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A total of 72 individuals, 24 with Stage III Grade B periodontitis (Group 1), 24 with Stage III Grade C periodontitis (Group 2), and 24 periodontally healthy (control group) (Group 3), were included in the study. GCF and clinical periodontal parameters were obtained at baseline. MIP3β and MIP3α levels in GCF were determined by ELISA. conditions: Periodontal Diseases studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 72 type: ACTUAL name: Routine periodontal examination measure: CCL19/MIP3beta(β) levels measure: CCL20/MIP3alpha(α) levels measure: CCL19/MIP3beta(β) levels and clinical parameters measure: CCL20/MIP3alpha(α) levels and clinical parameters sex: ALL minimumAge: 22 Years maximumAge: 55 Years stdAges: ADULT facility: Ordu University, Faculty of Dentistry city: Ordu zip: 52100 country: Turkey lat: 40.97782 lon: 37.89047 hasResults: False
<\|newrecord\|> nctId: NCT06291441 id: WUIPS briefTitle: Women Urinary Incontinence Prevalence Study (WUIPS) overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-06 date: 2025-12 date: 2024-03-04 date: 2024-03-04 name: IRCCS San Raffaele class: OTHER name: Università Vita-Salute San Raffaele briefSummary: The goal of this multicenter prospective and prevalence observational study is to punctually investigate and describe prevalence, predictors, quality of life and costs of Urinary Incontinence (UI) among female patients, female caregivers and female personnel in four hospitals in Northern Italy: San Raffaele hospital in Milan, San Raffaele Turro hospital in Milan, Zingonia Policlinico San Marco (BG) and Policlinico San Pietro in Ponte San Pietro (BG). conditions: Female Urinary Incontinence studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 1842 type: ESTIMATED name: No intervention measure: Prevalence of middle-aged women with urinary incontinence measure: Predictors of urinary incontinence in middle-aged women measure: Quality of life of middle-aged women with urinary incontinence measure: Social impact of middle-aged women with urinary incontinence measure: Costs of urinary incontinence for middle-aged women sex: FEMALE minimumAge: 40 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Policlinico San Marco Zingonia city: Osio Sotto state: Bergamo zip: 24040 country: Italy name: Elisabetta Bagnato role: CONTACT email: elisabetta.bagnato@grupposandonato.it name: Giulia Villa role: CONTACT phone: 0291751779 email: villa.giulia@hsr.it lat: 45.61608 lon: 9.58905 facility: Policlinico San Pietro Ponte San Pietro city: Bergamo zip: 24036 country: Italy name: Elisabetta Bagnato role: CONTACT email: elisabetta.bagnato@grupposandonato.it name: Giulia Villa role: CONTACT phone: 0291751779 email: villa.giulia@hsr.it lat: 45.69601 lon: 9.66721 facility: San Raffaele Turro Hospital (MI) city: Milan zip: 20127 country: Italy lat: 45.46427 lon: 9.18951 facility: San Raffaele Hospital (MI) city: Milan zip: 20132 country: Italy name: Sara Trapani role: CONTACT phone: +39 3389879403 email: trapani.sara@hsr.it name: Giulia Villa role: CONTACT phone: 0291751779 email: villa.giulia@hsr.it name: Stefania Rinaldi role: SUB_INVESTIGATOR name: Caglioni Martina role: SUB_INVESTIGATOR lat: 45.46427 lon: 9.18951 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2023-08-23 uploadDate: 2024-02-15T07:26 filename: Prot_000.pdf size: 544090 hasResults: False
<\|newrecord\|> nctId: NCT06291428 id: F-CNIC-2024-007 briefTitle: Raman Spectroscopy Compared to Flow Cytometry overallStatus: NOT_YET_RECRUITING date: 2024-10-15 date: 2026-12-30 date: 2026-12-30 date: 2024-03-04 date: 2024-03-04 name: Hospital Regional de Alta Especialidad del Bajio class: OTHER name: Optics research center briefSummary: The detection of MRD is associated with an increased risk of relapse and adverse prognosis in all patient groups diagnosed with acute lymphoblastic leukemia (ALL). However, it has a sensitivity level that detects one leukemic cell in 10,000 normal cells, along with other disadvantages such as the need for a panel of fluorescent antibodies for MRD detection, and its measurement is not standardized in many centers. New determination techniques may be necessary for MRD evaluation. Raman spectroscopy is proposed as a potential technique for MRD measurement, which is based on the inelastic scattering of light that occurs when it interacts with matter, causing optical scattering, where a portion of the radiation changes its wavelength (by Raman effect).
Objectives:
MAIN OBJECTIVE:
To evaluate the presence of MRD in patients with ALL by comparing a standard evaluation method using flow cytometry with a new proposed method using Raman spectroscopy.
SPECIFIC OBJECTIVES:
* To assess the presence of MRD using flow cytometry in patients with ALL.
* To assess the presence of MRD using Raman spectroscopy in patients with ALL.
* To perform a comparison between the MRD measurement techniques by determining sensitivity, specificity, positive predictive value, and negative predictive value.
* To establish the validation of using Raman spectroscopy as a method for MRD evaluation.
Study Design:
An observational, cross-sectional, comparative, and diagnostic test study will be conducted on bone marrow aspirate samples from adult and pediatric ALL patients to evaluate the presence of MRD using Raman spectroscopy, comparing the results of this technique with those obtained using flow cytometry. As a diagnostic test study, sensitivity, specificity, positive predictive value, and negative predictive value will be evaluated. The study will be conducted on adult and pediatric patients diagnosed with acute lymphoblastic leukemia treated at the hemato-oncology department of the UMAE No. 1 National Medical Center Bajio and the UMAE Hospital Gynecology-Pediatrics No. 48.
Inclusion Criteria:
Patients diagnosed with ALL for whom MRD determination is clinically necessary will be included in the study. Their results will be evaluated using the gold standard, flow cytometry, and compared with results obtained through Raman spectroscopy. conditions: Acute Lymphoblastic Leukemia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Raman spectroscopy measure: measurable residual disease sex: ALL minimumAge: 2 Years maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06291415 id: 2022-523-GLOB1 briefTitle: The Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Adult Subjects With Immune Thrombocytopenia (ITP) overallStatus: RECRUITING date: 2024-04-02 date: 2026-04 date: 2026-11 date: 2024-03-04 date: 2024-04-19 name: Hutchmed class: INDUSTRY briefSummary: This is an open-label, multicenter study to evaluate the safety, tolerability, and efficacy of HMPL-523 in adult subjects with ITP. conditions: Immune Thrombocytopenia conditions: Blood Platelet Disorder conditions: Hematologic Diseases conditions: Purpura, Thrombocytopenic conditions: Purpura conditions: Blood Coagulation Disorder conditions: Thrombotic Microangiopathies conditions: Hemorrhagic Disorders conditions: Autoimmune Diseases conditions: Immune System Diseases conditions: Hemorrhage conditions: Pathologic Processes conditions: Skin Manifestations conditions: Thrombocytopenia conditions: Purpura, Thrombocytopenic, Idiopathic conditions: Primary Immune Thrombocytopenia conditions: ITP - Immune Thrombocytopenia studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Part 1: Dose escalation stage - subjects will receive one of 3 dose levels of HMPL-523 to determine the recommended dose of HMPL-523 for the randomized dose optimization- stage (Part 2)
Part 2: subjects will be randomized in a 1:1 ratio between the 2 dose levels recommended by the SRC to better understand the exposure/efficacy/toxicity relationship. At the end of Part 2, the SRC will evaluate the safety, tolerability, preliminary efficacy, and PK data to determine the Recommended Phase 3 dose (RP3D) of HMPL-523. primaryPurpose: TREATMENT masking: NONE count: 48 type: ESTIMATED name: HMPL-523 measure: Safety and tolerability of HMPL-523 in adult subjects with primary ITP measure: Dose Limiting Toxicities measure: Cmax (maximum plasma drug concentration) measure: AUCtau (area under the concentration-time curve over a dosage interval) measure: Tmax (time to reach maximum plasma drug concentration) measure: Cmin (minimum plasma drug concentration) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Center for Cancer and Blood Disorders status: RECRUITING city: Bethesda state: Maryland zip: 20817 country: United States name: Ralph V Boccia, MD role: CONTACT name: Ralph V Boccia, MD role: PRINCIPAL_INVESTIGATOR lat: 38.98067 lon: -77.10026 facility: Massachusetts General Hospital status: NOT_YET_RECRUITING city: Boston state: Massachusetts zip: 02114 country: United States name: David J Kuter, MD role: CONTACT name: David J Kuter, MD role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Taussig Cancer Institute status: NOT_YET_RECRUITING city: Cleveland state: Ohio zip: 44106 country: United States name: Alan Lichtin, MD role: CONTACT name: Alan Lichtin, MD role: PRINCIPAL_INVESTIGATOR lat: 41.4995 lon: -81.69541 facility: Peninsula Private Hospital status: NOT_YET_RECRUITING city: Frankston state: Victoria country: Australia name: Huy Tran, MD role: CONTACT name: Huy Tran, MD role: PRINCIPAL_INVESTIGATOR lat: -38.14458 lon: 145.12291 facility: The Perth Blood Institute (PBI) Hollywood Specialist Centre status: NOT_YET_RECRUITING city: West Perth state: Western Australia country: Australia name: Ross Baker, MD role: CONTACT name: Ross Baker, MD role: PRINCIPAL_INVESTIGATOR lat: -31.94896 lon: 115.84199 facility: Marien Hospital Dusseldorf status: NOT_YET_RECRUITING city: Düsseldorf zip: 40479 country: Germany name: Stefanie Groepper, MD role: CONTACT name: Stefanie Groepper, MD role: PRINCIPAL_INVESTIGATOR lat: 51.22172 lon: 6.77616 facility: Sykehuset Ostfold Kalnes (fosta) / Osfold Hospital Trust (MSL) status: NOT_YET_RECRUITING city: Grålum zip: 1714 country: Norway name: Waleed Ghanima, MD role: CONTACT name: Waleed Ghanima, MD role: PRINCIPAL_INVESTIGATOR lat: 59.29048 lon: 11.06668 facility: Hospital del Mar Barcelona status: NOT_YET_RECRUITING city: Barcelona zip: 08003 country: Spain name: Blanca Gonzalez, MD role: CONTACT name: Blanca Gonzalez, MD role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: Hospital Universitari Vall d'Hebron status: NOT_YET_RECRUITING city: Barcelona country: Spain name: David Ferreiras, MD role: CONTACT name: David Ferreiras, MD role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 facility: University de Burgos status: NOT_YET_RECRUITING city: Burgos zip: 09001 country: Spain name: Jose Gonzalez Lopez, MD role: CONTACT name: Jose Gonzalez Lopez, MD role: PRINCIPAL_INVESTIGATOR lat: 42.34106 lon: -3.70184 facility: Hospital Gregorio Maranon Madrid status: NOT_YET_RECRUITING city: Madrid zip: 28007 country: Spain name: Cristina Izquierdo, MD role: CONTACT name: Cristina Izquierdo, MD role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 facility: Clinica Universidad de Navarra status: NOT_YET_RECRUITING city: Madrid zip: 28027 country: Spain name: Carlos Garcia Grande, MD role: CONTACT name: Carlos Garcia Grande, MD role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 facility: Hospital Infanta Leonor status: NOT_YET_RECRUITING city: Madrid zip: 28031 country: Spain name: Angeles Foncillas, MD role: CONTACT name: Angeles Foncillas, MD role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 facility: Fundacion Jimenez Diaz status: NOT_YET_RECRUITING city: Madrid zip: 28040 country: Spain name: Pilar Llamas Sillero, MD role: CONTACT name: Pilar Llamas Sillero, MD role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 facility: Hospital Morales Meseguer status: NOT_YET_RECRUITING city: Murcia zip: 30008 country: Spain name: Maria Lozano, MD role: CONTACT name: Maria Lozano, MD role: PRINCIPAL_INVESTIGATOR lat: 37.98704 lon: -1.13004 hasResults: False
<\|newrecord\|> nctId: NCT06291402 id: RC 34-1-2024 briefTitle: Nasal Packing Duration and Development of Pharyngitis After Septorhinoplasty Surgery overallStatus: NOT_YET_RECRUITING date: 2024-03-10 date: 2024-06-15 date: 2024-06-15 date: 2024-03-04 date: 2024-03-04 name: Al-Azhar University class: OTHER name: Benha University briefSummary: Septoplasty or septal reconstruction is a corrective surgical procedure performed to straighten the nasal septum. It may be associated with numerous complications. To minimize these complications, both nasal cavities are frequently packed with different types of nasal packing. In our study we will try to find relationship between duration of nasal packing and postrhinoplasty sore throat and pharyngitis. conditions: Rhinitis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Sore throat measure: Dysphagia measure: Throat irritation sex: ALL minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Neveen Kohaf city: Tanta zip: 11865 country: Egypt name: Neveen Kohaf, Ph.D role: CONTACT phone: +201060383012 email: nevenabdo@azhar.edu.eg name: Haney Bauiomy, M.D role: PRINCIPAL_INVESTIGATOR name: Ahmed Abosakaya, M.D role: PRINCIPAL_INVESTIGATOR lat: 30.78847 lon: 31.00192 hasResults: False
<\|newrecord\|> nctId: NCT06291389 id: RC.2.8.2023 briefTitle: Intraoperative Peak Airway Pressure Changes on Postoperative Pulmonary Function After Muscle Plication overallStatus: NOT_YET_RECRUITING date: 2024-03-10 date: 2024-05-15 date: 2024-05-15 date: 2024-03-04 date: 2024-03-04 name: Al-Azhar University class: OTHER name: Benha University briefSummary: An abdominal panniculus excision procedure is known as an abdominoplasty (panniculectomy). Musculofascial plication is a crucial aspect of abdominoplasty, especially for patients with significant divarication of the recti muscles. This study aimed to evaluate the effect of intraoperative changes in peak airway pressure (PAP) after muscle plication on postoperative pulmonary function. conditions: Abdominal Compartment Syndrome studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 120 type: ESTIMATED measure: Intraoperative peak airway pressure (PAP) measure: Duration of oxygen therapy measure: Post operative Tidal Volume (Vt) (Measured by spirometer) measure: Post operative Respiratory Rate (RR) measure: Hospital stay. sex: ALL minimumAge: 20 Years maximumAge: 50 Years stdAges: ADULT facility: Neveen Kohaf city: Tanta zip: 11865 country: Egypt name: Haney Bauiomy role: PRINCIPAL_INVESTIGATOR name: Ahmed Abosakaya role: PRINCIPAL_INVESTIGATOR lat: 30.78847 lon: 31.00192 hasResults: False
<\|newrecord\|> nctId: NCT06291376 id: D928FC00001 briefTitle: Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN) acronym: ICAN overallStatus: RECRUITING date: 2024-03-29 date: 2026-02-23 date: 2029-10-25 date: 2024-03-04 date: 2024-04-29 name: Alexion Pharmaceuticals, Inc. class: INDUSTRY briefSummary: The primary objective of this study to evaluate the efficacy of ravulizumab compared with placebo to reduce proteinuria and slow the rate of eGFR decline in adult participants with IgAN who are at risk of disease progression. conditions: Immunoglobulin A Nephropathy conditions: IgAN studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 470 type: ESTIMATED name: Ravulizumab name: Placebo measure: Change from Baseline in Proteinuria Based on 24-hour Urine Protein Creatinine Ratio (UPCR) at Week 34 measure: Glomerular Filtration Rate (eGFR) Over 106 Weeks measure: Change from Baseline in Proteinuria Based on 24-hour Urine Protein Creatinine Ratio (UPCR) at Weeks 10, 26, 34, 50, and 106 measure: Change From Baseline in eGFR at Weeks 34, 50, and 106 measure: Change From Baseline in Albuminuria Based on Urine Albumin to Creatinine Ratio (UACR) at Weeks 10, 26, 34, 50, and 106 measure: Reduction in 24-hour UPCR ≥ 50% From Baseline to Weeks 10, 26, 34, 50, and 106 measure: Number of Participants With Partial Remission at Weeks 34, 50, and 106 measure: Change from Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at Weeks 34, 50, and 106 measure: Number of Participants With Composite Kidney Failure Endpoint measure: Reduction in 24-hour UPCR ≥ 50% From Baseline at both Weeks 34 and 106 measure: Number of Participants With Kidney Hierarchical Composite Endpoint sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site status: NOT_YET_RECRUITING city: Alabaster state: Alabama zip: 35007 country: United States lat: 33.24428 lon: -86.81638 facility: Research Site status: NOT_YET_RECRUITING city: Phoenix state: Arizona zip: 85054 country: United States lat: 33.44838 lon: -112.07404 facility: Research Site status: NOT_YET_RECRUITING city: Loma Linda state: California zip: 92354 country: United States lat: 34.04835 lon: -117.26115 facility: Research Site status: NOT_YET_RECRUITING city: Los Angeles state: California zip: 90022 country: United States lat: 34.05223 lon: -118.24368 facility: Research Site status: NOT_YET_RECRUITING city: Los Angeles state: California zip: 90027 country: United States lat: 34.05223 lon: -118.24368 facility: Research Site status: NOT_YET_RECRUITING city: Los Angeles state: California zip: 90095 country: United States lat: 34.05223 lon: -118.24368 facility: Research Site status: NOT_YET_RECRUITING city: San Francisco state: California zip: 94143 country: United States lat: 37.77493 lon: -122.41942 facility: Research Site status: NOT_YET_RECRUITING city: Stanford state: California zip: 94305 country: United States lat: 37.42411 lon: -122.16608 facility: Research Site status: NOT_YET_RECRUITING city: Torrance state: California zip: 90502 country: United States lat: 33.83585 lon: -118.34063 facility: Research Site status: NOT_YET_RECRUITING city: Aurora state: Colorado zip: 80045 country: United States lat: 39.72943 lon: -104.83192 facility: Research Site status: NOT_YET_RECRUITING city: Bay Pines state: Florida zip: 33744 country: United States lat: 27.81419 lon: -82.77816 facility: Research Site status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33136 country: United States lat: 25.77427 lon: -80.19366 facility: Research Site status: RECRUITING city: Orlando state: Florida zip: 32806 country: United States lat: 28.53834 lon: -81.37924 facility: Research Site status: RECRUITING city: Acworth state: Georgia zip: 30101 country: United States lat: 34.06635 lon: -84.67837 facility: Research Site status: RECRUITING city: Lawrenceville state: Georgia zip: 30046 country: United States lat: 33.95621 lon: -83.98796 facility: Research Site status: NOT_YET_RECRUITING city: Augusta state: Maine zip: 04330 country: United States lat: 44.31062 lon: -69.77949 facility: Research Site status: NOT_YET_RECRUITING city: Boston state: Massachusetts zip: 02111 country: United States lat: 42.35843 lon: -71.05977 facility: Research Site status: NOT_YET_RECRUITING city: Boston state: Massachusetts zip: 02114 country: United States lat: 42.35843 lon: -71.05977 facility: Research Site status: RECRUITING city: Pontiac state: Michigan zip: 48341 country: United States lat: 42.63892 lon: -83.29105 facility: Research Site status: NOT_YET_RECRUITING city: Minneapolis state: Minnesota zip: 55435 country: United States lat: 44.97997 lon: -93.26384 facility: Research Site status: NOT_YET_RECRUITING city: Minneapolis state: Minnesota zip: 55455 country: United States lat: 44.97997 lon: -93.26384 facility: Research Site status: RECRUITING city: Saint Peters state: Missouri zip: 63376 country: United States lat: 38.80033 lon: -90.62651 facility: Research Site status: NOT_YET_RECRUITING city: North Las Vegas state: Nevada zip: 89086 country: United States lat: 36.19886 lon: -115.1175 facility: Research Site status: NOT_YET_RECRUITING city: Albany state: New York zip: 12208 country: United States lat: 42.65258 lon: -73.75623 facility: Research Site status: NOT_YET_RECRUITING city: Bronx state: New York zip: 10468 country: United States lat: 40.84985 lon: -73.86641 facility: Research Site status: NOT_YET_RECRUITING city: East Setauket state: New York zip: 11733 country: United States lat: 40.94149 lon: -73.10594 facility: Research Site status: NOT_YET_RECRUITING city: Charleston state: South Carolina zip: 29425 country: United States lat: 32.77657 lon: -79.93092 facility: Research Site status: NOT_YET_RECRUITING city: Arlington state: Texas zip: 76002 country: United States lat: 32.73569 lon: -97.10807 facility: Research Site status: NOT_YET_RECRUITING city: Houston state: Texas zip: 77054 country: United States lat: 29.76328 lon: -95.36327 facility: Research Site status: NOT_YET_RECRUITING city: Shenandoah state: Texas zip: 77384 country: United States lat: 30.18022 lon: -95.45577 facility: Research Site status: NOT_YET_RECRUITING city: Charlottesville state: Virginia zip: 22903 country: United States lat: 38.02931 lon: -78.47668 facility: Research Site status: NOT_YET_RECRUITING city: Milwaukee state: Wisconsin zip: 53226 country: United States lat: 43.0389 lon: -87.90647 facility: Research Site status: NOT_YET_RECRUITING city: Ciudad Autonoma Bs As zip: C1015ABO country: Argentina lat: -34.61315 lon: -58.37723 facility: Research Site status: NOT_YET_RECRUITING city: Córdoba zip: X5016LIG country: Argentina lat: -31.4135 lon: -64.18105 facility: Research Site status: NOT_YET_RECRUITING city: La Plata zip: B1902COS country: Argentina lat: -34.92145 lon: -57.95453 facility: Research Site status: NOT_YET_RECRUITING city: Rosario zip: 2000 country: Argentina lat: -32.94682 lon: -60.63932 facility: Research Site status: WITHDRAWN city: San Luis zip: D5700 country: Argentina lat: -33.29501 lon: -66.33563 facility: Research Site status: NOT_YET_RECRUITING city: Canberra zip: 2605 country: Australia lat: -35.28346 lon: 149.12807 facility: Research Site status: NOT_YET_RECRUITING city: Clayton zip: 3168 country: Australia lat: -37.91667 lon: 145.11667 facility: Research Site status: NOT_YET_RECRUITING city: Concord zip: 2139 country: Australia lat: -33.84722 lon: 151.10381 facility: Research Site status: NOT_YET_RECRUITING city: Herston zip: 4029 country: Australia lat: -27.44453 lon: 153.01852 facility: Research Site status: NOT_YET_RECRUITING city: Liverpool zip: 2170 country: Australia lat: -33.90011 lon: 150.93328 facility: Research Site status: NOT_YET_RECRUITING city: Southport zip: 4222 country: Australia lat: -27.96724 lon: 153.39796 facility: Research Site status: NOT_YET_RECRUITING city: St Albans zip: 3021 country: Australia lat: -37.73901 lon: 144.80024 facility: Research Site status: NOT_YET_RECRUITING city: Graz zip: 8036 country: Austria lat: 47.06667 lon: 15.45 facility: Research Site status: NOT_YET_RECRUITING city: Innsbruck zip: 6020 country: Austria lat: 47.26266 lon: 11.39454 facility: Research Site status: NOT_YET_RECRUITING city: Linz zip: 4020 country: Austria lat: 48.30639 lon: 14.28611 facility: Research Site status: NOT_YET_RECRUITING city: Brussels zip: 1090 country: Belgium lat: 50.85045 lon: 4.34878 facility: Research Site status: NOT_YET_RECRUITING city: Edegem zip: 2650 country: Belgium lat: 51.15662 lon: 4.44504 facility: Research Site status: NOT_YET_RECRUITING city: Leuven zip: 3000 country: Belgium lat: 50.87959 lon: 4.70093 facility: Research Site status: NOT_YET_RECRUITING city: Liège zip: 4000 country: Belgium lat: 50.63373 lon: 5.56749 facility: Research Site status: NOT_YET_RECRUITING city: Roeselare zip: 8800 country: Belgium lat: 50.94653 lon: 3.12269 facility: Research Site status: NOT_YET_RECRUITING city: Belo Horizonte zip: 30130-100 country: Brazil lat: -19.92083 lon: -43.93778 facility: Research Site status: NOT_YET_RECRUITING city: Belo Horizonte zip: 30150-221 country: Brazil lat: -19.92083 lon: -43.93778 facility: Research Site status: NOT_YET_RECRUITING city: Botucatu zip: 18618-687 country: Brazil lat: -22.88583 lon: -48.445 facility: Research Site status: NOT_YET_RECRUITING city: Curitiba zip: 80440-020 country: Brazil lat: -25.42778 lon: -49.27306 facility: Research Site status: NOT_YET_RECRUITING city: Fortaleza zip: 60430-270 country: Brazil lat: -3.71722 lon: -38.54306 facility: Research Site status: NOT_YET_RECRUITING city: Recife zip: 50670-901 country: Brazil lat: -8.05389 lon: -34.88111 facility: Research Site status: NOT_YET_RECRUITING city: Ribeirão Preto zip: 14051-140 country: Brazil lat: -21.1775 lon: -47.81028 facility: Research Site status: NOT_YET_RECRUITING city: S.J. Do Rio Preto zip: 15090-000 country: Brazil facility: Research Site status: NOT_YET_RECRUITING city: Salvador zip: 40170-130 country: Brazil lat: -12.97111 lon: -38.51083 facility: Research Site status: NOT_YET_RECRUITING city: São Paulo zip: 04038-002 country: Brazil lat: -23.5475 lon: -46.63611 facility: Research Site status: NOT_YET_RECRUITING city: São Paulo zip: 05403-000 country: Brazil lat: -23.5475 lon: -46.63611 facility: Research Site status: NOT_YET_RECRUITING city: Winnipeg state: Manitoba zip: R2V 3M3 country: Canada lat: 49.8844 lon: -97.14704 facility: Research Site status: NOT_YET_RECRUITING city: London state: Ontario zip: N6A 5W9 country: Canada lat: 42.98339 lon: -81.23304 facility: Research Site status: NOT_YET_RECRUITING city: Araucania zip: 4781151 country: Chile facility: Research Site status: NOT_YET_RECRUITING city: Providencia zip: 7500000 country: Chile lat: -33.43107 lon: -70.60454 facility: Research Site status: NOT_YET_RECRUITING city: Santiago zip: 7500922 country: Chile lat: -33.45694 lon: -70.64827 facility: Research Site status: NOT_YET_RECRUITING city: Santiago zip: 8330044 country: Chile lat: -33.45694 lon: -70.64827 facility: Research Site status: NOT_YET_RECRUITING city: Valdivia zip: 4070022 country: Chile lat: -39.81422 lon: -73.24589 facility: Research Site status: NOT_YET_RECRUITING city: Baotou zip: 14010 country: China lat: 40.65222 lon: 109.82222 facility: Research Site status: NOT_YET_RECRUITING city: Beijing zip: 100029 country: China lat: 39.9075 lon: 116.39723 facility: Research Site status: NOT_YET_RECRUITING city: Beijing zip: 100034 country: China lat: 39.9075 lon: 116.39723 facility: Research Site status: NOT_YET_RECRUITING city: Beijing zip: 100044 country: China lat: 39.9075 lon: 116.39723 facility: Research Site status: NOT_YET_RECRUITING city: Changsha zip: 410013 country: China lat: 28.19874 lon: 112.97087 facility: Research Site status: NOT_YET_RECRUITING city: Chengdu zip: 610000 country: China lat: 30.66667 lon: 104.06667 facility: Research Site status: NOT_YET_RECRUITING city: Chengdu zip: 610072 country: China lat: 30.66667 lon: 104.06667 facility: Research Site status: NOT_YET_RECRUITING city: Chongqing zip: 400010 country: China lat: 29.56278 lon: 106.55278 facility: Research Site status: NOT_YET_RECRUITING city: Guangzhou zip: 510080 country: China lat: 23.11667 lon: 113.25 facility: Research Site status: NOT_YET_RECRUITING city: Guangzhou zip: 510100 country: China lat: 23.11667 lon: 113.25 facility: Research Site status: NOT_YET_RECRUITING city: Guangzhou zip: 510280 country: China lat: 23.11667 lon: 113.25 facility: Research Site status: NOT_YET_RECRUITING city: Hangzhou zip: 310003 country: China lat: 30.29365 lon: 120.16142 facility: Research Site status: NOT_YET_RECRUITING city: Hangzhou zip: 310009 country: China lat: 30.29365 lon: 120.16142 facility: Research Site status: NOT_YET_RECRUITING city: Jinan zip: 250012 country: China lat: 36.66833 lon: 116.99722 facility: 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NOT_YET_RECRUITING city: Ankara zip: 06230 country: Turkey lat: 39.91987 lon: 32.85427 facility: Research Site status: NOT_YET_RECRUITING city: Ankara zip: 06560 country: Turkey lat: 39.91987 lon: 32.85427 facility: Research Site status: NOT_YET_RECRUITING city: Bursa zip: 16059 country: Turkey lat: 40.19559 lon: 29.06013 facility: Research Site status: NOT_YET_RECRUITING city: Istanbul zip: 34098 country: Turkey lat: 41.01384 lon: 28.94966 facility: Research Site status: NOT_YET_RECRUITING city: Istanbul zip: 34452 country: Turkey lat: 41.01384 lon: 28.94966 facility: Research Site status: NOT_YET_RECRUITING city: Kayseri zip: 38039 country: Turkey lat: 38.73222 lon: 35.48528 facility: Research Site status: NOT_YET_RECRUITING city: Kocaeli zip: 41380 country: Turkey lat: 39.62497 lon: 27.51145 facility: Research Site status: NOT_YET_RECRUITING city: Konya zip: 42080 country: Turkey lat: 37.87135 lon: 32.48464 facility: Research Site status: NOT_YET_RECRUITING city: Cambridge zip: CB2 0QQ country: United Kingdom lat: 52.2 lon: 0.11667 facility: Research Site status: NOT_YET_RECRUITING city: Doncaster zip: DN2 5LT country: United Kingdom lat: 53.52285 lon: -1.13116 facility: Research Site status: NOT_YET_RECRUITING city: Leicester zip: Le5 4PW country: United Kingdom lat: 52.6386 lon: -1.13169 facility: Research Site status: NOT_YET_RECRUITING city: London zip: E1 1BB country: United Kingdom lat: 51.50853 lon: -0.12574 facility: Research Site status: NOT_YET_RECRUITING city: London zip: SE1 9RT country: United Kingdom lat: 51.50853 lon: -0.12574 facility: Research Site status: NOT_YET_RECRUITING city: London zip: SE5 9NU country: United Kingdom lat: 51.50853 lon: -0.12574 facility: Research Site status: NOT_YET_RECRUITING city: Salford zip: M6 8HD country: United Kingdom lat: 53.48771 lon: -2.29042 hasResults: False
<\|newrecord\|> nctId: NCT06291363 id: 2024-3612 briefTitle: Impact of Administration of Esmolol on Nociception Level-guided Control of Nociception. acronym: ESMONOL overallStatus: NOT_YET_RECRUITING date: 2024-04-04 date: 2025-03-03 date: 2025-03-04 date: 2024-03-04 date: 2024-03-25 name: Ciusss de L'Est de l'Île de Montréal class: OTHER briefSummary: This study aims to evaluate esmolol's perfusion impact during induction and maintenance of general anesthesia, using Nociception-Level-guided control of nociception, in adult patients undergoing laparoscopic and lower abdominal surgery, on intraoperative remifentanil consumption and postoperative pain in the Post-Anesthesia Care Unit. conditions: Opioid Use, Unspecified conditions: Anesthesia conditions: Nociceptive Pain studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Two groups of patients randomized into Group "ESMOLOL" for esmolol and group "Standard of Care" for a total of 64 participants. primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Randomization will be done prior to the entrance in the OR, the day of the surgery. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 64 type: ESTIMATED name: Esmolol Hydrochloride name: Saline measure: Intra operative remifentanil administration measure: The NOL Index variation before and after orotracheal intubation and first surgical incision measure: The mean intraoperative blood pressure and heart rate measure: doses and time weighted of norepinephrine (mg); ephedrine (mg), glycopyrrolate (mg) and atropine (mg) measure: Total time with NOL value above > 25 measure: The total time and time weighted average of hypotension and/or bradycardia measure: The time to first analgesic requirement in PACU measure: The amount of morphine equivalent consumption measure: The intensity of pain at rest and under stress measure: Postoperative nausea and vomiting (PONV) and antiemetics use measure: The time spent in PACU sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Île de Montréal city: Montréal-Est state: Quebec zip: H1T2M4 country: Canada name: Pascal Laferrière-Langois, MD FRQS role: CONTACT phone: +1-819-432-5847 email: pascal.laferriere-langlois@umontreal.ca name: Pascal Laferrière-Langois, MD FRQS role: PRINCIPAL_INVESTIGATOR lat: 45.63202 lon: -73.5075 typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-02-26 uploadDate: 2024-03-21T17:38 filename: Prot_000.pdf size: 732855 hasResults: False
<\|newrecord\|> nctId: NCT06291350 id: 23-AOI-05 briefTitle: Peridontal and Intestinal Microbiota in Patients With Gingival Scarring Pemphigoid acronym: MICROPC overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2026-03-15 date: 2026-09-15 date: 2024-03-04 date: 2024-03-15 name: Centre Hospitalier Universitaire de Nice class: OTHER briefSummary: Patients suffering from Mucous Membrane Pemphigoid with desquamative gingivitis (MMPg) generally present a more degraded periodontal condition compared with controls. Bullous disease could represent a risk factor for plaque-induced periodontal disease, and vice versa.
Indeed, the dysbiotic periodontal microbiota could aggravate the gingival damage specific to MMP, either directly by activating inflammatory pathways, or indirectly by degrading cellular and matrix components. On the other hand, areas of erosive gingiva generated by the autoimmune process could increase the virulent power of periodontal pathobionts, by representing accessible, nutrient-rich connective surfaces. Moreover, in recent years, bacterial studies based on a high-throughput metagenomic approach have suggested the existence of a relationship between the oral and intestinal microbiota in patients with degraded periodontal conditions and suffering from autoimmune inflammatory diseases (inflammatory bowel disease, acute graft-versus-host disease). This relationship can also be envisaged in MMPg patients who meet the conditions that allow this type of pathological process to occur: autoimmune disease; disruption of the gingival epithelial barrier in erosive gingival areas (increasing the risk of antigen exposure); large amounts of thick plaque; degraded periodontal condition with the presence of numerous periodontal pockets from which periodontopathogenic bacteria can translocate intra-tissularly and cause distant adverse consequences.
The main aim of this observational, multicentre, case-control, matched study is to compare the composition of the periodontal microbiota between MMPg patients and control patients (arm 2 and arm 3). The secondary objectives are to compare the composition of periodontal and intestinal microbiota in cases and control patients (arm 2 and arm 3), to compare periodontal microbiota composition in cases and control patients (arm 2) according to periodontitis severity, and to compare gut microbiota composition between cases and control patients (arm 2 and arm3). To date, no such study exists. conditions: Pemphigoid, Benign Mucous Membrane conditions: Gingivitis Hyperplastic studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 45 type: ESTIMATED name: Plaque sampling and stool collection name: periodontal examination measure: composition of the periodontal microbiota measure: Compare the composition (name and number of bacterial colonies) of periodontal in MMP and control patients (arm 2 and arm 3). measure: Compare the composition (name and number of bacterial colonies) intestinal microbiota in MMP and control patients (arm 2 and arm 3). measure: Compare (name and number of bacterial colonies) periodontal microbiota composition in MMP and control patients (arm 2) according to periodontitis severity (non-severe/severe) measure: Compare (name and number of bacterial colonies) gut microbiota composition between MMP and control patients (arm 2 and arm3) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nice University Hospital city: Nice zip: 06000 country: France name: Sophie DRIDI, PUPH role: CONTACT phone: 04 92 03 30 07 email: dr.sm.dridi@free.fr name: Rachida Yatimi role: CONTACT phone: 04 92 03 30 07 email: yatimi.r@chu-nice.fr name: Sophie DRIDI role: PRINCIPAL_INVESTIGATOR lat: 43.70313 lon: 7.26608 facility: Paris hospital Pitié Salpetrière (APHP) city: Paris zip: 75013 country: France name: Juliette ROCHEFORT role: CONTACT phone: 0142178416 email: juliette.rochefort@aphp.fr name: Juliette ROCHEFORT role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Paris hospital Bretonneau (APHP) city: Paris zip: 75018 country: France name: Anne-Laure AJEIL role: CONTACT phone: 0153111800 email: anne-laure.ejeil@aphp.fr name: Anne-Laure AJEIL role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 hasResults: False
<\|newrecord\|> nctId: NCT06291337 id: Pro2019001483 id: 10-204Mc type: OTHER domain: Rutgers IRB briefTitle: Ibuprofen Inhibits Human Sweet Taste overallStatus: COMPLETED date: 2020-06-01 date: 2023-09-01 date: 2023-09-30 date: 2024-03-04 date: 2024-03-04 name: Rutgers, The State University of New Jersey class: OTHER name: Monell Chemical Senses Center briefSummary: The sweet taste receptor, TAS1R2-TAS1R3, is expressed both orally, where it signals sweet taste, and extraorally in the intestine and pancreas, where it may affect glucose absorption and metabolism. Recently, ibuprofen and naproxen have been identified to inhibit human T1R3 when heterologously expressed in cells. In the present study, the initial objective was to determine if ibuprofen and naproxen inhibit interactions of sugars with human sweet taste receptor under normal, physiological conditions. Ten healthy participants were asked to rate sweetness intensity for a range of sweet stimuli (sucrose, fructose, sucralose) after a prerinse of ibuprofen, naproxen or water. Both ibuprofen and naproxen inhibited sweet taste intensity in a dose-dependent manner. In association studies, ibuprofen use has been linked to preserved metabolic function, as its use is correlated with lower rates of Alzheimer's disease, diabetes and colon cancer. Here the investigators present a potential novel pathway for systemic ibuprofen to impact these metabolic diseases. conditions: Treatment of Sweet Taste Receptors Without or With an Oral Rinse of Ibuprofen Solution in Healthy Participants conditions: Treatment of Sweet Taste Receptors Without or With an Oral Rinse of Naproxen Solution in Healthy Participants studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: We are testing individual sin a within subject control for their sweet taste ratings of sugars without and with oral rinses of ibuprofen and naproxen. primaryPurpose: BASIC_SCIENCE masking: NONE count: 32 type: ACTUAL name: Inhibition of Sweet Taste by Ibuprofen Oral Rinses name: Inhibition of Sweet Taste by Naproxen Oral Rinses measure: Sweet taste ratings measure: Sugar detection thresholds sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Food Science and Nutritional Sciences city: New Brunswick state: New Jersey zip: 08901 country: United States lat: 40.48622 lon: -74.45182 hasResults: False
<\|newrecord\|> nctId: NCT06291324 id: IRB00103472 id: LCI-SUPP-CRF-WATD-001 type: OTHER domain: Atrium Health briefTitle: WATD and Cancer-Related Fatigue: A Study For Patients Undergoing Anti-Cancer Treatment overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-12-15 date: 2025-12-15 date: 2024-03-04 date: 2024-03-04 name: Wake Forest University Health Sciences class: OTHER name: Atrium Health Levine Cancer Institute briefSummary: The purpose of this study is to evaluate the feasibility of using a commercial WATD (Wearable Activity Tracker Device) to collect HRV (Heart Rate Variability) data from pancreatic and breast cancer patients. conditions: Pancreatic Cancer conditions: Breast Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 46 type: ESTIMATED measure: Adherence and acceptability measure: Theme measure: Heart rate variability (HRV) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Levine Cancer Institute city: Charlotte state: North Carolina zip: 28204 country: United States name: Alicia Patrick role: CONTACT phone: 980-292-1746 email: alicia.patrick@atriumhealth.org name: Dori Beeler, PhD role: PRINCIPAL_INVESTIGATOR lat: 35.22709 lon: -80.84313 hasResults: False
<\|newrecord\|> nctId: NCT06291311 id: MT_NIPP-HPV_ERBE briefTitle: Non-Invasive Plasma Treatment for Cervical Infections: Targeting High- and Low-Risk HPV Variants overallStatus: RECRUITING date: 2023-12-27 date: 2024-06 date: 2025-12 date: 2024-03-04 date: 2024-03-04 name: University Hospital Tuebingen class: OTHER briefSummary: This is a prospective, single-center, observational proof-of-principle clinical trial at the Department of Women's Health of the University Hospital Tübingen. conditions: HPV Infection conditions: Cervical Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 50 type: ESTIMATED name: Cold physical Plasma name: Control group measure: HPV eradication rate measure: Correlation of HPV Genotyping measure: HPV-Quality-of-Life (HPV-QoL) measure: Tissue Tolerance and Compatibility of NIPP Treatment measure: Detection of Intracellular Molecular Plasma Mechanisms sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Tuebingen, Department of Women's Health status: RECRUITING city: Tuebingen zip: 72076 country: Germany name: Martin Weiss, Dr. med. role: CONTACT phone: +4970712982211 email: martin.weiss@med.uni-tuebingen.de lat: 48.52266 lon: 9.05222 hasResults: False
<\|newrecord\|> nctId: NCT06291298 id: STUDY006542 briefTitle: Novel Adaptive Cognitive Training in Autistic Adults With Co-occurring Insomnia overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-04-01 date: 2024-03-04 date: 2024-03-04 name: University of South Florida class: OTHER briefSummary: The proposed study will test the usability and feasibility of a novel cognitive training (COGMUSE) for autistic adults with co-occurring insomnia (COGMUSE- AUT). Participants (n=15) will complete the cognitive training intervention for 60 minutes per day, 3 times per week for 6 weeks at home totaling to 18 hours. Weekly check-ins will be conducted by study staff over Teams to ensure adherence to the treatment and provide an opportunity for qualitative feedback on the game sessions played. During these 6 weeks, participants will fill out daily (2x/day) electronic sleep diaries and wear an actigraph device (GENEActiv). GENEActiv is a watch-like device that monitors light and movement activity. conditions: Autism Spectrum Disorder conditions: Insomnia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Pilot test COGMUSE-AUT in a small sample of autistic adults with co-occurring insomnia on primary and secondary outcomes. primaryPurpose: OTHER masking: NONE count: 15 type: ESTIMATED name: COGMUSE-AUT measure: Objective Cognition-National Institute of Health Toolbox measure: Objective Slee-Daily Actigraphy measure: Subjective Sleep- Electronic Daily Sleep Diaries measure: Insomnia Severity Index measure: Sleep Habits Questionnaire measure: Pre-Sleep Arousal measure: WHO Quality of Life-BREF measure: Mood measure: Depression measure: Adaptive Behavior Assessment System (ABAS-III) measure: Game-related experience (completed during intervention) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06291285 id: NN7533-7587 id: U1111-1285-7491 type: OTHER domain: World Health Organization (WHO) briefTitle: A Study to Test How Either a Capsule or a Tablet With NDec (Decitabine and Tetrahydrouridine) Works in the Body of Healthy People overallStatus: NOT_YET_RECRUITING date: 2024-02-27 date: 2024-07-11 date: 2024-07-11 date: 2024-03-04 date: 2024-03-04 name: Novo Nordisk A/S class: INDUSTRY briefSummary: This study will look at two different oral formulations and compare them. The medicine in the study is called NDec and it is a combination of two medicines (decitabine and tetrahydrouridine). Both medicines are new for the treatment of sickle cell disease, a rare blood disease. The purpose of the study is to compare the absorption of two different NDec versions (a tablet and a capsule). Participant will either get first the tablet and then the capsule, or the other way around. The order in which participant get them is decided by chance. The study will last for about 12 to 45 days depending on the wash-out period between the two stays in the clinic and from recruitment to the first study day. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: SINGLE whoMasked: INVESTIGATOR count: 48 type: ESTIMATED name: Decitabine-THU name: Decitabine-THU measure: AUC0-inf,DEC,SD: Area under the plasma decitabine concentration-time curve after a single dose measure: AUC0-inf,THU,SD: Area under the plasma tetrahydrouridine concentration-time curve after a single dose measure: Cmax,DEC,SD: Maximum plasma concentration of decitabine after a single dose measure: Cmax,THU,SD: Maximum plasma concentration of tetrahydrouridine after a single dose measure: t½,DEC,SD: Terminal half-life for decitabine after a single dose measure: t½,THU,SD: Terminal half-life for tetrahydrouridine after a single dose measure: tmax,DEC,SD: Time to maximum observed plasma decitabine concentration after a single dose measure: tmax,THU,SD:: Time to maximum observed plasma tetrahydrouridine concentration after a single dose measure: Maximum change from pre dose in dNA methyltransferase 1 (DNMT1) protein expression after a single dose measure: Maximum change from pre dose in cytidine deaminase (CDA) activity after a single dose sex: ALL minimumAge: 18 Years maximumAge: 64 Years stdAges: ADULT facility: ICON-Salt Lake City city: Millcreek state: Utah zip: 84124 country: United States lat: 40.68689 lon: -111.87549 facility: Profil Institut für Stoffwechselforschung GmbH city: Neuss zip: 41460 country: Germany lat: 51.19807 lon: 6.68504 hasResults: False
<\|newrecord\|> nctId: NCT06291272 id: FMHS 328-0723 briefTitle: Effect of Methylcellulose or Psyllium on Fermentation of inUlin Assessed USing MRI acronym: RUFUS overallStatus: RECRUITING date: 2023-10-15 date: 2024-06-30 date: 2024-10-30 date: 2024-03-04 date: 2024-03-04 name: University of Nottingham class: OTHER name: Quadram Institute Bioscience briefSummary: Our challenge is to understand how fibre interacts with whole-gut function to alter colonic fermentation of FODMAPs. We will exploit the recent availability of a range of food grade modified celluloses which can form gels at body temperature to perform human studies to explore whether the beneficial effect of psyllium is unique or will be found with all gelling substances (4). We are currently performing the COCOA2 study using a modified methylcellulose (results awaited). We now wish to perform a pilot study to image what happens in the colon when methylcellulose is ingested to enable us to plan the next step in our research programme. conditions: Colon, Irritable studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: 3 way cross -over primaryPurpose: BASIC_SCIENCE masking: TRIPLE maskingDescription: Opaque plastic bags containing test meals prepared by some one not involved in analysis pf results whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 18 type: ESTIMATED name: Psyllium name: Methylcellulose name: Inulin name: Maltodextrin measure: colonic gas volume measure: colonic gas volume at 6 hours measure: Breath hydrogen measure: Oro-cecal transit time measure: 24 hour breath hydrogen sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Nottingham Digestive Disease Centre status: RECRUITING city: Nottingham state: Nottinghamshire zip: NG7 2UH country: United Kingdom name: Alaa Alhasani, BSc role: CONTACT phone: 01159429924 email: alyaa11@exmail.nottingham.ac.uk name: Robin Spiller role: CONTACT phone: +447824328319 email: robin.spiller@nottingham.ac.uk lat: 52.9536 lon: -1.15047 hasResults: False
<\|newrecord\|> nctId: NCT06291259 id: CTO 4081 briefTitle: Mpox Prospective Observational Cohort Study acronym: MPOCS overallStatus: RECRUITING date: 2022-06-21 date: 2024-09 date: 2024-09 date: 2024-03-04 date: 2024-03-04 name: Unity Health Toronto class: OTHER briefSummary: The goal of this multicentre prospective observational cohort study is to shed light on the following unknowns:
1. The clinical manifestations of Mpox infection since the 2022 outbreak in Canada.
2. The social and psychological impacts of Mpox infection since the 2022 outbreak in Canada
3. The transmissibility of Mpox infection
4. Viral shedding over time in infected individuals
The study is divided into Part 1 (corresponding to the acute phase of illness) and Part 2 (corresponding to the convalescent phase of the illness); part 2 will be optional. Participants enrolled during the acute phase of illness will complete part 1 of the study and will be invited to participate in Part 2 as well. Part 1 of the study will include the following three core components, at baseline and weekly (±3 days) until one week after the resolution of all symptoms (i.e. one week after complete healing of skin lesions):
1. Collection of clinical data through chart review and research staff interviews with study participants
2. Participant self-administered online questionnaires at baseline and a thrice-weekly 'acute phase participant diary'
3. Specimen collection for Mpox-related testing Optional components for Part 1 include baseline-only, questionnaire-only, and frequent sampling.
Other optional components for all participants include in the Image Atlas, an online database of clinical images of mpox, designed to provide clinicians and community members of what mpox looks like in real life, and the biobank, which will store research samples for potential future studies. conditions: Monkeypox studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 250 type: ESTIMATED measure: Description of clinical manifestation measure: Psychosocial impact measure: Transmission-related aspects of mpox infection measure: Virologic aspects of mpox infection over time sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: BC Centre For Excellence status: RECRUITING city: Vancouver state: British Columbia zip: V6Z 1Y6 country: Canada name: Brody Lyon role: CONTACT phone: 604-682-2344 phoneExt: 66230 email: blyons@bccfe.ca name: Mark Hull, MD role: PRINCIPAL_INVESTIGATOR lat: 49.24966 lon: -123.11934 facility: Unity Health Toronto status: RECRUITING city: Toronto state: Ontario zip: M5B 1T8 country: Canada name: Shreya Shah role: CONTACT phone: 416-360-4000 phoneExt: 77312 email: shreya.khera@unityhealth.to name: Darrell HS Tan role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 facility: University Health Network status: RECRUITING city: Toronto state: Ontario country: Canada name: Asmaa Mabrouk role: CONTACT phone: 416-340-4800 phoneExt: 2240 email: Asmaa.mabrouk@uhn.ca name: Sharon Walmsley, MD role: PRINCIPAL_INVESTIGATOR lat: 43.70011 lon: -79.4163 hasResults: False
<\|newrecord\|> nctId: NCT06291246 id: 23-1823 id: K12TR004416-01 type: NIH link: https://reporter.nih.gov/quickSearch/K12TR004416-01 briefTitle: Expediting Access to Services for Equity (EASE) acronym: EASE overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-06-30 date: 2026-06-30 date: 2024-03-04 date: 2024-03-04 name: University of North Carolina, Chapel Hill class: OTHER name: National Center for Advancing Translational Sciences (NCATS) briefSummary: The goal of this clinical trial is to assess whether telehealth-based Family Navigation (FN) expedites enrollment (e.g., reduces time in days) in community-based autism intervention for Black toddlers under the age of 3 after their initial diagnosis of autism.
The main questions it aims to answer are:
* Does Family Navigation decrease the time to initiation of intervention for Black toddlers with autism?
* Does Family Navigation improve developmental outcomes at 18 months post-diagnosis of autism?
* Does Family Navigation improve caregiver well-being?
Caregivers in the Family Navigation condition will receive 4 research-based individual sessions with a trained navigator to support them in identifying and enrolling in recommended autism early intervention services. All navigation sessions will be delivered virtually via phone/Zoom.
Researchers will compare participants who receive family navigation to participants who receive the standard of care (educational materials) to see if family navigation outperforms the standard of care. conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 86 type: ESTIMATED name: Virtual Family Navigation name: Educational Materials measure: Time to initiation of autism specific intervention measure: Caregiver Well-Being Score measure: Child's Developmental Functioning Score measure: Child's Adaptive Functioning Score measure: Appropriateness of Intervention Score measure: Feasibility of Intervention Score measure: Acceptability of Intervention Score sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Carolina Institute for Developmental Disabilities city: Carrboro state: North Carolina zip: 27510 country: United States lat: 35.91014 lon: -79.07529 hasResults: False
<\|newrecord\|> nctId: NCT06291233 id: HUM00236812 id: 1R01MH132656-01 type: NIH link: https://reporter.nih.gov/quickSearch/1R01MH132656-01 briefTitle: A Hybrid Effectiveness-Implementation Randomized Clinical Trial (RCT) of Virtual Interview Training for Autistic Transition-Age Youth overallStatus: ENROLLING_BY_INVITATION date: 2024-03-01 date: 2026-03-01 date: 2026-03-01 date: 2024-03-04 date: 2024-04-05 name: University of Michigan class: OTHER name: National Institute of Mental Health (NIMH) briefSummary: The purpose of the study is to see if an internet job interview training program can help people that have autism improve interview skills and access to jobs.
Participants will be randomized to use Virtual Interview Training (VIT) or continue services as usual (active control group). conditions: Autism Spectrum Disorder studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 200 type: ESTIMATED name: Virtual Interview Training (VIT) name: Services-as-usual measure: Competitive Employment based on self-report employment surveys measure: Change in Job Interview Skills from Mock Interview Rating Scale (MIRS) measure: Change in Job Interview Skills from Measure of Job Interview Skills (MOJO-iSkills) measure: Time to Employment measure: Vocational Index Score measure: Vocational Index Score measure: Change in Interview Anxiety using a modified version of the brief Personal Report of Public Speaking Apprehension (PRSPA) measure: Change in Interview Motivation measure: Change in Social Responsiveness using the Social Responsiveness Scale 2nd version (SRS-2) measure: Change in Job Search Behavior using the Job Search Behavior Scale (JSBS) measure: Change in Work Readiness using the Work Readiness Scale (WRS) measure: Change in Work Motivation using the Work Motivation Scale (WMS) measure: Change in Social Cognition using the Bell-Lysaker Emotion Recognition Task Adult (BLERT-A) measure: Change in Interview Knowledge sex: ALL minimumAge: 16 Years maximumAge: 26 Years stdAges: CHILD stdAges: ADULT facility: The San Diego State University city: San Diego state: California zip: 92182 country: United States lat: 32.71533 lon: -117.15726 facility: University of Michigan city: Ann Arbor state: Michigan zip: 48109 country: United States lat: 42.27756 lon: -83.74088 facility: Disability Network Wayne County city: Detroit state: Michigan zip: 48235 country: United States lat: 42.33143 lon: -83.04575 facility: Lincoln Park city: Lincoln Park state: Michigan zip: 48146 country: United States lat: 42.25059 lon: -83.17854 hasResults: False
<\|newrecord\|> nctId: NCT06291220 id: M24-291 id: 2023-507637-19 type: OTHER domain: EU CT briefTitle: A Study Assessing Adverse Event and How Oral ABBV-453 Moves Through the Body in Adult Participants With Relapsed or Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) overallStatus: NOT_YET_RECRUITING date: 2024-06-02 date: 2029-07-21 date: 2029-07-21 date: 2024-03-04 date: 2024-03-04 name: AbbVie class: INDUSTRY briefSummary: Chronic lymphocytic leukemia (CLL) is the most common leukemia in Western countries. The purpose of this study is to assess how well ABBV-453 works adult participants with relapsed/refractory (R/R) untreated CLL/small lymphocytic lymphoma (SLL). Adverse events, pharmacokinetics, and change in disease activity will be assessed.
ABBV-453 is an investigational drug for the treatment of CLL and SLL. There are 2 parts to this study. In part A participants will be placed 1 of 5 cohorts with a specific target dose for each cohort and receive obinutuzumab during the debulking period followed escalating doses of ABBV-453, until the appropriate target dose is achieved. In part B participants will be placed in 2 cohorts and receive up to the maximum dose in part A, with cohort 2.1 including a debulking period (obinutuzumab) as in part A. Approximately 80 adult participants with previously R/R CLL/SLL will be enrolled in the study in approximately 28 sites across the world.
Participants in part A will placed into 1 of 5 cohorts with a specific target dose for each cohort and will receive intravenous (IV) obinutuzumab as part of the debulking period, followed by escalating doses of oral ABBV-453 until the appropriate target dose is achieved. Participants in part B will be place in one of 2 cohorts. Participants in cohort 2.1 will receive IV obinutuzumab as part of the debulking period, followed by escalating doses of oral ABBV-453 until the maximum target dose from part A is achieved. Participants in cohort 2.2 will receive no treatment during the the debulking period, followed by escalating doses of oral ABBV-453 until the maximum target dose from part A is achieved. The estimated study duration is 5 years.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects. conditions: Chronic Lymphocytic Leukemia conditions: Small Lymphocytic Lymphoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Obinutuzumab name: ABBV-453 measure: Part A and B: Percentage of Participants With Adverse Events (AEs) measure: Part A: Maximum Administered Dose (MAD) of ABBV-453 measure: Part A: Maximum Tolerated Dose (MTD) of ABBV-453 measure: Part A and B: Maximum Observed Plasma Concentration (Cmax) of ABBV-453 measure: Part A and B: Time to Maximum Observed Concentration (Tmax) of ABBV-453 measure: Part A and B: Area Under the Plasma/Serum Concentration Versus Time Curve (AUC) of ABBV-453 measure: Part A and B: Overall Response Rate (ORR) measure: Part A and B: Duration of Response (DOR) for Participants with PR/nPR or Better measure: Part A and B: Complete response rate (CRR) measure: Part A and B: Duration of Complete Response (DOCR) measure: Part A and B: Percentage of Participants Achieving an Minimal Residual Disease (MRD) Response among Participants Achieving a PR, nPR, CR, or CRi measure: Part A and B: Progression-free survival (PFS) measure: Part A and B: Overall survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06291207 id: AD-224P3 briefTitle: A Study to Evaluate the Efficacy and Safety of AD-224 overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2024-12 date: 2024-03-04 date: 2024-03-06 name: Addpharma Inc. class: INDUSTRY briefSummary: The purpose of this study is to evaluate the efficacy and safety of AD-224 conditions: Hypertension,Essential studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 252 type: ESTIMATED name: AD-224A name: AD-224B name: AD-224C name: Placebo of AD-224A name: Placebo of AD-224B name: Placebo of AD-224C measure: Change rate of MSSBP sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06291194 id: 22DE30902 briefTitle: Efficacy and Safety of AJU-S56 5% in Dry Eye Syndrome Patients overallStatus: RECRUITING date: 2023-11-10 date: 2024-05 date: 2024-05 date: 2024-03-04 date: 2024-04-08 name: AJU Pharm Co., Ltd. class: INDUSTRY name: GL Pharm Tech Corporation briefSummary: This study is planned to Evaluate the Efficacy and Safety of test drug (AJU-S56 5%) compared to control drug(vehicle) in Patients with Dry Eye Disease. conditions: Dry Eye Syndromes studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 396 type: ESTIMATED name: AJU-S56 5% name: Placebo Group(Vehicle) measure: Total corneal staining score (TCSS) measure: LGCSS measure: TFBUT sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AJU Pharm Co., Ltd. status: RECRUITING city: Seoul country: Korea, Republic of name: JUNGMIN LEE role: CONTACT phone: +82-02-2630-0700 email: ajuf13001@ajupharm.co.kr lat: 37.566 lon: 126.9784 hasResults: False
<\|newrecord\|> nctId: NCT06291181 id: Soh-Med-24-01-05MD briefTitle: Studying the Distribution of Accessory Gene Regulator (Agr) Quorum Sensing System and the Prevalence of Linezolid and Mupirocin Resistance in Biofilm Producer/Non Producer Staphylococcus Aureus in Sohag University Hospitals overallStatus: COMPLETED date: 2023-01-01 date: 2023-06-30 date: 2023-06-30 date: 2024-03-04 date: 2024-03-04 name: Sohag University class: OTHER briefSummary: Staphylococcus aureus is an important pathogen causing a wide spectrum of infections . The organism usually colonizes the skin and mucous of humans and several animal species. Multiple body sites can be colonized in humans, however, the anterior nares of the nose are the most frequent carriage site for S. aureus. Other sites for carriage include the skin, perineum, and pharynx . It has been shown that there is an increased prevalence of staphylococcus infections, which may be attributed to its carriage in anterior nares and hands of health care workers and patients .
The pathogenic mechanisms enabling S. aureus to cause serious infections could include: biofilm which protects organisms from host immune response; opsonophagocytosis and antimicrobial agents, thus leading to chronic and persistent infections.
Antibiotic resistance associated with S.aureus infections is a great concern for the clinicians to prevent spread of infections. Methicillin was commonly used for these infections before the emergence of MRSA which is developed due to irrational use of antibiotics, prolonged hospital stay, nasal and hand carriage in health care staff. Also vancomycin, linezolid and mupirocin are used in treating infections,as well as decolonization of carriers .
Mupirocin act by inhibiting the protein synthesis of bacteria by binding specifically to isoleucyl-tRNAsynthetase enzyme. The irrational use of Mupirocin among patients and its carriage in health care staff has led to the emergence of resistance to this antibiotic. .
MupA, plasmid mediated gene, has a great role in mupirocinresistence as it had a supplementary modified isoleucyltRNAsynthetase which leads to the high level resistance to Mupirocin. The mupA gene has the ability to facilitate and disseminate the resistance mechanism in different patterns .
Linezolid,theﬁrstoxazolidinonedrug,waslaunchedin2001andis still displaying excellent in vitro activity against Staphylococcus epidermidis on a global scale,although outbreaks of linezolidresistant S. epidermidis (LRSE) are occasionally reported..
Linezolid resistance is mediated by, mutations in the 23S rRNA gene, altering the drug-binding site, and/or the 50S ribosomal proteins L3, L4 and L22, impairing linezolid binding;,Oracquisition of the primarily plasmid-encoded genes cfr, encoding a methyltransferase, or optrA, encoding an ABC transporter, or the cfr homologues cfr(B) and cfr(C).
While cfr can mediate the PhLOPSA phenotype (resistance to phenicols, lincosamides,oxazolidinones, pleuromutilins and streptogramin A compounds), optrA confers oxazolidinone and phenicolresistance only..
Pathogenecity of S. aureus is regulated by various factors ,one of them is the accessory gene regulatory (agr) system. It consists of 2 divergently transcribed loci (3 kb) controlled by means of 2 promoters P2 and P3. Most of clinical isolates of acute infections have a functional agr system and all, like strains, produce RNAIII in vitro and in vivo.
Agr deficiency has been related to increased biofilm formation because RNAIII reduces the expression of surface adhesins and increases the production of capsule, toxins, and proteases. The agr system is supposed to regulate over 70 genes, 23 of which are renowned virulence factors.
There are 2 classes of virulence factors regulated by agr. The first class includes virulence factors implicated in attachment to the host and immune evasion, whereas the second class contains genes engaged in the production of exoproteins related to invasion and toxin production . The activation of the agr system switches the bacterium from an adhesive, colonizing commensal into an invasive and aggressive pathogen(Roux A et al; 2009).
Major virulence factors in S. aureus, exfoliative toxins (ETs), toxic shock syndrome toxin (TSST-1), and staphylococcal enterotoxins (SEs) are involved in host colonization, invasion of damaged skin and mucus, gastrointestinal infection, and prevarication of host defense mechanisms. Indeed, agr operon including agrA, agrB, agrC, and agrD genes regulate over 70 genes in S. aureus 23 of which control its pathogenicity and invasive infections .
Moreover, S. aureus can be stratified into 4 different groups (agr I, agr II, agr III, and agr IV) according to the sequences of agrC (auto inducing peptide) and agrD (cyclic AIP) genes. It is stated that agr types are different in their properties and prevalence in various geographical areas thus, identification of predominant types in each region may well be functional . conditions: Staphylococcus Aureus studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 265 type: ACTUAL name: antibiotic sensitivity test measure: resistence of staphylococci to mupirocin and linezolid antibiotics sex: ALL minimumAge: 3 Years maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sohag university Hospital city: Sohag country: Egypt lat: 26.55695 lon: 31.69478 hasResults: False
<\|newrecord\|> nctId: NCT06291168 id: CMT002 briefTitle: Comparison of The Effectiveness of Spinal Manipulation and Yoga in Chronic Low Back Pain acronym: CTESMYCLBP overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-03-01 date: 2024-06-01 date: 2024-03-04 date: 2024-03-04 name: SEFA HAKTAN HATIK class: OTHER briefSummary: The aim of our study was to compare the effectiveness of chiropractic manipulation and yoga-based exercise techniques on pain, functionality, depression and anxiety in patients with long-term low back pain. conditions: Low Back Pain conditions: Spinal Manipulation conditions: Yoga studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The 60 participants will be divided into three groups. These groups will be randomly divided into three groups as chiropractic manipulation group (n=20), yoga-based exercise group (n=20) and conventional exercise group (control group) (n=20). Exercise programs will be performed under the supervision of a physiotherapist. Chiropractic manipulation will be applied to the lumbar region and sacroiliac joint in the side lying position. Data will be analyzed in SPSS 29.0 IBM program. Kruskal-Wallis H test will be used for difference analysis between groups, Kruskal-Wallis H test will be used for comparisons between groups by taking the differences between measurement times and the significance level will be determined as p\<0.05. primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Chiropractic Manipulation (HVLA - High Velocity Low Amplitude) name: Yoga-Based Exercise Program name: Conventional Exercises measure: Numeric Rating Scale (NRS) measure: Roland-Morris Disability Questionnaire measure: Hospital Anxiety and Depression Scale (HADS) measure: Range of Motion (ROM) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06291155 id: HUM00222335 briefTitle: Renal Mechanism of SGLT2 Inhibition overallStatus: RECRUITING date: 2024-01-01 date: 2026-12-31 date: 2028-06-30 date: 2024-03-04 date: 2024-03-04 name: University of Michigan class: OTHER name: University of Colorado, Denver name: Renal Pre-Competitive Consortium (RPC3) briefSummary: The goal of this open-label, non-randomized clinical trial is to determine what effects, if any, an FDA-approved drug class known as SGLT2 inhibitors (Canagliflozin or INVOKANA) has any protective effects on kidney function in Type 2 diabetes. We are looking for participants 18-80 years of age, who have had a clinical diagnosis of Type 2 diabetes for ≥ 3 years.
Participants will be asked to sign a consent and complete a screening visit prior to study entry including the following procedures for this study:
Consent and Screening:
* Laboratory tests to determine baseline health
* Ultrasound to measure kidney size and ensure presence of 2 functioning kidneys
Month 0:
* Study entry kidney MRI (day 0)
* Study entry kidney biopsy (within 30 days of MRI)
* Study entry visit for dispensing 100 mg/daily Canagliflozin medication 3 month supply
Month 3:
* Study visit to dispense remaining 3 months of 100 mg/daily Canagliflozin medication
* Review of systems
Month 6:
* Follow-up kidney MRI
* Follow-up kidney biopsy
Study participants will also be requested to provide blood and urine samples for biobanking purposes. They will also be provided the opportunity to provide a stool sample at two time points, as well as the option to participate in a related study collecting samples to create induced Pluripotent Stem Cells (iPSCs).
Participants will be compensated for their time and loss of work time, additionally, a nominal additional compensation for optional stool and iPSC samples. conditions: Type 2 Diabetes conditions: Diabetic Kidney Disease studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This is an open-label, non-randomized mechanistic trial of an FDA-approved drug primaryPurpose: DIAGNOSTIC masking: NONE count: 20 type: ESTIMATED name: SGLT2 inhibitor measure: Glomerular basement membrane (GBM) width and mesangial expansion measure: Kidney Transcript Changes sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Michigan status: RECRUITING city: Ann Arbor state: Michigan zip: 48109 country: United States name: Chrysta C Lienczewski, BS role: CONTACT phone: 734-615-5021 email: boridley@umich.edu name: Markus Bitzer, MD role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 hasResults: False
<\|newrecord\|> nctId: NCT06291142 id: R129030 id: IRAS 315004 type: OTHER domain: IRAS briefTitle: Early Diagnosis of SSc in the General Rheumatology Clinic - Pilot overallStatus: ENROLLING_BY_INVITATION date: 2023-11-22 date: 2024-09 date: 2025-03 date: 2024-03-04 date: 2024-03-08 name: University of Manchester class: OTHER name: National Institute for Health Research, United Kingdom name: Royal Bolton Hospital NHS Foundation Trust name: Alder Hey Children's NHS Foundation Trust name: University Hospitals of Morecambe Bay NHS Trust name: Stockport NHS Foundation Trust name: Medway NHS Foundation Trust name: Northern Care Alliance NHS Foundation Trust name: Royal Free Hospital NHS Foundation Trust briefSummary: The goal of this observational pilot data acquisition study is to establish if target users can obtain diagnostic quality images in the clinic, from participants with Systemic Sclerosis (SSc), and SSc spectrum conditions. The main questions it aims to answer are:
* Can a range of healthcare professionals, including non-specialists, use the capillaroscopy image acquisition system to take high quality images that can be used to create a clinical report?
* Can the investigators collect user and patient feedback on the usability of the capillaroscopy system, to help develop the software and to develop the clinical report
* Which microscope light source, from four different light wavelengths is better to see the blood vessels in skin with more melanin content.
Participants will be asked to attend a single clinic visit where they will undergo a brief, non-invasive nailfold capillaroscopy examination, using the software-guided capillaroscopy system.
Participants and rheumatology healthcare professionals will be invited to take part in one or more focus groups and interviews, to collect feedback and to contribute to the development of the image acquisition software and the clinical report. conditions: Systemic Sclerosis conditions: Raynaud Phenomenon studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 105 type: ESTIMATED name: Observation - Nailfold capillaroscopy measure: Pilot Image Acquisition measure: Qualitative Feedback measure: Skin tone sub-study data set sex: ALL minimumAge: 6 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Northern Care Alliance NHS Foundation Trust city: Salford zip: M6 8HD country: United Kingdom lat: 53.48771 lon: -2.29042 hasResults: False
<\|newrecord\|> nctId: NCT06291129 id: CAAE: 61347422.4.0000.5626 briefTitle: Gingival Health and Malocclusion Among Type 1 Diabetic Children and Adolescents overallStatus: ACTIVE_NOT_RECRUITING date: 2022-10-30 date: 2023-10-30 date: 2024-10-30 date: 2024-03-04 date: 2024-03-04 name: Universidade Federal Fluminense class: OTHER briefSummary: Introduction: This study aims to evaluate the gingivitis, periodontal profile and malocclusion in children and adolescents with diabetes. Methods: The sample consisted of 36 children, who were distributed into two groups: DM; n=18 and NDM; n=18. Periodontal parameters considered were plaque Index (PI), gingival Index (GI), probing depth of pocket (PPD), gingival recession (GR) and clinical attachment level (CAL). Gingival biotype clinical parameters: Gingival transparency to probing, Height of keratinized mucosa and Gingival thickness on permanent incisors and molars. Malocclusion were evaluated by the Dental Aesthetic Index (DAI) and the Angle's Classification. The statistical analyses were Shapiro Wilk test and T test. conditions: Gingivitis conditions: Periodontal Diseases conditions: Diabetes conditions: Diabetes Mellitus, Type 1 conditions: Malocclusion conditions: Malocclusion in Children studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 36 type: ESTIMATED name: Periodontal therapy measure: Bleeding on probing sex: ALL minimumAge: 8 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Universidade Federal Fluminense city: Nova Friburgo state: Rio De Janeiro zip: 28625650 country: Brazil lat: -22.28194 lon: -42.53111 hasResults: False
<\|newrecord\|> nctId: NCT06291116 id: 2022/0345/HP briefTitle: Safety of RotigotiNe in Patients With Autosomal Dominant Polycystic Kidney Disease acronym: ETERNAL-PKD overallStatus: NOT_YET_RECRUITING date: 2025-01-01 date: 2029-05-01 date: 2029-05-01 date: 2024-03-04 date: 2024-03-04 name: University Hospital, Rouen class: OTHER briefSummary: Autosomal dominant polycystic kidney disease (ADPKD) is the most common hereditary kidney disease linked to mutation of the PKD1 or PKD2 genes encoding polycystins 1 and 2. Patients develop renal cysts with progressive impairment of renal function leading to renal failure. terminal renal failure for 1/3 of them. These patients also present early with high blood pressure and cardiovascular complications, notably intracerebral aneurysms. This phenotype is linked to abnormal polycystins on the cilia of renal epithelial and vascular endothelial cells which no longer ensure the mechanotransduction of shear forces linked to urinary and blood flow leading to the modification of numerous cellular functions.
Experimental results suggested that stimulation of dopamine receptor type 5 (DR5) could restore the mechanosensitivity of endothelial cells, a hypothesis supported by our first results showing that local administration of dopamine improves endothelial function in patients with ADPKD. through restoration of endothelial NO release upon increased blood flow. Similar positive results on endothelial function and hemodynamics were recently obtained in the IMPROVE-PKD study with rotigotine, a dopamine agonist administered via transdermal patches for 2 months at a low dose (4 mg/24h).
Dopaminergic stimulation could also prevent abnormalities linked to polycystin deficiency at the renal level and we therefore hypothesize that rotigotine could slow the progression of ADPKD both at the renal and cardiovascular levels.
This phase 2 study aims to ensure the good long-term tolerance of rotigotine in patients with ADPKD and to collect preliminary data on its renal impact. conditions: Kidney Diseases studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: standard care + rotigotine at 4 mg/24h for 24 months. name: standard care for 24 months. measure: Evaluate the safety and tolerability of rotigotine administered at a dose of 4 mg/24h for 24 months in patients with ADPKD sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06291103 id: 2022/0342/HP briefTitle: Screening for Subclinical Antibody Mediated Rejection and Efficacy of Belatacept in the Context of de Novo Donor Specific Antibody After Kidney Transplantation (BELA-M-R) acronym: BELA-M-R overallStatus: NOT_YET_RECRUITING date: 2025-01-01 date: 2031-03-01 date: 2031-03-01 date: 2024-03-04 date: 2024-03-04 name: University Hospital, Rouen class: OTHER briefSummary: Antibody mediated rejection (ABMR) is a major cause of graft loss after kidney transplantation (KT) and is mainly associated with preformed anti-HLA donor specific antibodies (DSAs) (phenotype 1) or de novo DSAs (dnDSAs) (phenotype 2). Preexisting DSA-associated ABMR have superior graft survival compared with dnDSA-associated ABMR, which could partly be explained by the fact that patients with de novo DSA-associated ABMR have biopsy later, when graft dysfunction and/or proteinuria are already present. ABMR is a progressive process with an early stage called subclinical ABMR (sABMR), in which histological lesions are present in the kidney graft without clinical graft dysfunction. These early lesions are now well recognized as risk factors for transplant glomerulopathy and poor graft survival in phenotype 1 ABMR (ref 5). The impact of sABMR associated with dnDSA at any time post-transplant has been less studied and reported. Recently, we published a retrospective multicenter study within the Spiesser Group that included 123 patients without graft dysfunction who underwent graft biopsy because of the presence of dnDSA (One Lambda, MFI \> 1000). Performing a kidney graft biopsy after dnDSA indentification without renal dysfunction leads to the diagnosis of active sABMR in 35 % of cases. Nevertheless, we did not observe any effect of standard of care treatment in active sABMR. Very recently, an expert consensus for the recommended treatment for ABMR after KT was published. They concluded the clear lack of evidence but a standard of care for ABMR was nevertheless defined. Therefore, we propose to evaluate a new strategy for active sABMR, testing a conversion from calcineurin inhibitor (CNI) to belatacept associated with the recently recommended standard of care (SOC) compared to continuing CNI. Belatacept might help to manage nonadherence, decrease the toxicity of CNI on an endothelium already affected by microvascular inflammation, and reduce DSA titers.
The monitoring of dnDSA after KT and an indication graft biopsy in case of appearance, even in the absence of graft dysfunction, is not part of a routine clinical practice in all KT centers. This strategy could be a valuable option, in order to begin treatment of ABMR before graft dysfunction occurs, and therefore to improve prognosis associated with phenotype 2 ABMR. Parajuli et al.4 suggested that early diagnosis and treatment of sABMR with SOC, using DSA monitoring may improve outcomes after KT, but this is a retrospective and no-randomized study. This study will be the first prospective randomized study in the context of de novo DSA. We will evaluate a new combination of treatment for ABMR in the context of dnDSA with subclinical lesions and in the same time may help to determine the real incidence of sABMR in KT recipients with subclinical dnDSA. The use of belatacept in the context of sABMR to improve the non-adherence and to decrease the endothelial toxicity had never been evaluated in a prospective way. conditions: Kidney Transplant Rejection studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 290 type: ESTIMATED name: Conversion to Belatacep name: Standard of care treatment (SOC regimen) with Tacrolimus measure: The efficacy of belatacept combined with standard of care, compared to calcineurin inhibitors (CNI) combined with standard of care, among kidney transplant recipients with sABMR sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06291090 id: 22-0789 id: K08DA049905 type: NIH link: https://reporter.nih.gov/quickSearch/K08DA049905 briefTitle: A Multi-site Intervention to Expand Hospital Based OUD Treatment Provision overallStatus: RECRUITING date: 2023-01-18 date: 2024-04-30 date: 2025-05-01 date: 2024-03-04 date: 2024-03-29 name: University of Colorado, Denver class: OTHER name: National Institute on Drug Abuse (NIDA) briefSummary: The investigators implemented a multi-site hospital-based opioid use disorder (OUD) treatment intervention across 12 hospitals in Colorado to address an OUD treatment gap among hospitalized adults with OUD. conditions: Opioid Use Disorder studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This intervention will be implemented across 12 hospitals primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 400 type: ESTIMATED name: OUD treatment intervention measure: Change in buprenorphine prescribing at hospital discharge measure: Change in rates of methadone prescribing during hospitalization measure: Change in average (mean) COWS score over time measure: Change in naloxone prescribing at hospital discharge sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Colorado Anschutz Medicl Campus status: RECRUITING city: Aurora state: Colorado zip: 80045 country: United States name: Susan L Calcaterra, MD role: CONTACT phone: 248-703-5947 email: susan.calcaterra@cuanschutz.edu lat: 39.72943 lon: -104.83192 hasResults: False

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