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<|newrecord|> nctId: NCT06350799 id: 01741 briefTitle: Chronic Obstructive Pulmonary Disease and Community Health Worker Home-visits overallStatus: COMPLETED date: 2019-03-14 date: 2021-05-27 date: 2023-04-28 date: 2024-04-05 date: 2024-04-05 name: VA Puget Sound Health Care System class: FED name: Public Health - Seattle and King County name: University of Washington briefSummary: We examined a Community Health Worker (CHW) program for Chronic Obstructive Pulmonary Disease (COPD) in Veteran Participants. The goal of this study was to assess participants' perceived acceptability, appropriateness, and feasibility of the intervention, explore participants' COPD health outcomes, and gather insights from participants and CHWs to inform potential improvements.
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Veteran participants enrolled in the 12-week intervention and received a series of 9 CHW home, phone, or video visits. These visits provided education and chronic disease self-management practices to improve COPD health.
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Researchers examined the participant and CHW perception of the intervention through qualitative interviews and surveys. conditions: COPD studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 9 type: ACTUAL measure: Acceptability, Appropriateness, Feasibility sex: ALL minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: VA Puget Sound Health Care System city: Seattle state: Washington zip: 98108 country: United States lat: 47.60621 lon: -122.33207 hasResults: False
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<|newrecord|> nctId: NCT06350786 id: ROM Study id: PZ00P1_201972 type: OTHER_GRANT domain: Swiss National Science Foundation briefTitle: Conditioned Open-label Placebos to Facilitate Opioid Reduction in Patients With Chronic Non-cancer Pain acronym: ROM overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-05 date: 2025-07 date: 2024-04-05 date: 2024-04-05 name: Cosima Locher class: OTHER name: Brown University name: University of Basel briefSummary: This study aims to evaluate whether the reduction of the daily morphine equivalent dose (MED) in patients with chronic non-cancer pain (CNCP) can be decreased with an open-label placebo (OLP) intervention in comparison to an electronic monitoring (EM) control group. The participants will receive the intervention (OPL or EM) over the duration of six weeks. Diverse psychological and health measures will be assessed with questionnaires over the course of the intervention. Furthermore, evaluation outcomes, qualitative outcomes and safety outcomes will be assessed. It is hypothesized that the OLP-intervention group in comparison to the EM-control group will have a significantly lower consumption of MED over the course of the study. Furthermore, this study aims to evaluate whether the OLP intervention can reduce opioid withdrawal symptoms in comparison to the control group. conditions: Chronic Non-cancer Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 86 type: ESTIMATED name: P-Dragees blue Lichtenstein, Placebo dragees name: Control group (EM) measure: Daily opioid consumption (MED): measure: Subjective opioid withdrawal symptoms measure: Pain severity measure: Pain disability measure: Anxiety measure: Depression measure: Pain Opioid Analgesics Beliefs Scale - Cancer measure: Treatment Expectancy measure: Placebo pill count measure: Opioid adherence measure: Rationale credibility measure: Placebo understanding measure: Patient Provider Connection measure: Medication history measure: Primary treating physicians' acceptability of the OLP approach: measure: Primary treating physicians' treatment expectancies measure: Qualitative Outcomes measure: Safety Outcomes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06350773 id: FMBSUREC/06122022/ Zaher briefTitle: Phosphodiesterase Type 5 Inhibitors in Patients With Group 2 Pulmonary Hypertension overallStatus: RECRUITING date: 2023-01-10 date: 2024-07 date: 2024-11 date: 2024-04-05 date: 2024-04-08 name: Beni-Suef University class: OTHER briefSummary: The goal of this clinical trial is to test the efficacy of tadalafil in patients with group II pulmonary hypertension with elevated pulmonary vascular resistance (PVR). The main question it aims to answer is:
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• Can tadalafil improve patients with group II pulmonary hypertension with elevated PVR? Participants will undergo right heart catheterization (RHC) to make sure they are fulfilling the inclusion criteria, then will be asked to take tadalafil 20 mg for two weeks then 40 mg if tolerated for 12 weeks, then participants will be followed up. Investigators will compare the drug group with another age- and sex- matched control placebo group. conditions: Group 2 Pulmonary Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: tadalafil 20 mg then 40 mg if tolerated measure: Functional capacity of the patients measure: heart failure symptoms measure: right ventricular function measure: right ventricular function measure: right ventricular function measure: right ventricular function measure: right ventricular function sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beni Suef University status: RECRUITING city: Cairo state: Beni Suef zip: 62511 country: Egypt name: Hesham Boshra Mahmoud, Doctorate role: CONTACT phone: 201001402250 email: [email protected] lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06350760 id: UJA_PROCARE-I+ briefTitle: Transdiagnostic, Indicated Preventive Intervention for Adolescents At High Risk of Emotional Problems W/Add-On Modules acronym: PROCARE-I+ overallStatus: RECRUITING date: 2023-03-15 date: 2024-07-31 date: 2024-12-31 date: 2024-04-05 date: 2024-04-05 name: University of Jaén class: OTHER name: Universidad Miguel Hernandez de Elche name: University Rovira i Virgili name: University of Miami briefSummary: PROCARE is a preventive intervention that has shown its effectiveness in selective prevention to reduce young people's risk of developing emotional problems. In this study, an uncontrolled pre-post study is carried out where this personalized transdiagnostic preventive intervention in online mode is applied in the indicated population, with the following objectives: 1) provide data about whether there are improvements in the emotional state of adolescents after implementing PROCARE-I+; and 2) evaluate if there is any risk factor that predicts anxiety-depressive symptoms and/or emotional difficulties. The sample was made up of 30 adolescents who showed symptoms of anxiety and/or depression and a high risk of developing an emotional disorder and who benefited from the preventive, transdiagnostic, online and personalized intervention called PROCARE-I+. After the analysis of the data collected at the pre-intervention and post-intervention time, the data revealed that the intervention had an impact on improving the emotional state of the adolescents in terms of anxious-depressive symptomatology, quality of life and emotional regulation. On the other hand, the data revealed the absence of predictive relationships between the presence of a risk factor and suffering from symptoms of anxiety and depression; In contrast, predictive relationships were found between the presence of the family risk factor and suffering from some emotional difficulty. conditions: Anxiety Disorders and Symptoms conditions: Depressive Symptoms studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: To-arm interventions are carried out, measuring at the pre-intervention moment and at the post-intervention moment. primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: Active control condition name: PROCARE-I+ 8-session measure: Self-reported anxiety and mood symptomatology measure: Factors associated with adolescents' mental health measure: Resilience measure measure: Health-related quality of life measure: Absence of emotional disorders measure: Economic evaluations measure: Psychological flexibility measure: Emotional regulation measure: Bullying measure: Expressed Emotion measure: Ecoanxiety measure: Exam anxiety measure: Videogames addiction measure: Smartphone addiction sex: ALL minimumAge: 12 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Universidad Miguel Hernández status: RECRUITING city: Elche state: Alicante zip: 03202 country: Spain name: José Antonio Piqueras, Ph. D. role: CONTACT phone: 966658343 email: [email protected] name: José Antonio Piqueras, Ph. D. role: SUB_INVESTIGATOR lat: 38.26218 lon: -0.70107 facility: University of Jaén status: RECRUITING city: Jaén state: Jaen zip: 23071 country: Spain name: Luis Joaquín García-López, Ph. D. role: CONTACT phone: 953213412 email: [email protected] name: Luis Joaquín García-López, Ph. D. role: PRINCIPAL_INVESTIGATOR name: José Antonio Muela-Martínez, Ph. D. role: PRINCIPAL_INVESTIGATOR name: Lourdes Espinosa-Fernández, Ph. D. role: PRINCIPAL_INVESTIGATOR name: Laura Zafra-Palomino, Ph. D. stud role: PRINCIPAL_INVESTIGATOR name: David Jiménez-Vázquez, Ph. D. stud role: PRINCIPAL_INVESTIGATOR lat: 37.76922 lon: -3.79028 facility: Universitat Rovira i Virgili status: RECRUITING city: Tarragona zip: 43003 country: Spain name: Josefa Canals, M.D. role: CONTACT phone: 977257895 email: [email protected] name: Josefa Canals, M.D. role: SUB_INVESTIGATOR lat: 41.11667 lon: 1.25 hasResults: False
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<|newrecord|> nctId: NCT06350747 id: CelalBayarU-SBF-OT-02 briefTitle: The Effect of Laughter Yoga on Nurses' Perceived Stress, Sleep Quality, and Burnout Levels overallStatus: RECRUITING date: 2024-04-01 date: 2024-07-01 date: 2024-07-30 date: 2024-04-05 date: 2024-04-18 name: Celal Bayar University class: OTHER briefSummary: The aim of the study was to investigate the effects of laughter yoga on nurses' perceived stress, sleep quality, and burnout levels. conditions: Healthy Participants studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: pretest-posttest with control group primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 64 type: ESTIMATED name: Laughter Yoga measure: Perceived Stress Scale measure: Jenkins Sleep Scale measure: Maslach Burnout Scale sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Manisa Celal Bayar Üniversitesi Hafsa Sultan Hastanesi status: RECRUITING city: Manisa zip: 45060 country: Turkey name: Özge Topsakal, PhD role: CONTACT phone: 05549165599 email: [email protected] lat: 38.61202 lon: 27.42647 hasResults: False
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<|newrecord|> nctId: NCT06350734 id: 18-004675 id: NCI-2024-00973 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 18-004675 type: OTHER domain: Mayo Clinic Institutional Review Board briefTitle: Quality of Life After Treatment for Bladder Cancer: The Bladder Cancer Survivorship Study overallStatus: RECRUITING date: 2018-10-12 date: 2029-01-31 date: 2029-01-31 date: 2024-04-05 date: 2024-04-05 name: Mayo Clinic class: OTHER briefSummary: This study evaluates the effect of bladder cancer treatment on quality of life. conditions: Stage 0a Bladder Cancer AJCC v8 conditions: Stage 0is Bladder Cancer AJCC v8 conditions: Stage I Bladder Cancer AJCC v8 conditions: Stage II Bladder Cancer AJCC v8 conditions: Stage IIIA Bladder Cancer AJCC v8 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 704 type: ESTIMATED name: Non-Interventional Study measure: Change in quality of life outcomes - PROMIS-29 measure: Change in quality of life outcomes - Bladder Cancer Index measure: Patient level characteristics sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Arizona status: RECRUITING city: Scottsdale state: Arizona zip: 85259 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: [email protected] name: Mark D. Tyson, M.D., M.P.H. role: PRINCIPAL_INVESTIGATOR lat: 33.50921 lon: -111.89903 facility: Mayo Clinic in Florida status: RECRUITING city: Jacksonville state: Florida zip: 32224-9980 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: [email protected] name: Paul R. Young, M.D. role: PRINCIPAL_INVESTIGATOR lat: 30.33218 lon: -81.65565 facility: Mayo Clinic in Rochester status: RECRUITING city: Rochester state: Minnesota zip: 55905 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: [email protected] name: Matthew T. Gettman, M.D. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False
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<|newrecord|> nctId: NCT06350721 id: DizzyVR briefTitle: Feasibility, Usability and Safety of the Vestibular Rehabilitation Using the Immersive Virtual Reality Software DizzyVR acronym: DizzyVR overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-06-01 date: 2024-10-01 date: 2024-04-05 date: 2024-04-05 name: Universidad Loyola Andalucia class: OTHER name: University of Seville name: Universitat Politècnica de València name: Universidad de Zaragoza briefSummary: The goal of this pilot study is to assess the safety and feasibility of the immersive virtual reality system called DizzyVR in participants diagnosed with a vestibular disorder. The main questions it aims to answer are:
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* To assess the feasibility, usability and safety of the system DizzyVR for the vestibular rehabilitation in participants with vestibular disorders.
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* To detect and record possible adverse events due to the use of DizzyVR.
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* To examine the degree of adherence of the participants to the intervention.
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* To know the average success rate of the different games in each session.
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* To evaluate the average difficulty levels overcome throughout the intervention.
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* To know the usability and satisfaction with the system reported by participants and therapists.
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Participants will receive the vestibular rehabilitation based on the novel immersive virtual systema, DizzyVR. conditions: Vestibular Disorder conditions: Physical Disability studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 10 type: ESTIMATED name: DizzyVR measure: Retention rate of participants measure: User Satisfaction Evaluation Questionnaire (USEQ) measure: Register of risk and number of adverse events experimented by the stakeholders measure: Adherence rate measure: Dropout rates sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06350708 id: 2024-18304-33663 id: 336664 type: OTHER domain: Integrated Research Application System (IRAS) briefTitle: Virtual Reality (VR) Paediatric Tracheostomy Training overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-07-10 date: 2024-07-10 date: 2024-04-05 date: 2024-04-05 name: University of Manchester class: OTHER briefSummary: This study aims to evaluate the use of an unsupervised virtual reality training tool. This tool is used to teach nurses, doctors and other healthcare workers and their students how to manage tracheostomy emergencies in children. conditions: Educational Study studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 69 type: ESTIMATED name: Virtual reality (VR) tracheostomy educational tool measure: Performance in simulation (time to key specific intervention, time to completion of scenario, and number of correct interventions completed) measure: Knowledge using a bespoke knowledge multiple choice questionnaire adapted from a validated question bank. measure: Participant satisfaction measured using a bespoke data collection tool. measure: Virtual Reality Sickness measure: Usability using the validated system usability scale sex: ALL minimumAge: 18 Years maximumAge: 68 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Manchester city: Manchester state: Greater Manchester zip: M13 9PL country: United Kingdom name: Jonathan R Abbas, MBChB role: CONTACT email: [email protected] lat: 53.48095 lon: -2.23743 hasResults: False
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<|newrecord|> nctId: NCT06350695 id: HP-00103478 id: 1R21AG080424-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R21AG080424-01 briefTitle: The ROle of Compression StocKings in Heart Failure Patients acronym: ROCK-HF overallStatus: RECRUITING date: 2024-01-17 date: 2025-06-01 date: 2026-01-01 date: 2024-04-05 date: 2024-04-05 name: University of Maryland, Baltimore class: OTHER name: National Institute on Aging (NIA) briefSummary: Congestive heart failure (CHF) occurs when the heart is weak and not able to effectively pump blood to the body. One of the common manifestations of CHF is fluid overload and swelling of the legs. Diuretics or "water pills" are usually the treatment for fluid overload and leg swelling; however, in some patients' diuretics are no longer effective or the effectiveness is limited due to poor kidney function. The presence of chronic swelling of the legs could potentially damage the veins; additionally, it could lead to chronic skin changes in the legs and in the worst cases to a leg ulcer. Compression stockings are used in patients with venous diseases to reduce the swelling of the legs and improve mobility and quality of life. Although, there is a theoretical risk that compression stockings might push the fluid of the legs back to the heart and lungs worsening the CHF. The purpose of this study is to determine whether the use of knee-high tight socks (tight stockings with strong compression) vs. knee-high soft socks (soft stockings with minimum compression) are effective in preventing swelling and skin changes and safe in patients with CHF. During the first visit (in-person) a routine medical test will be performed including blood tests, review of the medication doses, current weight, an ultrasound images of the veins, (venous reflux ultrasound), questions about health status and a brief physical exam. The participants will be randomly assigned to receive tight compression vs. soft compression socks. Participants will be asked to wear the socks at least 8 hours a day for 5 days a week. There will be a total of 3 virtual visit (by video or telephone); the first one after one week, then after one month and two months. During the virtual visit participants will be asked about symptoms, current medications and doses, and current weight. The participants are expected to return to the clinic after 3 months for a second in-person visit. During this visit the investigators will ask questions about participant's health, they will perform a brief physical exam of their legs, and check participants weight and medicines; also, a venous ultrasound of the legs, questions about health status will be performed. The duration of the study is 3 months. conditions: Heart Failure，Congestive conditions: Leg Edema conditions: Venous Insufficiency conditions: Venous Ulcers studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a prospective randomized-control 1:1 single blind study primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 50 type: ESTIMATED name: low grade compression stockings (10-15 mmHg) name: high grade compression stockings (20-30 mmHg) measure: Incidence of adverse events. measure: Change in symptoms of heart failure. measure: Change in kidney function. measure: Change in venous reflux. measure: Change in C Class from the CEAP classification for venous insufficiency. measure: Mobility of the patient sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Maryland status: RECRUITING city: Baltimore state: Maryland zip: 21201 country: United States name: Rydica Newton, Research Coordinator role: CONTACT phone: 410-706-3941 email: [email protected] name: Kim Nordstrom role: CONTACT email: [email protected] name: Rafael S Cires-Drouet, MD role: PRINCIPAL_INVESTIGATOR lat: 39.29038 lon: -76.61219 hasResults: False
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<|newrecord|> nctId: NCT06350682 id: HP-00107323 briefTitle: Resilient HIV Implementation Science With SGM Youths Using Evidence acronym: RISE overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2027-09 date: 2028-06 date: 2024-04-05 date: 2024-04-05 name: University of Maryland, Baltimore class: OTHER name: University of Florida briefSummary: The Resilient HIV Implementation Science with SGM Youths using Evidence (RISE) Clinical Research Center will use a Type 2 hybrid-effectiveness-implementation study to evaluate the effectiveness and implementation of HMP, a youth-tailored digital health platform. It is hypothesized that SGM youths in the HMP intervention group will demonstrate improved PrEP initiation and viral load suppression over 12 months compared to the delayed HMP group. conditions: Hiv studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 1500 type: ESTIMATED name: HealthMPowerment (HMP) measure: PrEP initiation for HIV seronegative seropositive measure: Viral load suppression for HIV measure: RE-AIM measure: HIV testing cascade measure: PrEP continuum measure: HIV care and treatment continuum measure: Implementation effectiveness sex: MALE minimumAge: 15 Years maximumAge: 24 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06350669 id: 9576-22-SMC briefTitle: App-supported Vestibular Rehabilitation (RCT) overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-12 date: 2026-03 date: 2024-04-05 date: 2024-04-22 name: University of Haifa class: OTHER name: Sheba Medical Center name: Ben-Gurion University of the Negev briefSummary: A randomized controlled trial to assess the efficacy of an app-assisted vestibular rehabilitation in increasing adherence to VR and treatment outcomes conditions: Vestibular Disorder conditions: Vestibular Diseases conditions: Vestibular Abnormality studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The patients will be randomly assigned to either the intervention group (app-assisted vestibular rehabilitation) or the control group ("standard" vestibular rehabilitation/no app) primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 24 type: ESTIMATED name: Vestibular rehabilitation phone application measure: Adherence measures measure: Timed up and go (TUG) measure: Demographics and medical history intake measure: Vestibular functions- physical examination measure: Oculomotor functions- physical examination measure: Visual Analogue Scale (VAS) measure: Dizziness Handicap Inventory (DHI) measure: Activities-specific Balance Confidence Scale (ABC) measure: Dynamic Gait Index (DGI) measure: 10-Meters Walk Test (10MWT) measure: 2-Minute Walk Test (2MWT) measure: Dynamic Visual Acuity (DVA) measure: Video Head Impulse Test (vHIT) measure: Suppression Head Impulse Test (SHIMP) measure: Exercise difficulty levels and symptoms severity measure: Cognitive reserve index questionnaire (CRIQ) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sheba Medical Center city: Ramat Gan country: Israel name: Yoav Gimmon, PT, Ph.D role: CONTACT email: [email protected] name: Amit Wolfovitz, M.D role: PRINCIPAL_INVESTIGATOR name: Shelly Levy-Tzedek, PhD role: PRINCIPAL_INVESTIGATOR name: Liran Kalderon, M.Sc.PT role: PRINCIPAL_INVESTIGATOR lat: 32.08227 lon: 34.81065 hasResults: False
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<|newrecord|> nctId: NCT06350656 id: IRBN282022/CHUSTE briefTitle: Study of Cerebral Compliance in Neurosurgical Intensive Care Units (EC2) acronym: EC2 overallStatus: RECRUITING date: 2023-03-31 date: 2024-04 date: 2024-04 date: 2024-04-05 date: 2024-04-05 name: Centre Hospitalier Universitaire de Saint Etienne class: OTHER briefSummary: Despite the massive use of intracranial pressure in neuro-resuscitation, there is still no cerebral compliance evaluation index used in current practice to guide therapy.
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In treatment guidelines for intracranial hypertension, patients are placed in a prone position at about 30 degrees. Several times a day, during nursing care, patients are flattened, which corresponds to a cerebral compliance test by adding a volume of cerebrospinal fluid to the cranial box. conditions: Cerebrospinal; Disorder studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 30 type: ESTIMATED name: Clinical data collection name: Therapeutic data collection name: IntraCranial Pression (ICP) values collection measure: Intracranial pressure (mmHg) measure: Correlation between ICP (Intra Cranial Pressure) doses and cerebral compliance sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CENTRE HOSPITALIER Charponnay status: RECRUITING city: Chaponnay zip: 69970 country: France name: PIERRE-HENRI MURGAT, MD role: PRINCIPAL_INVESTIGATOR lat: 45.63097 lon: 4.94299 facility: CENTRE HOSPITALIER UNIVERSITAIRE Grenoble status: RECRUITING city: Grenoble zip: 38000 country: France name: JEAN FRANCOIS PAYEN, MD role: PRINCIPAL_INVESTIGATOR lat: 45.16667 lon: 5.71667 facility: HOPITAL NORD La Tronche status: RECRUITING city: La Tronche zip: 38170 country: France name: KEVIN LAGARDE, MD role: PRINCIPAL_INVESTIGATOR lat: 45.20429 lon: 5.73645 facility: APHP status: RECRUITING city: Paris zip: 75010 country: France name: SAMUEL GAUGUIN, MD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Hopital Lariboisiere - Ahph status: RECRUITING city: Paris zip: 75010 country: France name: JEROME CARTAILLIER, MD role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: CENTRE HOSPITALIER UNIVERSITAIRE Rennes status: RECRUITING city: Rennes zip: 35000 country: France name: YOANN LAUNEY, MD PHD role: PRINCIPAL_INVESTIGATOR lat: 48.11198 lon: -1.67429 facility: CENTRE HOSPITALIER UNIVERSITAIRE Saint-Etienne status: RECRUITING city: Saint-Étienne zip: 42055 country: France name: CLEMENT MAGAND, MD role: PRINCIPAL_INVESTIGATOR lat: 45.43389 lon: 4.39 hasResults: False
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<|newrecord|> nctId: NCT06350643 id: 287064 id: P50MD017319-03S1 type: NIH link: https://reporter.nih.gov/quickSearch/P50MD017319-03S1 briefTitle: The Black Health Block Quit and Screen Project overallStatus: NOT_YET_RECRUITING date: 2024-07 date: 2024-12 date: 2024-12 date: 2024-04-05 date: 2024-04-05 name: University of Arkansas class: OTHER name: Virginia Commonwealth University name: Coalition for a Tobacco Free Arkansas name: National Institute on Minority Health and Health Disparities (NIMHD) name: National Medical Association briefSummary: The Black Health Block Quit and Screen Project seeks to engage Black health care providers in helping Black smokers quit tobacco use, including menthol cigarettes and flavored cigars, and screen for lung cancer early as strategies to reduce multiple chronic disease disparities.
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The goal of this clinical trial is to test the feasibility and impact of the Black Health Block Culturally Tailored Training alone versus the Health Disparities and Lung Cancer Screening Training + the Black Health Block Culturally Tailored training modules on changes in knowledge, attitudes, and behavioral intentions related to provider advice to quit smoking and referrals for low dose computed tomography among health care providers randomly assigned to each condition. Participants will complete the training modules and complete pre- and post-tests to assess these outcomes. conditions: Knowledge conditions: Attitudes conditions: Behavioral Intention studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 300 type: ESTIMATED name: Black Health Block Culturally Tailored training name: Health Disparities and Lung Cancer Screening training measure: Familiarity with treatment guidelines for tobacco and nicotine treatment measure: Weaver et al. 2012 Provider Attitudes and Perceptions about smoking cessation measure: Weaver et al. 2012 Provider Perceptions about provider barriers to providing smoking cessation interventions to patients measure: Provider Perceptions about patient barriers to smoking cessation measure: Behavioral intentions to screen and advise patients about smoking cessation measure: Familiarity with lung cancer screening guidelines measure: Knowledge about low dose computed tomography for lung cancer screening measure: Perceptions about shared decision-making for low dose computed tomography for lung cancer screening measure: Perceptions about provider barriers to referring patients to low dose computed tomography for lung cancer screening measure: Provider Perceptions about patient barriers to get screened for lung cancer measure: Behavioral intentions to advise patients to get screened for lung cancer via low dose computed tomography measure: Diversity of enrolled healthcare providers measure: Retention: Percent of providers complete the training after enrolling measure: Adherence to completing training modules: Percent of modules completed measure: Preferences regarding training measure: Satisfaction with training sex: ALL minimumAge: 21 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Virginia Commonwealth Univesity city: Richmond state: Virginia zip: 23284 country: United States name: Mignonne Guy, PhD role: CONTACT phone: 804-828-1731 email: [email protected] name: Mignonne Guy, PhD role: PRINCIPAL_INVESTIGATOR lat: 37.55376 lon: -77.46026 hasResults: False
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<|newrecord|> nctId: NCT06350630 id: 20PH284 id: 2024-512653-25-00 type: CTIS briefTitle: Therapeutic Effect of Hydroxychloroquine on Immunoglobulin A (IgA) Nephropathy Course QUIgAN Study acronym: QUIgAN overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-12-31 date: 2030-12-31 date: 2024-04-05 date: 2024-04-05 name: Centre Hospitalier Universitaire de Saint Etienne class: OTHER name: Ministry of Health, France briefSummary: immunoglobulin A (IgA) nephropathy (Berger disease) is the most frequent primary glomerulonephritis worldwide. This disease accounts for about 5% of the causes of end stage renal disease in France, representing a major public health issue. Its pathophysiology seems to be triggered by mucosal immunity abnormalities leading to the systemic misaddressing of mucosal IgA, generation of circulating immunoglobulin A1 (IgA1) immune complexes finally deposited in renal glomeruli leading to renal tissue inflammation and scarring processes. Among this pathogeny, innate immunity is involved at several steps, including mucosal immunity.
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In this regard, hydroxychloroquine has been shown to generate a global anti-inflammatory effect, particularly through its action on Toll like receptors and dendritic cells. This drug is well tolerated, widely used for other auto-immune diseases (e.g. Systemic Lupus Erythematosus) and very low priced.
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One randomized controlled study conducted in China has recently shown a significant drop in proteinuria of IgA nephropathy patients treated with hydroxychloroquine (-48.4%) compared to the placebo group (+10.0%), after a quite short-term follow-up (6 months) and a moderate statistical power (30 patients in each group).
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Considering (i) the potential mechanism of therapeutic effect on this disease, (ii) the well documented safety profile of the drug for rheumatologic indications and posologies, and its low cost (iii) its efficacy in reducing proteinuria in IgA nephropathy patients in a preliminary Chinese randomized control study, the investigators aim in this study at establishing the beneficial impact of hydroxychloroquine on IgA nephropathy in a double blind randomized controlled trial on a Caucasian French population with harder outcomes and a longer follow-up compared to the Chinese preliminary study. conditions: IgA Nephropathy studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: double blind trial randomized primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 334 type: ESTIMATED name: Hydroxychloroquine Oral Tablet name: Placebo oral tablet measure: Absolute difference in estimate Glomerular Filtration Rate (GFR) between hydroxychloroquine group and control group evolution measure: nephrological follow-up: proteinuria measure: nephrological follow-up: albuminuria measure: nephrological follow-up: GFR measure: nephrological follow-up: hematuria measure: nephrological follow-up: systolic and diastolic blood pressure measure: nephrological follow-up: proteinuria measure: nephrological follow-up: albuminuria measure: nephrological follow-up: GFR measure: nephrological follow-up: hematuria measure: nephrological follow-up: systolic and diastolic blood pressure measure: nephrological follow-up: proteinuria measure: nephrological follow-up: albuminuria measure: nephrological follow-up: hematuria measure: nephrological follow-up: systolic and diastolic blood pressure measure: end stage renal disease (GFR< 15mL/min/1.73m²) measure: death measure: adverse events (pruritus, gastro-intestinal disorders) and serious adverse events (QT enlargement, cardiomyopathy, ophthalmologic disorders, neuromyopathy, cytopenia) sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU Gabriel Montpied city: Clermont-Ferrand zip: 63000 country: France lat: 45.77966 lon: 3.08628 facility: Hospices Civils de Lyon city: Lyon zip: 69437 country: France lat: 45.74848 lon: 4.84669 facility: AP-HM Hôpital de la Conception city: Marseille zip: 13385 country: France name: Thomas ROBERT, MD role: CONTACT phone: 0662426166 phoneExt: +33 email: [email protected] lat: 43.29551 lon: 5.38958 facility: APHP Hôpital Bichat city: Paris zip: 75018 country: France name: Eric DAUGAS, PU-PH role: CONTACT phone: 0140257101 phoneExt: +33 email: [email protected] lat: 48.85341 lon: 2.3488 facility: APHP Hôpital de Tenon city: Paris zip: 75020 country: France name: Khalil EL KAROUI, PU-PH role: CONTACT phone: 0156016317 phoneExt: +33 email: [email protected] lat: 48.85341 lon: 2.3488 facility: CHU Lyon Sud city: Pierre-Bénite zip: 69495 country: France name: Sarah MEZAACHE, MD role: CONTACT phone: 0478863712 phoneExt: +33 email: [email protected] lat: 45.7009 lon: 4.82511 facility: CHU de Saint-Etienne city: Saint-Étienne zip: 42055 country: France name: Nicolas MAILLARD, MD role: CONTACT phone: 0477828127 phoneExt: +33 email: [email protected] name: Carine LABRUYERE role: CONTACT phone: 0477120469 phoneExt: +33 email: [email protected] lat: 45.43389 lon: 4.39 hasResults: False
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<|newrecord|> nctId: NCT06350617 id: 2023-12-028 briefTitle: Personalized rTMS Protocol Based on Functional Reserve to Enhance Ambulatory Function in PD Patients overallStatus: RECRUITING date: 2024-02-20 date: 2025-09-30 date: 2025-09-30 date: 2024-04-05 date: 2024-04-05 name: Samsung Medical Center class: OTHER name: National Research Foundation of Korea name: Ministry of Food and Drug Safety, Korea name: Seoul National University Hospital name: Bucheon St. Mary's Hospital name: Saint Vincent's Hospital, Korea name: Severance Hospital name: Kumoh National Institute of Technology name: NEUROPHET briefSummary: The objective of this study was to determine the effects of protocols of repetitive transcranial magnetic stimulation (rTMS) therapy based on the functional reserve of each patient with Parkinson's disease, compared to conventional high-frequency rTMS therapy on bilateral primary motor cortex (M1). Investigators hypothesized that the functional reserve of each patient with Parkinson's disease will be different, and therefore an appropriate simulating target for rTMS therapy is needed. In addition, this approach could be more effective compared to conventional protocols applied to patient with Parkinson's disease regardless of their severity, predicted mechanism of motor function recovery, or functional reserves. conditions: Parkinson's Disease and Parkinsonism studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: prospective, single-blind with blind observer, parallel-group design, multi-center, randomized controlled clinical trial primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: The participants, assessors, and investigators will be blinded, not be aware of the group allocation. Statistical analysis will also be conducted by data analysts without awareness of the group allocation. Only clinicians applying rTMS intervention will not be blinded, as they will apply rTMS over different stimulation sites based on the protocols. Blinding will be continued until the end of the study, including data analysis. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: High-Frequency, ipsilateral M1 name: High-Frequency, bilateral M1 name: High-Frequency, Lt. DLPFC name: High-Frequency, bilateral M1 measure: Differences of Timed Up and Go Test (TUG) measure: Differences of Timed Up and Go Test (TUG) measure: Differences of Timed Up and Go Test (TUG) measure: Differences of Timed Up and Go Test-Cognitive (TUG-Cog) measure: Differences of Timed Up and Go Test-Cognitive (TUG-Cog) measure: Differences of Timed Up and Go Test-Cognitive (TUG-Cog) measure: Differences of Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part III measure: Differences of MDS-UPDRS, Part III measure: Differences of New Freezing of Gait Questionnaire (FoG-Q) measure: Differences of New Freezing of Gait Questionnaire (FoG-Q) measure: Differences of Digit span Test measure: Differences of Digit span Test measure: Differences of Trail making Test measure: Differences of Trail making Test measure: Differences of Gait lab parameter (Gait speed) measure: Differences of Gait lab parameter (Gait speed) measure: Differences of Gait lab parameter (Stride length) measure: Differences of Gait lab parameter (Stride length) measure: Differences of Gait lab parameter (Step count) measure: Differences of Gait lab parameter (Step count) measure: Differences of Gait lab parameter (Cadence) measure: Differences of Gait lab parameter (Cadence) measure: Differences of Gait lab parameter (Swing ratio) measure: Differences of Gait lab parameter (Swing ratio) measure: Differences of Gait lab parameter (Stride time) measure: Differences of Gait lab parameter (Stride time) measure: Differences of Gait lab parameter (Pressure distribution) measure: Differences of Gait lab parameter (Pressure distribution) sex: ALL minimumAge: 50 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Samsung Medical Center status: RECRUITING city: Seoul zip: 06351 country: Korea, Republic of name: Won Hyuk Chang, PhD role: CONTACT phone: +82-2-3410-6068 email: [email protected] lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06350604 id: PRO-2023-355 briefTitle: Project WHADE: A Partner-Based Physical Activity Program for Women overallStatus: RECRUITING date: 2024-01-02 date: 2024-06 date: 2024-07 date: 2024-04-05 date: 2024-04-05 name: Rowan University class: OTHER briefSummary: This study is designed to test the feasibility and acceptability of a new method for supporting physical activity among women ages 40-65 who have risk factors for cardiovascular disease. Each participant receives a trained physical activity coach and a physical activity partner; the partner is another woman in the program. Partners communicate with each other between weekly coaching sessions to provide support for physical activity behavior change. conditions: Hypertension conditions: Type 2 Diabetes conditions: Metabolic Syndrome conditions: Smoking conditions: High Cholesterol conditions: PreDiabetes conditions: Prehypertension studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: All participants receive the same intervention primaryPurpose: PREVENTION masking: NONE count: 60 type: ESTIMATED name: Project WHADE: A Partner-Based Physical Activity Program for Women measure: Frequency of partner communication measure: Satisfaction with partner communication measure: Physical activity behavior - steps measure: Physical activity behavior - active minutes sex: FEMALE minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rowan University status: RECRUITING city: Glassboro state: New Jersey zip: 08028 country: United States name: Sofia Gular, B.A. role: CONTACT phone: 856-256-4872 email: [email protected] name: Danielle Arigo, Ph.D. role: CONTACT phone: 8562564500 phoneExt: 53775 email: [email protected] lat: 39.70289 lon: -75.11184 hasResults: False
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<|newrecord|> nctId: NCT06350591 id: 6038674 briefTitle: Evaluating Changes in Skeletal Muscle Proteins Following Resistance Exercise and Single-Leg Disuse overallStatus: RECRUITING date: 2024-04-01 date: 2024-08 date: 2024-08 date: 2024-04-05 date: 2024-04-05 name: Queen's University class: OTHER briefSummary: Skeletal muscle plays a critical role in supporting human health. Beyond its role in providing the force to move, skeletal muscle accounts for a large proportion of metabolic rate, glucose disposal, and amino acid storage. Skeletal muscle is dynamically regulated by environmental stimuli, such as loading (i.e., resistance training\]) and unloading (i.e., disuse atrophy) as well as the intake of essential amino acids (EAAs). However, the precise mechanisms that regulate skeletal muscle mass in response to various conditions (e.g., EAA supplementation, resistance training, and unloading) are not completely understood. Therefore, concerted efforts to better understand the mechanisms regulating skeletal muscle size are needed that aid in the development of therapeutic interventions to combat age, disease, and disuse related muscular atrophy. conditions: Healthy conditions: Skeletal Muscle Atrophy conditions: Skeletal Muscle Hypertrophy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: parallel, within-subject design primaryPurpose: BASIC_SCIENCE masking: NONE count: 14 type: ESTIMATED name: Immobilization name: Resistance training measure: Changes in average rates of muscle synthesis measure: Dynamic proteomic profiling measure: Protein expression (phosphorylation and content) of novel and known targets implicated in protein translation and mitochondrial-related protein expression measure: Muscle torque measure: Quadriceps skeletal muscle volume sex: FEMALE minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: School of Kinesiology and Health Studies status: RECRUITING city: Kingston state: Ontario zip: K7L 3N6 country: Canada name: Chris McGlory, PhD role: CONTACT phone: 6135336000 phoneExt: 75410 email: [email protected] name: Kristine Boileau, BSc role: CONTACT email: [email protected] name: Chris McGlory, PhD role: PRINCIPAL_INVESTIGATOR lat: 44.22976 lon: -76.48101 hasResults: False
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<|newrecord|> nctId: NCT06350578 id: BUHOOTH-D-23-00073 briefTitle: A Randomized Clinical Trial Comparing Hall vs. Conventional Technique in Primary Molars. overallStatus: RECRUITING date: 2023-12-06 date: 2025-03 date: 2025-06 date: 2024-04-05 date: 2024-04-05 name: Primary Health Care Corporation, Qatar class: OTHER_GOV briefSummary: This study aims to assess the comparative effectiveness of the Hall technique (HT) and the conventional technique (CT) for placing Stainless Steel Crowns (SSCs) in primary molars with approximal caries. conditions: Dental Caries studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A binary outcome non-inferiority randomized trial. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Single-blind whoMasked: CARE_PROVIDER count: 80 type: ESTIMATED name: Hall Crown Technique name: Conventional SSC Technique measure: Restoration survival at 12 months measure: Occlusal vertical dimension (OVD) resolution measure: Tooth survival measure: Procedural time measure: Participant's cooperation measure: Participant's pain perception measure: Treatment perceptions and opinions of the parents sex: ALL minimumAge: 3 Years maximumAge: 9 Years stdAges: CHILD facility: Primary Healthcare Corporation status: RECRUITING city: Doha country: Qatar name: Research Section role: CONTACT phone: +97444069917 email: [email protected] lat: 25.28545 lon: 51.53096 hasResults: False
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<|newrecord|> nctId: NCT06350565 id: DEX20240104 briefTitle: A Clinical Pharmacological Study of Dose Halving of Dexamethasone in Pregnant Women With Preterm Labour With Preterm Birth at Greater Than or Equal to 34 Gestational Weeks (34GW+) overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2025-04-30 date: 2025-12-31 date: 2024-04-05 date: 2024-04-16 name: Peking University Third Hospital class: OTHER briefSummary: This study plans to conduct a DEX dose halving study and a normal dose study in 34+0-35+6 GW women with preterm preterm labour. In addition, this study plans to conduct a DEX dose halving study and a normal dose study in 34-38+6 GW preterm pregnant women with GDM or diabetic co-pregnancy to explore the feasibility of dose halving in pregnant women with diabetes mellitus. conditions: Respiratory Distress Syndrome of Newborn studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: Dexamethasone measure: Respiratory distress syndrome measure: PK parameters (analysed in conjunction with population pharmacokinetic (PPK) modelling): area under the blood concentration curve, Cmax, Tmax, Kel, t1/2, CL, VZ measure: Pharmacodynamics measure: Measurability indicators measure: Blood biochemistry findings in newborns measure: DEX potential safety marker test sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06350552 id: PA224ES-1-03 briefTitle: Prevalence of Postural Abnormalities in Dialysis Patients overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-04 date: 2024-04 date: 2024-04-05 date: 2024-04-23 name: Pardis Specialized Wellness Institute class: OTHER briefSummary: The goal of this observational study is to investigate and compare the prevalence of forward head , hyper kyphosis and balance in hemodialysis and peritoneal dialysis patients. The main questions it mains to answer are:
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What is the prevalence of forward head posture in hemodialysis and peritoneal dialysis patients? What is the prevalence of hyper kyphosis in hemodialysis and peritoneal dialysis patients? Is there any relation between postural abnormalities and physical function in hemodialysis and peritoneal dialysis patients?
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Participants will answer 2 questionnaires and will do some functional tests. conditions: End Stage Renal Disease conditions: Hemodialysis Complication conditions: Peritoneal Dialysis Complication studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 390 type: ESTIMATED measure: Prevalence of thoracic hyper kyphosis measure: Prevalence of forward head measure: Balance level measure: Cardiopulmonary function's level measure: Fall risk level sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Khorshid Dialysis Center city: Isfahan country: Iran, Islamic Republic of lat: 32.65246 lon: 51.67462 hasResults: False
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<|newrecord|> nctId: NCT06350539 id: 10-007 briefTitle: Personalized Models for Cancer Research overallStatus: RECRUITING date: 2024-02-15 date: 2034-02-15 date: 2034-02-15 date: 2024-04-05 date: 2024-04-05 name: New York Stem Cell Foundation Research Institute class: OTHER name: Stevens Institute of Technology briefSummary: The New York Stem Cell Foundation (NYSCF) Research Institute is performing this research to accelerate cancer research ranging from disease mechanisms to personalized medicine approaches that will help to realize the promise of precision medicine for oncology. conditions: Solid Tumor, Adult studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 500 type: ESTIMATED name: Biological Sample Collection measure: Implement organoid culture technologies. measure: Validate genotypic and phenotypic relevance of tumor-derived organoids for biobanking. measure: Establish functional testing using organoid cultures alone or in combination with additional cell types. measure: Perform drug testing and screens to identify new targets and/or new therapeutic strategies to effectively treat cancer. measure: Develop a Laboratory Developed Test (LDT) for CLEP/FDA approval that will inform clinicians of each patient's tumor responses to FDA approved drugs. measure: Develop stem cells from individual patient samples to study tumor evolution. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: New York Stem Cell Foundation Research Institute status: RECRUITING city: New York state: New York zip: 10019 country: United States name: Becca Wood role: CONTACT phone: 212-927-1801 email: [email protected] name: Lisa Voltolina role: CONTACT phone: 6462133911 email: [email protected] name: Laura Andres-Martin, PhD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False
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<|newrecord|> nctId: NCT06350526 id: PULMHEMA briefTitle: Radiological Characterization of Pulmonary Involvement in Patients With Hematological Diseases overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-03-01 date: 2025-06-01 date: 2024-04-05 date: 2024-04-05 name: New Valley University class: OTHER briefSummary: Hematologic malignancies are heterogeneous groups of neoplasia, with frequent pulmonary complications. These complications may be secondary to the patient's comorbidities, to the hemopathy itself, or its treatments. Divided into infectious and non-infectious complications, the etiologies are numerous and varied. This makes the diagnostic approach complex for the clinicians conditions: Hematologic Diseases studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 200 type: ESTIMATED name: Complete Blood Count name: C-reactive protein name: O2 saturation name: Serum ferritin and D-dimer name: Liver and renal function tests name: Lactate dehydrogenase name: coronavirus (SARS-CoV-2) swab name: CT chest measure: Number of patients who had certain radiological patterns associated with pulmonary complications in patients diagnosed with various hematological diseases measure: Number of patients who developed complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06350513 id: NecmettinE briefTitle: The Effect of Animated Movies and Storybooks on Fear and Anxiety Levels in Children With Type 1 Diabetes overallStatus: NOT_YET_RECRUITING date: 2024-03-25 date: 2024-09-25 date: 2025-02-25 date: 2024-04-05 date: 2024-04-05 name: Selverhan Yurttutan class: OTHER briefSummary: This study aims to evaluate the effects of animated films and story books on the fear and anxiety levels of children with newly diagnosed type 1 diabetes. conditions: Diabetes Mellitus, Type 1 conditions: Child, Only conditions: Anxiety conditions: Fear conditions: Nurse studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Group (Experiment-Control) Randomized Controlled Experimental primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 64 type: ESTIMATED name: Animation movie, story book measure: State Anxiety Inventory for Children (STAI-C) measure: State Anxiety Inventory for Children (STAI-C) measure: State Anxiety Inventory for Children (STAI-C) measure: Children's Fear Scale measure: Children's Fear Scale measure: Children's Fear Scale sex: ALL minimumAge: 7 Years maximumAge: 12 Years stdAges: CHILD facility: Semra Köse city: Konya state: Meram country: Turkey lat: 37.87135 lon: 32.48464 facility: Necmettin Erbakan Üniversity city: Konya country: Turkey lat: 37.87135 lon: 32.48464 hasResults: False
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<|newrecord|> nctId: NCT06350500 id: I-3858823 briefTitle: A Patient Navigation Program for Addressing Disparities in Breast Cancer Care overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-01-01 date: 2026-01-01 date: 2024-04-05 date: 2024-04-09 name: Roswell Park Cancer Institute class: OTHER briefSummary: This clinical trial evaluates a patient navigation program for addressing disparities in breast cancer care. The navigation program is designed to help improve patient knowledge about clinical and supportive care services, navigate to existing services, help manage barriers to care, and enhance patient skills related to management of cancer treatment. Offering a patient navigation program may increase health equity and improve social needs and quality of life over time for newly diagnosed breast cancer patients. conditions: Breast Carcinoma conditions: Breast Ductal Carcinoma in Situ studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 126 type: ESTIMATED name: Patient Navigation name: Questionnaire measure: Enrollment rate measure: Reasons for refusal measure: Retention Rate measure: Reasons for discontinuation measure: European Organization for Research and Treatment of Cancer Quality of Life Scale (EORTC QLQ-C30) measure: Social Determinates of health measure: Barriers to care measure: Use of supportive services measure: Patient Satisfaction survey sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06350487 id: SMC2024-01-089-003 briefTitle: The Efficacy of Enavogliflozin in Heart Failure With Preserved Ejection Fraction acronym: ENRICH-PEF overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-12-31 date: 2026-06-30 date: 2024-04-05 date: 2024-04-08 name: Samsung Medical Center class: OTHER briefSummary: The aim of prospective, open label, single center, randomized controlled trial is to investigate the efficacy of enavogliflozin on exercise performance, diastolic dysfunction, and quality of life in patients with heart failure with preserved ejection fraction (HFpEF). conditions: Heart Failure, Preserved Ejection Fraction studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: A prospective, open label, single center, randomized controlled trial. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: Clinical outcome assessment will be performed under blinded assessment about the allocated treatment group. whoMasked: OUTCOMES_ASSESSOR count: 154 type: ESTIMATED name: SGLT2 inhibitor measure: Change in peak oxygen consumption (VO2) measure: Change in minute ventilation to carbon dioxide output ratio (VE/VCO2 slope) measure: Change in Left atrial volume index (LAVI) before and after maximal exercise measure: Change in Lateral Early diastolic transmitral filling velocity over early diastolic relaxation velocity at mitral annulus (E/e') before and after maximal exercise measure: Change in Left ventricular mass index (LVMI) before and after maximal exercise measure: Change in LV wall thickness before and after maximal exercise measure: Change in LV global longitudinal strain before and after maximal exercise measure: Change in LA strain before and after maximal exercise measure: Change in right ventricular (RV) free wall strain before and after maximal exercise measure: Change in health-related quality of life assessed by the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CS) measure: Change in N-Terminal pro-B-type Natriuretic Peptide (NT-proBNP) level measure: Change in chronotropic response reserve assessed by change in heart rate from rest to peak exercise measure: Change in serum iron measure: Change in ferritin measure: Change in total iron binding capacity measure: Change in hemoglobin measure: All-cause death measure: Hospitalization for heart failure sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Samsung Medical Center city: Seoul zip: 06351 country: Korea, Republic of name: Jeong Hoon Yang, MD, PhD role: CONTACT phone: 82-2-3410-3419 email: [email protected] name: David Hong, MD role: CONTACT phone: 82-2-3410-3419 email: [email protected] lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06350474 id: SIMPLIFY-IP-19 Dnase briefTitle: Impact of Discontinuing Dornase Alfa in People With CF on Highly Effective CFTR Modulator Therapy-A SIMPLIFY Sub-Study acronym: SIMPLIFY-DN overallStatus: COMPLETED date: 2020-08-25 date: 2022-07-11 date: 2022-07-11 date: 2024-04-05 date: 2024-04-05 name: Nicole Hamblett class: OTHER name: Cystic Fibrosis Foundation name: Dartmouth-Hitchcock Medical Center name: University of Washington briefSummary: Despite the increasingly common use of cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies in treating cystic fibrosis (CF), it is still largely unknown whether or not other chronic therapies can be safely stopped. This SIMPLIFY sub-study is being done to test whether or not it is safe to stop taking dornase alfa (Dnase) in those people that are also taking elexacaftor/tezacaftor/ivacaftor (ETI).
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ETI is a combination CFTR modulator therapy that was approved by the Food and Drug Administration for people with CF who have at least one F508del mutation. The three drugs that make up ETI work together to allow many more chloride ions to move into and out of the cells, improving the balance of salt and water in the lungs. These changes result in better clearance of mucus from the lungs and improvements in lung function.
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Dornase alfa (Dnase) also improves clearance of mucus from the lungs to support lung function and has been available to people with CF for many years. Dnase is considered to be relatively burdensome and it is not known whether Dnase can improve or maintain lung function above what is already gained through ETI use.
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The goal of this SIMPLIFY sub-study is to get information about whether or not it is safe to stop Dnase by testing if there is a change in lung function in participants with cystic fibrosis (CF) who are assigned to stop taking Dnase as compared to those who are assigned to keep taking Dnase while continuing to take ETI.
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This is a sub study of master protocol SIMPLIFY-IP-19, NCT04378153.
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The sub study investigating the impact of discontinuing and continuing hypertonic saline is registered under NCTXXXXXXX (will add once available). conditions: Cystic Fibrosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 477 type: ACTUAL name: Discontinuation of dornase alfa (Dnase) name: Continuation of dornase alfa (Dnase) measure: Absolute Change in FEV1 % Predicted From Week 0 to Week 6 measure: Absolute Change in LCI 2.5 From Baseline to Week 6 measure: Absolute Change in Respiratory Symptoms, as Measured by the CF Respiratory Symptoms Diary-Chronic Respiratory Infection Symptom Severity Score (CRISS) From Week 0 to Week 6 measure: Absolute Change in Respiratory Symptoms, as Measured by CFQ-R Respiratory Domain From Week 0 to Week 6 measure: Absolute Change in FEV1 % Predicted From Week -2 to Week 0 measure: Absolute Change in FEV1 % Predicted From Week 0 to Week 2 measure: Number and Percent of Participants Initiating Acute Antibiotics From Week 0 to Week 6 measure: Number and Percent of Participants Hospitalized From Week 0 to Week 6 measure: Number and percent of participants Experiencing Pulmonary Exacerbations from Week 0 to Week 6 measure: Number and Percent of Participants Experiencing Adverse Events (AEs) From Week 0 to Week 6 measure: Rate of Adverse Events (AEs) From Week 0 to Week 6 Therapy Arms measure: Number and Percent of Participants with Temporary or Permanent Changes From Assigned Therapy Regimen Due to Adverse Event From Week 0 to Week 6 sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alabama at Birmingham city: Birmingham state: Alabama zip: 35294 country: United States lat: 33.52066 lon: -86.80249 facility: Providence Alaska Medical Center city: Anchorage state: Alaska zip: 99508 country: United States lat: 61.21806 lon: -149.90028 facility: Tucson Cystic Fibrosis Center city: Tucson state: Arizona zip: 85724 country: United States lat: 32.22174 lon: -110.92648 facility: Arkansas Children's Hospital city: Little Rock state: Arkansas zip: 72202 country: United States lat: 34.74648 lon: -92.28959 facility: Miller Children's and Women's Hospital Long Beach city: Long Beach state: California zip: 90806 country: United States lat: 33.76696 lon: -118.18923 facility: CHOC Children's Hospital city: Orange state: California zip: 92868 country: United States lat: 33.78779 lon: -117.85311 facility: Stanford University Medical Center city: Palo Alto state: California zip: 94304 country: United States lat: 37.44188 lon: -122.14302 facility: Rady Children's Hospital and Health Center at the University of California San Diego city: San Diego state: California zip: 92123 country: United States lat: 32.71533 lon: -117.15726 facility: University of California, San Francisco - Adult Center city: San Francisco state: California zip: 94143 country: United States lat: 37.77493 lon: -122.41942 facility: University of California, San Francisco - Peds Center city: San Francisco state: California zip: 94158 country: United States lat: 37.77493 lon: -122.41942 facility: Children's Hospital Colorado city: Aurora state: Colorado zip: 80045 country: United States lat: 39.72943 lon: -104.83192 facility: National Jewish Health city: Denver state: Colorado zip: 80206 country: United States lat: 39.73915 lon: -104.9847 facility: Yale University School of Medicine city: New Haven state: Connecticut zip: 06520 country: United States lat: 41.30815 lon: -72.92816 facility: University of Florida city: Gainesville state: Florida zip: 32610 country: United States lat: 29.65163 lon: -82.32483 facility: Nemours Children's Clinic - Jacksonville city: Jacksonville state: Florida zip: 32207 country: United States lat: 30.33218 lon: -81.65565 facility: Central Florida Pulmonary Group city: Orlando state: Florida zip: 32803 country: United States lat: 28.53834 lon: -81.37924 facility: The Nemours Children's Clinic - Orlando city: Orlando state: Florida zip: 32827 country: United States lat: 28.53834 lon: -81.37924 facility: Nemours Children's Clinic - Pensacola city: Pensacola state: Florida zip: 32514 country: United States lat: 30.42131 lon: -87.21691 facility: All Children's Hospital city: Saint Petersburg state: Florida zip: 33701 country: United States lat: 27.77086 lon: -82.67927 facility: Tampa General Hospital city: Tampa state: Florida zip: 33606 country: United States lat: 27.94752 lon: -82.45843 facility: Emory University city: Atlanta state: Georgia zip: 30324 country: United States lat: 33.749 lon: -84.38798 facility: Saint Luke's Cystic Fibrosis Center of Idaho city: Boise state: Idaho zip: 83702 country: United States lat: 43.6135 lon: -116.20345 facility: Northwestern University city: Chicago state: Illinois zip: 60611 country: United States lat: 41.85003 lon: -87.65005 facility: OSF Saint Francis Medical Center city: Peoria state: Illinois zip: 61637 country: United States lat: 40.69365 lon: -89.58899 facility: Riley Hospital for Children city: Indianapolis state: Indiana zip: 46202 country: United States lat: 39.76838 lon: -86.15804 facility: University of Iowa city: Iowa City state: Iowa zip: 52242 country: United States lat: 41.66113 lon: -91.53017 facility: University of Kansas Medical Center city: Kansas City state: Kansas zip: 66160 country: United States lat: 39.11417 lon: -94.62746 facility: University of Kentucky city: Lexington state: Kentucky zip: 40506 country: United States lat: 37.98869 lon: -84.47772 facility: University of Louisville city: Louisville state: Kentucky zip: 40202 country: United States lat: 38.25424 lon: -85.75941 facility: Tulane University city: Metairie state: Louisiana zip: 70001 country: United States lat: 29.98409 lon: -90.15285 facility: Maine Medical Partners Pediatric Specialty Care city: Portland state: Maine zip: 04102 country: United States lat: 43.66147 lon: -70.25533 facility: John Hopkins Hospital city: Baltimore state: Maryland zip: 21205 country: United States lat: 39.29038 lon: -76.61219 facility: Boston Children's Hospital city: Boston state: Massachusetts zip: 02115 country: United States lat: 42.35843 lon: -71.05977 facility: University of Michigan, Michigan Medicine city: Ann Arbor state: Michigan zip: 48109 country: United States lat: 42.27756 lon: -83.74088 facility: Wayne State University Harper University Hospital city: Detroit state: Michigan zip: 48201 country: United States lat: 42.33143 lon: -83.04575 facility: Corewell Health Helen DeVos city: Grand Rapids state: Michigan zip: 49546 country: United States lat: 42.96336 lon: -85.66809 facility: Children's Hospitals and Clinics of Minnesota city: Minneapolis state: Minnesota zip: 55404 country: United States lat: 44.97997 lon: -93.26384 facility: The Minnesota Cystic Fibrosis Center city: Minneapolis state: Minnesota zip: 55455 country: United States lat: 44.97997 lon: -93.26384 facility: Children's Mercy Kansas City city: Kansas City state: Missouri zip: 64108 country: United States lat: 39.09973 lon: -94.57857 facility: Washington University School of Medicine city: Saint Louis state: Missouri zip: 63110 country: United States lat: 38.62727 lon: -90.19789 facility: Billings Clinic city: Billings state: Montana zip: 59101 country: United States lat: 45.78329 lon: -108.50069 facility: Dartmouth Hitchcock Medical Center city: Lebanon state: New Hampshire zip: 03756 country: United States lat: 43.64229 lon: -72.25176 facility: Monmouth Medical Center city: Eatontown state: New Jersey zip: 07724 country: United States lat: 40.29622 lon: -74.05097 facility: Morristown Medical Center city: Morristown state: New Jersey zip: 07960 country: United States lat: 40.79677 lon: -74.48154 facility: Rutgers - Robert Wood Johnson Medical School city: New Brunswick state: New Jersey zip: 08903 country: United States lat: 40.48622 lon: -74.45182 facility: Cohen Children's Medical Center of New York city: New Hyde Park state: New York zip: 11042 country: United States lat: 40.7351 lon: -73.68791 facility: Beth Israel Medical Center city: New York state: New York zip: 10003 country: United States lat: 40.71427 lon: -74.00597 facility: Lenox Hill Hospital Cystic Fibrosis Center city: New York state: New York zip: 10028 country: United States lat: 40.71427 lon: -74.00597 facility: Columbia University Cystic Fibrosis Program city: New York state: New York zip: 10032 country: United States lat: 40.71427 lon: -74.00597 facility: University of Rochester Medical Center Strong Memorial city: Rochester state: New York zip: 14642 country: United States lat: 43.15478 lon: -77.61556 facility: SUNY Upstate Medical University city: Syracuse state: New York zip: 13210 country: United States lat: 43.04812 lon: -76.14742 facility: New York Medical College at Westchester Medical Center city: Valhalla state: New York zip: 10595 country: United States lat: 41.07482 lon: -73.77513 facility: University of North Carolina at Chapel Hill city: Chapel Hill state: North Carolina zip: 27517 country: United States lat: 35.9132 lon: -79.05584 facility: Atrium Health Wake Forest Baptist city: Winston-Salem state: North Carolina zip: 27157 country: United States lat: 36.09986 lon: -80.24422 facility: Children's Hospital Medical Center of Akron city: Akron state: Ohio zip: 44308 country: United States lat: 41.08144 lon: -81.51901 facility: Cincinnati Children's Hospital Medical Center city: Cincinnati state: Ohio zip: 45229 country: United States lat: 39.12713 lon: -84.51435 facility: Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center city: Cleveland state: Ohio zip: 44146 country: United States lat: 41.4995 lon: -81.69541 facility: Cleveland Clinic Cystic Fibrosis Program city: Cleveland state: Ohio zip: 44195 country: United States lat: 41.4995 lon: -81.69541 facility: Nationwide Children's Hospital city: Columbus state: Ohio zip: 43205 country: United States lat: 39.96118 lon: -82.99879 facility: Dayton Children's Hospital city: Dayton state: Ohio zip: 45404 country: United States lat: 39.75895 lon: -84.19161 facility: Oregon Health & Sciences University city: Portland state: Oregon zip: 97239 country: United States lat: 45.52345 lon: -122.67621 facility: Hershey Medical Center Pennsylvania State University city: Hershey state: Pennsylvania zip: 17033 country: United States lat: 40.28592 lon: -76.65025 facility: University of Pennsylvania city: Philadelphia state: Pennsylvania zip: 19104 country: United States lat: 39.95233 lon: -75.16379 facility: University of Pittsburgh Medical Center city: Pittsburgh state: Pennsylvania zip: 15224 country: United States lat: 40.44062 lon: -79.99589 facility: Medical University of South Carolina city: Charleston state: South Carolina zip: 29425 country: United States lat: 32.77657 lon: -79.93092 facility: Dell Children's Medical Center of Central Texas city: Austin state: Texas zip: 78723 country: United States lat: 30.26715 lon: -97.74306 facility: University of Texas Southwestern / Children's Health city: Dallas state: Texas zip: 75207 country: United States lat: 32.78306 lon: -96.80667 facility: University of Texas Southwestern city: Dallas state: Texas zip: 75390 country: United States lat: 32.78306 lon: -96.80667 facility: Cook Children's Medical Center city: Fort Worth state: Texas zip: 76104 country: United States lat: 32.72541 lon: -97.32085 facility: University of Texas Health Center at Tyler city: Tyler state: Texas zip: 75708 country: United States lat: 32.35126 lon: -95.30106 facility: Primary Children's Cystic Fibrosis Center city: Salt Lake City state: Utah zip: 84113 country: United States lat: 40.76078 lon: -111.89105 facility: University of Vermont Medical Center city: Burlington state: Vermont zip: 05401 country: United States lat: 44.47588 lon: -73.21207 facility: University of Virginia city: Charlottesville state: Virginia zip: 22904 country: United States lat: 38.02931 lon: -78.47668 facility: Virginia Commonwealth University city: Richmond state: Virginia zip: 23219 country: United States lat: 37.55376 lon: -77.46026 facility: Seattle Children's Hospital city: Seattle state: Washington zip: 98105 country: United States lat: 47.60621 lon: -122.33207 facility: University of Washington Medical Center city: Seattle state: Washington zip: 98195 country: United States lat: 47.60621 lon: -122.33207 facility: Providence Medical Group, Cystic Fibrosis Center city: Spokane state: Washington zip: 99204 country: United States lat: 47.65966 lon: -117.42908 facility: West Virginia University - Morgantown city: Morgantown state: West Virginia zip: 26506 country: United States lat: 39.62953 lon: -79.9559 facility: University of Wisconsin city: Madison state: Wisconsin zip: 53792 country: United States lat: 43.07305 lon: -89.40123 facility: Children's Wisconsin city: Milwaukee state: Wisconsin zip: 53226 country: United States lat: 43.0389 lon: -87.90647 facility: Froedtert & Medical College of Wisconsin city: Milwaukee state: Wisconsin zip: 53226 country: United States lat: 43.0389 lon: -87.90647 hasResults: False
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<|newrecord|> nctId: NCT06350461 id: SIMPLIFY-IP-19 HS briefTitle: Impact of Discontinuing Hypertonic Saline in People With CF on Highly Effective CFTR Modulators- A SIMPLIFY Sub-Study acronym: SIMPLIFY-HS overallStatus: COMPLETED date: 2020-08-25 date: 2022-07-11 date: 2022-07-11 date: 2024-04-05 date: 2024-04-05 name: Nicole Hamblett class: OTHER name: Cystic Fibrosis Foundation name: Dartmouth-Hitchcock Medical Center name: University of Washington briefSummary: Despite the increasingly common use of cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies in treating cystic fibrosis (CF), it is still largely unknown whether or not other chronic therapies can be safely stopped. This SIMPLIFY sub-study is being done to test whether or not it is safe to stop taking inhaled hypertonic saline in those people that are also taking elexacaftor/tezacaftor/ivacaftor (ETI).
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ETI is a combination CFTR modulator therapy that was approved by the Food and Drug Administration for people with CF who have at least one F508del mutation. The three drugs that make up ETI work together to allow many more chloride ions to move into and out of the cells, improving the balance of salt and water in the lungs. These changes result in better clearance of mucus from the lungs and improvements in lung function.
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Inhaled hypertonic saline (HS) also improves clearance of mucus from the lungs to support lung function and has been available to people with CF for many years. HS is considered to be relatively burdensome and it is not known whether HS can improve or maintain lung function above what is already gained through ETI use.
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The goal of this SIMPLIFY sub-study is to get information about whether or not it is safe to stop hypertonic saline by testing if there is a change in lung function in participants with cystic fibrosis (CF) who are assigned to stop taking HS as compared to those who are assigned to keep taking HS while continuing to take ETI.
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This is a sub study of master protocol SIMPLIFY-IP-19, NCT04378153.
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The sub study investigating the impact of discontinuing and continuing dornase alfa is registered under NCTXXXXXXX (will add once available). conditions: Cystic Fibrosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 370 type: ACTUAL name: Discontinuation of hypertonic saline (HS) name: Continuation of hypertonic saline (HS) measure: Absolute Change in FEV1 % Predicted From Week 0 to Week 6 measure: Absolute Change in LCI 2.5 From Baseline to Week 6 measure: Absolute Change in Respiratory Symptoms, as Measured by the CF Respiratory Symptoms Diary-Chronic Respiratory Infection Symptom Severity Score (CRISS) From Week 0 to Week 6 measure: Absolute Change in Respiratory Symptoms, as Measured by CFQ-R Respiratory Domain From Week 0 to Week 6 measure: Absolute Change in FEV1 % Predicted From Week -2 to Week 0 measure: Absolute Change in FEV1 % Predicted From Week 0 to Week 2 measure: Number and Percent of Participants Initiating Acute Antibiotics From Week 0 to Week 6 measure: Number and Percent of Participants Hospitalized From Week 0 to Week 6 measure: Number and percent of participants Experiencing Pulmonary Exacerbations from Week 0 to Week 6 measure: Number and Percent of Participants Experiencing Adverse Events (AEs) From Week 0 to Week 6 measure: Rate of Adverse Events (AEs) From Week 0 to Week 6 Therapy Arms measure: Number and Percent of Participants with Temporary or Permanent Changes From Assigned Therapy Regimen Due to Adverse Event From Week 0 to Week 6 sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alabama at Birmingham city: Birmingham state: Alabama zip: 35294 country: United States lat: 33.52066 lon: -86.80249 facility: Providence Alaska Medical Center city: Anchorage state: Alaska zip: 99508 country: United States lat: 61.21806 lon: -149.90028 facility: Tucson Cystic Fibrosis Center city: Tucson state: Arizona zip: 85724 country: United States lat: 32.22174 lon: -110.92648 facility: Arkansas Children's Hospital city: Little Rock state: Arkansas zip: 72202 country: United States lat: 34.74648 lon: -92.28959 facility: Miller Children's and Women's Hospital Long Beach city: Long Beach state: California zip: 90806 country: United States lat: 33.76696 lon: -118.18923 facility: CHOC Children's Hospital city: Orange state: California zip: 92868 country: United States lat: 33.78779 lon: -117.85311 facility: Stanford University Medical Center city: Palo Alto state: California zip: 94304 country: United States lat: 37.44188 lon: -122.14302 facility: Rady Children's Hospital and Health Center at the University of California San Diego city: San Diego state: California zip: 92123 country: United States lat: 32.71533 lon: -117.15726 facility: University of California, San Francisco - Adult Center city: San Francisco state: California zip: 94143 country: United States lat: 37.77493 lon: -122.41942 facility: University of California, San Francisco - Peds Center city: San Francisco state: California zip: 94158 country: United States lat: 37.77493 lon: -122.41942 facility: Children's Hospital Colorado city: Aurora state: Colorado zip: 80045 country: United States lat: 39.72943 lon: -104.83192 facility: National Jewish Health city: Denver state: Colorado zip: 80206 country: United States lat: 39.73915 lon: -104.9847 facility: Yale University School of Medicine city: New Haven state: Connecticut zip: 06520 country: United States lat: 41.30815 lon: -72.92816 facility: University of Florida city: Gainesville state: Florida zip: 32610 country: United States lat: 29.65163 lon: -82.32483 facility: Nemours Children's Clinic - Jacksonville city: Jacksonville state: Florida zip: 32207 country: United States lat: 30.33218 lon: -81.65565 facility: Central Florida Pulmonary Group city: Orlando state: Florida zip: 32803 country: United States lat: 28.53834 lon: -81.37924 facility: The Nemours Children's Clinic - Orlando city: Orlando state: Florida zip: 32827 country: United States lat: 28.53834 lon: -81.37924 facility: Nemours Children's Clinic - Pensacola city: Pensacola state: Florida zip: 32514 country: United States lat: 30.42131 lon: -87.21691 facility: All Children's Hospital city: Saint Petersburg state: Florida zip: 33701 country: United States lat: 27.77086 lon: -82.67927 facility: Tampa General Hospital city: Tampa state: Florida zip: 33606 country: United States lat: 27.94752 lon: -82.45843 facility: Emory University city: Atlanta state: Georgia zip: 30324 country: United States lat: 33.749 lon: -84.38798 facility: Saint Luke's Cystic Fibrosis Center of Idaho city: Boise state: Idaho zip: 83702 country: United States lat: 43.6135 lon: -116.20345 facility: Northwestern University city: Chicago state: Illinois zip: 60611 country: United States lat: 41.85003 lon: -87.65005 facility: OSF Saint Francis Medical Center city: Peoria state: Illinois zip: 61637 country: United States lat: 40.69365 lon: -89.58899 facility: Riley Hospital for Children city: Indianapolis state: Indiana zip: 46202 country: United States lat: 39.76838 lon: -86.15804 facility: University of Iowa city: Iowa City state: Iowa zip: 52242 country: United States lat: 41.66113 lon: -91.53017 facility: University of Kansas Medical Center city: Kansas City state: Kansas zip: 66160 country: United States lat: 39.11417 lon: -94.62746 facility: University of Kentucky city: Lexington state: Kentucky zip: 40506 country: United States lat: 37.98869 lon: -84.47772 facility: University of Louisville city: Louisville state: Kentucky zip: 40202 country: United States lat: 38.25424 lon: -85.75941 facility: Tulane University city: Metairie state: Louisiana zip: 70001 country: United States lat: 29.98409 lon: -90.15285 facility: Maine Medical Partners Pediatric Specialty Care city: Portland state: Maine zip: 04102 country: United States lat: 43.66147 lon: -70.25533 facility: Johns Hopkins University city: Baltimore state: Maryland zip: 21287 country: United States lat: 39.29038 lon: -76.61219 facility: Boston Children's Hospital city: Boston state: Massachusetts zip: 02115 country: United States lat: 42.35843 lon: -71.05977 facility: University of Michigan, Michigan Medicine city: Ann Arbor state: Michigan zip: 48109 country: United States lat: 42.27756 lon: -83.74088 facility: Wayne State University Harper University Hospital city: Detroit state: Michigan zip: 48201 country: United States lat: 42.33143 lon: -83.04575 facility: Corewell Health Helen DeVos city: Grand Rapids state: Michigan zip: 49546 country: United States lat: 42.96336 lon: -85.66809 facility: Children's Hospitals and Clinics of Minnesota city: Minneapolis state: Minnesota zip: 55404 country: United States lat: 44.97997 lon: -93.26384 facility: The Minnesota Cystic Fibrosis Center city: Minneapolis state: Minnesota zip: 55455 country: United States lat: 44.97997 lon: -93.26384 facility: Children's Mercy Kansas City city: Kansas City state: Missouri zip: 64108 country: United States lat: 39.09973 lon: -94.57857 facility: Washington University School of Medicine city: Saint Louis state: Missouri zip: 63110 country: United States lat: 38.62727 lon: -90.19789 facility: Billings Clinic city: Billings state: Montana zip: 59101 country: United States lat: 45.78329 lon: -108.50069 facility: Dartmouth Hitchcock Medical Center city: Lebanon state: New Hampshire zip: 03756 country: United States lat: 43.64229 lon: -72.25176 facility: Monmouth Medical Center city: Eatontown state: New Jersey zip: 07724 country: United States lat: 40.29622 lon: -74.05097 facility: Morristown Medical Center city: Morristown state: New Jersey zip: 07960 country: United States lat: 40.79677 lon: -74.48154 facility: Rutgers - Robert Wood Johnson Medical School city: New Brunswick state: New Jersey zip: 08903 country: United States lat: 40.48622 lon: -74.45182 facility: Cohen Children's Medical Center of New York city: New Hyde Park state: New York zip: 11042 country: United States lat: 40.7351 lon: -73.68791 facility: Beth Israel Medical Center city: New York state: New York zip: 10003 country: United States lat: 40.71427 lon: -74.00597 facility: Lenox Hill Hospital Cystic Fibrosis Center city: New York state: New York zip: 10028 country: United States lat: 40.71427 lon: -74.00597 facility: Columbia University Cystic Fibrosis Program city: New York state: New York zip: 10032 country: United States lat: 40.71427 lon: -74.00597 facility: University of Rochester Medical Center Strong Memorial city: Rochester state: New York zip: 14642 country: United States lat: 43.15478 lon: -77.61556 facility: SUNY Upstate Medical University city: Syracuse state: New York zip: 13210 country: United States lat: 43.04812 lon: -76.14742 facility: New York Medical College at Westchester Medical Center city: Valhalla state: New York zip: 10595 country: United States lat: 41.07482 lon: -73.77513 facility: University of North Carolina at Chapel Hill city: Chapel Hill state: North Carolina zip: 27517 country: United States lat: 35.9132 lon: -79.05584 facility: Atrium Health Wake Forest Baptist city: Winston-Salem state: North Carolina zip: 27157 country: United States lat: 36.09986 lon: -80.24422 facility: Children's Hospital Medical Center of Akron city: Akron state: Ohio zip: 44308 country: United States lat: 41.08144 lon: -81.51901 facility: Cincinnati Children's Hospital Medical Center city: Cincinnati state: Ohio zip: 45229 country: United States lat: 39.12713 lon: -84.51435 facility: Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center city: Cleveland state: Ohio zip: 44146 country: United States lat: 41.4995 lon: -81.69541 facility: Cleveland Clinic Cystic Fibrosis Program city: Cleveland state: Ohio zip: 44195 country: United States lat: 41.4995 lon: -81.69541 facility: Nationwide Children's Hospital city: Columbus state: Ohio zip: 43205 country: United States lat: 39.96118 lon: -82.99879 facility: Dayton Children's Hospital city: Dayton state: Ohio zip: 45404 country: United States lat: 39.75895 lon: -84.19161 facility: Oregon Health & Sciences University city: Portland state: Oregon zip: 97239 country: United States lat: 45.52345 lon: -122.67621 facility: Hershey Medical Center Pennsylvania State University city: Hershey state: Pennsylvania zip: 17033 country: United States lat: 40.28592 lon: -76.65025 facility: University of Pennsylvania city: Philadelphia state: Pennsylvania zip: 19104 country: United States lat: 39.95233 lon: -75.16379 facility: University of Pittsburgh Medical Center city: Pittsburgh state: Pennsylvania zip: 15224 country: United States lat: 40.44062 lon: -79.99589 facility: Medical University of South Carolina city: Charleston state: South Carolina zip: 29425 country: United States lat: 32.77657 lon: -79.93092 facility: Dell Children's Medical Center of Central Texas city: Austin state: Texas zip: 78723 country: United States lat: 30.26715 lon: -97.74306 facility: University of Texas Southwestern / Children's Health city: Dallas state: Texas zip: 75207 country: United States lat: 32.78306 lon: -96.80667 facility: University of Texas Southwestern city: Dallas state: Texas zip: 75390 country: United States lat: 32.78306 lon: -96.80667 facility: Cook Children's Medical Center city: Fort Worth state: Texas zip: 76104 country: United States lat: 32.72541 lon: -97.32085 facility: University of Texas Health Center at Tyler city: Tyler state: Texas zip: 75708 country: United States lat: 32.35126 lon: -95.30106 facility: Primary Children's Cystic Fibrosis Center city: Salt Lake City state: Utah zip: 84113 country: United States lat: 40.76078 lon: -111.89105 facility: University of Vermont Medical Center city: Burlington state: Vermont zip: 05401 country: United States lat: 44.47588 lon: -73.21207 facility: University of Virginia city: Charlottesville state: Virginia zip: 22904 country: United States lat: 38.02931 lon: -78.47668 facility: Virginia Commonwealth University city: Richmond state: Virginia zip: 23219 country: United States lat: 37.55376 lon: -77.46026 facility: Seattle Children's Hospital city: Seattle state: Washington zip: 98105 country: United States lat: 47.60621 lon: -122.33207 facility: University of Washington Medical Center city: Seattle state: Washington zip: 98195 country: United States lat: 47.60621 lon: -122.33207 facility: Providence Medical Group, Cystic Fibrosis Clinic city: Spokane state: Washington zip: 99204 country: United States lat: 47.65966 lon: -117.42908 facility: West Virginia University - Morgantown city: Morgantown state: West Virginia zip: 26506 country: United States lat: 39.62953 lon: -79.9559 facility: University of Wisconsin city: Madison state: Wisconsin zip: 53792 country: United States lat: 43.07305 lon: -89.40123 facility: Children's Wisconsin city: Milwaukee state: Wisconsin zip: 53226 country: United States lat: 43.0389 lon: -87.90647 facility: Froedtert & Medical College of Wisconsin city: Milwaukee state: Wisconsin zip: 53226 country: United States lat: 43.0389 lon: -87.90647 hasResults: False
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<|newrecord|> nctId: NCT06350448 id: WMT-CN-RH briefTitle: Washed Microbiota Transplantation for Rhinitis overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2029-05-01 date: 2029-08-01 date: 2024-04-05 date: 2024-04-05 name: The Second Hospital of Nanjing Medical University class: OTHER briefSummary: The common symptoms of rhinitis include nasal itching, sneezing, anterior or posterior nasal leakage, and nasal congestion. Rhinitis can be classified as allergic rhinitis (AR) and non-allergic rhinitis (NAR) based on the presence of a specific allergen. Increasing evidence showed that gut microbiota can influence the development of AR. Although few studies have reported the association between NAR and gut microbiota, we found that washed microbiota transplantation (WMT) could improve nasal symptoms, whether it is AR or NAR. This clinical trial aims to evaluate the efficacy and safety of WMT for rhinitis. conditions: Rhinitis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Washed Microbiota Transplantation measure: Changes in the reflective total nasal symptom score (rTNSS) measure: Changes in the combined symptoms and medication score (CSMS) measure: Changes in the rhinoconjunctivitis quality of life questionnaire (RQLQ) score measure: Changes in the single reflective nasal symptoms score measure: Specific IgE measure: Inflammatory factors measure: Flow cytometric analysis of lymphocyte clusters measure: The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0 sex: ALL minimumAge: 6 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University city: Nanjing state: Jiangsu zip: 210011 country: China name: Faming Zhang, MD,PhD role: CONTACT phone: 086-25-58509883 email: [email protected] lat: 32.06167 lon: 118.77778 hasResults: False
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<|newrecord|> nctId: NCT06350435 id: CUHK 2023.569 briefTitle: Effects of Prefabricated Foot Orthoses With and Without Metatarsal Pads on Central Metatarsalgia overallStatus: ACTIVE_NOT_RECRUITING date: 2023-12-18 date: 2024-04-26 date: 2024-05-31 date: 2024-04-05 date: 2024-04-05 name: Chinese University of Hong Kong class: OTHER name: Pamela Youde Nethersole Eastern Hospital briefSummary: Compare the effects of prefabricated foot orthoses with and without metatarsal pads on pain intensity in the 2nd to 4th metatarsophalangeal joints, foot and ankle functional abilities as well as the occurrence of plantar callosities among patients with central metatarsalgia. conditions: Metatarsalgia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 32 type: ACTUAL name: Prefabricated foot orthoses (PFO) with metatarsal pads name: Prefabricated foot orthoses (PFO) without metatarsal pads measure: Pain intensity at the 2nd to 4th metatarsophalangeal joints during walking in shoes on Visual Analogue Scale measure: Foot and Ankle Outcome Score measure: Size of callosities and corns on the plantar area of the 2nd to 4th metatarsophalangeal joints sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pamela Youde Nethersole Eastern Hospital city: Hong Kong country: Hong Kong lat: 22.27832 lon: 114.17469 hasResults: False
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<|newrecord|> nctId: NCT06350422 id: Microgravity-ChinaPLAGH briefTitle: Neuroimage Genome Study of Neuroplasticity Associated With Microgravity overallStatus: ACTIVE_NOT_RECRUITING date: 2022-01-01 date: 2024-10-31 date: 2024-12-31 date: 2024-04-05 date: 2024-04-05 name: Chinese PLA General Hospital class: OTHER briefSummary: This clinical trial investigates the neuroplasticity and cognitive status changes of the human brain in microgravity. To explore the relationship between cognitive status changes and brain functional activities, gray matter and white matter changes under microgravity exposure, screen and identify representative image markers, so as to provide decision-making information for the cognitive status changes of relevant personnel under microgravity environment. conditions: Microgravity conditions: Neuroplasticity conditions: MRI conditions: Repeatable Battery for the Assessment of Neuropsychological Status studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 26 type: ACTUAL name: Head-Down tilt Bed Rest test measure: Local brain functional activity measure: Brain functional connectivity measure: Brain structure - Morphology measure: Brain fiber bundle and brain Diffusion index measure: Brain blood flow measure: Imaging indexes and clinical scale scores sex: MALE minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Chinese PLA General Hospital city: Beijing country: China lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06350409 id: CTN-0146 id: UG1DA015831-22S4 type: NIH link: https://reporter.nih.gov/quickSearch/UG1DA015831-22S4 briefTitle: Adolescent Outcomes of Post-operative Opioid EXposure acronym: APEX overallStatus: NOT_YET_RECRUITING date: 2024-08-10 date: 2026-09-10 date: 2026-10-10 date: 2024-04-05 date: 2024-04-10 name: Sharon Levy class: OTHER name: National Institute on Drug Abuse (NIDA) name: National Institutes of Health (NIH) briefSummary: The goal of this observational study is to examine the factors associated with the transition from medical exposure to opioids with "signposts" of future opioid use disorder among adolescent surgical patients. The main question aims to identify factors (moderators, mediators, and covariates) associated with risk factors for opioid use disorder (ROUD) in the 12 months following major surgery with opioid exposure among adolescents aged 12-17. Participants will be asked to complete electronic surveys pre- and post-operatively and approve the collection of peri-operative data from the Electronic Medical Record to assess correlations. conditions: Opioid Use Disorder conditions: Pain, Chronic studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20000 type: ESTIMATED measure: Risk of opioid use disorder due to prolonged pain that develops within the first year after surgery. measure: Risk of opioid use disorder due to prolonged opioid use that develops within the first year after surgery. measure: Risk of opioid use disorder due to postoperative non-medical use of prescription opioids (NMUPO) that develops within the first year after surgery. measure: Risk of opioid use disorder due to increased rate of change in substance use that develops within the first year after surgery. measure: Risk of opioid use disorder due to post-surgical trauma that develops within the first year after surgery. sex: ALL minimumAge: 12 Years maximumAge: 17 Years stdAges: CHILD facility: Boston Childrens Hopsital - Division of Addiction Medicine city: Boston state: Massachusetts zip: 02115 country: United States name: Melissa Brogna, MSW role: CONTACT phone: 857-218-4311 email: [email protected] lat: 42.35843 lon: -71.05977 hasResults: False
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<|newrecord|> nctId: NCT06350396 id: CPLTRDDM2024 briefTitle: pBFS-guided rTMS Over DMPFC for Treatment-Resistant Depression overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12-30 date: 2025-06-30 date: 2024-04-05 date: 2024-04-05 name: Changping Laboratory class: OTHER briefSummary: This study is a multicenter, randomized, double-blind, placebo-controlled trial aimed at exploring the effectiveness and safety of rTMS intervention with DMPFC targets guided by pBFS in patients with treatment-resistant depression. conditions: Treatment Resistant Depression conditions: Major Depressive Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 270 type: ESTIMATED name: active rTMS treatment name: sham rTMS treatment measure: Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline to Immediate Post-treatment measure: Remission and response rates were estimated using Montgomery-Asberg Depression Rating Scale(MADRS) measure: Remission and response rates were estimated using Hamilton Depression Rating Scale (HAMD-17) measure: Changes in the MADRS from baseline to each visit measure: Changes in the HAMD-17 from baseline to each visit measure: cognitive change in Digit Symbol Substitution Test (DSST) measure: cognitive change in continuous performance test (CPT) measure: cognitive change in Trail-Making Test (TMT) measure: cognitive change in Digit Span Test (DST) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hebei Mental Health Center city: Hebei state: Baoding country: China name: Lili Zhang role: CONTACT facility: West China Hospital, Sichuan University city: Chengdu country: China name: Qiyong Gong role: CONTACT lat: 30.66667 lon: 104.06667 facility: Inner Mongolia Mental Health Center city: Hohhot country: China name: Dongsheng Lv role: CONTACT lat: 40.81056 lon: 111.65222 facility: Shandong Daizhuang Hospital city: Jining country: China name: Zhonggang Wang role: CONTACT lat: 35.405 lon: 116.58139 facility: The Second Affiliated Hospital of Xinxiang Medical University city: Xinxiang country: China name: Yongfeng Yang role: CONTACT lat: 35.19033 lon: 113.80151 hasResults: False
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<|newrecord|> nctId: NCT06350383 id: K01TW011775 type: NIH link: https://reporter.nih.gov/quickSearch/K01TW011775 briefTitle: Adapting a Low-cost Intimate Partner Violence and Mental Health Response Intervention overallStatus: NOT_YET_RECRUITING date: 2024-05-06 date: 2025-01-06 date: 2025-01-06 date: 2024-04-05 date: 2024-04-05 name: Columbia University class: OTHER name: Drexel University name: Africa Mental Health Research and Training Foundation briefSummary: The goal of this feasibility study (clinical trial) is to test a low-cost, combined, adapted intimate partner violence (IPV) and mental health intervention (Wings of Hope: WINGS + Problem Management Plus: PM+) that can be carried out by lay community health workers as a foundation for a potential low-cost essential services package for women experiencing IPV and related mental health challenges in informal settlements in Kenya. The main aims of the study are to (1) assess the safety, feasibility, and acceptability of WINGS+PM+ among women experiencing IPV in informal settlements in Kenya; (2) to test preliminary efficacy of program mediating outcomes in addition to the distal outcome (incidence/severity of IPV), while closely monitoring fidelity or process measures, including attendance/retention, adherence, quality of delivery, participant satisfaction, safety and quality improvement and adaptation modifications; and (3) generate data on distributions of study outcomes to calculate the power to detect a meaningful effect size in a future efficacy trial. Women experiencing IPV (n=260) will be recruited from the outpatient walk-in departments at the Kianda 42 Hospital in Kibera informal settlement (n=130) and Upendo Clinic in Mathare informal settlement (n=130). Consenting women will be screened for experiences of recent IPV (last 3 months). Subsequently 130 eligible IPV survivors from the Kianda 42 Hospital and 130 from the Upendo Clinic will be randomized to either receive the combined WINGS+PM+ intervention (n=65) or the PM+-only intervention (control/comparison arm) (n=65) at each clinic. conditions: Violence, Domestic conditions: Psychological Distress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two-arm, parallel-group design primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: Participants will not be told which arm they have been randomized to. Additionally, to reduce contamination, community health volunteers (CHVs) will either carry out assessment or intervention, not both. Assessors will not be told to which arm participants they are assessing have been assigned. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 260 type: ESTIMATED name: WINGS+PM+ name: PM+-only measure: World Health Organization (WHO) Violence Against Women (VAW) diagnostic instrument measure: Receipt of violence services measure: Domestic Violence Coping Self-efficacy Scale (DVCSE) measure: Multidimensional Scale of Perceived Social Support (MSPSS) measure: Safety Behavior Checklist measure: Psychological distress (GHQ-12) measure: Functioning (WHODAS 2.0) measure: Short form of the Posttraumatic Stress Disorder Checklist (PCL-5) measure: Personalized outcomes (PSYCHLOPS) measure: Quality control/intervention fidelity measure: Facilitator Satisfaction and ease of intervention delivery (EBPAS-36) measure: Adverse events measure: Participant satisfaction with intervention measure: Number of participants in attendance at sessions measure: Retention Rate sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06350370 id: NCC3489 briefTitle: Short-term and Long-term Outcomes of Colorectal Cancer Treated With Natural Orifice Specimen Extraction Surgery : a National Registry-based Study overallStatus: RECRUITING date: 2019-01-01 date: 2023-01-01 date: 2028-01-01 date: 2024-04-05 date: 2024-04-05 name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences class: OTHER briefSummary: Natural orifice specimen extraction surgery (NOSES) has gained widespread recognition among scholars and has gradually been promoted and popularized around the world. However, the development of NOSES is still in the exploratory stage and there is a lack of strong evidence from evidence-based medicine to support its feasibility and safety, which has greatly affected its clinical application and development. Based on this, at the call of Professor Xishan Wang, the Chinese NOSES Alliance conducted a large retrospective clinical study involving multiple centers. By summarizing the NOSES cases of nearly 100 centers in China, the study aims to clarify the current status of NOSES surgery in China. Additionally, a comprehensive analysis and summary was conducted by combining the basic information of NOSES patients, perioperative data, postoperative pathological data, and follow-up information to further demonstrate the safety and feasibility of NOSES in the treatment of colorectal cancer. This study also provides more real and objective evidence-based medicine support for the promotion and development of NOSES surgery. conditions: Colorectal Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 8000 type: ESTIMATED name: Natural orifice specimen extraction measure: Rate of short-term complication measure: Operative duration measure: Intraoperative blood loss measure: Time to first flatus after surgery measure: Time to first stool after surgery measure: Length of stay after surgery measure: 3-year disease free survival measure: 3-year overall survival sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cancer Hospital Chinese Academy of Medical Sciences status: RECRUITING city: Beijing state: Beijing zip: 100021 country: China name: Xishan Wang role: CONTACT phone: 13261967603 email: [email protected] name: Mingguang Zhang role: CONTACT phone: +8613261967603 email: [email protected] name: Xishan Wang, M.D. role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06350357 id: 2024B014 briefTitle: Conventional Clipping Versus Punching Closure overallStatus: RECRUITING date: 2024-04-01 date: 2025-12-31 date: 2025-12-31 date: 2024-04-05 date: 2024-04-05 name: Ningbo No. 1 Hospital class: OTHER briefSummary: Endoscopic submucosal dissection (ESD) is an important minimally invasive treatment method for early digestive tract tumors, with a high cure rate, and it is widely used in clinical practice. And wound closure after ESD is a great challenge, which is closely related to postoperative perforation bleeding. Clip closure is one of the most commonly used closure methods. However, when the wound is large or when the wound is located more difficult to operate, conventional closure may lead to delayed perforation, and postoperative clips may be prone to early spontaneous shedding. The authors have recently reported a method that may be able to close larger and difficult wounds because the grooves can better fix the metal clips. The latest study suggests that this approach may be safe and effective, but the study has a small sample size and has no controls. Therefore, high-quality clinical study evidence related to punch closure is required in the strategy of defect closure after ESD, in order to better evaluate the feasibility and safety of this new endoscopic closure method. conditions: the Rate of Complete Closure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 130 type: ESTIMATED name: punching closure name: Conventional clipping measure: Completely closed measure: delayed hemorrhage sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ningbo first hospital status: RECRUITING city: Ningbo state: Zhejiang country: China name: Lei Xu role: CONTACT phone: +86-13486659126 email: [email protected] lat: 29.87819 lon: 121.54945 hasResults: False
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<|newrecord|> nctId: NCT06350344 id: HZKY-PJ-2024-8-2 briefTitle: Smart Technology Facilitated Patient-centered Venous Thromboembolism Management acronym: SmaVTE-COR overallStatus: NOT_YET_RECRUITING date: 2024-11-01 date: 2026-10-31 date: 2027-10-31 date: 2024-04-05 date: 2024-04-11 name: Navy General Hospital, Beijing class: OTHER briefSummary: Smart technologies, such as wearable devices, mobile technologies, and artificial intelligence, are being investigated for use in health management. These technologies have the potential to be applied in disease pre-warning, decision-making support, health education, and healthcare maintenance. They are expected to address the challenges in managing thrombosis, improve access to high-quality medical resources in various regions, and enhance the development of a network for thrombosis rescue and treatment prevention.
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The objective of this study is to observe the long-term effect of mobile venous thromboembolism application (mVTEA) based patient-centered management of venous thromboembolism (VTE) on thromboprophylaxis, and establish a foundation of evidence for managing patients with high-risk VTE. conditions: Venous Thromboembolism conditions: Digital Health conditions: Health Education studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 2353 type: ESTIMATED name: mobile venous thromboembolism application (mVTEA) measure: VTE-related composite event measure: VTE-KAP questionnaire score measure: Generic quality of life measure: VTE events measure: Major bleeding measure: VTE-related hospitalization measure: New-onset of atrial fibrillation or atrial flutter measure: Death sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sixth Medical Center of Chinese PLA General Hospital city: Beijing state: Beijing zip: 100048 country: China lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06350331 id: HZKY-PJ-2024-8-1 briefTitle: Smart Technology Facilitated Patient-centered Venous Thromboembolism Management acronym: SmaVTE-RCT overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-10-31 date: 2024-10-31 date: 2024-04-05 date: 2024-04-11 name: Navy General Hospital, Beijing class: OTHER briefSummary: Smart technologies, such as wearable devices, mobile technologies, and artificial intelligence, are being investigated for use in health management. These technologies have the potential to be applied in disease pre-warning, decision-making support, health education, and healthcare maintenance. They are expected to address the challenges in managing thrombosis, improve access to high-quality medical resources in various regions, and enhance the development of a network for thrombosis rescue and treatment prevention.
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The objective of this study is to evaluate the impact of mobile venous thromboembolism application (mVTEA) based patient-centered management of venous thromboembolism (VTE) on patients' perceptions of thromboprophylaxis, in order to enhance clinical practice and establish a foundation of evidence for managing patients with VTE. conditions: Venous Thromboembolism conditions: Digital Health conditions: Health Education studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 256 type: ESTIMATED name: mobile venous thromboembolism application (mVTEA) measure: VTE-KAP questionnaire score measure: Knowledge, attitude, and practice scores in the VTE-KAP questionnaire measure: Generic quality of life measure: VTE events measure: Chronic thromboembolic pulmonary hypertension (CTEPH) measure: Chronic thromboembolic pulmonary disease (CTEPD) measure: Post-pulmonary embolism syndrome (PPES) measure: Major bleeding measure: VTE-related hospitalization measure: VTE-related rehospitalization measure: New-onset of atrial fibrillation or atrial flutter measure: Death sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sixth Medical Center of Chinese PLA General Hospital city: Beijing state: Beijing zip: 100048 country: China name: ZHI-GENG JIN, Doctor role: CONTACT phone: 8615801402223 email: [email protected] lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06350318 id: MCC-22005 briefTitle: Rituximab and Zanubrutinib in Patients With Indolent B-cell Lymphomas overallStatus: RECRUITING date: 2024-03-13 date: 2029-03 date: 2029-03 date: 2024-04-05 date: 2024-04-23 name: H. Lee Moffitt Cancer Center and Research Institute class: OTHER name: BeiGene, Ltd. briefSummary: The purpose of the study is to establish the safety and efficacy of zanubrutinib in combination with rituximab for people with untreated B-cell lymphomas (marginal zone lymphoma and follicular lymphomas). conditions: Follicular Lymphoma conditions: Marginal Zone Lymphoma conditions: B-Cell Lymphoma studyType: INTERVENTIONAL phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 43 type: ESTIMATED name: Zanubrutinib name: Rituximab measure: Overall Response Rate: Cohort A measure: Overall Response Rate: Cohort B measure: Efficacy of Zanubrutinib and Rituximab measure: Safety and tolerability of combination Zanubrutinib and Rituximab sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Moffitt Cancer Center status: RECRUITING city: Tampa state: Florida zip: 33612 country: United States name: Richard Corona role: CONTACT phone: 813-745-3465 email: [email protected] name: Sameh Gaballa, MD role: PRINCIPAL_INVESTIGATOR lat: 27.94752 lon: -82.45843 hasResults: False
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<|newrecord|> nctId: NCT06350305 id: Screening for high-risk COPD briefTitle: Screening for High-risk Chronic Obstructive Pulmonary Disease overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-04-30 date: 2027-10-31 date: 2024-04-05 date: 2024-04-11 name: Henan University of Traditional Chinese Medicine class: OTHER briefSummary: This study is a multicenter cross-sectional study design aimed at screening risk factors for the combination of disease and syndrome in high-risk individuals with chronic obstructive pulmonary disease (COPD). conditions: High-risk COPD studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: CROSS_SECTIONAL count: 3600 type: ESTIMATED name: questionnaire survey measure: COPD screening questionnaire from Terrassa (EGARPOC) measure: COPD assessment in primary care to identify undiagnosed respiratory disease and exacerbation risk questionnaire (CAPTURE) measure: COPD Assessment Test (CAT) measure: COPD screening questionnaire (COPD-Q) measure: chronic obstructive pulmonary disease diagnostic questionnaire (CDQ) measure: modified chronic obstructive pulmonary disease diagnostic questionnaire (mCDQ) measure: Simple screening questionnaire measure: lung function questionnaire (LFQ) measure: chronic obstructive pulmonary disease screening questionnaire (COPD-SQ) measure: chronic obstructive pulmonary disease population screener questionnaire (COPD-PS) measure: Chronic Obstructive Pulmonary Disease Risk Scale (COPDRS) measure: Standardised Scale of Physical Fitness in Chinese Medicine measure: Syndrome therapeutic evaluation scale of chronic obstructive pulmonary disease (COPD-STES) sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Henan University of Chinese Medicine city: Zhengzhou state: Henan zip: 450000 country: China name: yang Xie, doctor role: CONTACT phone: 0371-66248624 email: [email protected] lat: 34.75778 lon: 113.64861 hasResults: False
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<|newrecord|> nctId: NCT06350292 id: 0161464 briefTitle: SLEEP-COPE: Sleep Intervention for Oppositional Children overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-01-01 date: 2025-02-01 date: 2024-04-05 date: 2024-04-05 name: University of South Florida class: OTHER briefSummary: Children with Oppositional Defiant Disorder (ODD) are at risk for insomnia, arousal dysfunction, mood problems, and noncompliance. Cognitive behavioral treatment for insomnia (CBT-I) holds promise for improving insomnia and related concerns. Telehealth delivery will reduce the burden of in-person sessions, particularly in areas where there is low mental healthcare access. Telehealth CBT-I is efficacious in adults and children but has not been tested in children with ODD. The proposed trial is the next logical step - development and iterative testing of SLEEP-COPE, a brief dyadic telehealth CBT-I for children with ODD and their parents. conditions: Insomnia Chronic conditions: Oppositional Defiant Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 25 type: ESTIMATED name: SLEEP: COPE measure: Child Daily Sleep Diaries measure: Parent Daily Sleep Diaries measure: Child Actigraphy measure: Parent Actigraphy measure: Child Salivary Cortisol measure: Child Hair Cortisol measure: The Revised Childhood Anxiety and Depression Scale measure: PROMIS Child Sleep Disturbance measure: Alabama Parenting Questionnaire measure: Perceived Stress Scale measure: Child Disruptive Behavior Disorders Checklist measure: Beck Depression Inventory-II measure: State-Trait Anxiety Inventory measure: PROMIS Adult Sleep Disturbance measure: Pediatric Sleep Questionnaire measure: Epworth Sleepiness Scale sex: ALL minimumAge: 8 Years maximumAge: 12 Years stdAges: CHILD hasResults: False
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<|newrecord|> nctId: NCT06350279 id: HSK39297-101 briefTitle: A Phase I Study to Assess the Safety,Tolerability, PK, PD, and Food Effect of HSK39297 in Healthy Subjects overallStatus: RECRUITING date: 2023-12-25 date: 2024-05-31 date: 2024-07-31 date: 2024-04-05 date: 2024-04-05 name: Haisco Pharmaceutical Group Co., Ltd. class: INDUSTRY briefSummary: This is a Phase I, randomized, subject-blinded, placebo controlled study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD),and food effect (FE) of HSK39297 following (1) a single ascending dose (part 1), (2) 10 days of multiple ascending dose (part 2), and (3) a single dose two-period crossover FE cohort. conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 96 type: ESTIMATED name: HSK39297 measure: The number and severity of treatment emergent adverse events (TEAEs) . measure: AUC measure: Cmax measure: Tmax measure: t1/2 measure: AP change measure: Bb sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Beijing Tongren Hospital status: RECRUITING city: Beijing country: China name: Laichun Lu role: CONTACT lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06350266 id: 2024-0183 briefTitle: Informing Low-acuity Emergency Department Patients of Non-emergent Resources overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2024-12 date: 2024-12 date: 2024-04-05 date: 2024-04-05 name: Geisinger Clinic class: OTHER briefSummary: The goal of this campaign is to reduce unnecessary ED visits/encourage patients with low acuity visits to follow up with an appropriate provider and/or to seek care outside of the ED in the future. In this campaign, patients will be assigned to receive or not receive outreach following ED discharge that is aligned with the goal. Outreach will occur via a text message, as well as information added to the patient's after visit summary, and will include one or more calls to action that make patients aware of other Geisinger resources and avenues through which they can seek care outside of the ED. These may include, but are not limited to, walk-in urgent care, virtual urgent care, PCP appointments, and/or other ways in which to contact Geisinger. We will measure whether ED use differs across patients in different outreach conditions. We will also examine whether patients followed through on the message-specific calls to action in the messages differently across conditions. conditions: Emergency Service, Hospital studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE maskingDescription: Patients will be aware of their own messages but not of messages sent to other patients or in other arms. count: 8300 type: ESTIMATED name: Information about healthcare resources measure: Return to ED measure: PCP appointment scheduled measure: PCP visit measure: Telehealth appointment scheduled measure: Telehealth appointment attended measure: Urgent care visit measure: Call made to PCP measure: Any of the suggested actions taken sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06350253 id: 22-X-187 briefTitle: Comparison Of Measured To Predicted Resting Metabolism overallStatus: RECRUITING date: 2023-03-14 date: 2024-12-31 date: 2025-12-31 date: 2024-04-05 date: 2024-04-05 name: Ohio University class: OTHER briefSummary: The purpose of this study is to compare RMR values from the BIA, predicted equations, and indirect calorimetry. conditions: Body Weight studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 150 type: ESTIMATED name: Metabolic cart name: MedGem name: BIA measure: Resting metabolic rate sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Ohio University Exercise Physiology Lab status: RECRUITING city: Athens state: Ohio zip: 45701 country: United States name: Angela Hillman, PhD role: CONTACT phone: 740-593-0153 email: [email protected] lat: 39.32924 lon: -82.10126 hasResults: False
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<|newrecord|> nctId: NCT06350240 id: KUzunAkkaya briefTitle: Effects of Textured Insoles and Exercise in Children With Joint Hypermobility overallStatus: RECRUITING date: 2023-11-01 date: 2024-11-01 date: 2024-11-30 date: 2024-04-05 date: 2024-04-05 name: Gazi University class: OTHER name: TÜBİTAK briefSummary: Joint hypermobility is the condition that the joints have a greater range of motion than normal and can be observed frequently in children. In children with joint hypermobility, motor problems, tactile and proprioceptive sensory disorders can be observed. It is very important to support children with joint hypermobility with intervention programs that are rich in both motor and sensory aspects. The aim of this project is to create an exercise protocol rich in tactile, proprioceptive senses for children with joint hypermobility and to examine the effects of using textured insoles in addition to exercise on tactile sense, balance, foot load distribution and quality of life in children. conditions: Child, Only conditions: Joint Laxity conditions: Exercise conditions: Textured Insoles studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 40 type: ESTIMATED name: Exercise name: Exercise+texture insoles measure: Tactile sense measure: Foot load distribution measure: Balance measure: Foot posture measure: Quality of life assessment sex: ALL minimumAge: 5 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Gazi University status: RECRUITING city: Ankara country: Turkey name: Kamile Uzun Akkaya, Phd role: CONTACT lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06350227 id: WestChinaSU briefTitle: Impact of Different Hemostasis Methods on Ovarian Function and Fertility During Laparoscopic Ovarian Cystectomy of Benign Ovarian Cyst overallStatus: RECRUITING date: 2024-01-04 date: 2026-01 date: 2026-06 date: 2024-04-05 date: 2024-04-05 name: West China Second University Hospital class: OTHER briefSummary: The purpose of this study is to compare the impact of different hemostasis methods during laparoscopic ovarian cystectomy on ovarian function and fertility in women with benign ovarian cysts. conditions: Ovarian Cyst Benign studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 165 type: ESTIMATED name: the absorbable hemostat and suture name: electrocoagulation and suture name: suture measure: Antral Follicle Count (AFC) measure: Anti-Mullerian hormone (AMH) sex: FEMALE minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: West China Second University Hospital, Sichuan University status: RECRUITING city: Chengdu state: Sichuan country: China name: Yanru Long role: CONTACT phone: 86-13550169017 email: [email protected] lat: 30.66667 lon: 104.06667 hasResults: False
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<|newrecord|> nctId: NCT06350214 id: #2005-06; #2011-17; #2018-01 briefTitle: Physical Activity and Nutrition in Cancer Survivors overallStatus: COMPLETED date: 2007-01-01 date: 2018-12-31 date: 2018-12-31 date: 2024-04-05 date: 2024-04-05 name: West China Hospital class: OTHER briefSummary: This study aims to investigate the independent and combined associations between physical activity and nutrition condition with mortality among cancer survivors. conditions: Cancer conditions: Nutrition, Healthy conditions: Physical Inactivity studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 3100 type: ACTUAL name: physical activity and nutrition assessment measure: All-cause mortality measure: Cause-specific mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06350201 id: KY2024.0124.02 briefTitle: Machine Learning-based Classification of Symptom Clusters and Online CBT overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-01 date: 2024-12-01 date: 2024-04-05 date: 2024-04-09 name: Wuhan Mental Health Centre class: OTHER briefSummary: To breakthrough the bottleneck identified, we will conduct a cross-sectional study to develop a symptom clustering model for depression and anxiety. A wide range of statistical methods as well as machine learning approaches were explored, and a cohesive hierarchical clustering algorithm will be used. After developing the model, a symptom-matched intervention program based on problem solving therapy will be formulated. We are supposed to examine whether its use for personalizing symptom-matched psychological treatment can lead to improved patient outcomes, compared with usual care. This project is expected to provide a new and precise method for the emotion management, which will provide a standardized intervention pathway combining screening with treatment for the management of depression symptom and anxiety symptom. A preciser intervention matched to individual symptoms may provide important insight in improving patient outcome as well as a standardized mood management pathway targeting to the early detection and intervention for community residents. conditions: Depression and Anxiety Symptom studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: cognitive behavior therapy name: control group measure: The Patient Health Questionnaire (PHQ-9) measure: 7-tiem Generalized Anxiety Disorder Scale,GAD-.7 sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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