obstructive Pulmonary Disease (COPD) and healthy adults. In addition, to the best of our knowledge, the suitability of this test in a virtual environment has not been evaluated in the literature. Therefore, the main aim of this study is to examine the applicability of this test in a virtual environment., conditionsModule conditions: Healthy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 30, type: ACTUAL, outcomesModule primaryOutcomes measure: 6 Minute Pegboard and Ring Test, primaryOutcomes measure: Immersive virtual reality version of the 6 Minute Pegboard and Ring Test, secondaryOutcomes measure: Quick Shoulder-Hand Syndromes Questionnaire, secondaryOutcomes measure: Assessment of handgrip, secondaryOutcomes measure: 9 Hole Peg Test, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gaziantep İslamic Science and Technology University, city: Gaziantep, state: Şahinbey, zip: 27000, country: Turkey, geoPoint lat: 37.05944, lon: 37.3825, hasResults: False
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protocolSection identificationModule nctId: NCT06319079, orgStudyIdInfo id: UCTH 2024, briefTitle: Effect of Consumption of a Milk Product Designed for Lactating Women on Human Milk Composition, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2027-07, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri, class: OTHER, descriptionModule briefSummary: Vulnerable populations, who have deficient diets, may produce human milk (HML) that is not adequate in all nutrients and this will have consequences on the growth and development of the child. In 2021 at IDIP, a specific milk product for pregnant and lactating women Super Mil Mamá ( SMM, whole milk powder fortified with multiple vitamins, minerals and DHA ) has been designed and developed as part of a key strategy to incorporate in public policies for the first 1000 days of life. However, the potential benefits of this product have not yet been evaluated at the population level.The main objective is to evaluate the effect of the consumption of a milk product (SMM) designed for lactating women on the composition of human milk and the nutritional status of iron and DHA in infant red blood cells in a vulnerable population through a randomized, triple-blind, controlled clinical trial.Specific objectives To compare the concentrations of DHA, Vitamins A, E, and D, Iron, Iodine, Zinc and Calcium in human milk before and after dietary supplementation with SMM.To compare the concentrations of DHA, Vitamins A, E, D and Zinc in blood and the nutritional status of maternal iron before and after dietary supplementation with SMM.To analyze the relationship between micronutrients measured in maternal blood and human milk after dietary supplementation with SMM.To compare the concentrations of micronutrients measured in blood and human milk in women who received SMM and those who received commercial milk (CM) at the end of supplementation.To compare the iron nutritional status and DHA content in red blood cells of infants of mothers who consumed SMM or LC.To evaluate the relationship between the concentration of micronutrients in human milk and infant growth during the first six months of life., conditionsModule conditions: Lactating Mothers, conditions: Infants, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, maskingDescription: The powder milk containers (both SMM and commercial milk) will be packaged by Addvance SA (in the Province of Santa Fe), each of the products will have a label that differentiates them but only the company Addvance SA will know that information. In this project, neither the participating mothers, researchers, and technical staff assigned to the project nor the professional who performs the data analysis knows what product each participant will receive., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Fortified powder milk, interventions name: Powder milk, outcomesModule primaryOutcomes measure: breast milk DHA concentration, primaryOutcomes measure: breast milk Vitamin A concentration, primaryOutcomes measure: breast milk Vitamin E concentration, primaryOutcomes measure: breast milk Vitamin D concentration, primaryOutcomes measure: breast milk Zinc concentration, primaryOutcomes measure: breast milk Calcium concentration, primaryOutcomes measure: breast milk Iron concentration, primaryOutcomes measure: breast milk Iodine concentration, secondaryOutcomes measure: mother red blood cell DHA concentration, secondaryOutcomes measure: mother Vit A concentration, secondaryOutcomes measure: mother Vit E concentration, secondaryOutcomes measure: mother Vit D concentration, secondaryOutcomes measure: mother Zinc concentration, secondaryOutcomes measure: mother hemoglobin concentration, secondaryOutcomes measure: mother serum ferritin concentration, secondaryOutcomes measure: child hemoglobin concentration, secondaryOutcomes measure: child serum ferritin concentration, secondaryOutcomes measure: child red blood cell DHA concentration, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06319066, orgStudyIdInfo id: RGNS65-152, briefTitle: Customized Foot Orthoses With Orthotic Wedges for Plantar Heel Pain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Mahidol University, class: OTHER, descriptionModule briefSummary: The present study will use a randomized controlled trial (RCT) to determine the effectiveness of customized foot orthosis (CFO) for the treatment of patients with PHP. Three treatment groups including the CFO without wedge, the CFO with wedge type 1 (W1), and the CFO with wedge type 2 (W2) will be randomly assigned to each participant by a computer-generated randomization. The opaque-sealed envelopes will be used to allocate the groups of participant., conditionsModule conditions: Foot Orthoses, conditions: Fasciitis, Plantar, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: The present study will use a randomized controlled trial (RCT) to determine the effectiveness of CFO for the treatment of patients with PHP. Three treatment groups including the CFO without wedge, the CFO with W1, and the CFO with W2 will be randomly assigned to each participant by a computer-generated randomization. The opaque-sealed envelopes will be used to allocate the groups of participant., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Participants will be allocated to the control (CFO without wedge) or experimental (CFO with W1 or W2) groups according to the seal-envelop randomization technique. Then, they will be assessed all outcomes for the baseline including pain intensity, foot function, plantar fascia thickness, balance outcomes, and gait parameters by the 2nd physical therapist. And the participants will receive the assigned treatment by the 1st physical therapist., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: orthotic wedge, interventions name: CFO, outcomesModule primaryOutcomes measure: Pain intensity and foot function, primaryOutcomes measure: Plantar Fascia Thickness, primaryOutcomes measure: Gait assessment, primaryOutcomes measure: Balance assessment, secondaryOutcomes measure: Low back and Lower-extremity pain, secondaryOutcomes measure: Transversus abdominis (TrA) Thickness, otherOutcomes measure: Subjective assessment, otherOutcomes measure: Physical assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06319053, orgStudyIdInfo id: NL85402.078.23, briefTitle: The Turbine-based Insufflator Safety and Feasibility Study, acronym: TBI, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-10, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Erasmus Medical Center, class: OTHER, collaborators name: Politecnico di Milano University, collaborators name: Health∼Holland, Topsector Life Sciences & Health, collaborators name: Spatium Medical B.V., collaborators name: IDE Group B.V., descriptionModule briefSummary: The turbine-based insufflator for minimal access surgery provides a new technological basis for minimal invasive surgery insufflation. Turbine technology permits highly accurate pressure control, an intra-abdominal volume that is dynamically adapted to ventilation, and oscillometric measurements of abdominal compliance. This first-in-human study aims to evaluate technologic feasibility in terms of pressure stability performance and the safety of the device., conditionsModule conditions: Laparoscopy, conditions: Pneumoperitoneum, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SEQUENTIAL, interventionModelDescription: Consecutive patients from who informed consent can be acquired. The number of twelve participants was determined in conjunction with the Ethical Board of Erasmus MC, primaryPurpose: DEVICE_FEASIBILITY, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Turbine-based insufflator, outcomesModule primaryOutcomes measure: Occurrence of (serious) adverse device effects [Safety and feasibility of the device], secondaryOutcomes measure: Observation of insufflation pressure stability by continuously monitoring and recording., secondaryOutcomes measure: Gas volume exchange, secondaryOutcomes measure: Estimation of the abdominal compliance, secondaryOutcomes measure: Intra-abdominal target pressure in relation to the abdominal compliance, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Erasmus MC, University Medical Center Rotterdam, status: RECRUITING, city: Rotterdam, state: Zuid Holland, zip: 3015 GD, country: Netherlands, contacts name: J. Vlot, MD, PhD, role: CONTACT, phone: +31107039568, email: john.vlot@erasmusmc.nl, contacts name: A.I. de Jong, MD, role: CONTACT, phone: +31107037641, email: a.i.dejong@erasmusmc.nl, geoPoint lat: 51.9225, lon: 4.47917, hasResults: False
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protocolSection identificationModule nctId: NCT06319040, orgStudyIdInfo id: MEDİPOL MEGA 1, briefTitle: The Effect Of Addıtıonal Surgery On Muscle Strength, Proprıoceptıon And Balance In Anterıor Crucıate Lıgament Surgery, statusModule overallStatus: COMPLETED, startDateStruct date: 2018-12-06, primaryCompletionDateStruct date: 2019-03-07, completionDateStruct date: 2019-06-07, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Medipol University, class: OTHER, descriptionModule briefSummary: Meniscal tears and RAMP lesions are frequently seen together with ACL injuries. The aim of this study was to evaluate the effects of meniscus repair and RAMP lesion repair ACL reconstruction surgery in terms of muscle strength, proprioception, and balance. In our study, the clinical outcomes of both anterior cruciate ligament reconstruction (ACLR), medial meniscus repair (MR) and RAMP lesion repair (RR) have been compared with those of isolated ACLR., conditionsModule conditions: Anterior Cruciate Ligament Injuries, conditions: Meniscus Lesion, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 45, type: ACTUAL, armsInterventionsModule interventions name: Muscle strength measurement, interventions name: Knee joint proprioception, interventions name: Balance, interventions name: Fall risk test, interventions name: Tegner Activity Level, interventions name: Lysholm Knee Scoring Scale, outcomesModule primaryOutcomes measure: muscle strength measurement, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Istanbul Medipol University, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06319027, orgStudyIdInfo id: EAF223, secondaryIdInfos id: NCI-2023-08557, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: EAF223, type: OTHER, domain: ECOG-ACRIN Cancer Research Group, secondaryIdInfos id: EAF223, type: OTHER, domain: CTEP, secondaryIdInfos id: U10CA180820, type: NIH, link: https://reporter.nih.gov/quickSearch/U10CA180820, briefTitle: Identifying Findings on Brain Scans That Could Help Make Better Predictions About Brain Cancer Progression, The GABLE Trial, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-12, primaryCompletionDateStruct date: 2027-05-31, completionDateStruct date: 2027-05-31, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: ECOG-ACRIN Cancer Research Group, class: NETWORK, descriptionModule briefSummary: This phase II trial studies whether different imaging techniques can provide additional and more accurate information than the usual approach for assessing the activity of tumors in patients with newly diagnosed glioblastoma. The usual approach for this currently is magnetic resonance imaging (MRI). This study is trying to learn more about the meaning of changes in MRI scans after treatment, as while the appearance of some of these changes may reflect progressing tumor, some may be due the treatment. Dynamic susceptibility contrast (DSC)-MRIs, along with positron emission tomography (PET) and/or magnetic resonance (MR) spectroscopy, may help doctors tell which changes are a reflection of the treatment and which changes may be due to progressing tumor., conditionsModule conditions: Glioblastoma, IDH-Wildtype, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging, interventions name: Fluciclovine F18, interventions name: Gadolinium-Chelate, interventions name: Magnetic Resonance Spectroscopy, interventions name: Positron Emission Tomography, outcomesModule primaryOutcomes measure: Overall survival (OS), primaryOutcomes measure: Event free survival (EFS), secondaryOutcomes measure: True disease progression and pseudo-progression (PsP), secondaryOutcomes measure: Progression-free survival (PFS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06319014, orgStudyIdInfo id: 23-001568, briefTitle: Physical Activity to Mitigate PreEclampsia Risk, acronym: PAMPER, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-31, primaryCompletionDateStruct date: 2026-04-01, completionDateStruct date: 2026-10-01, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: East Carolina University, class: OTHER, descriptionModule briefSummary: The purpose of this study is to compare the effects of aerobic (AE), resistance (RE), and combination (AERE) exercise throughout pregnancy on selected maternal and fetal/neonatal physiological variables in women at-risk for preeclampsia. The central hypothesis of this project is that exercise will decrease severity and occurrence of preeclampsia symptoms, thus improving maternal, pregnancy, and birth outcomes.Aim 1. Determine the influence of different exercise modes during pregnancy at risk of preeclampsia on maternal cardiometabolic health.Aim 2. Determine the most effective exercise mode in pregnancy at risk of preeclampsia on improving birth and infant health outcomes., conditionsModule conditions: Pre-Eclampsia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Pregnant women will be randomized to one of four groups: aerobic exercise, resistance exercise, combination (aerobic + resistance), or control (no exercise). All exercise participants will be prescribed exercise that meets guidelines of the American College of Obstetricians and Gynecologists (ACOG), American College of Sports Medicine (ACSM), and the American Heart Association (AHA); 150 minutes per week, moderate intensity (60-80% aerobic capacity, Rating of Perceived Exertion, rating of perceived exertion (RPE), 12-15) per week. These limits are the same as those that generated previous positive findings for our preliminary data., primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 224, type: ESTIMATED, armsInterventionsModule interventions name: Exercise Modes, outcomesModule primaryOutcomes measure: Systolic Blood Pressure (16wks), primaryOutcomes measure: Systolic Blood Pressure (20wks), primaryOutcomes measure: Systolic Blood Pressure (24wks), primaryOutcomes measure: Systolic Blood Pressure (28wks), primaryOutcomes measure: Systolic Blood Pressure (32wks), primaryOutcomes measure: Systolic Blood Pressure (36wks), primaryOutcomes measure: Maternal Cardiometabolic Risk (CMR) Score, primaryOutcomes measure: Symptom Occurrence, primaryOutcomes measure: Placental Efficiency, primaryOutcomes measure: Birth Weight, primaryOutcomes measure: Infant Cardiometabolic Risk (CMR) Score, secondaryOutcomes measure: Maternal Heart Rate (16wks), secondaryOutcomes measure: Maternal Heart Rate (20wks), secondaryOutcomes measure: Maternal Heart Rate (24wks), secondaryOutcomes measure: Maternal Heart Rate (28wks), secondaryOutcomes measure: Maternal Heart Rate (32wks), secondaryOutcomes measure: Maternal Heart Rate (36wks), secondaryOutcomes measure: Maternal Blood Pressure (16wks), secondaryOutcomes measure: Maternal Blood Pressure (20wks), secondaryOutcomes measure: Maternal Blood Pressure (24wks), secondaryOutcomes measure: Maternal Blood Pressure (28wks), secondaryOutcomes measure: Maternal Blood Pressure (32wks), secondaryOutcomes measure: Maternal Blood Pressure (36wks), secondaryOutcomes measure: Maternal Body Fat % (16wks), secondaryOutcomes measure: Maternal Body Fat % (20wks), secondaryOutcomes measure: Maternal Body Fat % (24wks), secondaryOutcomes measure: Maternal Body Fat % (28wks), secondaryOutcomes measure: Maternal Body Fat % (32wks), secondaryOutcomes measure: Maternal Body Fat % (36wks), secondaryOutcomes measure: Maternal Circumferences (16wks), secondaryOutcomes measure: Maternal Circumferences (20wks), secondaryOutcomes measure: Maternal Circumferences (24wks), secondaryOutcomes measure: Maternal Circumferences (28wks), secondaryOutcomes measure: Maternal Circumferences (32wks), secondaryOutcomes measure: Maternal Circumferences (36wks), secondaryOutcomes measure: Gestational Weight Gain, secondaryOutcomes measure: Delivery Mode, secondaryOutcomes measure: Maternal Blood Glucose (16wks), secondaryOutcomes measure: Maternal Blood Glucose (20wks), secondaryOutcomes measure: Maternal Blood Glucose (24wks), secondaryOutcomes measure: Maternal Blood Glucose (28wks), secondaryOutcomes measure: Maternal Blood Glucose (32wks), secondaryOutcomes measure: Maternal Blood Glucose (36wks), secondaryOutcomes measure: Maternal Blood Lipids (16wks), secondaryOutcomes measure: Maternal Blood Lipids (20wks), secondaryOutcomes measure: Maternal Blood Lipids (24wks), secondaryOutcomes measure: Maternal Blood Lipids (28wks), secondaryOutcomes measure: Maternal Blood Lipids (32wks), secondaryOutcomes measure: Maternal Blood Lipids (36wks), secondaryOutcomes measure: Maternal Plasma Inflammatory Markers (16wks), secondaryOutcomes measure: Maternal Plasma Inflammatory Markers (20wks), secondaryOutcomes measure: Maternal Plasma Inflammatory Markers (24wks), secondaryOutcomes measure: Maternal Plasma Inflammatory Markers (28wks), secondaryOutcomes measure: Maternal Plasma Inflammatory Markers (32wks), secondaryOutcomes measure: Maternal Plasma Inflammatory Markers (36wks), secondaryOutcomes measure: -omics Metabolites (16wks), secondaryOutcomes measure: -omics Metabolites (20wks), secondaryOutcomes measure: -omics Metabolites (24wks), secondaryOutcomes measure: -omics Metabolites (28wks), secondaryOutcomes measure: -omics Metabolites (32wks), secondaryOutcomes measure: -omics Metabolites (36wks), secondaryOutcomes measure: Cord Blood and Placental Inflammatory Markers, secondaryOutcomes measure: Cord Blood and Placental -omics Metabolites, secondaryOutcomes measure: Infant Body Morphometric Measures, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06319001, orgStudyIdInfo id: 2688791, briefTitle: Cardiovascular Reactivity to Physical Stress, acronym: REACT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2027-01-01, completionDateStruct date: 2027-01-01, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Western Norway University of Applied Sciences, class: OTHER, descriptionModule briefSummary: It is well-accepted that an exaggerated blood pressure (BP) response to physical stress has a prognostic value, indicating a higher cardiovascular risk (e.g., sudden cardiac death, myocardial infarction, future hypertension, and left ventricular hypertrophy). However, there is a limited understanding of the underlying mechanisms and therapuetic strategies modulating this response. Therefore, this pilot project aims to explore whether one session of low-volume high-intensity interval training (low-volume HIIT) or combined intermittent heat and cold bath (sauna+cold bath) can decrease BP responses to physical stress. Furthermore, the secondary goal is to investigate whether one brief session learning about positive stress expectations magnifies the decrease in BP following low-volume HIIT and sauna+ cold bath., conditionsModule conditions: Blood Pressure, conditions: Stress, Physiological, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Combined randomized controlled trial with two parallel groups, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 58, type: ESTIMATED, armsInterventionsModule interventions name: Low-volume high intensity exercise, interventions name: Combined intermittent sauna and cold water bath (sauna+cold bath)., outcomesModule primaryOutcomes measure: Blood pressure (unit: mmHg) response to laboratory stressors, secondaryOutcomes measure: Resting blood pressure (mmHg)., secondaryOutcomes measure: Endothelial function (% dilation), secondaryOutcomes measure: Subjective ratings of expectancies (point score)., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Western Norway University of Applied Sciences, status: RECRUITING, city: Bergen, state: Vestland, zip: 5063, country: Norway, contacts name: Ann-Katrin Grotle, role: CONTACT, phone: +4790960580, email: ann-katrin.grotle@hvl.no, geoPoint lat: 60.39299, lon: 5.32415, hasResults: False
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protocolSection identificationModule nctId: NCT06318988, orgStudyIdInfo id: S67030, briefTitle: Outcomes of Different Treatment Options in Chronic Venous Disease, acronym: VOS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-11-01, completionDateStruct date: 2027-05-01, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Universitaire Ziekenhuizen KU Leuven, class: OTHER, descriptionModule briefSummary: This study aims to describe conservative and invasive treatments for patients with chronic venous disease (CVD) in Belgium, and their association with clinical and patient-reported outcomes during a follow-up of 24 months., conditionsModule conditions: Chronic Venous Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 2000, type: ESTIMATED, armsInterventionsModule interventions name: Radiofrequency ablation using Closure fast, interventions name: Aethoxysclerol, interventions name: Daflon, interventions name: Compression stocking, outcomesModule primaryOutcomes measure: Change in Chronic Venous Insufficiency QOL questionnaire- 20 (CIVIQ-20) score, secondaryOutcomes measure: Intervention as secondary/add-on treatment, secondaryOutcomes measure: The change in the Chronic Venous Insufficiency QOL questionnaire-20 score (CIVIQ-20), secondaryOutcomes measure: The change in the clinical part of the Clinical, Etiological, Anatomical and Pathophysiological classification (CEAP classification), secondaryOutcomes measure: The change in the revised Venous Clinical Severity Score (rVCSS), secondaryOutcomes measure: The change in the symptoms, recorded with a questionnaire, secondaryOutcomes measure: The change in satisfaction score, secondaryOutcomes measure: Adverse Events (AEs)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06318975, orgStudyIdInfo id: RAPTOR, secondaryIdInfos id: R01AA029074, type: NIH, link: https://reporter.nih.gov/quickSearch/R01AA029074, briefTitle: Text-Based Messaging Strategies for Preventing Subsequent Problematic Alcohol Use, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-01, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: University of Virginia, class: OTHER, collaborators name: University of Memphis, collaborators name: National Institute on Alcohol Abuse and Alcoholism (NIAAA), descriptionModule briefSummary: Binge drinking, and its health/social consequences are substantial public health concerns, with a high prevalence in young adults, especially in the US military. Alcohol consumption in the military is very high and normative, but there is zero tolerance for alcohol-related legal trouble, and Air Force Airmen who experience this (e.g., DUI, sexual assault) typically receive a disciplinary action referred to as an Alcohol Related Incident (ARI).Brief Alcohol Interventions (BAIs) for alcohol misuse are effective in young adults who report binge drinking. Many BAI studies targeted young adults who drink hazardously; these individuals are typically not interested in abstaining but may try decreasing the amount or change the manner in which they drink in order to reduce harmful consequences. The investigators previously published the results of a BAI group-based intervention that reduced ARIs in over 150,000 Airmen on average by 16%. Since 2010, the BAI has been disseminated to most USAF Airmen in Technical Training. However, it is clear additional research is needed to enhance the efficacy of the intervention and reduce risks associated with problem drinking. One strategy to improve health outcomes is well-timed, tailored, and automated text messages. Building on the researchers' preliminary study where text messages reduced driving after drinking as well as total drinks consumed before driving, text messaging may be highly effective when sent at the precise time that Airmen gain access to alcohol (the first time they are allowed off base), a standard time for all Technical Trainees.One challenge to conducting alcohol research in the military is the lack of privileged communication. As a result, it is difficult to obtain valid self-reports due to a tendency to deny or minimize use. The investigators recently developed and validated a method for collecting anonymous data over time. This will be the first study in the military, as well as the first large scale, adequately powered trial, where intervention effects will be tracked out to a 6-month follow-up. The study's Specific Aims are to randomize approximately 3000 Airmen to either the current BAI versus the BAI+Text messages timed to occur before, during, and after Airmen have access to alcohol; and to evaluate the efficacy of the intervention at the end of training and 6 months post-training using repeated surveys with unique identifiers allowing researchers to match surveys while maintaining anonymity., conditionsModule conditions: Alcohol Drinking, conditions: Binge Drinking, conditions: Text Messaging, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 3000, type: ESTIMATED, armsInterventionsModule interventions name: Brief Alcohol Intervention, interventions name: Automated and Tailored Text Messages, outcomesModule primaryOutcomes measure: AUDIT, primaryOutcomes measure: Daily Drinking Questionnaire with NIAAA recommended assessment items, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: JBSA Lackland, status: RECRUITING, city: San Antonio, state: Texas, zip: 78236, country: United States, contacts name: Tina Boothe, MPH, role: CONTACT, email: tlb7aq@virginia.edu, geoPoint lat: 29.42412, lon: -98.49363, documentSection largeDocumentModule largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-09-25, uploadDate: 2024-02-28T11:41, filename: ICF_000.pdf, size: 160063, hasResults: False
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protocolSection identificationModule nctId: NCT06318962, orgStudyIdInfo id: UMemphis, secondaryIdInfos id: SPC-1000007404 GR127268, type: OTHER, domain: Department of Defense, briefTitle: Examining the Efficacy of a Digital Therapeutic to Prevent Suicidal Behaviors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-07, primaryCompletionDateStruct date: 2027-08-01, completionDateStruct date: 2027-08-01, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: University of Memphis, class: OTHER, descriptionModule briefSummary: The primary aim of the project is to test the efficacy of BCBT delivered via a digital platform (i.e., smartphone) to Servicemembers with recent suicidal ideation and/or suicide attempts presenting to primary care clinics. Given existing challenges of scaling empirically-supported treatments/interventions for suicidality with fidelity, this project could lead to markedly expanded access to BCBT, along with improving our understanding about what intervention strategies are most effective and how they can be delivered with meaningful fidelity. Aviva, the digital version of BCBT, was developed for use with patients across the full spectrum of healthcare settings, including primary care. Aviva is not an emergency alert system, rather a digital platform for delivery of the full scope of BCBT treatment components. An open-label single group Phase I clinical trial has demonstrated the safety, tolerability, feasibility, fidelity, and potential efficacy of Aviva, with participants completing modules over 8 weeks, and follow-up assessments at weeks 1, 4, and 8. Subsequent refinements included the addition of technical features that would allow patients to revisit and/or repeat previously completed modules, along with integration of more characters for delivering video vignettes and greater opportunities for skills practice and treatment engagement. These modifications have further enhanced Aviva safety, tolerability, and fidelity, consistent with the original BCBT protocol. Not only is it hypothesized that Aviva will result in significantly larger reductions in severity of suicidal ideation than participants randomized to the control condition, but also that greater app engagement will be negatively correlated with severity of suicidal thinking. Moderators and mediators (i.e. suicidal beliefs, wish to live, impulsive decision-making) of intervention effects will also be examined. The study will be conducted at the primary care clinics at Fort Carson, with a goal of enrolling 720 patients across a two-year timeframe. Participants will be identified using each clinic's existing suicide risk assessment methods, including the PHQ-9 suicide risk item and a score of 1 or higher on the CSSRS Screener (Recent). Participants will be randomly assigned to one of two treatment conditions, Aviva or control (i.e., development of a safety plan consistent with local procedures and policies, along with referral for standard mental health care and suicide risk management in accordance with local policies and procedures). In an effort to address potential performance bias specific to smartphone use, participants in the control condition will download the Suicide Safety Plan app to their smartphones. Those in the Aviva condition will also complete weekly check-ins with Project 2 research clinicians to review treatment adherence, identify and respond to any logistical/operational problems, and respond to any unexpected emergencies and/or participant safety concerns. Participants will have up to five data points: baseline, 3, 6, 9, and 12 months. All data available from all participants and all time points will be included in the analyses, consistent with the intent-to-treat principle. Across our two previous clinical trials and our in-progress RCT, attrition during the first 12 months postbaseline was \<30% and we anticipate similar rates in this trial., conditionsModule conditions: Suicidal Behaviors, conditions: Suicide Ideation, conditions: Depression/Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Aviva, outcomesModule primaryOutcomes measure: Self Injurious Thoughts and Behaviors Interview Revised, secondaryOutcomes measure: Beck Scale for Suicide Ideation, secondaryOutcomes measure: Beck Hopelessness Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fort Carson, status: RECRUITING, city: Colorado Springs, state: Colorado, zip: 80829, country: United States, contacts name: Michelle Wine Chief Psychologist, Ph.D., role: CONTACT, phone: 719-526-7461, email: michelle.d.wine.civ@health.mil, contacts name: Michelle Wine, Ph.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.83388, lon: -104.82136, hasResults: False
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protocolSection identificationModule nctId: NCT06318949, orgStudyIdInfo id: 87RI22_0007 (MALAHBAR), briefTitle: Albumin Modifications as Early Biomarkers of Chronic Liver Diseases, acronym: MALAHBAR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2029-06-01, completionDateStruct date: 2029-12-01, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: University Hospital, Limoges, class: OTHER, descriptionModule briefSummary: Chronic liver diseases, affecting over 800 million people worldwide, lead to approximately 2 million annual deaths. The need for early, sensitive diagnostic strategies to prevent disease progression and reduce mortality is still unmet. The traditional serum markers lack sensitivity and specificity, leading to the integration of these biomarkers into panel tests with algorithms or imaging measures. Despite their widespread use, these tests have limitations at an individual level, including an inability to predict disease progression or response to treatment. To address these shortcomings, our project proposes utilizing albumin post-translational modifications (PTM) as a predictive biomarker for liver disease progression. The hypothesis is that albumin modifications occur in the early stages of hepatocellular damage and are indicative of future liver diseases. These modifications can be detected through serum albumin isoform determination, albumin isoforms profiles or the albumin's ligand-binding capacities. Innovatively, the study will use the Serum Enhanced Binding (SEB) test, which identifies reduced ligand-binding capacities, and discusses a second patent for determining a typical isoform profile based on the hepatic injury type.Our preliminary results from animal models and a proof-of-concept studies with patients support this hypotheses. Our previous studies demonstrated also significant differences in albumin isoform profiles in response to different types of hepatic injury and high sensitivity and specificity in the SEB test among cirrhotic patients.The primary objective of the MALAHBAR project is to evaluate the capacity of albumin PTM to predict liver disease progression over three years in chronic liver disease patients. Secondary objectives include assessing the predictive ability of different albumin isoforms and the SEB test for liver disease progression, evaluating diagnostic performances and confirming characteristic albumin isoform profiles related to specific hepatic injuries. The study could represent a significant advancement in liver disease diagnostics and management, offering new insights into the role of albumin in liver pathology., conditionsModule conditions: Chronic Liver Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Prospective multicentre study of biomarker validation, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 756, type: ESTIMATED, armsInterventionsModule interventions name: blood sampling, outcomesModule primaryOutcomes measure: Ability of HSA PTM to predict the evolution of liver damage at 3 year in patients with an advanced chronic liver disease (ACLD) as recently defined in the BAVENO VII recommendations based on FibroScan., secondaryOutcomes measure: ability of post-translational HSA modifications to predict the evolution of liver damage at 3 years based on liver-related events or on the worsening of the disease stage evaluated by the de Child Pugh or MELD score., secondaryOutcomes measure: ability of the different isoforms of HSA to predict the evolution of liver damage at 1 and 2 years provided that data are available in the medical file., secondaryOutcomes measure: ability of SEB test to predict the evolution of liver damage at 3 years (and at 1 and 2 years provided data are available in the medical file)., secondaryOutcomes measure: diagnostic performances of the SEB test and of the different isoforms of HSA at each stage of the liver disease., secondaryOutcomes measure: confirm that the isoforms of HAS present in the characteristic patterns (type of isoform and intensity) of the nature of the liver damage., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Angers Univeristy Hospital, city: Angers, zip: 49100, country: France, contacts name: Jerome BOURSIER, MD, role: CONTACT, email: JeBoursier@chu-angers.fr, contacts name: Jerome BOURSIER, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.46667, lon: -0.55, locations facility: Limoges University Hospital, city: Limoges, zip: 87042, country: France, contacts name: Souleiman EL BALKHI, MD, role: CONTACT, email: Souleiman.ElBalkhi@chu-limoges.fr, contacts name: Paul CARRIER, MD, role: CONTACT, email: Paul.Carrier@chu-limoges.fr, contacts name: Paul CARRIER, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.83153, lon: 1.25781, locations facility: Poitiers University Hospital, city: Poitiers, zip: 86000, country: France, contacts name: Valentin ROLLE, MD, role: CONTACT, email: v.rolle@chu-poitiers.fr, contacts name: Valentin ROLLE, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 46.58333, lon: 0.33333, locations facility: Rennes University Hospital, city: Rennes, zip: 35000, country: France, contacts name: Florent ARTRU, MD, role: CONTACT, email: florent.artru@chu-rennes.fr, contacts name: Florent ARTRU, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.11198, lon: -1.67429, locations facility: Tours University Hospital, city: Tours, zip: 37170, country: France, contacts name: Laure ELKRIEF, MD, role: CONTACT, email: l.elkrief@chu-tours.fr, contacts name: Laure ELKRIEF, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.38333, lon: 0.68333, locations facility: Pointe à Pitre University Hospital, city: Pointe-a-Pitre, zip: 97159, country: Guadeloupe, contacts name: Moana GELU-SIMEON, role: CONTACT, email: moana.simeon@chu-guadeloupe.fr, contacts name: Moana GELU-SIMEON, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 16.24125, lon: -61.53614, hasResults: False
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protocolSection identificationModule nctId: NCT06318936, orgStudyIdInfo id: 22-677, briefTitle: Respiratory Syncytial Virus (RSV) Burden in Older Adults in Primary Care in The Netherlands, acronym: RAPID, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-11-01, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-05-01, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: UMC Utrecht, class: OTHER, collaborators name: Janssen-Cilag B.V., descriptionModule briefSummary: RSV infection is a leading cause of medical care in older adults, sometimes leading to hospital admission and severe outcomes. Although the majority of RSV infections are managed outside hospitals, little is known on the burden of RSV in older adults in the primary care setting. Accurate estimates of the RSV burden in primary care is particularly relevant since vaccines against RSV infection in older adults will likely become available for the general population soon. The use of high-quality point-of-care (POC) molecular viral diagnostics allows to identify RSV infected older adults and would therefore contribute to fill one of the most important gaps in knowledge facilitating implementation of RSV vaccination of older adultsWith this prospective, observational study, we aim to define the disease burden of RSV infection in older adults in the primary care setting., conditionsModule conditions: RSV Infection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Burden of medically attended RSV infection in the Dutch primary care, secondaryOutcomes measure: RSV-related health care consumption and indirect costs in older adults, secondaryOutcomes measure: Proportion of medically attended RSV infection amongst all medically attended acute respiratory infections in older adults in the primary care setting, secondaryOutcomes measure: Association between disease severity and several clinical and demographic parameters (e.g. age, cardiopulmonary comorbidity, smoking status, chronic immunosuppressive medication use) and RSV burden (by disease severity and healthcare usage), secondaryOutcomes measure: Incidence of RSV-related secondary bacterial pneumonia events and antibiotic use, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Medical Center Utrecht, status: RECRUITING, city: Utrecht, zip: 3584CX, country: Netherlands, contacts name: Joanne Wildenbeest, MD, PhD, role: CONTACT, phone: 0031887563776, email: J.G.Wildenbeest@umcutrecht.nl, geoPoint lat: 52.09083, lon: 5.12222, hasResults: False
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protocolSection identificationModule nctId: NCT06318923, orgStudyIdInfo id: RC-P00117, briefTitle: Social and Moral Cognition in Multiple Sclerosis, acronym: COSMOS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-19, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-10-30, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Lille Catholic University, class: OTHER, descriptionModule briefSummary: Multiple Sclerosis (MS) is a chronic, progressive disease that affects young adults (aged between 20 and 40) and has a major impact on patients' quality of life. Cognitive disorders in MS are common, affecting 40-60% of patients. Among these disorders, the presence of social cognition disorders is common. Within social cognition, the moral judgment has been an object of research in order to understand the determinants of moral decision-making: how and why individuals make moral choices with regard to a set of prescriptions and social norms. Compared to control subjects, MS patients show a decrease in moral permissiveness, as well as an increase in moral relativity and emotional reactivity. Thus, it would seem that MS patients issue more deontological choices (lower moral permissiveness). Given that these patients also exhibit empathy deficits and higher alexithymia, these patterns are surprising. Indeed, in other clinical populations, low empathic abilities and high alexithymia are linked to utilitarian rather than deontological moral judgments.The objective of this project is to analyze the process of decision-making carried out by patients during moral dilemma situations in comparison with control individuals and verify whether the presence of a positivity bias could explain the more deontological choices made by some patients. Indeed, some work has shown that older individuals make more deontological moral judgments than younger adults. These results are also observed with young individuals when their future temporal perspectives have been experimentally constrained., conditionsModule conditions: Multiple Sclerosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Socio-demographic questionnaire, moral judgment task, cognitive tests, psychoaffective assessment, interventions name: MS questionnaire, interventions name: MONTREAL COGNITIVE ASSESSMENT (MoCA) test, outcomesModule primaryOutcomes measure: Moral dilemma judgments, secondaryOutcomes measure: Explicit time perspective inventory test, secondaryOutcomes measure: Implicit time perspective inventory test, secondaryOutcomes measure: Dot Probe Task, secondaryOutcomes measure: Level of moral permissibility, secondaryOutcomes measure: Level of emotional reactivity, secondaryOutcomes measure: Moral relativity level, secondaryOutcomes measure: Brief International Cognitive Assessment for Multiple Sclerosis, secondaryOutcomes measure: The Beck Depression Inventory, secondaryOutcomes measure: State-Trait Anxiety Inventory, secondaryOutcomes measure: Toronto Alexithymia Scale (TAS)-20, secondaryOutcomes measure: Empathy quotient-8 (EQ-8), secondaryOutcomes measure: Electrodermal response, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Hôpital Saint-Vincent-de-Paul - Neurologie, status: RECRUITING, city: Lille, country: France, contacts name: Béatrice DEGRAEVE, role: CONTACT, contacts name: Laurent ZIKOS, role: SUB_INVESTIGATOR, geoPoint lat: 50.63297, lon: 3.05858, locations facility: Hôpital Saint-Philibert - Neurologie, status: RECRUITING, city: Lomme, country: France, contacts name: Béatrice DEGRAEVE, role: CONTACT, contacts name: Laurent ZIKOS, role: SUB_INVESTIGATOR, geoPoint lat: 50.64358, lon: 2.98715, hasResults: False
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protocolSection identificationModule nctId: NCT06318910, orgStudyIdInfo id: MU-SRF-RS-27 C/66, briefTitle: Customized Foot Orthoses on Muscle Activity During Standing and Gait in Plantar Heel Pain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-11-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Mahidol University, class: OTHER, descriptionModule briefSummary: The present study will use a randomized controlled trial (RCT) to determine the effectiveness of customized foot orthosis (CFO) for the treatment of patients with PHP. Three treatment groups including the CFO without wedge, the CFO with wedge type 1 (W1), and the CFO with wedge type 2 (W2) will be randomly assigned to each participant by a computer-generated randomization. The opaque-sealed envelopes will be used to allocate the groups of participant., conditionsModule conditions: Foot Orthoses, conditions: Fasciitis, Plantar, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: The present study will use a randomized controlled trial (RCT) to determine the effectiveness of CFO for the treatment of patients with PHP. Three treatment groups including the CFO without wedge, the CFO with W1, and the CFO with W2 will be randomly assigned to each participant by a computer-generated randomization. The opaque-sealed envelopes will be used to allocate the groups of participant., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Participants will be allocated to the control (CFO without wedge) or experimental (CFO with W1 or W2) groups according to the seal-envelop randomization technique. Then, they will be assessed all outcomes for the baseline including pain intensity, foot function, lower-extremity muscle activity during gait and standing by the 2nd physical therapist. And the participants will receive the assigned treatment by the 1st physical therapist., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: orthotic wedge, interventions name: CFO, outcomesModule primaryOutcomes measure: Pain intensity and foot function, primaryOutcomes measure: EMG of lower leg muscles, otherOutcomes measure: Subjective assessment, otherOutcomes measure: Physical assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, hasResults: False
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protocolSection identificationModule nctId: NCT06318897, orgStudyIdInfo id: 2023-0645, secondaryIdInfos id: NCI-2024-02384, type: OTHER, domain: NCI-CTRP Clinical Registry, briefTitle: Open-label, Single Center, Single-arm, Phase 2 Study of Neoadjuvant Pembrolizumab in Combination With Carboplatin and Paclitaxel in Patients With Stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-30, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2027-09-30, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: M.D. Anderson Cancer Center, class: OTHER, descriptionModule briefSummary: To look at the effectiveness of the combination of pembrolizumab, carboplatin, and paclitaxel in participants with stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer., conditionsModule conditions: Stage 1 cT1b-T1cN0M0, conditions: Triple Negative Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: Carboplatin, interventions name: Paclitaxel, interventions name: Pembrolizumab, interventions name: Doxorubicin, interventions name: Cyclophosphamide, 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: Oluchi Oke, MD, role: CONTACT, phone: 832-729-8362, email: oukaegbu@mdanderson.org, contacts name: Oluchi Oke, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False
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protocolSection identificationModule nctId: NCT06318884, orgStudyIdInfo id: SCTB35-X101, briefTitle: A First-in-human Study of SCTB35 in Patients With Relapse/Refractory B-cell Non-Hodgkin Lymphoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-10, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: Sinocelltech Ltd., class: INDUSTRY, descriptionModule briefSummary: This is a Phase I clinical study designed to evaluate the safety, tolerability, and pharmacokinetics, and preliminary efficacy of SCTB35 monotherapy, an bispecific antibody, in patients with relapsed and/or refractory B-cell non-Hodgkin lymphoma., conditionsModule conditions: Non-Hodgkin Lymphoma, B-cell, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 76, type: ESTIMATED, armsInterventionsModule interventions name: SCTB35 injection, outcomesModule primaryOutcomes measure: Dose-escalation part: dose limited toxicity (DLT), primaryOutcomes measure: Dose-escalation part: incidence rate of adverse event (AE), primaryOutcomes measure: Dose-expansion part: objective response rate (ORR), secondaryOutcomes measure: Dose-escalation part: ORR, secondaryOutcomes measure: Dose-escalation part: CR rate (CRR), secondaryOutcomes measure: Dose-escalation part: best of overall response (BOR), secondaryOutcomes measure: Dose-escalation part: duration of response (DOR), secondaryOutcomes measure: Dose-escalation part: progression-free survival (PFS), secondaryOutcomes measure: Dose-escalation part: time to response (TTR), secondaryOutcomes measure: Dose-escalation part: overall survival (OS), secondaryOutcomes measure: Dose-escalation part: blood concentrations of SCTB35, secondaryOutcomes measure: Dose-escalation part: anti-drug antibodies of SCTB35, secondaryOutcomes measure: Dose-expansion part: CRR, secondaryOutcomes measure: Dose-expansion part: BOR, secondaryOutcomes measure: Dose-expansion part: DOR, secondaryOutcomes measure: Dose-expansion part: PFS, secondaryOutcomes measure: Dose-expansion part: TTR, secondaryOutcomes measure: Dose-expansion part: OS, secondaryOutcomes measure: Dose-expansion part: AE, secondaryOutcomes measure: Dose-expansion part: blood concentrations of SCTB35, secondaryOutcomes measure: Dose-expansion part: anti-drug antibodies of SCTB35, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beijing Cancer Hospital, city: Beijing, state: Beijing, zip: 100142, country: China, contacts name: Yuqin Song, M.D., role: CONTACT, phone: 010-88196118, email: SongYQ_VIP@163.com, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Henan Cancer Hospital, city: Zhengzhou, state: Henan, country: China, contacts name: Keshu Zhou, M.D., role: CONTACT, phone: 13674902391, email: dr_zkshu23810@163.com, geoPoint lat: 34.75778, lon: 113.64861, locations facility: Tianjin Medical University Cancer Institute & Hospital, city: Tianjin, state: Tianjin, zip: 300060, country: China, contacts name: Lanfang Li, M.D., role: CONTACT, phone: 18622221613, email: lilanfangmeng@163.com, geoPoint lat: 39.14222, lon: 117.17667, hasResults: False
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protocolSection identificationModule nctId: NCT06318871, orgStudyIdInfo id: 23-688, briefTitle: A Phase 0 Pilot Study of Memory-like Natural Killer (NK) Cell Immune Therapy in Combination With N-803 in Patients With Renal Cell Carcinoma or Urothelial Carcinoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-02-28, completionDateStruct date: 2030-02-28, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Dana-Farber Cancer Institute, class: OTHER, collaborators name: Kidney Cancer Association, collaborators name: ImmunityBio, Inc., descriptionModule briefSummary: The goal of this research study is to establish the safety and then to explore the effectiveness of infusing the combination of cytokine-induced memory-like (CIML) natural killer (NK) cells, a type of immune cell in the blood that is collected and bathed in special proteins to help identify and treat curtained advanced cancers, combined with N-803, a medication that increases the activity of Interleukin-15, which is a cytokine that activates immune cells, in advanced clear cell renal cell carcinoma and urothelial carcinoma.Names of the study therapies involved in this study are/is:* CIML NK cell therapy (a NK cell therapy)* N-803 (a type of recombinant human IL-15 superagonist), conditionsModule conditions: Renal Carcinoma, conditions: Renal Cell Carcinoma, conditions: Urothelial Carcinoma, designModule studyType: INTERVENTIONAL, phases: EARLY_PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 5, type: ESTIMATED, armsInterventionsModule interventions name: Cytokine Induced Memory-like Natural Killer (CIML NK) Cells, interventions name: N-803, outcomesModule primaryOutcomes measure: Feasibility Failure Rate (FFR), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Brigham and Women's Hospital, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Wenxin Xu, MD, role: CONTACT, phone: 617-632-6534, email: wenxin_xu1@dfci.harvard.edu, contacts name: Wenxin Xu, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Dana-Farber Cancer Institute, city: Boston, state: Massachusetts, zip: 02215, country: United States, contacts name: Wenxin Xu, MD, role: CONTACT, phone: 617-632-6534, email: Wenxin_Xu1@dfci.harvard.edu, contacts name: Wenxin Xu, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, hasResults: False
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protocolSection identificationModule nctId: NCT06318858, orgStudyIdInfo id: MU-CIRB 2022/313.1411, briefTitle: Daily and Weekly Iron Supplementation in Infants, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-15, primaryCompletionDateStruct date: 2024-08-14, completionDateStruct date: 2024-10-14, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Mahidol University, class: OTHER, collaborators name: Suranaree University of Technology, descriptionModule briefSummary: This study aims to compare the efficacy of daily iron supplementation and weekly iron supplementation in infants aged 6-12 months on the prevalence of anemia, hemoglobin level, and serum ferritin levels. Infants will be enrolled at 6 months and will be randomly assigned to receive either daily or weekly iron supplementation for the first 3 months and will be followed by weekly iron supplementation for another 3 months., conditionsModule conditions: Anemia, conditions: Iron Status, conditions: Infants, conditions: Iron, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: group 1: daily iron syrup supplementation group 2: weekly iron syrup supplementation, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, maskingDescription: Letter codes were assigned to the iron syrup and the placebo by researchers who have not involved in the study. The codes have been kept until data analysis and report writing are complete., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Iron supplement, outcomesModule primaryOutcomes measure: Anemia status, primaryOutcomes measure: Iron status, secondaryOutcomes measure: Weight, secondaryOutcomes measure: Length, secondaryOutcomes measure: Dietary intake, secondaryOutcomes measure: Head circumference (HC), otherOutcomes measure: Hemoglobin typing, otherOutcomes measure: C-reactive protein (CRP), otherOutcomes measure: Alpha-1 acid glycoprotein (AGP), otherOutcomes measure: Serum transferrin receptor, otherOutcomes measure: Serum Retinol Binding Protein (RBP), eligibilityModule sex: ALL, minimumAge: 6 Months, maximumAge: 12 Months, stdAges: CHILD, contactsLocationsModule locations facility: Samphran District Hospital, status: RECRUITING, city: Sam Phran, state: Nakhon Pathom, zip: 73110, country: Thailand, contacts name: Tinnakorn Chuenchom, MD, role: CONTACT, phone: 6634311021, phoneExt: 105, contacts name: Somchai Janelapwattanakul, MD, role: CONTACT, phone: 6634352052, phoneExt: 4001, geoPoint lat: 13.72698, lon: 100.21526, hasResults: False
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protocolSection identificationModule nctId: NCT06318845, orgStudyIdInfo id: 2302CS-1, briefTitle: Phase 1 Study to Evaluate the Safety and Pharmacokinetic Drug Interaction of DHP2302R1 and DHP2302R2, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2024-07-19, completionDateStruct date: 2024-08-02, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Daehwa Pharmaceutical Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to investigate the safety and drug interaction of DHP2302R1 and DHP2302R2 when administered alone versus in combination in healthy South Korean adult participants., conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 42, type: ACTUAL, armsInterventionsModule interventions name: DHP2302R1, interventions name: DHP2302R2, outcomesModule primaryOutcomes measure: AUClast of DHP2302R1 and DHP2302R2, primaryOutcomes measure: Cmax of DHP2302R1 and DHP2302R2, secondaryOutcomes measure: Tmax of DHP2302R1 and DHP2302R2, secondaryOutcomes measure: AUC0-48 of DHP2302R1 and DHP2302R2, secondaryOutcomes measure: AUCinf of DHP2302R1 and DHP2302R2, secondaryOutcomes measure: t1/2 of DHP2302R1 and DHP2302R2, secondaryOutcomes measure: CL/F of DHP2302R1 and DHP2302R2, secondaryOutcomes measure: Vz/F of DHP2302R1 and DHP2302R2, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: H Plus Yangji Hospital, city: Seoul, state: Gwanak-gu, zip: 08779, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False
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protocolSection identificationModule nctId: NCT06318832, orgStudyIdInfo id: 124609, briefTitle: Optimizing a Wellbeing Program for Care-partners of Those With SCI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Lawson Health Research Institute, class: OTHER, descriptionModule briefSummary: Spinal cord injuries (SCI) have a devastating effect not only on individuals incurring the life changing event, but also on those who are involved in their care. Family care-partners of those with SCI (fcSCI) may experience significant negative effects including impaired mental health, high levels of burden, poor adjustment to role, decreased quality of life and strain on relationships. Cognitive behaviour therapy (CBT) is an evidence-based treatment strategy that helps individuals recognize and challenge their unhelpful thoughts and behaviours that contribute to their mental health concerns. However, barriers such as availability to specialized care, costs, rural and remote location, or concerns about stigma may limit access to care. Internet delivered CBT (ICBT) has the potential to reach a much wider group of people that may have unequal access to health care.In a previous feasibility study, the team demonstrated the preliminary effectiveness of a tailored ICBT Wellbeing program for fcSCI. However, our understanding of which components of the program can result in optimal management is limited. The main purpose of this study is to evaluate the effectiveness of different components of the Wellbeing program including: therapist guidance, peer support groups, and booster sessions on symptoms of depression among fcSCI. The team will evaluate which intervention components result in meaningful improvement in symptoms of depression. Through collaborations with SCI community organizations and rehabilitation institutions, participants will be recruited across Canada. The researchers will also develop a model to examine the most cost-effective intervention package from the different components. The Wellbeing for fcSCI program can provide personalized service to individuals while being flexible and easily accessible, improving overall wellbeing and access to health care services., conditionsModule conditions: Internet-Delivered Cognitive Behavioural Therapy, conditions: Depression, conditions: Anxiety, conditions: Spinal Cord Injuries, conditions: Caregiver Burnout, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 154, type: ESTIMATED, armsInterventionsModule interventions name: ICBT, outcomesModule primaryOutcomes measure: Change in depression, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06318819, orgStudyIdInfo id: 159-11-19., briefTitle: Plaque Removal Effectiveness of a Flossing Device Compared to the Conventional Flossing in Adults, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-11-01, primaryCompletionDateStruct date: 2020-03-15, completionDateStruct date: 2020-05-31, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Maha A. Bahammam, class: OTHER, collaborators name: King Abdulaziz University, descriptionModule briefSummary: * Objective: To evaluate the effectiveness in plaque removal of the new device; Dental floss holders and compare the results to the conventional way of flossing.* Methods: Thirty adult male and female participants participated in this randomized, single-use, single-blind clinical study. Participants were randomly assigned to one of two groups; Group A: Consists of 30 participants in whom Dental Floss Holders (DFH) was constructed to either maxillary or mandibular arch randomly. Group B: Consists of 30 participants in whom conventional flossing (CF) was done to the other arch.Participants attended the first visit for primary impression taking in order to construct the DFH. In the second visit, participants were examined by a blinded examiner to record their plaque index using O'Leary index. Then, they flossed using DFH and CF according to the group they were assigned to. Participants were monitored to ensure proper coverage of all the areas following precise instructions. They then brushed their teeth for approximately 2 minutes using modified bass technique. Next, plaque index was recorded again using the O'leary index. Time was recorded during flossing of each arch. Finally, participants were given a questionnaire to assess their satisfaction of the device.* Results: The differences between the groups showed the DFH group with a 62.8% reduction in whole mouth plaque and 63.3% for proximal plaque compared to 52.9% and 50.4% for the CF group, respectively (p = 0.01). The DFH was more time efficient in removing plaque from the marginal regions with an average time of 00:00:37 in comparison to the CF which averaged in 00:02:07 (p \< 0.001). A total of 26 participants (86.7%) preferred using the DFH over the CF.* Conclusion: With the combination of toothbrushing, the Dental Floss Holders is significantly more effective and time efficient than conventional flossing in removing plaque from tooth surfaces., conditionsModule conditions: Tooth Decay, conditions: Cavities of Teeth, conditions: Gingivitis, conditions: Plaque, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ACTUAL, armsInterventionsModule interventions name: Dental Floss Holders, outcomesModule primaryOutcomes measure: Dental Floss Holders (DFH), primaryOutcomes measure: Conventional flossing (CF), eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 26 Years, stdAges: ADULT, contactsLocationsModule locations facility: King Abdulaziz University, city: Jeddah, country: Saudi Arabia, geoPoint lat: 21.54238, lon: 39.19797, hasResults: False
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protocolSection identificationModule nctId: NCT06318806, orgStudyIdInfo id: 2024-3633, briefTitle: Towards Remission and Full Recovery From Obsessive-compulsive Disorder, acronym: RCT2023, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2029-09-30, completionDateStruct date: 2029-09-30, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Ciusss de L'Est de l'Île de Montréal, class: OTHER, collaborators name: Canadian Institutes of Health Research (CIHR), descriptionModule briefSummary: Obsessive-compulsive disorder (OCD) is a disabling psychiatric illness that is characterized by distressing obsessional thoughts and time-consuming compulsive rituals. Exposure and Response Prevention (ERP) is a first-line psychological treatment of choice that requires patients to face their fears by being exposed to feared stimuli. This treatment has been shown to reduce symptoms in a significant proportion of patients. However, it is considered a difficult treatment and only a minority reach remission. Residual symptoms typically remain, or reappear after treatment, which is a risk for relapse. Inference-based Cognitive Behavioral Therapy (I-CBT) is a promising evidence-based treatment developed to overcome these limitations. I-CBT has already been found to be as effective as ERP and significantly more acceptable and easier to adhere to. There is also evidence that I-CBT is more effective for subgroups of patients. Consequently, the current research project is focused on improving treatments outcomes for those provide those who have previously unable to reach remission of their symptoms with ERP. Following an initial treatment with ERP, those that have been unable to reach remission, will be randomized to either I-CBT or more ERP. It is expected that I-CBT will be significantly more effective than providing patients with more of the same. In addition, the study aims to predict treatment outcome in order to be able to tell in advance which patients do not respond to ERP. The project is designed to maximize beneficial health outcomes with a stepped-care approach to treatment, but also to work towards a more personalized choice by being able to match patients in advance with the treatment that works best for them, conditionsModule conditions: Obsessive-Compulsive Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The study is a single site parallel-group randomized-controlled trial with an active run-in treatment. In the first phase of the trial, participants diagnosed with OCD will receive an active run-in treatment consisting of 18 sessions of ERP. In the second phase, non-remitters will be randomly allocated to another 18 sessions of I-CBT or continued treatment with ERP. Non-remission is operationalized in accordance with validated cut-off points established through international consensus and empirical findings (a score of \>12 on the YBOCS and a CGI-S rating of 3 or higher (mild to extremely ill) after the run-in treatment with ERP). I-CBT and continued ERP will be followed by a 6-month and 12-month follow-up conforming to current thinking on relapse and recovery in OCD. Treatments will be administered by trained therapists on a weekly one-on-one basis via videoconferencing for the duration of one hour., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Psychological, outcomesModule primaryOutcomes measure: Yale-Brown Obsessive-Compulsive Scale -2 (Y-BOCS-2), primaryOutcomes measure: Clinical Global Impression Scale (CGI), secondaryOutcomes measure: Vancouver Obsessional Compulsive Inventory (VOCI), secondaryOutcomes measure: Beck Depression Inventory (BDI), secondaryOutcomes measure: Beck Anxiety Inventory (BAI), secondaryOutcomes measure: Inferential Confusion Questionnaire (ICQ), secondaryOutcomes measure: Dysfunctional Reasoning Processes Task (DRPT), secondaryOutcomes measure: Fear of Self Questionnaire (FSQ-20), secondaryOutcomes measure: Obsessive Beliefs Questionnaire (OBQ-20), secondaryOutcomes measure: Brunnsviken Brief Quality of Life Scale (BBQ), secondaryOutcomes measure: Sheehan Disability Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06318793, orgStudyIdInfo id: 2024Ao001*, briefTitle: Preoperative Inflammatory Markers Predict Postoperative Complications After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy for Peritoneal Colorectal Carcinomatosis, statusModule overallStatus: COMPLETED, startDateStruct date: 2012-09, primaryCompletionDateStruct date: 2023-07, completionDateStruct date: 2023-12, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: CHU de Reims, class: OTHER, descriptionModule briefSummary: A retrospective study of a single-center prospective database of patients who underwent curative CRS-HIPEC for peritoneal carcinomatosis (PC) of colo-rectal cancer (CRC), between September 2012 and July 2023 at Reims Hospital-University was conducted. Inclusion criteria were: patients older than 18 years with a performance status ≤ 2, who underwent complete (no macroscopic residual disease) CRS-HIPEC was performed. Exclusion criteria were the presence of an infectious disease prior to surgery, CRS without HIPEC, incomplete CRS and expressed refusal to participate in the study.During the month prior to surgery, patients underwent a thorough diagnostic workup, including chest and abdominopelvic computed tomography (CT) scans, complete haematological and biochemical tests, and cytobacteriological analysis of urine. Blood tests included leukocytes, neutrophils, lymphocytes, platelet count, albumin and CRP. Within one week before surgery, patients were examined by both the surgeon and the anaesthetist.Variables with a normal distribution are presented as mean-SD, while those with a non-normal distribution are presented as median and range. Categorical variables are presented as counts and percentages. Chi-Square or Fisher's exact test was used to compare qualitative variables. Linear regression analysis was used to assess any association between preoperative inflammatory biomarkers and patient comorbidities and disease characteristics. Preoperative levels of inflammatory biomarkers were compared between patients with no postoperative complication (POC) and patients with POC and major POC using the non-parametric Mann-Whitney U test. Optimal cut-off values for significant inflammatory biomarkers were determined using the Youden index. Receiver operating curves (ROC) were calculated to determine the area under the curve (AUC). Univariable and multivariable analyses including cut-off values of significant biomarkers were performed in a binary logistic regression analysis and expressed as odds ratios (OR). All tests were two-tailed and results were considered significant if the p-value was \< 0.05. Statistical analyses were performed using R software (version 4.0.5)., conditionsModule conditions: Peritoneal Carcinomatosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 166, type: ACTUAL, armsInterventionsModule, outcomesModule primaryOutcomes measure: Concentration of C-reactive protein (CRP), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Chu Reims, city: Reims, zip: 51092, country: France, geoPoint lat: 49.25, lon: 4.03333, hasResults: False
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protocolSection identificationModule nctId: NCT06318780, orgStudyIdInfo id: PI2023_843_0171, briefTitle: Concordance of Three Imaging Methods by Dynamic CT, Contrast Ultrasound and CT Angiography in the Characterization of Endoleaks in Patients With an Aortic Endoprosthesis, acronym: LEAKDYN, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2029-02, completionDateStruct date: 2031-02, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire, Amiens, class: OTHER, descriptionModule briefSummary: Among patients who have undergone EVAR, there is a significant risk of 20-50% endoleak. These endoleaks often require secondary interventions to reduce the risk of expansion or rupture. Currently, three-phase CT angiography and CEUS ultrasound are recommended in the post-operative monitoring of EVAR but these remain limited in characterizing the type and source of endoleak. In this study the investigators will study the interest of d-CTA for a better detection and characterization of endoleaks., conditionsModule conditions: Aortic Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 69, type: ESTIMATED, armsInterventionsModule interventions name: three-phase CT angiography, interventions name: CEUS ultrasound, outcomesModule primaryOutcomes measure: Endoleak classification using the CT angiography, primaryOutcomes measure: Variation of Endoleak classification between CEUS ultrasound and the CT angiography, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU Amiens Picardie, status: RECRUITING, city: Amiens, state: Picardie, zip: 80054, country: France, contacts name: Thierry REIX, PhD, role: CONTACT, phone: +33322455929, email: reix.thierry@chu-amiens.fr, geoPoint lat: 49.9, lon: 2.3, hasResults: False
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protocolSection identificationModule nctId: NCT06318767, orgStudyIdInfo id: PI2023_843_0141, briefTitle: Predictive Value of Systolic Rise Time of the Plantar Arch on the Risk of Major Adverse Limb Events (MALE) and Major Adverse Cardiovascular Events (MACE) in Peripheral Artery Disease (PAD) at Critical Ischaemia Stage, acronym: TAMIS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire, Amiens, class: OTHER, descriptionModule briefSummary: Peripheral artery disease (PAD), vascular disease of atheromatous origin, is a frequent pathology, with a steady and significant increase in prevalence over the last decades. It has various symptoms ranging from mild arterial claudication to critical limb ischemia. The critical ischaemia stage in PAD is defined by rest pain or trophic disorders and is a special situation because of the number of cardiovascular deaths at 1 year (25%), 60% at 5 years and acute ischaemic recurrence at 1 year (25%).It is a medico-surgical pathology. A haemodynamic marker is needed to monitor patients, as it is predictive of limb progression, cardiovascular events and mortality. The Systolic Rise Time (SRT) of the plantar footpad is a recently described haemodynamic measurement of proven value in the diagnosis of PAD. The aim of this study is to show the prognostic value of the Systolic Rise Time on Major Adverse Limb Events (MALE)., conditionsModule conditions: Major Adverse Limb Events, conditions: Major Adverse Cardiovascular Events, conditions: Peripheral Artery Disease, conditions: Critical Limb Ischemia, conditions: Hemodynamic Measure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 134, type: ESTIMATED, armsInterventionsModule interventions name: hemodynamic measure of the Systolic Time Rise, outcomesModule primaryOutcomes measure: occurrence of limb ischemia, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU Amiens, status: RECRUITING, city: Amiens, zip: 80480, country: France, contacts name: SOUDET Simon, MD, role: CONTACT, phone: 03 22 88 72 89, email: soudet.simon@chu-amiens.fr, geoPoint lat: 49.9, lon: 2.3, hasResults: False
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protocolSection identificationModule nctId: NCT06318754, orgStudyIdInfo id: HP-00104241, briefTitle: Large-Bore Mechanic Thrombectomy for the Treatment of Symptomatic Portomesenteric Vein Thrombosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: University of Maryland, Baltimore, class: OTHER, collaborators name: Inari Medical, descriptionModule briefSummary: A single site study evaluating the safety, feasibility, and effectiveness of percutaneous large-bore mechanical thrombectomy using the Inari Triever Aspiration Catheter for the treatment of portomesenteric vein thrombosis (PMVT)., conditionsModule conditions: Thrombosis, conditions: Thrombectomy, conditions: Portal Vein, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Inari Triever Aspiration Catheter, outcomesModule primaryOutcomes measure: Technical Success, primaryOutcomes measure: Clinical Success, primaryOutcomes measure: Primary Patency, primaryOutcomes measure: Intermediate functional success, secondaryOutcomes measure: Secondary Patency, secondaryOutcomes measure: Duration of hospitalization, secondaryOutcomes measure: Duration of ICU days, secondaryOutcomes measure: Blood loss during intervention, secondaryOutcomes measure: Transfusion, secondaryOutcomes measure: Major and minor complications, secondaryOutcomes measure: 30-day mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06318741, orgStudyIdInfo id: KayseriCHkinezyofobi, briefTitle: Effects of Aerobic Exercise in Obese Patients With Atherosclerotic Cardiovascular Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Kayseri City Hospital, class: OTHER_GOV, descriptionModule briefSummary: Obesity is classified using body mass index (BMI) (BMI ≥25 overweight, BMI ≥30 obese, BMI ≥40 morbidly obese). Obese patients are Class 1 according to BMI; BMI:30-34.9 and Class 2; BMI: It is classified as 35-39.9. Patients with classes 1 and 2 will be included in the study. Obesity can be accompanied by comorbidities such as atherosclerotic vascular and cardiac pathologies, hyperlipidemia, hypertension, coronary artery disease, diabetes mellitus, so obesity treatment should be managed multidisciplinary. The basic approach to obesity treatment is diet, exercise, medical treatment, treatment of comorbid conditions and surgery. Aerobic exercise therapy, which is one of the conservative approaches in the treatment of obesity, also has an important place in the treatment of cardiovascular diseases associated with obesity. Atherosclerotic cardiovascular disease (AKD) is one of the most important causes of morbidity and mortality worldwide. Negative changes in functional capacity, quality of life and psychosocial situations are observed due to disorders associated with this disease. Physical activity is among the modifiable risk factors in atherosclerotic diseases. However, patients have a fear of movement related to angina-like symptoms, with the thought that the symptoms may recur during exercise. Lack of physical activity due to fear of movement leads to obesity, which in turn leads to aggravation of atherosclerosis and an increase in the incidence of cardiovascular events, which negatively affects individual and psychosocial capacity. Cardiopulmonary exercise test (CPET) is a non-invasive procedure that evaluates the individual's capacity during dynamic exercise and provides diagnostic and prognostic information. CPET is based on the investigation of the respiratory system, cardiovascular system and cellular response to exercise performed under controlled metabolic conditions. It allows holistic evaluation of the response to exercise, including not only the pulmonary and cardiovascular systems but also the musculoskeletal system. Fear of movement or kinesiophobia; It is defined as a state of fear and avoidance of activity and physical movement resulting from the feeling of sensitivity to painful injury and repeated injury., conditionsModule conditions: Obesity, conditions: Coronary Artery Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: aerobic exercise on the treadmill+For both groups, patients will be recommended joint range of motion (ROM), stretching, strengthening, posture and balance and flexibility exercises for all joints., interventions name: Walking at an intensity of 12-13 RPE+For both groups, patients will be recommended ROM, stretching, strengthening, posture and balance and flexibility exercises for all joints., outcomesModule primaryOutcomes measure: Tampa Kinesiophobia Scale, secondaryOutcomes measure: Cardiopulmonary exercise test, secondaryOutcomes measure: 6 Minutes Walking Test, secondaryOutcomes measure: Body anthropometric measurements, secondaryOutcomes measure: Hospital anxiety and depression scale, secondaryOutcomes measure: international physical activity score, secondaryOutcomes measure: MacNew Heart Disease Health-Related Quality of Life Survey, secondaryOutcomes measure: Numerical Rating Scale, 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: NCT06318728, orgStudyIdInfo id: CAEE - 70162723.0.0000.8093, briefTitle: Musculotendinous Adaptations in High and Low- Performance Triathletes, acronym: MAT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-07-16, completionDateStruct date: 2024-10-04, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: University of Brasilia, class: OTHER, descriptionModule briefSummary: This study aims to investigate the musculotendinous adaptations in the Achilles tendon and the muscles composing the triceps surae induced by triathlon training and competitions in high-performance and low-performance athletes. Twenty high-performance triathletes, twenty low-performance triathletes, and twenty physically active and healthy individuals of both genders will be recruited to constitute the research groups. Ultrasonography will be employed as the assessment method for the structures of the Achilles tendon and the muscular architecture of the triceps surae. The quality and portability of ultrasonography, coupled with its real-time information capabilities, make it the appropriate choice for this evaluation. The VISA-A scale (Victorian Institute of Sport Achilles Assessment) will be used to measure pain and function of the Achilles tendon. The reliability of ultrasonography measures will be obtained by evaluating images of individuals using the intraclass correlation coefficient, allowing for the analysis of result reproducibility. Data analysis will involve comparisons among the high-performance, low-performance, and physically active groups, aiming to identify differences in musculotendinous adaptations related to performance and injury predisposition. Structural changes occurring in these structures and their potential association with sports performance and/or injury predisposition will be explored. Overall, this study utilizes a comparative cross-sectional research design, where different groups are assessed regarding musculotendinous adaptations in the Achilles tendon and triceps surae through ultrasound-derived measures. The use of the VISA-A scale and the assessment of measure reliability will provide additional data on pain, function, and result reproducibility., conditionsModule conditions: Athletes, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Morphological Properties: Tendon Length (TL)., primaryOutcomes measure: Evaluation of Achilles Tendon Shape (fusiform or parallel), primaryOutcomes measure: Echogenicity of the Tendon (homogeneous and heterogeneous areas), primaryOutcomes measure: Mechanical properties of the Achilles Tendon: Force, primaryOutcomes measure: Mechanical properties of the Achilles Tendon: Stress, primaryOutcomes measure: Mechanical properties of the Achilles Tendon: Strain, primaryOutcomes measure: Material Properties of the Achilles Tendon: Elastic Modulus, primaryOutcomes measure: Muscle Thickness, primaryOutcomes measure: Muscle Properties: Pennation Angle (PA), primaryOutcomes measure: Muscle Properties: Fascicle Length (FL), primaryOutcomes measure: Muscle Echogenicity, primaryOutcomes measure: Assessment of Muscle Electrical Activation, primaryOutcomes measure: Muscle Torque Evaluation, primaryOutcomes measure: Evaluation of Muscle and Achilles Tendon Stiffness through 2D Shear Wave Elastography (SWE):, secondaryOutcomes measure: Ankle pain and function, eligibilityModule sex: ALL, minimumAge: 17 Years, maximumAge: 52 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False
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protocolSection identificationModule nctId: NCT06318715, orgStudyIdInfo id: 23-0009-A, briefTitle: Modified Deep Extubation vs. Standard Awake Extubation, acronym: mDE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-03, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Samuel Lunenfeld Research Institute, Mount Sinai Hospital, class: OTHER, descriptionModule briefSummary: The proposed study is to compare a modified DE technique, which is regularly used for low-risk patients by staff anesthesiologists at our institution, to a standard awake extubation. This modified deep extubation (mDE) occurs while the patient is still anaesthetized but at a lower dose of anaesthetic gas than previously described, and balanced with long acting opioids to attenuate the airway reaction. As previously stated, the literature shows that the risks of DE are equivalent to those of regular AE practice. Our hypothesis is that mDE will shorten the time from the end of the surgery (completion of last stitch) to the moment the patient is ready to leave the OR by at least 5 minutes when compared to standard AE practice., conditionsModule conditions: Extubation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: modified deep extubation (mDE), interventions name: standard awake extubation, outcomesModule primaryOutcomes measure: Time from the end of the surgery to leaving the OR, secondaryOutcomes measure: Time from the end of the surgery to extubation, secondaryOutcomes measure: Time from the end of the surgery to discharge from PACU, secondaryOutcomes measure: oral airway, secondaryOutcomes measure: jaw-thrust maneuver, secondaryOutcomes measure: hypertension, secondaryOutcomes measure: breath holding, secondaryOutcomes measure: bag-mask ventilation, secondaryOutcomes measure: coughing, secondaryOutcomes measure: bucking, secondaryOutcomes measure: laryngospasm, secondaryOutcomes measure: treat laryngospasm, secondaryOutcomes measure: desaturation, secondaryOutcomes measure: reintubation, secondaryOutcomes measure: Patient's experience, secondaryOutcomes measure: BP, secondaryOutcomes measure: HR, secondaryOutcomes measure: EtCO2, secondaryOutcomes measure: SaO2, secondaryOutcomes measure: Sevorane MAC, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Anesthesia Mount Sinai Hospital, status: RECRUITING, city: Toronto, state: Ontario, zip: M5G 1X5, country: Canada, contacts name: Naveed Siddiqui, MD, role: CONTACT, phone: 416-586-4800, phoneExt: 5270, email: naveed.siddiqui@uhn.on.ca, contacts name: Naveed Siddiqui, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False
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protocolSection identificationModule nctId: NCT06318702, orgStudyIdInfo id: 2023-KAEK-180, briefTitle: The Effect of Constructivist Learning Model Based Gynecological Cancer Education, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-12-25, primaryCompletionDateStruct date: 2024-01-20, completionDateStruct date: 2024-02-20, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Kastamonu University, class: OTHER, descriptionModule briefSummary: This is a randomised controlled study.The study was conducted to determine the effect of the constructivist education model given to women on gynecological cancer awareness, health Anxiety and spiritual well-being in women . The study population was composed of women living in Kastamonu. Women will be assigned to control and experimental groups. Women in the control group will receive gynecological education from Cancer Early Diagnosis, Screening and Education Centers (KETEM). The other group will receive gynecological cancer education based on the constructivist model.The hypotheses of the study are as follows:H0: The of constructivist learning model -based health education programme does not have an effect on gynecologic cancer awareness, spiritual well-being and health anxiety.H1: The of constructivist learning model -based health education programme have an effect on gynecologic cancer awareness, spiritual well-being and health anxiety., conditionsModule conditions: Gynecologic Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SCREENING, maskingInfo masking: NONE, enrollmentInfo count: 107, type: ACTUAL, armsInterventionsModule interventions name: Education, outcomesModule primaryOutcomes measure: gynecologic cancer awareness, primaryOutcomes measure: spiritual well-being, primaryOutcomes measure: health anxiety scores, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 69 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kastamonu University, city: Merkez, state: Kastamonu, zip: 37150, country: Turkey, hasResults: False
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protocolSection identificationModule nctId: NCT06318689, orgStudyIdInfo id: 2023/0211/OB, briefTitle: In Situ Exploration of Vascular Function in Vasoplegic Shock Following Cardiac Surgery With Cardiopulmonary Bypass, acronym: Vaso-shock, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-05, primaryCompletionDateStruct date: 2026-02-05, completionDateStruct date: 2026-05-05, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: University Hospital, Rouen, class: OTHER, descriptionModule briefSummary: The goal of this observational study is to assess in situ vascular function, glycocalyx and microcirculation in postoperative vasoplegic shock following cardiac surgery with cardiopulmonary bypass.The main question is to investigate the relationship between NO-dependent vasomotor reserve and the presence of vasoplegic shock following cardiac surgery with cardiopulmonary bypass.Participants will have two visits, during which a number of non-invasive examinations will be carried out to study glycocalyx, microcirculation and vascular function. Biological and morphological data will be collected up to 3 months after inclusion, as well as information on treatments administered and outcome.Researchers will compare a group of patients with vasoplegic shock against a group without vasoplegic shock in order to study possible alterations in function in the vasoplegic shock group., conditionsModule conditions: Cardiac Surgical Procedures, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 124, type: ESTIMATED, outcomesModule primaryOutcomes measure: Association between the percentage of brachial artery variation measured by the flow-mediated vasodilation method and the presence of vasoplegic shock at incusion., secondaryOutcomes measure: Association between the percentage of brachial artery variation measured by the flow-mediated vasodilation method and the presence of vasoplegic shock at 48 hours., secondaryOutcomes measure: Pefused boundary region (PBR, µm) obtained from Glycocheck with the presence of vasoplegic shock., secondaryOutcomes measure: Microvascular blood flow (10^3 microns^3 / sec / mm^2) obtained from Glycocheck with the presence of vasoplegic shock, secondaryOutcomes measure: Total density (number of 10 micron long vessel segments with diameter of 4 to 25 microns per tissue surface area /mm^2) obtained from Glycocheck with the presence of vasoplegic shock, secondaryOutcomes measure: Endothelial function markers (Endothelin-1, pg/mL) with the presence of vasoplegic shock, secondaryOutcomes measure: Endothelial function markers (syndecan-1, pg/mL) with the presence of vasoplegic shock, secondaryOutcomes measure: Endothelial function markers (interleukin-6, pg/mL) with the presence of vasoplegic shock, secondaryOutcomes measure: Endothelial function markers (VCAM-1, pg/mL) with the presence of vasoplegic shock, secondaryOutcomes measure: Multivariate analysis explaining the occurrence of vasoplegic shock., secondaryOutcomes measure: Multivariate analysis explaining the occurrence of an altered perfused boundary region (µm)., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rouen University Hospital, status: RECRUITING, city: Rouen, state: Normandie, zip: 76000, country: France, contacts name: Emmanuel Besnier, MD, PhD, role: CONTACT, phone: 33232881705, email: emmanuel.besnier@chu-rouen.fr, contacts name: Domitille Renard, MD, role: CONTACT, phone: 33232881705, email: domitille.renard@chu-rouen.fr, geoPoint lat: 49.44313, lon: 1.09932, hasResults: False
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protocolSection identificationModule nctId: NCT06318676, orgStudyIdInfo id: CA057-1009, briefTitle: A Study to Evaluate the Drug Levels of Mezigdomide in Adult Participants With Renal Impairment, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-03-05, completionDateStruct date: 2025-03-05, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Celgene, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the drug levels of mezigdomide in participants with renal impairment., conditionsModule conditions: Renal Impairment, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: Mezigdomide, outcomesModule primaryOutcomes measure: Maximum observed concentration (Cmax), primaryOutcomes measure: Area under the plasma concentration-time curve (AUC), primaryOutcomes measure: Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)), secondaryOutcomes measure: Number of participants with adverse events (AEs), secondaryOutcomes measure: Number of participants with serious adverse events (SAEs), secondaryOutcomes measure: Number of participants with physical examination findings, secondaryOutcomes measure: Number of participants with vital sign abnormalities, secondaryOutcomes measure: Number of participants with 12-lead electrocardiogram (ECG) findings, secondaryOutcomes measure: Maximum observed concentration (Cmax), secondaryOutcomes measure: Time of maximum observed concentration (Tmax), secondaryOutcomes measure: Area under the plasma concentration-time curve (AUC), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 82 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: PANAX, city: Miami Lakes, state: Florida, zip: 33014, country: United States, contacts name: Robert Perry, Site 0002, role: CONTACT, phone: 3056984500107, geoPoint lat: 25.90871, lon: -80.30866, locations facility: Local Institution - 0003, city: Orlando, state: Florida, zip: 32808, country: United States, contacts name: Site 0003, role: CONTACT, geoPoint lat: 28.53834, lon: -81.37924, locations facility: Orlando Clinical Research Center OCRC, city: Orlando, state: Florida, zip: 32809, country: United States, contacts name: Thomas Marbury, Site 0001, role: CONTACT, phone: 407-257-3462, geoPoint lat: 28.53834, lon: -81.37924, hasResults: False
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protocolSection identificationModule nctId: NCT06318663, orgStudyIdInfo id: STUDY00007685, briefTitle: Survivor Mom Companion Comparison Study, acronym: SMC, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-12, primaryCompletionDateStruct date: 2024-12-12, completionDateStruct date: 2024-12-12, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: State University of New York at Buffalo, class: OTHER, descriptionModule briefSummary: The overall goal of the SMC is to help reduce posttraumatic stress symptomology for pregnant persons with a history of trauma., conditionsModule conditions: Posttraumatic Stress Symptom, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Survivor Mom Companion, outcomesModule primaryOutcomes measure: Childhood Trauma Questionnaire, primaryOutcomes measure: Primary Care Post Traumatic Stress Disorder Screen for Diagnostic and Statistical Manual of Mental Disorders-5, primaryOutcomes measure: Adverse Childhood Experiences Questionnaire, primaryOutcomes measure: Post Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, primaryOutcomes measure: Dissociative Subtype of Post Traumatic Stress Scale, secondaryOutcomes measure: Patient Health Questionnaire-9, secondaryOutcomes measure: State Trait Anger Expression Inventory, secondaryOutcomes measure: Symptoms Checklist-90 Revised/Interpersonal Sensitivity Subscale, secondaryOutcomes measure: Difficulties in Emotion Regulation Scale Short Form, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Buffalo Prenatal-Perinatal Network, status: RECRUITING, city: Buffalo, state: New York, zip: 14203, country: United States, contacts name: LuAnne Brown, role: CONTACT, email: lb@bppn.org, geoPoint lat: 42.88645, lon: -78.87837, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-08-28, uploadDate: 2024-03-15T14:52, filename: Prot_SAP_000.pdf, size: 217043, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-08-28, uploadDate: 2024-03-15T14:53, filename: ICF_001.pdf, size: 270737, hasResults: False
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protocolSection identificationModule nctId: NCT06318650, orgStudyIdInfo id: 19124PER6_3_1, briefTitle: Post Extraction Changes After Ridge Preservation Using Allogeneic Dentin Matrix Vs Demineralized Freeze Dried Allograft, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2024-12-01, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: the aim of this study is to establish if there are clinical, radio-graphical and histomorphometrical differences between using Allogenic Demineralized Dentin matrix versus Demineralized Freeze-Dried Bone Allograft (DFDBA) as a clinical application in alveolar bone regeneration procedures related to implant dentistry, including socket preservation, alveolar ridge augmentation, after tooth extraction in the esthetic zone.Will ridge preservation using Allogeneic Dentin Matrix be more effective than Demineralized Freeze-Dried Bone Allograft in managing the post extraction hard tissue alterations?The initial therapy consists of periodontal treatment (phase I therapy) including supragingival scaling, subgingival debridement if needed, adjustment of faulty restoration and polishing. The mechanical plaque control instructions for each patient include brushing and interdental cleaning techniques. alginate impression will be taken to fabricate an acrylic stent to be used as reference for measurements of width of ridge clinically.Flapless and atraumatic tooth extraction will be initiated, Then the socket will be filled either with Allogeneic Dentin Matrix or Demineralized freeze-dried bone allograft (DFDBA) up to the crestal level of then bone followed by placement of a collagen membrane to cover the socket. criss-cross horizontal mattress suturing techniqueIntervention group: The socket will be filled with Allogeneic Dentin Matrix Control group: The socket will be filled with Demineralized freeze-dried bone allograft (DFDBA).For both groups, All the subjects will be evaluated at pre-surgical, baseline and 6 months post surgical months for clinical parameters and baseline( immediate post-surgical and 6 months post-surgical . Outcomes: Change in ridge width clinically after 6 months, Change in the radiographic buccal vertical bone level, Change in the radiographic palatal vertical bone level,Change in the radiographic horizontal bone level,Percentage of new vital bone formation,Percentage of residual bone graft and Implant Primary Stability., conditionsModule conditions: Socket Preservation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A Randomized Controlled Clinical Trial, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 22, type: ESTIMATED, armsInterventionsModule interventions name: Demineralized Dentin Matrix, interventions name: Demineralized freeze-dried bone allograft (DFDBA), outcomesModule primaryOutcomes measure: Change in Ridge width over 6 months, secondaryOutcomes measure: Change in the radiographic vertical bone level, secondaryOutcomes measure: Change in the radiographic horizontal bone level, secondaryOutcomes measure: Percentage of new vital bone formation and residual graft, secondaryOutcomes measure: Implant Primary Stability, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Dentistry Cairo University, status: RECRUITING, city: Cairo, zip: 12613, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False
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protocolSection identificationModule nctId: NCT06318637, orgStudyIdInfo id: CCSSKB005432, briefTitle: A Study to Evaluate the Acceptability and Feasibility of a Bedtime Routine for Neonates, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-21, primaryCompletionDateStruct date: 2024-12-23, completionDateStruct date: 2024-12-23, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Johnson & Johnson Consumer Inc. (J&JCI), class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to assess, via caregiver questionnaire, the acceptability and feasibility of implementing a bedtime routine for newborns., conditionsModule conditions: Newborn, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Baby Wash/Shampoo, interventions name: Daily Activities, interventions name: Body Lotion, outcomesModule primaryOutcomes measure: Bedtime Routine Acceptability and Feasibility to Caregivers, primaryOutcomes measure: Bedtime Routine Acceptability and Feasibility to Caregivers, primaryOutcomes measure: Bedtime Routine Acceptability and Feasibility to Caregivers, primaryOutcomes measure: Bedtime Routine Acceptability and Feasibility to Caregivers, eligibilityModule sex: ALL, minimumAge: 2 Weeks, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: SGS North America, Inc., city: Richardson, state: Texas, zip: 75081, country: United States, geoPoint lat: 32.94818, lon: -96.72972, hasResults: False
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protocolSection identificationModule nctId: NCT06318624, orgStudyIdInfo id: KHSU-2023/11, briefTitle: Immediate Effects of Ankle MWM and Taping on Gait and Balance in Stroke Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-14, primaryCompletionDateStruct date: 2024-09-15, completionDateStruct date: 2024-10-11, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Kutahya Health Sciences University, class: OTHER, descriptionModule briefSummary: Disorders caused by stroke may lead to significant limitations, especially in ankle range of motion, and may cause impairments in walking and balance functions. This limitation in ankle range of motion leads to difficulties in weight transfer, stability, and balance. As a result, there is a decrease in walking performance and an increased risk of falls. Various interventions have been used to improve ankle dorsiflexion passive range of motion, including gastrosoleus muscle stretching, muscle strengthening training, functional electrical stimulation training, proprioceptive control training, taping, manual therapy, different mobilization techniques, and ankle mobilization with motion (MWM).There are limited studies investigating the immediate effects of MWM and taping on gait and balance in stroke patients. This study was planned to investigate the effect of Mulligan's ankle MWM technique and talus stabilization taping on spatiotemporal gait and balance parameters in stroke patients., conditionsModule conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: There are 2 different groups in the study. One of them is the intervention group and the other is the sham group., whoMasked: PARTICIPANT, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Mobilisation with Movement and Taping, interventions name: Sham, outcomesModule primaryOutcomes measure: Stride length, primaryOutcomes measure: Stride width, primaryOutcomes measure: Cadance, primaryOutcomes measure: Walking speed, primaryOutcomes measure: The symmetry of the center of pressure changes during walking, primaryOutcomes measure: The maximum force on the feet during walking, primaryOutcomes measure: The distribution of pressure on the feet, primaryOutcomes measure: Balance, secondaryOutcomes measure: 10-meter walk test, secondaryOutcomes measure: Timed up and go test, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Kutahya Health Sciences University, status: RECRUITING, city: Kütahya, zip: 43100, country: Turkey, contacts name: Fatıma Yaman, PhD, MD, role: CONTACT, phone: +905066802926, email: fatimacakir84@hotmail.com, contacts name: Berna Kılıç, PT, role: SUB_INVESTIGATOR, geoPoint lat: 39.42417, lon: 29.98333, hasResults: False
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protocolSection identificationModule nctId: NCT06318611, orgStudyIdInfo id: 09.2022.575, briefTitle: Sleep Patterns and Chronotype in Children With and Without Type 1 Diabetes, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-05-01, primaryCompletionDateStruct date: 2023-05-01, completionDateStruct date: 2023-05-01, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Koç University, class: OTHER, collaborators name: Marmara University, descriptionModule briefSummary: Type 1 diabetes (T1D) is one of the most common chronic childhood diseases. Recent studies have highlighted the strong association between type 1 diabetes and sleep health problems. Sleep problems have been reported to include sleep onset, sleep maintenance, frequent nighttime awakenings, and daytime sleepiness. Studies show that children with T1D sleep significantly less than their peers without diabetes, and that this is associated with poorer glycemic control in type 1 diabetes due to impaired glucose metabolism.This study aimed to compare sleep health composite dimensions and chronotype in children and adolescents with and without T1D, and to explore the relationship between sleep and glycemic variability in T1D.The study was designed as a prospective observational case-control study. The estimated sample size is calculated as 168.The sleep health composite dimensions were measured using actigraphy, sleep diaries, and self- or parental reports. Sleep disturbance will be assessed using the Diagnostic and Statistical Manual for Mental Disorders (DSM-5) Level 2-Sleep Disturbance Scale Short Form, and the Children's Chronotype Questionnaire will be used to determine the chronotype. Sleep/wake patterns were also assessed using sleep diaries. Glycemic variability was assessed using continuous glucose monitoring (CGM) device parameters., conditionsModule conditions: Type1diabetes, conditions: Sleep, conditions: Chronotype, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 168, type: ACTUAL, armsInterventionsModule interventions name: sleep, chronotype, outcomesModule primaryOutcomes measure: Sleep health composite, primaryOutcomes measure: Chronotype, secondaryOutcomes measure: Glycemic variability, secondaryOutcomes measure: Glycemic control, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Necla İpar, city: İstanbul, zip: 34010, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False
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protocolSection identificationModule nctId: NCT06318598, orgStudyIdInfo id: 23M202, briefTitle: Biomarker-driven Phenotypic Dissection of Amyotrophic Lateral Sclerosis, acronym: DRIVEALS, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-11, primaryCompletionDateStruct date: 2026-04-10, completionDateStruct date: 2026-04-10, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, collaborators name: Azienda Ospedaliera Città della Salute e della Scienza di Torino, collaborators name: Ospedale San Raffaele, descriptionModule briefSummary: The goal of this observational study is to understand the clinical variability in a population of ALS patients using multidimensional biomarkers. The main questions it aims to answer are:* Which set of biomarkers explain genotypic-phenotypic correlations in ALS?* Which set of biomarkers can be used to subdivide the ALS population in homogeneous subgroups?Participants will undergo:* neurological evaluation* neurophysiological evaluation* neuropsychological evaluation* whole exome sequencing* biomarker measurement in CSF and plasma, conditionsModule conditions: Amyotrophic Lateral Sclerosis, conditions: Motor Neuron Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, outcomesModule primaryOutcomes measure: genetic screening, primaryOutcomes measure: biomarker assessment, secondaryOutcomes measure: clinical assessment, secondaryOutcomes measure: neuropsychological assessment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ospedale San Raffaele, status: RECRUITING, city: Milano, state: MI, zip: 20132, country: Italy, contacts name: Yuri Falzone, MD, PhD, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Ospedale San Luca, status: RECRUITING, city: Milano, state: MI, zip: 20149, country: Italy, contacts name: Alberto Doretti, MD, role: CONTACT, phone: +0261911, phoneExt: 2937, email: a.doretti@auxologico.it, geoPoint lat: 45.46427, lon: 9.18951, locations facility: AOU Città della Salute e della Scienza, status: RECRUITING, city: Torino, state: TO, zip: 10126, country: Italy, contacts name: Adriano Chiò, MD, role: CONTACT, geoPoint lat: 45.07049, lon: 7.68682, hasResults: False
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protocolSection identificationModule nctId: NCT06318585, orgStudyIdInfo id: 23C306, briefTitle: Creation of a Clinical Database for the Study of Phenotypic Variability in Motor Neuron Diseases, acronym: ALS-PHENO, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-04-03, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, descriptionModule briefSummary: Study Description: Characterization of Motor Neuron Disease PhenotypesThe goal of this observational study is to understand the clinical presentation of motor neuron disease (MND) in patients attending the Neurology Department of the Istituto Auxologico Italiano. The main questions it aims to answer are:* What are the specific clinical phenotypes associated with MND?* How can these phenotypes contribute to a better understanding of the disease's underlying mechanisms and improve prognostic accuracy?Participants will undergo:* Clinical evaluation using validated scales* Neurophysiological and neuroradiological instrumental assessment* Neuropsychological evaluation* Collection of biological materials for genetic screening and biomarker assessment, if necessary., conditionsModule conditions: Amyotrophic Lateral Sclerosis, conditions: Motor Neuron Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 200, type: ESTIMATED, outcomesModule primaryOutcomes measure: no. of patients with classic ALS, primaryOutcomes measure: no. of patients with bulbar ALS, primaryOutcomes measure: no. of patients with LMN phenotypes (flail arm, flail leg, PMA), primaryOutcomes measure: no. of patients with UMN phenotypes (pyramidal ALS, PLS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ospedale San Luca, status: RECRUITING, city: Milano, state: MI, zip: 20149, country: Italy, contacts name: Alberto Doretti, MD, role: CONTACT, phone: +0261911, phoneExt: 2937, email: a.doretti@auxologico.it, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False
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protocolSection identificationModule nctId: NCT06318572, orgStudyIdInfo id: PR(AG)166/2021, briefTitle: Development of Self-administrable Psychological Intervention Programs Supported by New Technologies as a Treatment for Patients With Functional Digestive Disorders., statusModule overallStatus: RECRUITING, startDateStruct date: 2023-03-09, primaryCompletionDateStruct date: 2024-12-30, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Hospital Universitari Vall d'Hebron Research Institute, class: OTHER, descriptionModule briefSummary: Disorders of gut-brain interaction (DGBI) are produced by disturbances in the interplay between the gut and the central nervous system. Several psychological factors like anxiety, depression and altered coping are over-represented in these disorders. Recent surveys have shown that DGBI affect up to 40 % of the general population.Psychological interventions like cognitive behavioral therapy and hypnosis have been shown to be beneficial for managing these disorders. However, access to psychological interventions is very limited due to lack of resources to treat these very frequent conditions.OBJECTIVE: To determine the effects of psychological interventions using specifically developed therapeutic programs based on virtual reality, for telematic use at home, on symptoms severity, comorbidities, visceral sensitivity and intestinal dysbiosis in patients with DGBI.METHODOLOGY: After development of a program of psycho-education on DGBI using interactive immersion by means of virtual reality (VR) a randomized clinical trial will be developed. Consecutive patients will be randomized 1:1 to active treatment or placebo. In each patient in the active treatment group a session of psychoeducation using specifically developed VR-video leaded by a gastroenterologists, will be followed by telematic weekly group sessions of psycho-education leaded by a psychologist. During the 6 weeks of the treatment period patients will be instructed to perform self-administrable sessions of psychotherapy at home (by means VR). Patients in the placebo group willl take a placebo capsule daily.OUTCOME MEASURES. In all patients, severity of symptoms (primary outcome), QoL, somatic and psychological comorbidities (using specific questionnaires), visceral sensitivity (by means of a barostat) and microbiota analysis, will be performed before and at the end of the treatment period. Symptom severity will be assess also in follow-up phone calls at 3 and 6 months., conditionsModule conditions: Irritable Bowel Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Psychological intervention, interventions name: Placebo, outcomesModule primaryOutcomes measure: Severity of abdominal symptoms, secondaryOutcomes measure: IBS related Quality of life, secondaryOutcomes measure: Stress, secondaryOutcomes measure: Anxiety and depression, secondaryOutcomes measure: Somatic co-morbidities, secondaryOutcomes measure: Rectal sensitivity, secondaryOutcomes measure: Analysis of gut microbiota composition, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Universitari Vall d'Hebron, status: RECRUITING, city: Barcelona, zip: 08035, country: Spain, contacts name: Jordi Serra, MD, role: CONTACT, phone: 34 932746259, email: jordi.serra@vallhebron.cat, contacts role: CONTACT, email: jordi.serra@vallhebron.cat, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False
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protocolSection identificationModule nctId: NCT06318559, orgStudyIdInfo id: 027-FPO22, briefTitle: Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention, acronym: RIDERS, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-06-29, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-19, lastUpdatePostDateStruct date: 2024-03-19, sponsorCollaboratorsModule leadSponsor name: Fondazione del Piemonte per l'Oncologia, class: OTHER, collaborators name: San Luigi Gonzaga Hospital, descriptionModule briefSummary: This is a prospective randomized multicenter study aimed at comparing 3D AI-AR-RARP vs. no 3D, verifying the impact of this new technology on oncological and functional outcomes after the procedure., conditionsModule conditions: Cancer of Prostate, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients will be randomized using an Excel® macro in 2 group: 3D and no3D, stratifying them by age, PSA, cT, PSA density, prostate volume, lesion volume, extracapsular extension (ECE), seminal vesicle invasion (SVI), biopsy ISUP., primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: 3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomy, outcomesModule primaryOutcomes measure: Perioperative surgical oncological outcomes, secondaryOutcomes measure: Micturition outcomes, secondaryOutcomes measure: Sexual function outcomes, secondaryOutcomes measure: Oncological outcomes, otherOutcomes measure: Verify the potential application of AI, eligibilityModule sex: MALE, minimumAge: 40 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo, status: RECRUITING, city: Candiolo, state: Turin, zip: 10060, country: Italy, contacts name: Enrico Checcucci, MD, role: CONTACT, phone: +390119933632, email: enrico.checcucci@ircc.it, geoPoint lat: 44.95858, lon: 7.59812, locations facility: AOU san Luigi Gonzaga, status: RECRUITING, city: Orbassano, state: Turin, zip: 10060, country: Italy, contacts name: Francesco Porpiglia, MD, role: CONTACT, geoPoint lat: 45.00547, lon: 7.53813, hasResults: False
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