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<|newrecord|> nctId: NCT06378905 id: 141/57 briefTitle: Cukurova Score Validation Study acronym: CUKUROVA overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-03 date: 2027-03 date: 2024-04-23 date: 2024-04-23 name: Cukurova University class: OTHER name: Muğla Sıtkı Koçman University name: Sakarya University name: Gazi University name: Ankara Etlik City Hospital name: Kayseri City Hospital name: Mersin University name: Selçuk University name: Bezmialem Vakif University name: Uludag University name: Mersin City Hospital name: Marmara University name: Prof. Dr. Cemil Tascıoglu City Hospital name: Ankara University name: Ege University name: Hacettepe University name: Akdeniz University name: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital name: Mustafa Kemal University name: Trakya University briefSummary: Despite significant advancements in imaging technologies, surgical techniques, chemotherapeutic regimens, and treatment strategies in recent years, ovarian cancer continues to remain the most deadly gynecological malignancy. Approximately 90% of ovarian cancers originate from the coelomic epithelium or modified mesothelial cells and are classified as epithelial ovarian cancers. The majority of patients with epithelial ovarian cancer (70-80%) present in advanced stages. The primary treatment for advanced-stage (stage 3-4) disease consists of primary cytoreductive surgery followed by adjuvant chemotherapy. Cytoreductive surgery aims to remove all visible tumor implants regardless of the extent of the disease and achieve no visible residual tumor (complete cytoreduction, R0) at the end of the surgery. In cases where R0 cannot be achieved (due to poor general condition and/or extensive tumor that cannot be completely excised surgically), the option of neoadjuvant chemotherapy followed by interval cytoreductive surgery is considered. Primary cytoreductive surgery is still the preferred option and is considered a quality indicator for centers performing advanced-stage ovarian cancer surgeries. Despite advancements in surgery, the decision for interval surgery following primary surgery or neoadjuvant chemotherapy is often based on the surgeon's experience, imaging results, and clinic preferences. Various methods and scores have been published and applied to predict which patients are suitable for primary surgery.
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The Cukurova score developed in our clinic conceptualizes prioritizing surgical procedures using radiological imaging and diagnostic exploratory laparoscopy to achieve complete cytoreduction in harmony with the patient's clinical and performance status, rather than focusing solely on tumor burden. The score showed high success rates for complete cytoreduction and also was useful in terms of predicting the morbidity and mortality. However, the Cukurova score study was conducted in single center. Validation of scores in centers with different capacities is expected to facilitate their widespread use and acceptance. Therefore, in this study, the investigators plan to conduct a validation study of the score in a total of 20 centers in Turkey, including our center. This study aims to evaluate the validity of the Cukurova score in predicting outcomes of primary cytoreduction in advanced ovarian cancer patients and thus determining the decision for primary cytoreductive surgery or neoadjuvant chemotherapy followed by interval cytoreductive surgery. conditions: Epithelial Ovarian Cancer conditions: Primary Cytoreduction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 130 type: ESTIMATED measure: Rate of complete cytoreduction measure: Rate of postoperative 90-days mortality measure: Rate of postoperative morbidity sex: FEMALE minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cukurova University city: Adana zip: 01330 country: Turkey name: Ghanim Khatib, MD role: CONTACT phone: 03223386060 email: ghanim.khatib@gmail.com name: Ghanim Khatib, MD role: CONTACT phone: +903223386060 phoneExt: Khatib email: ghanim.khatib@gmail.com name: Ghanim Khatib, MD,Ass.Prof role: PRINCIPAL_INVESTIGATOR lat: 37.00167 lon: 35.32889 hasResults: False
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<|newrecord|> nctId: NCT06378892 id: CRO-2023-78 briefTitle: A Study to Evaluate the Combination of Platinum-pemetrexed Based Chemotherapy Plus Lorlatinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) With Exclusively Extracranial Disease Progression on Lorlatinib acronym: ALK-PPL overallStatus: RECRUITING date: 2024-03-15 date: 2028-05 date: 2028-05 date: 2024-04-23 date: 2024-04-23 name: Centro di Riferimento Oncologico - Aviano class: OTHER briefSummary: This study aims to evaluate the activity and safety of the combination of platinum-pemetrexed based chemotherapy plus Lorlatinib in ALK positive Non-Small Cell Lung Cancer (NSCLC) with exclusively extracranial disease progression on Lorlatinib. Platinum-pemetrexed based chemotherapy plus Lorlatinib will be administered for an induction phase of four cycles. Subsequently, patients with response or stability of disease at radiological assessment will start the maintenance phase with pemetrexed-Lorlatinib in 21-day cycles until progression, unacceptable toxicity, death, or withdrawal of consent. conditions: Non Small Cell Lung Cancer Metastatic conditions: ALK Gene Mutation studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: Lorlatinib measure: Compare Progression Free Survival between patients treated with Pemetrexed (PT)/pem-based chemotherapy plus Lorlatinib after Lorlatinib versus retrospective data of 3,2 months for patients treated with PT/pem-based chemotherapy after Lorlatinib. measure: Intracranial Progression Free Survival (PFS) in patients treated with PT/pem-based chemotherapy plus Lorlatinib after Lorlatinib. measure: Overall survival (OS) in patients treated with PT/pem-based chemotherapy plus Lorlatinib after Lorlatinib progression measure: Describe the safety of PT/pem-based chemotherapy plus Lorlatinib combination sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centro di Riferimento Oncologico (CRO) IRCCS status: RECRUITING city: Aviano zip: 33081 country: Italy name: Alessandra Bearz role: CONTACT phone: 0434659294 email: abearz@cro.it lat: 46.07056 lon: 12.59472 facility: Azienda Ospedaliero-Universitaria Careggi Oncologia Medica status: NOT_YET_RECRUITING city: Firenze zip: 50134 country: Italy name: Lorenzo Antonuzzo role: CONTACT phone: 0557947298 email: antonuzzol@aou-careggi.toscana.it lat: 43.77925 lon: 11.24626 facility: Azienda USL Toscana Nord Ovest Oncologia Medica, Ospedale Versilia status: NOT_YET_RECRUITING city: Lido Di Camaiore zip: 55049 country: Italy name: Camerini Andrea role: CONTACT phone: 05846057282 email: andrea.camerini@uslnordovest.toscana.it lat: 43.90012 lon: 10.2269 facility: Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino amadori" status: NOT_YET_RECRUITING city: Meldola zip: 47014 country: Italy name: Delmonte Angelo role: CONTACT phone: 0543739100 email: angelo.delmonte@irst.emr.it lat: 44.12775 lon: 12.0626 facility: Fondazione IRCCS San Gerardo dei Tintori status: NOT_YET_RECRUITING city: Monza zip: 20900 country: Italy name: Cortinovis Diego Luigi role: CONTACT phone: 0392336040 email: diegoluigi.cortinovis@irccs-sangerardo.it lat: 45.58005 lon: 9.27246 facility: IOV Istituto Oncologico Veneto IRCCS status: NOT_YET_RECRUITING city: Padova zip: 35128 country: Italy name: Pasello Giulia role: CONTACT phone: 0498215608 email: giulia.pasello@iov.veneto.it lat: 45.40797 lon: 11.88586 facility: Azienda Ospedaliero-Universitaria di Parma status: NOT_YET_RECRUITING city: Parma zip: 43126 country: Italy name: Tiseo Marcello role: CONTACT phone: 0521702316 email: mtiseo@ao.pr.it lat: 44.79935 lon: 10.32618 facility: Azienda Ospedaliera di Perugia status: NOT_YET_RECRUITING city: Perugia zip: 06129 country: Italy name: Metro Giulio role: CONTACT phone: 0755783695 email: giulio.metro@ospedale.perugia.it lat: 43.1122 lon: 12.38878 facility: Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) status: NOT_YET_RECRUITING city: Udine zip: 33010 country: Italy name: Giacomo Pellizzari role: CONTACT phone: 0432552754 email: giacomo.pelizzari@asufc.sanita.fvg.it lat: 46.0693 lon: 13.23715 hasResults: False
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<|newrecord|> nctId: NCT06378879 id: 1073/1/3/26 briefTitle: Intermittent Boluses Versus Infusion of Propofol During Gastroscopy overallStatus: NOT_YET_RECRUITING date: 2024-05-06 date: 2025-04-30 date: 2025-07-30 date: 2024-04-23 date: 2024-04-23 name: Al-Balqa Applied University class: OTHER name: Luzmila Hospital briefSummary: It is unclear whether continuous infusion or intermittent bolus injection of propofol is better for achieving adequate sedation during a standard upper endoscopy. The study aimed to compare the efficacy and safety of continuous infusion and intermittent bolus injection of Propofol (Diprivan) during a standard upper endoscopy. In this prospective study, patients will be randomly assigned to undergo a standard upper endoscopy with either continuous infusion (CI group) or intermittent bolus injection (BI group) of Propofol (Diprivan) administered by an anesthesiologist. The primary outcome will be to assess the quality of sedation by the endoscopist (VAS). In addition to other sedation-related parameters that will include sedation induction time (minutes), total dose of propofol (mg), recovery time (minutes) using Aldrete score, any involuntary patient movement, and adverse events. conditions: Anesthesia studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 100 type: ESTIMATED name: Propofol 100 MG in 10 ML Injection measure: Sedation induction time (minutes) measure: Total dose of propofol (mg) measure: Recovery time (minutes) measure: Involuntary movement measure: Quality of sedation measure: Adverse events sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06378866 id: MC230502 id: NCI-2024-02978 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: 23-012176 type: OTHER domain: Mayo Clinic Institutional Review Board id: MC230502 type: OTHER domain: Mayo Clinic in Rochester briefTitle: Stereotactic Body Radiation Therapy Plus Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy for Treatment of Metastatic, Recurrent Hormone-Sensitive Prostate Cancer, DIVINE Trial acronym: DIVINE overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2029-04-30 date: 2029-04-30 date: 2024-04-23 date: 2024-04-23 name: Mayo Clinic class: OTHER briefSummary: This phase II trial studies the effects of stereotactic body radiation therapy (SBRT) and the timing of treatment with androgen receptor pathway inhibitor (ARPI) plus androgen deprivation therapy (ADT) in treating patients with hormone sensitive prostate cancer that has spread from where it first started to other places in the body (metastatic), and that has come back after a period of improvement (recurrent). SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Androgen can cause the growth of prostate cells. ADT lowers the amount of androgen made by the body. This may help stop the growth of tumor cells that need androgen to grow. Androgen receptor pathway inhibitors work by blocking the effects of androgen to stop the growth and spread of tumor cells. Giving SBRT alone with watchful waiting may be as effective in treating prostate cancer as giving SBRT together with ARPI and ADT. conditions: Recurrent Castration-Sensitive Prostate Carcinoma conditions: Stage IVB Prostate Cancer AJCC v8 conditions: Recurrent Prostate Cancer conditions: Castration-resistant Prostate Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 120 type: ESTIMATED name: Abiraterone name: Apalutamide name: Biospecimen Collection name: Bone Scan name: Computed Tomography name: Darolutamide name: Degarelix name: Enzalutamide name: Goserelin name: Histrelin name: Leuprolide name: Magnetic Resonance Imaging name: Patient Observation name: Positron Emission Tomography name: Prednisone name: Questionnaire Administration name: Relugolix name: Stereotactic Body Radiation Therapy name: Triptorelin measure: Modified radiographic progression-free survival (mrPFS) measure: Overall survival (OS) measure: Biologic progression-free survival (bPFS) measure: Time to local progression (TLP) measure: Time to distant progression (TDP) measure: Adverse event (AE) rate sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Mayo Clinic in Rochester city: Rochester state: Minnesota zip: 55905 country: United States name: Clinical Trials Referral Office role: CONTACT phone: 855-776-0015 email: mayocliniccancerstudies@mayo.edu name: Jacob J. Orme, M.D., Ph.D. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 hasResults: False
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<|newrecord|> nctId: NCT06378853 id: 2023DZKY-049-01 briefTitle: Risk Factors of Postoperative Complications and Survival Rate in Pancreatic Ductal Adenocarcinoma Patients overallStatus: COMPLETED date: 2019-01-01 date: 2023-12-31 date: 2024-02-28 date: 2024-04-23 date: 2024-04-23 name: Jinling Hospital, China class: OTHER briefSummary: By evaluating the nutritional status of patients with pancreatic ductal adenocarcinoma (PDAC) admitted to Jinling Hospital, collecting relevant clinical data. we aim to conduct correlation analysis with patient clinical information, such as survival time, hospitalization time, nutritional status, hematological indicators, etc., in order to reveal the prognostic factors for overall survival and postoperative complications of PDAC patients. conditions: Pancreatic Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 548 type: ACTUAL name: no intervention measure: complications measure: overall survival measure: risk factors sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Jinling Hospital city: Nanjing country: China lat: 32.06167 lon: 118.77778 hasResults: False
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<|newrecord|> nctId: NCT06378840 id: KY2021-268-B briefTitle: the Predictive Value of Immune Cell in Locally Advanced Cervical Cancer overallStatus: RECRUITING date: 2022-01-01 date: 2024-12-30 date: 2024-12-30 date: 2024-04-23 date: 2024-04-23 name: RenJi Hospital class: OTHER briefSummary: To explore the predictive value of immune cells by single-cell sequencing on the outcome of locally advanced cervical cancer treated by concurrent chemoradiotherapy Followed by PD-1 inhibitor conditions: Locally Advanced Cervical Carcinoma conditions: Concurrent Chemoradiotherapy conditions: Immunotherapy studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 20 type: ESTIMATED name: Nab-paclitaxel/Platinum, Sintilimab measure: the change of immune cells in the blood after chemoradiotherapy and immunotherapy measure: the predictive value of the changed immune cell subtype in the blood on the side effect of immunotherapy measure: the predictive value of the changed immune cell subtype in the blood on the effect of chemoradiotherapy and immunotherapy measure: the change of immune cells in the tissue after chemoradiotherapy measure: the predictive value of the changed immune cell subtype in the tissue on the effect of chemoradiotherapy and immunotherapy measure: the predictive value of the changed immune cell subtype in the tumor microenvironment on the side effect of immunotherapy sex: FEMALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: RenJi hospital status: RECRUITING city: Shanghai zip: 200127 country: China name: Haiyan Chen, Dr role: CONTACT phone: +862168383624 email: chenhaiyan@renji.com lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06378827 id: 418-1/2 briefTitle: Intraoperative Dexmedetomidine and Coronary Artery Bypass Graft Surgery overallStatus: RECRUITING date: 2024-04-03 date: 2024-07 date: 2024-10 date: 2024-04-23 date: 2024-04-23 name: University of Novi Sad class: OTHER briefSummary: This is a prospective randomized clinical trial designed to determine the effect of intraoperative dexmedetomidine administration on renal function after coronary artery bypass graft surgery. conditions: Acute Kidney Injury studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 100 type: ESTIMATED name: Dexmedetomidine measure: Indicator of renal function measure: An early biomarker of kidney injury measure: The change of inflammatory markers measure: Length of postoperative mechanical ventilation measure: Length of stay in the intensive care unit sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Novi Sad, Faculty of Medicine status: RECRUITING city: Novi Sad zip: 21000 country: Serbia name: Ranko Zdravkovic role: CONTACT phone: +381654674620 email: ranko.zdravkovic@mf.uns.ac.rs lat: 45.25167 lon: 19.83694 hasResults: False
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<|newrecord|> nctId: NCT06378814 id: IRAS N335444 briefTitle: Outcome of Selective & Nonselective Caries Removal in Permanent Teeth acronym: RCT-SNCR overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-04-30 date: 2030-04-30 date: 2024-04-23 date: 2024-04-29 name: King's College London class: OTHER name: Guy's and St Thomas' NHS Foundation Trust briefSummary: Patients presenting with deep decay within permanent teeth presents a common clinical challenge to dentists. The aim of this trial is to compare the success rate of the non-selective caries removal (NSCR) and selective caries removal (SCR) in managing deep caries, as both methods are commonly used in clinical practice.
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This study will be a randomized controlled trial, with participants divided into two groups: NSCR group and SCR group. Participants of deep caries lesions (reaching more than two-thirds of dentin on periapical radiographs) Both groups will undergo either NSCR or SCR, followed by Partial Pulpotomy (PP) in cases with pulp exposure. Success rates will be assessed at follow-up visits scheduled 1, 3, and 5 years radiographs will be used to assess for pulp health(vitality).
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The success rate of the two categories will be assessed using a scale that includes factors such as tooth vitality, caries recurrence, and clinical signs of pulpitis. The scale will be applied at follow-up visits. The trial will be conducted in post-graduate dental clinics at Guy's hospital.
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Deep caries in permanent teeth is a common clinical problem that can lead to pulp exposure and subsequent restorative challenges. The aim of this study is to provide evidence-based guidance for clinicians in managing deep caries lesions, as both NSCR and SCR are commonly used in clinical practice. The results of this study will help clinicians to make informed decisions when choosing the appropriate treatment approach for their patients.
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In conclusion, this trial aims to compare the success rate of NSCR and SCR in managing deep caries lesions in permanent teeth, as both methods are commonly used in clinical practice. The results of this study will provide valuable insights into the effectiveness of these two treatment approaches and will help clinicians to make informed decisions when choosing the appropriate treatment approaches. conditions: Deep Caries conditions: Carious Exposure of Pulp studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: two arms parallel randomized clinical trial primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 168 type: ESTIMATED name: Selective Caries Removal (No Pulp Exposure) name: Non-Selective Caries Removal (No Pulp exposure) name: Partial Pulpotomy (Pulp Exposed) measure: To compare the success rate of maintaining pulp vitality assessed by pulp sensibility test between Selective Caries Removal or Non- Selective Caries Removal techniques after one year of the intervention. measure: Periapical Health Assessment Using Periapical Index Score in Deep Caries Lesion Treatment measure: Quality of Life Assessment ( Using OHIP-14 questionnaire) in Deep Caries Lesion Treatment: A Comparative Study of Selective Caries Removal and Partial Pulpotomy sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06378801 id: RADX-P-2408 briefTitle: Radicle Relaxation 24: A Study of Health and Wellness Products on Stress and Related Health Outcomes overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-29 date: 2024-05 date: 2024-08 date: 2024-04-22 date: 2024-04-24 name: Radicle Science class: INDUSTRY briefSummary: A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on stress and related health outcomes conditions: Stress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Participants will be stratified based on gender at birth, then randomized to one of the study arms primaryPurpose: OTHER masking: DOUBLE maskingDescription: The investigator is blinded to the participants' study product assignment. Participants are blinded to the study product they are assigned. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 500 type: ACTUAL name: Placebo Control Form 1 name: Relaxation Active Study Product 1.1 measure: Change in stress measure: Change in feelings of anxiety measure: Change in cognitive function measure: Change in mood (emotional distress-depression) measure: Minimal clinically important difference (MCID) in stress measure: Minimal clinically important difference (MCID) in feelings of anxiety measure: Minimal clinically important difference (MCID) in cognitive function measure: Minimal clinically important difference (MCID) in mood (emotional distress-depression) measure: Change in concentration of at-home (direct-to-consumer) specimen assays either saliva, blood or stool sex: ALL minimumAge: 21 Years maximumAge: 105 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Radicle Science, Inc city: Del Mar state: California zip: 92014 country: United States lat: 32.95949 lon: -117.26531 hasResults: False
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<|newrecord|> nctId: NCT06378788 id: 2023/211 briefTitle: Muscle Architecture and Muscle Strength in Fibromyalgia overallStatus: RECRUITING date: 2024-02-01 date: 2024-04-30 date: 2024-06-30 date: 2024-04-22 date: 2024-04-25 name: Bezmialem Vakif University class: OTHER briefSummary: The goal of this observational study is to determine whether there is decrease in muscle mass and muscle strength in Fibromyalgia Syndrome (FMS) patients in comparison to controls. And to determine whether these parameters are correlated with clinical ones. Briefly the main questions investigators aims to answer are:
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* Is there a significant difference in muscle morphology between FMS and controls?
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* Is there a significant difference in muscle strength between FMS and controls?
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* Is there a relationship between muscle thickness and pennation angle of the Quadriceps, gastrocnemius medialis, gastrocnemius lateralis and Tibialis anterior muscles and disease activity, pain and functionality?
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* Is there a correlation between muscle strength in FMS and disease activity, pain and functionality? conditions: Fibromyalgia conditions: Sarcopenia conditions: Muscle Weakness studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: CROSS_SECTIONAL count: 30 type: ESTIMATED name: Demographic information form name: widespread pain index (WPI) name: symptom severity scale (SSS) name: Fibromyalgia Impact Questionnaire (FIQ) name: Tender Point examination name: Muscle Architecture visualized with ultrasound name: Sarcopenia assessed by measuring isometric strengths of different parts of the body name: Timed Up & Go (TUG) measure: Quadriceps Femoris Vastus Lateralis Muscle Thickness measure: Quadriceps Femoris Vastus Lateralis Fascicle Length measure: Quadriceps Femoris Vastus Medialis Muscle Thickness measure: Quadriceps Femoris Vastus Medialis Fascicle Length measure: Quadriceps Femoris Rectus Femoris Muscle Thickness measure: Quadriceps Femoris Rectus Femoris Fascicle Length measure: Tibialis Anterior Muscle Thickness measure: Tibialis Anterior Muscle Fascicle Length measure: Gastrocnemius Muscle Vastus Medialis Muscle Thickness measure: Gastrocnemius Muscle Vastus Medialis Fascicle Length measure: Gastrocnemius Muscle Vastus Lateralis Muscle Thickness measure: Gastrocnemius Muscle Vastus Lateralis Fascicle Length measure: Cervical Muscle strength measure: Truncal Muscle strength measure: Shoulder Muscle strength measure: Hip Muscle strength measure: Knee Muscle strength measure: Ankle Muscle strength measure: Timed Up & Go (TUG) sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bezmialem Vakif University status: RECRUITING city: Istanbul state: Fatih zip: 34093 country: Turkey name: Mehmet Serkan Kılıçoğlu, Ass.Prof. role: CONTACT phone: +902124530453 email: drserkankilicoglu@yahoo.com name: Delal Ozturk, Res.Ass. role: CONTACT phone: +902124530453 email: drdelalozturk@gmail.com lat: 41.01384 lon: 28.94966 hasResults: False
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<|newrecord|> nctId: NCT06378775 id: H23-03334 briefTitle: Robotically-assisted Minimally-invasive Direct Coronary Artery Bypass With Stenting, Randomized Against Coronary Artery Bypass Graft Surgery acronym: ROBOT RCT overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-05-01 date: 2028-12-01 date: 2024-04-22 date: 2024-04-23 name: Cardiology Research UBC class: OTHER briefSummary: The study objective is to compare standard CABG to a hybrid revascularization strategy (RA-MIDCAB + PCI) in patients who have multi-vessel CAD and an indication for surgery, but who have a slightly higher risk of post-operative complications. conditions: Coronary Artery Disease conditions: Multivessel Coronary Artery Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Coronary Artery Bypass Graft name: Robotically-assisted minimally-invasive direct coronary artery bypass name: Percutaneous Coronary Intervention measure: Post-operative Length of Stay measure: Conversion to sternotomy / CABG measure: Intubation duration measure: ICU length of stay sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06378762 id: 6/2021 briefTitle: Interference of Endurance Training on Strength Development and Neuromuscular Adaptations overallStatus: ACTIVE_NOT_RECRUITING date: 2022-04-01 date: 2024-07-30 date: 2025-07-30 date: 2024-04-22 date: 2024-04-22 name: University of Lisbon class: OTHER name: Fundação para a Ciência e a Tecnologia briefSummary: This study aims to find out if performing combined strength and endurance exercise in the same program (called concurrent training-CT) leads to similar long-term improvements in neuromuscular function as doing each type of exercise separately. The main questions it seeks to answer are:
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Does performing CT result in similar improvements in strength and power as doing just strength training? Does performing CT result in similar improvements in cardiorespiratory fitness as doing just endurance training? Are neuromuscular adaptations similar between CT and just strength training? Researchers will compare the results between three groups: the CT group, the endurance training group (E), and the strength training group (S) to answer these questions. conditions: Exercise studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 30 type: ACTUAL name: Endurance Exercise name: Strength Exercise name: Concurrent Exercise measure: Maximal Isometric Strength measure: Maximal Dynamic Strength measure: Surface EMG measure: H-reflex excitability measure: V-wave measure: Lower Body Muscle Power measure: Muscle architecture of the quadriceps femoris sex: MALE minimumAge: 18 Years maximumAge: 30 Years stdAges: ADULT facility: Faculdade de Motricidade Humana - Universidade de Lisboa city: Lisboa state: Cruz Quebrada - Dafundo zip: 1499-002 country: Portugal lat: 38.71667 lon: -9.13333 hasResults: False
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<|newrecord|> nctId: NCT06378749 id: 1R43CA275673 type: NIH link: https://reporter.nih.gov/quickSearch/1R43CA275673 briefTitle: Previvors Recharge: A Resilience Program for Cancer Previvors acronym: PreCharge overallStatus: RECRUITING date: 2024-04-11 date: 2024-07-31 date: 2024-07-31 date: 2024-04-22 date: 2024-04-24 name: Pro-Change Behavior Systems class: OTHER briefSummary: It is estimated that 1 in 279 people may be carriers of a Hereditary Cancer Syndromes (HCS), a cancer risk that is associated with germline mutations (inherited genetic mutations passed directly from a parent to a child that create a genetic predisposition to certain types of cancer). Individuals with an HCS who have never been diagnosed with cancer (Previvors) have up to an 80% lifetime risk of developing cancer and are at an increased risk of developing multiple primary cancers during their lifetime, often with onset at an early age. Previvors face multiple forms of adversity, including a multitude of annual cancer screenings and the uncertainty of not only their own health but the health of affected family members. This study will examine the acceptability and preliminary effects of PreCharge, a resilience-boosting solution specifically designed for Previvors and delivered primarily via bi-directional text messaging. PreCharge uses proven approaches to behavior change tailoring to increase resilience by promoting a positive mindset, strong social connections, and a deep sense of meaning and purpose while also proactively addressing scanxiety. Up to 150 Hereditary Cancer Previvors will be recruited for a 30-day pilot test. Participants will complete a baseline assessment, and then be provided with 30 days of access to the PreCharge program. At the end of the 30 days, they will be prompted to complete a follow-up assessment. Outcomes include 1) acceptability of the program, as evidenced by obtaining 75% endorsement that users would recommend the program to a fellow Previvor; (2) engagement as evidenced by continued receipt of text messages and one or more interactions with the online tools by at least 70% of participants; and (3) benefit from the program, evidenced by statistically significant pre-post improvement on the Connor Davidson Resilience Scale. conditions: Hereditary Cancer conditions: Mental Health Issue studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 150 type: ESTIMATED name: PreCharge measure: Connor Davidson Resilience Scale (CDRISC) measure: Cantril/Gallup Life Evaluation Index measure: Acceptance and Action Questionnaire (AAQII) measure: Patient Health Questionnaire-2 (PHQ-2) measure: Generalized Anxiety Disorder-2 (GAD-2) measure: Cancer Behavior Inventory (CBI-B V2.0-12) measure: Net Promoter Score (NPS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pro-Change Behavior Systems status: RECRUITING city: Narragansett state: Rhode Island zip: 02882 country: United States name: Kerry E Evers, PhD role: CONTACT phone: 401-360-2985 email: kevers@prochange.com name: Madison Gilmore role: CONTACT phone: 401-360-2988 email: mgilmore@prochange.com name: Kerry E Evers, PhD role: PRINCIPAL_INVESTIGATOR lat: 41.4501 lon: -71.4495 hasResults: False
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<|newrecord|> nctId: NCT06378736 id: 21-1027 briefTitle: Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus overallStatus: RECRUITING date: 2024-01-22 date: 2026-03-23 date: 2026-03-23 date: 2024-04-22 date: 2024-04-29 name: Northwell Health class: OTHER briefSummary: Patients with systemic lupus erythematosus (SLE) often experience a frustrating decline of their cognitive skills that includes considerable problems in attention, learning, and memory. This lupus-related cognitive dysfunction (termed SLE-CD) is recognized as the most prevalent of the nineteen neuropsychiatric SLE syndromes, as it affects up to 80% of patients and can significantly decrease their quality of life. The goal is to have tools that can be used for diagnosis and for monitoring responses after targeted interventions and therapies. This study will focus on electroencephalographic (EEG) signals, which will be detected noninvasively from scalp placed surface electrodes while the subjects are in a state of wakeful rest. Our hypothesis is that a subset of brain oscillations known as theta and gamma, and their co-modulation or coupling will be disrupted in SLE patients. This research protocol will subject patients with systemic lupus erythematosus (SLE) to scalp electroencephalography (EEG), with the goal of determining whether specific EEG patterns ('theta-gamma coupling') appear abnormal during wakeful-rest periods of 20 minutes. The investigators are interested in using scalp EEG because it is a standard, safe and robust technique for monitoring the electrophysiological activity of neurons in the cerebral cortex. conditions: Systemic Lupus Erythematosus studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: Electroencephalography (EEG) signals, which will be detected noninvasively from dry scalp surface electrodes while the subjects are in a state of wakeful rest. measure: A measure of the amount and relationship of theta and gamma waves in the EEG recording. The ability to perform the block building task and the ability to choose among unfolded three-dimensional objects. sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Northwell Health-Feinstein Insitute status: RECRUITING city: Manhasset state: New York zip: 11030 country: United States name: Bruce T Volpe, MD role: CONTACT phone: 516-562-3384 email: bvolpe1@northwell.edu name: Celina B. Fernandez, MS role: CONTACT phone: 5165623646 email: cfernandez14@northwell.edu lat: 40.79788 lon: -73.69957 hasResults: False
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<|newrecord|> nctId: NCT06378723 id: 2024/01/24 briefTitle: The Relationship Between Upper Extremity Functionality, Trunk Control and Balance in Children With Cerebral Palsy overallStatus: ACTIVE_NOT_RECRUITING date: 2024-02-01 date: 2024-04-15 date: 2024-04-16 date: 2024-04-22 date: 2024-04-23 name: Eastern Mediterranean University class: OTHER briefSummary: The aim of this study is to examine the relationship between trunk control, upper extremity functionality and balance in children with cerebral palsy and to compare this relationship with healthy sedentary children.This study is carried out through Eastern Mediterranean University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Pediatric Rehabilitation Unit. conditions: Cerebral Palsy conditions: Diplegic Cerebral Palsy conditions: Balance; Distorted studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 53 type: ACTUAL name: Balance Tests measure: trunk control measure: upper extremity functionality measure: balance measure: Weight and Height sex: ALL minimumAge: 8 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Eastern Mediterranean University city: Famagusta zip: 99628 country: Cyprus lat: 35.12054 lon: 33.93894 facility: Yeni Sihirli Eller Özel Eğitim ve Rehabilitasyon Merkezi city: Adana state: Çukurova zip: 01170 country: Turkey lat: 37.00167 lon: 35.32889 hasResults: False
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<|newrecord|> nctId: NCT06378710 id: 22-0219 briefTitle: Haemodynamic and Respiratory Effects of a Low Positive End Expiratory Pressure Associated With a Fluid Challenge in Knee-chest Position acronym: OPTIPEP overallStatus: RECRUITING date: 2023-01-20 date: 2025-01-20 date: 2025-01-30 date: 2024-04-22 date: 2024-04-22 name: University Hospital, Caen class: OTHER briefSummary: The genu pectoral position is a surgical position used for spine surgery. This surgical position will lead to physiological hemodynamic and respiratory changes during the procedure.
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The knee-pectoral position notably induces an increase in CRF and improves pulmonary ventilation/perfusion ratios. On the other hand, it has been shown that it is accompanied by a reduction in cardiac output of approximately 15% Protective perioperative ventilation including a tidal volume between 6 and 8 ml/kg of theoretical ideal weight, PEEP and alveolar recruitment maneuvers is applied in the operating room to reduce postoperative pulmonary complications. The application of high PEEP and the performance of recruitment maneuvers induce arterial hypotension through changes in intra- and transpulmonary pressures. However, investigators hypothesize that the deleterious hemodynamic effects of PEEP seem to counterbalance its beneficial respiratory effects in this particular position.
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The combination of the effects of the knee-pectoral position and protective ventilation could be potentiated and be the cause of the sometimes severe arterial hypotension observed in clinical practice. Since this position improves pulmonary ventilation perfusion ratios, the investigators hypothesized that a lower PEEP and the elimination of intraoperative recruitment maneuvers could be beneficial from a hemodynamic point of view without being deleterious in terms of perioperative pulmonary complications. An exploratory study was carried out at the CAEN University Hospital in 2021 under the name PEEP POSTURE (CLERS Agreement No. 2198 of February 17, 2021) on 90 patients aiming to collect hemodynamic and respiratory parameters in 3 surgical positions: supine decubitus, ventral decubitus , pectoral genu. No difference was found in the evolution of respiratory compliance. On the other hand, a significant drop in SBP, DBP and MAP in the pectoral position was shown compared to the supine group as well as greater vascular filling.
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The investigators therefore hypothesize that a reduction in PEEP and optimization of vascular filling could help reduce the adverse effects on blood pressure linked to the surgical position. conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 84 type: ESTIMATED name: Optimized PEEP measure: Number of occurrences of a MAP sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: CAEN University Hospital status: RECRUITING city: Caen country: France name: Mariam BOUTROS, MD role: CONTACT phone: 02.31.06.31.06 email: boutros-m@chu-caen.fr lat: 49.18585 lon: -0.35912 hasResults: False
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<|newrecord|> nctId: NCT06378697 id: AK111-303 briefTitle: A Phase III Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Active Ankylosing Spondylitis overallStatus: RECRUITING date: 2023-11-10 date: 2025-02-28 date: 2026-04-30 date: 2024-04-22 date: 2024-04-22 name: Akeso class: INDUSTRY briefSummary: This is a randomized, double-blind, placebo-controlled, multi-center phase III clinical study to evaluate the efficacy and safety of AK111 in the treatment of subjects with active ankylosing spondylitis. conditions: Ankylosing Spondylitis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 510 type: ESTIMATED name: AK111 name: Placebo+AK111 measure: the response rate of ASAS20 measure: The response rate of ASAS40 measure: The response rate of ASAS20 measure: The response rate of ASAS40 measure: The response rate of ASAS5/6 measure: Change from baseline on the ASDAS-CRP measure: Change from baseline on the SF-36 PCS measure: Change from baseline on the ASQoL scores measure: Treatment-emergent adverse events measure: Serious adverse events measure: Clinically significant examination results sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: 1006-The First Affiliated Hospital of Bengbu Medical University status: RECRUITING city: Bengbu state: Anhui country: China lat: 32.94083 lon: 117.36083 facility: 1038-Anhui Provincial Hospital status: RECRUITING city: Hefei state: Anhui country: China lat: 31.86389 lon: 117.28083 facility: 1001-Peking University Third Hospital status: RECRUITING city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: 1002-Xuanwu Hospital Capital Medical University status: RECRUITING city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: 1042-Peking University Shougang Hospital status: RECRUITING city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: 1049-The First Affiliated Hospital of Xiamen University status: RECRUITING city: Xiamen state: Fujian country: China lat: 24.47979 lon: 118.08187 facility: 1027-Lanzhou University Second Hospital status: RECRUITING city: Lanzhou state: Gansu country: China lat: 36.05701 lon: 103.83987 facility: 1005-Nanfang Hospital status: RECRUITING city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 facility: 1025-Guangzhou First People's Hospital status: RECRUITING city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 facility: 1030-Jieyang People's Hospital status: RECRUITING city: Jieyang state: Guangdong country: China lat: 23.5418 lon: 116.36581 facility: 1008-The Seventh Affiliated Hospital, Sun Yat-sen University status: RECRUITING city: Shenzhen state: Guangdong country: China lat: 22.54554 lon: 114.0683 facility: 1026-Shenzhen People's Hospital status: RECRUITING city: Shenzhen state: Guangdong country: China lat: 22.54554 lon: 114.0683 facility: 1056-Zhongshan Traditional Chinese Medicine Hospital status: RECRUITING city: Zhongshan state: Guangdong country: China lat: 21.31992 lon: 110.5723 facility: 1024-Liuzhou People's Hospital status: RECRUITING city: Liuzhou state: Guangxi country: China facility: 1021-The People's Hospital of Guangxi Zhuang Autonomous Region status: RECRUITING city: Nanning state: Guangxi country: China lat: 22.81667 lon: 108.31667 facility: 1022-The First Affiliated Hospital of Hainan Medical University status: RECRUITING city: Haikou state: Hainan country: China lat: 20.04583 lon: 110.34167 facility: 1034-Affiliated Hospital of Hebei University status: RECRUITING city: Baoding state: Hebei country: China lat: 38.85111 lon: 115.49028 facility: 1012-Hebei Petro China Central Hospital status: RECRUITING city: Langfang state: Hebei country: China lat: 39.50972 lon: 116.69472 facility: 1029-Hebei General Hospital status: RECRUITING city: Shijiazhuang state: Hebei country: China lat: 38.04139 lon: 114.47861 facility: 1033-The First Hospital of Qiqihar status: RECRUITING city: Qiqihar state: Heilongjiang country: China lat: 47.34088 lon: 123.96045 facility: 1045-The First Affiliated Hospital of Henan University of Science and Technology status: RECRUITING city: Luoyang state: Henan country: China lat: 34.68361 lon: 112.45361 facility: 1053-Nanyang Central Hospital status: RECRUITING city: Nanyang state: Henan country: China lat: 32.99472 lon: 112.53278 facility: 1051-Shiyan People's Hospital status: RECRUITING city: Shiyan state: Hubei country: China lat: 32.6475 lon: 110.77806 facility: 1031-The First Affiliated Hospital of University of South China status: RECRUITING city: Hengyang state: Hunan country: China lat: 26.88946 lon: 112.61888 facility: 1032-Yueyang Central Hospital status: RECRUITING city: Yueyang state: Hunan country: China lat: 29.37455 lon: 113.09481 facility: 1011-Zhuzhou Central Hospital status: RECRUITING city: Zhuzhou state: Hunan country: China lat: 27.83333 lon: 113.15 facility: 1017-Changzhou NO.2 People's Hospital status: RECRUITING city: Changzhou state: Jiangsu country: China lat: 31.77359 lon: 119.95401 facility: 1037-The Second People's Hospital of Lianyungang status: RECRUITING city: Lianyungang state: Jiangsu country: China lat: 34.59845 lon: 119.21556 facility: 1004-Zhongda Hospital Southeast University status: RECRUITING city: Nanjing state: Jiangsu country: China lat: 32.06167 lon: 118.77778 facility: 1007-Nanjing Drum Tower Hospital status: RECRUITING city: Nanjing state: Jiangsu country: China lat: 32.06167 lon: 118.77778 facility: 1036-Jiangsu Province Hospital status: RECRUITING city: Nanjing state: Jiangsu country: China lat: 32.06167 lon: 118.77778 facility: 1018-Affiliated Hospital of Nantong University status: RECRUITING city: Nantong state: Jiangsu country: China lat: 32.03028 lon: 120.87472 facility: 1035-Wuxi People's Hospital status: RECRUITING city: Wuxi state: Jiangsu country: China lat: 31.56887 lon: 120.28857 facility: 1013-Xuzhou Central Hospital status: RECRUITING city: Xuzhou state: Jiangsu country: China lat: 34.18045 lon: 117.15707 facility: 1014-Affiliated Hospital of Jiangsu University status: RECRUITING city: Zhenjiang state: Jiangsu country: China lat: 32.21086 lon: 119.45508 facility: 1047-The First Affiliated Hospital of Gannan Medical College status: RECRUITING city: Ganzhou state: Jiangxi country: China facility: 1020-The Second Affiliated Hospital of Nanchang University status: RECRUITING city: Nanchang state: Jiangxi country: China lat: 28.68396 lon: 115.85306 facility: 1039-The First Affiliated Hospital of Nanchang University status: RECRUITING city: Nanchang state: Jiangxi country: China lat: 28.68396 lon: 115.85306 facility: 1046-Pingxiang People's Hospital status: RECRUITING city: Pingxiang state: Jiangxi country: China lat: 27.61672 lon: 113.85353 facility: 1044-Jilin Provincial People's Hospital status: RECRUITING city: Changchun state: Jilin country: China lat: 43.88 lon: 125.32278 facility: 1028- Jining First People's Hospital status: RECRUITING city: Jining state: Shandong country: China lat: 35.405 lon: 116.58139 facility: 1019-Linyi City People Hospital status: RECRUITING city: Linyi state: Shandong country: China lat: 35.06306 lon: 118.34278 facility: 1055-Weifang People's Hospital status: RECRUITING city: Weifang state: Shandong country: China lat: 36.71 lon: 119.10194 facility: 1016-Zaozhuang Municipal Hospital status: RECRUITING city: Zaozhuang state: Shandong country: China lat: 34.86472 lon: 117.55417 facility: 1054-Linfen Central Hospital status: RECRUITING city: Linfen state: Shanxi country: China lat: 36.08889 lon: 111.51889 facility: 1009-Second Hospital of Shanxi Medical University status: RECRUITING city: Taiyuan state: Shanxi country: China lat: 37.86944 lon: 112.56028 facility: 1043-Yuncheng Central Hospital status: RECRUITING city: Yuncheng state: Shanxi country: China lat: 35.02306 lon: 110.99278 facility: 1010-West China Hospital,Sichuan University status: RECRUITING city: Chengdu state: Sichuan country: China lat: 30.66667 lon: 104.06667 facility: 1048-Mianyang Central Hospital status: RECRUITING city: Mianyang state: Sichuan country: China lat: 31.46784 lon: 104.68168 facility: 1041-Affiliated Hospital of North Sichuan Medical College status: RECRUITING city: Nanchong state: Sichuan country: China lat: 30.79508 lon: 106.08473 facility: 1023-The People's Hospital of Xinjiang Uyghur Autonomous Region status: RECRUITING city: Urumqi state: Xinjiang country: China lat: 43.80096 lon: 87.60046 facility: 1040- Huzhou Third People's Hospital status: RECRUITING city: Huzhou state: Zhejiang country: China lat: 30.8703 lon: 120.0933 facility: 1015-Taizhou Hospital of Zhejiang Province status: RECRUITING city: Taizhou state: Zhejiang country: China lat: 32.49069 lon: 119.90812 facility: 1050-The First Affiliated Hospital of Wenzhou Medical University status: RECRUITING city: Wenzhou state: Zhejiang country: China lat: 27.99942 lon: 120.66682 hasResults: False
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<|newrecord|> nctId: NCT06378684 id: JW22105 briefTitle: To Evaluate the Safety and Pharmacokinetic Interactions in Healthy Volunteers overallStatus: COMPLETED date: 2023-09-10 date: 2023-12-23 date: 2024-01-13 date: 2024-04-22 date: 2024-04-22 name: JW Pharmaceutical class: INDUSTRY briefSummary: The objective is to evaluate the safety and Pharmacokinetic Interactions after adminitration drug(Treatment A or B or A+B) in Healthy Volunteers conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: OTHER masking: NONE count: 48 type: ACTUAL name: Group 1: JW0104(Period 1), C2207(Period 2), JW0104 + C2207(Period 3) name: Group 2: JW0104 + C2207(Period 1), JW0104(Period 2), C2207(Period 3) name: Group 3: C2207(Period 1), JW0104 + C2207(Period 2), JW0104(Period 3) name: Group 4: JW0104(Period 1), JW0104 + C2207(Period 2), C2207(Period 3) name: Group 5: JW0104 + C2207(Period 1), C2207(Period 2), JW0104(Period 3) name: Group 6: C2207(Period 1), JW0104(Period 2), JW0104 + C2207(Period 3) measure: Cmax,ss measure: AUCτ,ss sex: ALL minimumAge: 19 Years maximumAge: 55 Years stdAges: ADULT facility: Clinical Trial Center, Severance Hospital city: Seoul country: Korea, Republic of lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06378671 id: ColdCough briefTitle: Single-center Clinical Study on the Safety and Effect of Bronchoscopic Cryotherapy in Patients With Chronic Cough acronym: ColdCough overallStatus: RECRUITING date: 2024-04 date: 2024-07 date: 2024-09 date: 2024-04-22 date: 2024-04-25 name: Guangzhou Medical University class: OTHER name: Ningbo SensCure Biotechnology Co., Ltd. briefSummary: Chronic cough is one of the most common complaints in respiratory specialty clinics, imposing significant economic burden on patients and severely affecting their quality of life. Currently, the pathogenesis of chronic refractory cough remains incompletely understood, and treatment remains a major challenge in clinical practice. Cryotherapy treatment via bronchoscopy has shown efficacy in certain airway diseases, but there is currently no research reporting its effects on chronic refractory cough.
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The goal of this clinical trial is to learn if Cryotherapy treatment works to treat individuals with chronic cough. It will also learn about The safety and effectiveness of the cryotherapy treatment system produced by Ningbo SensCure Biotechnology Co., Ltd.. The main questions it aims to answer are:
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* Does cryotherapy treatment lower the frequency and severity of cough and enhance quality of life?
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* Will there be safety or operational performance issues when using this cryotherapy treatment system? Researchers will compare cryotherapy treatment with no treatment to determine if cryotherapy treatment is effective for treating chronic cough.
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Participants will:
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* Take routine bronchoscopy examination, lavage, and mucosal biopsy ,with/without cryotherapy treatment locally (around the left and right main bronchi, upper trachea, and carina)
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* undergo a screening period of approximately 28 days. Follow-up visits and necessary examinations will be scheduled for the 3rd day after treatment initiation and at weeks 1, 2, 4, 8, and 12 thereafter.
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* Monitor vital signs and clinical manifestations. conditions: Chronic Cough studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: a prospective, single-center, double-blind ,randomized controlled clinical trial primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 20 type: ESTIMATED name: General treatment name: Cryotherapy Treatment measure: Device/Surgery-Related Serious Adverse Events measure: Device/Surgery Adverse Event Rate measure: Serious Adverse Event Rate measure: Device Defect Rate measure: Cough Visual Analogue Scale (VAS) measure: Cough frequency within 2 hours measure: Modified Cough Evaluation Tool (CET) measure: Leicester Cough Questionnaire (LCQ) measure: Tracheal Vibratory Cough Stimulation Test measure: Capsaicin Cough Stimulation Test measure: Performance evaluation of Cryotherapy Ablation Equipment measure: Performance evaluation of Cryotherapy Ablation Catheter sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The First Affiliated Hospital of Guangzhou Medical University status: RECRUITING city: Guangzhou state: Guangdong zip: 510163 country: China name: Shiyue Li role: CONTACT phone: +86 13902233925 email: lishiyue@gird.cn lat: 23.11667 lon: 113.25 hasResults: False
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<|newrecord|> nctId: NCT06378658 id: 22253 briefTitle: A Study to Learn About How Food and Esomeprazole Affect the Level of BAY2927088 in the Blood When Taken Together in Healthy Participants overallStatus: RECRUITING date: 2024-03-29 date: 2024-05-20 date: 2024-05-20 date: 2024-04-22 date: 2024-04-22 name: Bayer class: INDUSTRY briefSummary: Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) mutations.
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Advanced NSCLC refers to a type of lung cancer that has spread from the lungs to nearby tissues or other body parts. People with advanced NSCLC may have changes in certain proteins, like EGFR and HER2, that cause uncontrolled cell growth and increased spread of cancer.
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In this study, participants will be healthy and will not benefit from taking the study treatment, BAY2927088. However, the study will provide information about how to test BAY2927088 in future studies with people who have advanced NSCLC with EGFR or HER2 mutations.
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BAY2927088 is under development for the treatment of advanced NSCLC with EGFR or HER2 mutations. It is expected to work against these changed proteins, which might slow down the spread of cancer.
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The absorption of BAY2927088 into the blood is dependent on the amount of acid present in the stomach. Esomeprazole is a medicine which is used in the treatment of heartburn and excessive acid in the stomach. Both food and esomeprazole may change the amount of acid present in the stomach.
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The main purpose of this study is to find out how food and esomeprazole may affect the absorption of BAY2927088 into the blood of healthy participants. For this, researchers will measure the levels of BAY2927088 in participants' blood when it is given with or without food as well as with or without esomeprazole. Researchers will then calculate the following:
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* Area under the curve (AUC): a measure of the total amount of BAY2927088 in participants' blood over time
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* Maximum observed concentration (Cmax): the highest amount of BAY2927088 in participants' blood
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The study will have 4 treatment periods:
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- Periods 1 to 3 (Day 1 to Day 9): All participants will take BAY2927088 with a low-fat meal, with a high-fat meal, and on an empty stomach, but in a different order, over the 3 study periods. Each period will last for 3 days and BAY2927088 will be given on the first day of each period.
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On Day 9, participants will take esomeprazole on an empty stomach.
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- Period 4 (Day 10 to Day 14): On Days 10 and 11, participants will take esomeprazole on an empty stomach. On Day 12, participants will take esomeprazole on an empty stomach. After 1 and a half hours, participants will take low-fat meal and BAY2927088.
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On Day 13, participants will take esomeprazole on an empty stomach.
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Participants will be in this study for about 8 weeks with 3 visits to the study clinic.
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Participants will visit the study clinic:
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* at least once, 2 to 28 days before the treatment starts, to confirm they can take part in this study
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* once on the day before the treatment starts and will stay in the clinic until Day 14 of the treatment
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* once, 7 to 10 days after last dose of BAY2927088, for a health check-up
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During the study, the doctors and their study team will:
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* do physical examinations
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* collect blood samples from the participants to measure the levels of BAY2927088
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* check participants' health by performing tests, such as blood and urine tests, and checking heart health using an electrocardiogram (ECG)
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* ask the participants questions about how they are feeling and what adverse events they are having An adverse event is any medical problem that a participant has during a study. The study doctors keep track of all adverse events, irrespective of whether they think it is related or not to the study treatment. conditions: Advanced Non-small Cell Lung Cancer conditions: EGFR Mutation conditions: HER2 Mutation conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: OTHER masking: NONE count: 21 type: ESTIMATED name: BAY2927088 name: Esomeprazole name: Food measure: Cmax for BAY2927088 in plasma measure: AUC for BAY2927088 in plasma measure: Number of participants with treatment-emergent adverse events (TEAEs) sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: PAREXEL International, Baltimore status: RECRUITING city: Baltimore state: Maryland zip: 21225 country: United States lat: 39.29038 lon: -76.61219 hasResults: False
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<|newrecord|> nctId: NCT06378645 id: 2023-01682 briefTitle: Effect of Propofol vs. Sevoflurane on Erections During Narcosis In Transurethral Surgery acronym: PENIS overallStatus: RECRUITING date: 2024-02-01 date: 2026-12-01 date: 2026-12-01 date: 2024-04-22 date: 2024-04-22 name: Etienne Xavier Keller class: OTHER briefSummary: Penile erection is an unwanted event in transurethral (through the urethra) surgeries, which may be associated with adverse outcomes such as impaired access, prolonged operation time, the need to abort the operation, or the necessity for ancillary measures to achieve penile flaccidity, such as the injection of certain medications directly into the penis.
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To reduce greenhouse gas emissions, the primary use of propofol instead of gaseous agents is being recommended for general anesthesia. Whether propofol may be associated with an increased or decreased rate of unwanted intraoperative penile erection compared to other anesthetic agents is not known. More generally, there are no high-quality studies available to evaluate the impact of the type of general anesthesia on the risk of unwanted penile erections during surgery.
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This study aims to determine whether general anesthesia with propofol is more likely to cause intraoperative erections compared to sevoflurane during transurethral operations. conditions: Erection; Incomplete studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE maskingDescription: The authorized study nurse will hand the upcoming envelope with the treatment allocation to the anesthesiologist. The patient and the urologists (who is measuring the outcome) will not know which form of general anesthesia will be performed. Herewith, blankets in the operating room will hide installations used by the anesthesiologists to prevent the urologists witnessing the assigned narcosis form. Before the surgical sign-out, while still scrubbed in and with the patient under anesthesia, the anesthesiologists will ask the urologists about the outcome questionnaire. Together, they will fill in the paper case report form (CRF). whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 200 type: ESTIMATED name: General Anesthesia: Propofol name: General Anesthesia: Sevoflurane measure: Intraoperative Penile Erection measure: Prolongation of the surgery measure: Change in operative strategy measure: Adaptions of instruments or approaches measure: Altered operative outcome measure: Necessity for a drug application to decrease penile tumescence measure: Complications arisen sex: MALE minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Zurich status: RECRUITING city: Zürich zip: 8091 country: Switzerland name: Etienne X Keller, Ass Prof, MD role: CONTACT phone: +41 44 255 54 40 email: etiennexavier.keller@usz.ch lat: 47.36667 lon: 8.54999 hasResults: False
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<|newrecord|> nctId: NCT06378632 id: CLN0011 DETECT-HF briefTitle: AN INTERNATIONAL, OBSERVATIONAL, BLINDED STUDY TO ASSESS THE PERFORMANCE OF THE CORDIO HEARO SYSTEM acronym: DETECT-HF overallStatus: RECRUITING date: 2022-02-11 date: 2024-07-15 date: 2024-12-01 date: 2024-04-22 date: 2024-04-22 name: Cordio Medical class: INDUSTRY briefSummary: Study Design:
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This is an international, multicenter, observational, non-interventional, prospective, blinded, single-arm, two-period study, to collect patient utterances that will be retrospectively analyzed to determine the sensitivity and UPNR of the HearO system. conditions: Heart Failure studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 500 type: ESTIMATED name: Hearo App measure: Heart Failure Events (HFEs) sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Eastern Shore Research Institute status: RECRUITING city: Fairhope state: Alabama zip: 36532 country: United States name: Jessica Huckleberry, SC role: CONTACT phone: 251-990-1920 email: jessicahuckleberry@yahoo.com name: Michael Pursley, MD role: PRINCIPAL_INVESTIGATOR lat: 30.52297 lon: -87.90333 facility: UC San Diego Health status: RECRUITING city: La Jolla state: California zip: 92037 country: United States name: Joshua Gillman, SC role: CONTACT phone: 858-246-2511 email: j1gillman@health.ucsd.edu name: Nicholas Wettersten, MD role: PRINCIPAL_INVESTIGATOR lat: 32.84727 lon: -117.2742 facility: VA Loma Linda Healthcare System status: RECRUITING city: Loma Linda state: California zip: 92357 country: United States name: Vicki Simpson, SC role: CONTACT phone: 909-593-6361 email: vicki.simpson@va.gov name: Jay Patel, MD role: PRINCIPAL_INVESTIGATOR lat: 34.04835 lon: -117.26115 facility: VA San Diego status: RECRUITING city: San Diego state: California zip: 92161 country: United States name: Jonathan Narita, SC role: CONTACT phone: 858-642-3512 email: jonathan.narita@va.gov name: Nancy Gardetto, MD role: PRINCIPAL_INVESTIGATOR lat: 32.71533 lon: -117.15726 facility: University of California, San Francisco status: RECRUITING city: San Francisco state: California zip: 94117 country: United States name: Priscilla Zhang, SC role: CONTACT phone: 415-514-7903 email: priscilla.zhang@ucsf.edu name: Liviu Klein, MD role: PRINCIPAL_INVESTIGATOR lat: 37.77493 lon: -122.41942 facility: Kaiser Permanente San Francisco status: RECRUITING city: San Francisco state: California zip: 94118 country: United States name: Priscilla Chung, SC role: CONTACT phone: 415-833-3480 email: priscilla.s.chung@kp.org name: Jana Svetlichanaya, MD role: PRINCIPAL_INVESTIGATOR lat: 37.77493 lon: -122.41942 facility: Nature Coast Clinical Research status: RECRUITING city: Crystal River state: Florida zip: 34429 country: United States name: Nina Smith, SC role: CONTACT phone: 352-563-1865 email: nsmith@encoredocs.com name: Susan Pasupuleti, MD role: PRINCIPAL_INVESTIGATOR lat: 28.90248 lon: -82.5926 facility: Jacksonville Center for Clinical Research status: RECRUITING city: Jacksonville state: Florida zip: 32216 country: United States name: Taylor Johnson, SC role: CONTACT phone: 904-730-0101 email: tjohnson@encoredocs.com name: Michael Koren, MD role: PRINCIPAL_INVESTIGATOR lat: 30.33218 lon: -81.65565 facility: Amavita Clinical Research status: RECRUITING city: Miami state: Florida zip: 33137 country: United States name: Nereisy Alonso, SC role: CONTACT phone: 786-703-5941 email: researchadmin@amavita.health name: Pedro Martinez Clark, MD role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 facility: Advance Medical Research Services Corp (AMRS) status: RECRUITING city: Miami state: Florida zip: 33173 country: United States name: Adam Rachid, SC role: CONTACT phone: 305-928-8845 email: arachid.amrs@gmail.com name: Yordan Orive Gomez, MD role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 facility: Baptist Health (Miami Cardiac & Vascular Institute) status: RECRUITING city: Miami state: Florida zip: 33173 country: United States name: Margie Mckercher, SC role: CONTACT phone: 786-595-8075 email: margie.mchercher@baptisthealth.net name: Sandra Chaparro, MD role: PRINCIPAL_INVESTIGATOR lat: 25.77427 lon: -80.19366 facility: Comprehensive Medical & Research Center status: RECRUITING city: Plantation state: Florida zip: 33317 country: United States name: Wilmer Santiesteban Garcia, SC role: CONTACT phone: 954-368-3529 email: wsantiesteban@compmedical.net name: William Korey, MD role: PRINCIPAL_INVESTIGATOR lat: 26.13421 lon: -80.23184 facility: St. Johns Center for Clinical Research status: RECRUITING city: Saint Augustine state: Florida zip: 32086 country: United States name: Valerie Hayes, SC role: CONTACT phone: 904-209-0043 email: vhayes@encoredocs.com name: Ameeth Vedre, MD role: PRINCIPAL_INVESTIGATOR lat: 29.89469 lon: -81.31452 facility: Tampa General Hospital status: RECRUITING city: Tampa state: Florida zip: 33606 country: United States name: Kiria Almeida-Tamayo, SC role: CONTACT phone: 813-844-8058 email: kalmeidatamayo@tgh.org name: Debbie Hoffman, MD role: PRINCIPAL_INVESTIGATOR lat: 27.94752 lon: -82.45843 facility: West Georgia Cardiology status: RECRUITING city: Carrollton state: Georgia zip: 30117 country: United States name: Justina Okeke, SC role: CONTACT phone: 678-839-7285 email: justina.okeke@westgacardiology.com name: Charlie Rouse, MD role: PRINCIPAL_INVESTIGATOR lat: 33.58011 lon: -85.07661 facility: University of Chicago status: RECRUITING city: Chicago state: Illinois zip: 60637 country: United States name: Veronica Herzog, SC role: CONTACT phone: 773-834-9794 email: vherzog@bsd.uchicago.edu name: Gene Kim, MD role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 facility: Advocate Illinois Masonic Medical Center status: RECRUITING city: Chicago state: Illinois zip: 60657 country: United States name: Maci Eiber, SC role: CONTACT phone: 773-296-0969 email: maci.eiber@aah.org name: Sorin Danciu, MD role: PRINCIPAL_INVESTIGATOR lat: 41.85003 lon: -87.65005 facility: Advocate Illinois Masonic Health Center status: RECRUITING city: Downers Grove state: Illinois zip: 60515 country: United States name: Debra Heidenreich, SC role: CONTACT phone: 630-352-2338 email: debra.heidenreich@aah.org name: Sorin Danciu, MD role: PRINCIPAL_INVESTIGATOR lat: 41.80892 lon: -88.01117 facility: Midwest Cardiovascular Center status: RECRUITING city: Naperville state: Illinois zip: 60540 country: United States name: Josilyn Klimek, SC role: CONTACT phone: 630-600-0730 email: josilyn.klimek@cardio.com name: Maria Rosa Costanzo, MD role: PRINCIPAL_INVESTIGATOR lat: 41.78586 lon: -88.14729 facility: Robert J. Dole VA Medical Center status: RECRUITING city: Wichita state: Kansas zip: 67218 country: United States name: Deborah Garner, sc role: CONTACT phone: 316-685-2221 phoneExt: 53352 email: deborah.garner@va.gov name: Freidy Eid, MD role: PRINCIPAL_INVESTIGATOR lat: 37.69224 lon: -97.33754 facility: St. Elizabeth Healthcare status: RECRUITING city: Edgewood state: Kentucky zip: 41017 country: United States name: Cynthia Mulcahy, SC role: CONTACT phone: 859-301-4046 email: cynthia.mulcahy@stelizabeth.com name: Haree Vongooru, MD role: PRINCIPAL_INVESTIGATOR lat: 39.01867 lon: -84.58189 facility: Cardiovascular Institute of the South status: RECRUITING city: Houma state: Louisiana zip: 70360 country: United States name: Kimberly Lirette, SC role: CONTACT phone: 985-873-5619 email: kimberly.lirette@cardio.com name: Peter Fail, MD role: PRINCIPAL_INVESTIGATOR lat: 29.59577 lon: -90.71953 facility: Cardiovascular Institute of the South status: RECRUITING city: Lafayette state: Louisiana zip: 70503 country: United States name: June Jones, SC role: CONTACT phone: 337-289-8429 email: june.jones@cardio.com name: Wade May, MD role: PRINCIPAL_INVESTIGATOR lat: 30.22409 lon: -92.01984 facility: University Medical Center New Orleans status: RECRUITING city: New Orleans state: Louisiana zip: 70112 country: United States name: Katasha Washington, SC role: CONTACT phone: 504-702-4704 email: katasha.washington@lcmchealth.org name: Frank Smart, MD role: PRINCIPAL_INVESTIGATOR lat: 29.95465 lon: -90.07507 facility: Nebraska Heart Center status: RECRUITING city: Lincoln state: Nebraska zip: 68526 country: United States name: Julie Potter, SC role: CONTACT phone: 402-328-3950 email: julie.potter@commonspirit.org name: Steven Krueger, MD role: PRINCIPAL_INVESTIGATOR lat: 40.8 lon: -96.66696 facility: VA Southern Nevada Healthcare System status: RECRUITING city: North Las Vegas state: Nevada zip: 89086 country: United States name: Rosalinda Cruz, SC role: CONTACT phone: 702-791-9000 phoneExt: 15575 email: Rosalinda.cruz@va.gov name: Marriyam Moten, MD role: PRINCIPAL_INVESTIGATOR lat: 36.19886 lon: -115.1175 facility: Mount Sinai Morningside status: RECRUITING city: New York state: New York zip: 10025 country: United States name: Kathy Idrissi, SC role: CONTACT phone: 646-561-1170 email: katharine.idrissi2@mountsinai.org name: Kiran Mahmood, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: The Mount Sinai Hospital status: RECRUITING city: New York state: New York zip: 10029 country: United States name: Lovelyne Julien, SC role: CONTACT phone: 212-241-1537 email: lovelyne.julien@mountsinai.org name: Anuradha Lala - Trindade, MD role: PRINCIPAL_INVESTIGATOR lat: 40.71427 lon: -74.00597 facility: St. Francis Hospital status: RECRUITING city: Roslyn state: New York zip: 11576 country: United States name: Lyn Santiago, SC role: CONTACT phone: 516-562-6763 email: lyn.santiago@chsli.org name: Rita Jermyn, MD role: PRINCIPAL_INVESTIGATOR lat: 40.79982 lon: -73.65096 facility: Mission Hospital status: RECRUITING city: Asheville state: North Carolina zip: 28803 country: United States name: Josephine Purbrick, SC role: CONTACT phone: 828-412-9149 email: josephine.purbrick@sarahcannon.com name: Vinay Thohan, MD role: PRINCIPAL_INVESTIGATOR lat: 35.60095 lon: -82.55402 facility: Moses H. Cone Memorial Hospital status: RECRUITING city: Greensboro state: North Carolina zip: 27401 country: United States name: Michelle McCart, SC role: CONTACT phone: 336-832-3799 email: michelle.mccart@conehealth.com name: Daniel Bensimhon, MD role: PRINCIPAL_INVESTIGATOR lat: 36.07264 lon: -79.79198 facility: The Lindner Research Center at The Christ Hospital status: RECRUITING city: Cincinnati state: Ohio zip: 45219 country: United States name: Kathryn Gloria, SC role: CONTACT email: katherineaubre.glori@thechristhospital.com name: Eugene Chung, MD role: PRINCIPAL_INVESTIGATOR lat: 39.12713 lon: -84.51435 facility: Cleveland Clinic status: RECRUITING city: Cleveland state: Ohio zip: 44106 country: United States name: Savi Radesic role: CONTACT phone: 216-445-6916 email: radesis@ccf.org name: W.H. Wilson Tang, MD role: PRINCIPAL_INVESTIGATOR lat: 41.4995 lon: -81.69541 facility: The Ohio State University status: RECRUITING city: Columbus state: Ohio zip: 43210 country: United States name: Carina Pannelle role: CONTACT phone: 614-366-8650 email: carina.panelle@osumc.edu name: Rami Kahwash, MD role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 facility: Vanderbilt University Medical Center status: RECRUITING city: Nashville state: Tennessee zip: 37232 country: United States name: Terry Weyand, SC role: CONTACT phone: 615-322-9349 email: terry.l.weyand@vumc.org name: JoAnn Lindenfeld, MD role: PRINCIPAL_INVESTIGATOR lat: 36.16589 lon: -86.78444 facility: Rio Grande Regional Hospital status: RECRUITING city: McAllen state: Texas zip: 78503 country: United States name: Dina Garcia, SC role: CONTACT phone: 956-632-6054 email: dina.garcia2@hcahealthcare.com name: Norman Ramirez, MD role: PRINCIPAL_INVESTIGATOR lat: 26.20341 lon: -98.23001 facility: Methodist Hospital of San Antonio status: RECRUITING city: San Antonio state: Texas zip: 78229 country: United States name: Maurene Cantu role: CONTACT phone: 210-218-4950 email: maurene.cantu@hcahealthcare.com name: Sachin Gupta, MD role: PRINCIPAL_INVESTIGATOR lat: 29.42412 lon: -98.49363 facility: University Hospital Samson Assuta Ashdod status: RECRUITING city: Ashdod country: Israel name: Sapir Swisa, SC role: CONTACT name: Alexander Goldman, MD role: PRINCIPAL_INVESTIGATOR lat: 31.79211 lon: 34.64967 facility: Assuta Be'er Sheva Medical Center status: RECRUITING city: Be'er Sheva country: Israel name: Alex Demitriev, SC role: CONTACT name: Amos Katz, MD role: PRINCIPAL_INVESTIGATOR lat: 31.25181 lon: 34.7913 facility: Rambam Medical Center status: RECRUITING city: Haifa country: Israel name: Ludmila Helmer, SC role: CONTACT phone: 972-4-7773475 name: Oren Caspi, MD role: PRINCIPAL_INVESTIGATOR lat: 32.81841 lon: 34.9885 facility: Shaare Zedek Medical Center status: RECRUITING city: Jerusalem country: Israel name: Hadas Barda, SC role: CONTACT phone: 972-2-6666769 name: Tal Hasin, MD role: PRINCIPAL_INVESTIGATOR lat: 31.76904 lon: 35.21633 facility: Galiee Medical Center status: RECRUITING city: Nahariya country: Israel name: Etti Lasri Kadosh, SC role: CONTACT phone: 972-4-9107747 name: Shaul Atar, MD role: PRINCIPAL_INVESTIGATOR lat: 33.00892 lon: 35.09814 facility: Tel Aviv Sourasky (Ichilov) Medical Center status: RECRUITING city: Tel Aviv country: Israel name: Tal Fux, SC role: CONTACT phone: 972-3-6972420 name: Michal Laufer Perl, MD role: PRINCIPAL_INVESTIGATOR lat: 32.08088 lon: 34.78057 facility: Poriya Medical Center status: RECRUITING city: Tiberias country: Israel name: Jannat Mukari, SC role: CONTACT phone: 972-4-6652201 name: Wadi Kinany, MD role: PRINCIPAL_INVESTIGATOR lat: 32.79221 lon: 35.53124 hasResults: False
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<|newrecord|> nctId: NCT06378619 id: CSAPG-50 briefTitle: Tapping Test and the Archimedean Spiral for the Differential Diagnosis of Tremor. Machine Learning Approach acronym: MATSEP overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-06 date: 2025-06 date: 2024-04-22 date: 2024-04-22 name: Consorci Sanitari de l'Alt Penedès i Garraf class: OTHER briefSummary: In clinical practice, it is sometimes difficult to establish whether a patient's tremor is due to Parkinson's disease or essential tremor. The distinction is crucial as the health implications differ significantly between the two conditions. Therefore, the present study aims to develop a diagnostic method based on machine learning techniques to help differentiate whether a patient's tremor is due to one condition or the other. To achieve this, 110 patients with tremor, correctly diagnosed with either Parkinson's disease or essential tremor, will participate. They will undergo two diagnostic tests (tapping test and Archimedean spiral) to capture data that can be processed using machine learning techniques. conditions: Tremor conditions: Essential Tremor conditions: Parkinson Disease studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: PROSPECTIVE count: 110 type: ESTIMATED name: Tapping Test name: Archimedes Spiral measure: Sensitivity measure: Specificity measure: Reliability sex: ALL minimumAge: 45 Years maximumAge: 79 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Sant Camil-Consorci Sanitari Alt'Pènedes i Garraf city: Barcelona state: Cataluña zip: 08810 country: Spain name: José Luis Camacho, MD role: CONTACT phone: +34 938960025 email: jlcamacho@csapg.cat name: Noemí Casaponsa role: CONTACT phone: +34 938960025 phoneExt: 43197 email: recerca@csapg.cat name: José Luis Camacho, MD role: PRINCIPAL_INVESTIGATOR lat: 41.38879 lon: 2.15899 hasResults: False
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<|newrecord|> nctId: NCT06378606 id: P.T.REC/012/004907 briefTitle: Effect of Technology on Cognitive Function in Elderly acronym: cogntion overallStatus: RECRUITING date: 2023-07-01 date: 2024-06-01 date: 2024-06-01 date: 2024-04-22 date: 2024-04-22 name: Nourhan Hesham Ali class: OTHER name: Cairo University briefSummary: Cognitive technology therapies, including interactive video gaming, computer soft wares and mobile technology, have been used to implement cognitive training and rehabilitation programs. Potential advantages to using technology-based interventions include enhanced accessibility and cost-effectiveness, providing a user experience to be good communicator, immersive and comprehensive. conditions: Cognitive Impairment studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: The aim of study is to find the effects of screen based cognitive therapy on mild dementia in elderly . primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: The aim of study is to find the effects of screen based cognitive therapy on mild dementia in elderly . whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: cognitive therapy measure: Cognitive functions assessment measure: Quality of life survey sex: ALL minimumAge: 65 Years maximumAge: 85 Years stdAges: OLDER_ADULT facility: Nour Ali status: RECRUITING city: Cairo state: Giza zip: 12511 country: Egypt name: Nour Ali, master role: CONTACT phone: 01156860154 email: nourheshame854@gmail.com lat: 30.06263 lon: 31.24967 hasResults: False
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<|newrecord|> nctId: NCT06378593 id: 3HP-2827-102 briefTitle: A Study of 3HP-2827 in Treatment of Unresectable or Metastatic Solid Tumors With FGFR2 Alterations overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2028-03 date: 2028-06 date: 2024-04-22 date: 2024-04-22 name: 3H (Suzhou) Pharmaceuticals Co., Ltd. class: INDUSTRY briefSummary: The study is being conducted to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of 3HP-2827 in the treatment of unresectable or metastatic solid tumors with FGFR2 alterations. conditions: Solid Tumors With FGFR2 Alterations, Adult studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 130 type: ESTIMATED name: 3HP-2827 measure: Dose Escalation Stage- incidence of adverse events (AEs) measure: Dose Escalation Stage- incidence of dose-limiting toxicities (DLTs) measure: Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted Vital Signs measure: Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results measure: Dose Escalation Stage -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters measure: Dose Escalation Stage -determine the maximum tolerated dose (MTD) and/or the recommended dose (RD) for expansion stage or recommended Phase II dose (RP2D) of 3HP-2827 measure: Expansion stage -Objective response rate（ORR） measure: Maximum concentration (Cmax) during the dosing interval of 3HP-2827 and/or its major metabolites as monotherapy. measure: Time to maximum concentration (Tmax) of 3HP-2827 and/or its major metabolites as monotherapy. measure: Apparent clearance (CL/F) of 3HP-2827 and/or its major metabolites as monotherapy. measure: Area under the concentration-time curve (AUC) of 3HP-2827 and/or its major metabolites as monotherapy. measure: Terminal half life (t1/2) of 3HP-2827 and/or its major metabolites as monotherapy. measure: Apparent volume of distribution (Vz/F) of 3HP-2827 and/or its major metabolites as monotherapy. measure: Duration of Response (DOR) as assessed by RECIST v1.1 measure: Disease control rate (DCR) as assessed by RECIST v1.1 measure: Progression-free survival (PFS) as assessed by RECIST v1.1 measure: Overall survival (OS) measure: Dose escalation stage - Objective Response Rate (ORR) measure: Expansion Stage- incidence of adverse events (AEs) measure: Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted Vital Signs measure: Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted Clinical Laboratory Test Results measure: Expansion Stage -Percentage of Participants With Changes From Baseline in Targeted ECG Parameters measure: Expansion Stage -Changes in patient-reported outcomes as assessed by the European Organization for Research and Treatment of Cancer Core QoL Questionnaire (EORTC QLQ-C30) in patients with advanced solid tumors sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Cancer Hospital city: Beijing state: Beijing zip: 100142 country: China name: Lin Shen, MD role: CONTACT lat: 39.9075 lon: 116.39723 facility: ZhongShan Hospital city: Shanghai state: Shanghai zip: 200123 country: China name: Jia Fan, MD role: CONTACT lat: 31.22222 lon: 121.45806 hasResults: False
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<|newrecord|> nctId: NCT06378580 id: LGF22H160084 id: LGF22H160084 type: OTHER_GRANT domain: Zhejiang Provincial Basic Public Welfare Research Program briefTitle: The Prognostic Impact of Surufatinib for the Treatment of Advanced Pancreatic Ductal Adenocarcinoma overallStatus: COMPLETED date: 2022-07-01 date: 2023-07-01 date: 2024-04-01 date: 2024-04-22 date: 2024-04-22 name: Luo Cong class: OTHER briefSummary: Pancreatic ductal adenocarcinoma (PDAC) is a highly aggressive tumor with a poor prognosis, despite the emergence of chemotherapies, unmet medical needs and limited treatment options still exist for patients with metastatic PDAC (mPDAC). Surufatinib is a small-molecule tyrosine kinase inhibitor that targets vascular endothelial growth factor (VEGFR) 1, 2, 3, fibroblast growth factor receptor 1 (FGFR1), and colony stimulating factor 1 receptor (CSF-1R), and ex vivo experiments have demonstrated its effect on PC models.
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A retrospective analysis of patients with PDAC who underwent surufatinib at Zhejiang Cancer Hospital (Hangzhou,China) from July 2022 to July 2023.The database was extracted from the preoperative demographics, blood markers, and surgical pathology information of patients undergoing surufatinib in the investigators' hospital. conditions: Pancreatic Cancer studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: RETROSPECTIVE count: 72 type: ACTUAL name: Surufatinib combine immune checkpoint inhibitor name: AG/FOLFIRINOX measure: Median progression-free survival sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Zhejiang Province Cancer Hospital city: Hangzhou state: Zhejiang zip: 310000 country: China lat: 30.29365 lon: 120.16142 hasResults: False
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<|newrecord|> nctId: NCT06378567 id: HCD J8923 briefTitle: A Study to Assess the Effects of Dietary Supplement Drinks on Sleep, Stress and Mood overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-05 date: 2024-05 date: 2024-04-22 date: 2024-04-22 name: The Water Street Collective class: INDUSTRY name: British American Tobacco (Investments) Limited name: HCD Research briefSummary: A home placement, randomized, double blind, placebo-controlled, study to determine the effect of dietary liquid shot beverage products on self-reported measures of sleep, stress and mood on generally healthy participants with current self-reported mild/moderate sleep difficulties (but not clinical insomnia) and mild/moderate stress. conditions: Sleep conditions: Mood conditions: Stress studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Parallel Assignment primaryPurpose: OTHER masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 180 type: ESTIMATED name: Dietary supplement liquid shot beverage products measure: Sleep Disturbance measure: Sleep Impairment measure: Insomnia Severity measure: Restorative Sleep measure: Contentedness/Anxiety measure: Profile of Mood States (POMS) measure: Daily Sleep diary sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Sago Atlanta - The Palisades Complex city: Atlanta state: Georgia zip: 30328 country: United States name: Melissa Hall role: CONTACT phone: 770-396-8700 email: connect@sago.com lat: 33.749 lon: -84.38798 hasResults: False
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<|newrecord|> nctId: NCT06378554 id: IRB00111227 briefTitle: Cereset Research for Performance Improvement in a Hospital Nursing Unit overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2026-05 date: 2024-04-22 date: 2024-04-22 name: Wake Forest University Health Sciences class: OTHER name: Susanne Marcus Collins Foundation, Inc. briefSummary: The purpose of this study is to explore whether an implementation process composed of offering CR to staff in a single hospital nursing unit has any potential impact on unit-level quality measures post-implementation. conditions: Health Personnel conditions: Stress conditions: Anxiety conditions: Job Performance conditions: Insomnia conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 30 type: ESTIMATED name: Cereset Research measure: Percent of ortho trauma unit staff who complete Cereset intervention sex: ALL minimumAge: 18 Years maximumAge: 100 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Wake Forest University Health Sciences city: Winston-Salem state: North Carolina zip: 27157 country: United States name: Dawn C Higgins role: CONTACT phone: 336-716-9447 email: dkellar@wakehealth.edu lat: 36.09986 lon: -80.24422 hasResults: False
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<|newrecord|> nctId: NCT06378541 id: SDR 21-267 briefTitle: Smartphone App Enhanced Facilitation Among Veterans in a Mental Health Inpatient Setting (Project HOPE) acronym: Project HOPE overallStatus: NOT_YET_RECRUITING date: 2024-11-01 date: 2028-10-31 date: 2028-10-31 date: 2024-04-22 date: 2024-04-22 name: VA Office of Research and Development class: FED briefSummary: This study will test whether a new intervention, Virtual Hope Box Enhanced Facilitation (VHB-EF), reduces suicide risk in Veterans after discharge from inpatient psychiatric hospitalization. Additionally, this study will also conduct interviews with Veterans and healthcare providers to explore barriers and facilitators to future adoption of the VHB-EF intervention in healthcare settings. conditions: Suicide Prevention conditions: Suicide Attempt conditions: Suicidal Ideation studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 928 type: ESTIMATED name: Virtual Hope Box Enhanced Facilitation name: Enhanced Usual Care measure: Suicide attempts (measured by the Columbia Suicide Severity Rating Scale [C-SSRS] and medical chart review) measure: Suicidal ideation (measured by the Scale for Suicidal Ideation [SSI]) measure: Self-efficacy to resist a future suicide attempt (measured by the Self-Efficacy to Avoid Suicidal Action [SEASA] scale) measure: Ability to cope with stressful situations (measured by the Coping Self-Efficacy [CSE] scale) measure: Reasons to live (measured by the Brief Reasons for Living Inventory [BRFL]) measure: Depression symptoms (measured by the Patient Health Questionnaire [PHQ-9]) measure: Mental Health Treatment Utilization (measured by the Treatment Services Review [TSR]) measure: Demographics measure: Borderline personality disorder features (measured by the Personality Assessment Inventory-Borderline Features Scale [PAI-BOR]) measure: Alcohol misuse (measured by the Alcohol Use Identification Test [AUDIT]) measure: Drug use (measured by the Drug Abuse Screening Test [DAST-10]) measure: Anxiety (measured by the Generalized Anxiety Disorder 7 [GAD-7]) measure: Coping strategies (measured by the Brief-COPE scale) measure: Virtual Hope Box (VHB) frequency measure: VHB app beliefs, usage, and treatment satisfaction sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: VA Ann Arbor Healthcare System, Ann Arbor, MI city: Ann Arbor state: Michigan zip: 48105-2303 country: United States name: Fatima Makki, MPH MSW role: CONTACT phone: 734-845-3623 email: fatima.makki@va.gov name: Courtney L Bagge, PhD MA role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA city: Seattle state: Washington zip: 98108-1532 country: United States name: Mark Reger, PhD role: CONTACT phone: 253-583-3295 email: Mark.Reger@va.gov lat: 47.60621 lon: -122.33207 hasResults: False
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<|newrecord|> nctId: NCT06378528 id: 2023-1706 id: Protocol Version Jan 2024 type: OTHER domain: UW Madison id: A538900 type: OTHER domain: UW Madison briefTitle: Ketamine-assisted Psychotherapy for Adolescent PTSD (KAP) overallStatus: NOT_YET_RECRUITING date: 2024-08 date: 2025-08 date: 2025-08 date: 2024-04-22 date: 2024-04-22 name: University of Wisconsin, Madison class: OTHER briefSummary: The objectives of this study are to investigate the feasibility, tolerability, and efficacy of repeated ketamine-assisted psychotherapy sessions in adolescents with severe posttraumatic stress disorder. The study will enroll adolescents with a current diagnosis of posttraumatic stress disorder (PTSD) to complete three intravenous ketamine administrations immediately prior to a psychotherapy session over the span of six weeks. All participants will complete an initial set of preparatory sessions, and each dosing session will be followed by three integration sessions. Finally, participants will complete 7 nights of at-home sleep recordings. The investigators hypothesize that this protocol will be well-tolerated by adolescents and that patients will experience decreases in PTSD symptom severity at follow-up. conditions: Posttraumatic Stress Disorder studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: single group, open label, pilot study primaryPurpose: TREATMENT masking: NONE count: 5 type: ESTIMATED name: Ketamine name: SmartSleep EEG recording headband measure: Summary of Adverse Events Attributable to Ketamine Administration measure: Number of Participants Adhering to the Study Protocol measure: Number of Visits Completed Throughout the Study Duration measure: Changes in PTSD symptom severity as measured by the Clinician Administered PTSD Scale Child/Adolescent Version (CAPS-CA) measure: Exploratory Measurements: Change waveform recorded with Philips SmartSleep headband, measured in Hz sex: ALL minimumAge: 15 Years maximumAge: 17 Years stdAges: CHILD facility: University of Wisconsin city: Madison state: Wisconsin zip: 53705 country: United States name: Sara Heyn, JD, PhD role: SUB_INVESTIGATOR name: Stephanie Jones, PhD role: SUB_INVESTIGATOR name: Steven Garlow, MD, PhD role: SUB_INVESTIGATOR name: Paul Hutson, PharmD role: SUB_INVESTIGATOR lat: 43.07305 lon: -89.40123 hasResults: False
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<|newrecord|> nctId: NCT06378515 id: Glymphactive briefTitle: Physical Activity, Sleep and Brain Health Based on the Glymphatic System overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-04 date: 2025-12 date: 2024-04-22 date: 2024-04-22 name: University of Valencia class: OTHER name: University of Oulu briefSummary: This study is aiming to analyze the impact of physical activity on neurohydrodynamics and glymphatic activity on young adults. This study is designed as a multicenter descriptive observational study with information collection at two different times: before performing a short exercise routine and during its performance using a wearable wireless device Glymphometer. conditions: Brain Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 77 type: ESTIMATED name: Physical activity, postural changes and cognitive tasks measure: Brain health measure: Physical activity (habitual) measure: Sleep duration measure: Sleep Quality measure: Chronotype measure: Self-reported health status measure: Other variables sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06378502 id: antibiotic-resistence briefTitle: The Effect of Different Antibiotic Protocols on Peri-implant Tissue Health overallStatus: NOT_YET_RECRUITING date: 2024-05-03 date: 2025-12-30 date: 2026-06-30 date: 2024-04-22 date: 2024-04-22 name: Universita degli Studi di Genova class: OTHER briefSummary: The aim of the present project (non-inferiority trial) is to evaluate the effect of different antibiotic strategies (long-span vs. short-span) for implant surgery on peri-implant tissue health, oral microbiome (included resistome) and salivary MiRNomics in healthy patients. conditions: Antibiotic studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 80 type: ESTIMATED name: Amoxicillin Short name: Amoxicillin Long measure: Mean peri-implant bone loss measure: Incidence of biological and technical complications at the implant site measure: implant survival rate measure: Antibiotic sensitivity measure: Peri-implant myco-, microbiome and resistome measure: Salivary miRNomics measure: Adverse reactions measure: Development of a 3D bone model measure: Plaque index (PI) measure: Bleeding on probing (BOP) measure: Peri-implant pocket probing depth (PPD) sex: ALL minimumAge: 35 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06378489 id: 2022-0346-01 briefTitle: The Use of Etonogestrel Contraceptive Implant as Treatment for Endometrial Hyperplasia Without Atypia: A Cohort Study overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-01-31 date: 2025-05-31 date: 2024-04-22 date: 2024-04-22 name: University of the Philippines class: OTHER name: Organon briefSummary: Endometrial hyperplasia without atypia is a condition in which the endometrium (the lining of the uterus) becomes abnormally thick. Although endometrial hyperplasia without atypia is not cancer, it can lead to endometrial cancer in 1-3% of women. This disease is treated by giving progestins. The optimal route, dosage and duration of progestin treatment for endometrial hyperplasia has not yet been determined until now. However, several publications have suggested the use of levonorgestrel releasing IUD as first-line treatment for endometrial hyperplasia without atypia. The other common medications used are the oral progestins medroxyprogesterone (MPA) and norethisterone acetate (NETA).
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The etonogestrel implant (Implant NXT) has been approved for contraceptive use by the US FDA in 2006. The mchanism of action of the implant for contraception suggests a potential application for its use in the treatment on hyperplasia. Off-label use of the implant for adrnomyosis, endometriosis and chronic pelvic pain has already been described in various studies. However, its therapeutic effect on endometrial hyperplasia without atypia has not been studied yet. The researchers propose to use the etonogestrel implant (Implant NXT) as novel treatment for endometrial hyperplasia without atypia. The study aims to determine the rate of regression to normal endometrium among patients with endometrial hyperplasia without atypia at 3 and 6 months after insertion of the implant. conditions: Endometrial Hyperplasia Without Atypia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 60 type: ESTIMATED name: Etonogestrel implant measure: Rate of (resolution) regression to normal endometrium measure: Endometrial thickness (by ultrasound) sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06378476 id: 855188 briefTitle: Supportive Understanding and Patient-centered Partnership for Optimizing Renal Treatment acronym: SUPPORT overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-06 date: 2025-09 date: 2024-04-22 date: 2024-04-24 name: University of Pennsylvania class: OTHER briefSummary: Black and Hispanic people face higher risks of chronic kidney disease (CKD) but have unequal access to the highest-quality kidney care. Black adults with CKD face 1.5 times higher hospitalization risks than non-Black adults with CKD. Once reaching end stage kidney disease (ESKD), Black patients are half as likely to receive a transplant and are often excluded from home dialysis. Structural racism creates complex barriers to optimal CKD care, providing an explanation for these findings. The Penn Medicine IMPaCT Community Health Worker (CHW) program is a rigorously tested approach to employ people from local communities to dismantle structural racism within health care systems and improve outcomes for marginalized patients. This trial will innovate by training CHWs to focus specifically on CKD care for minoritized people. The investigators will also train primary care clinicians caring for CKD patients on how to provide trauma-informed care (TIC). The first aim is to determine the feasibility, acceptability, and reach of a clinic-level TIC training to address the needs and concerns of Black and other minoritized patients. The second aim will be to conduct a three arm trial comparing individuals in usual care to individuals randomized to either our tailored CHW intervention in conjunction with clinic-level TIC training or to clinic-level TIC intervention only. The investigators will examine whether patients in the intervention arms have greater improvements in quality of life (primary). The investigators will also explore the impact of the interventions on patient activation, hospitalizations, and ESKD treatment preferences. conditions: Chronic Kidney Diseases conditions: Racism, Systemic conditions: Trauma, Psychological studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: SINGLE maskingDescription: Research coordinators collecting baseline and outcomes data from participants will be blinded to arm. whoMasked: OUTCOMES_ASSESSOR count: 150 type: ESTIMATED name: IMPaCT Community Health Worker Program name: Trauma-Informed Care Training measure: Kidney Disease Quality of Life Instrument (KDQOL) measure: Patient Activation Measure measure: All-Cause Hospitalizations measure: Patient preferences for end-stage renal disease treatment sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06378463 id: PSY-2324-S-0362 briefTitle: Cognitive Remediation and Transcranial Direct Current Stimulation in Severe Mental Illness (SMI) acronym: HEADDSET+ overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2027-04 date: 2027-04 date: 2024-04-22 date: 2024-04-22 name: University of Groningen class: OTHER name: Stichting Cosis name: Lentis Psychiatric Institute name: GGZ Friesland briefSummary: Seven per cent of patients suffering from severe mental illness (SMI) need long-term intensive treatment and support in a clinical setting or sheltered living. These service users often experience problems on multiple domains, such as persistent complaints as a result of medication resistance, physical health problems and self-care, psychosocial and cognitive dysfunctioning. Cognitive remediation (CR) training is a type of training aimed at improving thinking abilities (cognitive functioning) and daily functioning. However, we don't yet know if CR training can also help people with SMI who need supported housing due to their severe cognitive and daily living problems. In this project, we are investigating whether we can improve daily functioning in this group by using a form of CR training that focuses on learning new cognitive skills and how to use these new skills in everyday life. Additionally, we are exploring whether combining CR training with mild brain stimulation (transcranial Direct Current Stimulation) can enhance the effects of CR training. conditions: Severe Mental Illness studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a pragmatic triple-blinded, randomized, sham-controlled trial, following a non-concurrent multiple baseline design, with the participants serving as their own control. Participants will be randomized over two groups: CIRCuiTS +sham tDCS (group 1), or CIRCuiTS + active tDCS (group 2). The trial will start with a first measurement (T0), followed by a waiting period of 16 weeks and a second measurement (T1). The waiting period serves as the control condition (service users are their own control). Next, the participants will be allocated to 16-20 weeks of either CIRCuiTS + sham tDCS or CIRCuiTS + active tDCS. This period of 16-20 weeks is not fixed as it depends upon how fast participants go through the program. This is followed by a third measurement after treatment (T2). There will be a fourth measurement six months after the end of the intervention (T3). primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Participants will be randomly assigned to CR + sham tDCS (group 1) or CR + active tDCS (group 2) with a 1:1 allocation as per a computer-generated randomization plan using permuted blocks of random sizes. The block sizes will not be disclosed to ensure concealment. As such, both the researcher as the participant can stay blind to the tDCS treatment condition. Also, the assessors who will do neuropsychological tests are blind to the condition the participant is in and are blind to the type and aim of the treatment. After finishing measurement T2, the participants can indicate if they suspect to have experienced either the real or the sham tDCS treatment. The patients will be informed about the type of treatment they have received when all participants completed measurement T3. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 126 type: ESTIMATED name: Cognitive remediation + active tDCS name: Cognitive remediation + sham tDCS measure: Independent Living Skills Survey self- and observer-rated questionnaire (ILSS) measure: Goal Attainment Scale (GAS) measure: Controlled Oral World Association Task (COWAT) measure: Trail Making Test (TMT) measure: Digit span (forward & backward) measure: Wechsler Memory Scale - Visual Reproduction I and II measure: Stroop Color and Word Task (SCWT) measure: 15 Word Test (15-WT) measure: Behavioral Assessment of the Dysexecutive System (BADS) - Key Search task measure: Cognitive Failure Questionnaire (CFQ) measure: Self-Evaluation of Negative Symptoms (SNS) measure: DEX self/informant measure: General Self-Efficacy Scale (GSES) measure: Nurses' Observation Scale of Cognitive Abilities (NOSCA) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cosis city: Assen state: Drenthe zip: 9400 AE country: Netherlands name: Liesbeth Brand, MSc role: CONTACT phone: +31682079633 email: l.brand@cosis.nu lat: 52.99667 lon: 6.5625 facility: Lentis city: Zuidlaren state: Drenthe zip: 9470 AC country: Netherlands name: Lisette van der meer, PhD role: CONTACT phone: +31628259303 email: l.vandermeer@lentis.nl lat: 53.09417 lon: 6.68194 facility: GGZ Friesland city: Leeuwarden state: Friesland zip: 8932 PA country: Netherlands name: Sander De Vos, PhD role: CONTACT phone: +31 6 47368400 email: sander.de.vos@ggzfriesland.nl lat: 53.20139 lon: 5.80859 hasResults: False
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<|newrecord|> nctId: NCT06378450 id: 2022-23892-31512-2 briefTitle: Dose-Response Effects of Mindfulness Meditation overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2024-11-30 date: 2024-11-30 date: 2024-04-22 date: 2024-04-24 name: University of Melbourne class: OTHER briefSummary: The goal of this randomized controlled trial is to test for evidence of dose-response effects in a sample of healthy adults with little to no prior experience with meditation.
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The main question it aims to answer is whether larger doses of mindfulness meditation yield greater positive changes in wellbeing than smaller doses.
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Our hypotheses are that (1) larger doses of mindfulness training will yield significantly larger effects, and (2) different doses will be significantly associated with variation in participant engagement, with lower engagement associated with higher doses.
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Researchers will compare each of three dose conditions, 10-min, 20-min, 30-min, against a minimal dose condition of 3-4 min.
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Participants will take a 28-day mindfulness meditation course, with guided audio instructions provided daily throughout the intervention period (excluding one rest day per week). They will also be asked to respond to surveys before, during, and after the intervention. conditions: Well-Being, Psychological conditions: Depression studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 860 type: ESTIMATED name: Mindfulness meditation guided practice measure: Psychological wellbeing measure: Psychological Distress measure: Anxiety measure: Depression measure: Nonattachment measure: Trait Mindfulness measure: Decentering measure: Equanimity measure: Repetitive Negative Thoughts measure: Emotional Regulation measure: Attentional Control measure: Emotional Reactivity measure: Social Anxiety measure: Sleep Quality measure: Momentary Mood measure: State Mindfulness measure: Attention measure: Decentering measure: Mindful Attitudes sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06378437 id: GLB-001-02 briefTitle: A Study of GLB-001 in Patients With Myeloid Malignancies overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2026-12-31 date: 2027-12-31 date: 2024-04-22 date: 2024-04-22 name: Hangzhou GluBio Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: Study GLB-001-02 is a phase 1, open-label clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of GLB-001 in study participants with relapsed or refractory or intolerant myeloid malignancies including polycythemia vera (PV), essential thrombocythemia (ET), myelofibrosis (MF), lower-risk myelodysplastic syndrome (LR-MDS), higher-risk myelodysplastic syndromes (HR-MDS), and acute myeloid leukemia (AML). This study consists of 3 parts, dose escalation (Phase 1a), dose exploration (Phase 1b) and dose expansion (Phase 1c). Dose escalation (Phase 1a) and dose exploration (Phase 1b) will evaluate the safety, tolerability, PK, PD and preliminary efficacy of GLB-001, administered orally, in study participants with PV/ET, or study participants with MF/LR-MDS/HR-MDS/AML, respectively. Dose expansion (Phase 1c) will be followed to determine the relationships among dose, exposure, toxicity, tolerability and clinical activity, to identify minimally active dose, and to select the recommended dose(s) for phase 2 study. Approximately 108 study participants may be enrolled in the study. conditions: Polycythemia Vera conditions: Essential Thrombocythemia conditions: Myelofibrosis conditions: Myelodysplastic Syndromes conditions: Acute Myeloid Leukemia conditions: Myeloid Malignancy studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 108 type: ESTIMATED name: GLB-001 measure: Dose-limiting Toxicity (DLT) measure: Maximum Tolerated Dose (MTD) measure: Recommended Expansion Doses (RED) measure: Incidence, Relatedness, Seriousness and Severity of Adverse Events (AEs) measure: Recommended Phase 2 Dose (RP2D) measure: Response Assessment in Study Participants With PV measure: Response Assessment in Study Participants With ET measure: Response Assessment in Study Participants With MF measure: Response Assessment in Study Participants With LR-MDS measure: Response Assessment in Study Participants With HR-MDS measure: Response Assessment in Study Participants With AML measure: GLB-001 and GLB-C183-A-2 (diastereoisomer of GLB-001) Pharmacokinetics after Single Administration - AUC0-last measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - AUC0-24 measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - AUC0-inf measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - Cmax measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - Tmax measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - T1/2 measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - Vz/F measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - CL/F measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - λz measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Tmax,ss measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Cav,ss measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Cmax,ss measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Cmin,ss measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - AUC0-tau measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration-AUC0-last measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - λz measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Vz/F measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - CLss/F measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - T1/2 measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Rac [AUC] measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Rac [Cmax] measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration-DF sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Henan Cancer Hospital city: Zhengzhou state: Henan zip: 450003 country: China name: Hu Zhou, MD role: CONTACT phone: 86-0371-65587320 lat: 34.75778 lon: 113.64861 facility: Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences city: Tianjin state: Tianjin zip: 300020 country: China name: Lei Zhang, MD role: CONTACT phone: 86-022-23909240 lat: 39.14222 lon: 117.17667 facility: The First Affilicated Hospital, Zhejiang University School of Medicine city: Hangzhou state: Zhejiang zip: 310003 country: China name: Hongyan Tong, MD role: CONTACT phone: 86-0571-87236114 lat: 30.29365 lon: 120.16142 hasResults: False
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<|newrecord|> nctId: NCT06378424 id: 2023-6/6 briefTitle: The Effectiveness of Local Dry Cold, Hot and Vibration Applications in Peripheral Intravenous Catheterization overallStatus: COMPLETED date: 2023-03-22 date: 2023-03-22 date: 2023-08-23 date: 2024-04-22 date: 2024-04-22 name: Uludag University class: OTHER briefSummary: Aim: The aim of the present study was to examine the effect on venous dilation, procedure duration and pain severity of local hot, cold and vibration applications performed on the intervention area before peripheral intravenous catheterization in adults.
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Methods: The study included 120 adults who were randomly selected between March and August 2023. One application group (n=30) received local hot application, one group (n=30) received local cold application, and one (n=30) received local vibration using the Buzzy® device. The applications, to the site of the peripheral intravenous catheterization, lasted one minute. The control group (n=30) the received standard peripheral intravenous catheterization application. The groups' venous dilation was assessed on the vein assessment scale and the level of pain felt during catheterization was assessed using a visual analog scale. conditions: Pain Management conditions: Emergency Unit conditions: Diarrhea conditions: Nausea conditions: Vomiting studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 120 type: ACTUAL name: Cold Application name: Heat Application name: Vibration Application measure: pain intensity in mm measure: venous dilation in score measure: procedure duration in sec measure: weight measure: height sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Bursa Uludag University Hospital city: Bursa state: Nilüfer country: Turkey lat: 40.19559 lon: 29.06013 hasResults: False
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<|newrecord|> nctId: NCT06378411 id: P109 briefTitle: Development and Application of a Musical Game for Motor Rehabilitation overallStatus: RECRUITING date: 2024-04-04 date: 2024-07 date: 2024-10 date: 2024-04-22 date: 2024-04-22 name: Universidade da Madeira class: OTHER briefSummary: The aim of this study is to develop, adapt a musical game for residents of RAM, and evaluated the usability and correlation between this game with the improvement of motor coordination in short time. conditions: Health People conditions: Survivors of Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 45 type: ESTIMATED name: Music Game Intervention measure: Motor Coordination measure: Usability sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Universidade da Madeira status: RECRUITING city: Funchal country: Portugal name: Yasmim Moniz, Master role: CONTACT phone: +351 968412551 email: yasmimfernandes08@hotmail.com role: CONTACT email: yasmimfernandes08@hotmail.com lat: 32.66568 lon: -16.92547 hasResults: False
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<|newrecord|> nctId: NCT06378398 id: UMCC 2023.037 id: HUM00247729 type: OTHER domain: University of Michigan id: UMI23-13-01 type: OTHER domain: DCP Protocol Number id: 1UG1CA242632-01A1 type: NIH link: https://reporter.nih.gov/quickSearch/1UG1CA242632-01A1 briefTitle: A Trial of Omeprazole and Low Dose Aspirin to Identify Colorectal Biomarkers of Preventive Efficacy overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2024-08 date: 2024-08 date: 2024-04-22 date: 2024-04-22 name: University of Michigan Rogel Cancer Center class: OTHER name: National Cancer Institute (NCI) briefSummary: This trial will obtain biomarker data on the possible preventive effects of omeprazole and low-dose aspirin in colorectal tissue. Persons who have had 5 or more adenomas, 5 or more serrated polyps, or an incompletely removed adenoma or serrated polyp in the colon or rectum are potentially eligible. Before participating in the study, study staff will explain the study and review the consent form. If you are interested and provide consent, study staff will then confirm your eligibility. Once enrolled, participants will take two 20 mg omeprazole tablets and two 81 mg aspirin tablets each day before the first meal each day for 25-45 days.
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The study does involve biopsies of the colorectal tissue before and after taking the study medications. The biopsies are samples of tissue, about the size of a grain of rice, that will be taken from the colon or rectum before and after taking the study medications. This is done during a usual, clinical colonoscopy exam and during one more limited exam, called flexible sigmoidoscopy, that is done for the research study. The flexible sigmoidoscopy requires less preparation. Which procedure comes first depends on what fits best with each participant's clinical scenario. Biopsies of both normal mucosa and polyps (if possible) are collected. conditions: Colorectal Neoplasia studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 24 type: ESTIMATED name: Omeprazole name: Aspirin measure: Identification of biomarkers for omeprazole/aspirin combination treatment in the human colorectum measure: Evaluation of gene expression changes sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The University of Michigan Rogel Cancer Center city: Ann Arbor state: Michigan zip: 48109 country: United States name: Kirsten Tuck role: CONTACT phone: 734-763-1141 email: KLtuck@med.umich.edu name: Elena Stoffel, MD role: PRINCIPAL_INVESTIGATOR lat: 42.27756 lon: -83.74088 facility: Ohio State University Comprehensive Cancer Center city: Columbus state: Ohio zip: 43210 country: United States name: Kebire Gofar role: CONTACT email: Kebire.Gofar@osumc.edu name: Peter Stanich, MD role: PRINCIPAL_INVESTIGATOR lat: 39.96118 lon: -82.99879 hasResults: False
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<|newrecord|> nctId: NCT06378385 id: DevelopmentCEOAS briefTitle: Development and Content Validation of the Childhood Early Oral Aging Syndrome (CEOAS) Index for the Deciduous Dentition overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-10-31 date: 2024-12-20 date: 2024-04-22 date: 2024-04-25 name: University of Nove de Julho class: OTHER briefSummary: Premature, non-physiological tooth wear in childhood has numerous repercussions for oral health. This is a growing problem with multifactorial causes and associated with the current lifestyle. The aim of the present study was the development and determination of content validity of the Childhood Early Oral Aging Syndrome (CEOAS) index for the primary dentition as a diagnostic and epidemiological survey tool considering the current changes found in this population. conditions: Aging studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 6 type: ESTIMATED name: Childhood Early Oral Aging Syndrome index measure: Development of CEOAS index measure: Validation of CEOAS index sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universidade Metropolitana de Santos - UNIMES city: Santos state: São Paulo zip: 11045-002 country: Brazil lat: -23.96083 lon: -46.33361 hasResults: False
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<|newrecord|> nctId: NCT06378372 id: ETICA-ULE-064-2023 briefTitle: How Does Pianistic Musical Training Influence the Development of Alzheimer's Disease? overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-08-01 date: 2025-06-01 date: 2024-04-22 date: 2024-04-22 name: David Franco Castellanos class: OTHER name: Jesús Ángel Seco Calvo name: Javier Tejada Garcia briefSummary: The goal of this clinical trial is to learn about and describe how pianistic training influences the development of Alzheimer's disease.
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The key question is: Can pianistic practice influence the development of Alzheimer's disease?
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Participants will receive piano lessons for 4 weeks (20 sessions) and we will evaluate the evolution of the different parameters described by the tests carried out. conditions: Dementia of Alzheimer Type conditions: Dementia conditions: Dementia, Vascular conditions: Dementia, Mixed conditions: Dementia Frontal conditions: Dementia With Lewy Bodies conditions: Cognitive Decline conditions: Neurologic Disorder conditions: Neurologic Dysfunction conditions: Neurologic Deficits studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: An intervention based on teaching the piano in an individualized way primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 20 type: ESTIMATED name: Music therapy based on piano learning measure: State of global deterioration measure: Minimental Test measure: RDRS-2 Rapid Disability Assessment Scale measure: MONTREAL COGNITIVE ASSESSMENT (MOCA) measure: WAIS-IV measure: Behavioral disorders: BEHAVE-AD measure: NPI - CUMMINGS measure: Evaluation of the caregiver's burden (Zarit test) sex: ALL minimumAge: 50 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universidad de León city: León state: Castilla Y León zip: 24004 country: Spain lat: 42.60003 lon: -5.57032 hasResults: False
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<|newrecord|> nctId: NCT06378359 id: IDIM-2023-32364 briefTitle: Effectiveness of Screening and Decolonization of S. Aureus to Prevent S. Aureus Surgical Site Infections in Surgery Outpatients overallStatus: RECRUITING date: 2024-01-29 date: 2025-12-31 date: 2026-12-31 date: 2024-04-22 date: 2024-04-22 name: University of Minnesota class: OTHER briefSummary: The purpose of the study is to determine the effectiveness, safety, and health-care utilization and costs of a preoperative Staphylococcus aureus (SA) screening and decolonization bundle, (5 days of nasal mupirocin ointment, chlorhexidine gluconate (CHG) body wash, and CHG mouth rinse), in eradicating SA carriage compared to other SA decolonization approaches. The study will conduct a single center pilot trial to compare efficacy of different SA decolonization approaches in pre-surgical patients, in eradicating SA carriage, after obtaining informed consent.
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The study will compare four different approaches, Arm 1) screen for SA carriage and using the three-drug decolonization bundle for 5 days among patients with SA colonization, non SA carriers in this arm will get two pre-op showers with CHG soap, Arm 2) all participants receive the three drug decolonization bundle, Arm 3) all receive pre-op nasal povidone iodine the day of surgery plus two pre-op showers with CHG soap, and Arm 4) all receive nasal alcohol gel the day of surgery plus two pre op showers with CHG soap.
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The primary efficacy outcome will be eradication of SA colonization at all 5 body sites. Secondary outcomes will be SA surgical site infections (SSIs), all SSIs, and SA healthcare associated infections (HAIs). The study will also compare eradication of SA from each of the 5 body sites as a secondary outcome. conditions: Staphylococcus Aureus Colonization conditions: Surgical Site Infections conditions: Healthcare Associated Infections studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 250 type: ESTIMATED name: Screening and decolonization for SA carriers with the 3 drug bundle name: No screening for SA name: no screening name: Nasal povidone-iodine on surgery day plus 2 CHG pre-op showers without screening. name: Nasal alcohol gel on surgery day plus 2 CHG pre-op showers without screening measure: Efficacy in eradicating Staphylococcus aureus (SA) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Minnesota Medical Center and Clinics status: RECRUITING city: Minneapolis state: Minnesota zip: 55414 country: United States name: Pragya Karki, MD role: CONTACT phone: 612-301-6316 email: pkarki@umn.edu lat: 44.97997 lon: -93.26384 hasResults: False
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