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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: jhysmc@gmail.com name: David Hong, MD role: CONTACT phone: 82-2-3410-3419 email: hongdawi@naver.com 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).
|
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.
|
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.
|
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.
|
This is a sub study of master protocol SIMPLIFY-IP-19, NCT04378153.
|
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: fzhang@njmu.edu.cn 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: Melissa.Brogna@childrens.harvard.edu 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: wxshan_cams@163.com name: Mingguang Zhang role: CONTACT phone: +8613261967603 email: zmgslimshady@163.com 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: xulei22@163.com 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: lwgjzg@163.com 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: Richard.Corona@moffitt.org 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: xieyanghn@163.com 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: hillman@ohio.edu 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: 2801443341@qq.com 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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<|newrecord|> nctId: NCT06350188 id: ECM#2024-506 briefTitle: Efficacy of Kinesiotape on Treatment of Nonspecific Cardiac Chest Pain overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-22 date: 2024-06-22 date: 2024-07-22 date: 2024-04-05 date: 2024-04-05 name: Cairo University class: OTHER briefSummary: purpose of the study To investigate the effect of Kinesio-tape on treatment of nonspecific cardiac chest pain conditions: Nonspecific Cardiac Chest Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ACTUAL name: experimental name: traditional measure: PAIN USING VIISUSL ANALOGE SCALE measure: PERSSURE PAIN THRESHOLD measure: SHOULDER RANGE OF MOTION measure: shoulder pain and disability sex: ALL minimumAge: 20 Years maximumAge: 35 Years stdAges: ADULT facility: Huda Badr Abd Elhamed city: Cairo country: Egypt lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06350175 id: 2212697123 briefTitle: Emergency Department Management of Tobacco Use Disorder overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-03 date: 2025-06 date: 2024-04-05 date: 2024-04-16 name: West Virginia University class: OTHER briefSummary: The objective of this study is to determine the effectiveness of ED initiated NRT on tobacco cessation point abstinence rates as reported by patients at 2 weeks and 1 month post randomization, and continued abstinence rates at 3 months compared to standard of care therapy. conditions: Tobacco Use Disorder conditions: Tobacco Use Cessation studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 100 type: ESTIMATED name: Nicotine Replacement Therapy Agent name: West Virginia Quit Line measure: Percentage of Continued Abstinence Rate (2 weeks) measure: Percentage of Continued Abstinence Rate (1 month) measure: Percentage of Continued Abstinence Rate (3 months) measure: Patient Health Questionnaire 2 (Baseline) measure: Patient Health Questionnaire 2 (3 months from baseline) measure: Heaviness of Smoking Index (Baseline) measure: Heaviness of Smoking Index (3 months from baseline) measure: Richmond Test (Baseline) measure: Richmond Test (3 months from baseline) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: West Virginia University city: Morgantown state: West Virginia zip: 26505 country: United States lat: 39.62953 lon: -79.9559 hasResults: False
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<|newrecord|> nctId: NCT06350162 id: ASTRUM-LC12 briefTitle: Testing the Addition of Radiation Therapy to the Immune Therapy Treatment for ES-SCLC overallStatus: RECRUITING date: 2023-10-18 date: 2024-12-31 date: 2025-12-31 date: 2024-04-05 date: 2024-04-05 name: Zhejiang Cancer Hospital class: OTHER briefSummary: This phase II trial compares the effect of adding radiation therapy to the usual maintenance therapy with Serplulimab versus Serplulimab alone in patients who have already received Serplulimab plus chemotherapy for the treatment of extensive stage small cell lung cancer . conditions: Extensive Stage Lung Small Cell Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Serplulimab name: Chest Radiation measure: 1-year Progression-free survival rate measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Duration of response (DOR) measure: Disease control rate (DCR) measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhejiang Cancer Hospital status: RECRUITING city: Hangzhou country: China name: jing Qin role: CONTACT lat: 30.29365 lon: 120.16142 hasResults: False
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<|newrecord|> nctId: NCT06350149 id: STUDY00004637 id: 1R21DK128731-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1R21DK128731-01A1 briefTitle: A Pilot and Feasibility Study to Evaluate High vs Low Glycemic Index Mixed Meal Tolerance Test in Adolescents and Young Adults With Cystic Fibrosis overallStatus: RECRUITING date: 2024-03-22 date: 2025-09 date: 2025-09 date: 2024-04-05 date: 2024-04-05 name: Emory University class: OTHER name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) briefSummary: The goal of this study is to determine the extent to which excess dietary simple sugars serve as a secondary mediating factor in Cystic fibrosis-related diabetes (CFRD) development. The main questions it aims to answer are:
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* Whether conducting a randomized 2x2 factorial design that evaluates acute postprandial changes in glucose over 2 hours following ingestion of a mixed meal challenge that varies by glycemic index and consumption of a sugar-sweetened beverage is acceptable and feasible.
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* What are the preliminary changes in postprandial hyperglycemia, islet cell function, and incretin response to a high or low Glycemic Index mixed meal tolerance test (MMTT) with and without Sugar-Sweetened Beverages (SSB) in adolescents and young adults with CF
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Participants will be randomized to a mixed diet and blood will be drawn before and after the mixed meal challenge. conditions: Cystic Fibrosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: OTHER masking: NONE count: 40 type: ESTIMATED name: Sugar Sweetened Beverages (SSB) name: Hi GI name: Lo GI measure: Recruitment Rate measure: Refusal Rate measure: Investigator Fidelity measure: Participant Fidelity measure: Acceptability measure: Retention Rates measure: Recruitment measure: Change in plasma Cysteine (Cys) measure: Change in plasma Cystine (CySS) measure: Change in plasma Glutathione (GSH) measure: Change in plasma Glutathione Disulfide (GSSG) measure: Change in redox potentials (EhCys/ CySS and EhGSH/GSSG) measure: Insulinogenic index measure: Whole body insulin sensitivity index (WBISI-Matsuda) measure: Disposition Index measure: Change in plasma Eh Cys/CySS measure: Change in incremental glucose AUC measure: Changes in Plasma insulin measure: Changes in Plasma C-peptide measure: Changes in Plasma Glucagon measure: Changes in Plasma Incretins: glucagon-like peptide-1 (GLP-1) measure: Changes in Plasma Incretins: total glucose-dependent insulinotropic polypeptide (GIP) sex: ALL minimumAge: 12 Years maximumAge: 21 Years stdAges: CHILD stdAges: ADULT facility: Center for Advanced Pediatrics: Emory Healthcare status: RECRUITING city: Atlanta state: Georgia zip: 30329 country: United States name: Tanicia Daley, MD role: CONTACT phone: 404-785-5437 email: tanicia.daley@emory.edu name: Arlene Stecenko, MD role: CONTACT phone: 404-727-1460 email: astecen@emory.edu name: Tanicia Daley, MD role: PRINCIPAL_INVESTIGATOR name: Jessica Alvarez, PhD role: SUB_INVESTIGATOR name: Arlene Stecenko, MD role: SUB_INVESTIGATOR lat: 33.749 lon: -84.38798 hasResults: False
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<|newrecord|> nctId: NCT06350136 id: 2024/05-37 briefTitle: The Effect of Self-Management Support Provided to Hypertension Patients Affected by the Earthquake Via Tele-Nursing on Patients' Treatment Compliance and Self-Care Management overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-12-01 date: 2025-06-01 date: 2024-04-05 date: 2024-04-08 name: Firat University class: OTHER briefSummary: This important research includes a randomized controlled trial evaluating the potential of self-management support provided via telenursing to earthquake-affected hypertension patients to improve patients' treatment adherence and overall self-care management. This study will be carried out at Fırat University Hospital and will cover a wide range of effects on health outcomes in individuals receiving hypertension treatment. The sample selected from hypertension patients, which constitute the population of the research, was based on predetermined power analysis criteria. It has been determined that at least 51 hypertension patients should be included in each of the intervention and control groups, and accordingly, a total of 150 hypertension patients will be included in the study.
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. The results obtained within this framework may provide guidance in the development and implementation of Turkey's health policies, and may also shed light on strategies for the management of other similar health problems. On the other hand, strengthening the digital health infrastructure and effective management of chronic diseases, which are among the health-related targets of the Development Plan, further emphasize the importance of this research. The success of the self-management model supported by tele-nursing can serve as an example in the integration of digital health technologies into Turkey's healthcare system and be an important step towards achieving strategic goals in this field. conditions: With Tele-Nursing studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 150 type: ESTIMATED name: With Tele-Nursing measure: Hill-Bone Hypertension Treatment Compliance Scale measure: Self-Care Management Scale in Chronic Diseases; measure: Psychological Impact of Earthquake Scale: measure: Earthquake Stress Coping Strategies Scale sex: ALL minimumAge: 55 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06350123 id: D6405C00002 briefTitle: Efficacy, Safety and Tolerability of Balcinrenone/Dapagliflozin Compared to Dapagliflozin in Adults With Chronic Kidney Disease. acronym: MIRO-CKD overallStatus: NOT_YET_RECRUITING date: 2024-05-06 date: 2026-01-13 date: 2026-01-13 date: 2024-04-05 date: 2024-04-05 name: AstraZeneca class: INDUSTRY briefSummary: The purpose of the study is to evaluate the efficacy, safety and tolerability of balcinrenone/dapagliflozin compared with dapagliflozin alone on patients with chronic kidney disease (CKD) and albuminuria. This study will evaluate the effect of the balcinrenone/dapagliflozin on urinary albumin-to-creatinine ratio (UACR), compared with dapagliflozin in patients with CKD. This is a dose-finding study aiming to identify an optimal dose of balcinrenone/dapagliflozin for a future Phase III study in patients with CKD. conditions: Chronic Kidney Disease studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multicentre, randomised, double-blind, dose-finding, parallel group, double-dummy primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 300 type: ESTIMATED name: Balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg name: Balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg name: Dapagliflozin 10 mg and matching placebo for balcinrenone/dapa gliflozin measure: Relative change in UACR from baseline to Week 12 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site city: San Carlos state: California zip: 94070 country: United States lat: 37.50716 lon: -122.26052 facility: Research Site city: Waterbury state: Connecticut zip: 06708 country: United States lat: 41.55815 lon: -73.0515 facility: Research Site city: Hialeah state: Florida zip: 33012 country: United States lat: 25.8576 lon: -80.27811 facility: Research Site city: Salt Lake City state: Utah zip: 84124 country: United States lat: 40.76078 lon: -111.89105 facility: Research Site city: Norfolk state: Virginia zip: 23504 country: United States lat: 36.84681 lon: -76.28522 facility: Research Site city: Linz zip: 4021 country: Austria lat: 48.30639 lon: 14.28611 facility: Research Site city: St. Pölten zip: 3100 country: Austria lat: 48.2 lon: 15.63333 facility: Research Site city: Vienna zip: A-1090 country: Austria lat: 48.20849 lon: 16.37208 facility: Research Site city: Wels zip: 4600 country: Austria lat: 48.16667 lon: 14.03333 facility: Research Site city: Wien zip: 1030 country: Austria lat: 48.20849 lon: 16.37208 facility: Research Site city: Wien zip: 1130 country: Austria lat: 48.20849 lon: 16.37208 facility: Research Site city: Wien zip: 1190 country: Austria lat: 48.20849 lon: 16.37208 facility: Research Site city: Burgas zip: 8018 country: Bulgaria lat: 42.50606 lon: 27.46781 facility: Research Site city: Dobrich zip: 9300 country: Bulgaria lat: 43.56667 lon: 27.83333 facility: Research Site city: Pleven zip: 5800 country: Bulgaria lat: 43.41667 lon: 24.61667 facility: Research Site city: Plovdiv zip: 4000 country: Bulgaria lat: 42.15 lon: 24.75 facility: Research Site city: Sofia zip: 1680 country: Bulgaria lat: 42.69751 lon: 23.32415 facility: Research Site city: London state: Ontario zip: N6A 5A5 country: Canada lat: 42.98339 lon: -81.23304 facility: Research Site city: Waterloo state: Ontario zip: N2T 0C1 country: Canada lat: 43.4668 lon: -80.51639 facility: Research Site city: Montreal state: Quebec zip: H4J 1C5 country: Canada lat: 45.50884 lon: -73.58781 facility: Research Site city: Quebec zip: G1R 2J6 country: Canada lat: 46.81228 lon: -71.21454 facility: Research Site city: Bari zip: 70124 country: Italy lat: 41.11148 lon: 16.8554 facility: Research Site city: Bologna zip: 40138 country: Italy lat: 44.49381 lon: 11.33875 facility: Research Site city: Genoa zip: 16132 country: Italy lat: 44.40478 lon: 8.94438 facility: Research Site city: Parma zip: 43126 country: Italy lat: 44.79935 lon: 10.32618 facility: Research Site city: Pavia zip: 27100 country: Italy lat: 45.19205 lon: 9.15917 facility: Research Site city: Ipoh zip: 30990 country: Malaysia lat: 4.5841 lon: 101.0829 facility: Research Site city: Kota Bahru zip: 15586 country: Malaysia lat: 6.13328 lon: 102.2386 facility: Research Site city: Kuala Lumpur zip: 59100 country: Malaysia lat: 3.1412 lon: 101.68653 facility: Research Site city: Białystok zip: 15-481 country: Poland lat: 53.13333 lon: 23.16433 facility: Research Site city: Gdańsk zip: 80-546 country: Poland lat: 54.35205 lon: 18.64637 facility: Research Site city: Grodzisk Mazowiecki zip: 05-825 country: Poland lat: 52.10387 lon: 20.6337 facility: Research Site city: Leżajsk zip: 37-300 country: Poland lat: 50.26257 lon: 22.41932 facility: Research Site city: Ruda Śląska zip: 41-709 country: Poland lat: 50.2584 lon: 18.85632 facility: Research Site city: Szczecin zip: 70-111 country: Poland lat: 53.42894 lon: 14.55302 facility: Research Site city: Warszawa zip: 02-798 country: Poland lat: 52.22977 lon: 21.01178 facility: Research Site city: Łódź zip: 92-213 country: Poland lat: 51.75 lon: 19.46667 facility: Research Site city: Żywiec zip: 34-300 country: Poland lat: 49.68529 lon: 19.19243 facility: Research Site city: Barcelona zip: 08036 country: Spain lat: 41.38879 lon: 2.15899 facility: Research Site city: Barcelona zip: 8035 country: Spain lat: 41.38879 lon: 2.15899 facility: Research Site city: Cordoba zip: 14004 country: Spain lat: 37.89155 lon: -4.77275 facility: Research Site city: Palma de Mallorca zip: 07010 country: Spain lat: 39.56939 lon: 2.65024 facility: Research Site city: Sevilla zip: 41013 country: Spain lat: 37.38283 lon: -5.97317 facility: Research Site city: Valencia zip: 46026 country: Spain lat: 39.46975 lon: -0.37739 facility: Research Site city: Kaohsiung zip: 80756 country: Taiwan lat: 22.61626 lon: 120.31333 facility: Research Site city: New Taipei City zip: 220 country: Taiwan lat: 25.01111 lon: 121.44583 facility: Research Site city: Taichung zip: 40201 country: Taiwan lat: 24.1469 lon: 120.6839 facility: Research Site city: Tainan zip: 710 country: Taiwan lat: 22.99083 lon: 120.21333 facility: Research Site city: Taipei City zip: 110 country: Taiwan lat: 25.04776 lon: 121.53185 facility: Research Site city: Taipei City zip: 11217 country: Taiwan lat: 25.04776 lon: 121.53185 facility: Research Site city: Taipei zip: 10002 country: Taiwan lat: 25.04776 lon: 121.53185 facility: Research Site city: Taipei zip: 11490 country: Taiwan lat: 25.04776 lon: 121.53185 hasResults: False
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<|newrecord|> nctId: NCT06350110 id: ESBI202492 briefTitle: Fourth-gen CAR T Cells Targeting BCMA/CD19 for Refractory Systemic Lupus Erythematosus (SLE) acronym: BAH242 overallStatus: NOT_YET_RECRUITING date: 2024-11-10 date: 2025-12-10 date: 2025-12-28 date: 2024-04-05 date: 2024-04-05 name: Essen Biotech class: OTHER briefSummary: This study is a preliminary investigation, with a single-group design, not randomized and transparent, focusing on treatment. Its purpose is to identify the highest dose of BH002 injection (CD19-BCMA CAR-T cells) that patients suffering from resistant systemic lupus erythematosus can tolerate. conditions: Systemic Lupus Erythematosus conditions: Lupus Nephritis conditions: Autoimmune Diseases conditions: Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis conditions: Granulomatous Polyangiitis conditions: Microscopic Polyangiitis conditions: Systemic Sclerosis conditions: Idiopathic Inflammatory Myopathies conditions: Sjogren's Syndrome studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Single Group Assignment
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Patients enrolled in this clinical trial will receive a carefully designed treatment regimen. Prior to the infusion of CD19 and BCMA CAR-T cells, participants will undergo preconditioning chemotherapy. This chemotherapy serves to create an optimal environment for the CAR-T cell therapy to effectively target and eliminate malignant B cells. Following chemotherapy, participants will receive the infusion of CD19 and BCMA CAR-T cells.
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Monitoring and Follow-up:
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Following the CAR-T cell infusion, patients will be subjected to rigorous monitoring to assess safety and treatment response. primaryPurpose: TREATMENT masking: NONE maskingDescription: Open-label clinical trials are a category of clinical research where the masking is minimal or nonexistent. In such trials, both the participants and the researchers are fully aware of the treatment assignments, which means participants know the treatment they are receiving, and researchers are aware of each participant's treatment group. count: 75 type: ESTIMATED name: CD19- BCMA CAR-T cells measure: Incidence and severity of dose limiting toxicities (DLTs) following chemotherapy preparative regimen and infusion of CD19/BCMA chimeric antigen receptor (CAR) T cells measure: Rate of successful manufacture and expansion of the CD19/BCMA chimeric antigen receptor (CAR) T cells sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: District one hospital city: Shanghai country: China lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06350097 id: D516NC00001 briefTitle: Phase III, Open-label Study of First-line Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Locally Advanced or Metastatic Non-small Cell Lung Cancer acronym: TROPION-Lung14 overallStatus: NOT_YET_RECRUITING date: 2024-05-16 date: 2028-03-21 date: 2032-05-25 date: 2024-04-05 date: 2024-04-10 name: AstraZeneca class: INDUSTRY name: Daiichi Sankyo briefSummary: The purpose of this study is to evaluate efficacy and safety of osimertinib (tablet) in combination with Datopotamab Deruxtecan (i.v. infusion) compared with osimertinib (tablet) monotherapy as a first-line therapy in participants with locally advanced or metastatic EGFRm (Ex19del and/or L858R) NSCLC.
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Study details include:
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1. The study duration will be event-driven, with an estimated duration of approximately 9 years.
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2. Participants may receive study treatment until disease progression, unacceptable toxicity, or other specific discontinuation criteria are met.
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3. The visit frequency will be every 3 weeks during the treatment period.
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Note: Participants on osimertinib treatment (osimertinib only arm or who have discontinued Datopotamab Deruxtecan while are still receiving osimertinib) are required to attend visits to perform assessments every 6 weeks from Cycle 7 until Cycle 17 and then visits every 12 weeks until disease progression, IP discontinuation or primary PFS DCO. Participants who are receiving osimertinib + Datopotamab Deruxtecan are still required to attend visit to perform assessment every 3 weeks (q3w) per SoA. conditions: Non-small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 582 type: ESTIMATED name: Osimertinib name: Datopotamab Deruxtecan measure: To demonstrate the superiority of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of PFS by BICR in all randomised participants. measure: To demonstrate the superiority of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of OS in all randomised participants. measure: To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of PFS on CNS metastases in participants with CNS metastases at baseline measure: To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of PFS by investigator in all randomised participants. measure: To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of ORR in all randomised participants with measurable disease at baseline. measure: To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of DoR in all randomised participants with measurable disease at baseline. measure: To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib on the prevention of CNS metastases measure: To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan relative to osimertinib by assessment of PFS2 in all randomised participants measure: To assess the PK of osimertinib and Datopotamab Deruxtecan measure: To investigate the immunogenicity of Datopotamab Deruxtecan measure: To compare the local EGFR mutation test result used for patient selection with the retrospective central cobas® EGFR Mutation Test v2 results from baseline tumour samples measure: To demonstrate the effectiveness of osimertinib in combination with Datopotamab Deruxtecan vs. osimertinib monotherapy based on the cobas® EGFR Mutation Test v2 plasma screening test result for Ex19del or L858R EGFR mutations sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site city: Clayton zip: 3168 country: Australia lat: -37.91667 lon: 145.11667 facility: Research Site city: Kogarah zip: 2217 country: Australia lat: -33.98333 lon: 151.11667 facility: Research Site city: Changchun zip: 130000 country: China lat: 43.88 lon: 125.32278 facility: Research Site city: Chongqing zip: 400030 country: China lat: 29.56278 lon: 106.55278 facility: Research Site city: Jinan zip: 250021 country: China lat: 36.66833 lon: 116.99722 facility: Research Site city: Jinan zip: 250117 country: China lat: 36.66833 lon: 116.99722 facility: Research Site city: Kunming zip: 650118 country: China lat: 25.03889 lon: 102.71833 facility: Research Site city: Linhai zip: 318000 country: China lat: 28.85535 lon: 121.14469 facility: Research Site city: Shanghai zip: 200030 country: China lat: 31.22222 lon: 121.45806 facility: Research Site city: Seoul zip: 06351 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Research Site city: Seoul zip: 120-752 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Research Site city: Seoul zip: 13620 country: Korea, Republic of lat: 37.566 lon: 126.9784 facility: Research Site city: Taipei City zip: 106 country: Taiwan lat: 25.04776 lon: 121.53185 facility: Research Site city: Taipei zip: 10002 country: Taiwan lat: 25.04776 lon: 121.53185 facility: Research Site city: Taoyuan zip: 333 country: Taiwan lat: 24.95233 lon: 121.20193 hasResults: False
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<|newrecord|> nctId: NCT06350084 id: 2023/381 briefTitle: Effect of Mother's Touch and Nurse's Therapeutic Touch on Pain Level and Crying Time During Heel Blood Collection overallStatus: RECRUITING date: 2023-09-04 date: 2024-07-31 date: 2024-12-31 date: 2024-04-05 date: 2024-04-08 name: Burdur Mehmet Akif Ersoy University class: OTHER briefSummary: This prospective study is planned as a randomized controlled study with the purpose of determining the effect of Mother's Touch and Nurse's Therapeutic Touch on pain levels and crying times by newborns during heel blood collection. conditions: Pain, Acute conditions: Newborn conditions: Crying studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Mother's Touch name: Nurse's Therapeutic Touch measure: NIPS (Neonatal Infant Pain Scale) measure: Crying times measure: Processing time sex: ALL minimumAge: 2 Days maximumAge: 4 Days stdAges: CHILD facility: Burdur Bucak State Hospital status: RECRUITING city: Burdur state: Bucak zip: 15030 country: Turkey name: Selda Ateş Beşirik, PhD. role: CONTACT phone: +905076228189 email: seldaates07@gmail.com name: Selda Ateş Beşirik, PhD. role: PRINCIPAL_INVESTIGATOR name: Emine Geçkil, Prof. role: SUB_INVESTIGATOR lat: 37.72028 lon: 30.29083 hasResults: False
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<|newrecord|> nctId: NCT06350071 id: 2023/06 briefTitle: Effect of Kangaroo Care and Swaddling Methods on Pain Level and Crying Time During Heel Blood Collection overallStatus: RECRUITING date: 2023-06-19 date: 2024-07-31 date: 2024-12-31 date: 2024-04-05 date: 2024-04-08 name: Burdur Mehmet Akif Ersoy University class: OTHER briefSummary: This prospective study is planned as a randomized controlled study with the purpose of determining the effect of kangaroo care and swaddling methods on pain levels and crying times by newborns during heel blood collection. conditions: Pain, Acute conditions: Newborns conditions: Crying studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Kangaroo Care name: Swaddling measure: NIPS (Neonatal Infant Pain Scale) measure: Crying times measure: Processing time sex: ALL minimumAge: 1 Day maximumAge: 4 Days stdAges: CHILD facility: Burdur Bucak State Hospital status: RECRUITING city: Burdur state: Bucak zip: 15030 country: Turkey name: Selda Ateş Beşirik, PhD. role: CONTACT phone: +905076228189 email: seldaates07@gmail.com name: Selda Ateş Beşirik, PhD. role: PRINCIPAL_INVESTIGATOR name: Emine Geçkil, Prof. role: SUB_INVESTIGATOR lat: 37.72028 lon: 30.29083 hasResults: False
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<|newrecord|> nctId: NCT06350058 id: 202012005 briefTitle: Phase I Clinical Trial of Inactivated Rotavirus Vaccine in a Population Aged 6 Weeks-49 Years Old overallStatus: ACTIVE_NOT_RECRUITING date: 2021-08-03 date: 2023-11-30 date: 2024-10-31 date: 2024-04-05 date: 2024-04-05 name: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd class: INDUSTRY briefSummary: The research objective is to evaluate the safety and tolerability of the inactivated rotavirus vaccine and explore its preliminary immunogenicity. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 375 type: ACTUAL name: Inactivated rotavirus vaccine (low dose) name: Inactivated rotavirus vaccine (high dose) name: Placebo measure: Incidence rate of AE measure: Incidence rate of SAE sex: ALL minimumAge: 6 Weeks maximumAge: 49 Years stdAges: CHILD stdAges: ADULT facility: Hebei Provincial Center for Disease Control and Prevention city: Shijiangzhuang state: Hebei zip: 050021 country: China lat: 34.61038 lon: 113.58554 hasResults: False
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<|newrecord|> nctId: NCT06350045 id: supra 11th puncture PCNL briefTitle: High Supracostal Versus Subcostal Puncture in Adult PCNL overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-01 date: 2028-04-01 date: 2028-04-01 date: 2024-04-05 date: 2024-04-05 name: Assiut University class: OTHER briefSummary: as the supra eleventh puncture PCNL is not well investigated in the literature we will conduct that randomised trial in comparison to the subcostal one conditions: Urolithiasis studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: closed envelop whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 162 type: ACTUAL name: PCNL measure: Rate of complications measure: Stone free rate measure: duration of Hospital stay. measure: Operative time sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Assiut University Hospital city: Assiut zip: 11751 country: Egypt lat: 27.18096 lon: 31.18368 hasResults: False
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<|newrecord|> nctId: NCT06350032 id: TREPaed id: 2023-505082-91-00 type: CTIS briefTitle: Investigational Trial to Evaluate Safety and Tolerability of Treprostinil in Children Diagnosed With PAH overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2028-11 date: 2028-11 date: 2024-04-05 date: 2024-04-05 name: AOP Orphan Pharmaceuticals AG class: INDUSTRY briefSummary: The goal of this clinical trial is to evaluate safety and tolerability of preservative-free parenteral treprostinil in paediatric patients with PAH (PH Group 1) who are below 18 years of age. The main question it aims to answer is:
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• if preservative-free parenteral treprostinil is safe and tolerable in the treatment of paediatric PAH in patients who are either treatment-naïve or have been previously treated with commercially available parenteral treprostinil formulations.
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Participants will receive either subcutaneous (SC) or intravenous (IV) preservative-free treprostinil and will be observed for 5 months (20 weeks ± 1 week). conditions: Pulmonary Arterial Hypertension studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: preservative-free parenteral treprostinil measure: Frequency and seriousness of adverse events and adverse drug reactions measure: Change from baseline in quality of Life (QoL) measure: Change from baseline in 6-minute walk distance (6MWD) measure: Change from baseline in World Health Organization Functional Class (WHO FC) measure: Change from baseline in echocardiography (ECHO) parameters - RA/RV enlargement measure: Change from baseline in echocardiography (ECHO) parameters - RV systolic dysfunction measure: Change from baseline in echocardiography (ECHO) parameters - RV/LV end-systolic ratio (PSAX) measure: Change from baseline in echocardiography (ECHO) parameters - tricuspid annular plane systolic excursion (TAPSE) measure: Change from baseline in echocardiography (ECHO) parameters - S/D ratio (TR jet) measure: Change from baseline in echocardiography (ECHO) parameters - Pulmonary Artery Acceleration Time (PAAT) measure: Change from baseline in echocardiography (ECHO) parameters - pericardial effusion measure: Change from baseline in echocardiography (ECHO) parameters - eccentricity index measure: Change from baseline in echocardiography (ECHO) parameters - acceleration time measure: Change from baseline in plasma N-terminal pro-brain natriuretic peptide (NT-proBNP) levels measure: Treprostinil plasma concentration sex: ALL maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Medizinische Universität Wien city: Vienna zip: 1090 country: Austria name: Sulaimi Albinni, MD role: PRINCIPAL_INVESTIGATOR lat: 48.20849 lon: 16.37208 facility: Necker-Enfants Malades Hospital, Paris city: Paris zip: 75015 country: France name: Damien Bonnet, Prof role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Gottsegen National Cardiovascular Center city: Budapest zip: H-1096 country: Hungary name: Laszlo Ablonczy, MD role: PRINCIPAL_INVESTIGATOR lat: 47.49801 lon: 19.03991 facility: Ramón y Cajal University Hospital city: Madrid zip: 28034 country: Spain name: Maria J del Cerro, Prof role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 hasResults: False
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<|newrecord|> nctId: NCT06350019 id: 26379996/91 briefTitle: Vascular Effects of Penil revascularızatıon overallStatus: COMPLETED date: 2013-01-01 date: 2014-08-15 date: 2014-12-25 date: 2024-04-05 date: 2024-04-05 name: Ankara Yildirim Beyazıt University class: OTHER briefSummary: Purpose: The aim of this study is to measure the effects of penile revascularization surgery performed in vascular origin erectile dysfunction (ED) on penile vascular hemodynamic and to determine the importance of vascular parameters in postoperative patient follow-up.
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Methods: A total of 35 participants who underwent penile revascularization surgery due to vascular ED were included in this study. In the preoperative period and at the 3rd postoperative month, penile color doppler ultrasonography (PCDU) was performed to evaluate cavernosal arteries, dorsal arteries, deep dorsal vein and inferior epigastric artery (IEA) separately. During this evaluation, peak systolic velocity (PSV), end diastolic velocity (EDV), and resistive index (RI) were measured. The International Index of Erectile Function questionnaire (IIEF) was applied to all patients in the preoperative period and at the 3rd postoperative month. The relationship between changes in (IIEF) questionnaire score and penile vascular hemodynamic changes in the postoperative period was evaluated. conditions: Erectile Dysfunction conditions: Erectile Dysfunction Due to Arterial Disease conditions: Erectile Dysfunction Due to Venous Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 35 type: ACTUAL name: Penile revascularızation measure: The importance of resistive index in evaluating the postoperative success of penile revascularization sex: MALE minimumAge: 23 Years maximumAge: 69 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06350006 id: SHR-A1904-301 briefTitle: SHR-A1904 Combinations in CLDN18.2-Positive Advanced Solid Tumor overallStatus: RECRUITING date: 2024-05-30 date: 2027-12-30 date: 2028-12-30 date: 2024-04-05 date: 2024-04-26 name: Shanghai Hengrui Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: This study consists of two research phases:
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Phase Ib (includes dose escalation phase and efficacy extension phase): To explore the safety, tolerability and initial efficacy of SHR-A1904 in the treatment of CLDN18.2-positive advanced solid tumors, and to determine the recommended dose and recommended population for the Phase III combination study.
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Phase III: A randomized, double-blind, multicenter clinical study of SHR-1904 combined with chemotherapy and immunotherapy Versus chemotherapy combined with immunotherapy for CLDN18.2-positive advanced solid tumors. conditions: Cldn18.2-positive Advanced Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study is a multicenter Phase Ib/III clinical study. Phase Ib consists of two phases, IB-A for dose escalation and IB-B for efficacy extension. The Phase III multi-center, randomized controlled, double-blind study was designed to evaluate the efficacy and safety of SHR-A1904 combined chemotherapy and immunotherapy versus chemotherapy combined immunotherapy in first-line treatment of CLDN18.2-positive solid tumors patients. primaryPurpose: TREATMENT masking: NONE count: 924 type: ESTIMATED name: SHR-A1904; Adebrelimab name: SHR-A1904; CAPOX; Adebrelimab measure: Incidence and severity of AE measure: Dose Limiting Toxicity (DLT) measure: Maximal Tolerable Dose (MTD) measure: Phase III Recommended Dose (RP3D) measure: Progression-free survival (PFS) assessed by blind Independent Center Review (BICR) based on RECIST 1.1 criteria measure: SHR-A1904 toxin binding antibody measure: SHR-A1904 Total antibody measure: Immunogenicity indicators of SHR-A1904: drug resistant antibody (ADA) and neutralizing antibody (NAb) measure: Expression level of CLDN18.2 in tumor tissues measure: Overall survival (OS) measure: Incidence and severity of AE sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sun Yat-sen University Cancer Center status: RECRUITING city: Guangzhou state: Guangdong zip: 510060 country: China name: Ruihua Xu role: CONTACT lat: 23.11667 lon: 113.25 hasResults: False
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<|newrecord|> nctId: NCT06349993 id: pd003 briefTitle: Digital Intervention for Depression and Anxiety in Adolescents overallStatus: RECRUITING date: 2024-04-17 date: 2024-12-30 date: 2025-07-01 date: 2024-04-05 date: 2024-04-22 name: Adai Technology (Beijing) Co., Ltd. class: OTHER briefSummary: The goal of this clinical trial is to evaluate the effectiveness of digital interventions in treating depression and anxiety in adolescents. The main question it aims to answer is: Can digital interventions effectively alleviate symptoms of depression and anxiety in adolescents? The trial will include a comparison group where researchers will compare the effects of the digital intervention to traditional health education methods to assess their relative efficacy.
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Participants will be asked to engage with the digital intervention platform for a period of two months. conditions: Depression conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Digital Intervention name: Health Education measure: Hamilton Depression Rating Scale measure: Hamilton Anxiety Rating Scale measure: ADHD(attention deficit hyperactivity disorder) Rating Scale-IV measure: PHQ-9 (Patient Health Questionnaire-9) measure: GAD-7 (Generalized Anxiety Disorder-7) sex: ALL minimumAge: 10 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: West China Hospital status: RECRUITING city: Chengdu state: Sichuang country: China name: Liqun Zhang role: CONTACT lat: 30.66667 lon: 104.06667 hasResults: False
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<|newrecord|> nctId: NCT06349980 id: HLX53-HCC201 briefTitle: A Study to Explore the Reasonable Dosage and Evaluate the Efficacy, Safety and Tolerability of HLX10 and HLX04 With or Without HLX53 in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients. overallStatus: NOT_YET_RECRUITING date: 2024-05-10 date: 2027-02-10 date: 2027-02-10 date: 2024-04-05 date: 2024-04-09 name: Shanghai Henlius Biotech class: INDUSTRY briefSummary: The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of Serplulimab Injection (HLX10, a Recombinant Anti-PD-1 Antibody) and HLX04 (a Biosimilar to Bevacizumab) With or Without HLX53 (an Anti-TIGIT Fc Fusion Protein) in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients. conditions: Carcinoma, Hepatocellular studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 117 type: ESTIMATED name: HLX53 (1000mg) name: HLX53 (2000mg) name: HLX10 name: HLX04 name: Placebo measure: ORR measure: PFS measure: ORR measure: PFS measure: OS measure: Incidence and severity of adverse events (AEs) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06349967 id: WCH-2023-1592 briefTitle: Nab-paclitaxel Combined With Cadonilimab (AK104) for the Second-line Treatment of Advanced Gastric Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2027-04-30 date: 2027-05-30 date: 2024-04-05 date: 2024-04-05 name: West China Hospital class: OTHER briefSummary: Currently, standard treatment options for gastric cancer failed to first-line treatment include monotherapy with paclitaxel/irinotecan/docetaxel/albumin paclitaxel, or paclitaxel combined with ramucirumab. However, the efficacy of these regimens is still far from satisfactory. The aim of the study is to evaluate the efficacy and safety of nab-paclitaxel combined with cadonilimab for the second-line treatment of advanced gastric cancer. conditions: Gastric Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 59 type: ESTIMATED name: Nab-paclitaxel Combined With Cadonilimab (AK104) measure: overall response rate (ORR) measure: disease control rate (DCR) measure: overall survival (OS) measure: progression-free survival (PFS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06349954 id: BFHHZS20240064 briefTitle: Effectiveness and Safety of Single-session Endoscopic Stone Extraction overallStatus: RECRUITING date: 2024-04-15 date: 2024-12-01 date: 2024-12-01 date: 2024-04-05 date: 2024-04-18 name: Beijing Friendship Hospital class: OTHER briefSummary: This is a prospective study, including approximately 64 patients with acute cholangitis accompanied with choledocholithiasis at Beijing Friendship Hospital. All patients will be randomly allocate into single-session or two-session endoscopic stone extraction. The investigators assessed the outcomes of single-session and two-session endoscopic stone extraction. conditions: Choledocholithiasis With Acute Cholangitis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: All patients will be randomly allocated into single-session group or two-session group. primaryPurpose: TREATMENT masking: NONE count: 64 type: ESTIMATED name: single-session ERCP name: two-session ERCP measure: Success rate of complete stone removal measure: ERCP-related complication rate measure: Length of stay measure: Hospital expenses sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Friendship Hospital status: RECRUITING city: Beijing state: Beijing zip: 100050 country: China name: Wei Jiang role: CONTACT phone: 18663186116 email: jfw899w@outlook.com lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06349941 id: STU-2023-0745 briefTitle: Telemedicine in Rural Patients With Heart Failure acronym: RURAL-HF overallStatus: NOT_YET_RECRUITING date: 2024-07-01 date: 2024-12-01 date: 2024-12-01 date: 2024-04-05 date: 2024-04-05 name: University of Texas Southwestern Medical Center class: OTHER briefSummary: We propose a pilot trial examining the effectiveness of a mHealth-based home cardiac rehabilitation program using a telemedicine platform for the identification, recruitment, and retention of an underserved rural population with heart failure with reduced ejection fraction.(HFrEF). The goal of the pilot trial will be to demonstrate the feasibility of a telemedicine platform for the recruitment and retention of underserved rural patients in clinical trials. Participants will participate in a cardiac rehabilitation program delivered through a smartphone application called Movn. They will be monitored for 14 weeks. conditions: Heart Failure studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Pilot trial primaryPurpose: OTHER masking: NONE count: 100 type: ESTIMATED name: Movn app measure: Physical activity levels measure: Quality of life using KCCQ score measure: Enrollment rate measure: Loss to follow up sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06349928 id: MASF_Dancers01 briefTitle: "The Show Must go on" : The Experience of Injuries Among Dancers: Fears, Thoughts, and Beliefs. A Qualitative Study overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-10-30 date: 2025-04-01 date: 2024-04-05 date: 2024-04-05 name: University of Siena class: OTHER briefSummary: This qualitative, cross-sectional study aims at describing the experience of Italian dancers with injury.
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Dancers face a high risk of sustaining one or more injuries during their career (87-94%), which may lead to physical, psychological, and socioeconomic consequences affecting dancer's lives and careers both short and long-term.
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Dancers report fearing injury and its consequences and believing in the existence of a stigma around injury and injured colleagues; many of them also try to self-manage pain and delay reporting injuries to healthcare professionals, possibly making its outcomes worse.
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This study will collect data from dancers via focus groups and individual interviews, investigating dancers' experiences, thoughts, and beliefs about injury. Records from the interviews will be transcribed ad verbatim and analyzed using the framework method to synthetize the data and highlight the most meaningful content.
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Understanding dancers' thoughts and behaviors regarding past or possible future injuries may be beneficial in improving treatment efficacy and designing adequate education and prevention strategies. It may also help raise awareness of dancers' complex and unique needs, and the importance of having accessible, specialized professionals around dance companies and schools. conditions: Injuries conditions: Dancing conditions: Injury;Sports conditions: Stress, Psychological studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 40 type: ESTIMATED name: Focus group or interview measure: Experience and perception of injury amongst dancers measure: Understanding of injury prevention and pain management amongst dancers sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06349915 id: 2023-15217 briefTitle: A Pilot Evaluation of a Digital Peer Support Intervention for Suicidal Adolescents acronym: SWEEP overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2026-04 date: 2026-04 date: 2024-04-05 date: 2024-04-05 name: Albert Einstein College of Medicine class: OTHER name: American Foundation for Suicide Prevention name: Yeshiva University briefSummary: Suicide risk has increased among youth in underserved communities, where access to mental healthcare is limited. To address this need, the investigator team plans to evaluate the preliminary efficacy of a brief, low-cost, culturally responsive digital intervention for ethnically diverse youth at risk for suicide in The Bronx, NY. In collaboration with community stakeholders, suicide recovery narratives, featuring adolescents' experiences related to recovery from suicidal thoughts will be developed. A smartphone ecological momentary assessment app will be used to evaluate whether a curriculum of these narratives provides anti-suicidal benefits to at-risk adolescents. conditions: Suicide studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The first 6 participants will serve as a brief pilot to validate outcomes and the acceptability of the intervention. The study team may make slight changes to the intervention (e.g., time of day the suicide recovery narratives are administered, or which narratives are presented) before recruiting the remaining 40 participants. primaryPurpose: PREVENTION masking: NONE count: 46 type: ESTIMATED name: Supporting Wellbeing with Everyday Experiences of Peers (SWEEP) measure: Suicidal Thoughts measure: Suicidal Urge Resistance measure: Social Connectedness measure: Optimism measure: Social Support measure: Intervention Acceptability measure: Emotions measure: Treatment Readiness sex: ALL minimumAge: 14 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06349902 id: Pro00077561 briefTitle: Re-link HCV in Substance-Use Telemedicine Program overallStatus: RECRUITING date: 2024-03-12 date: 2024-08-31 date: 2024-12-31 date: 2024-04-05 date: 2024-04-05 name: trueNorth Medical Centres class: OTHER name: Gilead Sciences briefSummary: This is an observational, retrospective \& prospective cohort study. The retrospective element of the study is a chart review to identify people with diagnosed but untreated HCV and re-link them to care. The observational prospective cohort element of the study will examine the HCV linkage to care, treatment initiation, treatment completion \& cure rates of these HCV clients achieved through this chart review and re-linking approach. conditions: Hepatitis C studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 5000 type: ESTIMATED name: Re-Link measure: number of patients identified as having diagnosed but untreated HCV measure: percentage of patients identified as having diagnosed but untreated HCV that are re-linked to HCV care measure: treatment initiation rates measure: treatment completion dates measure: cure rates sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: trueNorth Medical Centre status: RECRUITING city: Toronto state: Ontario zip: M5B 2A5 country: Canada name: Hannah O'Reilly, BSc role: CONTACT phone: 8888783563 phoneExt: 6452 email: hannah.oreilly@truenorthmedical.com role: CONTACT phoneExt: Cavacuiti email: drccavacuiti@truenorthmedical.com name: Chris Cavacuiti, BA, MD, MHSc role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False
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<|newrecord|> nctId: NCT06349889 id: MA-NPC-II-004 briefTitle: Adebrelimab and Chemoradiotherapy in High-risk Locoregionally Advanced Nasopharyngeal Carcinoma overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2028-05-01 date: 2028-05-01 date: 2024-04-05 date: 2024-04-09 name: Sun Yat-sen University class: OTHER name: Nanfang Hospital, Southern Medical University name: West China Hospital briefSummary: This trial aims to study the role of Adebrelimab combined with induction chemotherapy plus concurrent chemoradiotherapy (IC+CCRT) for high-risk locoregionally advanced nasopharyngeal carcinoma(LANPC). conditions: Nasopharyngeal Carcinoma conditions: Nasopharyngeal Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 50 type: ESTIMATED name: Adebrelimab measure: Failure-free survival (FFS) measure: Overall survival (OS) measure: Distant metastasis-free survival (DMFS) measure: Locoregional recurrence-free survival (LRRFS) measure: Adverse events (AEs) and serious adverse events (SAEs) measure: Quality of life (QoL) measure: Failure-free survival (FFS) within different subgroups sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nanfang Hospital, Southern Medical University city: Guangzhou state: Guangdong zip: 510000 country: China name: Jian Guan, M.D. role: CONTACT lat: 23.11667 lon: 113.25 facility: West China Hospital, Sichuan University city: Chengdu state: Sichuan zip: 610000 country: China name: Lei Liu, M.D. role: CONTACT lat: 30.66667 lon: 104.06667 hasResults: False
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<|newrecord|> nctId: NCT06349876 id: SUEZ MED - IRB Approval NO: 6 briefTitle: Cholecystectomy in Patients With Silent Common Bile Duct Stones overallStatus: COMPLETED date: 2023-02-15 date: 2023-07-15 date: 2024-01-15 date: 2024-04-05 date: 2024-04-23 name: Suez University class: OTHER briefSummary: Aim of this study is to evaluate the efficacy of performing only cholecystectomy in patients with asymptomatic common bile duct stones without dealing with common bile duct stones conditions: Performing Cholecystectomy in Patients With Chronic Calcular Choleycystits studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ACTUAL name: laparoscopic cholecystectomy measure: number of patients developed jaundice post cholecystectomy sex: ALL minimumAge: 25 Years maximumAge: 60 Years stdAges: ADULT facility: Qeft Teatching Hospital city: Qinā country: Egypt lat: 26.16418 lon: 32.72671 facility: Qena Faculty of Medicine city: Qinā country: Egypt lat: 26.16418 lon: 32.72671 facility: Suez Faculty of Medicine city: Suez zip: 43221 country: Egypt lat: 29.97371 lon: 32.52627 hasResults: False
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<|newrecord|> nctId: NCT06349863 id: W23.225 briefTitle: Dutch CHolEcystitis Snapshot Study acronym: Dutch-CHESS overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-10-31 date: 2025-04-30 date: 2024-04-05 date: 2024-04-11 name: St. Antonius Hospital class: OTHER name: St. Antonius Onderzoeksfonds name: Dutch Snapshot Research Group name: Nederlandse Leverpatientenvereniging briefSummary: Background: Cholecystitis is treated by in various types of hospitals by different specialists, and treatment strategy is influenced by logistical and medical reasons and personal preference. This may significantly impact hospital stay and other outcomes.
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Purpose: To determine the variation in treatment of cholecystitis in the Netherlands and its impact on outcome.
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Methods: Nation-wide cohort study of all patients diagnosed and treated for cholecystitis during a 6 month period. The primary outcome will be the proportion of patients with an acute cholecystitis in which the guideline is followed. This group will be compared to those in which the guideline is not followed, focussing on total hospital stay and complications. Secondary aims are to determine: factors related to guideline compliance; the best method of cystic duct closure; the best treatment strategy for a \>7-day existing cholecystitis; factors predictive for concomitant common bile duct stones; strategies following gallbladder drainage. Multivariable analysis and propensity score matching will be used when appropriate for the etiological study aims. The TRIPOD guideline for prediction modelling will be used for the predictive study aims. Hospitals will receive their own results, set out against the national average and best practices, thereafter subsequent changes in hospital practice will be recorded.
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Conclusion: This study will determine the variation in treatment of cholecystitis in the Netherlands and its impact on clinical outcome. Its results will serve as an important incentive to create optimal, uniform cholecystitis treatment in the Netherlands. conditions: Cholecystitis conditions: Cholecystitis; Gallstone conditions: Cholecystitis; Choledocholithiasis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 3000 type: ESTIMATED measure: Total hospital stay sex: ALL minimumAge: 18 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06349850 id: Soh-Med-24-03-06MS briefTitle: Predictive Value of Serum Uric Acid to High Density Lipoprotein Cholesterol Ratio for Diabetic Kidney Injury in Type 2 Diabetes overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-09 date: 2024-09 date: 2024-04-05 date: 2024-04-05 name: Sohag University class: OTHER briefSummary: An prospective observetional study to asses the predictive value of serum uric acid to high density lipoprotein cholesterol ratio for diabetic kidney injury in type 2 diabetes conditions: Diabetic Kidney Disease studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 100 type: ESTIMATED name: serum uric acid level to plasma HDL-c level ratio (UHR) measure: Uric acid to HDL-c ratio (UHR) sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06349837 id: ECLIPSE-02 briefTitle: Safety and Tolerability of LDRT Plus Concurrent Partial SBRT and Tislelizumab in Patients With Bulky Tumors overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2025-03-31 date: 2026-03-31 date: 2024-04-05 date: 2024-04-05 name: Sichuan University class: OTHER briefSummary: This is a 3+3 dose escalation phase I study which aims to evaluate the safety and tolerability of low dose radiotherapy (LDRT) plus concurrent partial Stereotactic Ablative Radiotherapy (SBRT) and Tislelizumab in Patients with bulky tumors who have failed standard therapy. At least 9 participants will be enrolled in this study. conditions: Solid Tumor studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 9 type: ESTIMATED name: Tislelizumab name: Low Dose Radiotherapy name: Stereotactic Ablative Radiotherapy measure: Dose Limiting Toxicities measure: Objective Response Rate (ORR) measure: Progression Free Survival (PFS) measure: Overall Survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06349824 id: 004AEstb/EC/01/2022 briefTitle: Dextrose, Steroid, PRP: Choosing the Right Injection for CRS Relief; a RCT overallStatus: COMPLETED date: 2023-10-10 date: 2024-03-30 date: 2024-03-30 date: 2024-04-05 date: 2024-04-05 name: Sheikh Zayed Medical College class: OTHER_GOV briefSummary: USG guided injections to relieve carpal tunnel syndrome with dextrose water or steroid or PRP conditions: Carpal Tunnel Syndrome studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ACTUAL name: injection Dextrose water name: USG machine measure: VAS sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sheikh Zayed Medical College city: Rahim yar khan state: Punjab zip: 64200 country: Pakistan lat: 28.41987 lon: 70.30345 hasResults: False
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<|newrecord|> nctId: NCT06349811 id: BL-M05D1-101 briefTitle: A Study of BL-M05D1 in Patients With Locally Advanced or Metastatic Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-05 date: 2026-05 date: 2024-04-05 date: 2024-04-09 name: Sichuan Baili Pharmaceutical Co., Ltd. class: INDUSTRY name: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd. briefSummary: This study is an open-label, multicenter, dose-escalation, and extended-enrollment nonrandomized phase I study to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of BL-M05D1 in patients with locally advanced or metastatic solid tumors. conditions: Locally Advanced or Metastatic Solid Tumors studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: BL-M05D1 measure: Phase Ia: Dose limiting toxicity (DLT) measure: Phase Ia: Maximum tolerated dose (MTD) measure: Phase Ib: Recommended Phase II Dose (RP2D) measure: Treatment-Emergent Adverse Event (TEAE) measure: Cmax measure: Tmax measure: T1/2 measure: AUC0-t measure: CL (Clearance) measure: Ctrough measure: ADA (anti-drug antibody) measure: Phase Ib: Objective Response Rate (ORR) measure: Phase Ib: Disease Control Rate (DCR) measure: Phase Ib: Duration of Response (DOR) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Cancer Hospital city: Beijing state: Beijing country: China name: Lin Shen role: CONTACT lat: 39.9075 lon: 116.39723 hasResults: False
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<|newrecord|> nctId: NCT06349798 id: DR200177 briefTitle: Early and Late Effects of Nefopam in Multimodal Analgesia After Total Hip Arthroplasty (NEFARTHRO) acronym: NEFARTHRO overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2026-09 date: 2027-04 date: 2024-04-05 date: 2024-04-05 name: University Hospital, Tours class: OTHER briefSummary: NEFARTHRO is a multicentric randomized controlled trial comparing the effects of discontinuous infusions of nefopam (bolus) versus continuous infusion of intravenous nefopam (via an infusion pump) versus placebo on the opioid-request during the first 24 hours following a Total Hip arthroplasty, as part of multimodal analgesia including at least paracetamol and a Non-Steroidal Anti-Inflammatory Drug (NSAID).
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The primary endpoint is cumulative morphine consumption for the first postoperative 24 hours, expressed in mg of iv equivalent morphine, including titration in the Post Anesthesia Care Unit (PACU).
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Patients will be followed during 6 months. conditions: Total Hip Arthroplasty studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multicenter, double-blind, randomized controlled trial in 3 parallel groups (placebo group, nefopam bolus group and nefopam Continuous Intra-Venous Infusion CIVI group). primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Patient, investigator and outcome assessor will be blind., A nurse anesthetist who will not be involved in the follow up of the patient will receive the kit and prepare the syringes. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 546 type: ESTIMATED name: Nefopam name: Nefopam name: NaCl 0.9% measure: Cumulative morphine consumption from the end of surgery (Day 0 - Hour 0) to the first 24 hours after surgery, expressed in mg of intravenous morphine (including titration in the Post-Anesthesia care Unit PACU). measure: Maximum self-assessed pain using the Numeric Rating Scale ranging from 0 (no pain) to 10 (maximum pain) at rest in the PACU, at rest and on walking between PACU discharge and Hour 24, at Hour 24, and at hospital discharge. measure: Time to return to walking. measure: Time to leave room. measure: Time to climb stairs. measure: Length of stay. measure: Time to abandon canes/crutches. measure: Opioid analgesic consumption between days 1 and 5 or at hospital discharge measure: Chronic pain at 6 months (at rest and walking) using a standardized phone questionnaire. measure: Neuropathic pain score (DN2)The DN2 is a simplified version of the DN4, with 7 items: burning, painful cold, electric shocks, tingling, pins and needles, numbness, itching (scored 0=absent, 1=present). measure: Incidence of all serious AEs during patient follow-up and non-serious AEs. measure: Incidence of patients with morphine side effects measure: Financial impact of spreading the recommended strategy following the results of the clinical study, estimated per year and over a 5-year period, from the point of view of the French Health Insurance and from the hospital perspective. sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Anaesthesia - Intensive care city: Angers zip: 49933 country: France name: Emmanuel RINEAU, MD role: CONTACT phone: 02 41 35 39 51 phoneExt: +33 email: Emmanuel.Rineau@chu-angers.fr name: Emmanuel RINEAU, MD role: PRINCIPAL_INVESTIGATOR lat: 47.46667 lon: -0.55 facility: Anaesthesia - Intensive care city: Blois zip: 41016 country: France name: Raphaël DARMON, MD role: CONTACT phone: 02 54 55 66 33 phoneExt: +33 email: darmonr@ch-blois.fr name: Raphaël DARMON, MD role: PRINCIPAL_INVESTIGATOR lat: 47.58333 lon: 1.33333 facility: Anaesthesia - Intensive care city: Chartres zip: 28018 country: France name: Elias CHADDOUK, MD role: CONTACT phone: 02 37 30 30 30 phoneExt: +33 email: echaddouk@ch-chartres.fr name: Elias CHADDOUK, MD role: PRINCIPAL_INVESTIGATOR lat: 48.44685 lon: 1.48925 facility: Anaesthesia - Intensive care city: Nantes zip: 44000 country: France name: Raphaël CINOTTI, MD role: CONTACT phone: 02 53 48 22 30 phoneExt: +33 email: Raphael.CINOTTI@chu-nantes.fr name: Raphaël CINOTTI, MD role: PRINCIPAL_INVESTIGATOR lat: 47.21725 lon: -1.55336 facility: Anaesthesia - Intensive care city: Orléans zip: 45067 country: France name: Léa PARCOT, MD role: CONTACT phone: 02 38 22 97 17 phoneExt: +33 email: lea.pascot@chr-orleans.fr name: Léa PARCOT, MD role: PRINCIPAL_INVESTIGATOR lat: 47.90289 lon: 1.90389 facility: Anaesthesia - Intensive care city: Poitiers zip: 86021 country: France name: Denis FRASCA, MD role: CONTACT phone: 05 49 44 38 95 phoneExt: +33 email: denis.frasca@univ-poitiers.fr name: Denis FRASCA, MD role: PRINCIPAL_INVESTIGATOR lat: 46.58333 lon: 0.33333 facility: Anesthesia - intensive care city: Tours zip: 37044 country: France name: Francis REMERAND, MD role: CONTACT phone: 02 47 47 84 80 phoneExt: +33 email: F.REMERAND@chu-tours.fr name: Francis REMERAND, MD role: PRINCIPAL_INVESTIGATOR lat: 47.38333 lon: 0.68333 hasResults: False
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<|newrecord|> nctId: NCT06349785 id: P.T.REC/012/003858 briefTitle: Manual Hyperinflation and Physical Therapy Program on Lung Recruitment Mechanically Ventilated Pediatric Patients acronym: MHI overallStatus: COMPLETED date: 2023-12-20 date: 2024-03-01 date: 2024-03-29 date: 2024-04-05 date: 2024-04-05 name: New Ismailia National University class: OTHER briefSummary: The purpose of this study is to investigate the immediate combined effects of Manual Hyperinflation and standard Physical therapy program on lung recruitment and secretion mass in mechanically ventilated pediatric patients aged between 10-15 years 'old conditions: Mechanical Ventilation Complication conditions: Physical Disability studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized controlled trial primaryPurpose: SUPPORTIVE_CARE masking: SINGLE maskingDescription: using sealed envelopes, whoMasked: PARTICIPANT count: 32 type: ACTUAL name: rehabilitation of mechanically ventilated patients name: supportive care measure: change the respiratory functions measure: change the respiratory mechanics measure: change the bronchospasm measure: change the amount of ventilation measure: decreasing the amount of secretions measure: weaning from mechanical ventilator sex: ALL minimumAge: 10 Years maximumAge: 15 Years stdAges: CHILD facility: College of Medicine city: Ismailia zip: 41522 country: Egypt lat: 30.60427 lon: 32.27225 hasResults: False
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<|newrecord|> nctId: NCT06349772 id: FY2024-203 briefTitle: Zynrelef vs Exparel: The Battle of Postoperative Pain Control After Robotic Sleeve Gastrectomy overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-04-01 date: 2025-04-01 date: 2024-04-05 date: 2024-04-08 name: Texas Tech University Health Sciences Center class: OTHER briefSummary: The purpose of this study is to evaluate the use of an injectable combination of bupivacaine and meloxicam (Zynrelef) vs injectable liposomal bupivacaine (Exparel), two extended local anesthesia strategies currently approved by FDA and on the market for post-surgical pain control. The investigators plan on randomizing study participants to either Exparel or Zynrelef at the closure site of robotic sleeve gastrectomy and assessing their pain control postoperatively both in the hospital and at home. The investigators will measure the outcome of two drugs, Zynrelief, and Exparel on postoperative pain score -using the NRS pin score up to 72 hours after surgery. The total opioid use will be recorded in forms that will be used to measure pain score and total opioid use and will be collected to the Excel sheet. The cost of the drug will be calculated for internal use for Hospital purpose only. conditions: Post Operative Pain studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomizing study participants to either Exparel or Zynrelef at the closure site of robotic sleeve gastrectomy and assessing their pain control postoperatively primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 130 type: ESTIMATED name: Zynrelef name: Exparel measure: postoperative pain score measure: Total postoperative opioid use measure: Proportion of total rescue medication use sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06349759 id: OPI-NYXDLD-302 briefTitle: Safety and Efficacy of 0.75% Phentolamine Ophthalmic Solution in Subjects With Post-refractive Surgery Visual Disturbances acronym: LYNX-2 overallStatus: RECRUITING date: 2024-04-01 date: 2025-09 date: 2025-11 date: 2024-04-05 date: 2024-04-08 name: Ocuphire Pharma, Inc. class: INDUSTRY name: Viatris Inc. briefSummary: Safety and efficacy of 0.75% Phentolamine Ophthalmic Solution to improve mesopic low contrast visual acuity in subjects with post-refractive surgery visual disturbances. conditions: Mesopic Vision conditions: Night Vision Loss studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist name: Placebo measure: Percent of subjects with an increase of at least 15 ETDRS letters read (≥ 3 lines) in the study eye in mLCVA compared to Baseline (Day 1 pre-dose) at Day 15 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: United States, California status: RECRUITING city: Newport Beach state: California zip: 92663 country: United States lat: 33.61891 lon: -117.92895 facility: United States, North Carolina status: RECRUITING city: Garner state: North Carolina zip: 27529 country: United States lat: 35.71126 lon: -78.61417 facility: United States, Rhode Island status: RECRUITING city: Warwick state: Rhode Island zip: 02888 country: United States lat: 41.7001 lon: -71.41617 hasResults: False
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<|newrecord|> nctId: NCT06349746 id: collage of physical therapy briefTitle: Cervical Unilateral Antero-posterior Mobilization and Thoracic Central Postro-anterior Mobilization in Treatment of Shoulder Impingement Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-05 date: 2024-06 date: 2024-04-05 date: 2024-04-05 name: Egyptian Chinese University class: OTHER name: Benha University briefSummary: Shoulder impingement syndrome (SIS) is a complex, multi-factorial problem that is treated with a variety of different conservative options. The conservative option that has shown effectiveness is manual therapy of the cervical and thoracic spine conditions: Shoulder Impingement studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: this study will be conducted to compare one group receiving selected therapeutic exercises and other group recieve cervical and thoracic mobilization added to selected therapeutic exercise Program on pain intensity, Pain-free shoulder flexion and scaption active ROM, muscle strength of external rotator and abductors, shoulder functional status in patients with Shoulder Impingement Syndrome. primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: patients and outcomes assessor will be masked about the grouping of the study whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: therapeutic exercises name: mobilization exercise measure: pain intensity measure: shoulder flexion and abduction range of motion measure: muscle strength sex: ALL minimumAge: 20 Years maximumAge: 45 Years stdAges: ADULT hasResults: False
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