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1. Non-response group: Exercise performance during the tapering period (week 7) shows a significant increase compared to post-intervention (week 6) and is higher than pre-intervention (week 3) exercise performance.
2. Response group: Exercise performance during the tapering period (week 7) shows a significant increase compared to post-intervention (week 6) and is higher than the change in exercise performance during normal training (= week 3 - week 1). whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 158 type: ESTIMATED name: High-intensity intensive training name: Taper measure: Stressor measure: Recovery regulation measure: Mood state measure: Peak power output measure: Maximal heart rate measure: Fatigue state sex: ALL minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University status: RECRUITING city: Taipei zip: 112304 country: Taiwan name: Wei-Wun Tsai role: CONTACT phone: +886-02-2826-7939 email: tmwk@nycu.edu.tw lat: 25.04776 lon: 121.53185 hasResults: False
<\|newrecord\|> nctId: NCT06295003 id: CEFA-COVID briefTitle: Impact of COVID-19 Pandemic on Headache Evaluations in the Pediatric Emergency Department overallStatus: COMPLETED date: 2022-04-30 date: 2022-05-30 date: 2022-05-30 date: 2024-03-06 date: 2024-03-06 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER briefSummary: Background: To evaluate the impact of COVID-19 on evaluations in the pediatric emergency department (ED) because of headache as main symptom.
Methods: Number and clinical features of patients evaluated in the pediatric ED of a single site in Milan,Italy, were collected between January 2017 and January 2022. The impact of COVID-19 on evaluation rates was quantified by using the incidence rate ratio (IRR) and 95% confidence intervals (CI) between the pandemic (March 2020 to January 2022) and the prepandemic period (January 2017 to February 2020). conditions: COVID-19 conditions: Headache Disorders conditions: Emergency Service, Hospital studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 700 type: ACTUAL measure: During the study period, 890 evaluations were registered: the number of partecipants was 689 over the prepandemic period and 201 over the pandemic period. Mean age at evaluation was 10 years (range: 1 to 17 years). measure: Evaluation rates per month were 18.1 during the prepandemic period and 8.7 during COVID-19 pandemic, with peaks in autumn and winter and drops in summer. The reduction in evaluation rate was higher for secondary headache when compared with primary one sex: ALL minimumAge: 2 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Pediatric Emergency Department Clinica de Marchi, Foundation IRCCS Ca' Granda, Ospedale Maggiore Policlinico city: Milan country: Italy lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06294990 id: 2023-505854-16-00 briefTitle: Klinefelter Syndrome and Testosterone Treatment in Puberty acronym: TiPY overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2029-12-31 date: 2029-12-31 date: 2024-03-06 date: 2024-03-06 name: Lise Aksglæde class: OTHER briefSummary: The goal of this randomized clinical trial is to study the effect of testosterone replacement therapy during puberty in boys with Klinefelter syndrome (KS, 47,XXY).
The main questions to answer are how treatment with testosterone will affect body fat mass, lipid and glucose metabolism, growth and body proportions, bone mineralization as well as effects on neurocognitive development and emotional and social difficulties.
Participants will be randomized to two years treatment with testosterone or placebo. conditions: Klinefelter Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Multi-center, national, randomized, double-blind, placebo-controlled intervention study primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 32 type: ESTIMATED name: Testosterone gel name: Placebo measure: Changes in body fat mass measure: Pubertal development and virilization measure: Height measure: Weight measure: Bone mineralization measure: Neuropsychological evaluation measure: Neuropsychological evaluation, sex: MALE minimumAge: 10 Years maximumAge: 14 Years stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06294977 id: CRISI-COVID briefTitle: Impact of COVID-19 Pandemic on Epilepsy Evaluations in the Pediatric Emergency Department overallStatus: COMPLETED date: 2022-11-30 date: 2022-12-30 date: 2022-12-30 date: 2024-03-06 date: 2024-03-06 name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico class: OTHER briefSummary: Background. Seizures are a common cause of evaluation in the pediatric emergency department (ED). Several studies about the impact of COVID-19 pandemic on ED attendances report a considerable reduction in general pediatric care. The aim of our study was to evaluate the impact of COVID-19 on the admission to the pediatric ED for seizures.
Materials and methods. We performed a retrospective study to assess the rate of ED admission for seizures at the pediatric ED of the Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico of Milan between January 2017 and December 2021, comparing the pre-pandemic (from January 2017 to February 2020) and pandemic periods (from March 2020 to December 2021). conditions: Epilepsy conditions: Emergency Services, Hospital conditions: COVID-19 studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 1000 type: ACTUAL measure: During the study period, 1,091 patients with seizures were admitted to pediatric ED, 776 before the pandemic and 315 during the pandemic. In particular, the evaluation rates per month were 20.4 before the pandemic and 14.3 afterward measure: Patients with a history of previous seizures showed a greater decrease in the monthly number of ED visits compared to those with a first seizure. An increased rate of unprovoked seizures and a decreased rate of provoked ones were observed in the pandemic sex: ALL minimumAge: 1 Month maximumAge: 17 Years stdAges: CHILD facility: Pediatric Emergency Department Clinica de Marchi, Foundation IRCCS Ca' Granda, Ospedale Maggiore Policlinico city: Milan country: Italy lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06294964 id: Sleep Education briefTitle: Intervention and Effect of Sleep Pattern on Cardio-cerebrovascular Disease overallStatus: ENROLLING_BY_INVITATION date: 2024-03-01 date: 2025-06-01 date: 2026-11-30 date: 2024-03-06 date: 2024-03-06 name: RenJi Hospital class: OTHER briefSummary: Because of the growing population of older people, cardio-cerebrovascular diseases has been the most important aging-related chronic disease, studying the pathogenesis and early warning mechanisms of cardio-cerebrovascular diseases in depth, exploring optimal strategies for early diagnosis and treatments of cardio-cerebrovascular diseases has becoming the urgent public health problem in China. Aging causes cellular changes that change the sleep status in older adults, leading to an increased risk of disease and death. Meanwhile, the rising prevalence of chronic diseases among older adults also increases the impact of sleep deprivation. Insufficient sleep has being a serious challenge to the health status of the elderly. However, there is no clinically significant treatment for sleep disorders caused by chronic diseases. Medication helps to sleep but will also lead to drug dependence and increasing the risk of recurrent sleep disorders, which is unfavorable for disease control.
Studies have shown that older adults who sleep 7-8 hours at night have better physical and mental health, cognition and quality of life. Shorter sleep durations (6 hours or less) and longer sleep durations (greater than 9 hours) had strong associations with adverse health outcomes such as cardiovascular, metabolic, immune, cognitive diseases, other psychiatric disorders, and mortality.
Therefore, on the basis of the established Pudong community cohort, the project applicant led the team to adopt an open-label, blind endpoint, and cluster-randomized two-phase trial method to randomly assign cohort members into intervention group and control group. According to the sleep health intervention plan formulated by the clinical team, family doctor provides health education materials according to the actual situation of the intervention group regularly. Family doctors in the control group used conventional management methods. The final assessment was that compared to control group, whether the intervention group improved members' sleep quality, reduced members' cardiovascular disease events, and individual cardiovascular disease morbidity and all-cause mortality during the study period. conditions: Cardiovascular Diseases conditions: Non-Communicable Chronic Diseases studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 12800 type: ESTIMATED name: sleep education, behavioral education measure: the incidence and/or prevalence of cardiovascular diseases such as myocardial infarction, stroke, heart failure, and cardiovascular death measure: all cause death sex: ALL minimumAge: 60 Years maximumAge: 120 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Cardiology, Ren Ji Hospital city: Shanghai country: China lat: 31.22222 lon: 121.45806 hasResults: False
<\|newrecord\|> nctId: NCT06294951 id: IIT-2023-0225 briefTitle: fMRI for BPS: A Descriptive Study of Findings and Symptoms overallStatus: RECRUITING date: 2024-03-01 date: 2026-12-31 date: 2026-12-31 date: 2024-03-06 date: 2024-03-06 name: RenJi Hospital class: OTHER briefSummary: The goal of this observational study is to investigate the relationship between functional magnetic resonance imaging (fMRI) findings of the brain and symptom presentation in patients with bladder pain syndrome (BPS). The main questions it aims to answer are:
1. To explore the distribution characteristics of fMRI imaging and possible target lesions in the patient population.
2. To provide appropriate clues and evidence for etiological exploration and therapeutic targeting of BPS.
Participants will undergo fMRI as well as other routine laboratory tests and queries. conditions: Bladder Pain Syndrome studyType: OBSERVATIONAL observationalModel: CASE_CONTROL timePerspective: OTHER count: 120 type: ESTIMATED name: fMRI measure: fMRI findings sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Renji Hospital, Shanghai Jiao Tong University School of Medicine status: RECRUITING city: Shanghai state: Shanghai zip: 200127 country: China name: Zhebin Du, Dr. role: CONTACT phone: +86-13512179027 email: Dzbdzb1989@163.com name: Zhebin Du, Dr. role: PRINCIPAL_INVESTIGATOR name: Yinghui Fan, Dr. role: PRINCIPAL_INVESTIGATOR name: Yingfu Jiao, Dr. role: SUB_INVESTIGATOR name: Liang Dong, Dr. role: SUB_INVESTIGATOR name: Qixiang Song, Dr. role: SUB_INVESTIGATOR name: Xinxing Du, Dr. role: SUB_INVESTIGATOR name: Yanhao Dong, Dr. role: SUB_INVESTIGATOR lat: 31.22222 lon: 121.45806 hasResults: False
<\|newrecord\|> nctId: NCT06294938 id: M.WRI-2023-INQ-2224 briefTitle: Glycemic Index of Cacao Fruit Pulp in Healthy, Human Subjects overallStatus: COMPLETED date: 2022-09-30 date: 2023-01-24 date: 2023-05-23 date: 2024-03-06 date: 2024-03-06 name: Mars Wrigley class: INDUSTRY name: INQUIS Clinical Research briefSummary: Cacao fruit pulp is a sweet and fruity carbohydrate-rich edible mucilage that is often discarded. The objective of this study is to assess the glycemic response and determine the glycemic index of cacao fruit pulp. conditions: Blood Sugar; High conditions: Blood Sugar; Low studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: acute, open-labeled, randomized design primaryPurpose: BASIC_SCIENCE masking: NONE count: 10 type: ACTUAL name: Cacao fruit pulp name: Dextrose measure: Plasma Glucose measure: Incremental area under the curve measure: Peak plasma glucose sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: INQUIS Clinical Research city: Toronto state: Onterio zip: M5C 2N8 country: Canada lat: 43.70011 lon: -79.4163 hasResults: False
<\|newrecord\|> nctId: NCT06294925 id: C5041041 id: EFFECT-UC type: OTHER domain: Alias Study Number briefTitle: A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis acronym: EFFECT-UC overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2027-04-01 date: 2027-04-20 date: 2024-03-06 date: 2024-03-06 name: Pfizer class: INDUSTRY briefSummary: The purpose of this real world non-interventional study is to learn about the effects of etrasimod as treatment for patients with moderate to severe ulcerative colitis.
Patients will be treated according to standard of care and will only be included in the study if etrasimod is the best treatment choice according to the treating physician. Additionally, patients have to be between 18 and 65 years of age and should not have taken etrasimod in the past.
All patients will be prescribed etrasimod according to standard of care. Assessments will be conducted according to standard of care with the exception of health questionnaires which will be completed by the patients online on their own device.
The study duration is 52 weeks with 28 days of safety follow-up. Patients will visit their treating physician as they would if they were not enrolled in the study. During the study duration, patients will be asked to complete health questionnaires on a regular basis either on their mobile phone, tablet or computer.
The effects of etrasimod will be analyzed for each patient comparing to their disease activity prior to the start of etrasimod. conditions: Colitis, Ulcerative studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 260 type: ESTIMATED name: Etrasimod measure: Proportion of patients with symptomatic remission measure: Proportion of patients with symptomatic remission measure: Proportion of patients with clinical response measure: Proportion of patients with clinical response. measure: Proportion of corticosteroid-free patients with symptomatic remission sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06294912 id: 7602-003 id: MK-7602-003 type: OTHER domain: Merck briefTitle: A Study to Evaluate Antimalarial Activity and Safety of MK-7602 in Healthy Adults (MK-7602-003) overallStatus: NOT_YET_RECRUITING date: 2024-04-02 date: 2025-03-10 date: 2025-03-10 date: 2024-03-06 date: 2024-03-06 name: Merck Sharp & Dohme LLC class: INDUSTRY briefSummary: The purpose of this study is to assess the antimalarial activity, pharmacokinetics, and safety of MK-7602 in healthy adults following Plasmodium falciparum (P. falciparum) infection. conditions: Malaria studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 42 type: ESTIMATED name: Plasmodium falciparum name: MK-7602 name: Artemether/lumefantrine name: Primaquine name: Artesunate name: Atovaquone/proguanil measure: Parasite reduction ratio (PRR48) (Parts 1 and 2) measure: Parasite Clearance Half-life (PCt1/2) (Parts 1 and 2) measure: Parasite Regrowth (Parts 1 and 2) measure: Part 1 Single dose: Area Under the Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) of MK-7602 measure: Part 1 Single dose: Maximum Plasma Concentration (Cmax) of MK-7602 measure: Part 1 Single dose: Concentration at 24 Hours (C24) of MK-7602 measure: Part 1 Single dose: Time to Maximum Plasma Concentration (Tmax) of MK-7602 measure: Part 1 Single dose: Elimination Half-life (t1/2) of MK-7602 measure: Part 2 Multiple dose: Area Under the Curve Time 0 to End of the Dosing Interval (AUC0-tau) of MK-7602 measure: Part 2 Multiple dose: Maximum Plasma Concentration (Cmax) of MK-7602 measure: Part 2 Multiple dose: Time to Maximum Plasma Concentration (Tmax) of MK-7602 measure: Part 2 Multiple dose: Elimination Half-life (t1/2) of MK-7602 measure: Number of Participants Who Experience an Adverse Event (AE) measure: Number of Participants Who Discontinue Study Intervention Due to an AE sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06294899 id: 23/222-P briefTitle: CRP and Lung Ultrasound in Respiratory Evaluation acronym: PLURE overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-05-30 date: 2028-09-01 date: 2024-03-06 date: 2024-03-06 name: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina class: OTHER briefSummary: Lower respiratory tract infections (LRTIs) are one of the most common reasons for consultation in Primary Care centres. Differentiating between viral and bacterial aetiologies can be challenging, leading to inappropriate antibiotic prescribing. Lung ultrasound (LUS), an imaging test that gained particular relevance since the beginning of the SARS-CoV-2 pandemic, offers several advantages over the classic chest X-ray in detecting and monitoring LRTIs, especially when pleural involvement exists.
This study aims to correlate LUS findings with capillary blood C-Reactive Protein (CRP) values in patients with LRTIs, evaluating LUS as a diagnostic tool and its impact on therapeutic decisions. The descriptive observational study, conducted from January 2024 to December 2026 in Lleida, will include LRTI patients attending Primary Care centres. By validating LUS as a rapid and non-invasive diagnostic tool, unnecessary antibiotic prescriptions can be reduced, promoting LUS as a complementary test in Primary Care consultations. This will facilitate appropriate diagnosis and treatment decisions for patients with LRTIs, enhancing the overall management of respiratory infections. conditions: C-Reactive Protein conditions: Ultrasonography conditions: Primary Health Care conditions: Lower Respiratory Tract Infection studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 202 type: ESTIMATED name: Lung ultrasound measure: Ultrasound patterns measure: C-Reactive Protein sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06294886 id: Innovis RD-2401 briefTitle: Vaginal Fluid Collection for Detection of Endometrial Cancer overallStatus: RECRUITING date: 2024-02-19 date: 2024-06-01 date: 2024-06-01 date: 2024-03-06 date: 2024-03-07 name: Innovis LLC class: INDUSTRY briefSummary: The primary objective of this study is to obtain de-identified vaginal fluid specimens from participants with an endometrial tissue biopsy-based histopathological diagnosis of endometrial cancer (EC), endometrial hyperplasia (AEH) with atypia or endometrial intraepithelial neoplasia (EIN).
The samples will be used for the purpose of research and development of a new molecular diagnostic test for the detection of EC, AEH and EIN. conditions: Endometrial Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: Screening test to detect endometrial cancer and precancer measure: Detection of endometrial cancer and precancer sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Trials365 status: RECRUITING city: Shreveport state: Louisiana zip: 71118 country: United States name: Jen Cory role: CONTACT phone: 318-408-1198 email: j.cory@trials365.org name: Destin Black, MD role: PRINCIPAL_INVESTIGATOR lat: 32.52515 lon: -93.75018 hasResults: False
<\|newrecord\|> nctId: NCT06294873 id: Innovis RD-2301 briefTitle: Stool Sample Collection Study overallStatus: RECRUITING date: 2023-07-20 date: 2024-04-30 date: 2024-04-30 date: 2024-03-06 date: 2024-03-06 name: Innovis LLC class: INDUSTRY name: Exact Sciences Corporation briefSummary: The primary objective of this study is to obtain de-identified stool specimens from participants with colonoscopic biopsy-based histopathologic diagnosis of colorectal cancer (CRC) and/or a ≥1 cm colorectal polyp/adenoma/mass found during pre-enrollment colonoscopy that is of sufficient size to require surgical excision or complex colonoscopic polypectomy.
The samples will be used for the purpose of research and development of a new molecular diagnostic test for the detection of neoplasms of the aerodigestive tract. conditions: Colorectal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: A screening device for the detection of colorectal and other aerodigestive tract cancers measure: Detection of colon cancer or precancer sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Associated Gastroenterology Medical Group status: RECRUITING city: Anaheim state: California zip: 92810 country: United States name: Brian Riff, MD role: CONTACT phone: 714-778-1300 phoneExt: 227 email: briff@agmg.com name: Brian Riff, MD role: PRINCIPAL_INVESTIGATOR lat: 33.83529 lon: -117.9145 facility: Sarkis Clinical Trials status: RECRUITING city: Ocala state: Florida zip: 34474 country: United States name: Jen Corcoran role: CONTACT phone: 352-363-5395 phoneExt: 272 email: merci@ehsfamily.com name: Vishnu Reddy, MD role: PRINCIPAL_INVESTIGATOR lat: 29.1872 lon: -82.14009 facility: Gastro One status: RECRUITING city: Cordova state: Tennessee zip: 38018 country: United States name: Brian Dragutsky role: CONTACT phone: 901-606-8924 email: brian.dragutsky@onegi.com name: Ziad Younes, MD role: PRINCIPAL_INVESTIGATOR lat: 35.15565 lon: -89.7762 hasResults: False
<\|newrecord\|> nctId: NCT06294860 id: 01C317 briefTitle: Biological Age in Children With GH Deficiency Undergoing Hormone Replacement Therapy acronym: ETABIOGHD overallStatus: RECRUITING date: 2023-06-19 date: 2024-12-31 date: 2024-12-31 date: 2024-03-06 date: 2024-03-12 name: Istituto Auxologico Italiano class: OTHER briefSummary: The primary objective of the study is to evaluate the epigenetic age in children with GH deficiency, before and after 6 months of treatment with growth hormone replacement therapy. The secondary objective is to correlate the epigenetic age with the auxometric and biochemical parameters used in the clinical-endocrinological practice. The results of the study will be useful to set up the clinical and biochemical follow-up of the hormone replacement therapy with rhGH and to understand the biomolecular mechanisms at the base of the debated "anti" or "pro" aging action of GH, the most important anabolic hormone of the human organism. conditions: Growth Hormone Deficiency conditions: Short Stature studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 12 type: ESTIMATED measure: Measurement of biological (epigenetic) age sex: ALL minimumAge: 5 Years maximumAge: 15 Years stdAges: CHILD facility: Istituto Auxologico Italiano status: RECRUITING city: Milano zip: 20145 country: Italy name: Alessandro Sartorio role: CONTACT phone: +390261911 phoneExt: 2426 email: sartorio@auxologico.it lat: 45.46427 lon: 9.18951 hasResults: False
<\|newrecord\|> nctId: NCT06294847 id: 2021_0025 briefTitle: Ursodeoxycholic Acid (UDCA) as a Neuroprotective Adjuvant Treatment to Rhegmatogenous Retinal Detachment Surgery acronym: UDCA overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-04 date: 2027-10 date: 2024-03-06 date: 2024-04-11 name: Hopital Foch class: OTHER briefSummary: This study is indicated for patients with extended rhegmatogenous retinal detachment (RRD) (≥ 2 quadrants) with macula OFF lasting 7 days or less, pseudophakic or aphakic, and scheduled to undergo surgical intervention with vitrectomy and gas tamponade in one of the ophthalmology departments participating in the study.
The main objective is to assess the effectiveness of UDCA in visual acuity recovery at 3 months (i.e., the difference between preoperative visual acuity and visual acuity 3 months after surgery) in pseudophakic or aphakic patients who have undergone successful surgical intervention (reattachment of the retina) through vitrectomy and gas tamponade following rhegmatogenous retinal detachment (RRD).
120 patients will be enrolled and randomized in two groups:
* the experimental arm "UDCA Group," with oral administration of ursodeoxycholic acid (Ursolvan®)
* the control group "Placebo Group," with oral administration of the placebo. conditions: Retinal Detachment studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 120 type: ESTIMATED name: Ursolvan name: Placebo measure: Difference in visual recovery (difference between preoperative and postoperative visual acuity) at 3 months postoperative (after a successful reapplication procedure) of at least 6 letters (ETDRS scale) between the two groups (treatment and placebo) measure: Central Nervous Epithelium (CNE) thickness measure: Automated microperimetry at 1, 3, and 6 months: Macular sensitivity difference between the two groups. measure: Contrast sensitivity measurement using the Clinic CSF2.0 application. measure: Presence/absence of abnormal signs on optical coherence tomography (OCT) images (cysts, folds, membrane, ellipsoid zone, external limiting membrane). measure: Retinal thickness measured by OCT (retinal layers and presence of cysts, layer segmentation and measurement in the central 1 and 3 mm in ETDRS quadrants). measure: Number of macular cones and retinal pigment epithelium (RPE) cells measured by Adaptive Optics at 1, 3, and 6 months with the "Cellularis" device that allows visualization of cones and RPE. measure: Blood test: liver parameters - AST (SGOT), ALT (SGPT), PAL, and γ-GT. measure: Evolution of the best visual acuity measured at Day 0, Day 7, Day 30, Day 60, Day 90, and Day 180: Difference between the treated and placebo groups in the progression curves of visual acuity. measure: Presence of metamorphopsia. measure: Tolerance and occurrence of adverse events. measure: National Eye Institute Visual Functioning Questionnaire-25 (NEIVFQ-25) quality of life questionnaire before surgery, at ±7 days postoperative, and at 3 months postoperative. measure: Correlation between protein levels, bile acids, or other molecular markers in ocular and/or blood fluids and functional and anatomical ocular parameters pre- and post-operatively at different observation times. measure: Correlation between the effective duration of treatment and functional and anatomical outcomes at different observation times. sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Cochin city: Paris zip: 75014 country: France name: EYMARD Pauline, Dr role: CONTACT email: pauline.eymard@aphp.fr name: EYMARD Pauline role: PRINCIPAL_INVESTIGATOR lat: 48.85341 lon: 2.3488 facility: Hôpital Foch city: Suresnes zip: 92150 country: France name: Behar Cohen Francine, Pr role: CONTACT phone: 01 46 25 22 75 email: .behar-cohen@hopital-foch.com name: Behar Cohen Francine, Pr role: PRINCIPAL_INVESTIGATOR lat: 48.87143 lon: 2.22929 hasResults: False
<\|newrecord\|> nctId: NCT06294834 id: STUDY22010071 id: 90SIMS0010 type: OTHER_GRANT domain: NIDILRR briefTitle: Improving Clinician Capacity to Provide Interventions for Manual Wheelchair Users acronym: SKILL overallStatus: RECRUITING date: 2023-02-22 date: 2026-08-30 date: 2026-12-30 date: 2024-03-06 date: 2024-03-06 name: University of Pittsburgh class: OTHER name: Dalhousie University name: National Institute on Disability, Independent Living, and Rehabilitation Research briefSummary: The objective of this study is to determine the effectiveness of remote manual wheelchair skills training program for clinicians. The study will use three-group approach: intervention with remote feedback (Group 1), control group (Group 2), and structured self-study (Group 3). This demonstrates how the intervention compares not only to a control, but also to the next "best alternative" - therapists sourcing web-based training materials and learning independently. conditions: Wheelchair Skills studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Randomized, single-blinded, two-period cross-over study design for Groups 1 and 2. Participants will complete baseline assessments and then be randomized to either Group 1 or Group 2. After enrollment for Groups 1 and 2 is complete, participants will be enrolled into Group 3. primaryPurpose: OTHER masking: SINGLE maskingDescription: For therapists, we will use a randomized, single-blinded, two-period cross-over study design for Groups 1 and 2. Participants will complete baseline assessments and then be randomized to either Group 1 or Group 2. After we have completed enrollment for Groups 1 and 2 we will enroll participants into Group 3.
Rehabilitation professionals who are not therapists will be enrolled in Group 4. whoMasked: PARTICIPANT count: 240 type: ESTIMATED name: Part 1 of intervention A - Wheelchair skills training modules name: Part 2 of intervention A - Asynchronous feedback from a remote trainer name: Intervention B: Education on wheelchair provision measure: Change in Wheelchair Skills Test Questionnaire (WST-Q) score measure: Change in Self-Efficacy on Assessing, Training, and Spotting (SEATS) score measure: Change in number of wheelchair users trained measure: Change in quality of wheelchair skills trained measure: Change in rehab professional Wheelchair Skills Test Questionnaire (WST-Q) score measure: Change in rehab professional Self-Efficacy on Assessing, Training, and Spotting (SEATS) score measure: Change in rehab professional quantity of wheelchair users trained measure: Change in rehab professional quality of wheelchair training sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Pittsburgh / Rehab Neural Engineering Labs status: RECRUITING city: Pittsburgh state: Pennsylvania zip: 15219 country: United States name: Lee Tempest, BS role: CONTACT phone: 412-232-9326 email: tempestml@upmc.edu name: Debbie Harrington, BS role: CONTACT phone: 412-383-1355 email: debbie.harrington@pitt.edu lat: 40.44062 lon: -79.99589 hasResults: False
<\|newrecord\|> nctId: NCT06294821 id: 00003845 briefTitle: 4AP to Delay Carpal Tunnel Release (CTR) acronym: CTR overallStatus: NOT_YET_RECRUITING date: 2024-09 date: 2027-12 date: 2028-07 date: 2024-03-06 date: 2024-03-12 name: John Elfar class: OTHER briefSummary: The investigators have found recent promising data supporting the use of a currently FDA approved drug, 4-aminopyridine, in the treatment of nerve injury including compression neuropathy. The purpose of this research is determine whether 4-aminopyridine can delay the need for formal surgical release in patients with known carpal tunnel syndrome who would otherwise undergo surgery. conditions: Compression Neuropathy conditions: Carpal Tunnel Syndrome studyType: INTERVENTIONAL phases: PHASE2 phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR count: 160 type: ESTIMATED name: 4-Aminopyridine name: Placebo measure: Results of symptomatic improvement in the Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ) measure: Results of symptomatic improvement in the Michigan Hand Outcomes Questionnaire (MHQ) measure: Electrodiagnostic improvement following treatment sex: ALL minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06294808 id: 2017-2601 briefTitle: Predicting Survival After Surgical Resection for the Entire Spectrum of Anatomically Resectable HCC overallStatus: COMPLETED date: 2017-07-17 date: 2020-06-30 date: 2020-06-30 date: 2024-03-06 date: 2024-03-06 name: National Cancer Centre, Singapore class: OTHER name: Singapore General Hospital briefSummary: Clinical outcomes after surgical resection in HCC is a continuum and is clearly related to tumor burden but needs better definition. The researchers describe the use of the "metro ticket" approach to analyze surgical outcomes over the whole spectrum of anatomically resectable HCC to define overall survival including intermediate stage tumors (BCLC B). The analysis the researchers provide in this study enables the clinician to select the optimal surgical resection candidate based on robust long term survival data.
In addition, study compares outcome for open surgery vs laparoscopic surgery, survival outcome for viral and non-viral HCC using Albumin-Bilirubin (ALBI) for more comprehensive study result. conditions: Hepatocellular Carcinoma Resectable studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 1043 type: ACTUAL measure: 5-year mortality. measure: Concordance of pre-operative radiological and post operative surgical specimen. measure: Agreement between TBI calculated from pre-operative imaging versus those obtained from post-surgical pathological assessment. sex: ALL minimumAge: 21 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: National Cancer Centre, Singapore city: Singapore zip: 168583 country: Singapore lat: 1.28967 lon: 103.85007 facility: Singapore General Hospital city: Singapore zip: 169608 country: Singapore lat: 1.28967 lon: 103.85007 hasResults: False
<\|newrecord\|> nctId: NCT06294795 id: 2-2024 briefTitle: Toric Intraocular Lens Implantation in Pediatric Cataract acronym: TILIPC overallStatus: RECRUITING date: 2024-03-01 date: 2024-12-31 date: 2025-12-31 date: 2024-03-06 date: 2024-03-15 name: Kazakh Eye Research Institute class: NETWORK briefSummary: To evaluate the visual and refractive outcomes after an intraocular lens (IOL) implantation in pediatric eyes with cataract and preexisting corneal astigmatism conditions: Cataract Congenital conditions: Astigmatism conditions: IOL studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: congenital/pediatric cataract surgery name: Non-Toric IOLs name: Toric IOLs measure: Uncorrected (UCDVA) and corrected (CDVA) distance visual acuity measure: Uncorrected (UCNVA) and corrected (CNVA) near visual acuity measure: Refraction measurements measure: Keratometry measurements sex: ALL minimumAge: 6 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Kazakh Eye Research Institute status: RECRUITING city: Almaty zip: 050012 country: Kazakhstan name: Kairat Ruslanuly, MD role: CONTACT phone: +77019008387 email: ruslanuly.kairat@gmail.com name: Zhansaya Sultanbayeva, MD role: CONTACT phone: +77023777735 email: sultanbayeva.zhansaya@gmail.com name: Lukpan Orazbekov, MD role: PRINCIPAL_INVESTIGATOR name: Kairat Ruslanuly, MD role: SUB_INVESTIGATOR name: Zhansaya Sultanbayeva, MD role: SUB_INVESTIGATOR name: Meruert Ashimova, MD role: SUB_INVESTIGATOR lat: 43.25667 lon: 76.92861 facility: Kazakh Eye Research Institute status: RECRUITING city: Astana zip: 010000 country: Kazakhstan name: Gulnaz Kassymbekova, MD role: CONTACT phone: +77478538289 email: GulnazKassymbekova@gmail.com name: Asiya Beisebayeva, MD role: CONTACT phone: +77018333953 name: Aigerim Tuletova, MD role: PRINCIPAL_INVESTIGATOR name: Asiya Beisebayeva, MD role: SUB_INVESTIGATOR name: Gulnaz Kassymbekova, MD role: SUB_INVESTIGATOR lat: 51.1801 lon: 71.44598 hasResults: False
<\|newrecord\|> nctId: NCT06294782 id: 36/2022 briefTitle: PrOsPective Cohort Study for STereotactic Arhythmia Radioablation (STAR) of Refractory Ventricular Tachycardia acronym: POPSTAR overallStatus: RECRUITING date: 2022-04-15 date: 2025-02 date: 2025-02 date: 2024-03-06 date: 2024-03-06 name: University of Turin, Italy class: OTHER name: Azienda Unità Sanitaria Locale Reggio Emilia name: IRCCS Sacro Cuore Don Calabria di Negrar name: Fondazione IRCCS Policlinico San Matteo di Pavia briefSummary: This is a multicenter, interventional study. The study will enroll patients that fulfill the inclusion criteria over a 33-month period. Considering the small number of patients who will meet the study criteria, it is also possible to include retrospective patients who already underwent STAR (for instance, as part of a compassionate program) if they meet all the inclusion and exclusion criteria as well as the treatment planning standardized requirements and sign their consent to this trial. All patients prospectively enrolled will undergo a flow of investigations following a standardized approach. ICD programming will be standardized. conditions: Refractory Ventricular Tachycardia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: STereotactic Arhythmia Radioablation (STAR) measure: VT storm and incessant VT measure: adverse events sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Turin status: RECRUITING city: Turin country: Italy name: Gaetano Maria De Ferrari role: CONTACT lat: 45.07049 lon: 7.68682 hasResults: False
<\|newrecord\|> nctId: NCT06294769 id: 022024 Maria Fernanda briefTitle: Effect of Aromatherapy on Postoperative Pain: Randomized Clinical Trial overallStatus: NOT_YET_RECRUITING date: 2024-03-18 date: 2024-06-19 date: 2024-07-19 date: 2024-03-06 date: 2024-03-06 name: University of Sao Paulo class: OTHER briefSummary: Introduction: Pain is one of the main complications in the immediate postoperative period that can harm the patient and can be managed through pharmacological and non-pharmacological methods. Complementary Integrative Health Practices are non-pharmacological methods that use therapeutic resources based on traditional knowledge to treat symptoms. Among them, aromatherapy stands out, which consists of the use of essential oils through inhalation or topical application for therapeutic purposes and which can be used as a nursing intervention, especially in the context of perioperative care. Objective: To evaluate the effect of aromatherapy on postoperative pain in adult patients in the immediate postoperative period. Method: This is a randomized controlled clinical trial that will be carried out in a teaching hospital. The project was submitted to the Research Ethics Committees of the School of Nursing of the University of Sao Paulo and the University of Sao Paulo Hospital. Adult patients undergoing elective surgical procedures of any surgical specialty under anesthesia of any type will be included. Individuals diagnosed with dementia, cognitive impairment or chronic pain will be excluded; individuals with a history of asthma, allergic bronchitis, chronic obstructive pulmonary disease, contact dermatitis or allergy to cosmetics with lavender fragrance, or hypersensitivity to the compounds used in the intervention; procedure for reoperation for any reason. The intervention will consist of the application of aromatherapy with 2% lavender essential oil through the skin and inhalation by a nurse, associated with usual care, in the immediate postoperative period; the placebo group will only receive the application of grape seed vegetable oil associated with usual care. A numerical verbal scale will be applied to assess pain and vital parameters will be measured upon patient admission, every fifteen minutes in the first hour and every thirty minutes in the second hour or after 15, 30, 45, 60 minutes, 1h30 minutes and 2 hours after applying the intervention, in the post-anesthesia recovery room. Possible associations between variables will be verified using Pearson's Chi-square or Fisher's exact tests. Comparison between means or medians will be made using the Student's t or Mann-Whitney tests, depending on the normality determined according to the Kolmogorov-Smirnov test. The significance level adopted will be 5%. conditions: Acute Pain conditions: Perioperative/Postoperative Complications conditions: CAM conditions: Nurse's Role studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 138 type: ESTIMATED name: essencial oil of lavandula angustifolia name: grape seed vegetable oil measure: Acute pain measure: Blood pressure (both systolic and diastolic) measure: Heart rate measure: Respiratory frequency measure: Oxygen saturation measure: Temperature sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06294756 id: acquealbuleroma1 id: AR1221816703484E type: OTHER_GRANT domain: La Sapienza University, Rome, Italy briefTitle: Sulfureous Water Therapy in Viral Respiratory Diseases acronym: STWandRVD overallStatus: COMPLETED date: 2023-05-30 date: 2023-08-01 date: 2023-09-30 date: 2024-03-06 date: 2024-03-06 name: University of Roma La Sapienza class: OTHER name: Università degli studi di Roma Foro Italico name: Queen Mary University of London name: Bios Prevention Srl briefSummary: The goal of this double-blind, interventional, randomized case-control, pilot trial is to evaluate the effects of active sulfurous (STW) versus placebo (SDW) inhalations on blood test parameters, serum inflammatory cytokines, spirometry data, as well as qualitative and quantitative changes in the nasal microbiome of subjects affected by long Covid.
The main questions it aims to answer are:
* if STW inhalations are effective on respiratory issues due to long covid compared to the placebo inhalation (SDW)
* if STW inhalations are effective on long covid related fatigue issues compared to the placebo inhalation (SDW)
* if H2S inhaled with STW is effective in modulating (decreasing) cytokines which are related to long covid cytokine storm compared to placebo inhalation with no H2S (SDW)
* if STW inhalation modify nasal microbiome both from a qualitative and quantitative point of view respect to placebo inhalation (SDW) Participants will be randomly assigned to active inhalations (STW) or placebo inhalations (SDW) arm and subjected to 12 consecutive sessions of 20 minutes.
Both arms will be tested for:
* cytokines and inflammatory markers concentration (IL1b, IL6, ACE, GSS, S100B, Hs-CRP)
* spirometry (resting, forced, DLCO)
* exertion response (6 minutes walking test)
* nasal microbiome sampling at visit 1 (enrolment), at visit 2(right after the inhalation treatment) and at visit 3 (3 months after treatment).
Researchers will compare results reported by STW to those of SDW group to see if significative differences are detectable. conditions: Long-COVID conditions: Post COVID-19 Condition conditions: Chronic COVID-19 Syndrome conditions: Post Acute Sequelae of COVID-19 studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study is a double-blind, interventional, randomized case-control, pilot trial assessing the efficacy of sulfureous thermal water (STW) inhalations in patients diagnosed with long-COVID. The eligible subjects were randomized in a 1:1 ratio to either: active (STW) or placebo (SDW) group for the inhalation therapy and tested at 3 timepoints: Visit 1 (prior treatment), Visit 2 (just after treatment) , Visit 3 (3 months after treatment). primaryPurpose: TREATMENT masking: TRIPLE maskingDescription: Neither the participants nor any of the medical researchers or laboratory staff involved in the screening, enrolment, clinical evaluation, monitoring, and laboratory as well as statistics of the participant's analyses were aware of the study intervention received (STW vs SDW). A randomization list (1:1 active vs placebo) was created prior to recruiting. The inhalation assistant randomized the participant according to the list and administered the intervention. Therefore, the inhalation assistant was unblinded to the treatment assigned but blinded to the medical condition of the participants. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 30 type: ACTUAL name: Inhalation of Sulfurous Thermal Water name: Inhalation of Sterile Distilled non-pyrogenic Water measure: To determine whether Sulfurous Thermal water (STW) inhalations may have effects on post covid-pulmonary sequelae assessing changes in pulmonar functionality through spirometric parameters. measure: To determine whether Sulfurous Thermal water (STW) inhalations may have effects on post covid-pulmonary sequelae assessing changes in pulmonar functionality through spirometric parameters. measure: To determine whether Sulfurous Thermal water (STW) inhalations may have effects on post covid-pulmonary sequelae assessing changes in pulmonar functionality through spirometric parameters measure: To determine whether Sulfurous Thermal water (STW) inhalations can improve the cardiopulmonary response to physical exertion measured as SpO2, Heart rate, Borg score and traversed meters in patients affected by long COVID measure: To determine whether Sulfurous Thermal water (STW) inhalations can improve the cardiopulmonary response to physical exertion measured as SpO2, Heart rate, Borg score and traversed meters in patients affected by long COVID measure: To determine whether Sulfurous Thermal water (STW) inhalations can improve the cardiopulmonary response to physical exertion measured as SpO2, Heart rate, Borg score and traversed meters in patients affected by long COVID measure: To assess if H2S present in STW can interfere with concentration of inflammatory markers ( as IL1B, IL-6, ACE, S100B, GSS, Hs-CRP) typically alterated in long covid patients. measure: To assess if H2S present in STW can interfere with concentration of inflammatory markers ( as IL1B, IL-6, ACE, S100B, GSS, Hs-CRP) typically alterated in long covid patients. measure: To assess if H2S present in STW can interfere with concentration of inflammatory markers ( as IL1B, IL-6, ACE, S100B, GSS, Hs-CRP) typically alterated in long covid patients. measure: to assess whether thermal water inhalation with sulfurous water may determine qualitative and quantitative changes of the nasal microbiome by assessing alpha and beta diversity after nasal sample collection measure: to assess whether thermal water inhalation with sulfurous water may determine qualitative and quantitative changes of the nasal microbiome by assessing alpha and beta diversity after nasal sample collection measure: to assess whether thermal water inhalation with sulfurous water may determine qualitative and quantitative changes of the nasal microbiome by assessing alpha and beta diversity after nasal sample collection measure: to assess whether thermal water inhalation determine changes in the perceived impact of respiratory related impairment on the quality of life (Qol) through a validate Saint George respiratory questionnaire measure: to assess whether thermal water inhalation determine changes in the perceived impact of respiratory related impairment on the quality of life (Qol) through a validate Saint George respiratory questionnaire sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Acque Albule, Terme di Roma city: Tivoli state: Rome zip: 00019 country: Italy lat: 41.95952 lon: 12.8016 hasResults: False
<\|newrecord\|> nctId: NCT06294743 id: C202304001 briefTitle: Posterior Tibia Nerve Neuroprolotherapy for Dysmenorrhea overallStatus: RECRUITING date: 2023-11-23 date: 2025-12-31 date: 2025-12-31 date: 2024-03-06 date: 2024-03-06 name: Taichung Armed Forces General Hospital class: OTHER_GOV briefSummary: The goal of this crossover study is to assessed the treatment efficacy of posterior tibia nerve neuroprolotherapy on dysmenorrhea. The primary outcome is the improvement of Visual Analogue Scale. The main question it aims to answer is:
•Could the posterior tibial nerve neuroprolotherapy alleviate the pain of dysmenorrhea.
Participants will be randomly allocated into two groups, Group-1 will receive neuroprolotherapy in the first 2 menstrual cycles followed by oral acetaminophen(500mg) for the subsequent 2 menstrual cycles. Group02 will received oral acetaminophen(500mg) in initial 2 menstrual cycles, followed by receiving neuroprolotherapy for the subsequent 2 menstrual cycles. conditions: Dysmenorrhea conditions: Prolotherapy studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: CROSSOVER interventionModelDescription: Group-1, posterior tibial nerve neuroprolotherapy will be administered during the first two menstrual cycles, followed by oral acetaminophen (500mg) for the subsequent two menstrual cycles. Conversely.
Group-2, oral acetaminophen (500mg) will be given during the initial two menstrual cycles, followed by a transition to posterior tibial nerve neuroprolotherapy for the last two menstrual cycles. primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Posterior tibial nerve neuroprolotherapy name: Acetaminophen 500Mg Tab measure: Visual Analogue Scale measure: The SF-36v2® Health Survey sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Taichung Armed Forces General Hospital status: RECRUITING city: Taichung state: Other (Non US) zip: 41168 country: Taiwan name: Jing-dung Shen, MD role: CONTACT phone: +886958878129 email: jdwhydo@gmail.com name: Jing-dung Shen, MD role: PRINCIPAL_INVESTIGATOR lat: 24.1469 lon: 120.6839 hasResults: False
<\|newrecord\|> nctId: NCT06294730 id: 2018/1891-31 briefTitle: COronary Microcirculation and Troponin Elevation in Septic Shock acronym: COMTESS overallStatus: RECRUITING date: 2019-06-13 date: 2024-06 date: 2024-12 date: 2024-03-05 date: 2024-03-05 name: Karolinska Institutet class: OTHER briefSummary: Plasma cardiac troponin (cTn) elevation is an indicator of increased mortality in patients with sepsis yet the underlying cause of troponin elevation in sepsis is not known. The COMTESS study investigates whether elevated high-sensitive cardiac Troponin T (hs-cTnT) levels in hemodynamically unstable patients with sepsis can be explained by an underlying coronary artery disease or a process within the coronary microcirculation. Fifty patients with sepsis and with hs-cTnT elevation (\>15 ng/L) will undergo coronary angiography, including an assessment of coronary flow using a method called thermo-dilution to record the index of microcirculatory resistance (IMR) in the left anterior descending artery (LAD). The relationship between IMR and hs-cTnT will subsequently be analysed. It is important to identify the underlying causes of elevated cTn during sepsis to target further research with an aim to improve the survival in patients suffering from this condition. conditions: Sepsis conditions: Myocardial Injury conditions: Coronary Microvascular Dysfunction conditions: Endothelial Dysfunction studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 50 type: ESTIMATED measure: Relationship between hs-cTnT and IMR measure: Relationship between hs-cTnT and CFR measure: Relationship between hs-cTnT and BRI measure: Relationship between hs-cTnT and number of diseased epicardial coronary vessels measure: Relationship between hs-cTnT and Synergy Between PCI With Taxus and Cardiac Surgery (SYNTAX)-score measure: Relationship between hs-cTnT and left ventricular end diastolic pressure (LVEDP) measure: Relationship between hs-cTnT and Tricuspid annular plane systolic excursion (TAPSE) measure: Relationship between hs-cTnT and echocardiographic measurements of left ventricular global strain measure: Relationship between hs-cTnT and echocardiographic measurements of left diastolic dysfunction measure: Relationship between measures of endothelial dysfunction and IMR measure: Relationship between measures NETs and IMR sex: ALL minimumAge: 40 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Karolinska Institutet, Danderyd University Hospital status: RECRUITING city: Stockholm zip: 182 88 country: Sweden name: Jonas Persson, MD, PhD role: CONTACT phone: +46 70-089 1412 email: jonas.persson@regionstockholm.se name: Samantha Lörstad, MD role: CONTACT phone: +46708693973 email: samantha.rutherford-lorstad@regionstockholm.se name: Jonas Persson, MD, PhD role: PRINCIPAL_INVESTIGATOR name: Samantha Lörstad, MD role: SUB_INVESTIGATOR name: Tomas Jernberg, MD, PhD role: SUB_INVESTIGATOR name: Sara Tehrani, MD, PhD role: SUB_INVESTIGATOR name: Per Åstrand, MD role: SUB_INVESTIGATOR name: Christina Ekenbäck, MD role: SUB_INVESTIGATOR name: Fadi Jokhaji, MD role: SUB_INVESTIGATOR name: Kambiz Shahgaldi, PhD role: SUB_INVESTIGATOR name: Charlotte Thålin, MD, PhD role: SUB_INVESTIGATOR name: Patrik Gille-Johnson, MD, PhD role: SUB_INVESTIGATOR lat: 59.33258 lon: 18.0649 hasResults: False
<\|newrecord\|> nctId: NCT06294717 id: AtaturkUPhStudentNeslihanATLI briefTitle: The Effect of Progressive Relaxation Exercises on Physiological Parameters, Pain and Anxiety After Cesarean Section overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2024-08-01 date: 2024-12-01 date: 2024-03-05 date: 2024-03-05 name: Ataturk University class: OTHER briefSummary: Caesarean section is a surgical procedure that can be performed before or during birth in cases where the life of the mother and fetus is threatened or upon the request of the mother and father. One of the most common problems after cesarean section is abdominal pain. Progressive relaxation exercises are a method that allows certain muscle groups in the body to first contract and then relax. Progressive relaxation exercises have been proven to have positive effects on anxiety. By applying progressive relaxation exercises, the parasympathetic nervous system is activated; Thus, heart and respiratory rate and blood pressure can be kept within normal limits. This study will be conducted to determine the physiological parameters, pain and anxiety levels of progressive relaxation exercises, one of the non-pharmacological methods, on women giving birth by cesarean section. conditions: Pain studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: SINGLE whoMasked: PARTICIPANT count: 2 type: ESTIMATED name: Progressive relaxation exercises will be applied. measure: Beck Anxiety Scale measure: Visual Analog Scale (VAS) sex: FEMALE minimumAge: 20 Years maximumAge: 35 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06294704 id: 2024/0004 briefTitle: Hybrid Closed Loop Insulin Pump and Bariatric Surgery in Patients With Type 1 Diabetes acronym: PompBariatDT1 overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2024-12-31 date: 2024-12-31 date: 2024-03-05 date: 2024-04-08 name: Centre Hospitalier Sud Francilien class: OTHER briefSummary: Bariatric surgery is increasingly performed on patients with type 1 diabetes. It exposes these patients to an increased risk of hypoglycemia, including severe hypoglycemia, and of severe episodes of hyperglycemia, beyond the perioperative period. The long-term efficacy and safety of hybrid closed-loop insulin pump in these patients has not yet been published. conditions: Bariatric Surgery conditions: Type 1 Diabetes studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 20 type: ESTIMATED name: bariatric surgery measure: time spent within glycemic target 70-180 mg/dL measure: Time spent in level 1 hyperglycemia (181-250 mg/dL) measure: Time spent in level 2 hyperglycemia (>250 mg/dL) measure: HbA1c measure: Coefficient of variation measure: Time spent in level 1 hypoglycemia (51-70 mg/dl) measure: Time spent in level 2 hypoglycemia (< 50 mg/gdl) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centre Hospitalier Sud Francilien city: Corbeil-Essonnes zip: 91106 country: France name: Caroline TOURTE role: CONTACT phone: +33161693150 email: caroline.tourte@chsf.fr lat: 48.60603 lon: 2.48757 hasResults: False
<\|newrecord\|> nctId: NCT06294691 id: infusion time & aGVHD-002 briefTitle: Effect of Stem Cell Infusion Time on aGVHD in Patients With Nonmalignant Hematologic Diseases overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-11-30 date: 2026-08-31 date: 2024-03-05 date: 2024-03-05 name: Anhui Provincial Hospital class: OTHER_GOV briefSummary: To observe the effect of stem cell infusion on the development of acute graft- versus-host disease (aGVHD) in patients with nonmalignant hematologic diseases after allogeneic peripheral blood hematopoietic stem cell transplantation (allo-PBSCT) conditions: Acute Graft-versus-host Disease studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 198 type: ESTIMATED name: Time of stem cell infusion measure: The cumulative incidence of grade III to IV aGVHD measure: The cumulative incidence of grade II to IV aGVHD measure: The cumulative incidence of neutrophil engraftment at 28 days after transplantation measure: The cumulative incidence of platelet recovery at 100 days after transplantation measure: The cumulative incidence of transplant-related mortality at 180 days after transplantation measure: The cumulative incidence of transplant-related mortality at 360 days after transplantation measure: The cumulative incidence of chronic GVHD at 360 days after transplantation measure: The probability of GVHD-free, relapse-free survival(GRFS) measure: The probability of disease-free survival(DFS) measure: The probability of overall survival(OS) sex: ALL minimumAge: 12 Years maximumAge: 60 Years stdAges: CHILD stdAges: ADULT facility: The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital) city: Hefei state: Anhui zip: 230036 country: China lat: 31.86389 lon: 117.28083 hasResults: False
<\|newrecord\|> nctId: NCT06294678 id: infusion time & aGVHD-001 briefTitle: Effect of Stem Cell Infusion Time on aGVHD in Patients With Hematological Malignancies overallStatus: NOT_YET_RECRUITING date: 2024-03-01 date: 2025-11-30 date: 2026-08-31 date: 2024-03-05 date: 2024-03-05 name: Anhui Provincial Hospital class: OTHER_GOV briefSummary: To observe the effect of stem cell infusion on the development of acute graft-versus-host disease (aGVHD) in patients with malignant hematologic diseases after allogeneic peripheral blood hematopoietic stem cell transplantation (allo-PBSCT) conditions: Acute Graft-versus-host Disease studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: NONE count: 198 type: ESTIMATED name: Time of stem cell infusion measure: The incidence of grade III to IV aGVHD measure: The incidence of grade II to IV aGVHD measure: The cumulative incidence of neutrophil engraftment at 28 days after transplantation measure: The cumulative incidence of platelet recovery at 100 days after transplantation measure: The cumulative incidence of transplant-related mortality at 180 days after transplantation measure: The cumulative incidence of transplant-related mortality at 360 days after transplantation measure: The cumulative incidence of chronic GVHD at 360 days after transplantation measure: The probability of GVHD-free, relapse-free survival(GRFS) measure: The probability of disease-free survival(DFS) measure: The probability of overall survival(OS) sex: ALL minimumAge: 12 Years maximumAge: 60 Years stdAges: CHILD stdAges: ADULT facility: The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital) city: Hefei state: Anhui zip: 230036 country: China lat: 31.86389 lon: 117.28083 hasResults: False
<\|newrecord\|> nctId: NCT06294665 id: MD113/2023 briefTitle: Comparison Between Bupivacaine-Dexmedetomidine Versus Bupivacaine-Dexamethasone in Pericapsular Nerve Group (PENG) Block overallStatus: RECRUITING date: 2024-03-01 date: 2024-12-01 date: 2025-01-01 date: 2024-03-05 date: 2024-03-05 name: Ain Shams University class: OTHER briefSummary: The aim of this work is to compare the effectiveness of bupivacaine- dexmedetomidine mixture versus bupivacaine-dexamethasone mixture in PENG Block as Post-operative Analgesia in Hip surgeries conditions: Hip Fractures conditions: Post Operative Pain studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Pericapsular Nerve Group (PENG) Block measure: The time to the first request of analgesia measure: Total doses of analgesia (Nalbuphine) given to patients in 24 hours postoperatively measure: Occurrence of side effects of drugs. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ain Shams University status: RECRUITING city: Cairo zip: 11122 country: Egypt name: Fatma Ebeid role: CONTACT phone: +201095569596 email: dr.fatma_ebeid@yahoo.com name: Mohamed Salama role: PRINCIPAL_INVESTIGATOR lat: 30.06263 lon: 31.24967 hasResults: False
<\|newrecord\|> nctId: NCT06294652 id: AGMT_Lymphoma_Reg briefTitle: AGMT Austrian Lymphoma Registry overallStatus: RECRUITING date: 2024-02-27 date: 2033-12-31 date: 2033-12-31 date: 2024-03-05 date: 2024-03-05 name: Arbeitsgemeinschaft medikamentoese Tumortherapie class: OTHER briefSummary: Lymphomas are a group of cancers that originate in the lymphatic system, a key component of the immune system. They can be broadly categorized into two main types: Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL).
There are different subtypes of HL, including classical Hodgkin lymphoma (cHL) and nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL). The subtypes of cHL include nodular sclerosis, mixed cellularity, lymphocyte-rich, and lymphocyte-depleted.
Non-Hodgkin lymphomas are more diverse and comprise a wide range of subtypes, each with distinct genetic, molecular, and clinical features. Common subtypes of NHL include Diffuse large B-cell lymphoma (DLBCL), Follicular lymphoma (FL), Mantle cell lymphoma (MCL), Chronic lymphocytic leukemia (CLL), myeloma, and other rarer subgroups.
Many of these diseases typically present with lymph node enlargement, bone marrow infiltration, general and lymphoma subtype specific symptoms and laboratory abnormalities.
Novel agents have improved the prognosis of high-risk lymphoma patients in the front-line and relapsed setting and more accurate prognostic tools enable less intensive treatment for low-risk patients, while maintaining their good prognosis.
Lymphoma disease have not been systematically assessed in Austria to date. This medical registry of the AGMT is thus the first Austrian-wide standardized documentation of epidemiology, clinical course and molecular and other biologic data of this disease. As lymphomas are a very heterogeneous group, not all subtypes will always be documented simultaneously in this registry. Which lymphoma subtype is to be documented can change over time, depending on which clinical question is currently in focus. conditions: Lymphoma studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: OTHER count: 4000 type: ESTIMATED measure: General Characteristics measure: Genetic Profiling measure: Proportion of lymphoma patients in Austria that require treatment measure: Proportion of lymphoma patients in Austria under active surveillance measure: Number of patients with concomitant diseases measure: Number of treatment and outcome of treatment measure: Patient Outcome measure: Toxicities sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Universitätsklinik für Innere Medizin III, PMU Salzburg status: RECRUITING city: Salzburg zip: 5020 country: Austria name: Richard Greil, MD role: PRINCIPAL_INVESTIGATOR lat: 47.79941 lon: 13.04399 hasResults: False
<\|newrecord\|> nctId: NCT06294639 id: XJA-20240224 briefTitle: ED50 of Esketamine for Laser Treatment in Children acronym: ESCALATE overallStatus: NOT_YET_RECRUITING date: 2024-03-27 date: 2025-03-27 date: 2025-04-27 date: 2024-03-05 date: 2024-03-05 name: Air Force Military Medical University, China class: OTHER briefSummary: There is limited research on the combined use of esketamine and alfentanil for anesthesia during facial laser treatment in pediatric patients, and the effective dosage of esketamine for inhibiting body movement remains unclear. We explore the effective dose of esketamine combined with alfentanil for the inhibition of body movement during facial laser treatment in pediatric patients. conditions: Anesthesia studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SEQUENTIAL interventionModelDescription: The Biased coin method is used primaryPurpose: OTHER masking: NONE maskingDescription: Esketamine will be prepared by an investigator who is not involved in anesthesia and outcome assessment. For all participants, esketamine will be diluted to the same volume. count: 40 type: ESTIMATED name: Esketamine measure: half effective dose of inhibition of body movement measure: number of patients with agitation during awake measure: number of patients with dizzy during awake measure: number of patients with nausea and vomiting during awake measure: number of patients with apnea during awake measure: satisfaction score of the parents to the anesthesia sex: ALL minimumAge: 3 Years maximumAge: 12 Years stdAges: CHILD hasResults: False
<\|newrecord\|> nctId: NCT06294626 id: ISozeri briefTitle: Examination of Neuromotor Development of Cases Diagnosed With Scaphocephaly overallStatus: COMPLETED date: 2019-01-01 date: 2023-12-31 date: 2023-12-31 date: 2024-03-05 date: 2024-03-05 name: Acıbadem Atunizade Hospital class: OTHER briefSummary: It's an observational study. Purpose of the study: To evaluate the neuromotor development of scaphocephaly cases.
21 infants diagnosed with scaphocephaly aged 2-17 months were included.
* Is there any delay in the neuromotor development of scaphocephaly cases?
* If delay is observed, in which area is it most common?
Denver-II Developmental Screening Test and Alberta Motor Infant Scale were applied to the participants. conditions: Craniosynostosis, Sagittal conditions: Scaphocephaly conditions: Developmental Delay studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 21 type: ACTUAL name: Group 1 measure: Denver-II Developmental Screening Test measure: Alberta Infant Motor Scale sex: ALL minimumAge: 2 Months maximumAge: 17 Months stdAges: CHILD facility: Acıbadem Altunizade Hospital city: Istanbul state: Uskudar country: Turkey lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06294613 id: CIV-23-07-043672 briefTitle: A Prospective, Open-label, Single-center, Study of the ACUSURGICAL Luca System for Treatment of Vitreoretinal Diseases overallStatus: RECRUITING date: 2024-02-08 date: 2024-07 date: 2024-07 date: 2024-03-05 date: 2024-03-13 name: Acusurgical class: INDUSTRY briefSummary: Prospective, interventional, open-label, non-controlled, monocentric study in Belgium of Luca, of up to 7 evaluable subjects, undergoing vitreoretinal surgery to treat intravitreal hemorrhage and macular pucker.
Only one eye per subject can be enrolled. conditions: Vitreoretinal Disease studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 7 type: ESTIMATED name: vitreoretinal surgery measure: Safety Outcome sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UZ Gent status: RECRUITING city: Gent state: East Flanders zip: 9000 country: Belgium name: Bart Leroy, PhD role: CONTACT phone: +32 9 33 25791 email: Bart.Leroy@uzgent.be lat: 51.05 lon: 3.71667 hasResults: False
<\|newrecord\|> nctId: NCT06294600 id: REACT id: 2023-507295-40 type: EUDRACT_NUMBER briefTitle: Clarithromycin Treatment to Prevent Sepsis Progression in CAP (REACT) acronym: REACT overallStatus: RECRUITING date: 2024-02-12 date: 2025-11-05 date: 2026-01-30 date: 2024-03-05 date: 2024-04-25 name: Hellenic Institute for the Study of Sepsis class: OTHER briefSummary: The primary objective of the REACT randomized clinical trial (RCT) is to optimize the clinical benefit from adjunctive clarithromycin treatment shown in the ACCESS trial and to provide evidence for the clinical benefit of early start of adjunctive oral clarithromycin guided by suPAR to prevent the progression into sepsis in patients with community-acquired pneumonia (CAP) at risk. This can be achieved by endpoints incorporating clinical benefit with the effect of treatment on the improvement of the immune dysregulation of CAP. The secondary objectives of REACT are to investigate the impact of early adjunctive treatment with clarithromycin on the resolution of CAP at the test-of-cure (TOC) visit. conditions: Community-acquired Pneumonia studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This is a prospective, 1:1 randomized, double-blind, placebo-controlled trial primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 330 type: ESTIMATED name: Clarithromycin 500mg name: Tablets measure: Change of baseline respiratory symptoms score measure: Change of baseline total sequential organ failure assessment (SOFA) score measure: Change of baseline on both plasma PCT and plasma IL-10 or IL-8 to IL-10 ratio measure: The number of patients that succeeded the resolution of CAP at the test of cure (TOC) visit. measure: Need for up-escalation of the SoC administered antibiotics. measure: Survival measure: Change of baseline sequential organ failure assessment (SOFA) score measure: Change of baseline on both plasma PCT and plasma IL-10 or IL-8 to IL-10 ratio measure: Cytokine production measure: 28-Day Mortality measure: 90-Day Mortality measure: Cost sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: 1st Department of Internal Medicine - General Hospital of Athens "Sismanogleio-Amalia Fleming" status: NOT_YET_RECRUITING city: Athens country: Greece name: Nikolaos Tsokos, MD, PhD role: CONTACT phone: 6973388487 email: ntsokos@hotmail.com lat: 37.97945 lon: 23.71622 facility: 1st Department of Internal Medicine, AHEPA University General Hospital of Thessaloniki status: NOT_YET_RECRUITING city: Athens country: Greece name: Simeon Metallidis, MD, PhD role: CONTACT phone: 6944361931 email: metallidissimeon@yahoo.gr lat: 37.97945 lon: 23.71622 facility: 1st Department of Internal Medicine, EVANGELISMOS Athens General Hospital status: NOT_YET_RECRUITING city: Athens country: Greece name: Theano Kontopoulou, MD, PhD role: CONTACT phone: 6944690525 email: tkontopoulou@yahoo.gr lat: 37.97945 lon: 23.71622 facility: 1st Department of Internal Medicine, G. GENNIMATAS Athens General Hospital status: RECRUITING city: Athens country: Greece name: Georgios Adamis, MD, PhD role: CONTACT phone: 6937463999 email: geo.adamis@gmail.com lat: 37.97945 lon: 23.71622 facility: 1st Department of Internal Medicine, General University Hospital of Ioannina status: NOT_YET_RECRUITING city: Athens country: Greece name: Charalampos Milionis, MD, PhD role: CONTACT phone: 6944521512 email: hmilioni@uoi.gr lat: 37.97945 lon: 23.71622 facility: 1st Department of Internal Medicine, KORGIALENEIO-BENAKEIO E.E.S. Athens General Hospital status: RECRUITING city: Athens country: Greece name: Vassiliki Tzavara, MD, PhD role: CONTACT phone: 6944849808 phoneExt: 0030 email: vtzavara2015@gmail.com lat: 37.97945 lon: 23.71622 facility: 1st Department of Internal Medicine, THRIASIO General Hospital of Elefsis status: RECRUITING city: Athens country: Greece name: Styliani Sympardi, MD, PhD role: CONTACT phone: 6971863078 email: lianasympa@hotmail.com lat: 37.97945 lon: 23.71622 facility: 1st University Department of Pulmonary Medicine, SOTIRIA General Hospital of Chest Diseases of Athens status: RECRUITING city: Athens country: Greece name: Petros Bakakos, MD, PhD role: CONTACT phone: 6974748113‬ email: petros44@hotmail.com lat: 37.97945 lon: 23.71622 facility: 2nd Department of Internal Medicine, Attikon University Hospital status: NOT_YET_RECRUITING city: Athens country: Greece name: Eleni Mpoutati, MD, PhD role: CONTACT phone: 6932434399 phoneExt: 0030 email: eboutati@med.uoa.gr lat: 37.97945 lon: 23.71622 facility: 2nd Department of Internal Medicine, THRIASIO General Hospital of Elefsis status: NOT_YET_RECRUITING city: Athens country: Greece name: Zoi Alexiou, MD, PhD role: CONTACT phone: 6944820763 email: z_alexiou@yahoo.gr lat: 37.97945 lon: 23.71622 facility: 2nd Department of Internal Medicine, TZANEIO Piraeus General Hospital status: RECRUITING city: Athens country: Greece name: Georgios Chrysos, MD, PhD role: CONTACT phone: 6945432120 email: gchrysos@gmail.com lat: 37.97945 lon: 23.71622 facility: 2nd Department of Internal Medicine, University General Hospital of Alexandroupolis status: NOT_YET_RECRUITING city: Athens country: Greece name: Periklis Panagopoulos, MD, PhD role: CONTACT phone: 6944410495 email: ppanago@med.duth.gr lat: 37.97945 lon: 23.71622 facility: 3rd Department of Internal Medicine - General State Hospital of Nikaia "Saint Panteleimon" - West Attica General Hospital status: RECRUITING city: Athens country: Greece name: Ilias Skopelitis, MD, PhD role: CONTACT phone: 6944688196 email: iskopelitis@hotmail.com lat: 37.97945 lon: 23.71622 facility: 3rd Department of Internal Medicine, General Hospital of Athens KORGIALENEIO- BENAKEIO E.E.S. status: RECRUITING city: Athens country: Greece name: Maria Chini, MD, PhD role: CONTACT phone: 6944576476 email: mariachini@gmail.com lat: 37.97945 lon: 23.71622 facility: 3rd University Department of Internal Medicine, SOTIRIA Athens General Hospital of Chest Diseases status: RECRUITING city: Athens country: Greece name: Garyfallia Poulakou, MD, PhD role: CONTACT phone: 6945597583 email: gpoulakou@gmail.com lat: 37.97945 lon: 23.71622 facility: 4th Department of Internal Medicine, Attikon University Hospital status: RECRUITING city: Athens country: Greece name: Antonios Papadopoulos, MD, PhD role: CONTACT phone: 6977302400 phoneExt: 0030 email: antpapa1@otenet.gr lat: 37.97945 lon: 23.71622 facility: 6th Pulmonary Medicine Department, SOTIRIA General Hospital of Chest Diseases of Athens status: NOT_YET_RECRUITING city: Athens country: Greece name: Ioannis Dimitroulis, MD, PhD role: CONTACT phone: 6932666007 email: idimit@hotmail.com lat: 37.97945 lon: 23.71622 facility: Department of Chest Medicine, EVANGELISMOS Athens General Hospital status: NOT_YET_RECRUITING city: Athens country: Greece name: Paraskevi Katsaounou, MD, PhD role: CONTACT phone: 2132033384 phoneExt: 0030 email: paraskevikatsaounou@gmail.com lat: 37.97945 lon: 23.71622 facility: Department of Internal Medicine, Larissa University General Hospital status: NOT_YET_RECRUITING city: Athens country: Greece name: George Dalekos, MD, PhD role: CONTACT phone: 6937759699 email: georgedalekos@gmail.com lat: 37.97945 lon: 23.71622 facility: Department of Internal Medicine, Patras University General Hospital status: RECRUITING city: Athens country: Greece name: Karolina Akinosoglou, MD, PhD role: CONTACT phone: 6977762897 email: akin@upatras.gr lat: 37.97945 lon: 23.71622 facility: Department of Pulmonary Medicine, General Hospital of Kerkira status: NOT_YET_RECRUITING city: Athens country: Greece name: Ilias Papanikolaou, MD, PhD role: CONTACT phone: 6974305925 email: icpapanikolaou@hotmail.com lat: 37.97945 lon: 23.71622 facility: Emergency Department, TZANEIO Piraeus General Hospital status: RECRUITING city: Athens country: Greece name: Styliani Gerakari, MD, PhD role: CONTACT phone: 6973308684 email: sgerakari76@gmail.com lat: 37.97945 lon: 23.71622 hasResults: False
<\|newrecord\|> nctId: NCT06294587 id: IRB-300012407 briefTitle: Evaluation of Free Gingival Graft Timing overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2026-07 date: 2027-07 date: 2024-03-05 date: 2024-03-05 name: University of Alabama at Birmingham class: OTHER briefSummary: This clinical trial aims to compare and evaluate the clinical outcomes between two distinct treatment sequences: free gingival graft surgery preceding guided bone regeneration and guided bone regeneration followed by free gingival graft. conditions: Ridge Augmentation conditions: Alveolar Mucosa studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: FGG Before GBR name: FGG after GBR measure: Volumetric outcome assessment measure: Buccal soft tissue profile sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Unversity of Alabama at Birmingham, School of Dentistry city: Birmingham state: Alabama zip: 35294-0007 country: United States name: Hussein Basma, DDS, MS role: CONTACT phone: 205-975-2888 email: basma86@uab.edu name: Sarah Startley, DMD role: CONTACT phone: 205-975-8711 email: ss1971@uab.edu name: Hussein Basma, DDS, MS role: PRINCIPAL_INVESTIGATOR lat: 33.52066 lon: -86.80249 hasResults: False
<\|newrecord\|> nctId: NCT06294574 id: 300011943 briefTitle: Improved Successful Retrieval Rate of HydroMARK Plus Breast Biopsy Site Marker in Comparison to HydroMARK as Well as Improved Surgeon Satisfaction overallStatus: NOT_YET_RECRUITING date: 2024-12 date: 2026-12 date: 2026-12 date: 2024-03-05 date: 2024-03-29 name: University of Alabama at Birmingham class: OTHER name: Mammotome briefSummary: The purpose of the study is to test how successful the retrieval rate of the new HydroMARK Plus Breast Biopsy Site Marker in comparison to HydroMARK. conditions: Breast Neoplasm studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 150 type: ESTIMATED name: HydroMARK Plus Clip measure: Retrieval rate of the HydroMARK Plus clip. measure: Level of satisfaction of the surgeon with the retrieval of the HydroMARK Plus clip. sex: FEMALE minimumAge: 18 Years maximumAge: 90 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The Kirklin Clinic city: Birmingham state: Alabama zip: 35249 country: United States name: Quenteeria Mooney role: CONTACT phone: 205-996-1082 email: qmooney@uabmc.edu name: Ceren Yalniz, MD role: PRINCIPAL_INVESTIGATOR lat: 33.52066 lon: -86.80249 hasResults: False
<\|newrecord\|> nctId: NCT06294561 id: TGRX-326-1003 briefTitle: TGRX-326 Pharmacokinetic Drug Interaction overallStatus: RECRUITING date: 2024-03-04 date: 2024-04-30 date: 2024-06-30 date: 2024-03-05 date: 2024-03-08 name: Shenzhen TargetRx, Inc. class: INDUSTRY name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School briefSummary: This is a drug-drug interaction study for TGRX-326 to evaluate the effects of CYP3A inhibitor/inducer drugs on pharmacokinetic profiles of TGRX-326, an ALK inhibitor indicated for treatment of Non-small cell lung cancer. conditions: Non Small Cell Lung Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 32 type: ESTIMATED name: Itraconazole+TGRX-326 name: Efavirenz+TGRX-326 measure: Plasma Tmax measure: Plasma Cmax measure: Plasma AUC(0-t) measure: Plasma AUC(0-inf) measure: T1/2 measure: Plasma volume of distribution (Vz/F) measure: Plasma clearance (CL/F) measure: Adverse events/serious adverse events measure: Corrected QT Interval sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: Nanjing Drug Tower Hospital status: RECRUITING city: Nanjing state: Jiangsu zip: 210008 country: China name: Juan Li, MD role: CONTACT phone: +862583105910 email: juanli2003@163.com lat: 32.06167 lon: 118.77778 hasResults: False
<\|newrecord\|> nctId: NCT06294548 id: IRB-300012272 (UAB 23152) briefTitle: A Study of Valemetostat Tosylate (DS-3201b) With Atezolizumab and Bevacizumab in HCC overallStatus: NOT_YET_RECRUITING date: 2024-05-31 date: 2027-05-31 date: 2027-12-31 date: 2024-03-05 date: 2024-03-15 name: University of Alabama at Birmingham class: OTHER briefSummary: This is a phase Ib/II, dose escalation and dose expansion study of valemetostat (DS-3201) with atezolizumab and bevacizumab in patients advanced Hepatocellular carcinoma (HCC) who did not receive prior systemic therapy for advanced HCC. conditions: Hepatocellular Carcinoma studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 45 type: ESTIMATED name: Valemetostat name: Atezolizumab name: Bevacizumab measure: Phase 1b measure: Phase II measure: Safety and pharmacokinetics (PK) measure: Progression free survival (PFS) measure: Overall survival (OS) measure: Duration of response (DoR) measure: Disease Control Rate (DCR) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Alabama at Birmingham city: Birmingham state: Alabama zip: 35294 country: United States name: Margaret Thomas, MPH role: CONTACT email: margaretannthomas@uabmc.edu name: Mehmet S Akce, MD role: PRINCIPAL_INVESTIGATOR lat: 33.52066 lon: -86.80249 hasResults: False
<\|newrecord\|> nctId: NCT06294535 id: 2024 briefTitle: The Accuracy of Reconstruction of Orbital Walls Fracture Using Prebent Mesh Versus Patient Specific Implant overallStatus: ENROLLING_BY_INVITATION date: 2023-12-11 date: 2024-05-18 date: 2024-06-06 date: 2024-03-05 date: 2024-03-19 name: Tanta University class: OTHER briefSummary: under GA, incision to access to orbital walls. Then insertion of prebent titanium mesh or customized titanium implant and fixation with miniscrews, examination of ocular motility using forced duction test followed by closure of flap. conditions: Orbital Fractures studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE maskingDescription: patient select randomly from closed label whoMasked: PARTICIPANT count: 20 type: ESTIMATED name: reconstruction of orbital walls measure: restoring the accurate position of eye measure: motility of eye measure: volume of orbit sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Faculty of Dentistry, Tanta University city: Tanta zip: 3111 country: Egypt lat: 30.78847 lon: 31.00192 hasResults: False
<\|newrecord\|> nctId: NCT06294522 id: 1984 briefTitle: Reconstruction of Nasal Floor for Three-dimensional Repair of Alveolar Cleft overallStatus: COMPLETED date: 2023-07-20 date: 2024-01-06 date: 2024-02-16 date: 2024-03-05 date: 2024-03-19 name: Tanta University class: OTHER briefSummary: reconstruction of alveolar cleft with autogenous bone after elevation of mucoperiosteal flap and suturing of nasal floor and palatal flap conditions: Alveolar Cleft studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 16 type: ACTUAL name: reconstruction of alveolar cleft measure: recurrence of oronasal fistula measure: volume of alveolar cleft after reconstruction measure: density of bone sex: ALL minimumAge: 9 Years maximumAge: 18 Years stdAges: CHILD stdAges: ADULT facility: Faculty of Dentistry, Tanta University city: Tanta zip: 3111 country: Egypt lat: 30.78847 lon: 31.00192 hasResults: False
<\|newrecord\|> nctId: NCT06294509 id: SMTaVNS 2024 id: 2024-00039 type: REGISTRY domain: BASEC briefTitle: taVNS Application Timing During Robotic Sensorimotor Task acronym: SMTaVNS2024 overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2025-01-01 date: 2025-04-01 date: 2024-03-05 date: 2024-03-08 name: Olivier Lambercy class: OTHER briefSummary: The goal of this clinical trial is to evaluate the feasibility and effectiveness of transcutaneous auricular vagus nerve stimulation (taVNS) in enhancing sensorimotor learning and adaptation. This study will focus on healthy individuals performing a robotic sensorimotor task.
Main Questions it Aims to Answer:
How does taVNS, with different timing protocols, affect the feasibility and effectiveness of performing a robotic sensorimotor task? What is the impact of taVNS on sensorimotor learning and adaptation?
Participants Will:
Be pseudo-randomly assigned to one of five experimental groups with different taVNS stimulation timings.
Perform a sensorimotor task multiple times across sessions, spanning a maximum of two weeks or until achieving 70% accuracy in two successive sessions.
Have kinematic data collected by a robot during the task. Have physiological data measured using external sensors. Fill out questionnaires about the feasibility of taVNS and other subjective measures after each session.
Comparison Group:
Researchers will compare the four experimental groups to each other to see if different taVNS stimulation timings affect sensorimotor learning outcomes, as well as to a control group that will receive no stimulation. conditions: Healthy studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Single-blinded, pseudo-randomised, exploratory, single-centre, national, longitudinal study primaryPurpose: BASIC_SCIENCE masking: SINGLE whoMasked: PARTICIPANT count: 75 type: ESTIMATED name: in-house developed transcutaneous auricular Vagus Nerve Stimulation device measure: Subjectively perceived tolerance of taVNS and perceived difficulty of motor task measure: Success of the sensorimotor challenge measure: Mean Change from Baseline in Galvanic Skin Response (GSR) measure: Mean Change from Baseline in Heart Rate (HR) measure: Mean Change from Baseline in Pupil Diameter (PD) measure: Mean Change from Baseline in electroencephalogram (EEG) measure: Subjectively perceived positive effects of taVNS on motor performance measure: Change of movement parameters from baseline measure: Associations between outcomes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06294496 id: 2023YFS0274 briefTitle: Study of Carotid Artery Stenosis Through the Integration of Multimodal Imaging and Computational Fluid Dynamics overallStatus: RECRUITING date: 2023-06-01 date: 2024-12-31 date: 2024-12-31 date: 2024-03-05 date: 2024-03-05 name: Sichuan Provincial People's Hospital class: OTHER briefSummary: Ischemic stroke affects 2.5 to 3 million people annually in China, ranking as the leading cause of death and disability. Cervical artery stenosis is a significant contributor to this problem, with about 50% of patients experiencing cognitive impairment due to reduced cerebral blood flow. Two main surgical approaches, carotid endarterectomy (CEA) and carotid artery stenting (CAS), are used to treat severe cervical artery stenosis, but their effects on various factors remain unclear.
This project collects multimodal imaging data, including CT perfusion and angiography, to create 3D models of cervical artery stenosis. Computational fluid dynamics and AI analysis are used to assess hemodynamics. By monitoring blood flow, oxygen levels, and evaluating postoperative outcomes, the goal is to tailor surgical approaches for better patient outcomes and improved quality of life. conditions: Carotid Stenosis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: CEA/CAS measure: Perioperative cardio-cerebrovascular adverse events measure: Compute fluid dynamics parameters measure: Clinical outcome sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sichuan Provincial People's Hospital status: RECRUITING city: Chengdu state: Sichuan zip: 610072 country: China name: Li Xiong, Master role: CONTACT phone: 028-87393020 email: lcl1206778081@163.com name: Chaoqun Zeng, Ph.D. role: SUB_INVESTIGATOR lat: 30.66667 lon: 104.06667 hasResults: False
<\|newrecord\|> nctId: NCT06294483 id: Soh-Med-24-01-09MS briefTitle: Comparison Between Early-onset and Late-onset Patients With Systemic Lupus Erythematosus. overallStatus: ENROLLING_BY_INVITATION date: 2024-01-10 date: 2024-07-30 date: 2024-08-30 date: 2024-03-05 date: 2024-03-05 name: Sohag University class: OTHER briefSummary: The present study aims to:
Compare clinical features, hematological indices and disease activity between the early-onset and late-onset patients with systemic lupus erythematosus.
Evaluate the relationship between hematological indices (mean platelet volume, platelet lymphocyte ratio and neutrophil lymphocyte ratio) and Systemic lupus erythematosus (SLE) disease manifestations and activity. conditions: Systemic Lupus Erythematosus studyType: OBSERVATIONAL observationalModel: CASE_CROSSOVER timePerspective: CROSS_SECTIONAL count: 100 type: ESTIMATED name: CBC name: Antinuclear Antibody tests (ANA) name: Rest of ANA profile name: C3 and C4 complement level. name: Anti phospholipid marker name: Serum creatinine and Alb/create ratio name: 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus. name: SLEDAI scores measure: Evaluate the hematological indices as (mean platelet volume) of our SLE patient. measure: Evaluate the hematological indices as (neutrophil lymphocyte ratio) of our SLE patient. measure: Evaluate the hematological indices ( platelet lymphocyte ratio ) of our SLE patient. measure: Compare the degree of disease activity between the early-onset and late-onset patients with systemic lupus erythematosus. measure: Evaluate the correlation between hematological indices (mean platelet volume, platelet lymphocyte ratio and neutrophil lymphocyte ratio) and Systemic lupus erythematosus (SLE) disease manifestations and activity. sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Sohag university hospital city: Sohag country: Egypt lat: 26.55695 lon: 31.69478 hasResults: False

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