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Outcome: Contamination rate and feasibility of both urine sampling techniques conditions: Urinary Tract Infections studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Patient will be assessed in triage and cases to be included in the study as per the inclusion criteria, after that patients will be randomized using computerized block randomization technique into two groups. Then, patients will be assigned to a bed, pulse oximetry to be applied, data collection sheet to be filled, confirm that infant had good feeding/ didn't pass urine over last 20 minutes and proper cleaning to be done. The next step will be, collecting urine sample according to randomization group. Group A patients (control group), urine to be collected by standardized catheterization technique while group B by standard CCU technique. Meanwhile, time of each procedure to be documented. Regarding group B , after collecting urine by CCU , we recommend to collect another sample by catheterization to guide the management and antibiotic choice. primaryPurpose: DIAGNOSTIC masking: SINGLE maskingDescription: The statistician who will analyze the data will be blinded. whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Bladder catheterization name: clean catch urine via bladder massage technique measure: Urine culture contamination rate measure: Parental satisfaction questionnaire measure: duration of the procedure measure: Pain score sex: ALL minimumAge: 1 Day maximumAge: 6 Months stdAges: CHILD typeAbbrev: Prot hasProtocol: True hasSap: False hasIcf: False label: Study Protocol date: 2024-01-01 uploadDate: 2024-02-14T09:44 filename: Prot_000.pdf size: 662911 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-01-01 uploadDate: 2024-02-14T09:45 filename: ICF_001.pdf size: 128074 hasResults: False
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<|newrecord|> nctId: NCT06265129 id: R.23.12.2429 briefTitle: The Association Between Obstructive Sleep Apnea Severity and Red Blood Cells Indices overallStatus: COMPLETED date: 2023-03-20 date: 2023-10-20 date: 2023-12-20 date: 2024-02-20 date: 2024-02-20 name: Mansoura University class: OTHER briefSummary: Obstructive sleep apnea syndrome (OSAS) is characterized by recurrent episodes of obstructive events (apnea and hypopnea) and intermittent hypoxia, which in turn contributes to the systemic inflammation that underlies this disease and its consequences (Ryan et al 2009, Gileles-Hillel et al 2014). This systemic inflammation leads to endothelial dysfunction, which contributes to the pathogenesis of cardiovascular complications in OSAS, in addition to the exposure to risk factors, such as male gender, older age, obesity, and lack of exercise (Lorenzi Filho et al 2010). Some red blood cells (RBC) and platelets indices have emerged as inflammatory biomarkers in various diseases (Tertemiz et al 2016) The severity of OSA is significantly associated with increase hematocrit, even after controlling for possible confounding variables. However, nocturnal hypoxemia in OSA does not usually lead to clinical polycythemia (Choi et al 2006). In patients referred with a clinical diagnosis of OSAS, RDW may be a marker for the severity of the condition. As RDW is usually included in a complete blood count, it could provide an inexpensive tool for triaging OSAS patients for polysomnography evaluation (Sökücü et al 2012). The hematological indices white blood cell count (WBC), neutrophil count, lymphocyte count, mean platelet volume (MPV), platelet distribution width (PDW), and red blood cell distribution width (RDW) have been proposed as alternative markers to those normally used clinically, e.g., interleukin-6 (IL6) and C-reactive protein, to evaluate the burden of inflammation in OSAS (Wu et al 2018) conditions: Obstructive Sleep Apnea studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: PROSPECTIVE count: 30 type: ACTUAL name: Complete blood picture (done in the morning after the night of monitored sleep by PSG. With stress on red blood cell indices (RBC count, MCV, MCH, RDW) measure: Red Blood Cells Indices sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tamer Awad Elsayed city: Mansoura state: Dakhlia zip: 050 country: Egypt lat: 31.03637 lon: 31.38069 hasResults: False
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<|newrecord|> nctId: NCT06265116 id: A0801024 CD briefTitle: One-Step Universal Adhesives: A 3-year Clinical Trial in Class II Composite Restorations overallStatus: RECRUITING date: 2024-01-23 date: 2027-01-23 date: 2027-01-30 date: 2024-02-20 date: 2024-02-20 name: Mansoura University class: OTHER briefSummary: to evaluate and compare the clinical performance and periodontal responses of four commercially available one-step universal adhesives with different formulations in Class II composite restorations over a three-year period. conditions: Dental Caries Class II conditions: Marginal Integrity of Composite Restorations With Universal Adhesives studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 48 type: ESTIMATED name: One-step universal adhesive measure: Percentage of functional and biological properties for each group sex: ALL minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Omar Abd El-Fattah Abd El-Maksoud status: RECRUITING city: Mansoura state: Dakahlia zip: 35516 country: Egypt name: Omar A Abd El-Maksoud role: CONTACT phone: 01024366555 email: [email protected] lat: 31.03637 lon: 31.38069 hasResults: False
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<|newrecord|> nctId: NCT06265103 id: 20190407 briefTitle: Epilepsy Learning Healthcare System (ELHS) acronym: ELHS overallStatus: RECRUITING date: 2019-03-20 date: 2099-02-14 date: 2099-02-14 date: 2024-02-20 date: 2024-02-20 name: Epilepsy Foundation of America class: OTHER briefSummary: The Epilepsy Learning Health System (ELHS) is a quality improvement and research network to improve outcomes for people with epilepsy. The ELHS is designed as a model of value-based chronic care for epilepsy as envisioned by the National Academies of Medicine Committee in their landmark reports "The Learning Health System" and "Epilepsy Across the Spectrum: Promoting Health and Understanding".
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The ELHS network is a collaboration among clinicians, patients and researchers that promotes the use of data for multiple purposes including one-on-one clinical care, population management, quality improvement and research. The ELHS Registry includes data on children and adults with epilepsy collected during the process of standard epilepsy care. These data are used to create population health reports and to track changes in outcomes over time. ELHS teams use quality improvement methods, such as Plan-Do-Study-Act (PDSA) cycles, to continuously learn how to improve care. conditions: Epilepsy conditions: Seizure Disorder conditions: Neurologic Disorder conditions: Rare Diseases studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: CROSS_SECTIONAL count: 1000 type: ESTIMATED name: Clinical care and quality improvement measure: Seizure Frequency measure: Seizure Freedom measure: Quality of Life documentation sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Barrow Neurological Institute Comprehensive Epilepsy Center status: RECRUITING city: Phoenix state: Arizona zip: 85013 country: United States name: Malinda Brooks-Busch, MPH role: CONTACT phone: 602-406-3443 email: [email protected] name: Sue Herman, MD role: PRINCIPAL_INVESTIGATOR lat: 33.44838 lon: -112.07404 facility: University of Southern California status: RECRUITING city: Los Angeles state: California zip: 90032 country: United States name: Alissa Maier, MPH role: CONTACT phone: 937-545-2627 email: [email protected] name: Christi Heck, MD role: PRINCIPAL_INVESTIGATOR lat: 34.05223 lon: -118.24368 facility: Epilepsy Foundation status: RECRUITING city: Bowie state: Maryland zip: 20716 country: United States name: Kathleen Farrell, MB BCh BAO role: CONTACT phone: 732-832-5983 email: [email protected] name: Saniya Griffin role: CONTACT email: [email protected] name: Brandy Fureman, Ph.D role: PRINCIPAL_INVESTIGATOR lat: 38.94278 lon: -76.73028 facility: Partners - Massachusetts General Hospital Epilepsy Service (MGH)/ Partners - Brigham and Women's (BWH) status: RECRUITING city: Boston state: Massachusetts zip: 02114 country: United States name: Jason Raymond Smith role: CONTACT phone: 617-726-3311 email: [email protected] name: Daniel Hoch, MD, Ph.D role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Beth Israel Deaconess Medical Center's Comprehensive Epilepsy Program status: NOT_YET_RECRUITING city: Boston state: Massachusetts zip: 02215 country: United States name: Jennifer Sabbagh role: CONTACT phone: 617-975-8545 email: [email protected] name: Bernard Chang, M.D., M.M.Sc. role: PRINCIPAL_INVESTIGATOR lat: 42.35843 lon: -71.05977 facility: Cincinnati Children's Hospital Comprehensive Epilepsy Center (CCHMC) status: NOT_YET_RECRUITING city: Cincinnati state: Ohio zip: 45229 country: United States name: Naima Griffin role: CONTACT phone: 513-636-9933 email: [email protected] name: Katie Holland role: PRINCIPAL_INVESTIGATOR lat: 39.12713 lon: -84.51435 facility: University of Cincinnati Gardner Neuroscience Institute Epilepsy Center status: NOT_YET_RECRUITING city: Cincinnati state: Ohio zip: 45267 country: United States name: Lucy Mendoza, CCRP role: CONTACT phone: 513-558-3020 email: [email protected] name: David Ficker, MD role: PRINCIPAL_INVESTIGATOR lat: 39.12713 lon: -84.51435 facility: Penn State Hershey status: NOT_YET_RECRUITING city: Hershey state: Pennsylvania zip: 17033 country: United States name: Jessica Beiler, MPH,CCRC role: CONTACT phone: 717-531-5656 email: [email protected] name: William Trescher, MD role: PRINCIPAL_INVESTIGATOR lat: 40.28592 lon: -76.65025 facility: Children's Hospital of Philadelphia (CHOP) status: NOT_YET_RECRUITING city: Philadelphia state: Pennsylvania zip: 19104 country: United States name: Nicholas Abend role: CONTACT email: [email protected] name: Nicholas Abend, MD, MSCE role: PRINCIPAL_INVESTIGATOR lat: 39.95233 lon: -75.16379 facility: UT Southwestern Children's Dallas status: RECRUITING city: Dallas state: Texas zip: 75063 country: United States name: Bonnie Jenkins, LCSW role: CONTACT phone: 214-456-0614 email: [email protected] name: Deepa Sirsi, MD role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 hasResults: False
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<|newrecord|> nctId: NCT06265090 id: F.P.T 2307017 briefTitle: Effect of Lumbar Stabilization Exercises Combined With Ball and Balloon Exercise in Treatment of Chronic Non-specific Low Back Pain overallStatus: COMPLETED date: 2022-01-10 date: 2022-12-20 date: 2023-01-10 date: 2024-02-20 date: 2024-02-20 name: Delta University for Science and Technology class: OTHER briefSummary: \[Background\] Low back pain occurs when a poor lifestyle weakens the muscular strength of the waist and excessive loads on and tensions of the muscles create pain. Mediating muscle weakening to stabilize the trunk is an important aspect in the recovery of body function in patients with LBP \[Purpose\], this study was conducted to investigate the effect of core stability exercises combined with ball and balloon exercises on chronic non-specific low back pain. \[Subjects and Methods\] a sixty patient of chronic non-specific low back pain were randomly assigned into two groups, group (A) received core stability exercises combined with ball and balloon exercises and group (B) received core stability exercises, these exercises were performed for three times a week for four weeks. Pain was assessed by visual analogue scale (VAS). Spinal function was measured by Arabic Oswestery Disability Index (AODI) and pulmonary function was assessed by pulmonary function test including forced expiratory volume in the first second (FEV1), forced vital capacity (FVC), FEV1/FVC, maximum voluntary ventilation (MVV) and peak expiratory flow (PEF) before and after the study.
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Keywords: core stability exercises, ball and balloon exercises, chronic non-specific low back pain conditions: Chronic Mechanical Low Back Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This randomized controlled experimental trial was carried out at the outpatient clinic of faculty of physical therapy, Delta University for science and technology from April 2023 to October 2023. The aims of the study and the study protocol were explained for each patient before participation in the study. All patients signed an approved informed consent form for participation in this study. Before starting the treatment program, a complete history and physical examination will be taken for all patients.
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Subjects:
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Seventy male and female physiotherapy students have chronic non-specific low back pain will be chosen from faculty of physical therapy, delta university for science and technology.
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The local ethics committee approved this study (Delta University for science and technology, faculty of Physical Therapy, Ethics committee F.P.T 2307017). primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: the participants were selected randomly without their knowledge about in experimental or control group the assessor was for assessment only and the therapist was for treatment only whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 60 type: ACTUAL name: therapeutic exercises name: exercises measure: visual analogue score measure: forced expiratory volume in the first second (FEV1) in liters measure: forced vital capacity (FVC) in liters measure: FVC/FEV1 ratio measure: maximum voluntary ventilation (MVV) measure: peak expiratory flow (PEF) in liter/min measure: Arabic Oswestery Disability Index (AODI) for functional assessment measure: weight measure: age measure: height sex: ALL minimumAge: 18 Years maximumAge: 25 Years stdAges: ADULT facility: Delta University For Science and Technology city: Al Manşūrah state: Gamasah zip: 11152 country: Egypt lat: 31.03637 lon: 31.38069 hasResults: False
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<|newrecord|> nctId: NCT06265077 id: 2023-199 briefTitle: Novel Preventive Approach Against Filgrastim-Induced Bone Pain in Cancer Patients overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2024-08 date: 2024-08 date: 2024-02-20 date: 2024-02-20 name: Noha Mansour class: OTHER briefSummary: No randomized controlled trial evaluated the safety and efficacy of double blockade on G-CSF induced bone pain. Therefore, this study aims to evaluate the efficacy and safety of double blockade on the incidence and severity of G-CSF induced bone pain. conditions: Breast Cancer conditions: Filgrastim Adverse Reaction studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: DOUBLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 60 type: ESTIMATED name: Placebo name: famotidine and loratadine measure: The incidence of grade 2 or 3 bone pain in cycle 1 according to Common Terminology Criteria for Adverse Events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06265064 id: KhonKaenUniversity briefTitle: STOP-Bang Score and Factors Predicting Difficult Intubation for Prediction of Difficult Mask Ventilation in Obese Patients overallStatus: COMPLETED date: 2022-07-11 date: 2023-10-31 date: 2023-10-31 date: 2024-02-20 date: 2024-02-20 name: Khon Kaen University class: OTHER briefSummary: The goal of this prospective observational study is to test combination of STOP-Bang score and factors predicting difficult intubation can improve accuracy of prediction difficult mask ventilation in obese patients that undergoing to elective surgery under general anesthesia.
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The main question\[s\] it aims to answer are:
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* Can combination of STOP-Bang score and factors predicting difficult intubation improve accuracy of prediction difficult mask ventilation in obese patients?
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* Study about complication after endotracheal tube insertion in obese patients that undergoing to elective surgery under general anesthesia.
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Participants who undergoing to elective surgery under general anesthesia will
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* Routine preoperative evaluation and ask about STOP bang questions, evaluate neck circumference, Mallampati grade,Thyromental distance (That routine physical examination for anesthetic care pre-operation)
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* In operation room, patients will be inducted anesthesia by anesthesiologist (step routine for general anesthesia),observe difficult mask ventilation grading before intubate endotracheal tube and complication after endotracheal tube insertion.
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If there is a comparison group:
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Researchers will compare obese patients with/without high STOP bang score \>=3 point plus factor predicting difficult intubation (Mallampati grade 3-4, Neck circumference \> 42 cm, Thyromental distance \< 6 cm)to prediction difficult mask ventilation conditions: Obesity conditions: OSA studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 278 type: ACTUAL name: STOP-Bang score >= 3 with factors predicting difficult intubation measure: Difficult mask ventilation measure: Resipiratory complication sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: KhonKaen University city: Nai Muang state: Khonkaen zip: +66 country: Thailand lat: 15.17901 lon: 100.1282 hasResults: False
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<|newrecord|> nctId: NCT06265051 id: 100939 briefTitle: Tirofiban After Successful MT Recanalization in AIS acronym: ATTRACTION overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-03-01 date: 2027-09-01 date: 2024-02-20 date: 2024-04-02 name: Xiang Luo class: OTHER name: Wuhan Central Hospital name: Wuhan University name: Renmin Hospital of Wuhan University name: Second Affiliated Hospital of Soochow University name: The First Affiliated Hospital of Zhengzhou University name: Wuhan Hospital of Traditional Chinese Medicine name: The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture name: Huangshi Central Hospital, China name: The First Affiliated Hospital of Yangtze University name: The Fifth Hospital of Wuhan name: Wuhan Puren Hospital name: Xiangyang No.1 People's Hospital name: Xianning Central Hospital name: Wuhan Hanyang Hospital name: Wuhan Third Hospital name: Yichang Central People's Hospital name: Affiliated Hospital of Chengde Medical University name: Beijing Tiantan Hospital name: Nanyang Central Hospital name: Jingzhou Central Hospital name: Taihe Hospital name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School briefSummary: Acute ischemic stroke with large vessel occlusion is a frequently occurring life-threatening condition. Although endovascular treatment can effectively open occluded vessels, the successful reperfusion rate exceeds 80%, but the rate of good prognosis is less than 50%. The current clinical focus is on how to improve futile recanalization. Tirofiban is widely used in the treatment of stroke, as it can effectively prevent vascular reocclusion and improve microcirculation perfusion. It has the potential to improve futile recanalization, but there is a lack of high-level evidence-based medical support. This multicenter, prospective, double-blind, randomized controlled trial was conducted to assess the effectiveness and safety of sequential tirofiban therapy following successful mechanical thrombectomy within 24 hours of onset. conditions: Acute Ischemic Stroke conditions: Vessel Occlusion studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 1360 type: ESTIMATED name: Tirofiban name: Saline placebo measure: Proportion of patients functionally independent (mRS score 0 to 2) at 90 days measure: Number of participants with symptomatic intracranial hemorrhage measure: Modified ranking scale (mRS) measure: Proportion of patients non-disabled (mRS score 0 to 1) or return to pre-morbid mRS score at 90 days (for patients with mRS > 1) measure: Proportion of patients ambulatory or bodily needs-capable or better (mRS score 0 to 3) measure: Number of participants with improvement of neurological function measure: Health-related quality of life, assessed with the European Quality Five Dimensions Five Level scale (EQ-5D-5L) measure: All-cause mortality measure: Proportion of intracranial hemorrhage of any type sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06265038 id: SANAT-CAGE-2022 briefTitle: Confirmatory Investigation to Evaluate the Performance and Safety of ReSpace TiCell Cage Implants in TLIF overallStatus: RECRUITING date: 2024-02-01 date: 2026-02-01 date: 2026-10-01 date: 2024-02-20 date: 2024-02-21 name: Sanatmetal Orthopaedic and Traumatologic Equipment Manufacturer Ltd. class: INDUSTRY briefSummary: The primary objective of this study is to confirm superiority for the efficacy of the ReSpace Ticell Cage implants in Transforaminal Lumbar Interbody Fusion compared to state-of-the-art.
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The secondary objective of the study is to evaluate further efficacy and safety of the ReSpace Ticell Cage implants in Transforaminal Lumbar Interbody Fusion with the following secondary efficacy and safety objectives:
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* To evaluate if implantation causes significant reduction in patient's back, hip/buttock, and leg pain.
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* To evaluate if implantation causes significant increase quality of life of the patients.
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* To evaluate if using the device can be considered as safe overall. conditions: Degenerative Instability conditions: Spondylolisthesis conditions: Post-discectomy Syndrome conditions: Post-traumatic Instability studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective, single-arm, open-label clinical trial. This clinical investigation addresses to collect data on clinical performance, effectiveness and safety of Sanatmetál's ReSpace TiCell Cage in human subjects following the good clinical practice according to the Medical Device Regulation (MDR) \& EN ISO 14155:2020. The study is conducted in Hungary at National Center for Spinal Disorders. primaryPurpose: OTHER masking: NONE count: 99 type: ESTIMATED name: ReSpace TiCell Cage measure: CT imaging_1 - cumulative fusion rate measure: CT imaging_2 - fusion status measure: Visual Analog Scale measure: Oswestry Disability Index (ODI) measure: AE and ADE measure: Complications measure: Surgical revisions sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Center for Spinal Disorders status: RECRUITING city: Budapest state: Pest zip: 1126 country: Hungary name: Aron Lazary, MD, PhD role: CONTACT phone: +36118877900 phoneExt: 5671 email: [email protected] lat: 47.49801 lon: 19.03991 hasResults: False
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<|newrecord|> nctId: NCT06265025 id: GM103-CT-101 briefTitle: GM103 Intratumoral Injection in Patients With Locally Advanced, Unresectable, Refractory and/or Metastatic Solid Tumors overallStatus: RECRUITING date: 2024-02-20 date: 2025-05-30 date: 2028-10-30 date: 2024-02-20 date: 2024-03-21 name: GeneMedicine Co., Ltd. class: INDUSTRY briefSummary: The purpose of this study is to measure safety, tolerability, and preliminary antitumor efficacy of GM103 administered alone and in combination with pembrolizumab in patients with locally advanced, unresectable, refractory and/or metastatic solid tumors (including but not limited to head and neck cancer, malignant melanoma, CRC, renal cell carcinoma, cervical cancer, and breast cancer). Study details include: conditions: Head and Neck Cancer conditions: Malignant Melanoma conditions: Colorectal Cancer conditions: Renal Cell Carcinoma conditions: Cervical Cancer conditions: Breast Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Dose escalation and dose expansion primaryPurpose: TREATMENT masking: NONE count: 125 type: ESTIMATED name: GM103 (Part A) name: GM103 (Part B) name: GM103 and Pembrolizumab (Part C) measure: Percentage of patients with DLTs by cohorts measure: Percentage of patients with DLTs measure: Incidence of AEs, AESIs, SAEs, AEs leading to discontinuation, and AEs resulting in death measure: ORR measure: DCR defined as the proportion of patients whose BOR was CR, PR and SD measure: Median PFS defined as the time from the date of the first administration of study drug to the date of disease progression or death measure: Incidence of GM103 detection measure: Changes in the level of anti-adenovirus antibodies(ADA) in blood compared to baseline (ADA in genome copies/mL using qPCR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cancer Center status: NOT_YET_RECRUITING city: Goyang-si state: Gyeonggi-do zip: 10408 country: Korea, Republic of name: WY Choi role: CONTACT lat: 37.65639 lon: 126.835 facility: Korea University Anam Hospital status: NOT_YET_RECRUITING city: Seoul zip: 02841 country: Korea, Republic of name: SH Lee role: CONTACT lat: 37.566 lon: 126.9784 facility: Hanyang University Seoul Hospital status: NOT_YET_RECRUITING city: Seoul zip: 04763 country: Korea, Republic of name: MS Chung role: CONTACT lat: 37.566 lon: 126.9784 facility: Severance Hospital, Yonsei University Health System status: RECRUITING city: Seoul country: Korea, Republic of name: JY Lee role: CONTACT lat: 37.566 lon: 126.9784 hasResults: False
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<|newrecord|> nctId: NCT06265012 id: PHV01-C-101 briefTitle: Study to Evaluate the Recombinant Vesicular Stomatitis Virus (rVSV)-Marburg Virus Vaccine Candidate (PHV01) in Healthy Adult Subjects acronym: PHV01 overallStatus: RECRUITING date: 2024-02-05 date: 2024-04-17 date: 2024-09-16 date: 2024-02-20 date: 2024-02-22 name: Public Health Vaccines LLC class: INDUSTRY name: Biomedical Advanced Research and Development Authority briefSummary: This is a Phase 1 randomized, single-blind, placebo-controlled, ascending dose study to evaluate the safety and immunogenicity of rVSV∆G-MARV-GP \[Angola\] (PHV01, Marburg Virus glycoprotein \[MARV GP\] Vaccine) in healthy adults. PHV01 is a live, attenuated rVSV vaccine expressing the MARV GP. The main questions it aims to answer are:
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* Which dose of PHV01 is safe to administer to, and well-tolerated by healthy adult subjects?
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* What is the immunologic response (Marburg-specific Immunoglobulin G (IgG) ELISA antibody and neutralizing antibodies) to each dose level?
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Participants will receive 1 intramuscular injection of PHV01 or placebo on Day 1 and will be followed for 181 days. conditions: Marburg Virus Disease studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: PREVENTION masking: QUADRUPLE maskingDescription: Single-blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 36 type: ESTIMATED name: PHV01 name: Placebo measure: Solicited Adverse Events (AEs) measure: Unsolicited AEs measure: Other AEs measure: Immunogenicity, Antibodies (Ab) measure: Immunogenicity, Neutralizing antibodies (NEUT) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: CenExel RCA status: RECRUITING city: Hollywood state: Florida zip: 33024 country: United States name: Terry Piedra role: CONTACT phone: 305-596-3125 email: [email protected] name: Amanda Gonzalez role: CONTACT phone: 813-817-7984 email: [email protected] name: Craig Shapiro, MD role: PRINCIPAL_INVESTIGATOR lat: 26.0112 lon: -80.14949 hasResults: False
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<|newrecord|> nctId: NCT06264999 id: 427976 briefTitle: Robotic Assisted Knee Arthroplasty - Retain the Anterior Cruciate Ligament or Not overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-04 date: 2026-04 date: 2024-02-20 date: 2024-02-23 name: St. Olavs Hospital class: OTHER name: Smith & Nephew, Inc. briefSummary: The goal of this clinical trial is to compare the function of the knee after retaining or sacrificing the anterior cruciate ligament in robotic assisted knee arthroplasty.
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The main questions it aims to answer are:
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Does retaining the anterior cruciate ligament improve postoperative gait? Participants will perform
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* Gait analysis
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* Stair performance test
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* CT based Micromotion analysis of the implant micromovement conditions: Arthritis Knee conditions: Arthroplasty conditions: Gait Analysis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Journey II CR name: Journey II XR measure: Preferred walking speed (meter/minute) after surgery measure: CT-RSA measured maximum total point of motion(MTPM) measure: evaluation of max walking speed(m/minute) measure: stride length(cm) measure: step length in mid stance phase (cm) measure: single leg support time(s) measure: double-leg support time(s) measure: stair performance(s) measure: Rating pain using NRS (Numeric Rating Scale). measure: KOOS-PS (Knee Injury and Osteoarthritis Outcome score) measure: Clinical evaluation of range of motion . measure: Rating outcome using EQ-5D-5L(European quality of life index version 5D-5L), measure: IKSS (International Knee Society System knee and function score) measure: FJS-12 (Forgotten Joint score) measure: Clinical evaluation of Anteroposterior stability. measure: Clinical evaluation of Mediolateral stability. measure: A long leg X-Ray identifying outliers with Hip Knee Ankle angle Varus <-3 ºor Valgus >3 º measure: Presence of eminence fractures sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St.Olavs Hospital city: Trondheim state: Trøndelag zip: 7006 country: Norway name: Anders Sjøstrøm, MD role: CONTACT phone: +4772575241 email: [email protected] name: Siri Bjørgen Winther, PhD role: SUB_INVESTIGATOR name: Sølvi Liabekk Selli role: SUB_INVESTIGATOR lat: 63.43049 lon: 10.39506 hasResults: False
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<|newrecord|> nctId: NCT06264986 id: 2023-09-02 briefTitle: The Effects of Ashwagandha (Withania Somnifera) Supplementation on Exercise Performance in Female Footballers overallStatus: ACTIVE_NOT_RECRUITING date: 2024-01-13 date: 2024-02-21 date: 2024-02-21 date: 2024-02-20 date: 2024-02-20 name: Blanca Roman-Viñas, MD class: OTHER briefSummary: The goal of this clinical trial is to evaluate the effects of short-term root extract ashwagandha supplementation on exercise performance in female footballers. The main question it aims to answer are:
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Will short-term supplementation of root extract ashwagandha improve muscle strength markers in female footballers? Will short-term supplementation of root extract ashwagandha improve perception of recovery following high-intensity exercise in female footballers?
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Participants will either supplement 600mg (5% withanolides) root extract ashwagandha or placebo once a day for 28 days. There will be three data points: baseline, 14 days and 28 days. Researchers will compare values of intervention against placebo to see if there is an effect on muscle strength or perception of recovery. conditions: Muscle Strength studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double-blind, placebo-controlled, randomised trial primaryPurpose: BASIC_SCIENCE masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 30 type: ACTUAL name: Ashwagandha name: Placebo measure: Increased lower body muscle strength measure: Increased maximum voluntary muscle strength measure: Increased upper body muscle strength and explosiveness measure: Improved overall muscle strength measure: Improved perception of wellbeing measure: Improved perception of recovery sex: FEMALE minimumAge: 17 Years maximumAge: 40 Years stdAges: CHILD stdAges: ADULT facility: Club Esportiu Seagull city: Badalona state: Barcelona zip: 08917 country: Spain lat: 41.45004 lon: 2.24741 hasResults: False
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<|newrecord|> nctId: NCT06264973 id: NL9318 briefTitle: Maternal and Fetal/Neonatal Pharmacokinetics and - Dynamics of Corticosteroids During Pregnancy acronym: MaDyCo overallStatus: RECRUITING date: 2021-01-01 date: 2025-06-01 date: 2025-12-01 date: 2024-02-20 date: 2024-02-20 name: Erasmus Medical Center class: OTHER briefSummary: Improving pregnancy outcome is essential in improving health of both parents and their offspring during the life course. Preterm birth (PTB) occurs in 10-15% of all pregnancies, is the leading cause of perinatal mortality and morbidity {Goldenberg, 2008}, has long-term adverse consequences for postnatal health {Huddy, 2001} and is a burden for health care expenditure. In order to improve neonatal outcome, antenatal corticosteroids (ACS) are routinely administered to women at risk for preterm delivery before 34 weeks of pregnancy. {Jobe, 2018;Roberts, 2017;Travers, 2018} However, the current, worldwide standard of care, for the use of ACS is still based on animal experiments performed in the 1970's. {Liggins, 1969} Although ACS treatment to improve neonatal outcome was clinically introduced in the 70's, still only two dosing regimens are used, neither of which have been investigated, re-evaluated or refined to determine the optimal doses or treatment interval. With the current health care approach of personalized medicine in mind, the same universal approach for everybody, independent of gestational age, number of fetus, maternal weight or comorbidity one dose does not fit all since it often has not the desired effect. Due to the lack of optimization of the above mentioned synthetic corticosteroid drug regimens {Kemp, 2019}, significant gaps in knowledge exist. An important aspect to set up, investigate and understand dosing and also dosing interval experiments, is knowledge of the maternal individual pharmacokinetics and pharmacogenetics of the drug of interest during pregnancy. conditions: Preterm Birth studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 100 type: ESTIMATED measure: Pharmacokinetics of antenatal corticosteroids by investigation of betamethasone concentrations in serum measure: Maternal age measure: Fetal sex measure: Maternal weight/BMI measure: Number of fetus measure: Parity: the number of times a woman has given birth to a live neonate (any gestation) or at 24 weeks or more measure: PE by urine measurement of protein-creatinine ratio measure: Oestradiol concentration in serum measure: Cord blood and neonatal blood measure: CYP3A4 level sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Erasmus Medical Center status: RECRUITING city: Rotterdam state: Zuid Holland zip: 3015GD country: Netherlands name: Sam Schoenmakers, MD, PhD role: CONTACT phone: +31107037439 email: [email protected] name: Emma Ronde-Salminen, MD role: CONTACT phone: 0031683997312 email: [email protected] lat: 51.9225 lon: 4.47917 hasResults: False
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<|newrecord|> nctId: NCT06264960 id: E10208771 briefTitle: The Effect of Music Therapy and Breathing Exercise on Anxiety and Pain in Patients Undergoing Coronary Angiography overallStatus: COMPLETED date: 2022-09-15 date: 2023-05-30 date: 2023-10-02 date: 2024-02-20 date: 2024-02-20 name: Ulku Gunes class: OTHER briefSummary: Coronary angiography serves as the primary diagnostic technique for cardiovascular disease. However, this invasive procedure commonly triggers pain, anxiety, and fear in patients. The objective of this randomized controlled trial was to examine the impact of music and breathing exercises on anxiety and pain levels in individuals undergoing coronary angiography. The study, conducted as a single-blind, randomized controlled trial, involved a sample of 165 patients, with 55 in each group: the control group, the breathing exercise group, and the music therapy group. Patients in the music group listened to music during angiography, those in the breathing exercise group practiced exercises 30 minutes before the procedure, while the control group received standard treatment. Anxiety levels were assessed both before and after the procedure, and pain levels were measured post-procedure. The study strictly adhered to the CONSORT statement guidelines. conditions: Procedural Pain conditions: Procedural Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: This single-center, single-blind, randomized controlled trial was conducted in Izmir, Turkey, from July 2021 to July 2022. Participants were randomly assigned to one of three groups: intervention 1 (music), intervention 2 (breathing exercises), or control (standard care), in a 1:1:1 ratio. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The nurse responsible for conducting all measurements, including pain and anxiety assessments using the Visual Analog Scale (VAS) and State-Trait Anxiety Inventory (STAI), was not part of the research team.
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The nurse, being independent and not aware of the participants' group assignments, helps to ensure that the assessments are conducted impartially, without knowledge of which intervention each participant received. whoMasked: OUTCOMES_ASSESSOR count: 512 type: ACTUAL name: Music therapy name: Breathing exercise measure: State-Trait Anxiety Inventory measure: Visual Analog Scale sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ege University city: Bornova state: İzmir zip: 35100 country: Turkey lat: 38.47921 lon: 27.2399 facility: Ülkü Güneş city: Bornova state: İzmir zip: 35100 country: Turkey lat: 38.47921 lon: 27.2399 hasResults: False
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<|newrecord|> nctId: NCT06264947 id: CMUH112-REC2-141 briefTitle: Efficacy of Laser Acupuncture on Zanzhu (BL02) for Dry Age-related Macular Degeneration overallStatus: ENROLLING_BY_INVITATION date: 2024-01-26 date: 2024-11-01 date: 2024-11-01 date: 2024-02-20 date: 2024-02-20 name: China Medical University Hospital class: OTHER briefSummary: This study is to see if laser acupuncture is a better way to treat dry-AMD (Age-related Macular Degeneration) compared to sham laser acupuncture, in the aspect of visual acuity. Investigators planed to recruit participants who are diagnosed with dry-AMD, and not younger than 20 years old. Before the study, investigators will measure the participants' BCVA (Best Corrected Visual Acuity), and then practice laser acupuncture and sham-laser acupuncture on experiment group and control group respectively. After the 4-week study, investigators will measure the participants' BCVA again. conditions: Age-related Macular Degeneration studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 30 type: ESTIMATED name: laser acupuncture name: sham laser acupuncture measure: BCVA (Best Corrected Visual Acuity) sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: China Medical University Hospital city: Taichung zip: 404 country: Taiwan lat: 24.1469 lon: 120.6839 hasResults: False
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<|newrecord|> nctId: NCT06264934 id: DiCECT briefTitle: An Investigation Into Dielectric Assessment of Permittivity and Cancer in Human Using a Novel Electrical Capacitance Tomography Scanner acronym: DiCECT overallStatus: RECRUITING date: 2024-01-25 date: 2024-12 date: 2024-12 date: 2024-02-20 date: 2024-02-23 name: Zedsen Limited class: INDUSTRY name: Imperial College Healthcare NHS Trust briefSummary: The goal of this observational study is to investigate the ability of a the Z-scanner to identify and differentiate cancer and benign lesions from healthy breast tissue based on permittivity. The main questions it aims to answer are:
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1. Determine the permittivity values of the Z-scanner associated with healthy, benign, and malignant tissue in human breasts.
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2. Determine the repeatability, reproducibility, inter-and intra-operator variability of the Z-scanner. conditions: Breast Cancer conditions: Benign Breast Disease studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 90 type: ESTIMATED name: Breast scan using the Z-scanner name: Breast scan using the Z-scanner measure: Measurement of complex permittivity of breast tissue components measure: Permittivity target-to-background contrast ratios for targets of interest (e.g. malignant lesion, benign lesion) measure: Repeatability of the Z-scanner measure: Reproducibility of the Z-scanner sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Imperial College Healthcare NHS Trust status: RECRUITING city: London country: United Kingdom name: Lesley Honeyfield role: CONTACT name: Adrian Lim role: PRINCIPAL_INVESTIGATOR name: Deborah Cunningham role: SUB_INVESTIGATOR name: Sylvie Flais role: SUB_INVESTIGATOR lat: 51.50853 lon: -0.12574 hasResults: False
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<|newrecord|> nctId: NCT06264921 id: NKT3447-101 briefTitle: A Study With NKT3447 for Adults With Advanced/Metastatic Solid Tumors overallStatus: RECRUITING date: 2024-02-23 date: 2025-03 date: 2025-05 date: 2024-02-20 date: 2024-04-12 name: NiKang Therapeutics, Inc. class: INDUSTRY briefSummary: The goal of the Dose Escalation phase of the study is to evaluate the safety, tolerability, and pharmacokinetics (PK) to determine the maximum tolerated dose (MTD) and/or preliminary recommended dose for expansion (RDE) of NKT3447 in adults with advanced or metastatic solid tumors. The goal of the Expansion phase of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and the preliminary antitumor activity of NKT3447 in adult subjects with cyclin E1 (CCNE1) amplified ovarian cancer at the RDEs selected in Dose Escalation and to determine the preliminary recommended phase 2 dose (RP2D). conditions: Solid Tumor conditions: Solid Tumor, Adult conditions: Advanced Solid Tumor conditions: Metastatic Tumor conditions: Ovarian Cancer conditions: Ovarian Neoplasms conditions: Ovarian Carcinoma conditions: Metastatic Ovarian Carcinoma conditions: Endometrial Cancer conditions: Endometrial Neoplasms conditions: Endometrial Diseases conditions: Metastatic Endometrial Cancer conditions: Metastatic Endometrial Carcinoma conditions: Advanced Endometrial Carcinoma conditions: Advanced Ovarian Carcinoma conditions: Gastric Cancer conditions: Advanced Gastric Carcinoma conditions: Metastatic Gastric Cancer conditions: Metastatic Gastric Carcinoma conditions: Small-cell Lung Cancer conditions: Small Cell Lung Carcinoma conditions: Triple Negative Breast Cancer conditions: Triple Negative Breast Neoplasms conditions: Platinum-resistant Ovarian Cancer conditions: Platinum-refractory Ovarian Carcinoma conditions: CCNE1 Amplification conditions: Hormone Receptor Negative Breast Carcinoma conditions: Human Epidermal Growth Factor 2 Negative Carcinoma of Breast conditions: Progesterone-receptor-positive Breast Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Dose Escalation and Dose Expansion primaryPurpose: TREATMENT masking: NONE maskingDescription: Randomized for the Expansion Phase count: 90 type: ESTIMATED name: NKT3447 measure: Number of Participants with Dose Limiting Toxicity (DLT) events measure: Objective Response Rate (ORR) measure: Progression-free survival (PFS) measure: Duration of Response (DOR) measure: Disease control rate measure: Overall Survival (OS) measure: Time to Response (TTR) measure: Number of Participants with Adverse Events measure: Maximum observed plasma concentration (Cmax) of NKT3447 measure: Time to maximum observed plasma concentration of NKT3447 (Tmax) measure: Observed trough concentration of NKT3447 (Ctrough) measure: Area under the plasma concentration-time curve (AUC0-t) of NKT3447 measure: Apparent clearance (CL/F) measure: Apparent volume of distribution (V/F) measure: Half-life (t1/2) measure: Accumulation ratio (AR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sarah Cannon Research Institute at HealthONE status: RECRUITING city: Denver state: Colorado zip: 80218 country: United States name: Kelly Mozzetta role: CONTACT name: Gerald Falchook, MD, MS role: PRINCIPAL_INVESTIGATOR lat: 39.73915 lon: -104.9847 facility: AdventHealth Cancer Institute status: RECRUITING city: Celebration state: Florida zip: 34747 country: United States name: Heather Osorio role: CONTACT email: [email protected] name: Karolina Kilowski, DO role: PRINCIPAL_INVESTIGATOR lat: 28.32529 lon: -81.53313 facility: The Gabrail Pharmacology Phase 1 Research Center status: RECRUITING city: Canton state: Ohio zip: 44718 country: United States name: Carrie Smith role: CONTACT email: [email protected] name: Nashat Y Gabrail, MD role: PRINCIPAL_INVESTIGATOR lat: 40.79895 lon: -81.37845 facility: Texas Oncology-Austin Midtown NEXT Oncology status: RECRUITING city: Austin state: Texas zip: 78758 country: United States name: Erica Torres role: CONTACT phone: 210-610-5205 email: [email protected] name: Andrae Vandross, MD role: PRINCIPAL_INVESTIGATOR lat: 30.26715 lon: -97.74306 facility: START Mountain Region status: RECRUITING city: West Valley City state: Utah zip: 84119 country: United States name: Marie Asay role: CONTACT phone: 801-907-4770 email: [email protected] name: Justin A Call, MD role: PRINCIPAL_INVESTIGATOR lat: 40.69161 lon: -112.00105 hasResults: False
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<|newrecord|> nctId: NCT06264908 id: 20240125-010-000 briefTitle: An Integrated Self Management Programme to Improve Outcomes in Patients With Hand Osteoarthritis acronym: OASIS-H overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-12 date: 2028-04 date: 2024-02-20 date: 2024-02-20 name: Dr Iris Tang Yan Ki class: OTHER name: Hospital Authority, Hong Kong briefSummary: The goal of this trial is to evaluate the efficacy of an integrated self-management programme in improving clinical outcomes in patients with hand osteoarthritis (OA).
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This is an open-labelled, randomized controlled trial with an objective to determine the efficacy of an integrated self-management programme versus routine clinical care for participants with symptomatic hand OA.
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Participants will be randomized into early intervention group and routine clinical care groups in a 1:1 ratio. Patients who randomized into early intervention group will receive 8 week integrated self-management programme delivered by occupational therapists and rheumatology nurse on hand OA management. Patients who randomized into routine clinical care group will receive usual clinical care for OA for 26 weeks and then receive an identical 8 weeks integrated self-management programme. The primary outcome is the improvement in pain at 26 weeks between the two groups. conditions: Hand Osteoarthritis studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Patients will be randomized into early intervention and routine clinical care (control) group. Patients in control group will crossover to receive the intervention at week 26. primaryPurpose: TREATMENT masking: NONE count: 90 type: ESTIMATED name: Integrated self-management programme measure: Change in Pain visual analogue scale (VAS) measure: Change in pain Visual Analogue Scale (VAS) measure: Change in Functional index hand osteoarthritis (FIHOA) measure: Change in Quick Disabilities of the Arm, Shoulder, and Hand (DASH) score measure: Change in Australian/Canadian Hand Osteoarthritis Index (AUSCAN) 3.1 measure: Change in Short-form 36 items health survey measure: Change in hand grip strength measure: Change in hand dexterity measurement measure: Radiographic changes measure: Adverse events measure: Use of rescue pain medication sex: ALL minimumAge: 40 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06264895 id: Trinity College Dublin 211202 briefTitle: Protocol for a Low Threshold Exercise Intervention for Women Experiencing Homelessness and Addiction. acronym: LEAP-W overallStatus: NOT_YET_RECRUITING date: 2024-02-26 date: 2024-07-31 date: 2024-07-31 date: 2024-02-20 date: 2024-02-20 name: University of Dublin, Trinity College class: OTHER briefSummary: Background: Frailty is a complex multi-dimensional state of increased vulnerability to adverse health outcomes and is usually associated with older age but there is growing evidence of accelerated ageing and frailty in non-geriatric populations, including those experiencing socio-economic deprivation and extreme social exclusion, such as people experiencing homelessness. Addiction, as a coping mechanism for prior trauma, is common among people who are homeless and can have a gendered dimension. Women experiencing homelessness and addiction have unique needs which require a gendered approach. The aim of this study is to explore the effectiveness of an exercise intervention to target the known physical functioning deficits and frailty which this population experiences.
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Methods: This mixed-methods study will explore physical functioning deficits and frailty in women experiencing homelessness and addiction, using a bespoke test battery and an exercise intervention. Physical function (10m Walk Test, 2 Minute Walk Test, Single Leg Stance Test, Chair Stand Test, hand grip dynamometry), frailty (Clinical Frailty Scale and the SHARE-FI) and nutritional status (Mini-Nutritional Status), pain (Numerical Pain Rating Scale) and quality of life (SF 12-V2) will be evaluated. The intervention will involve a 3-times weekly exercise programme with protein supplementation for 10 weeks. Following this, qualitative interviews, which will be thematically analysed using Braun \& Clarke methodology, will be conducted. This study will be conducted in Dublin from February to July 2024.
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Discussion: Little is kn own about frailty-focussed interventions in women experiencing homelessness and addiction. This proposed study will help to increase the knowledge base regarding the physical health burden and frailty experienced by this extremely vulnerable population and will deliver a targeted intervention with a gendered dimension to mitigate its affects. The findings of this research will help narrow this research gap and will guide clinicians and policy makers to implement unique gender-based treatment strategies for this population. conditions: Social Exclusion conditions: Chronic Disease conditions: Physical Disability conditions: Addiction studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: single -arm longitudinal cohort study primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: Exercise measure: Recruitment measure: Retention measure: Adverse events measure: Hand grip dynamometry measure: Limb circumference measure: 10 Metre Walk Test measure: 2 Minute Walk Test measure: The Chair Stand Test measure: Single Leg Stance Test measure: Numerical Rating Scale (NRS) measure: Clinical Frailty Scale (CFS) measure: SHARE-Frailty Instrument (FI) measure: Mini Nutritional Assessment (MNA) measure: Short Form-12 V2 sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06264882 id: 23-1518 id: U54AG062319 type: NIH link: https://reporter.nih.gov/quickSearch/U54AG062319 briefTitle: Cardiometabolic Consequences of the Loss of Ovarian Function acronym: LILAC overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2028-05-31 date: 2028-08-31 date: 2024-02-20 date: 2024-02-20 name: University of Colorado, Denver class: OTHER name: National Institute on Aging (NIA) briefSummary: The menopause transition is associated with a decrease in artery health and an increased risk for weight gain in storing fat in the stomach area which may increase the risk for heart disease. The purpose of this research is to study how the decrease in estrogen at menopause changes artery health and fat gain, and risk of disease in women as they age. The first aim in this study will determine whether short term and long term low estrogen levels in premenopausal women decreases artery function and whether this is related to an increase in fat in the stomach area. The second aim will determine whether the changes in artery health and body fat are related to changes in a pathway that breaks down an important amino acid called tryptophan. This pathway is thought to play a role in regulating the aging process. Therefore, the investigators will determine whether the decrease in artery health and the increase in body fat in the stomach region with low estrogen is related to changes in this pathway in the blood, in vascular cells and fat tissue. Because estrogen levels fluctuate in premenopausal women, the investigators will use an approach (intervention) that controls estrogen levels to address these aims. The investigators will use a medication that is typically used to treat endometriosis or uterine fibroids to lower estrogen levels and an estrogen patch to increase estrogen in some women. Some women will receive a patch that has no estrogen (called a placebo patch). The intervention period will be 20 weeks. The study will provide us with new knowledge on how low estrogen with menopause affects artery health and fat gain estrogen. conditions: Menopause conditions: Estrogen Deficiency conditions: Aging conditions: Adiposity studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 100 type: ESTIMATED name: Degarelix name: Transdermal Estradiol Patch name: Transdermal Placebo Patch measure: Brachial artery flow mediated dilation (FMD) measure: Visceral fat area (VFA) measure: Subcutaneous fat area measure: Tryptophan-Kynurenine metabolites measure: Body composition - mass measure: Body composition - bone measure: Oxidized LDL measure: Total antioxidant status measure: Pro-inflammatory cytokines measure: Blood lipids and lipoproteins measure: Blood glucose measure: Insulin measure: Adipokines measure: Physical activity levels measure: Endothelial cell protein measures measure: Ex vivo serum exposure studies measure: Cerebrovascular function measure: Arterial Stiffness measure: Carotid artery stiffness measure: Blood pressure measure: Self reported sleep quality measure: Cognitive function sex: FEMALE minimumAge: 20 Years maximumAge: 45 Years stdAges: ADULT facility: University of Colorado Anschutz Medical Campus city: Aurora state: Colorado zip: 80045 country: United States lat: 39.72943 lon: -104.83192 hasResults: False
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<|newrecord|> nctId: NCT06264869 id: 141123 briefTitle: Interdental Guided Creeping Technique overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2024-11 date: 2024-11 date: 2024-02-20 date: 2024-02-20 name: October 6 University class: OTHER briefSummary: The aim of this randomized clinical trial is to treat interdental papillary deficiency with minimally invasive interdental guided creeping technique (IGCT) comparing collagen membrane versus connective tissue graft. conditions: Interdental Papilla Recession studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 20 type: ESTIMATED name: Interdental guided creeping technique (IGCT) and connective tissue graft (CTG) name: Interdental guided creeping technique (IGCT) and collagen membrane (CM) measure: Black triangle height measure: Percentage of interdental papillary fill measure: Papillary gain, black triangle reduction measure: Papillary height, attached gingiva width measure: Pocket depth, clinical attachment level, keratinized tissue thickness measure: Plaque index measure: Gingival index measure: Duration of surgery measure: Patient Reported Outcome measure: Patient Reported Outcome sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06264856 id: 202210096RIND briefTitle: Bronchoscopy for Thoracic Trauma Patients overallStatus: SUSPENDED date: 2024-12-01 date: 2025-12-31 date: 2025-12-31 date: 2024-02-20 date: 2024-02-20 name: National Taiwan University Hospital class: OTHER briefSummary: The study aims to evaluate the effectiveness of bronchoscopic sputum suction in patients with severe thoracic illness-induced respiratory failure. The study will compare the outcomes of patients who receive bronchoscopic sputum suction versus blind negative pressure aspiration for sputum removal. The study will measure baseline data, postoperative blood gas conditions, and clinical parameters, such as time of invasive ventilation, total time of ventilation, hospital stay, weaning success rate, reintubation rate, ventilator-associated pneumonia incidence, and fatality rate. The study aims to determine whether bronchoscopy-assisted sputum removal is superior to blind negative pressure aspiration in improving patient outcomes. conditions: Chest Trauma studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: bronchoscopic sputum suction name: negative pressure aspiration suction measure: Rate of pneumonia measure: Intensive Care Unit admission interval measure: admission interval measure: tracheostomy rate measure: intubation rate sex: ALL minimumAge: 20 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Traumatology, National Taiwain University Hospital city: Taipei zip: 10002 country: Taiwan lat: 25.04776 lon: 121.53185 facility: NTUH Hsin-Chu Branch; NTUH Yun-Lin Branch city: Taipei zip: 100; 300; 640; 280 country: Taiwan lat: 25.04776 lon: 121.53185 hasResults: False
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<|newrecord|> nctId: NCT06264843 id: 724 briefTitle: Peripheral Bypass Trial for Completion Control acronym: PATENT overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2027-12 date: 2027-12 date: 2024-02-20 date: 2024-02-20 name: Medistim ASA class: INDUSTRY briefSummary: The goal of the study is to identify and validate flow measurement and ultrasound images in patients undergoing vein bypass surgery below-knee and above ankle conditions: Chronic Limb-Threatening Ischemia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: OTHER masking: NONE count: 450 type: ESTIMATED name: Medistim MiraQ system with TTFM and L15 HFUS probes measure: Primary graft patency rate sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06264830 id: 202307103DIPC briefTitle: 3D Visualization System in Highly Myopic Cataract Operation acronym: 3D-HiMCO overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2024-12 date: 2024-12 date: 2024-02-20 date: 2024-04-16 name: National Taiwan University Hospital class: OTHER name: Alcon Research briefSummary: This study aims to investigate the impact of depth of field differences between the use of the 3D imaging system (NGENUITY® 3D Visualization System, Alcon, TX, USA) and conventional optical microscope in cataract surgery for highly myopic patients on intraoperative parameters and outcomes. conditions: Cataract conditions: High Myopia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: Alcon-NGENUITY®(NG)-system name: Standard cataract operation measure: Number of times of Microscopic focus adjustment, measured by counting from the video recordings measure: Total moving distance in millimeter of microscope-lens-system relative to suspension arm, measured by ruler set on microscope measure: Distance of subjective focus change in millimeter between corneal surface and surface of posterior capsule, measured by ruler set on microscope measure: Total operation time measure: Cumulative dissipated energy (CDE) of phacoemulsification, that is automatically measured and demonstrated on the screen of phacoemulsification machine (Centurion) measure: Number of Participants with intraoperative complication measure: Best-corrected visual acuity of the operated eye of Participants at each postoperative follow-up within 3 month, measured with Snellen chart under standard condition (6 meters in distance and standard illumination of environment) measure: Number of Participants with post-operative complication measure: Intraocular pressure of the operated eye of participants at each postoperative follow-up within 3 month, measured with pneumatic tonometer sex: ALL minimumAge: 20 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Ophthalmology, National Taiwan University Hospital city: Taipei zip: 100 country: Taiwan name: Tzyy-Chang Ho, MD role: CONTACT phone: 886-2-23123456 phoneExt: 62579 email: [email protected] name: Cheng-Yung Lee, MD role: CONTACT phone: 886-2-23123456 phoneExt: 65190 email: [email protected] lat: 25.04776 lon: 121.53185 hasResults: False
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<|newrecord|> nctId: NCT06264817 id: EC 48 LyberT briefTitle: Auto-Adjustable MOBIDERm Autofit Armsleeve in the Management of Upper Limb Lymphedema. acronym: LyberT overallStatus: NOT_YET_RECRUITING date: 2024-03-15 date: 2025-03-15 date: 2025-04-15 date: 2024-02-20 date: 2024-02-20 name: Thuasne class: INDUSTRY briefSummary: This study aims to assess Auto-Adjustable MOBIDERM® Autofit Armsleeve effect on upper limb volume excess compared to the compression bandages to manage the volume of upper limb lymphedema in patients with breast cancer related lymphedema conditions: Lymphedema of Upper Limb studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Prospective, multi-center, interventional, controlled-randomized, single blinded study primaryPurpose: TREATMENT masking: SINGLE maskingDescription: For the same patient, all measurements will be performed as far as possible by the same health professional who doesn't have the knowledge of patient's group. whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: MOBIDERM Autofit Armsleeve name: Compressive bandaging measure: Volume excess variation measure: Resource consumption measure: Resource consumption measure: Resource consumption measure: Lymphedema related Quality of life (QoL) measure: Doctors' opinion on improving the patient's health condition measure: Patient's opinion on Global Impression of Change measure: Satisfaction about the device measure: The safety measure: Compliance to treatment measure: General quality of life (QoL) measure: Skin elasticity measure: Ttissue induration sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Pinar BORMAN city: Ankara country: Turkey name: Pinar BORMAN role: CONTACT lat: 39.91987 lon: 32.85427 hasResults: False
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<|newrecord|> nctId: NCT06264804 id: [2023] No. 86 briefTitle: Risk Factors for Progressive Suction Loss in Corneal Refractive Surgery overallStatus: RECRUITING date: 2024-02-16 date: 2024-07-01 date: 2024-12-01 date: 2024-02-20 date: 2024-04-02 name: Yifeng Yu class: OTHER briefSummary: The goal of this Prospective observational studiesis to Characteristics of progressive suction loss. conditions: Refractive Surgery studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 800 type: ESTIMATED measure: Identify risk factors for progressive suction loss sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Yuyifeng status: RECRUITING city: Nanchang state: Jiangxi zip: 330008 country: China name: yifeng Yu, Doctorate role: CONTACT phone: +8613979180258 email: [email protected] lat: 28.68396 lon: 115.85306 hasResults: False
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<|newrecord|> nctId: NCT06264791 id: STUDY00018516 id: K99AA030591 type: NIH link: https://reporter.nih.gov/quickSearch/K99AA030591 briefTitle: Stress-motivated Alcohol Use as a Value-based Decision-making Process overallStatus: RECRUITING date: 2024-02-01 date: 2024-10-01 date: 2024-10-01 date: 2024-02-20 date: 2024-02-20 name: University of Washington class: OTHER name: National Institute on Alcohol Abuse and Alcoholism (NIAAA) briefSummary: The goal of this experimental study is to improve our understanding of the effects of stress on the decision to consume (more) alcohol in regular drinkers. The main question\[s\] it aims to answer are:
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* Does psychological stress affect the decision to consume (more) alcohol?
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* How does psychological stress affect the decision to consume (more) alcohol? Participants will be randomly assigned to one of four conditions (stress alcohol, stress no alcohol, no stress alcohol, no stress no alcohol) and complete a value-based decision-making task twice (once before and once after the manipulations). conditions: Psychological Stress conditions: Alcohol Intoxication studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: BASIC_SCIENCE masking: NONE count: 160 type: ESTIMATED name: Stress name: Alcohol measure: Proportion of choices for alcoholic over non-alcoholic drinks. sex: ALL minimumAge: 21 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Washington status: RECRUITING city: Seattle state: Washington zip: 98105 country: United States name: Jonas Dora, PhD role: CONTACT phone: 206-741-6330 email: [email protected] lat: 47.60621 lon: -122.33207 hasResults: False
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<|newrecord|> nctId: NCT06264778 id: 2023013 briefTitle: Exploration of Fenestration Decompression Combined With Dalafenib in the Treatment of BRAF Mutant Ameloblastoma overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-11-01 date: 2025-12-31 date: 2024-02-20 date: 2024-02-20 name: Shandong University class: OTHER briefSummary: This pilot clinical trial plans to carry out dabrafenib adjuvant therapy combined with lesion curettage after fenestrated decompressive surgery for BRAF mutation-positive multicystic ameloblastoma to explore the effectiveness of this therapy in preventing tumor recurrence, reducing or even avoiding postoperative deformity and dysfunction. effect. Based on this, we plan to launch a prospective clinical study of dabrafenib in the treatment of BRAF V600E ameloblastoma, verify the feasibility of drug treatment or drug-assisted treatment of ameloblastoma, and provide patients with a safer Effective new treatment options will benefit more patients. conditions: Ameloblastoma studyType: INTERVENTIONAL phases: PHASE3 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: This study is a single-arm study that does not involve randomization or blinding, nor does it establish a parallel control group and uses external control. primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Dabrafenib measure: objective response rate measure: Relapse-free survival sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
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<|newrecord|> nctId: NCT06264765 id: 22-12-23 briefTitle: Scalp Block -Craniotomi acronym: scalp block overallStatus: RECRUITING date: 2024-01-01 date: 2025-01-01 date: 2026-01-01 date: 2024-02-20 date: 2024-02-20 name: Aydin Adnan Menderes University class: OTHER briefSummary: Postoperative pain after craniotomy is an important clinical problem as it can lead to hypertension and increased intracranial pressure. Multimodal analgesia methods are performed by anesthesiologists in different ways depending on the anesthetist's preference.
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In addition, both techniques have been shown in studies to provide intraoperative hemodynamic stabilization in addition to their effects on postoperative pain. Although there are many studies on both techniques, the number of studies comparing scalp block with infiltration technique is very limited. Therefore, postoperative use of scalp block and incisional infiltration for postoperative pain after craniotomy is recommended. conditions: Hemodynamic Instability studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: randomized double blinding primaryPurpose: OTHER masking: DOUBLE maskingDescription: Blind patients and postoperative follow-ups will not know which group the patient is in the study. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 62 type: ESTIMATED name: scalp block name: Incisional infiltration measure: opioid consumption measure: The Numeric Rating Scale (NRS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ferdi Gülaştı status: RECRUITING city: Aydın zip: 09020 country: Turkey name: Ferdi Gülaştı role: CONTACT email: [email protected] lat: 37.84501 lon: 27.83963 hasResults: False
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<|newrecord|> nctId: NCT06264752 id: STUDY20120008 id: R01DK121730 type: NIH link: https://reporter.nih.gov/quickSearch/R01DK121730 briefTitle: Multi-hospital Electronic Decision Support for Drug-associated Acute Kidney Injury acronym: MEnD-AKI overallStatus: ENROLLING_BY_INVITATION date: 2024-02-15 date: 2026-01 date: 2026-04 date: 2024-02-20 date: 2024-02-20 name: University of Pittsburgh class: OTHER name: University of Florida name: University of Pittsburgh Medical Center name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) briefSummary: This study is a randomized controlled trial at eight hospitals within the University of Pittsburgh Medical Center-UPMC system. The project will assess the efficacy of a clinical surveillance system augmented with real-time predictive analytics to support a pharmacist-led intervention delivered to attending physicians (primary service) to reduce the progression and complications of drug-associated acute kidney injury (D-AKI) in hospitalized (non-ICU) adults. conditions: Acute Kidney Injury studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a prospective, randomized, interventional controlled trial at eight hospitals within the UPMC health-system. Researchers will randomize 39 hospital service clusters to receive either: 1) a Cerner electronic medical record (EMR)-based AKI passive alert which is standard of care at UPMC: this alert provides decision support within the EMR for the diagnosis and basic staging of AKI but without specific recommendations for management (Usual Care Arm); or 2) protocolized stage-based intervention delivered to the physician by a pharmacist for consideration and approval. Hospital service clusters will be allocated 1:1 to the intervention or usual care with a web-based system to maintain concealment using a randomized block design. primaryPurpose: PREVENTION masking: SINGLE maskingDescription: Statisticians performing the analysis will be blinded to the treatment allocation.
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The investigators will randomize clusters to intervention and control within strata defined hospitals to adjust for inherent subgroup differences. The allocation sequence list will be maintained by the data management team (DMT) using a secure web-based system where assignments will be maintained and accessed by the CDSS. Pharmacists will only receive alerts for patients of physicians randomized to the intervention. whoMasked: OUTCOMES_ASSESSOR count: 625 type: ESTIMATED name: Level A name: Level B name: Passive Alert measure: Major Adverse Kidney Events within 30 days of randomization (MAKE30) measure: Progression of AKI from time of Level B intervention (first alert generated) to hospital discharge measure: AKI Intensity: Duration of AKI for all stages; Duration of AKI Stage 2; Duration of AKI stage 3 measure: Nephrotoxic burden sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UPMC Altoona city: Altoona state: Pennsylvania zip: 16601 country: United States lat: 40.51868 lon: -78.39474 facility: UPMC Horizon city: Farrell state: Pennsylvania zip: 16121 country: United States lat: 41.21228 lon: -80.49674 facility: UPMC McKeesport city: McKeesport state: Pennsylvania zip: 15132 country: United States lat: 40.34785 lon: -79.86422 facility: UPMC Jameson city: New Castle state: Pennsylvania zip: 16105 country: United States lat: 41.00367 lon: -80.34701 facility: UPMC Magee city: Pittsburgh state: Pennsylvania zip: 15213 country: United States lat: 40.44062 lon: -79.99589 facility: UPMC Presbyterian/Montefiore city: Pittsburgh state: Pennsylvania zip: 15213 country: United States lat: 40.44062 lon: -79.99589 facility: UPMC Shadyside city: Pittsburgh state: Pennsylvania zip: 15232 country: United States lat: 40.44062 lon: -79.99589 facility: UPMC Williamsport city: Williamsport state: Pennsylvania zip: 17701 country: United States lat: 41.24119 lon: -77.00108 hasResults: False
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<|newrecord|> nctId: NCT06264739 id: 22-12-23/2 briefTitle: Erector Spinae Block -Dexmedetomidine acronym: esp -dex overallStatus: RECRUITING date: 2024-01-01 date: 2025-01-01 date: 2026-01-01 date: 2024-02-20 date: 2024-02-20 name: Aydin Adnan Menderes University class: OTHER briefSummary: Postoperative pain is common after spinal surgeries, including lumbar disc surgery. Surgical anesthesia and perioperative analgesic regimen are aimed at complete intraoperative amnesia, deep analgesia, effective control of autonomic responses and rapid discharge from the hospital.
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Although there are many studies on the use of these techniques for postoperative analgesia, the number of data comparing these techniques that can be used in meta-analyses is low. In our study, investigators aimed to compare the effects of remifentanil and dexmedetomidine accompanied by ESP block, which are different multimodal analgesia methods, on pain. conditions: Postoperative Acute Pain conditions: Opioid Consumption studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: randomized double blinding primaryPurpose: OTHER masking: DOUBLE maskingDescription: Blindness patients and those who follow up after surgery will not know which group is in the study. whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 74 type: ESTIMATED name: esp Dexmedetomidine (dekstomid) name: esp remifentanyl (ultiva) measure: opioid consumption measure: The Numeric Rating Scale (NRS) sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ferdi Gülaştı status: RECRUITING city: Aydın zip: 09020 country: Turkey name: Ferdi Gülaştı role: CONTACT email: [email protected] lat: 37.84501 lon: 27.83963 hasResults: False
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<|newrecord|> nctId: NCT06264726 id: 23-0254 id: R01HL150909 type: NIH link: https://reporter.nih.gov/quickSearch/R01HL150909 briefTitle: CommunityRx-Cardiovascular Disease acronym: CRx-CVD overallStatus: RECRUITING date: 2024-03-12 date: 2025-03-12 date: 2025-03-12 date: 2024-02-20 date: 2024-04-12 name: University of North Carolina, Chapel Hill class: OTHER name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: The goal of this single arm pre-test post-test design study is to test the impact of providing patients with information about community-based resources to address health-related social needs and cardiometabolic health in rural African American patients. The main question it aims to answer is:
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• What is the effectiveness of community resource information on patient self-efficacy to use community resources?
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Participants will be given:
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* A personalized "HealtheRx" resource with information about community resources related to food, housing, utility support, transportation, and crisis support. The HealtheRx is personalized for patients based on their age and zip code.
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* Access to a community resource navigator for support with using the HealtheRx upon request
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* 2 text messages with reminders about the HealtheRx and access to the community resource navigator conditions: Cardiovascular Diseases conditions: Self Efficacy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: PREVENTION masking: NONE count: 325 type: ESTIMATED name: HealtheRx measure: Change in participant self-efficacy for finding community resources measure: Change in participant knowledge of community resources measure: Change in participant utilization of community resources sex: ALL minimumAge: 2 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: OIC Family Medical Center - Fairview status: RECRUITING city: Rocky Mount state: North Carolina zip: 27801 country: United States name: Jesslyn Pope role: CONTACT email: [email protected] lat: 35.93821 lon: -77.79053 facility: OIC Family Medical Center - Happy Hill status: RECRUITING city: Rocky Mount state: North Carolina zip: 27804 country: United States name: Jesslyn Pope role: CONTACT email: [email protected] lat: 35.93821 lon: -77.79053 hasResults: False
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<|newrecord|> nctId: NCT06264713 id: CE/2023_041 briefTitle: Immersive Virtual REality for Treatment of Unilateral Spatial NEglect Via Eye-tracking Biofeedback acronym: IRENE overallStatus: RECRUITING date: 2023-11-01 date: 2025-11-01 date: 2025-12-01 date: 2024-02-20 date: 2024-02-22 name: I.R.C.C.S. Fondazione Santa Lucia class: OTHER briefSummary: The purpose of this study is to evaluate the effects of a treatment using virtual reality on the recovery of unilateral spatial neglect. The investigators hypothesize that the experimental group underwent to a protocol of active exercises within the virtual environment will show an improvement in the exploratory functions of the left hemispace, investigated with specific scales and clinical tests. conditions: Neglect, Hemispatial conditions: Stroke studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomised Clinical Trial primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Double blind randomisation. The patients and their families/caregivers are blinded with respect to the group allocation. The assessors are not informed about the group allocation for the entire period of the study. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 40 type: ESTIMATED name: Immersive Virtual Reality name: Sham Immersive Virtual Reality measure: Changes in the Behavioural Inattention Test measure: Changes in the Copying drawings with or without programming elements measure: Changes in the Barrage Test measure: Changes in the Wundt Justrow area illusion test measure: Changes in the Kessler Foundation Neglect Assessment Process measure: Changes in the Stroke Specific Quality of Life Scale measure: Changes in the Fugl-Meyer Assessment scale measure: Changes in reaction time e time of fixation sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: IRCCS Santa Lucia Foundation status: RECRUITING city: Rome state: Lazio zip: 00142 country: Italy name: Valeria Verna, MSc role: CONTACT phone: 0651501907 name: Valeria Verna, MSc role: PRINCIPAL_INVESTIGATOR name: Marco Tramontano, PhD role: SUB_INVESTIGATOR name: Alex Martino Cinnera, PhD role: SUB_INVESTIGATOR name: Viviana Betti, PhD role: SUB_INVESTIGATOR name: Matteo Marucci, PhD role: SUB_INVESTIGATOR name: Luisa Magnotti, BSc role: SUB_INVESTIGATOR name: Alessandro Matano, MSc role: SUB_INVESTIGATOR name: Aurora Tavernese, MSc role: SUB_INVESTIGATOR name: Paolucci Stefano, MD role: SUB_INVESTIGATOR lat: 41.89193 lon: 12.51133 hasResults: False
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<|newrecord|> nctId: NCT06264700 id: STUDY00003303 id: R44HL169085 type: NIH link: https://reporter.nih.gov/quickSearch/R44HL169085 briefTitle: Applying Directly Observed Therapy to Hydroxyurea to Realize Effectiveness acronym: ADHERE overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-12 date: 2025-12 date: 2024-02-20 date: 2024-02-20 name: Nationwide Children's Hospital class: OTHER name: Ann & Robert H Lurie Children's Hospital of Chicago name: Hasbro Children's Hospital name: National Institutes of Health (NIH) name: National Heart, Lung, and Blood Institute (NHLBI) briefSummary: This study is for caregivers of young children with sickle cell disease and adolescents with sickle cell disease who are currently prescribed hydroxyurea and are receiving care at one of the study sites. The study will assess retention and engagement during a pilot randomized control trial comparing video directly observed therapy (VDOT) to attention control. We also hope to understand more about patient and family preferences longer-term adherence monitoring and intervention.
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Participants will use an electronic adherence monitor (provided by the study team) to measure how often they are taking their hydroxyurea. Participants will also be asked to complete questionnaires throughout the study period to provide information about their expectations for, experience with, and satisfaction with the study materials. conditions: Sickle Cell Disease studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: After completing a one to three-month run-in period, participants will be randomized to receive six months of either VDOT or attention control. All participants will then complete six months of ongoing monitoring during which VDOT patients will receive intermittent communication to encourage adherence and both groups will continue to use their electronic adherence monitors. primaryPurpose: TREATMENT masking: SINGLE maskingDescription: The investigators will be blinded to prevent the possibility of any differential treatment that could affect the ability of the study team to evaluate the impact of VDOT on hydroxyurea adherence. As such, a statistician will create a randomization model and study staff will facilitate communication with participants as well as between participants and the VDOT team. whoMasked: INVESTIGATOR count: 60 type: ESTIMATED name: Video Directly Observed Therapy (VDOT) name: Health Reminder Tip Alerts measure: Retention Rate measure: Sustained Engagement measure: Electronic Adherence measure: Pediatric SCD Medication Self-Management Questionnaire measure: Frequency of acute care visits (ACS and VOC), ICU admissions, and LOS for hospitalizations measure: Laboratory Studies (i.e. MCV, HbF) measure: Treatment Satisfaction measure: Participant Satisfaction sex: ALL minimumAge: 11 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Lurie Children's Hospital city: Chicago state: Illinois zip: 60611 country: United States name: Sherif Badawy, MD role: CONTACT phone: 312-227-4836 email: [email protected] lat: 41.85003 lon: -87.65005 facility: Hasbro Children's Hospital city: Providence state: Rhode Island zip: 02903 country: United States name: Patrick McGann, MD, PhD role: CONTACT phone: 617-519-9555 email: [email protected] lat: 41.82399 lon: -71.41283 hasResults: False
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<|newrecord|> nctId: NCT06264687 id: HepcidinIVIron briefTitle: Hepcidin After Intravenous Iron Treatment overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-05-31 date: 2024-05-31 date: 2024-02-20 date: 2024-02-20 name: Pierre-Alexandre Krayenbühl class: OTHER briefSummary: The aim of this study is to investigate the hepcidin hormone response after intravenous iron administration. conditions: Iron Deficiency (Without Anemia) studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: PROSPECTIVE count: 10 type: ESTIMATED measure: Serum Hepcidin Change sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT hasResults: False
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<|newrecord|> nctId: NCT06264674 id: CLI-05993AB6-03 id: 2023-503333-22-00 type: OTHER domain: EMA CTIS briefTitle: Comparison Between CHF5993 pMDI 200/6/12,5mg HFA-152a VS CHF5993 pMDI 200/6/12,5mg HFA-134a in Subjects With Asthma (Trecos) acronym: TRECOS overallStatus: RECRUITING date: 2023-11-27 date: 2024-08-25 date: 2025-09-18 date: 2024-02-20 date: 2024-02-20 name: Chiesi Farmaceutici S.p.A. class: INDUSTRY briefSummary: The CLI-05993AB6-03 Study is an interventional study designed to compare potential for bronchoconstriction, safety and tolerability profile using of HFA 152a propellant versus using to HFA 134a. conditions: Asthma studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Double-blind multicentre, randomised, active-controlled, 2-arm, parallel-group primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Double-blind multicentre, randomised, active-controlled, 2-arm, parallel-group whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 790 type: ESTIMATED name: CHF5993 200/6/12.5 μg pMDI HFA-152a name: Inhaler CHF5993 200/6/12.5 μg pMDI HFA-134a measure: Relative change from pre-dose Forced Expiratory Volume in one second with (FEV1) (Safety Assessment to evaluate of the potential bronchoconstriction of the study treatment) measure: To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (relative change from pre-dose FEV1) measure: To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (absolute change from pre-dose FEV1) measure: To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (number and percentage of subjects with a relative decrease from pre-dose in FEV1) measure: To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (Absolute and relative changes from baseline in pre-dose FEV1) measure: To complete the evaluation of FEV1 and the potential for bronchoconstriction of the study treatment (Change from pre-dose in FEV1) measure: Peak expiratory flow (PEF) change from baseline at each inter-visit period over the entire treatment period measure: Percentage of days without intake of rescue medication. measure: Change in the average daily use of rescue medication. measure: Change on the average daily asthma symptoms. measure: Change from baseline in Asthma Control Questionnaire 7 (ACQ 7) score. measure: To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of Adverse Events (AEs) / Adverse Drug Reactions (ADRs). measure: To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of number of Adverse Events (AEs) of particular interest. measure: To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of incident rate of Adverse Events (AEs) of particular interest. measure: To measure the safety and tolerability of CHF5993 pMDI HFA-152a in terms of rate ration of Adverse Events (AEs) of particular interest. sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Medicines Evaluation Unit, Langley Building, Wythenshawe Hospital status: RECRUITING city: Manchester zip: M23 9QZ country: United Kingdom name: Dave Singh, MD role: CONTACT lat: 53.48095 lon: -2.23743 hasResults: False
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<|newrecord|> nctId: NCT06264661 id: HJM 006/22-R briefTitle: Effect of Cognitive Behavioral Therapy and Phototherapy on Glycosylated Hemoglobin, CLOCK Genes and Quality of Life in Patients With Type 2 Diabetes Mellitus and Insomnia overallStatus: COMPLETED date: 2022-08-08 date: 2022-09-30 date: 2022-11-30 date: 2024-02-20 date: 2024-02-20 name: Centro Interdisciplinario de Ciencias de la Salud Unidad Santo Tomás class: OTHER briefSummary: Purpose: To analyze the efficiency of Cognitive Behavioral Intervention in combination with phototherapy to reduce insomnia and improve glycemic control, quality of life, and CLOCK genes expression in patients with type 2 diabetes mellitus. Methods: Clinical, quasi-experimental, pre-post, explanatory, non-probability sampling. Subjects were invited to participate in Hospital Juárez de México. They received eight sessions of Cognitive Behavioral Therapy in combination with phototherapy. The assessment was carried out with validated instruments for Mexican population and gene expression was evaluated by real-time PCR. conditions: Type 2 Diabetes studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP interventionModelDescription: Clinical, quasi-experimental, pre-post, explanatory, non-probability sampling. Subjects were invited to participate in Hospital Juárez de México. They received eight sessions of Cognitive Behavioral Therapy in combination with phototherapy. The assessment was carried outwith validated instruments for Mexican population and gene expression was evaluated by real-time PCR. primaryPurpose: TREATMENT masking: NONE count: 23 type: ACTUAL name: Effect of Cognitive Behavioral Therapy with Phototherapy in glycated hemoglobin, CLOCK genes and quality of life in patients with type 2 diabetes mellitus and insomnia measure: Sleep quality measure: Glycosylated hemoglobin measure: Quality of life measure: Insomnia measure: Gene expression analysis of CLOCK measure: Gene expression analysis of BMAL1 measure: Gene expression analysis of PER1 measure: Gene expression analysis of PER2 sex: ALL minimumAge: 40 Years maximumAge: 60 Years stdAges: ADULT facility: Centro Interdisciplinario de Ciencias de la Salud Unidad Santo Tomás city: Cdmx state: México zip: 11360 country: Mexico hasResults: False
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<|newrecord|> nctId: NCT06264648 id: AIBU-FTR-OOP-04 briefTitle: Investigation of Palpation Pressure Sensitivity overallStatus: COMPLETED date: 2023-05-03 date: 2023-06-16 date: 2023-10-20 date: 2024-02-20 date: 2024-02-20 name: Abant Izzet Baysal University class: OTHER briefSummary: The study is planned for searching physiotherapists palpation abilities. There were 2 groups of physiotherapists. They were asked for to push target pressures. After making some exercise, the assesment was done again. conditions: Sensitivity Training Groups studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: 2 groups of physiotherapists with different fields of experience were attended to study. primaryPurpose: OTHER masking: NONE count: 63 type: ACTUAL name: Pressure sensitivity education measure: Measurement Palpation Pressure with Digital Scale measure: Measurement Palpation Pressure with Digital Scale sex: ALL minimumAge: 22 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Faculty of Health Sciences Bolu Abant İzzet Baysal University city: Bolu zip: 14300 country: Turkey lat: 40.73583 lon: 31.60611 hasResults: False
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<|newrecord|> nctId: NCT06264635 id: HS26227 briefTitle: Evaluating the Efficacy of Platelet-Rich-Plasma (PRP) for Erectile Dysfunction overallStatus: NOT_YET_RECRUITING date: 2024-03 date: 2025-03 date: 2025-03 date: 2024-02-20 date: 2024-03-08 name: University of Manitoba class: OTHER briefSummary: There is great interest in restorative therapies (platelet-rich plasma (PRP) injections, shockwave therapy and stem cell therapy) for ED given their non-invasive nature. However, data is still limited and requires further research prior to widespread adoption. Unfortunately, therapies such as PRP injections are being widely used without clinical evidence demonstrating its safety or effectiveness for the treatment of erectile dysfunction. 2-7 To date, there are no treatments that address the underlying cause of endothelial dysfunction, although low-intensity shockwave therapy for ED has shown promising results. Platelet-derived therapies targeting inflammation and promoting tissue/nerve regeneration and may represent a potential treatment option towards this direction. The investigators propose to perform Canada's first pilot RCT to evaluate and safety and efficacy of PRP for the treatment of ED. conditions: Erectile Dysfunction studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: The provider and patient are both blinded to which treatment (PRP vs saline) the patient is receiving whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER count: 60 type: ESTIMATED name: Platelet-Rich-Plasma name: Saline measure: International Index of Erectile Function (IIEF) measure: Adverse Events sex: MALE minimumAge: 30 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Men's Health Clinic city: Winnipeg state: Manitoba zip: R3K 1M3 country: Canada name: Premal Patel, MD role: CONTACT phone: 2042214476 email: [email protected] name: Jainik Shah, BFSc role: CONTACT phone: 6477721737 email: [email protected] lat: 49.8844 lon: -97.14704 hasResults: False
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<|newrecord|> nctId: NCT06264622 id: CEIC-2996 briefTitle: ABG+/GarlACE Effects on Cardiovascular Risk Factors in Subjects With Grade I Hypertension acronym: GARDOSE overallStatus: RECRUITING date: 2024-02-26 date: 2024-10-31 date: 2024-12-31 date: 2024-02-20 date: 2024-02-20 name: Universitat de Lleida class: OTHER name: Pharmactive Biotech Products S.L.U briefSummary: The goal of this clinical trial is to evaluate the dose response effect on cardiovascular disease risk factors of a Black Garlic Extract in subjects with Grade I Hypertension. The main questions it aims to answer are:
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* If the reduction in blood pressure (systolic and diastolic) is in a dose-response manner
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* If the changes in lipid profile are in a dose-response manner
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Participants will be randomly assign to a low dose (250 mg/day), high dose (600 mg/day) or placebo of a standardized Garlic Extract (ABG+/GarlACE) during 12 weeks conditions: Hypertension studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 180 type: ESTIMATED name: Low dose name: High dose name: Placebo measure: Blood Pressure measure: Blood Lipid Profile sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Lleida status: RECRUITING city: Lleida zip: 25198 country: Spain name: Jose Serrano, PhD role: CONTACT phone: 973702408 email: [email protected] name: Manuel Portero, PhD role: CONTACT phone: 973702408 email: [email protected] lat: 41.61674 lon: 0.62218 hasResults: False
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<|newrecord|> nctId: NCT06264609 id: 91026 briefTitle: Precision Medicine Approach for Osteoporosis - Follow Up Study overallStatus: ENROLLING_BY_INVITATION date: 2024-02-01 date: 2029-12-31 date: 2029-12-31 date: 2024-02-20 date: 2024-02-20 name: Hartmut Malluche, MD class: OTHER briefSummary: Osteoporosis is a health problem of major proportions. It affects more than 40 million Americans and results in more than 2 million fractures annually among Medicare patients alone. Hospital admissions for osteoporotic fractures exceed those of heart attacks, strokes and breast cancer combined. Osteoporosis is commonly considered a disease associated with menopause. This estrogen deficiency related bone loss is characterized by high bone turnover with increased resorption without commensurate changes in bone formation. It is in contrast to age-related bone loss, which starts as early as in the fourth decade of life and continues with increasing age. Age-related bone loss is usually associated with lower bone turnover and decreased bone formation is the main abnormality.
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Current therapies do not address age-related bone loss and the special needs of the age-related osteoporosis population is currently ignored. This is to a great degree due to difficulties associated with the bone biopsy necessary for unequivocal determination of bone turnover status. Thus, the current standard of care relies on starting with an antiresorber, which is of limited effectiveness in age-related osteoporosis, and in fact impedes the effectiveness of the appropriate anabolic medication. In a current ongoing study - Novel precision medicine approach to treatment of osteoporosis based on bone turnover. EIRB#70781; efforts are focused on addressing this particular problem.
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Our follow-up study seeks to achieve one specific aim: to compare effectiveness of Alendronate vs Teriparatide after participants have been switched at the end of treatment at year one, to the other drug at year two for the same duration of treatment. conditions: Osteoporosis studyType: INTERVENTIONAL phases: PHASE4 allocation: NON_RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: Alendronate name: Teriparatide name: Alendronate measure: Percent change in bone loss measure: Percent change in Bone Mass Density at the hip measure: Trabecular bone score (TBS) sex: FEMALE minimumAge: 45 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Kentucky city: Lexington state: Kentucky zip: 40536 country: United States lat: 37.98869 lon: -84.47772 hasResults: False
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<|newrecord|> nctId: NCT06264596 id: 2310-72 briefTitle: Epinephrine in Irrigation Fluid for Visualization During Ankle Surgery overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-04 date: 2026-04 date: 2024-02-20 date: 2024-02-22 name: The Guthrie Clinic class: OTHER briefSummary: The purpose of this study is to evaluate the effect of epinephrine in irrigation fluid for visual clarity in ankle arthroscopic surgery. conditions: Intraoperative Bleeding studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Concealed irrigation bags whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 78 type: ESTIMATED name: Epinephrine name: Normal Saline irrigation fluid measure: visual clarity during ankle arthroscopic surgery, which will be evaluated by visual analog scale measure: surgeon's discomfort related to bleeding, measured by visual numeric rating scale sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Robert Packer Hospital city: Sayre state: Pennsylvania zip: 18840 country: United States name: Wonyong Lee, MD role: CONTACT phone: 570-887-4882 email: [email protected] name: Wonyong Lee role: PRINCIPAL_INVESTIGATOR lat: 41.97896 lon: -76.5155 hasResults: False
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<|newrecord|> nctId: NCT06264583 id: IN-DE-980-6998 briefTitle: HDV-Europe: Prevalence and Outcome of HDV in HIV/HBV Coinfection overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-07-31 date: 2024-12-31 date: 2024-02-20 date: 2024-02-20 name: University Hospital, Bonn class: OTHER name: Swiss HIV Cohort Study name: ICONA Cohort name: Amsterdam UMC name: Royal Free Hospital NHS Foundation Trust name: King's College London name: University Hospital of Cologne name: Goethe University name: Heinrich-Heine University, Duesseldorf name: University Hospital, Essen name: ICH Hamburg name: Praxiszentrum Hohenstaufenring Köln name: Sorbonne University name: Henri Mondor University Hospital name: Hospital Universitario Infanta Leonor name: Hospital General Universitario Gregorio Marañon name: GEPCOI (Portuguese Group of Coinfection) briefSummary: The aim of this project is to set up a cross-sectional cohort study (France, Germany, The Netherlands, Poland, Spain, Switzerland, Italy, United Kingdom and Portugal) to assess the implementation of EACS guidelines for HDV-testing among PLWH with positive HbsAg and thereby evaluate the prevalence of HDV infection among HIV/HBV-coinfected in 2023, as well as corresponding risk factors. In addition to the testing itself, this study will also set up a cohort and databasee for future HDV studies among PLWH, including clinical, virological und laboratory parameters.
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1. Analyze the rate of HDV-testing and evaluate the prevalence of HDV-infection by testing.
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1. Evaluation of former screening of HDV by assessing existing data at study sites.
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2. Determination of the HDV prevalence in European PLWH and HBV coinfection.
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2. Setting up a database of all PLWH with HBV/HDV coinfection
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1. Analysis of transmission risk factors for HDV coinfection
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2. Asses the rate of HDV positive patients with ongoing HDV replication.
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