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The sample size calculation is based on an estimated VTE incidence of 5% over a mean follow-up of 12 months. Hence, a sample size of at least 1,200 patients in the derivation cohort is considered sufficient for the determination of a risk prediction model incorporating up to six predictor variables. A split-sample method will be used, with two-thirds of the study participants randomly assigned to the model derivation cohort (n=1,200) and one-third (n=600) to an independent validation cohort. The total number of patients recruited in the study will thus be of 1,800. A competing risk survival analysis with Fine \& Gray model will be used to study the association between prognostic variables and VTE occurrence, considering death as a competitive risk. The RPM will be identified through a bootstrap approach to reduce the risk of overfitting. Discrimination power of the RPM will be assessed using time-dependent Receiving Operating Characteristic curve, and model calibration will be evaluated graphically and with the calculation of relative calibration slopes.
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In conclusion, this prospective cohort study aims to overcome the limitations of current RPMs in gynecologic cancer patients, improving the accuracy of VTE risk stratification in this population. conditions: Cancer-associated Thrombosis conditions: Venous Thromboembolism conditions: Gynecologic Cancer conditions: Ovarian Cancer conditions: Cervix Cancer conditions: Endometrial Cancer conditions: Vaginal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 1800 type: ESTIMATED name: Anticoagulant measure: Venous thromboembolism measure: Bleeding sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Fondazione Policlinico Universitario A. Gemelli IRCCS city: Rome zip: 00168 country: Italy lat: 41.89193 lon: 12.51133 hasResults: False
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<|newrecord|> nctId: NCT06284330 id: STU-2023-0881 briefTitle: CHARGE Study: CHoice ARchitecture Genetic tEsting acronym: CHARGE overallStatus: RECRUITING date: 2024-02-16 date: 2025-03 date: 2025-08 date: 2024-02-28 date: 2024-04-05 name: University of Texas Southwestern Medical Center class: OTHER briefSummary: CHARGE is a hybrid type I feasibility study to compare a choice architecture intervention for cascade genetic testing to usual care. conditions: Hereditary Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 260 type: ESTIMATED name: Enhanced cascade testing measure: Rate of cascade genetic testing measure: Change in probands' family communication about genetic test results as measured by Proband survey measure: Proband's and relative's satisfaction with decision about participating in study measured at approximately 4- 7 months measure: Family functioning as reported by probands and relatives measured by Cancer Family Impact Scale measure: Proband's reaction to intervention materials as measured by proband survey. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UT Southwestern Medical Center status: RECRUITING city: Dallas state: Texas zip: 75390 country: United States name: Sukh Makhnoon, PhD, MS role: CONTACT phone: 214-648-3242 email: Chargestudy@utsouthwestern.edu name: Sukh Makhnoon, PhD, MS role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 hasResults: False
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<|newrecord|> nctId: NCT06284317 id: ETOP 25-23 briefTitle: A Study to Evaluate the Benefit of Adding Durvalumab After Chemotherapy, Durvalumab and Surgery in Patients With Early-stage, Operable, Non-small Cell Lung Cancer. acronym: ADOPT-lung overallStatus: NOT_YET_RECRUITING date: 2024-10 date: 2029-10 date: 2030-03 date: 2024-02-28 date: 2024-04-05 name: ETOP IBCSG Partners Foundation class: NETWORK name: AstraZeneca AG Switzerland briefSummary: ADOPT-LUNG is an international, multicentre, open-label randomised phase III trial. Protocol treatment consists of 3-4 cycles of neoadjuvant durvalumab in combination with platinum-based doublet chemotherapy, followed by surgery. Patients with R0 and R1 only resection will be randomised to receive either adjuvant durvalumab for 12 cycles (experimental arm) or observation (control arm). The primary objective of the study is to determine whether additional adjuvant immunotherapy with durvalumab after neoadjuvant chemo-immunotherapy has an effect on disease-free survival (DFS) in patients who do not achieve complete pathological response (pCR) as per local assessment according to the IASLC recommendations. conditions: Non Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 290 type: ESTIMATED name: Adjuvant durvalumab measure: Disease-free survival (DFS) measure: Response rate as per investigator assessment. measure: Proportion of patients undergoing surgery measure: Proportion of patients with surgical outcome R0 and R1 measure: pCR rate measure: Proportion of patients eligible for randomisation measure: Proportion of patients effectively randomised measure: Toxicity according to CTCAE v5.0 measure: DFS in patients with pCR measure: Overall survival (OS) in patients with/without pCR measure: DFS in patients with/without ctDNA clearance measure: Time to recurrence (TTR) in patients with/without pCR measure: Time to treatment discontinuation (TTD) in patients with/without pCR measure: Toxicity according to CTCAE v5.0 measure: Correlation between ctDNA clearance and pathological response measure: Correlation between ctDNA clearance and DFS measure: Correlation between ctDNA clearance and OS measure: Correlation between ctDNA clearance and initial PD-L1 assessment measure: Outcome (OS) measure: Outcome (event-free survival) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06284304 id: N22DES briefTitle: A Pilot Study of Dose dE-eScalaTion IN prostATe radIOtherapy usiNg the MRL acronym: DESTINATION overallStatus: RECRUITING date: 2024-02-29 date: 2025-04-01 date: 2027-04-01 date: 2024-02-28 date: 2024-03-05 name: The Netherlands Cancer Institute class: OTHER briefSummary: Trial design: A single centre phase II non-randomised study
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Trial population: Men with intermediate risk localised prostate cancer
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Recruitment target: 20 patients in total
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Trial objectives:
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* Primary To develop a 5 fraction de-escalated dose SBRT protocol capable of reducing side effects
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* Secondary
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* To assess levels of acute GU and GI toxicity (CTCAE)
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* To assess levels of late GU and GI toxicity (CTCAE)
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* To assess late sexual quality of life (expanded EPIC, IIEF-5)
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* To assess biochemical relapse-free survival at 2 years
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Trial treatment: All radiotherapy will be delivered on the MR-linac. Intraprostatic dose will be varied according to risk of local recurrence, based on mpMRI, PSA and histology. The whole prostate will receive 30 Gy in 5 fractions and the GTV plus intra-prostatic margin will receive an isotoxic 45 Gy prescription. conditions: Prostate Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 20 type: ESTIMATED name: De-escalated radiotherapy measure: Technical feasibility of treating prostate cancer with toxicity minimising radiotherapy on a MR-linac measure: Acute GU toxicity measure: Acute GI toxicity measure: Late GU toxicity measure: Late GI toxicity measure: PROMs measure: Biochemical free survival sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Netherlands Cancer Institute status: RECRUITING city: Amsterdam zip: 1066CX country: Netherlands name: Floris Pos, MD PhD role: CONTACT phone: +31 20 512 9111 email: f.pos@nki.nl lat: 52.37403 lon: 4.88969 hasResults: False
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<|newrecord|> nctId: NCT06284291 id: TMSpath id: RF-2021-12372804 type: OTHER_GRANT domain: Italian Ministry of Health briefTitle: Transcranial Magnetic Stimulation (TMS) in Genetic Epilepsies overallStatus: RECRUITING date: 2023-11-22 date: 2025-11-30 date: 2026-03-01 date: 2024-02-28 date: 2024-02-28 name: Meyer Children's Hospital IRCCS class: OTHER briefSummary: Transcranial magnetic stimulation (TMS) uses electromagnetic induction as an efficient, painless, non-invasive method to generate a suprathreshold current at the level of the encephalon, and provide in vivo measurements of cortical excitability and reactivity at the level of the motor cortex (TMS-EMG) or the entire cortical mantle (TMS-EEG). This study proposes TMS measurements as a diagnostic tool in patients to understand mechanisms of epileptogenesis related to genetic mutations, and prognostic to guide and monitor precision treatments. conditions: Epilepsy conditions: Genetic Disease studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 150 type: ESTIMATED name: transcranial magnetic stimulation (TMS) measure: Resting motor threshold measure: SICI measure: ICF measure: LICI measure: TEP amplitude measure: TEP latency sex: ALL minimumAge: 3 Years maximumAge: 70 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Meyer Children's Hospital IRCCS status: RECRUITING city: Firenze country: Italy name: Simona Balestrini, MD role: CONTACT email: simona.balestrini@meyer.it lat: 43.77925 lon: 11.24626 hasResults: False
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<|newrecord|> nctId: NCT06284278 id: NCKU_PPGP_diaphragm briefTitle: Telehealth: Diaphragmatic vs. Pelvic Exercise in Postpartum Pregnancy-related Pelvic Girdle Pain overallStatus: RECRUITING date: 2023-10-20 date: 2024-05-31 date: 2024-07-31 date: 2024-02-28 date: 2024-02-28 name: YI-JU TSAI class: OTHER briefSummary: The goal of this interventional study is to compare investigate the short-term and long-term effects of 8-week real-time telehealth-based diaphragmatic breathing exercise and pelvic stabilization exercise on pain, disability, and quality of life in postpartum women with pregnancy-related pelvic girdle pain. conditions: Postpartum conditions: Pregnancy Related conditions: Pelvic Girdle Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: PARTICIPANT count: 60 type: ESTIMATED name: Diaphragmatic breathing retraining name: Pelvic stabilization exercise name: pelvic anatomy education measure: Muscle function measures of lumbopelvic muscles measure: Diaphragm thickness measure: Diaphragm mobility measure: Diaphragm strength measure: Mechanical Property of Thoracolumbar Fascia measure: Functional performance of ASLR fatigue task measure: Functional performance of timed up and go test measure: Functional performance of 6m timed walk test measure: pain intensity measure of Numeric Rating Scale (NRS) measure: Disability Level: measure of pelvic girdle questionnaire(PGQ) measure: Health-related Quality of Life: Short Form-36 (SF36) measure: Fear Avoidance Belief: Tampa Scale of Kinesiophobia measure: Self-Efficacy: Pain Self-efficacy Questionnaire measure: Parenting Stress Level: Parenting Stress Index-Short Form (PSI-SF) measure: Self-perceived Change: Global Rating of Change Scale (GROC) sex: FEMALE minimumAge: 20 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cheng Kung University status: RECRUITING city: Tainan zip: 701 country: Taiwan name: Tsai Yi-Ju role: CONTACT phone: 06-2353535 phoneExt: 5930 email: lulilutsai@gmail.com lat: 22.99083 lon: 120.21333 hasResults: False
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<|newrecord|> nctId: NCT06284265 id: MMH-407-007 briefTitle: Clinical Trial of the Efficacy and Safety of Raphamin in Prevention of Recurrences of Chronic Bacterial Cystitis overallStatus: RECRUITING date: 2023-10-16 date: 2026-12-31 date: 2026-12-31 date: 2024-02-28 date: 2024-04-19 name: Materia Medica Holding class: INDUSTRY briefSummary: Clinical Trial of the Efficacy and Safety of Raphamin in Prevention of Recurrences of Chronic Bacterial Cystitis conditions: Cystitis Chronic conditions: Cystitis Bacterial conditions: Recurrence of Chronic Bacterial Cystitis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 632 type: ESTIMATED name: Raphamin name: Placebo measure: Time to the first recurrence of chronic bacterial cystitis measure: Percentage of patients with a reduction of recurrences of chronic bacterial cystitis measure: Average duration of episodes of recurrences of chronic bacterial cystitis measure: Average number of recurrences of chronic bacterial cystitis measure: Severity of chronic bacterial cystitis recurrences measure: Change in the severity of chronic bacterial cystitis recurrences measure: VAS score at the end of the follow-up period measure: The Presence of Adverse Events (AEs). measure: Changes in Vital Signs (Blood Pressure measured in mm Hg) measure: Changes in Vital Signs (Pulse Rate (Heart Rate) measured in beats per minute) measure: Changes in Vital Signs (Respiration Rate (Breathing Rate) measured in breaths per minute) measure: Proportion of patients with clinically significant laboratory abnormalities sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Scientific Center for Family Health and Human Reproduction Problems/Reproductive Health Department status: RECRUITING city: Irkutsk zip: 664003 country: Russian Federation name: Larisa Suturina, Prof. role: CONTACT name: Larisa Suturina, Prof. role: PRINCIPAL_INVESTIGATOR lat: 52.29778 lon: 104.29639 facility: Kazan State Medical University/Professor's clinic status: NOT_YET_RECRUITING city: Kazan zip: 420012 country: Russian Federation name: Ruslan Fatykhov, MD, PhD role: CONTACT name: Ruslan Fatykhov, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 55.78874 lon: 49.12214 facility: LLC "Fenareta" Women's and Men's Health Clinic" status: RECRUITING city: Kemerovo zip: 650000 country: Russian Federation name: Natalia Artymuk, Prof. role: CONTACT name: Natalia Artymuk, Prof. role: PRINCIPAL_INVESTIGATOR lat: 55.33333 lon: 86.08333 facility: City Clinical Hospital #15 named after O.M. Filatov Department of Health of Moscow status: RECRUITING city: Moscow zip: 111539 country: Russian Federation name: Vladimir Kuzmin, Prof. role: CONTACT name: Vladimir Kuzmin, Prof. role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: City Clinical Hospital # 13/Gynecology Department # 1 status: RECRUITING city: Moscow zip: 115280 country: Russian Federation name: Felix Grigoryan, PhD role: CONTACT name: Felix Grigoryan, PhD role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: Clinical Hospital # 85 of the Federal Medical and Biological Agency/Central polyclinic status: RECRUITING city: Moscow zip: 115409 country: Russian Federation name: Sergey Levakov, Prof. role: CONTACT name: Sergey Levakov, Prof. role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: Research Institute of Rheumatology named after V.A. Nasonova status: RECRUITING city: Moscow zip: 115522 country: Russian Federation name: Victoria Gelashvili, MD role: CONTACT name: Victoria Gelashvili, MD role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: National Medical Research Center for Obstetrics, Gynecology and Perinatology named after V.I. Kulakov/Department of Aesthetic Gynecology and Rehabilitation status: RECRUITING city: Moscow zip: 117198 country: Russian Federation name: Inna Apolikhina, Prof. role: CONTACT name: Inna Apolikhina, Prof. role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: Peoples' Friendship University of Russia/Department of Obstetrics and Gynecology with a course in perinatology status: WITHDRAWN city: Moscow zip: 117198 country: Russian Federation lat: 55.75222 lon: 37.61556 facility: Russian National Research Medical University named after N.I. Pirogov/Department of Obstetrics and Gynecology, Faculty of Medicine status: RECRUITING city: Moscow zip: 117997 country: Russian Federation name: Yulia Dobrokhotova, Prof. role: CONTACT name: Yulia Dobrokhotova, Prof. role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: City Clinical Hospital # 1 named after. N.I. Pirogov of the Moscow City Health Department status: RECRUITING city: Moscow zip: 119049 country: Russian Federation name: Sergey Kotov, PhD, MD role: CONTACT name: Sergey Kotov, PhD, MD role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: United hospital with clinic of the Administration of the President of the Russian Federation status: NOT_YET_RECRUITING city: Moscow zip: 119285 country: Russian Federation name: Nikolay Keshishev, MD, PhD role: CONTACT name: Nikolay Keshishev, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: City Clinical Hospital # 67 named after L.A. Vorokhobov status: NOT_YET_RECRUITING city: Moscow zip: 121423 country: Russian Federation name: Olga Perevozkina, MD, PhD role: CONTACT name: Olga Perevozkina, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: JSC "MEDSI Group of Companies" status: WITHDRAWN city: Moscow zip: 123056 country: Russian Federation lat: 55.75222 lon: 37.61556 facility: Moscow State Medical and Dental University named after A.I. Evdokimov/Department of Urologya status: RECRUITING city: Moscow zip: 127473 country: Russian Federation name: Dmitry Pushkar, Prof. role: CONTACT name: Dmitry Pushkar, Prof. role: PRINCIPAL_INVESTIGATOR lat: 55.75222 lon: 37.61556 facility: Privolzhsky District Medical Center status: RECRUITING city: Nizhny Novgorod zip: 603001 country: Russian Federation name: Vagif Atduev, Prof. role: CONTACT name: Vagif Atduev Vagif, Prof. role: PRINCIPAL_INVESTIGATOR lat: 56.32867 lon: 44.00205 facility: National Medical Research Center for Radiology/Research Institute of Urology and Interventional Radiology named after. N.A. Lopatkin status: NOT_YET_RECRUITING city: Obninsk zip: 105425 country: Russian Federation name: Tatyana Perepanova, Prof. role: CONTACT name: Tatyana Perepanova, Prof. role: PRINCIPAL_INVESTIGATOR lat: 55.09681 lon: 36.61006 facility: City Clinical Hospital status: NOT_YET_RECRUITING city: Pyatigorsk zip: 357500 country: Russian Federation name: Alexander Bardin, MD role: CONTACT name: Alexander Bardin, MD role: PRINCIPAL_INVESTIGATOR lat: 44.04861 lon: 43.05944 facility: Clinical and Diagnostic Center "Health" in Rostov-on-Don status: RECRUITING city: Rostov-on-Don zip: 344011 country: Russian Federation name: Igor Aboyan, Prof. role: CONTACT name: Igor Aboyan, Prof. role: PRINCIPAL_INVESTIGATOR lat: 47.23135 lon: 39.72328 facility: Rostov State Medical University/Department of Urology and Human Reproductive Health with a course of pediatric urology-andrology status: RECRUITING city: Rostov-on-Don zip: 344022 country: Russian Federation name: Mikhail Kogan, Prof. role: CONTACT name: Mikhail Kogan, Prof. role: PRINCIPAL_INVESTIGATOR lat: 47.23135 lon: 39.72328 facility: Rostov Central District Hospital status: NOT_YET_RECRUITING city: Rostov zip: 152155 country: Russian Federation name: Ariz Gyulmamedov, MD role: CONTACT name: Ariz Gyulmamedov, MD role: PRINCIPAL_INVESTIGATOR lat: 57.1914 lon: 39.41394 facility: JSC "Polyclinic Complex" status: WITHDRAWN city: Saint Petersburg zip: 190013 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: LLC "Medical Center Capital-Polis" status: NOT_YET_RECRUITING city: Saint Petersburg zip: 190013 country: Russian Federation name: Dmitry Gorelov, MD role: CONTACT name: Dmitry Gorelov, MD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: LLC "BioTechService" status: RECRUITING city: Saint Petersburg zip: 190121 country: Russian Federation name: Alexander Parshin, PhD role: CONTACT name: Alexander Parshin, PhD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: City clinic # 44 status: NOT_YET_RECRUITING city: Saint Petersburg zip: 192071 country: Russian Federation name: Farzali Farzaliev, MD role: CONTACT name: Farzali Farzaliev, MD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: All-Russian Center for Emergency and Radiation Medicine named after A.M. Nikiforov/Urology department status: RECRUITING city: Saint Petersburg zip: 194044 country: Russian Federation name: Vladislav Grigoriev, PhD role: CONTACT name: Vladislav Grigoriev, PhD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: St. Luke's Clinical Hospital status: RECRUITING city: Saint Petersburg zip: 194044 country: Russian Federation name: Orlov Igor, PhD role: CONTACT name: Orlov Igor, PhD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: City Multidisciplinary Hospital # 2/Urology department status: WITHDRAWN city: Saint Petersburg zip: 194354 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Llc "Medical Clinic" status: RECRUITING city: Saint Petersburg zip: 194356 country: Russian Federation name: Maxim Bushara, MD role: CONTACT name: Maxim Bushara, MD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: Medical and sanitary unit No. 70 - branch of the St. Petersburg State Unitary Enterprise of Passenger Road Transport status: RECRUITING city: Saint Petersburg zip: 195197 country: Russian Federation name: Vadim Zubarev, PhD, MD role: CONTACT name: Vadim Zubarev, PhD, MD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: LLC "Research Center Eco-Safety" status: TERMINATED city: Saint Petersburg zip: 196143 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: Jsc "Northwestern Center of Evidence-Based Medicine" status: WITHDRAWN city: Saint Petersburg zip: 196158 country: Russian Federation lat: 59.93863 lon: 30.31413 facility: City Hospital # 15 status: NOT_YET_RECRUITING city: Saint Petersburg zip: 198205 country: Russian Federation name: Konstantin Dunets, MD role: CONTACT name: Konstantin Dunets, MD role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: Research Institute of Obstetrics, Gynecology and Reproductology named after D.O. Ott/Department of Gynecology and Endocrinology status: RECRUITING city: Saint Petersburg zip: 199034 country: Russian Federation name: Maria Yarmolinskaya, Prof. role: CONTACT name: Maria Yarmolinskaya, Prof. role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: City Pokrovskaya Hospital/Department of Urology status: RECRUITING city: Saint Petersburg zip: 199106 country: Russian Federation name: Andrey Gorelov, Prof. role: CONTACT name: Andrey Gorelov, Prof. role: PRINCIPAL_INVESTIGATOR lat: 59.93863 lon: 30.31413 facility: Sertolovo City Hospital status: NOT_YET_RECRUITING city: Sertolovo zip: 188650 country: Russian Federation name: Alexander Shvets, MD role: CONTACT name: Alexander Shvets, MD role: PRINCIPAL_INVESTIGATOR lat: 60.1444 lon: 30.20165 facility: Siberian State Medical University/Faculty clinics of Siberian State Medical University status: NOT_YET_RECRUITING city: Tomsk zip: 634050 country: Russian Federation name: Victor Latypov, MD, PhD role: CONTACT name: Victor Latypov, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 56.49771 lon: 84.97437 facility: Bashkir State Medical University/Department of Obstetrics and Gynecology # 1 status: WITHDRAWN city: Ufa zip: 450008 country: Russian Federation lat: 54.74306 lon: 55.96779 facility: Voronezh State Medical University named after N.N. Burdenko/Department of Urology status: RECRUITING city: Voronezh zip: 394036 country: Russian Federation name: Andrey Kuzmenko, Prof. role: CONTACT name: Andrey Kuzmenko, Prof. role: PRINCIPAL_INVESTIGATOR lat: 51.67204 lon: 39.1843 facility: Vsevolozhsk Clinical Interdistrict Hospital/Center for Outpatient Surgery status: RECRUITING city: Vsevolozhsk zip: 188643 country: Russian Federation name: Nikolay Kanareikin, MD role: CONTACT name: Nikolay Kanareikin, MD role: PRINCIPAL_INVESTIGATOR lat: 60.01512 lon: 30.67314 facility: Yaroslavl State Medical University/Department of Urology and Nephrology status: NOT_YET_RECRUITING city: Yaroslavl zip: 150000 country: Russian Federation name: Igor Shormanov, Prof. role: CONTACT name: Igor Shormanov, Prof. role: PRINCIPAL_INVESTIGATOR lat: 57.62987 lon: 39.87368 facility: LLC "Clinic of Modern Medicine Dr. Bogorodskaya" status: NOT_YET_RECRUITING city: Yaroslavl zip: 150001 country: Russian Federation name: Andrey Soloviev, MD, PhD role: CONTACT name: Andrey Soloviev, MD, PhD role: PRINCIPAL_INVESTIGATOR lat: 57.62987 lon: 39.87368 facility: LLC "Medical Center for Diagnosis and Prevention Plus" status: RECRUITING city: Yaroslavl zip: 150040 country: Russian Federation name: Svetlana Isakova, MD role: CONTACT name: Svetlana Isakova, MD role: PRINCIPAL_INVESTIGATOR lat: 57.62987 lon: 39.87368 facility: Regional Clinical Hospital/Urology department status: RECRUITING city: Yaroslavl zip: 150062 country: Russian Federation name: Dmitry Komlev, PhD role: CONTACT name: Dmitry Komlev, PhD role: PRINCIPAL_INVESTIGATOR lat: 57.62987 lon: 39.87368 hasResults: False
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<|newrecord|> nctId: NCT06284252 id: TÜBİTAK-323S135 briefTitle: Virtual Game Simulation on Nursing Students' Physical Examination Skills overallStatus: NOT_YET_RECRUITING date: 2024-09-15 date: 2025-01-15 date: 2025-02-15 date: 2024-02-28 date: 2024-02-28 name: Necmettin Erbakan University class: OTHER name: TÜBİTAK briefSummary: The project is unique in that it will use virtual game simulation, a new learning method, and it will address the physical examination skills of nursing students, an area that has not been researched before. In the project, a randomized controlled research design with a pretest-posttest control group will be used. The population will consist of 200 second-year students enrolled in the Physical Examination in Nursing course at Necmettin Erbakan University, Faculty of Nursing, Department of Nursing, in the 2024-2025 Fall Semester. 120 students from the population who meet the research inclusion criteria will be randomly assigned to control (n=60) and experimental (n=60) groups according to their general academic success score. In collecting data; Introductory characteristics form, skill checklist for physical examination of the heart, skill checklist for physical examination of the abdomen, skill checklist for physical examination of the respiratory system and an evaluation form for the effect of virtual game simulation on skill practice for physical examination will be used. In the project, three different virtual game simulations will be developed for physical examinations of the heart, abdomen and respiratory system. During the fall semester, theoretical and laboratory demonstration applications will be carried out by the project team. A pre-test will be administered to all students, and then virtual game simulations will be made available to students in the experimental group for three weeks. Then, the virtual games will be closed to the students and a post-test will be administered to the experimental and control group students. After the final test application, virtual game simulations will be made available to students in the control group. In pre- and post-test applications, students will practice physical examination skills on simulated patients at three different stations (heart, abdomen and respiratory system) and will be evaluated by the project team according to skill checklists. After the skill evaluations, the students in the experimental group will be given a form to evaluate the effect of the virtual game simulation for physical examination on skill practice and will be asked to fill it out. conditions: Simulation of Physical Illness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Control group and intervention group primaryPurpose: OTHER masking: TRIPLE maskingDescription: Participant blinding: In order to ensure participant blinding, all students will register to the site where virtual game simulations will be hosted.
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Statistics blinding: In order to blind the statistics expert, at the end of data collection, the website expert will share the collected data with the statistics expert as group A and B data. The statistician will perform statistical analyzes without knowing which group is the control and which group is the experiment.
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Researcher blinding: In order to ensure researcher blinding, the expert who designed the web page for virtual game simulations selected the students who registered on the website, using the "A" and "B" codes, according to the list he received from the statistics expert, on the website with a random group as control and one group as experiment. will assign it to the site. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 120 type: ESTIMATED name: Virtual Gaming Simulation measure: Skill assessment for physical examination of the abdomen (Pretest) measure: Skill assessment for physical examination of the heart(Pretest) measure: Evaluation of physical examination skills of the respiratory system(Pretest) measure: Skill assessment for physical examination of the abdomen (Posttest) measure: Skill assessment for physical examination of the heart(Posttest) measure: Evaluation of physical examination skills of the respiratory system(Posttest) sex: ALL minimumAge: 19 Years maximumAge: 25 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06284239 id: Tell Me Game briefTitle: Using Games in Teaching Nursing History overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2024-05 date: 2024-06 date: 2024-02-28 date: 2024-03-21 name: Necmettin Erbakan University class: OTHER briefSummary: Innovative learning methods can be used in teaching nursing history. One of the most preferred among these methods is learning through games. It is known that today's Generation Z students prefer active learning methods and want to learn by having fun instead of learning by rote. It is reported that learning through games improves students' knowledge and skills and increases retention. One of the methods of learning through games is the "tell me" game. The "Tell Me" game involves the narrator explaining the words prepared specifically for the subject to a group of students without using prohibited words. Other students in the group try to know the word explained. Thus, both the student narrator and the student trying to know actively use their critical thinking and decision-making skills. This research aims to determine the effect of the tell-all game used in teaching nursing history on students' learning and opinions. conditions: Education Nursing studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: It refers to the intervention group in which the "Tell Me" game will be played. primaryPurpose: OTHER masking: DOUBLE maskingDescription: Participants will be informed about the research. However, participants will not know which group they belong to. At the same time, the statistical analysis of the research will be carried out by an independent statistician. Thus, blinding of both the participant and the outcome assessor will be ensured. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 66 type: ESTIMATED name: Tell me about the game. measure: Nursing History Knowledge Test measure: Nursing History Teaching Evaluation Form sex: ALL minimumAge: 20 Years maximumAge: 24 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06284226 id: CCT-ANK-11 briefTitle: An Exploratory Clinical Study to Evaluate the Safety and Efficacy of NK Cells (Combined With Standard Therapy) in the Treatment of Solid Tumor Patients acronym: CCT-ANK-11 overallStatus: WITHDRAWN date: 2022-03-25 date: 2025-06-30 date: 2025-12-31 date: 2024-02-28 date: 2024-04-16 name: Beijing Kejing Biotechnology Co., Ltd. class: INDUSTRY briefSummary: An exploratory clinical study to evaluate the safety and efficacy of NK cells (combined with standard therapy) in the treatment of solid tumor patients conditions: Solid Tumors (Pancreatic Cancer, Esophageal Cancer, Gastric Cancer, Cholangiocarcinoma, Lung Cancer and Ovarian Cancer) studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 0 type: ACTUAL name: Allogeneic NK(CCT-ANK-11) measure: To evaluate the safety and the efficacy sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06284213 id: 5U24NS100591 type: NIH link: https://reporter.nih.gov/quickSearch/5U24NS100591 briefTitle: Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia Consortium acronym: MarkVCID overallStatus: RECRUITING date: 2021-09-29 date: 2027-07 date: 2027-07 date: 2024-02-28 date: 2024-02-28 name: Massachusetts General Hospital class: OTHER name: Duke University name: Johns Hopkins University name: University of New Mexico name: University of Southern California name: University of Kentucky name: Rush University Medical Center name: University of Maryland, Baltimore name: University of California, San Francisco name: University of California, Los Angeles name: University of California, Davis name: University of Texas name: The University of Texas Health Science Center at San Antonio name: The University of Texas Health Science Center, Houston name: Mayo Clinic name: University of Mississippi Medical Center name: Washington University School of Medicine name: Olive View-UCLA Education & Research Institute briefSummary: Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia (MarkVCID) is an NIH-funded consortium dedicated to finding biomarkers involved in age-related thinking and memory problems. Alzheimer's disease and other dementias leave signatures on brain scans or in the blood called biomarkers. The MarkVCID study will measure a panel of candidate biomarkers in 1800 participants and watch them closely to see what they tell us about changes in brain function and risk of memory loss.
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Age-related problems in thinking and memory represent some of the greatest risks to public health in the US and globally. Diseases that affect small blood vessels in the brain have been shown to be major contributors to these changes. However, research and patient care can be held back by limited biomarkers that identify who should be treated.
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The MarkVCID Consortium includes 17 US medical centers, a Coordinating Center, an External Advisory Committee, and NIH leadership. Data and biospecimens collected as part of this research study will be stored in a research database and biorepositories, so that researchers can use this information to study brain function. conditions: Cognitive Impairment conditions: Dementia studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 1800 type: ESTIMATED name: No interventions measure: SVD progression as measured by decline in global cognition measure: SVD progression as measured by decline in executive function sex: ALL minimumAge: 60 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Southern California status: RECRUITING city: Los Angeles state: California zip: 90033 country: United States name: Danny JJ Wang, PhD, MSCE role: CONTACT phone: 323-442-7246 email: JJ.Wang@loni.usc.edu lat: 34.05223 lon: -118.24368 facility: University of California Los Angeles status: RECRUITING city: Los Angeles state: California zip: 90095 country: United States name: Jason Hinman, MD, PhD role: CONTACT phone: 310-794-1195 email: JHinman@mednet.ucla.edu lat: 34.05223 lon: -118.24368 facility: University of California Davis status: RECRUITING city: Sacramento state: California zip: 95817 country: United States name: Pauline Maillard, PhD role: CONTACT phone: 916-734-3588 email: pmaillard@ucdavis.edu lat: 38.58157 lon: -121.4944 facility: University of California San Francisco status: RECRUITING city: San Francisco state: California zip: 94158 country: United States name: Joel Kramer, PsyD role: CONTACT phone: 415-476-5572 email: Joel.Kramer@ucsf.edu lat: 37.77493 lon: -122.41942 facility: Olive View - UCLA Medical Center status: RECRUITING city: Sylmar state: California zip: 91342 country: United States name: Keith Vossel, MD role: CONTACT phone: 310-794-1195 email: KVossel@mednet.ucla.edu lat: 34.30778 lon: -118.44925 facility: Mayo Clinic Florida status: RECRUITING city: Jacksonville state: Florida zip: 32224 country: United States name: Gregory Day role: CONTACT phone: 904-953-0856 email: Day.Gregory@mayo.edu lat: 30.33218 lon: -81.65565 facility: Rush University Medical Center & Illinois Institute of Technology status: RECRUITING city: Chicago state: Illinois zip: 60612 country: United States name: Konstantinos Arfanakis, PhD role: CONTACT phone: 312-567-3864 email: Konstantinos_Arfanakis@rush.edu lat: 41.85003 lon: -87.65005 facility: University of Kentucky status: RECRUITING city: Lexington state: Kentucky zip: 40536 country: United States name: Gregory Jicha, MD, PhD role: CONTACT phone: 859-257-1000 email: gregory.jicha@uky.edu lat: 37.98869 lon: -84.47772 facility: University of Maryland, Baltimore status: RECRUITING city: Baltimore state: Maryland zip: 21201 country: United States name: Peiying Liu, PhD role: CONTACT phone: 410-706-2441 email: PeiyingLiu@som.umaryland.edu lat: 39.29038 lon: -76.61219 facility: Johns Hopkins University status: RECRUITING city: Baltimore state: Maryland zip: 21287 country: United States name: Hanzhang Lu, PhD role: CONTACT phone: 410-955-1431 email: hlu3@jhmi.edu lat: 39.29038 lon: -76.61219 facility: Mayo Clinic Rochester status: RECRUITING city: Rochester state: Minnesota zip: 55901 country: United States name: Ronald Petersen, MD, PhD role: CONTACT phone: 507-284-1588 email: peter8@mayo.edu lat: 44.02163 lon: -92.4699 facility: University of Mississippi Medical Center status: RECRUITING city: Jackson state: Mississippi zip: 39216 country: United States name: Gwen Windham, MD role: CONTACT phone: 601-984-5610 email: gwindham@umc.edu lat: 32.29876 lon: -90.18481 facility: Washington University in St. Louis status: RECRUITING city: Saint Louis state: Missouri zip: 63110 country: United States name: Jin-Moo Lee, MD, PhD role: CONTACT phone: 314-362-7382 email: leejm@wustl.edu lat: 38.62727 lon: -90.19789 facility: University of New Mexico status: RECRUITING city: Albuquerque state: New Mexico zip: 87131 country: United States name: Gary Rosenberg, MD role: CONTACT phone: 505-272-3315 email: GRosenberg@salud.unm.edu lat: 35.08449 lon: -106.65114 facility: University of Texas Southwestern status: RECRUITING city: Dallas state: Texas zip: 75390 country: United States name: Rong Zhang, PhD role: CONTACT phone: 214-345-4619 email: RongZhang@texashealth.org lat: 32.78306 lon: -96.80667 facility: University of Texas Health Science Center Houston status: RECRUITING city: Houston state: Texas zip: 77030 country: United States name: Sean Savitz, MD role: CONTACT phone: 713-500-7083 email: Sean.I.Savitz@uth.tmc.edu lat: 29.76328 lon: -95.36327 facility: University of Texas Health Science Center San Antonio status: RECRUITING city: San Antonio state: Texas zip: 78229 country: United States name: Claudia Satizabal, PhD role: CONTACT phone: 210-450-8417 email: satizabal@uthscsa.edu lat: 29.42412 lon: -98.49363 hasResults: False
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<|newrecord|> nctId: NCT06284200 id: sarcopenia eRA briefTitle: Presence and Comparison of Sarcopenia in Early Rheumatoid Arthritis and Rheumatoid Arthritis overallStatus: RECRUITING date: 2023-06-23 date: 2024-03-23 date: 2024-06-23 date: 2024-02-28 date: 2024-02-28 name: Kayseri City Hospital class: OTHER_GOV briefSummary: introduction: In this study, the presence of sarcopenia in cases with early rheumatoid arthritis and established rheumatoid arthritis will be compared.
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Materials and Method: According to the power analysis, 24 patients with early rheumatoid arthritis and 24 patients with established rheumatoid arthritis who meet the 2010 American College of Rheumatology (ACR) / European Alliance of Associations for Rheumatology (EULAR) rheumatoid arthritis (RA) classification criteria will be included in the study. conditions: Sarcopenia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 48 type: ESTIMATED measure: Evaluation of Muscle Mass measure: Evaluation of Muscle Strength measure: Evaluation of Muscle Performance measure: Rheumatoid Arthritis Quality of Life Scale measure: Health Assessment Questionnaire (HAQ) measure: Hospital Anxiety and Depression Scale (HADS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Health Sciences University, Kayseri Medicine Faculty status: RECRUITING city: Kocasinan state: Kayseri zip: 38125 country: Turkey name: MEHMET KÖKSAL, M.D. role: CONTACT phone: +905514043114 email: dr.mhmtkksl@gmail.com hasResults: False
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<|newrecord|> nctId: NCT06284187 id: KhonKaenH briefTitle: Diagnosis Test of Real-time Polymerase Chain Reaction (RT-PCR) for Pulmonary Tuberculosis overallStatus: COMPLETED date: 2023-01-01 date: 2023-10-31 date: 2023-12-31 date: 2024-02-28 date: 2024-02-28 name: Khon Kaen Hospital class: OTHER_GOV briefSummary: BACKGROUND: Pulmonary tuberculosis remains the leading cause of morbidity and mortality in Thailand. The microbiological detection of TB is important because of early and correct diagnosis, drug resistance testing and ensures that the effective treatment can be achieved and in a timely manner. Mycobacterial culture is the gold standard diagnostic test. Currently, a real-time polymerase chain reaction (RT-PCR) assay, such as Allplex™ MTB/MDRe Detection, Seegene is commonly used.
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OBJECTIVE: To evaluate the diagnosis value of the real-time multiplex PCR by using Allplex™ MTB/MDRe Detection kit to detect MTB from sputum specimens with a gold standard TB culture. conditions: Tuberculosis conditions: Pulmonary studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: RETROSPECTIVE count: 120 type: ACTUAL measure: Number of participants with pulmonary TB by Allplex™ MTB/MDRe sex: ALL minimumAge: 15 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Thananit Sangkomkamhang city: Khon Kaen zip: 40000 country: Thailand lat: 16.44671 lon: 102.833 hasResults: False
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<|newrecord|> nctId: NCT06284174 id: B-BR-109-054-T briefTitle: Effectiveness of Povidone-Iodine Versus Chlorhexidine Gluconate Solutions in Reducing Microbial Contamination in Spinal Surgery Wounds During Intraoperative Soaking. overallStatus: RECRUITING date: 2021-01-01 date: 2024-12-31 date: 2024-12-31 date: 2024-02-28 date: 2024-02-28 name: National Cheng-Kung University Hospital class: OTHER briefSummary: This study aims to assess the efficacy of intraoperative wound irrigation with iodine-containing and chlorhexidine-containing solutions in reducing bacterial colonization during spine surgery, and to determine which solution is more effective. Additionally, we aim to evaluate any side effects associated with the use of these two antiseptic solutions for wound irrigation. conditions: Spine Infection studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This research will include patients diagnosed with lumbar spinal stenosis causing nerve compression, who are scheduled for open spinal decompression and fusion surgery. Patients will be randomly assigned to one of three groups: a control group (soaked with 0.9% normal saline), an iodine group (soaked with 3.5% povidone-iodine solution), and a CHG group (soaked with 0.05% chlorhexidine gluconate). All groups will receive the same surgical pre-care, preoperative disinfection, and prophylactic antibiotics. Before wound closure, each group will undergo different irrigation solutions for soaking the wound for three minutes followed by rinsing with copious saline. Samples from deep and superficial tissues and implants will be taken for bacterial culture and molecular biochip analysis. primaryPurpose: PREVENTION masking: DOUBLE maskingDescription: Patients will be randomly assigned by computer to one of three groups: a control group (soaked with 0.9% normal saline), an iodine group (soaked with 3.5% povidone-iodine solution), and a CHG group (soaked with 0.05% chlorhexidine gluconate). All groups will receive the same surgical pre-care, preoperative disinfection, and prophylactic antibiotics.
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All patients understood the experimental process and signed the consent form. The patients did not know the group they were assigned to during the whole process. The bacterial culturers, examiners and clinical outcome assessors did not know the patient group. whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 105 type: ESTIMATED name: Povidone-iodine solution; chlorhexidine gluconate measure: Bacteria culture and Polymerase chain reaction exam measure: Post operative infection sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cheng Kung University Hospital status: RECRUITING city: Tainan zip: 704 country: Taiwan name: Wei-Ren Su, M.D., M.Sc. role: CONTACT phone: 886-6-2766689 email: suwr@ms28.hinet.net lat: 22.99083 lon: 120.21333 hasResults: False
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<|newrecord|> nctId: NCT06284161 id: RBHP 2020 GUY id: 2020-A02765-34 type: OTHER domain: ANSM briefTitle: QCT in ALS Diagnosis, Mechanistic Understanding and Follow-up acronym: PEM-SLA overallStatus: RECRUITING date: 2022-06-28 date: 2025-06-28 date: 2026-02-28 date: 2024-02-28 date: 2024-02-28 name: University Hospital, Clermont-Ferrand class: OTHER briefSummary: Multidisciplinary management of amyotrophic lateral sclerosis (ALS) can significantly increase survival but also improve the quality of life of patients. The evaluation of cortical-spinal motor neuron damage is currently based only on the assessment of clinical data. However, the alteration of the central motor pathway and conduction can be identified and quantified by different techniques using motor-evoked potentials (MEP). The combined quadriceps test (QCT) has been developed to assess central and peripheral motor pathway conduction. This test allows to quantify central and peripheral part of a mixed disorder, and to detect physiological hyporeflexia or hyperreflexia which, in the case of suspected ALS, can lead to interpretation problems.
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The evolution of the QCT parameters during the course of pathology will lead to determine the preponderance of an initial central involvement, but also its extension throughout the pathology. The study of these parameters as well as the clinical course of the disease could reveal a correlation between peripheral and central involvement. This link would provide arguments in favor of pathophysiological hypotheses of disease onset and progression. From a prognostic point of view and depending on the quantification of central and peripheral involvement, the QCT would make it possible to characterize the different ALS phenotypes. This phenotypic characterization would help identify prognostic factors at diagnosis.
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The investigators propose a cohort study with the exploration of central motor neuron damage by QCT during the course of ALS in order to provide arguments for a better mechanistic understanding and follow-up of this disease with a poor prognosis. conditions: Amyotrophic Lateral Sclerosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 30 type: ESTIMATED name: Quadriceps Combined Test measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Parameters from the QCT (Quadriceps Combined Test) measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data measure: Clinical and paraclinical likely course data sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CHU de Clermont-Ferrand status: RECRUITING city: Clermont-Ferrand zip: 63000 country: France name: Lise Laclautre role: CONTACT phone: +33473754963 email: promo_interne_drci@chu-clermontferrand.fr name: Nathalie Guy role: PRINCIPAL_INVESTIGATOR lat: 45.77966 lon: 3.08628 hasResults: False
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<|newrecord|> nctId: NCT06284148 id: Pro00093964 id: 5R18HS025654-03 type: AHRQ link: https://reporter.nih.gov/quickSearch/5R18HS025654-03 briefTitle: Confidential IPV Screening Tool overallStatus: COMPLETED date: 2010-10-06 date: 2023-07-31 date: 2023-07-31 date: 2024-02-28 date: 2024-02-28 name: Medical University of South Carolina class: OTHER name: Agency for Healthcare Research and Quality (AHRQ) briefSummary: Intimate partner violence (IPV) against women in the US is a serious public health problem and a human rights issue. Our research team has developed confidential screening tools using exam-room computer for intimate partner violence to be used in primary care. conditions: Violence, Domestic studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: This is a stepped wedge cluster randomized trial which has 3 sequences starting intervention in randomized order. primaryPurpose: SCREENING masking: NONE count: 19655 type: ACTUAL name: Screening for intimate partner violence name: Assessment and referral measure: IPV positive (Yes/No) measure: Screening completed (Yes/No) measure: Severity of risk measure: Physician compliance with IPV management tools sex: ALL minimumAge: 18 Years maximumAge: 49 Years stdAges: ADULT facility: Biomedical Informatics Center city: Charleston state: South Carolina zip: 29403 country: United States lat: 32.77657 lon: -79.93092 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2023-12-01 uploadDate: 2024-02-20T12:06 filename: Prot_SAP_000.pdf size: 179261 hasResults: False
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<|newrecord|> nctId: NCT06284135 id: 2017-PS-03 id: PV6099 type: OTHER domain: Martini-Klinik briefTitle: MICHL-trial: Impact of Peritoneal Bladder Flap in RARP Patients on Lymphoceles overallStatus: COMPLETED date: 2017-06-19 date: 2019-10-16 date: 2021-05-31 date: 2024-02-28 date: 2024-02-28 name: Martini-Klinik am UKE GmbH class: OTHER briefSummary: A two-armed prospective randomised, controlled, single-centre trial on 1080 patients with prostate cancer who underwent robot-assisted radical prostatectomy with bilateral pelvic lymph node dissection was carried out. Patients in the intervention arm received fixation of the peritoneal flap of the bladder to the plexus Santorini at the end of surgery (Michl-technique, MT); in the control group, surgery was performed without this modification. The primary endpoint was the rate of lymphoceles requiring intervention. conditions: Lymphocele After Surgical Procedure studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 1080 type: ACTUAL name: Michl-stitch measure: rate of lymphoceles requiring intervention after RARP measure: total lymphocele rate after RARP measure: other complications ≥ grade IIIa according to Clavien-Dindo after RARP measure: continence rates after RARP sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Martini-Klinik am UKE GmbH city: Hamburg zip: 20246 country: Germany lat: 53.57532 lon: 10.01534 hasResults: False
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<|newrecord|> nctId: NCT06284122 id: MorningLyte briefTitle: Study of Mosunetuzumab Plus Lenalidomide Compared to Anti-CD20 Anti-body + Chemotherapy in Follicular Lymphoma FLIPI2-5 acronym: MorningLyte overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-11 date: 2034-04 date: 2024-02-28 date: 2024-03-15 name: The Lymphoma Academic Research Organisation class: OTHER name: Lymphoma Study Association name: Swiss Group for Clinical Cancer Research name: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea briefSummary: This study is a phase III, randomized, open-label, international, multicenter, interventional trial, designed to compare the efficacy and safety of mosunetuzumab in combination with lenalidomide versus anti-CD20 monoclonal antibody (mAb) plus chemotherapy in patients with previously untreated FLIPI 2-5 follicular lymphoma. conditions: Follicular Lymphoma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 790 type: ESTIMATED name: Mosunetuzumab name: Lenalidomide name: Rituximab name: Obinutuzumab name: Cyclophosphamide name: Doxorubicin name: Vincristin name: Prednisone name: Rituximab name: Obinutuzumab name: Bendamustin measure: Progression Free Survival (PFS) measure: Progression Free Survival (PFS) measure: Overall Response (OR) measure: Complete Metabolic Rate (CMR) measure: Overall Response (OR) measure: Complete Metabolic Rate (CMR) measure: Best Overall Response (CMR + PMR) rate measure: Best Overall Response (CMR + PMR) rate measure: Progression of disease within 2 years (POD24) measure: PFS measure: PFS measure: Event Free Survival (EFS) by Lugano 2014 measure: Event Free Survival (EFS) by Lugano 2014 measure: Time to Next Anti-Lymphoma Treatment (TTNLT) measure: Time to Next Anti-Lymphoma Treatment (TTNLT) measure: Duration of response measure: Duration of response measure: Overall Response (OR) measure: Complete Metabolic Rate (CMR) measure: Duration of complete response measure: Duration of complete response measure: Overall Survival (OS) measure: Overall Survival (OS) measure: Incidence and severity of Adverse Events (AE) including Serious and Special Interest AE (SAEs and AESIs) measure: Incidence and severity of AEs including SAEs and AESIs measure: Tolerability, as assessed by incidence of dose interruptions, delays, dose reductions, and study treatment discontinuation measure: Tolerability, as assessed by incidence of dose interruptions, delays, dose reductions, and study treatment discontinuation measure: Incidence of Second Primary Malignancies (SPM) measure: Incidence of Second Primary Malignancies (SPM) measure: anti-drug antibodies (ADA) to mosunetuzumab measure: Time to deterioration in physical functioning measure: Time to deterioration in lymphoma symptoms measure: Maximum serum concentration of mosunetuzumab - Cmax measure: Minimum serum concentration of mosunetuzumab - Cmin measure: Area under the curve of serum concentration of mosunetuzumab - AUC measure: Maximum serum concentration of lenalidomide - Cmax measure: Minimum serum concentration of lenalidomide - Cmin measure: Area under the curve of serum concentration of lenalidomide - AUC sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: AZ SINT-JAN BRUGGE - OOSTENDE AV - Service Hématologie city: Brugge zip: 8000 country: Belgium name: Sylvia SNAUWAERT, Pr role: CONTACT lat: 51.20892 lon: 3.22424 facility: INSTITUT JULES BORDET - Service Hématologie city: Bruxelles zip: 1070 country: Belgium name: Marie MAEREVOET, MD role: CONTACT lat: 50.85045 lon: 4.34878 facility: UNIVERSITE CATHOLIQUE DE LOUVAIN SAINT-LUC - Service Hématologie city: Bruxelles zip: 1200 country: Belgium name: Eric VAN DEN NESTE, Pr role: CONTACT lat: 50.85045 lon: 4.34878 facility: GRAND HOPITAL DE CHARLEROI - Service Hématologie city: Charleroi zip: 6000 country: Belgium name: Delphine PRANGER, MD role: CONTACT lat: 50.41136 lon: 4.44448 facility: UNIVERSITAIR ZIEKENHUIS GENT - Service Hématologie city: Gent zip: 9000 country: Belgium name: Ciel DE WRIENDT, MD role: CONTACT lat: 51.05 lon: 3.71667 facility: CHU DE LIEGE - Service Hématologie city: Liège zip: 4000 country: Belgium name: Christophe BONNET, Pr role: CONTACT lat: 50.63373 lon: 5.56749 facility: CHR VERVIERS - LA TOURELLE - Service Hématologie city: Verviers zip: 4800 country: Belgium name: Gaetan VANSTRAELEN, MD role: CONTACT lat: 50.58907 lon: 5.86241 facility: CHU UCL NAMUR - SITE GODINNE - Service Hématologie city: Yvoir zip: 5530 country: Belgium name: Gilles CROCHET, MD role: CONTACT lat: 50.3279 lon: 4.88059 facility: CH d'AVIGNON - HOPITAL HENRI DUFFAUT - Service d'Onco-Hématologie city: Avignon zip: 84000 country: France name: Hacène ZERAZHI, MD role: CONTACT lat: 43.94834 lon: 4.80892 facility: CH DE LA COTE BASQUE - Service Hématologie city: Bayonne zip: 64100 country: France name: Sophie BERNARD, MD role: CONTACT lat: 43.48333 lon: -1.48333 facility: CHU JEAN MINJOZ - Service Hématologie city: Besançon zip: 25030 country: France name: Adrien CHAUCHET, MD role: CONTACT lat: 47.24878 lon: 6.01815 facility: INSTITUT BERGONIE - Service d'Oncologie Médicale city: Bordeaux zip: 33076 country: France name: Fontanet BIJOU, MD role: CONTACT lat: 44.84044 lon: -0.5805 facility: CENTRE HOSPITALIER JEAN ROUGIER - Service d'Oncologie - Hématologie city: Cahors zip: 46005 country: France name: Martin GAUTHIER, MD role: CONTACT lat: 44.4491 lon: 1.43663 facility: CH METROPOLE SAVOIE - SITE CHAMBERY - Service Hématologie city: Chambéry zip: 73011 country: France name: Arthur DONY, MD role: CONTACT lat: 45.56667 lon: 5.93333 facility: CHU ESTAING - Service Thérapie Cellulaire et Hématologie Clinique city: Clermont-Ferrand zip: 63003 country: France name: Romain GUIEZE, Pr role: CONTACT lat: 45.77966 lon: 3.08628 facility: HOPITAL HENRI MONDOR - Unité Hémopathies Lymphoïdes city: Créteil zip: 94010 country: France name: François LEMONNIER, MD role: CONTACT lat: 48.78333 lon: 2.46667 facility: CHU DIJON BOURGOGNE - Service Hématologie Clinique city: Dijon zip: 21000 country: France name: Amandine DURAND, MD role: CONTACT lat: 47.31667 lon: 5.01667 facility: CHD DE VENDEE - Service Hématologie city: La Roche-sur-Yon zip: 85925 country: France name: Nadine MORINEAU, MD role: CONTACT lat: 46.66667 lon: -1.43333 facility: CHU DE GRENOBLE - Service Hématologie city: La Tronche zip: 38700 country: France name: Sylvain CARRAS, MD role: CONTACT lat: 45.20429 lon: 5.73645 facility: HOPITAL SAINT VINCENT-DE-PAUL - Service Hématologie city: Lille zip: 59020 country: France name: Sandy AMORIM, MD role: CONTACT lat: 50.63297 lon: 3.05858 facility: CHRU DE LILLE - HOPITAL CLAUDE HURIEZ - Service Hématologie city: Lille zip: 59037 country: France name: Franck MORSCHHAUSER, Pr role: CONTACT lat: 50.63297 lon: 3.05858 facility: CHU DE LIMOGES - HOPITAL DUPUYTREN - Service Hématologie Clinique et Thérapie Cellulaire city: Limoges zip: 87042 country: France name: Julie ABRAHAM, MD role: CONTACT lat: 45.83153 lon: 1.25781 facility: INSTITUT PAOLI CALMETTES - Service Hématologie city: Marseille zip: 13273 country: France name: Gabriel BRISOU, MD role: CONTACT lat: 43.29551 lon: 5.38958 facility: CHU DE MONTPELLIER - Département d'Hématologie Clinique city: Montpellier zip: 34090 country: France name: Guillaume CARTRON, Pr role: CONTACT lat: 43.61092 lon: 3.87723 facility: GH REGION MULHOUSE ET SUD ALSACE - HOPITAL EMILE MULLER - Service Hématologie city: Mulhouse zip: 68100 country: France name: Bernard DRENOU, MD role: CONTACT lat: 47.75 lon: 7.33333 facility: CHU DE NANTES - Service Hématologie city: Nantes zip: 44093 country: France name: Thomas GASTINNE, MD role: CONTACT lat: 47.21725 lon: -1.55336 facility: CENTRE HOSPITALIER DE NIORT - Médecine interne city: Niort zip: 79021 country: France name: Gaëlle OLIVIER, MD role: CONTACT lat: 46.32313 lon: -0.45877 facility: HOPITAL SAINT-LOUIS - Service Hématologie city: Paris zip: 75475 country: France name: Catherine THIEBLEMONT, Pr role: CONTACT lat: 48.85341 lon: 2.3488 facility: CHU DE BORDEAUX - HOPITAL HAUT-LEVEQUE - CENTRE FRANCOIS MAGENDIE - Service d'Hématologie et Thérapie Cellulaire city: Pessac zip: 33604 country: France name: François-Xavier GROS, MD role: CONTACT lat: 44.81011 lon: -0.64129 facility: CHU LYON-SUD - Hématologie city: Pierre-Bénite zip: 69495 country: France lat: 45.7009 lon: 4.82511 facility: CHI POISSY SAINT-GERMAIN-EN-LAYE - Service Hématologie city: Poissy zip: 78303 country: France name: Mohammed BOUDERBALA, MD role: CONTACT lat: 48.92902 lon: 2.04952 facility: CHU DE POITIERS - HOPITAL DE LA MILETRIE - Service d'Oncologie Hématologique et Thérapie Cellulaire city: Poitiers zip: 86021 country: France name: Stéphanie GUIDEZ, MD role: CONTACT lat: 46.58333 lon: 0.33333 facility: CH ANNECY GENEVOIS - SITE D'ANNECY - Service Hématologie city: Pringy zip: 74374 country: France name: Hannah MOATTI, MD role: CONTACT lat: 45.94622 lon: 6.12608 facility: CHU DE REIMS - HOPITAL ROBERT DEBRE - Service Hématologie city: Reims zip: 57092 country: France name: Eric DUROT, MD role: CONTACT lat: 49.25 lon: 4.03333 facility: CHU PONTCHAILLOU - Hématologie Clinique city: Rennes zip: 35033 country: France name: Roch HOUOT, Pr role: CONTACT lat: 48.11198 lon: -1.67429 facility: CENTRE HENRI BECQUEREL - Service Hématologie city: Rouen zip: 76038 country: France lat: 49.44313 lon: 1.09932 facility: INSTITUT CURIE - SITE SAINT-CLOUD - Service Hématologie city: Saint-Cloud zip: 92210 country: France name: Clémentine SARKOZY, MD role: CONTACT lat: 48.84598 lon: 2.20289 facility: Institut de Cancérologie et d'Hématologie Universitaire de Saint-Étienne - Service Hématologie city: Saint-Priest-en-Jarez zip: 42270 country: France name: Ludovic FOUILLET, MD role: CONTACT lat: 45.47501 lon: 4.37614 facility: INSTITUT DE CANCEROLOGIE STRASBOURG EUROPE - Unité de Recherche Clinique city: Strasbourg zip: 67033 country: France name: Luc-Matthieu FORNECKER, Pr role: CONTACT lat: 48.58392 lon: 7.74553 facility: IUCT ONCOPOLE - Service Hématologie city: Toulouse zip: 31059 country: France name: Loïc YSEBAERT, MD role: CONTACT lat: 43.60426 lon: 1.44367 facility: CHU BRETONNEAU - Service Cancérologie - Hématologie et Thérapie Cellulaire city: Tours zip: 37044 country: France name: Laurianne DRIEU LA ROCHELLE, MD role: CONTACT lat: 47.38333 lon: 0.68333 facility: CH DE VALENCIENNES - HOPITAL JEAN BERNARD - Service Hématologie city: Valenciennes zip: 59322 country: France name: Sabine TRICOT, MD role: CONTACT lat: 50.35 lon: 3.53333 facility: CHU BRABOIS - Service Hématologie city: Vandœuvre-lès-Nancy zip: 54511 country: France name: Pierre FEUGIER, Pr role: CONTACT lat: 48.65 lon: 6.18333 facility: CH DE BRETAGNE ATLANTIQUE - HOPITAL CHUBERT - Service Hématologie city: Vannes zip: 56017 country: France name: Antoine BONNET, MD role: CONTACT lat: 47.66667 lon: -2.75 facility: GUSTAVE ROUSSY CANCER CAMPUS GRAND PARIS - Département Médecine Oncologique city: Villejuif zip: 94085 country: France name: Vincent RIBRAG, MD role: CONTACT lat: 48.7939 lon: 2.35992 facility: UNIVERSITATSKLINIKUM REGENSBURG - Klinik für Innere Medizin III city: Regensburg zip: 93053 country: Germany name: Stephanie MAYER, MD role: CONTACT lat: 49.01513 lon: 12.10161 facility: UNIV KLINIKUM ULM - INNERE MEDIZIN III - Service Hématologie city: Ulm zip: 89081 country: Germany name: Christian BUSKE, Pr role: CONTACT lat: 48.39841 lon: 9.99155 facility: INSTITUTO PORTUGUES DE ONCOLOGIA DE LISBOA FRANCISCO GENTIL - Departamento Hematologia city: Lisboa zip: 1099 country: Portugal name: Maria GOMES DA SILVA, Pr role: CONTACT lat: 38.71667 lon: -9.13333 facility: HOSPITAL CLINICO SALAMANCA - Servicio de Hematologia city: Salamanca zip: 37007 country: Spain name: Alejandro MARTIN GARCIA-SANCHO, MD role: CONTACT lat: 40.96882 lon: -5.66388 hasResults: False
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<|newrecord|> nctId: NCT06284109 id: 23-1036 briefTitle: Preoperative (Pre-amputation) Cryoanalgesia to Improve Post-amputation Phantom Limb Pain overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-31 date: 2024-12-31 date: 2024-02-28 date: 2024-04-23 name: The Cleveland Clinic class: OTHER name: Pacira Pharmaceuticals, Inc briefSummary: Investigators will evaluate preamputation cryoanalgesia on pain, mobility, opioid use and general physical and emotional disability using a pilot randomized trial design, to explore the amount and variability of improvement on those outcomes and to investigate the potentiality of conducting a future larger randomized controlled trial, which the investigators will assess quantitatively the benefits of cryoanalgesia. conditions: Postoperative Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Pre-Operative Patients will receive cryoanalgesia or sham cryoanalgesia before amputation. primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: All participants will receive nerve blocks with Local anesthetic. Participants will be Randomized on a 1:1 fashion to cryoanalgesia or sham cryoanalgesia, based on computer-generated codes and use random-sized blocks. Patients will not be told which group they are in. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Cryoanalgesia name: Sham Cryoanalgesia measure: Phantom limb pain score measure: Mobility measure: General physical and emotional disability measure: Opioid consumption measure: Residual limb pain sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06284096 id: 2023/391 briefTitle: The Personal Recovery Based Psychoeducation For Schizophrenia overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-06 date: 2024-06 date: 2024-02-28 date: 2024-03-07 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: This project aims to introduce a new psychoeducation program that helps individuals with schizophrenia to recover subjectively. The program's effectiveness will be evaluated through a randomized controlled research design. The goal is not only to emphasize clinical recovery but also to highlight the importance of individual recovery and promote its implementation. In this context, the following hypotheses have been formulated.
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Research Question:
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1) Does recovery-based psychoeducation have an impact on the subjective recovery level in individuals diagnosed with schizophrenia in remission?
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Hypotheses:
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H0a: Recovery-based psychoeducation does not affect the subjective recovery level in individuals diagnosed with schizophrenia in remission.
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H0b: Recovery-based psychoeducation does not effect on psychological resilience in individuals diagnosed with schizophrenia in remission.
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H0c: Recovery-based psychoeducation does not effect on hope in individuals diagnosed with schizophrenia in remission.
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H1a: Recovery-based psychoeducation affects the subjective recovery level in individuals diagnosed with schizophrenia in remission.
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H1b: Recovery-based psychoeducation has an effect on psychological resilience in individuals diagnosed with schizophrenia in remission.
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H1c: Recovery-based psychoeducation has an effect on hope in individuals diagnosed with schizophrenia in remission. conditions: Mental Health Recovery conditions: Schizophrenia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 60 type: ESTIMATED name: Psychoeducation measure: Personal Recovery levels of individuals diagnosed with schizophrenia measure: Psychological resilience levels of individuals diagnosed with schizophrenia measure: Hope levels of individuals diagnosed with schizophrenia sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Umraniye Community Mental Health Center affiliated with the Ministry of Health. city: Istanbul state: Umraniye zip: 34760 country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06284083 id: Cumhuriyet University Hospital briefTitle: Measuring Various Variables in Obstructive Sleep Apnea acronym: OUAS overallStatus: COMPLETED date: 2018-12-18 date: 2021-01-15 date: 2022-02-07 date: 2024-02-28 date: 2024-02-28 name: Cumhuriyet University class: OTHER briefSummary: This study included 90 volunteer Obstructive Sleep Apnea Syndrome patients. Only 7 mL blood samples collected from patients. Some biochemicals parameters analyzed in blood serum/plasma. conditions: Obstructive Sleep Apnea-hypopnea Syndrome studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study group consisted of 90 newly diagnosed OSAS patients who were admitted to the Clinic for Chest Diseases of the Research and Practice Hospital of Sivas Cumhuriyet University Faculty of Medicine. For the definitive diagnosis of OSAS, the patients were hospitalized overnight in the Sleep Center and polysomnography test was performed. OSAS patients, who were randomly selected without discrimination in terms of age and gender, were connected to the PSG device for one night and various measurements were taken and the values were recorded. The apnea/hypopnea index (AHI) was defined as the sum of the apnea and hypopnea number per hour of sleep. Volunteer patients were grouped into three based on apnea-hypopnea index (AHI) scores: mild OSAS (n=30; 5 ≤ AHI ≤ 13.70), moderate (n=30; 15.80 ≤ AHI ≤ 26.60) and severe (n=30; 34.10 ≤ AHI ≤ 86.30). The mean SpO2 percentages of the PSG device were measured from the fingertip with a system-defined pulse oximeter. primaryPurpose: HEALTH_SERVICES_RESEARCH masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 90 type: ACTUAL name: taking a blood sample measure: Agmatine, telomerase and trace element levels in blood serum vary depending on disease severity. measure: Polysomnographic measurement sex: ALL minimumAge: 18 Years maximumAge: 74 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sivas Cumhuriyet University city: Sivas state: Centre zip: 58140 country: Turkey lat: 39.74833 lon: 37.01611 hasResults: False
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<|newrecord|> nctId: NCT06284070 id: 202433 briefTitle: Application of FAPI and FDG PET Imaging in Patients With Different Types of Cancer overallStatus: RECRUITING date: 2024-01-01 date: 2029-12-31 date: 2029-12-31 date: 2024-02-28 date: 2024-02-28 name: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University class: OTHER briefSummary: Cancer associated fibroblasts (CAFs) can promote tumor cell proliferation, migration, invasion, and angiogenesis through immunosuppressive effects and the production of mediators, thereby promoting tumor growth and progression. The characteristic of CAFs is high expression of fibroblast activation protein (FAP). In approximately 90% of epithelial derived tumors, FAP is highly overexpressed on the membrane of CAFs. Contrary to CAFs, FAP expression is lower or absent in normal tissues. Therefore, FAP inhibitors (FAPI) targeting FAP can overcome the limitations of 18F-2-fluoro.2-deoxy-D-glucose fluorodeoxyglucose(18F-FDG) PET imaging. But like 18F-FDG, wound healing, fibrosis, and inflammation can also uptake FAPI.. Therefore, a comparison of the performance of 18F-FDG and 18F-FAPI PET imaging in diagnosing primary and metastatic lesions of various types of cancer is conducted to evaluate the potential value of these new radiopharmaceuticals as effective alternatives to 18F-FDG, highlighting their advantages and limitations. conditions: Cancer studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 2000 type: ESTIMATED measure: Diagnostic efficacy measure: SUV sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Nuclear Medicine, Daping Hospital of Army Medical University status: RECRUITING city: Chongqing state: Chongqing zip: 400010 country: China name: Xiao Chen, Ph.D role: CONTACT phone: 15922970174 email: xiaochen229@foxmail.com name: Xiao Chen, Ph.D role: PRINCIPAL_INVESTIGATOR name: Jinju Sun, MSc role: PRINCIPAL_INVESTIGATOR lat: 29.56278 lon: 106.55278 hasResults: False
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<|newrecord|> nctId: NCT06284057 id: CopperHealthCentre3 briefTitle: Lower Silesia Culotte Bifurcation Registry (LSCBR). acronym: LSCBR overallStatus: RECRUITING date: 2013-04-01 date: 2028-04-01 date: 2028-04-01 date: 2024-02-28 date: 2024-03-06 name: Regional Cardiology Center, The Copper Health Centre (MCZ), class: OTHER name: Department of Cardiology, Provincial Specialized Hospital in Legnica, 59-200 Legnica, Poland. briefSummary: The study aimed to evaluate the outcomes of bifurcation PCI using two techniques (Culotte vs. DK-Culotte) using data from a retrospective analysis. conditions: Safety Issues conditions: Efficacy, Self studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 400 type: ESTIMATED name: Bifurcation PCI with two stent technique Culotte Technique or Double Kiss (DK) Culotte measure: Target lesion failure (TLF) measure: MACE measure: Stent thrombosis measure: Stent restenosis sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Cardiology, Provincial Specialized Hospital in Legnica, status: RECRUITING city: Legnica state: Lower Silesia zip: 59-220 country: Poland name: Mateusz Barycki, M.D role: CONTACT phone: +48767211446 email: mateusz.barycki@gmail.com name: Piotr Rola, M.D. Ph.D role: CONTACT phone: +48767211446 email: piotr.rola@gmail.com name: Mateusz Barycki, MD role: PRINCIPAL_INVESTIGATOR name: Piotr Rola, MD PhD role: SUB_INVESTIGATOR lat: 51.21006 lon: 16.1619 facility: Department of Cardiology, The Copper Health Centre (MCZ) status: RECRUITING city: Lubin state: Lower Silesia zip: 59-300 country: Poland name: Adrian Włodarczak, Assoc Prof. role: CONTACT phone: +48768460300 email: wlodarczak.adrian@gmail.com name: Szymon Włodarczak, MD role: CONTACT phone: +4876 846 03 00 email: wlodarczak.szy@gmail.com name: Adrian Włodarczak, Assoc Prof. role: PRINCIPAL_INVESTIGATOR name: Szymon Włodarczak, MD role: SUB_INVESTIGATOR lat: 51.40089 lon: 16.20149 hasResults: False
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<|newrecord|> nctId: NCT06284044 id: NIHR204885 briefTitle: Facilitating Safe Transition to Home for Preterm Infants - a National Database Study overallStatus: RECRUITING date: 2023-12-01 date: 2024-11-30 date: 2024-11-30 date: 2024-02-28 date: 2024-03-27 name: University Hospitals of Derby and Burton NHS Foundation Trust class: OTHER briefSummary: Preterm infants (i.e. born before 37 completed weeks of pregnancy) often require additional care and are admitted to neonatal units. Readiness for discharge home typically requires a level of physiological maturity, such that an infant is: 1) able to breathe spontaneously without additional support; 2) able to maintain body temperature; 3) able to take all nutritional requirements orally; 4) weighs ≥1700 grams and is consistently gaining weight.
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Staying in the hospital longer than necessary can be detrimental to infants, stressful for families, and costly to the NHS. Reducing the length of stay by just one day would be meaningful to parents and could save the UK National Health Service (NHS) almost £25million per year. Currently little is known about whether, how long and why preterm infants stay in hospital beyond the point at which they are physiologically ready for discharge.
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This study will use data from babies' medical records from the whole of England and Wales to identify the age and postmenstrual age when preterm infants reach each of the physiological barriers to discharge and identify which physiological discharge barrier requires preterm infants to remain in hospital the longest. The study will quantify the difference between the time preterm infants become physiologically ready for discharge and actual discharge home and describe factors associated with extended stays. conditions: Premature Birth studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: OTHER count: 250000 type: ESTIMATED measure: Age and postmenstrual age when each of three physiological barriers are reached measure: Final barrier to discharge home measure: Number of days in hospital after surpassing all physiological discharge barriers sex: ALL minimumAge: 22 Weeks maximumAge: 36 Weeks stdAges: CHILD facility: University Hospitals of Derby and Burton status: RECRUITING city: Derby state: Derbyshire zip: DE22 3DT country: United Kingdom name: Janine Abramson, BSc Hon role: CONTACT phone: 01332 724690 email: janine.abramson@nottingham.ac.uk lat: 52.92277 lon: -1.47663 hasResults: False
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<|newrecord|> nctId: NCT06284031 id: Brachy Study briefTitle: Cervical Cancer Brachytherapy With Interstitial Needles in 3 Fractions overallStatus: RECRUITING date: 2023-06-26 date: 2026-06 date: 2026-12 date: 2024-02-28 date: 2024-02-28 name: National University Hospital, Singapore class: OTHER briefSummary: Aim To determine the feasibility and safety of 3 fractions of high dose rate (HDR) brachytherapy with interstitial needles for cervical cancer in the outpatient setting
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Primary objective To determine the clinical outcome (2-yr local control rate, loco-regional control rate, progression free survival and overall survival)
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Secondary objective To determine the long-term toxicities of this regimen based on CTCAE v5 conditions: Cervical Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 56 type: ESTIMATED name: 3 fractions HDR brachytherapy measure: Local control rate measure: Loco-regional control rate measure: Progression-free survival (PFS) measure: Overall survival (OS) measure: Long term toxicities sex: FEMALE minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National University Hospital status: RECRUITING city: Singapore zip: 119074 country: Singapore name: Fatin Aliyah, BSc role: CONTACT phone: +6581005851 email: fatin_hussin@nuhs.edu.sg name: Syadwa Abdul Shukor, MD role: SUB_INVESTIGATOR name: Yiat Horng Leong, MD role: SUB_INVESTIGATOR name: Shing Fung Lee, MD role: SUB_INVESTIGATOR name: Michelle Tseng, MD role: SUB_INVESTIGATOR lat: 1.28967 lon: 103.85007 hasResults: False
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<|newrecord|> nctId: NCT06284018 id: postnatal low back pain briefTitle: Effect of Progressive Muscle Relaxation Exercises Versus Pilates Exercises on Postnatal Low Back Pain overallStatus: NOT_YET_RECRUITING date: 2024-02-24 date: 2024-12-31 date: 2024-12-31 date: 2024-02-28 date: 2024-02-29 name: Cairo University class: OTHER briefSummary: This study was conducted to compare between the effect of progressive muscle relaxation exercises and the effect of pilates exercises on postnatal low back pain conditions: Low Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: intervention The design of the study was randomized controlled study. The patients were divided randomly into two equal groups (A\&B). Group A consisted of thirty postnatal women. They were treated by progressive muscle relaxation exercises three times per week for 4 weeks. Group B consisted of thirty postnatal women. They were treated by pilates exercises three times per week for 4 weeks. primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: Progressive Muscle Relaxation Exercises name: Pilates Exercises measure: Pressure Algometer measure: Oswestry Disability Index sex: FEMALE minimumAge: 25 Years maximumAge: 35 Years stdAges: ADULT facility: faculty of physical therapy: Cairo university city: Giza zip: 12662 country: Egypt lat: 30.00808 lon: 31.21093 hasResults: False
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<|newrecord|> nctId: NCT06284005 id: MOTU ATP - Studio clinico briefTitle: Multicentre Interventional Pilot Study on the Evaluation of the Functionality, Safety and Reliability of a New Robotic Prosthesis for the Lower Limb at the Transfemoral Level acronym: MOTU-ATP overallStatus: COMPLETED date: 2020-07-27 date: 2022-11-10 date: 2022-12-22 date: 2024-02-28 date: 2024-02-28 name: Fondazione Don Carlo Gnocchi Onlus class: OTHER briefSummary: The goal of this multicenter interventional pilot is to verify the functionality of a prosthesis for trans-femoral amputees.
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The main question it aims to answer are:
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* Is to verify the technical functionality, safety and reliability of the propulsive lower limb prosthesis prototype, with active ankle, so as to provide indications regarding the technical and functional developments to be implemented in the finalization of the device.
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* Provide an indication of the functional effectiveness of the device and its satisfaction by patients.
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Participants will perform:
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* walking tests inside parallel bars on flat and/or inclined terrain;
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* walking tests on treadmill;
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* stair climbing/descent tests. conditions: Amputation conditions: Amputation; Traumatic, Leg, Lower studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DEVICE_FEASIBILITY masking: NONE count: 4 type: ACTUAL name: WRL ATP measure: ad hoc check-list Adverse Event measure: ad hoc check-list Adverse Event measure: ad hoc check-list Adverse Event measure: ad hoc check-list Adverse Event measure: ad hoc check-list Adverse Event sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Fondazione Don Carlo Gnocchi city: Firenze state: FI zip: 50143 country: Italy lat: 43.77925 lon: 11.24626 hasResults: False
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<|newrecord|> nctId: NCT06283992 id: 2024p000095 id: K23MD016439 type: NIH link: https://reporter.nih.gov/quickSearch/K23MD016439 briefTitle: Digital Health Navigation for Latino Patients With Type II Diabetes overallStatus: RECRUITING date: 2024-03-31 date: 2026-05-31 date: 2027-05-31 date: 2024-02-28 date: 2024-03-28 name: Brigham and Women's Hospital class: OTHER name: National Institute on Minority Health and Health Disparities (NIMHD) briefSummary: The goal of this clinical trial is to learn about digital literacy training in adult, Latino patient with type II diabetes. The main question it aims to answer is: Can providing digital literacy training during a hospital admission can help patients with their after-hospital care by using the patient portal and telehealth? Participants will receive digital literacy training by a digital navigator that focuses on the main patient portal functions. Researchers will compare patients who receive digital literacy training to those who receive standard of care (educational sheet) to see if it impacts their use of the patient portal after discharge. conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Researchers will compare effectiveness between two arms: 1) patient education using a digital navigator on using digital tools after discharge and 2) usual care (educational sheet). primaryPurpose: HEALTH_SERVICES_RESEARCH masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 84 type: ESTIMATED name: Digital Navigation measure: Proportion of Participants Who Login to the Portal measure: Proportion of Participants that Perform Distinct Portal Functions measure: Proportion of participants that complete a telehealth measure: Proportion of participants that are re-admitted sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Brigham and Women's Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02120 country: United States name: Jorge A Rodriguez, MD role: CONTACT lat: 42.35843 lon: -71.05977 hasResults: False
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<|newrecord|> nctId: NCT06283979 id: 199723 briefTitle: A Randomized Controlled Phase II Trial of STIMULAN VG vs Standard of Care (SoC) for the Treatment of Osteomyelitis Associated With Stage IV Pressure Ulcers. acronym: BLADE OPU2 overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2024-12-01 date: 2025-12-01 date: 2024-02-28 date: 2024-02-29 name: Biocomposites Ltd class: INDUSTRY name: MCRA briefSummary: The purpose of this trial is to assess the safety, tolerability and between-group effect size of STIMULAN VG (with debridement) and a course of systemic antibiotics to standard of care (debridement and systemic antibiotics only) for the treatment of osteomyelitis associated stage IV pressure ulcers. conditions: Pressure Ulcer, Stage IV conditions: Osteomyelitis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: STIMULAN VG name: Standard of Care measure: Individual patient success and findings at the 8 week follow-up visit sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06283966 id: D5989C00001 briefTitle: A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease acronym: THARROS overallStatus: RECRUITING date: 2024-02-21 date: 2028-03-06 date: 2028-03-06 date: 2024-02-28 date: 2024-03-12 name: AstraZeneca class: INDUSTRY briefSummary: This study will evaluate the effect of triple ICS/LAMA/LABA therapy with BGF MDI 320/14.4/9.6 μg on cardiopulmonary outcomes relative to LAMA/LABA therapy with GFF MDI 14.4/9.6 μg in a population with COPD and elevated cardiopulmonary risk. conditions: COPD (Chronic Obstructive Pulmonary Disease) studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a Phase III randomized, double-blind, parallel group, multi-center event-driven study comparing BGF MDI 320/14.4/9.6 μg BID with GFF MDI 14.4/9.6 μg BID in participants with COPD who are at risk of a cardiopulmonary event. primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 5000 type: ESTIMATED name: BGF MDI 320/14.4/9.6 μg name: GFF MDI 14.4/9.6 μg measure: Time to first severe cardiac or COPD event measure: Time to first severe COPD exacerbation event measure: Time to first severe cardiac event measure: Time to cardiopulmonary death measure: Moderate/severe COPD exacerbation rate measure: Time to Myocardial Infarction (MI) hospitalization or cardiac death measure: Time to Heart Failure (HF) acute healthcare visit/hospitalization or cardiac death measure: Serious Adverse Events (SAEs) and Adverse Events leading to discontinuation (DAEs), Adverse Events of Special Interest (AESIs) of pneumonia leading to hospitalization or death sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Research Site status: NOT_YET_RECRUITING city: Athens state: Alabama zip: 35611 country: United States lat: 34.80243 lon: -86.97219 facility: Research Site status: NOT_YET_RECRUITING city: Cullman state: Alabama zip: 35058 country: United States lat: 34.17482 lon: -86.84361 facility: Research Site status: RECRUITING city: Fairhope state: Alabama zip: 36532 country: United States lat: 30.52297 lon: -87.90333 facility: Research Site status: NOT_YET_RECRUITING city: Huntsville state: Alabama zip: 35801 country: United States lat: 34.7304 lon: -86.58594 facility: Research Site status: NOT_YET_RECRUITING city: Mobile state: Alabama zip: 36608 country: United States lat: 30.69436 lon: -88.04305 facility: Research Site status: NOT_YET_RECRUITING city: Sheffield state: Alabama zip: 35660 country: United States lat: 34.76509 lon: -87.69864 facility: Research Site status: NOT_YET_RECRUITING city: Gilbert state: Arizona zip: 85296 country: United States lat: 33.35283 lon: -111.78903 facility: Research Site status: NOT_YET_RECRUITING city: Glendale state: Arizona zip: 85308 country: United States lat: 33.53865 lon: -112.18599 facility: Research Site status: RECRUITING city: Mesa state: Arizona zip: 85206 country: United States lat: 33.42227 lon: -111.82264 facility: Research Site status: NOT_YET_RECRUITING city: Mesa state: Arizona zip: 85213 country: United States lat: 33.42227 lon: -111.82264 facility: Research Site status: NOT_YET_RECRUITING city: Phoenix state: Arizona zip: 85006 country: United States lat: 33.44838 lon: -112.07404 facility: Research Site status: NOT_YET_RECRUITING city: Tempe state: Arizona zip: 85281 country: United States lat: 33.41477 lon: -111.90931 facility: Research Site status: NOT_YET_RECRUITING city: Tempe state: Arizona zip: 85283 country: United States lat: 33.41477 lon: -111.90931 facility: Research Site status: NOT_YET_RECRUITING city: Tucson state: Arizona zip: 85710 country: United States lat: 32.22174 lon: -110.92648 facility: Research Site status: NOT_YET_RECRUITING city: Apple Valley state: California zip: 92307 country: United States lat: 34.50083 lon: -117.18588 facility: Research Site status: NOT_YET_RECRUITING city: Banning state: California zip: 92220 country: United States lat: 33.92557 lon: -116.87641 facility: Research Site status: NOT_YET_RECRUITING city: Canoga Park state: California zip: 91303 country: United States lat: 34.20112 lon: -118.59814 facility: Research Site status: NOT_YET_RECRUITING city: Garden Grove state: California zip: 92844 country: United States lat: 33.77391 lon: -117.94145 facility: Research Site status: NOT_YET_RECRUITING city: Gardena state: California zip: 90247 country: United States lat: 33.88835 lon: -118.30896 facility: Research Site status: NOT_YET_RECRUITING city: Inglewood state: California zip: 90301 country: United States lat: 33.96168 lon: -118.35313 facility: Research Site status: NOT_YET_RECRUITING city: La Mesa state: California zip: 91942 country: United States lat: 32.76783 lon: -117.02308 facility: Research Site status: NOT_YET_RECRUITING city: La Palma state: California zip: 90623 country: United States lat: 33.8464 lon: -118.04673 facility: Research Site status: NOT_YET_RECRUITING city: Lomita state: California zip: 90717 country: United States lat: 33.79224 lon: -118.31507 facility: Research Site status: NOT_YET_RECRUITING city: Los Alamitos state: California zip: 90720 country: United States lat: 33.80307 lon: -118.07256 facility: Research Site status: NOT_YET_RECRUITING city: Newport Beach state: California zip: 92660 country: United States lat: 33.61891 lon: -117.92895 facility: Research Site status: RECRUITING city: Newport Beach state: California zip: 92663 country: United States lat: 33.61891 lon: -117.92895 facility: Research Site status: NOT_YET_RECRUITING city: North Hollywood state: California zip: 91602 country: United States lat: 34.17223 lon: -118.37897 facility: Research Site status: NOT_YET_RECRUITING city: Panorama City state: California zip: 91402 country: United States lat: 34.22473 lon: -118.44981 facility: Research Site status: NOT_YET_RECRUITING city: Pomona state: California zip: 91768 country: United States lat: 34.05529 lon: -117.75228 facility: Research Site status: NOT_YET_RECRUITING city: Sacramento state: California zip: 95823 country: United States lat: 38.58157 lon: -121.4944 facility: Research Site status: NOT_YET_RECRUITING city: Sacramento state: California zip: 95831 country: United States lat: 38.58157 lon: -121.4944 facility: Research Site status: NOT_YET_RECRUITING city: Salinas state: California zip: 93901 country: United States lat: 36.67774 lon: -121.6555 facility: Research Site status: NOT_YET_RECRUITING city: San Diego state: California zip: 92111 country: United States lat: 32.71533 lon: -117.15726 facility: Research Site status: NOT_YET_RECRUITING city: San Dimas state: California zip: 91773 country: United States lat: 34.10668 lon: -117.80673 facility: Research Site status: NOT_YET_RECRUITING city: Santa Ana state: California zip: 92704 country: United States lat: 33.74557 lon: -117.86783 facility: Research Site status: NOT_YET_RECRUITING city: Tarzana state: California zip: 91356 country: United States lat: 34.17334 lon: -118.55397 facility: Research Site status: NOT_YET_RECRUITING city: Thousand Oaks state: California zip: 91360 country: United States lat: 34.17056 lon: -118.83759 facility: Research Site status: NOT_YET_RECRUITING city: Vista state: California zip: 92081 country: United States lat: 33.20004 lon: -117.24254 facility: Research Site status: NOT_YET_RECRUITING city: Westminster state: California zip: 92683 country: United States lat: 33.75918 lon: -118.00673 facility: Research Site status: NOT_YET_RECRUITING city: Aurora state: Colorado zip: 80012 country: United States lat: 39.72943 lon: -104.83192 facility: Research Site status: NOT_YET_RECRUITING city: Denver state: Colorado zip: 80224 country: United States lat: 39.73915 lon: -104.9847 facility: Research Site status: NOT_YET_RECRUITING city: Denver state: Colorado zip: 80228 country: United States lat: 39.73915 lon: -104.9847 facility: Research Site status: NOT_YET_RECRUITING city: Washington state: District of Columbia zip: 20016 country: United States lat: 38.89511 lon: -77.03637 facility: Research Site status: NOT_YET_RECRUITING city: Boynton Beach state: Florida zip: 33435 country: United States lat: 26.52535 lon: -80.06643 facility: Research Site status: NOT_YET_RECRUITING city: Bradenton state: Florida zip: 34208 country: United States lat: 27.49893 lon: -82.57482 facility: Research Site status: NOT_YET_RECRUITING city: Cape Coral state: Florida zip: 33990 country: United States lat: 26.56285 lon: -81.94953 facility: Research Site status: NOT_YET_RECRUITING city: Clearwater state: Florida zip: 33756 country: United States lat: 27.96585 lon: -82.8001 facility: Research Site status: NOT_YET_RECRUITING city: Clearwater state: Florida zip: 33765 country: United States lat: 27.96585 lon: -82.8001 facility: Research Site status: NOT_YET_RECRUITING city: Crystal River state: Florida zip: 34429 country: United States lat: 28.90248 lon: -82.5926 facility: Research Site status: NOT_YET_RECRUITING city: Cutler Bay state: Florida zip: 33189 country: United States lat: 25.5783 lon: -80.3377 facility: Research Site status: NOT_YET_RECRUITING city: Edgewater state: Florida zip: 32132 country: United States lat: 28.98888 lon: -80.90228 facility: Research Site status: NOT_YET_RECRUITING city: Fort Lauderdale state: Florida zip: 33308 country: United States lat: 26.12231 lon: -80.14338 facility: Research Site status: NOT_YET_RECRUITING city: Fort Myers state: Florida zip: 33912 country: United States lat: 26.62168 lon: -81.84059 facility: Research Site status: NOT_YET_RECRUITING city: Hialeah state: Florida zip: 33013 country: United States lat: 25.8576 lon: -80.27811 facility: Research Site status: NOT_YET_RECRUITING city: Hollywood state: Florida zip: 33024 country: United States lat: 26.0112 lon: -80.14949 facility: Research Site status: NOT_YET_RECRUITING city: Kissimmee state: Florida zip: 34741 country: United States lat: 28.30468 lon: -81.41667 facility: Research Site status: NOT_YET_RECRUITING city: Kissimmee state: Florida zip: 34746 country: United States lat: 28.30468 lon: -81.41667 facility: Research Site status: NOT_YET_RECRUITING city: Lake City state: Florida zip: 32055 country: United States lat: 30.18968 lon: -82.63929 facility: Research Site status: NOT_YET_RECRUITING city: Lake Worth state: Florida zip: 33467 country: United States lat: 26.61708 lon: -80.07231 facility: Research Site status: NOT_YET_RECRUITING city: Lakeland state: Florida zip: 33813 country: United States lat: 28.03947 lon: -81.9498 facility: Research Site status: NOT_YET_RECRUITING city: Loxahatchee Groves state: Florida zip: 33470 country: United States lat: 26.68368 lon: -80.27977 facility: Research Site status: NOT_YET_RECRUITING city: Miami Lakes state: Florida zip: 33014 country: United States lat: 25.90871 lon: -80.30866 facility: Research Site status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33155 country: United States lat: 25.77427 lon: -80.19366 facility: Research Site status: RECRUITING city: Miami state: Florida zip: 33175 country: United States lat: 25.77427 lon: -80.19366 facility: Research Site status: NOT_YET_RECRUITING city: Miami state: Florida zip: 33256 country: United States lat: 25.77427 lon: -80.19366 facility: Research Site status: NOT_YET_RECRUITING city: Naples state: Florida zip: 34102 country: United States lat: 26.14234 lon: -81.79596 facility: Research Site status: NOT_YET_RECRUITING city: Ocala state: Florida zip: 34470 country: United States lat: 29.1872 lon: -82.14009 facility: Research Site status: NOT_YET_RECRUITING city: Orlando state: Florida zip: 32807 country: United States lat: 28.53834 lon: -81.37924 facility: Research Site status: NOT_YET_RECRUITING city: Orlando state: Florida zip: 32819 country: United States lat: 28.53834 lon: -81.37924 facility: Research Site status: NOT_YET_RECRUITING city: Orlando state: Florida zip: 32825 country: United States lat: 28.53834 lon: -81.37924 facility: Research Site status: NOT_YET_RECRUITING city: Ormond Beach state: Florida zip: 32174 country: United States lat: 29.28581 lon: -81.05589 facility: Research Site status: NOT_YET_RECRUITING city: Pembroke Pines state: Florida zip: 33024 country: United States lat: 26.00315 lon: -80.22394 facility: Research Site status: NOT_YET_RECRUITING city: Plantation state: Florida zip: 33324 country: United States lat: 26.13421 lon: -80.23184 facility: Research Site status: NOT_YET_RECRUITING city: Saint Petersburg state: Florida zip: 33713 country: United States lat: 27.77086 lon: -82.67927 facility: Research Site status: NOT_YET_RECRUITING city: Sun City Center state: Florida zip: 33573 country: United States lat: 27.71809 lon: -82.35176 facility: Research Site status: NOT_YET_RECRUITING city: Tamarac state: Florida zip: 33321 country: United States lat: 26.21286 lon: -80.24977 facility: Research Site status: NOT_YET_RECRUITING city: Tampa state: Florida zip: 33606 country: United States lat: 27.94752 lon: -82.45843 facility: Research Site status: NOT_YET_RECRUITING city: Tampa state: Florida zip: 33607 country: United States lat: 27.94752 lon: -82.45843 facility: Research Site status: NOT_YET_RECRUITING city: Tampa state: Florida zip: 33625 country: United States lat: 27.94752 lon: -82.45843 facility: Research Site status: NOT_YET_RECRUITING city: Atlanta state: Georgia zip: 30349 country: United States lat: 33.749 lon: -84.38798 facility: Research Site status: NOT_YET_RECRUITING city: Buford state: Georgia zip: 30519 country: United States lat: 34.12066 lon: -84.00435 facility: Research Site status: NOT_YET_RECRUITING city: Peachtree Corners state: Georgia zip: 30092 country: United States lat: 33.9701 lon: -84.22159 facility: Research Site status: NOT_YET_RECRUITING city: Savannah state: Georgia zip: 31406 country: United States lat: 32.08354 lon: -81.09983 facility: Research Site status: NOT_YET_RECRUITING city: Boise state: Idaho zip: 83706 country: United States lat: 43.6135 lon: -116.20345 facility: Research Site status: NOT_YET_RECRUITING city: Chicago state: Illinois zip: 60607 country: United States lat: 41.85003 lon: -87.65005 facility: Research Site status: NOT_YET_RECRUITING city: Winfield state: Illinois zip: 60190 country: United States lat: 41.8617 lon: -88.1609 facility: Research Site status: NOT_YET_RECRUITING city: Valparaiso state: Indiana zip: 46383 country: United States lat: 41.47309 lon: -87.06114 facility: Research Site status: NOT_YET_RECRUITING city: Newton state: Kansas zip: 67114 country: United States lat: 38.04668 lon: -97.34504 facility: Research Site status: NOT_YET_RECRUITING city: Wichita state: Kansas zip: 67218 country: United States lat: 37.69224 lon: -97.33754 facility: Research Site status: NOT_YET_RECRUITING city: Lexington state: Kentucky zip: 40503 country: United States lat: 37.98869 lon: -84.47772 facility: Research Site status: NOT_YET_RECRUITING city: Paducah state: Kentucky zip: 42001 country: United States lat: 37.08339 lon: -88.60005 facility: Research Site status: NOT_YET_RECRUITING city: Lafayette state: Louisiana zip: 70508 country: United States lat: 30.22409 lon: -92.01984 facility: Research Site status: NOT_YET_RECRUITING city: Monroe state: Louisiana zip: 71201 country: United States lat: 32.50931 lon: -92.1193 facility: Research Site status: RECRUITING city: Shreveport state: Louisiana zip: 71105 country: United States lat: 32.52515 lon: -93.75018 facility: Research Site status: NOT_YET_RECRUITING city: Zachary state: Louisiana zip: 70791 country: United States lat: 30.64852 lon: -91.1565 facility: Research Site status: NOT_YET_RECRUITING city: Oxon Hill state: Maryland zip: 20745 country: United States lat: 38.80345 lon: -76.9897 facility: Research Site status: NOT_YET_RECRUITING city: Potomac state: Maryland zip: 20854 country: United States lat: 39.01817 lon: -77.20859 facility: Research Site status: NOT_YET_RECRUITING city: Boston state: Massachusetts zip: 02115 country: United States lat: 42.35843 lon: -71.05977 facility: Research Site status: NOT_YET_RECRUITING city: Flint state: Michigan zip: 48504 country: United States lat: 43.01253 lon: -83.68746 facility: Research Site status: NOT_YET_RECRUITING city: Lathrup Village state: Michigan zip: 48076 country: United States lat: 42.49642 lon: -83.22271 facility: Research Site status: NOT_YET_RECRUITING city: Southfield state: Michigan zip: 48034 country: United States lat: 42.47337 lon: -83.22187 facility: Research Site status: RECRUITING city: Gulfport state: Mississippi zip: 39503 country: United States lat: 30.36742 lon: -89.09282 facility: Research Site status: NOT_YET_RECRUITING city: Olive Branch state: Mississippi zip: 38654 country: United States lat: 34.96176 lon: -89.82953 facility: Research Site status: NOT_YET_RECRUITING city: Kansas City state: Missouri zip: 64116 country: United States lat: 39.09973 lon: -94.57857 facility: Research Site status: NOT_YET_RECRUITING city: Liberty state: Missouri zip: 64068 country: United States lat: 39.24611 lon: -94.41912 facility: Research Site status: NOT_YET_RECRUITING city: Saint Louis state: Missouri zip: 63136 country: United States lat: 38.62727 lon: -90.19789 facility: Research Site status: RECRUITING city: Missoula state: Montana zip: 59808 country: United States lat: 46.87215 lon: -113.994 facility: Research Site status: NOT_YET_RECRUITING city: Fremont state: Nebraska zip: 68025 country: United States lat: 41.43333 lon: -96.49808 facility: Research Site status: NOT_YET_RECRUITING city: Grand Island state: Nebraska zip: 68803 country: United States lat: 40.92501 lon: -98.34201 facility: Research Site status: NOT_YET_RECRUITING city: Omaha state: Nebraska zip: 68134 country: United States lat: 41.25626 lon: -95.94043 facility: Research Site status: NOT_YET_RECRUITING city: Las Vegas state: Nevada zip: 89101 country: United States lat: 36.17497 lon: -115.13722 facility: Research Site status: NOT_YET_RECRUITING city: Las Vegas state: Nevada zip: 89102 country: United States lat: 36.17497 lon: -115.13722 facility: Research Site status: NOT_YET_RECRUITING city: Las Vegas state: Nevada zip: 89119 country: United States lat: 36.17497 lon: -115.13722 facility: Research Site status: NOT_YET_RECRUITING city: Lawrence Township state: New Jersey zip: 08648 country: United States lat: 40.29588 lon: -74.72009 facility: Research Site status: NOT_YET_RECRUITING city: Mullica Hill state: New Jersey zip: 08062 country: United States lat: 39.73928 lon: -75.22407 facility: Research Site status: NOT_YET_RECRUITING city: Toms River state: New Jersey zip: 08755 country: United States lat: 39.95373 lon: -74.19792 facility: Research Site status: WITHDRAWN city: Union City state: New Jersey zip: 07087 country: United States lat: 40.77955 lon: -74.02375 facility: Research Site status: WITHDRAWN city: Albuquerque state: New Mexico zip: 87109 country: United States lat: 35.08449 lon: -106.65114 facility: Research Site status: NOT_YET_RECRUITING city: Albany state: New York zip: 12205 country: United States lat: 42.65258 lon: -73.75623 facility: Research Site status: NOT_YET_RECRUITING city: Bronxville state: New York zip: 10708 country: United States lat: 40.93815 lon: -73.83208 facility: Research Site status: RECRUITING city: Bronx state: New York zip: 10455 country: United States lat: 40.84985 lon: -73.86641 facility: Research Site status: NOT_YET_RECRUITING city: Massapequa state: New York zip: 11758 country: United States lat: 40.68066 lon: -73.47429 facility: Research Site status: NOT_YET_RECRUITING city: New Windsor state: New York zip: 12553 country: United States lat: 41.47676 lon: -74.02375 facility: Research Site status: NOT_YET_RECRUITING city: New York state: New York zip: 10036 country: United States lat: 40.71427 lon: -74.00597 facility: Research Site status: NOT_YET_RECRUITING city: Vestal state: New York zip: 13850 country: United States lat: 42.08507 lon: -76.05381 facility: Research Site status: NOT_YET_RECRUITING city: Fayetteville state: North Carolina zip: 28303 country: United States lat: 35.05266 lon: -78.87836 facility: Research Site status: NOT_YET_RECRUITING city: Greensboro state: North Carolina zip: 27405 country: United States lat: 36.07264 lon: -79.79198 facility: Research Site status: NOT_YET_RECRUITING city: Greenville state: North Carolina zip: 27834 country: United States lat: 35.61266 lon: -77.36635 facility: Research Site status: NOT_YET_RECRUITING city: Huntersville state: North Carolina zip: 28078 country: United States lat: 35.41069 lon: -80.84285 facility: Research Site status: NOT_YET_RECRUITING city: Morehead City state: North Carolina zip: 28557 country: United States lat: 34.72294 lon: -76.72604 facility: Research Site status: NOT_YET_RECRUITING city: Raleigh state: North Carolina zip: 27612 country: United States lat: 35.7721 lon: -78.63861 facility: Research Site status: NOT_YET_RECRUITING city: Salisbury state: North Carolina zip: 28144 country: United States lat: 35.67097 lon: -80.47423 facility: Research Site status: NOT_YET_RECRUITING city: Statesville state: North Carolina zip: 28625 country: United States lat: 35.78264 lon: -80.8873 facility: Research Site status: NOT_YET_RECRUITING city: Statesville state: North Carolina zip: 28677 country: United States lat: 35.78264 lon: -80.8873 facility: Research Site status: NOT_YET_RECRUITING city: Wilmington state: North Carolina zip: 28401 country: United States lat: 34.22573 lon: -77.94471 facility: Research Site status: NOT_YET_RECRUITING city: Beavercreek state: Ohio zip: 45431 country: United States lat: 39.70923 lon: -84.06327 facility: Research Site status: NOT_YET_RECRUITING city: Blue Ash state: Ohio zip: 45242 country: United States lat: 39.232 lon: -84.37827 facility: Research Site status: NOT_YET_RECRUITING city: Cleveland state: Ohio zip: 44130 country: United States lat: 41.4995 lon: -81.69541 facility: Research Site status: RECRUITING city: Columbus state: Ohio zip: 43215 country: United States lat: 39.96118 lon: -82.99879 facility: Research Site status: NOT_YET_RECRUITING city: Columbus state: Ohio zip: 43235 country: United States lat: 39.96118 lon: -82.99879 facility: Research Site status: NOT_YET_RECRUITING city: Marion state: Ohio zip: 43302 country: United States lat: 40.58867 lon: -83.12852 facility: Research Site status: NOT_YET_RECRUITING city: Toledo state: Ohio zip: 43617 country: United States lat: 41.66394 lon: -83.55521 facility: Research Site status: NOT_YET_RECRUITING city: Norman state: Oklahoma zip: 73071 country: United States lat: 35.22257 lon: -97.43948 facility: Research Site status: NOT_YET_RECRUITING city: Oklahoma City state: Oklahoma zip: 73134 country: United States lat: 35.46756 lon: -97.51643 facility: Research Site status: NOT_YET_RECRUITING city: Tulsa state: Oklahoma zip: 74133 country: United States lat: 36.15398 lon: -95.99277 facility: Research Site status: NOT_YET_RECRUITING city: Grants Pass state: Oregon zip: 97527 country: United States lat: 42.43933 lon: -123.33067 facility: Research Site status: NOT_YET_RECRUITING city: Medford state: Oregon zip: 97504 country: United States lat: 42.32652 lon: -122.87559 facility: Research Site status: NOT_YET_RECRUITING city: Roseburg state: Oregon zip: 97471 country: United States lat: 43.2165 lon: -123.34174 facility: Research Site status: NOT_YET_RECRUITING city: Camp Hill state: Pennsylvania zip: 17011 country: United States lat: 40.23981 lon: -76.91997 facility: Research Site status: NOT_YET_RECRUITING city: DuBois state: Pennsylvania zip: 15801 country: United States lat: 41.11923 lon: -78.76003 facility: Research Site status: NOT_YET_RECRUITING city: Philadelphia state: Pennsylvania zip: 19140 country: United States lat: 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123.43278 facility: Research Site status: NOT_YET_RECRUITING city: Shenyang zip: 110083 country: China lat: 41.79222 lon: 123.43278 facility: Research Site status: NOT_YET_RECRUITING city: Shijiazhuang zip: 50051 country: China lat: 38.04139 lon: 114.47861 facility: Research Site status: NOT_YET_RECRUITING city: Siping zip: 136000 country: China lat: 43.16143 lon: 124.37785 facility: Research Site status: NOT_YET_RECRUITING city: Taicang zip: 215400 country: China facility: Research Site status: NOT_YET_RECRUITING city: Taiyuan zip: 030001 country: China lat: 37.86944 lon: 112.56028 facility: Research Site status: NOT_YET_RECRUITING city: Taiyuan zip: 030012 country: China lat: 37.86944 lon: 112.56028 facility: Research Site status: NOT_YET_RECRUITING city: Taiyuan zip: 030032 country: China lat: 37.86944 lon: 112.56028 facility: Research Site status: NOT_YET_RECRUITING city: Taizhou zip: 318000 country: China lat: 32.49069 lon: 119.90812 facility: Research Site status: 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zip: 750001 country: China lat: 38.46806 lon: 106.27306 facility: Research Site status: NOT_YET_RECRUITING city: Yinchuan zip: 750004 country: China lat: 38.46806 lon: 106.27306 facility: Research Site status: NOT_YET_RECRUITING city: Zhengzhou zip: 450006 country: China lat: 34.75778 lon: 113.64861 facility: Research Site status: NOT_YET_RECRUITING city: Barranquilla zip: 080020 country: Colombia lat: 10.96854 lon: -74.78132 facility: Research Site status: NOT_YET_RECRUITING city: Bogota zip: 111411 country: Colombia lat: 4.60971 lon: -74.08175 facility: Research Site status: NOT_YET_RECRUITING city: Medellin zip: 050025 country: Colombia lat: 6.25184 lon: -75.56359 facility: Research Site status: NOT_YET_RECRUITING city: Medellin zip: 050030 country: Colombia lat: 6.25184 lon: -75.56359 facility: Research Site status: NOT_YET_RECRUITING city: Rionegro zip: 054047 country: Colombia lat: 6.15515 lon: -75.37371 facility: Research Site status: NOT_YET_RECRUITING city: Brandys nad Labem zip: 250 01 country: Czechia lat: 50.18356 lon: 14.67244 facility: Research Site status: NOT_YET_RECRUITING city: Olomouc zip: 772 00 country: Czechia lat: 49.59552 lon: 17.25175 facility: Research Site status: NOT_YET_RECRUITING city: Ostrava zip: 702 00 country: Czechia lat: 49.83465 lon: 18.28204 facility: Research Site status: NOT_YET_RECRUITING city: Praha 1 zip: 110 00 country: Czechia lat: 50.08804 lon: 14.42076 facility: Research Site status: NOT_YET_RECRUITING city: Rokycany zip: 337 22 country: Czechia lat: 49.7427 lon: 13.59459 facility: Research Site status: NOT_YET_RECRUITING city: Aalborg zip: 9000 country: Denmark lat: 57.048 lon: 9.9187 facility: Research Site status: NOT_YET_RECRUITING city: Esbjerg zip: 6700 country: Denmark lat: 55.47028 lon: 8.45187 facility: Research Site status: NOT_YET_RECRUITING city: Hvidovre zip: 2650 country: Denmark lat: 55.65719 lon: 12.47364 facility: Research Site status: NOT_YET_RECRUITING city: København NV zip: 2400 country: Denmark 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zip: 29680 country: France lat: 48.72381 lon: -3.98709 facility: Research Site status: NOT_YET_RECRUITING city: Vandoeuvre-Les-Nancy Cedex zip: 54511 country: France lat: 48.65 lon: 6.18333 facility: Research Site status: NOT_YET_RECRUITING city: VANNES cedex zip: 56017 country: France lat: 47.66667 lon: -2.75 facility: Research Site status: NOT_YET_RECRUITING city: Augsburg zip: 86150 country: Germany lat: 48.37154 lon: 10.89851 facility: Research Site status: NOT_YET_RECRUITING city: Berlin zip: 10625 country: Germany lat: 52.52437 lon: 13.41053 facility: Research Site status: NOT_YET_RECRUITING city: Berlin zip: 10787 country: Germany lat: 52.52437 lon: 13.41053 facility: Research Site status: NOT_YET_RECRUITING city: Berlin zip: 10969 country: Germany lat: 52.52437 lon: 13.41053 facility: Research Site status: NOT_YET_RECRUITING city: Berlin zip: 12157 country: Germany lat: 52.52437 lon: 13.41053 facility: Research Site status: NOT_YET_RECRUITING city: Berlin zip: 12159 country: Germany lat: 52.52437 lon: 13.41053 facility: Research Site status: NOT_YET_RECRUITING city: Berlin zip: 12203 country: Germany lat: 52.52437 lon: 13.41053 facility: Research Site status: NOT_YET_RECRUITING city: Berlin zip: 12627 country: Germany lat: 52.52437 lon: 13.41053 facility: Research Site status: NOT_YET_RECRUITING city: Berlin zip: 13187 country: Germany lat: 52.52437 lon: 13.41053 facility: Research Site status: NOT_YET_RECRUITING city: Bremen zip: 28215 country: Germany lat: 53.07516 lon: 8.80777 facility: Research Site status: NOT_YET_RECRUITING city: Bremen zip: 28259 country: Germany lat: 53.07516 lon: 8.80777 facility: Research Site status: NOT_YET_RECRUITING city: Cottbus zip: 03050 country: Germany lat: 51.75769 lon: 14.32888 facility: Research Site status: NOT_YET_RECRUITING city: Dachau zip: 85221 country: Germany lat: 48.26 lon: 11.43402 facility: Research Site status: NOT_YET_RECRUITING city: Darmstadt zip: 64283 country: Germany lat: 49.87167 lon: 8.65027 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47.31667 lon: 21.11667 facility: Research Site status: NOT_YET_RECRUITING city: Szolnok zip: 5000 country: Hungary lat: 47.18333 lon: 20.2 facility: Research Site status: NOT_YET_RECRUITING city: Százhalombatta zip: 2440 country: Hungary lat: 47.32579 lon: 18.92141 facility: Research Site status: NOT_YET_RECRUITING city: Székesfehérvár zip: 8000 country: Hungary lat: 47.18995 lon: 18.41034 facility: Research Site status: NOT_YET_RECRUITING city: Tapolca zip: 8300 country: Hungary lat: 46.88152 lon: 17.44117 facility: Research Site status: NOT_YET_RECRUITING city: Aligarh zip: 202002 country: India lat: 27.88145 lon: 78.07464 facility: Research Site status: NOT_YET_RECRUITING city: Belagavi zip: 590010 country: India facility: Research Site status: NOT_YET_RECRUITING city: Dehradun zip: 248001 country: India lat: 30.32295 lon: 78.03168 facility: Research Site status: NOT_YET_RECRUITING city: Delhi zip: 110029 country: India lat: 28.65195 lon: 77.23149 facility: Research Site status: 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Italy lat: 40.85216 lon: 14.26811 facility: Research Site status: NOT_YET_RECRUITING city: Pavia zip: 27100 country: Italy lat: 45.19205 lon: 9.15917 facility: Research Site status: NOT_YET_RECRUITING city: Perugia zip: 06126 country: Italy lat: 43.1122 lon: 12.38878 facility: Research Site status: NOT_YET_RECRUITING city: Roma zip: 00128 country: Italy lat: 41.89193 lon: 12.51133 facility: Research Site status: NOT_YET_RECRUITING city: Roma zip: 00133 country: Italy lat: 41.89193 lon: 12.51133 facility: Research Site status: NOT_YET_RECRUITING city: Roma zip: 161 country: Italy lat: 41.89193 lon: 12.51133 facility: Research Site status: NOT_YET_RECRUITING city: Rome zip: 00189 country: Italy lat: 41.89193 lon: 12.51133 facility: Research Site status: NOT_YET_RECRUITING city: Siena zip: 53100 country: Italy lat: 43.31822 lon: 11.33064 facility: Research Site status: NOT_YET_RECRUITING city: Varese zip: 21100 country: Italy lat: 45.82058 lon: 8.82511 facility: Research Site status: 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<|newrecord|> nctId: NCT06283953 id: 2023P001695 id: IHS-2022C1-26100 type: OTHER_GRANT domain: Patient Centered Outcomes Research Institute (PCORI) briefTitle: Boosting Resources for Tracheostomy Care at Home acronym: BREATHE overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-12-01 date: 2027-10-01 date: 2024-02-28 date: 2024-02-28 name: Massachusetts General Hospital class: OTHER name: Children's Hospital Medical Center, Cincinnati name: Children's Hospital of Philadelphia name: Children's Hospitals and Clinics of Minnesota name: Children's National Research Institute name: Rady Children's Hospital, San Diego name: Patient-Centered Outcomes Research Institute briefSummary: The goal of this trial is to advance our understanding of how to best support caregivers of children with tracheostomies who are caring for their child at home. The main questions it aims to answer are:
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* How can we support caregivers post-discharge with both medical and nonmedical decisions about resuming life, work, and family activities, while safely caring for their child with a tracheostomy at home?
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* How can we leverage existing technology to facilitate communication between inpatient and outpatient care teams to better support needs of pediatric patients and caregivers post-discharge?
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Caregiver participants will be randomly assigned to receive Trach Me Home (gold standard discharge program) or Trach Me Home with additional components. Caregiver participants will complete three surveys over the course of 6 months. Researchers will see if caregivers in the Trach Me Home with additional components report lower caregiver burden at 4 weeks post discharge (primary outcome) and fewer hospital readmissions at 6 months than those in Trach Me Home arm. conditions: Tracheostomy conditions: Caregiver Burden studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: Blinding of care team delivering the interventions and of caregiver participants receiving the interventions is not possible for this study.
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The outcome assessors collecting the readmission data and statistician conducting analyses will be blinded to the assignment. whoMasked: OUTCOMES_ASSESSOR count: 480 type: ESTIMATED name: Trach@Home name: Trach Me Home measure: Caregiver Burden measure: Medical Complications Associated with Tracheostomy measure: 6-month Readmission Rate measure: Frequency of pediatrician communication measure: Primary care pediatrician satisfaction measure: Medical Complications Associated with Tracheostomy measure: Caregiver Burden measure: Number of readmissions sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of San Diego Rady Children's Hospital city: La Jolla state: California zip: 92093 country: United States name: Matthew Brigger, MD role: CONTACT email: mbrigger@rchsd.org name: Matthew Brigger, MD role: PRINCIPAL_INVESTIGATOR lat: 32.84727 lon: -117.2742 facility: Children's National Medical Center, Children's Research Institute city: Silver Spring state: Maryland zip: 20910 country: United States name: Habib Zalzal, MD role: CONTACT email: hzalzal@cnmc.org name: Habib Zalzal, MD role: PRINCIPAL_INVESTIGATOR lat: 38.99067 lon: -77.02609 facility: Massachusetts General Hospital city: Boston state: Massachusetts zip: 02114 country: United States name: Karen Sepucha, PhD role: CONTACT email: ksepucha@mgh.harvard.edu name: Christopher Hartnick, MD role: CONTACT lat: 42.35843 lon: -71.05977 facility: Children's Hospitals and Clinics of Minnesota city: Minneapolis state: Minnesota zip: 55404 country: United States name: Asitha Jayawardena, MD role: CONTACT email: asitha.jayawardena@childrensmn.org name: Asitha Jayawardena, MD role: PRINCIPAL_INVESTIGATOR lat: 44.97997 lon: -93.26384 facility: Cincinnati Children's Hospital Medical Center city: Cincinnati state: Ohio zip: 45229 country: United States name: Matthew Smith, MD role: CONTACT email: matthew.smith@cchmc.org name: Matthew Smith, MD role: PRINCIPAL_INVESTIGATOR lat: 39.12713 lon: -84.51435 facility: Children's Hospital of Philadelphia city: Philadelphia state: Pennsylvania zip: 19146 country: United States name: Luv Javia, MD role: CONTACT email: javia@chop.edu name: Luv Javia, MD role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 hasResults: False
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<|newrecord|> nctId: NCT06283940 id: 281694 briefTitle: Exercise-based Cardiac Rehabilitation in Patients With Aortic Stenosis After Transcatheter Aortic Valve Implantation acronym: TAVI overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2026-01 date: 2026-01 date: 2024-02-28 date: 2024-04-24 name: Vastra Gotaland Region class: OTHER_GOV briefSummary: Aortic valve stenosis (AS) is the most common valve disease among older individuals. In symptomatic AS, mortality is high, and the only treatment that improves prognosis and survival is transcatheter aortic valve implantation (TAVI). TAVI is a growing treatment in Sweden, allowing previously inoperable older patients with AS, who are often frail and have comorbidities, to receive intervention. This results in the need for postoperative cardiac rehabilitation for patients treated with TAVI. Previous systematic reviews and meta-analyses examining the effect of physiotherapist-led exercise-based cardiac rehabilitation (PT-X) after TAVI have shown that participation in PT-X can improve physical fitness (the highest measured oxygen uptake (VO2peak)), walking distance, walking speed, and health-related quality of life (HR-QoL). However, the included studies are limited, and there is selection bias, resulting in low evidence. Therefore, access to PT-X is currently almost non-existent in Sweden. As more patients undergo TAVI, it is crucial to investigate whether PT-X after TAVI can further improve physical fitness, HR-QoL, and reduce hospital admissions in older individuals with AS.
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Objective: Primary, to investigate whether participation in PT-X after TAVI can impact physical fitness, physical activity level, and health-related quality of life. Secondary, to study the prevalence of frailty and the number of hospital admissions during the first postoperative year after TAVI.
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Expected outcome: If patients with AS who have undergone TAVI can improve physical fitness, it could potentially strengthen the evidence and optimize the patient's physical capabilities. Increased access to PT-X and awareness of frailty in these patients could reduce the risk of falls and possibly the number of hospital readmissions. This would decrease healthcare consumption and improve the patient's quality of life. conditions: Aortic Valve Stenosis studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Intervention group and matched controls based on age, gender and exercise capacity in watt. primaryPurpose: TREATMENT masking: NONE maskingDescription: Data collection will be conducted by a physiotherapist not involved in the intervention. count: 135 type: ESTIMATED name: Physiotherapist-led exercise based cardiac rehabilitation (PT-X) measure: Exercise capacity in watt measure: Rating of perceived exertion Borg RPE scale 6-20 measure: Exercise capacity in Watt measure: Rating of perceived exertion Borg RPE scale 6-20 measure: Muscular endurance test, shoulder flexion measure: Muscular endurance test, shoulder flexion measure: Muscle endurance test, shoulder abduction measure: Muscle endurance test, shoulder abduction measure: Muscle endurance test, unilateral heel-lift measure: Muscle endurance test, unilateral heel-lift measure: Lower extremity function measure: Lower extremity function measure: Physical activity measure: Physical activity measure: Self-assessed level of physical activity measure: Self-assessed level of physical activity measure: Health Related Quality of Life measure: Health Related Quality of Life measure: Frailty measure: Frailty measure: Hospital admission measure: Hospital admission sex: ALL minimumAge: 65 Years stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06283927 id: MEC-2020-0812-5 briefTitle: The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma (ENCRAM 2302) acronym: RECSUR overallStatus: RECRUITING date: 2023-01-01 date: 2027-01-01 date: 2028-01-01 date: 2024-02-28 date: 2024-02-28 name: Jasper Gerritsen class: OTHER name: Haaglanden Medical Centre name: Universitaire Ziekenhuizen KU Leuven name: University Hospital Heidelberg name: Technical University of Munich name: Insel Gruppe AG, University Hospital Bern name: Massachusetts General Hospital name: University of California, San Francisco briefSummary: Previous evidence has indicated that resection for recurrent glioblastoma might benefit the prognosis of these patients in terms of overall survival. However, the demonstrated safety profile of this approach is contradictory in the literature and the specific benefits in distinct clinical and molecular patient subgroups remains ill-defined. The aim of this study, therefore, is to compare the effects of resection and best oncological treatment for recurrent glioblastoma as a whole and in clinically important subgroups.
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This study is an international, multicenter, prospective observational cohort study. Recurrent glioblastoma patients will undergo tumor resection or best oncological treatment at a 1:1 ratio as decided by the tumor board. Primary endpoints are: 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks after surgery and 2) overall survival. Secondary endpoints are: 1) progression-free survival (PFS), 2) NIHSS deterioration at 3 months and 6 months after surgery, 3) health-related quality of life (HRQoL) at 6 weeks, 3 months, and 6 months after surgery, and 4) frequency and severity of Serious Adverse Events (SAEs) in each arm. Estimated total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year.
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The study has been approved by the Medical Ethics Committee (METC Zuid-West Holland/Erasmus Medical Center; MEC-2020-0812). The results will be published in peer-reviewed academic journals and disseminated to patient organisations and media. conditions: Glioblastoma conditions: Glioblastoma Multiforme conditions: Glioblastoma, IDH-wildtype conditions: Glioblastoma Multiforme of Brain conditions: Glioblastoma Multiforme, Adult conditions: Recurrent Glioblastoma conditions: Astrocytoma, Malignant conditions: Astrocytoma of Brain studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 464 type: ESTIMATED name: Re-resection name: Temozolomide name: Lomustine name: Re-irradiation name: Experimental therapy name: Best supportive care measure: Overall survival measure: Neurological morbidity at 6 weeks measure: Neurological morbidity at 3 months measure: Neurological morbidity at 6 months measure: Progression-free survival measure: Residual tumor volume measure: Quality of life at 6 weeks (EORTC QLQ C30) measure: Quality of life at 3 months (EORTC QLQ C30) measure: Quality of life at 6 months (EORTC QLQ C30) measure: Quality of life at 6 weeks (EORTC QLQ BN20) measure: Quality of life at 3 months (EORTC QLQ BN20) measure: Quality of life at 6 months (EORTC QLQ BN20) measure: Quality of life at 6 weeks (EQ-5D) measure: Quality of life at 3 months (EQ-5D) measure: Quality of life at 6 months (EQ-5D) measure: Serious Adverse Events sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of California, San Francisco status: RECRUITING city: San Francisco state: California zip: 94143 country: United States name: Mitchel Berger, MD PhD role: CONTACT lat: 37.77493 lon: -122.41942 facility: Massachusetts General Hospital status: RECRUITING city: Boston state: Massachusetts zip: 02114 country: United States name: Brian Nahed, MD PhD role: CONTACT lat: 42.35843 lon: -71.05977 facility: University Hospital Leuven status: RECRUITING city: Leuven country: Belgium name: Steven De Vleeschouwer, MD PhD role: CONTACT lat: 50.87959 lon: 4.70093 facility: University Hospital Heidelberg status: RECRUITING city: Heidelberg country: Germany name: Christine Jungk, Dr. med. role: CONTACT lat: 49.40768 lon: 8.69079 facility: Technical University Munich status: NOT_YET_RECRUITING city: Munich country: Germany name: Arthur Wagner, MD role: CONTACT lat: 48.13743 lon: 11.57549 facility: Erasmus MC status: RECRUITING city: Rotterdam state: Zuid-Holland zip: 3015 CE country: Netherlands name: Arnaud Vincent, MD PhD role: CONTACT phone: +31639428949 email: a.vincent@erasmusmc.nl name: Jasper Gerritsen, MD role: CONTACT phone: +31629119553 email: j.gerritsen@erasmusmc.nl lat: 51.9225 lon: 4.47917 facility: Medical Center Haaglanden status: RECRUITING city: The Hague state: Zuid-Holland zip: 2261 CP country: Netherlands name: Marike Broekman, MD PhD role: CONTACT phone: +31639758253 email: m.broekman@haaglandenmc.nl lat: 52.07667 lon: 4.29861 facility: Inselspital Universitätsspital Bern status: NOT_YET_RECRUITING city: Bern country: Switzerland name: Philippe Schucht, MD PhD role: CONTACT lat: 46.94809 lon: 7.44744 hasResults: False
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<|newrecord|> nctId: NCT06283914 id: BIO-2024-0011 briefTitle: Imputation of Arterial Oxygen Partial Pressures Using Pulse Oximetry overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-08-01 date: 2024-09-01 date: 2024-02-28 date: 2024-02-28 name: American University of Beirut Medical Center class: OTHER briefSummary: The goal of this is prospective cohort study is to to study the relationship between PaO2 and SpO2 in the overall population undergoing general anesthesia in the OT. Secondary aims include studying the relationship between PaO2 and SpO2 in elderly and obese patients undergoing general anesthesia in the OT, validating the derivation of PaO2 from SpO2 using formulas derived by Rice et al. (2009), Pandharipande et al. (2009), and Gadrey et al. (2019) in patients undergoing general anesthesia in the OT, and, if the derivation formulas were not valid, to derive a formula for patients undergoing general anesthesia in the OT.
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The included blood samples are arterial blood sample collected for ABGs analysis through either an arterial catheter or an arterial blood puncture in adult patients (Age \>18 years) undergoing general anesthesia regardless of the acuity of the surgery (elective, emergency, or lifesaving), the hemodynamic stability of the patient, or the comorbidities. Patients undergoing cardiac or thoracic surgeries will be excluded. conditions: Oxygen Saturation conditions: Respiratory Distress Syndrome conditions: Anesthesia, General studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED measure: PaO2 measure: SpO2 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06283901 id: NL82013.018.22 briefTitle: Improving Diagnosis and Prediction of Outcome in Patients With Severe Disorders of Consciousness acronym: IMPROVE-DOC overallStatus: RECRUITING date: 2023-01-02 date: 2025-01-01 date: 2025-09-01 date: 2024-02-28 date: 2024-02-28 name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) class: OTHER briefSummary: Patients with acute severe brain injury are usually admitted to the Intensive Care Unit. A substantial proportion of these patients will have disorders of consciousness (DOC) after interruption of sedation. It is difficult to reliably predict neurological outcome in these patients. Dependent on the extent of permanently damaged brain areas, DOC in patients with acute severe brain injury may improve or persist, eventually evolving into a minimal conscious state (MCS) or unresponsive wakefulness syndrome (UWS). These conditions are accompanied by long term severe disability. In current practice, the decision to withdraw life-sustaining support is made by interpreting the results of repeated bedside neurological examination and conventional CT-brain imaging. Reliable identification of patients with a possible good outcome, in whom treatment should not be withdrawn, is difficult. In this prospective observational cohort study we aim to identify patients with a good neurological outcome. conditions: Traumatic Brain Injury conditions: Intracranial Hemorrhages conditions: Subarachnoid Hemorrhage conditions: Meningitis conditions: Encephalitis conditions: Stroke studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 160 type: ESTIMATED measure: Glasgow Outcome Scale Extended measure: Glasgow Outcome Scale Extended sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Radboud UMC status: RECRUITING city: Nijmegen state: Gelderland zip: 6525 GA country: Netherlands name: Astrid Hoedemaekers role: CONTACT lat: 51.8425 lon: 5.85278 facility: Amsterdam UMC status: RECRUITING city: Amsterdam state: Noord-Holland zip: 1105 AZ country: Netherlands name: Wolmet Haksteen, MD role: CONTACT phone: +31 020 - 566 9111 email: w.e.haksteen@amsterdamumc.nl lat: 52.37403 lon: 4.88969 facility: Haaglanden MC, locatie Westeinde status: RECRUITING city: Den Haag state: Zuid-Holland zip: 2512 VA country: Netherlands name: Sefanja Achterberg role: CONTACT lat: 52.07667 lon: 4.29861 facility: Erasmus MC status: NOT_YET_RECRUITING city: Rotterdam state: Zuid-Holland zip: 3015 GD country: Netherlands name: Mathieu van der Jagt role: CONTACT lat: 51.9225 lon: 4.47917 facility: UMC Groningen status: NOT_YET_RECRUITING city: Groningen zip: 9713 GZ country: Netherlands name: Joukje van der Naalt role: CONTACT lat: 53.21917 lon: 6.56667 hasResults: False
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<|newrecord|> nctId: NCT06283888 id: PRECISE-PCI briefTitle: CYP2C19 Genotype-Guided P2Y12 Receptor Inhibitor Selection After Complex Percutaneous Coronary Intervention overallStatus: RECRUITING date: 2024-04-01 date: 2028-04-01 date: 2028-12-01 date: 2024-02-28 date: 2024-03-20 name: Zunyi Medical College class: OTHER briefSummary: In Ease Asia clinical trials, P2Y12 inhibitor (ticagrelor or clopidogrel) monotherapy after 3-month dual antiplatelet therapy (DAPT) resulted in a lower incidence of clinically significant bleeding, without increasing risk of major adverse cardiac and cerebrovascular events, even if acute coronary syndrome (ACS) following complex percutaneous coronary intervention (PCI) when compared with standard DAPT. Although better understood "East Asian Paradox", finding the right CYP2C19 genotype-guided P2Y12 inhibitor selection to balance maintaining ischaemic prevention and less bleeding remains a topic in real-world clinical practice. conditions: ACS - Acute Coronary Syndrome conditions: CYP2C19 Polymorphism studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 1200 type: ESTIMATED name: CYP2C19 Genotype Guided DAPT name: Conventional DAPT measure: NACE (net adverse clinical event) measure: Incidence of clinically significant bleeding measure: Incidence of MACCE sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Affiliated Hospital of Zunyi Medical University status: RECRUITING city: Zunyi state: Guizhou zip: 563003 country: China name: Cai De Jin, MD role: CONTACT phone: 86+173-8576-9997 email: jincaide@zmu.edu.cn name: Yan Yan Jin, MD, PhD role: CONTACT phone: 86+157-7229-0925 email: jinyanyan850925@163.com name: Cai De Jin, MD role: PRINCIPAL_INVESTIGATOR name: Ran Zun Zhao, MD role: SUB_INVESTIGATOR lat: 27.68667 lon: 106.90722 hasResults: False
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<|newrecord|> nctId: NCT06283875 id: PROMISEPLUS-301 briefTitle: The Exploration of Personalized ctDNA Based MRD in the Clinical Significance of Cervical Cancer overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2026-01-30 date: 2029-01-30 date: 2024-02-28 date: 2024-02-28 name: Geneplus-Beijing Co. Ltd. class: INDUSTRY briefSummary: This study plans to enroll 80 patients with locally advanced cervical cancer (stage IB-ⅣA) confirmed by histology or cytology (according to the 2018 FIGO staging standard), who are expected to receive surgical resection or curative radiotherapy and chemotherapy. Collect baseline tumor tissue samples from patients during the treatment period, as well as peripheral blood samples (20 ml/time) from multiple treatment timepoints. Mutations in tumor tissue were detected by the 1021 genes panel, then personalized MRD monitoring probes were customized for patients, allowing for multi node peripheral blood sample ctDNA detection of enrolled patients. The clinical significance of ctDNA in prognostic stratification, recurrence monitoring, and efficacy prediction in surgical/non-surgical cervical cancer patients was explored. And compare the consistency and differences between ctDNA detection technology, imaging, and blood tumor markers in monitoring tumor disease progression, and evaluate the correlation between ctDNA status after curative treatment and patient PFS and RFS. conditions: Ovarian Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 80 type: ESTIMATED measure: DFS of enrolled patients for 2 years sex: FEMALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Soochow University city: Suzhou state: Jiangsu zip: 215006 country: China name: Jinhua Zhou role: CONTACT phone: +86 13914024750 email: jsjhzh@126.com name: Songbing Qin role: PRINCIPAL_INVESTIGATOR lat: 31.30408 lon: 120.59538 hasResults: False
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<|newrecord|> nctId: NCT06283862 id: HUM00231159b id: VMR2022-03 type: OTHER_GRANT domain: Michigan, State of, Licensing and Regulatory Affairs, Department of 573000 briefTitle: MIVetsCan: Can-Coach Trial (Phase 2) overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2027-02 date: 2027-02 date: 2024-02-28 date: 2024-02-28 name: University of Michigan class: OTHER name: Michigan, State of, Licensing and Regulatory Affairs briefSummary: The goal of the MIVetsCan Can-Coach Trial is to test four coaching sessions to help Veterans with chronic pain use their own cannabis products more effectively to manage pain and related symptoms. conditions: Chronic Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be randomized to immediately receive 4 sessions of tailored guidance or to receive it after 12 weeks, as a waitlist control condition. primaryPurpose: PREVENTION masking: NONE count: 468 type: ESTIMATED name: Educational Session measure: Patient Global Impression of Change (PGIC) score measure: Self-report of pain (intensity or severity) from a numerical rating scale of 0-10 measure: Anxiety as measured by the score on the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Profile version 2.1 measure: Pain interference trends as measured by the score on the PROMIS-29 Profile version 2.1 measure: Sleep disturbance as measured by the score on the PROMIS-29 Profile version 2.1 measure: Suicidal ideation as measured by the Positive and Negative Suicide Ideation (PANSI) - Positive ideation measure: Suicidal ideation as measured by the Positive and Negative Suicide Ideation (PANSI) - Negative ideation sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Michigan city: Ann Arbor state: Michigan zip: 48105 country: United States name: Vivian Kurtz role: CONTACT phone: 734-998-7156 email: vkurtz@med.umich.edu name: Kevin Boehnke role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 hasResults: False
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<|newrecord|> nctId: NCT06283849 id: SON-2024-32671 briefTitle: Collaborative Solutions for Breaking up Sedentary Time in Black Older Adults With Type 2 Diabetes: The Interrupt Diabetes Study overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-05-01 date: 2026-05-01 date: 2024-02-28 date: 2024-02-28 name: University of Minnesota class: OTHER briefSummary: The disparate burden of Type 2 Diabetes (T2D) faced by Black individuals makes attention to preventing or delaying the development of T2D and its associated cardiovascular (CV) complications, essential.
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Similar to differences in cardiovascular disease (CVD) rates across racial and ethnic groups of older people, there are differences in engagement in physical activity (PA), a significant contributor to CVD. Black adults are less likely to engage in physical activity PA than their non-Hispanic White peers, with 26.7% of Black Minnesotans reporting that they did not engage any leisure-time PA in the past month, compared to 19.6% of non-Hispanic White Minnesotans. Notably, recent research has demonstrated that high amounts SB (i.e., sitting or lying with low levels of energy expenditure) also have significant detrimental effects on health, beyond those of physical inactivity. Experimental data from lab-based studies demonstrate that breaking up prolonged SB can rapidly improve markers of cardiometabolic risk (e.g., glucose and endothelial function) but the majority of these studies have focused on young, healthy, White adults. Given the significant inequities and health disparities faced by Black individuals and the lack of adequate representation of Black older adults in studies examining SB in individuals with T2D, understanding psychosocial and societal contributors to and consequences of SB experienced by this population is an essential first step toward developing relevant interventions targeting SB, and ultimately, CV health.
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The disparate burden of T2D faced by Black individuals makes attention to preventing or delaying the development of T2D and its associated CV complications, essential.
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Similar to differences in CVD rates across racial and ethnic groups of older people, there are differences in engagement in physical activity (PA), a significant contributor to CVD. Black adults are less likely to engage in PA than their non-Hispanic White peers, with 26.7% of Black Minnesotans reporting that they did not engage any leisure-time PA in the past month, compared to 19.6% of non-Hispanic White Minnesotans. Notably, recent research has demonstrated that high amounts SB (i.e., sitting or lying with low levels of energy expenditure) also have significant detrimental effects on health, beyond those of physical inactivity. Experimental data from lab-based studies demonstrate that breaking up prolonged SB can rapidly improve markers of cardiometabolic risk (e.g., glucose and endothelial function) but the majority of these studies have focused on young, healthy, White adults. Given the significant inequities and health disparities faced by Black individuals and the lack of adequate representation of Black older adults in studies examining SB in individuals with T2D, understanding psychosocial and societal contributors to and consequences of SB experienced by this population is an essential first step toward developing relevant interventions targeting SB, and ultimately, CV health.
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The goal is to develop a deeper understanding of individuals' experiences of sedentary behavior (SB) and collaborate to design strategies to reduce SB. Using the Center for Chronic Disease Reduction and Equity Promotion Across Minnesota (C2DREAM) conceptual model, social-ecological framework, and COM-B model, the study will seek to understand the relationship between SB and individual, relationship, community, and societal factors. The study will also examine the context of SB and strategies that participants have used and could or would consider using to break up the time they spend sitting. conditions: Cardiovascular Diseases conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Explanatory sequential mixed methods study of N=30 Black adults aged 55 and older with T2D. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 30 type: ESTIMATED name: strategies to break up SB measure: sedentary time sex: ALL minimumAge: 55 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Minnesota city: Minneapolis state: Minnesota zip: 55414 country: United States name: Mary O Whipple, PhD, RN, PHN role: CONTACT phone: 612-625-4470 email: whipp042@umn.edu lat: 44.97997 lon: -93.26384 hasResults: False
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<|newrecord|> nctId: NCT06283836 id: Dexrem ATI 4-6 briefTitle: Dexmedetomidine vs. Remifentanil Conscious Sedation for Stapedotomy/Stapedectomy overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-03-01 date: 2025-03-15 date: 2024-02-28 date: 2024-02-28 name: Iuliu Hatieganu University of Medicine and Pharmacy class: OTHER briefSummary: Dexmedetomidine continuous intravenous infusion vs. remifentanil target-controlled infusion conscious sedation for stapedotomy/stapedectomy- a prospective, single-center, double-masked randomized trial
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The goal of this clinical trial is to compare monitored anesthesia care with continuous intravenous dexmedetomidine vs. remifentanil target-controlled infusion in patients undergoing stapedotomy or stapedectomy for otosclerosis. The aims of this research are:
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* to assess the patient's satisfaction with each sedation regimen
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* the surgeon will also grade their satisfaction regarding the surgical field The investigators will monitor and analyze the vitals during and after the intervention and document any intra- and postoperative complications.
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Participants will be randomly assigned to receive either dexmedetomidine or remifentanil, and the patient, the surgeon, and the investigator will not be aware of the treatment administered. conditions: Otosclerosis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Dexmedetomidine name: Remifentanil measure: Patient satisfaction measure: Surgeon satisfaction measure: mean arterial pressure measure: Heart Rate measure: the need for adjuncts during intervention sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cluj County Clinical Emergency Hospital city: Cluj Napoca state: Cluj zip: 400006 country: Romania name: Caius Mihai Breazu, MD, PhD role: CONTACT phone: +40743010012 email: csbreazu@yahoo.com name: ioan florin marchis, MD, PhD role: CONTACT phone: +40757065205 email: mosku17@yahoo.com lat: 46.76667 lon: 23.6 hasResults: False
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<|newrecord|> nctId: NCT06283823 id: 41821 briefTitle: Morphological Changes of Removable Orthodontic Retainers During the Use overallStatus: RECRUITING date: 2021-12-21 date: 2024-04-01 date: 2024-12-21 date: 2024-02-28 date: 2024-03-01 name: University of L'Aquila class: OTHER briefSummary: The retention is one of the stages of orthodontic treatment that aims to keep the teeth in the correct positions after orthodontic treatment. Without a retention phase, there is a tendency for the teeth to return to their initial position (relapse). To prevent relapse, at the end of orthodontic therapy the use of retaining devices to keep the teeth in their ideal position is required. The aim of the study is to analyse whether intraoral aging of removable retention devices can lead to morphological or dimensional changes, and whether or not these changes are related to orthodontic relapse, expressed as a change in the Peer Assessment Rating (PAR) index. The PAR index is an index that allows us to evaluate the relapse after orthodontic treatment. In this study the PAR index will be measured at the start of the retention period (T0), at the three-months follow-up (T1) and at the six months follow-up (T2). In particular, two types of thermoformed retainers with different cutouts will be evaluated to determine whether the presence of higher margins in a type of retainers allows to maintain greater stability over time and, therefore, to confer a mechanical and clinical advantage. conditions: Orthodontic Retainer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 36 type: ESTIMATED name: Thermoformed orthodontic retainer measure: Peer Assessment Rating (PAR) index measure: Volumetric superimposition of digital models measure: Thickness sex: ALL minimumAge: 18 Years maximumAge: 35 Years stdAges: ADULT facility: University of L'Aquila status: RECRUITING city: L'Aquila zip: 67100 country: Italy name: Michele Tepedino, DDS role: CONTACT phone: +39 340 276 1456 email: michele.tepedino@univaq.it lat: 42.35055 lon: 13.39954 hasResults: False
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<|newrecord|> nctId: NCT06283810 id: 2023/168 briefTitle: The Effects of Interpersonal Relationship Psychotherapy and Laughter Therapy overallStatus: RECRUITING date: 2024-02-01 date: 2024-06-30 date: 2024-09-30 date: 2024-02-28 date: 2024-03-06 name: Istanbul University - Cerrahpasa (IUC) class: OTHER briefSummary: Midwives, who have an important place in the health system, are expected to be equipped to meet the health care needs of women (Fışkın \& Doğan, 2020). Therefore, midwifery students, who are known to play a role in promoting women's health, should have good interpersonal relationships, good problem-solving skills, and high self-reflection and insight, which are assumed to be effective in both, in order to fulfill these responsibilities.
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Translated with DeepL.com (free version) conditions: Midwifery Students studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: SINGLE whoMasked: PARTICIPANT count: 40 type: ESTIMATED name: psychotherapy of interpersonal relationships name: laughter therapy name: Plasebo measure: self-reflection skills measure: problem solving skills measure: interpersonal relationship skills sex: FEMALE minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Istanbul University-Cerrahpasa status: RECRUITING city: Istanbul zip: 34320 country: Turkey name: Betül Uncu role: CONTACT phone: +095078421227 email: betul.uncu@iuc.edu.tr name: Nurten Kaya role: SUB_INVESTIGATOR name: Betül Uncu role: PRINCIPAL_INVESTIGATOR lat: 41.01384 lon: 28.94966 hasResults: False
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