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Participants will complete self-report questionnaires, complete eye-tracking tasks, and be clinically assessed through interviews by clinician researchers.
If there is a comparison group: Researchers will compare sham, traditional, and gamified treatment groups to see if they moderate symptoms of depression. conditions: Depression studyType: INTERVENTIONAL phases: EARLY_PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 600 type: ESTIMATED name: Traditional Attention Bias Modification name: Gamified Attention Bias Modification name: Sham Attention Bias Modification measure: QIDS (Quick Inventory of Depression Symptoms) SR-16 measure: Sheehan Disability Scale (SDS) measure: Snaith-Hamilton Pleasure Scale (SHAPS) measure: Hamilton Depression Rating Scale (HAM-D) measure: Generalized Anxiety Disorder (GAD-7) measure: Perseverative Thinking Questionnaire (PTQ) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Institute for Mental Health Research city: Austin state: Texas zip: 78705 country: United States name: Christopher G Beevers, PhD role: CONTACT email: beevers@utexas.edu role: CONTACT email: beevers@utexas.edu lat: 30.26715 lon: -97.74306 typeAbbrev: ICF hasProtocol: False hasSap: False hasIcf: True label: Informed Consent Form date: 2024-04-05 uploadDate: 2024-04-08T12:13 filename: ICF_000.pdf size: 143608 hasResults: False
<\|newrecord\|> nctId: NCT06361082 id: CORPG5N0061 briefTitle: Ultrasonic Backscatter Imaging for ACL Reconstruction and Shoulder Diseases overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-10 date: 2025-10 date: 2024-04-11 date: 2024-04-11 name: Chang Gung Memorial Hospital class: OTHER briefSummary: This study explores ultrasonic scattering imaging technology in patients undergoing anterior cruciate ligament (ACL) reconstruction and those with shoulder musculoskeletal disorders. Ultrasonography, widely utilized for diagnosing musculoskeletal conditions, faces limitations due to factors like operator experience and equipment settings, often lacking in quantifiable disease metrics. Nakagami imaging, employing the backscattering statistical distribution model, offers a quantitative assessment method that minimizes subjective interpretation by extracting tissue properties through the interaction between ultrasound and tissue microstructure. The Nakagami model effectively describes tissue scattering statistics, enabling the identification and classification of tissue features based on specific scattering conditions.
ACL reconstruction is commonly performed, with postoperative complications including joint stiffness and muscle strength decline, associated with changes in muscle quality and volume. Similarly, soft tissue injuries around the shoulder and ankle are prevalent in sports medicine, with ultrasound used to assess the severity of injuries to soft tissues such as the rotator cuff tendons/muscles and surrounding ligaments of the shoulder, as well as the medial and lateral ligament complexes of the ankle. Preliminary findings suggest that Nakagami imaging can differentiate layers within normal tendons, proposing its potential for visualizing and quantifying soft tissue lesions post-ultrasound, aiming for standardized diagnostic criteria.
The results of this project could significantly improve the diagnostic efficacy of musculoskeletal ultrasound, facilitating earlier treatment and reducing the socio-economic impacts. Academically, it positions the investigating team as pioneers in the application of ultrasound inverse scattering imaging technology. conditions: ACL Injury conditions: ACL Reconstruction studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: ACL reconstruction measure: MRI of affected limb- Cross sectional area measured in squared cm of quadriceps muscles measure: Ultrasound Nakagami back scattering analysis- Nakagami index measure: Physical examination of limbs- Angles of Range of Motion of knee measure: MRI of affected limb- Quality of knee structures documented with descriptions for MR signals measure: Physical examination of limbs- Laxity of knee ligaments of subjects number with any positive knee physical findings measure: Ultrasound of affected limb- Cross sectional area measured in squared cm of quadriceps muscles measure: Ultrasound of affected limb- Quality of knee structures documented with descriptions for echogenicity sex: ALL minimumAge: 20 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06361069 id: aslıakdeniz briefTitle: Reducing Anxiety in Children Undergoing Day Surgery overallStatus: COMPLETED date: 2023-04-01 date: 2023-08-01 date: 2024-01-01 date: 2024-04-11 date: 2024-04-11 name: Bilecik Seyh Edebali Universitesi class: OTHER briefSummary: Aim: This study was conducted to determine the efﬁcacy of finger puppets, distraction cards and kaleidoscope for reducing anxiety in children undergoing day surgery.
Methods: The study was conducted using the "pre-post test unmatched group model", one of the quasi-experimental methods. The study was conducted between April 2023 and January 2024 with children aged 6-12 years who were admitted to the pediatric clinic of a hospital for day surgery. A total of 85 children (including 20 children in the control group, 22 children in the finger puppet intervention group, 21 children in the distraction cards intervention group, and 22 children in the kaleidoscope intervention group) who were hospitalized in the pediatric clinic between April 2023 and January 2024 and who met the inclusion criteria were included in the study. Descriptive statistics, Mann Whitney U test, Kruskal Wallis and regression analysis were used in the evaluation of the data. conditions: Anxiety conditions: Child, Only conditions: Surgery studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The study was conducted using the "pre-post test unpaired group model", one of the quasi-experimental methods. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 85 type: ACTUAL name: distraction cards, kaleidoscope and finger puppet measure: Anxiety sex: ALL minimumAge: 6 Years maximumAge: 12 Years stdAges: CHILD facility: Bilecik Şeyh Edebali University city: Bilecik country: Turkey lat: 40.14192 lon: 29.97932 hasResults: False
<\|newrecord\|> nctId: NCT06361056 id: LCCC2140 briefTitle: Mobile Health App to Promote Participation of Black Women in Breast Cancer Clinical Trials overallStatus: RECRUITING date: 2022-05-02 date: 2025-01 date: 2026-01 date: 2024-04-11 date: 2024-04-17 name: UNC Lineberger Comprehensive Cancer Center class: OTHER briefSummary: This study explores the overall feasibility, impact, and satisfaction of using the "mHealth app" on clinic workflow for Black or African American women diagnosed with breast cancer.
The "mHealth app" which can be used as a platform to share clinical trial education and communication, was created and tested in previous steps of this study. conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 80 type: ESTIMATED name: Survey name: mHealth app measure: Feasibility of Mobile Health Application (mHealth app)- subjects measure: Feasibility of Mobile Health Application (mHealth app) - Clinicians and staff measure: Overall satisfaction sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: UNC Lineberger Comprehensive Cancer Center status: RECRUITING city: Chapel Hill state: North Carolina zip: 27514 country: United States name: Lauren Matthews role: CONTACT phone: 919-843-5321 email: lauren_matthews@med.unc.edu name: Marjory Charlot, MD, MPH, MSc role: PRINCIPAL_INVESTIGATOR lat: 35.9132 lon: -79.05584 hasResults: False
<\|newrecord\|> nctId: NCT06361043 id: 2023-01833 briefTitle: Conebeam CT-based Online Adaptive Radio-Therapy for Esophageal Cancer (ARTEC) acronym: ARTEC overallStatus: RECRUITING date: 2024-04-20 date: 2027-02-28 date: 2027-02-28 date: 2024-04-11 date: 2024-04-25 name: Insel Gruppe AG, University Hospital Bern class: OTHER briefSummary: Despite multimodal therapy, patients with esophageal cancer have poor prognosis with 5-year overall survival around 25%. Considering tumor-related death as main reason for high mortality rate in those patients, treatment-related cardio-pulmonary toxicities could also play a role in this regard. Online adaptive radiotherapy offers the possibility for daily re-planning and therefore helps radiation oncologists to better spare the organs at risk and reduce radiation-induced toxicity. Tha aim of ARTEC is to assess the pulmonary toxicity in patients with esophageal cancer treated with online adaptive radiotherapy. conditions: Esophageal Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 30 type: ESTIMATED measure: Number of patients with pulmonary toxicity measure: Number of patients with pathological complete response measure: Dosimetrical analysis between scheduled and adaptive plans sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Inselspital, University of Berne, Deparftment of Radio-Oncology status: RECRUITING city: Berne zip: 3010 country: Switzerland name: Hossein Hammatazad, MD role: CONTACT phone: +41 31 632 26 32 email: hossein.hemmatazad@insel.ch name: Timo Nannen role: CONTACT phone: +41 31 632 90 74 email: timo.nannen@insel.ch lat: 46.94809 lon: 7.44744 hasResults: False
<\|newrecord\|> nctId: NCT06361030 id: HMPL-012-C2-PC01 briefTitle: Surufatinib Combined With Gemcitabine Plus Nab-paclitaxel in Locally Advanced Pancreatic Cancer overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2026-06-01 date: 2027-06-01 date: 2024-04-11 date: 2024-04-11 name: Wuhan Union Hospital, China class: OTHER briefSummary: To evaluate the efficacy and safety of surufatinib combined with gemcitabine plus nab-paclitaxel in patients with locally advance d pancreatic cancer conditions: Pancreatic Cancer conditions: Pancreatic Cancer Non-resectable conditions: Pancreatic Ductal Adenocarcinoma, PDAC studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 40 type: ESTIMATED name: surufatinib combined with gemcitabine plus nab-paclitaxel measure: Surgical conversion rate measure: Objective Response Rate (ORR) measure: Disease control rate (DCR) measure: R0 surgical conversion rate measure: progression free survival(PFS) measure: Overall Survival (OS) measure: Adverse Event sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology city: Wuhan state: Hubei zip: 430000 country: China name: Heshui Wu role: CONTACT phone: +86 137-2011-7761 email: heshuiwu@hust.edu.cn name: Heshui Wu role: PRINCIPAL_INVESTIGATOR lat: 30.58333 lon: 114.26667 hasResults: False
<\|newrecord\|> nctId: NCT06361017 id: QNPY2022007 briefTitle: The Prediction of Hemorrhage Transformation by Cerebral Autoregulation in AIS Patient After Endovascular Thrombectomy acronym: PHASE overallStatus: ENROLLING_BY_INVITATION date: 2022-03-01 date: 2025-03-01 date: 2026-03-01 date: 2024-04-11 date: 2024-04-11 name: Xuanwu Hospital, Beijing class: OTHER briefSummary: This observational study was designed for observe the cerebral hemodynamics and dynamic cerebral autoregulation (dCA) after endovascular thrombectomy (EVT) in acute ischemic stroke (AIS) patients. And analysis the relationship between the dCA damage degree and hemorrhage transformation (HT) and clinical outcome.
Patients: patients with AIS caused by middle cerebral artery or internal carotid artery occlusion who accepted EVT.
dCA Examination: dCA examinations were performed at 24 hours, 48 hours, 72 hours, and 5 days after EVT.
The objectives of the study were as follows: The changes of cerebral hemodynamics and parameters of dCA in different time periods after EVT were analyzed. So as to determine the correlation between hemodynamics and dCA change and HT and clinical outcome after EVT and to explore the predictors of HT and adverse clinical outcomes. conditions: Acute Ischemic Stroke conditions: Endovascular Thrombectomy conditions: Dynamic Cerebral Autoregulation studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 300 type: ESTIMATED name: endovascular thrombectomy measure: The occurrence of hemorrhage transformation measure: Patients without hemorrhage transformation measure: The occurrence of unfavorable outcome measure: The occurrence of favorable outcome measure: The occurrence of long-term unfavorable outcome measure: The occurrence of long-term favorable outcome sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Department of Vascular Ultrasonography, Xuanwu Hospital of Capital Medical University city: Beijing state: Beijing zip: 100053 country: China lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06361004 id: DBS for TR-TS briefTitle: Exploring DBS Efficacy in Treatment-refractory Tourette's Syndrome overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2028-12-31 date: 2029-12-31 date: 2024-04-11 date: 2024-04-11 name: Xuanwu Hospital, Beijing class: OTHER briefSummary: The primary purpose of this study is to investigate the effect of deep brain stimulation (DBS) in patients with Treatment-refractory Tourette's syndrome (TR-TS) implantation targeting the Antero-medial globus pallidus interna (GPi), Antero-medial globus pallidus interna (amGPi), Postero-ventrolateral GPi (pvGPi), Centromedian nucleus, substantia periventricularis and nucleus ventro-oralis internus (Cm-Spv-Voi), Centre median nucleus and nucleus ventro-oralis (Cm-Voi), or Nucleus Accumbens/ Anterior Limb of Internal Capsule (NA-ALIC), or other unreported nuclei targets. conditions: Tourette's Syndrome studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Patients with Treatment-refractory Tourette's syndrome (TR-TS) primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Deep Brain Stimulation (DBS) measure: Yale Global Tic Severity Scale (YGTSS): Reduction in total tics on the YGTSS after 6 months measure: YGTSS-Total Motor: Change in YGTSS-Total Motor at week 2, month 3, month 6, and month 12. measure: YGTSS-Total Phonic: Change in YGTSS-Total phonic at week 2, month 3, month 6, and month 12. measure: YGTSS: remission, and response rate measure: Yale-Brown Obsessive Compulsive Scale (Y-BOCS): Change in Y-BOCS at week 2, month 3, month 6, and month 12. measure: Hamilton Anxiety Scale (HAMA): the change from baseline to 2 weeks, 3 months, 6 months, and 12 months in the HAMA total score. measure: Hamilton Depression Rating Scale (HAMD-17): the changes of HAMD-17 scores and its subscales from baseline to 2 weeks, 3 months, 6 months, and 12 months. measure: Pittsburgh Sleep Quality Index (PSQI): the change of PSQI from baseline to Week 2, Month 3, Month 6, and Month 12. measure: Clinical Global Impression-Severity (CGI-S): the change from baseline to 2 weeks, 3 months, 6 months, and 12 months in Clinical Global Impression-Severity (CGI-S) measure: Clinical Global Impression-Improvement (CGI-I): CGI-I score at Week 2, Month 1, Month 3, Month 6, and Month 12. measure: EuroQol-5 Dimension-level Scale (EQ-5D-5L): the change from baseline to Week 2, Month 3, Month 6, and Month 12 in EQ-5D-5L. measure: Young Mania Rating Scale (YMRS): the change from baseline to Week 2, Month 1, Month 3, Month 6, and Month 12. measure: Safety as indicated by the number of Adverse Events: Week 2, Month 3, Month 6, and Month 12. measure: Change from baseline in the Verbal Fluency Test (COWAT) measure: Change from baseline in the Trailmaking Test A&B measure: Change in Rey-Osterrieth Complex Figure Test sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xuanwu Hospital, Capital Medical University city: Beijing zip: 100053 country: China lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06360991 id: DBS for TR-OCD briefTitle: DBS for Treatment-resistant Obsessive-compulsive Disorder overallStatus: NOT_YET_RECRUITING date: 2024-04-20 date: 2028-12-31 date: 2029-12-31 date: 2024-04-11 date: 2024-04-11 name: Xuanwu Hospital, Beijing class: OTHER briefSummary: The primary purpose of this study is to investigate the effect of deep brain stimulation (DBS) implantation targeting the anteromedial region of subthalamic nucleus (amSTN), or nucleus accumbens (NAc), or bed nucleus of the stria terminalis (BNST), or ventral capsule/ventral striatum (VC/VS), or the ventral anterior limb of the internal capsule (vALIC) in patients with treatment-resistant obsessive-compulsive disorder (TR-OCD). conditions: Obsessive-Compulsive Disorder (OCD) studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Deep brain stimulation (DBS) measure: Yale-Brown Obsessive Compulsive Scale (Y-BOCS): the change from baseline to 1 year in the Y-BOCS total score. measure: Yale-Brown Obsessive Compulsive Scale (Y-BOCS): remission, response, and partial response rate measure: Hamilton Anxiety Scale (HAMA): the change from baseline to 2 weeks, 1 month, 3 months, 6 months, and 1 year in the HAMA total score. measure: Hamilton Depression Rating Scale (HAMD-17): the changes of HAMD-17 scores and its subscales from baseline to 2 weeks, 1 month, 3 months, 6 months, and 1 year. measure: Pittsburgh Sleep Quality Index (PSQI): the change of PSQI from baseline to Week 2, Month 1, Month 3, Month 6, and Month 1. measure: Clinical Global Impression-Severity (CGI-S): the change from baseline to 2 weeks, 1 month, 3 months, 6 months, and 1 year in Clinical Global Impression-Severity (CGI-S) measure: Clinical Global Impression-Improvement (CGI-I): CGI-I score at Week 2, Month 1, Month 3, Month 6, and Month 12. measure: EuroQol-5 Dimension-level Scale (EQ-5D-5L): the change from baseline to Week 2, Month 1, Month 3, Month 6, and Month 12 in EQ-5D-5L. measure: Young Mania Rating Scale (YMRS): the change from baseline to Week 2, Month 1, Month 3, Month 6, and Month 12. measure: Safety as indicated by the number of Adverse Events Week 2, Month 1, Month 3, Month 6, and Month 12. sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Xuanwu Hospital, Capital Medical University city: Beijing zip: 100053 country: China lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06360978 id: docetaxel as a radiosenstizer briefTitle: Efficacy and Toxicity of Docetaxel as a Radiosenstizer in Head and Neck Cancer overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2025-06 date: 2027-06 date: 2024-04-11 date: 2024-04-11 name: Assiut University class: OTHER briefSummary: Head and neck cancer (HNC) is the seventh most common cancer globally, accounting for more than 660,000 new cases and 325,000 deaths annually. The overall incidence of HNC continues to rise, with a predicted 30% increase annually by 2030., this increase has been recorded across both developed and developing countries.
Approximately 90% of HNCs are squamous cell carcinoma . The major risk factors of head and neck squamous cell carcinoma (HNSCC) are tobacco and heavy alcohol use and human papillomavirus infection . There has been a significant decline in smoking in high-income countries during the last few decades, which has led to a sharp decline in smoking related HNSCC . While increase in global incidence of human papillomavirus (HPV)-associated or positive (+) HNSCC Head and neck squamous cell carcinoma (HNSCC) is a highly challenging cancer, despite the advancements in treatment, the overall prognosis for HNSCC remains poor, with a five-year survival rate of around 50%.
Chemoradiation is one of the treatment options for locally advanced head and neck cancers, the drug of choice for radiosensitization is cisplatin Although cisplatin-based chemoradiotherapy (CRT) is the standard of care for locally advanced head and neck squamous cell carcinoma (LAHNSCC), cisplatin is contraindicated in many patients because of age, diminished renal functions and hearing loss so docetaxel studied as an alternative radiosensitizer in this group.
The addition of docetaxel to radiation improved DFS and OS in cisplatin-ineligible patients with LAHNSCC. conditions: Head and Neck Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 30 type: ESTIMATED name: Docetaxel measure: progression free survival measure: incidence of treatment adverse events measure: Overall survival (OS) sex: ALL minimumAge: 19 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06360965 id: Shoufa2024-3-7045 briefTitle: Clinical Trial of Acupoint Application in Improving the Sequelae of Pelvic Inflammatory Disease and Chronic Pelvic Pain overallStatus: RECRUITING date: 2024-01-01 date: 2026-03-31 date: 2026-12-31 date: 2024-04-11 date: 2024-04-11 name: Beijing Hospital of Integrated Traditional Chinese and Western Medicine class: OTHER briefSummary: Chronic Pelvic Pain is one of the common gynecological symptoms, characterized by persistent and non periodic pain in the pelvic cavity and surrounding tissues. It is often seen as a sequelae of pelvic inflammatory diseases caused by the failure to receive timely and correct treatment. This study compares the effectiveness of warm meridians and relieve pain plaster in relieving the sequelae of pelvic inflammatory disease and chronic pelvic pain symptoms, and evaluates the safety of improved patches and traditional patches, further promoting it to community grassroots hospitals. conditions: Pelvic Inflammatory Disease conditions: Chronic Pelvic Pain Syndrome studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: OUTCOMES_ASSESSOR count: 102 type: ESTIMATED name: Improved warm meridians and relieve pain plaster name: Traditional warm meridians and relieve pain plaster name: Placebo plaster measure: Main symptoms (lower abdominal pain) improvement level (visual analogue scale) measure: TCM syndrome score scale measure: Local physical sign rating scale measure: Pelvic masses and fluid accumulation measure: EuroQol Five Dimensions Questionnaire measure: Recurrence of abdominal pain during 1-month menstrual cycle was followed up. sex: FEMALE minimumAge: 18 Years maximumAge: 50 Years stdAges: ADULT facility: Beijing Hospital of Integrated Traditional Chinese and Western Medicine status: RECRUITING city: Beijing country: China name: YuNa Liu role: CONTACT phone: 86-010-88223667 email: kjk882236672@163.com lat: 39.9075 lon: 116.39723 hasResults: False
<\|newrecord\|> nctId: NCT06360952 id: T23-03 briefTitle: A Comparator Study of a Tasso Device Blood Sample to Traditional Venous Blood Sample for CBC overallStatus: NOT_YET_RECRUITING date: 2024-04-30 date: 2024-07-30 date: 2024-07-30 date: 2024-04-11 date: 2024-04-26 name: Tasso Inc. class: INDUSTRY name: The Leukemia and Lymphoma Society briefSummary: This study will evaluate the feasibility of using capillary blood samples collected with the Tasso device for analysis of CBC in diseased patients with leukemia, lymphoma, and/or other blood cell disorders.
This investigation will include a minimum of 40 sample sets from unique patients. conditions: Leukopenia conditions: Leukocytosis conditions: Neutropenia studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 40 type: ESTIMATED name: Tasso+ CBC measure: Agreement between capillary and venous blood in the measurement of White Blood Cells and Absolute Neutrophil Count measure: Agreement between capillary and venous blood in the measurement of secondary biomarkers measure: Patient acceptance of Tasso device sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lineberger Comprehensive Cancer Center city: Chapel Hill state: North Carolina zip: 27599 country: United States lat: 35.9132 lon: -79.05584 hasResults: False
<\|newrecord\|> nctId: NCT06360939 id: ETH02659 briefTitle: Radiotherapy vs Catheter Ablation for Ventricular Tachycardia in Structural Heart Disease acronym: Radioablate overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2026-04-15 date: 2027-04-15 date: 2024-04-11 date: 2024-04-11 name: Western Sydney Local Health District class: OTHER name: University of Sydney name: National Heart Foundation, Australia briefSummary: The goal of this randomized clinical trial is to test the efficacy of stereotactic body radiation therapy (SBRT) in treating ventricular tachycardia (VT) in patients with advanced structural heart disease. The main questions it aims to answer are:
* What is the efficacy of SBRT compared to catheter ablation (CA) in achieving a ≥ 75% reduction in VT burden at 6 months
* What is the comparable safety profile of SBRT vs CA Researchers will compare SBRT and CA (standard of care). conditions: Ventricular Tachycardia conditions: Cardiomyopathies conditions: Arrhythmias, Cardiac conditions: Ventricular Arrythmia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 60 type: ESTIMATED name: SBRT name: CA measure: VT burden measure: Recurrent sustained VT measure: VT storm measure: Absolute VT burden measure: Serious Adverse Events (SAE) and Adverse Events of Special Interest (AESI) measure: ICD shocks measure: Hospitalization measure: All cause mortality measure: Cardiovascular Mortality measure: Composite outcome of VT recurrence/hospitalisation/death/ cardiac transplantation measure: Ventricular function measure: Quality of Life as per Short Form - 36 (SF-36) Score measure: Quality of Life as per Implantable Cardioverter Defibrillator Concerns Questionnaire (ICDC) score measure: Number of AADs sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06360926 id: 2024-A00526-41 briefTitle: Improvement Image Quality for SuperSonic® MACH Ultrasound System acronym: MACH IQ overallStatus: NOT_YET_RECRUITING date: 2024-05 date: 2025-05 date: 2025-05 date: 2024-04-11 date: 2024-04-11 name: SuperSonic Imagine class: INDUSTRY briefSummary: The aim of this Study is to collect radiologist feedback to support the further development and improvement of the imaging modes implemented on the embedded software in the SuperSonic® Ultrasound System (including the probe). conditions: Diagnosis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: DIAGNOSTIC masking: NONE count: 100 type: ESTIMATED name: SuperSonic® Ultrasound System measure: Qualitative assessment of image quality sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06360913 id: 2023/09AOU/346 briefTitle: Blood Spot and Urine Metabolomic Screening Applied to Rare Diseases acronym: BUSARD overallStatus: RECRUITING date: 2024-01-03 date: 2028-01 date: 2028-01 date: 2024-04-11 date: 2024-04-12 name: Cliniques universitaires Saint-Luc- Université Catholique de Louvain class: OTHER briefSummary: The primary goal of this study is to establish a biobank of dried blood spots and urines from a large control cohort and collect several cohorts as large as possible of patients affected or suspected of being affected by rare diseases (mainly hereditary metabolic diseases) or by autism spectrum disorders.
A metabolomic database using a high-resolution mass spectrometer (i.e. the "Device") will be generated and specific biomarkers for the diseases will be confirmed or uncovered. The ultimate goal is to facilitate and improve the diagnosis and screening of the patients affected by these disorders, but also to improve the knowledge about the biochemical mechanisms involved over the course of the selected pathologies.
High-resolution mass spectrometry allows the measurement of thousands of metabolites in a single analysis. The current biochemical tests used for the diagnosis of hereditary metabolic diseases are only using a combination of maximum a few dozens of biomarkers in one analysis.
Objectives Unravel new biomarkers for diagnosis (+/- explore the altered pathways...) Uncover and/or validate newborn screening biomarkers through retrospective analysis of preserved newborn DBS from confirmed patients (useful for first or second tier biochemical NBS testing!) Validation of LC-MS qTOF for metabolomics screening as first line diagnostic test (thousands of metabolites) using diagnostic algorithms (modified z-scores) \& continuous optimization by adding new cases and new controls in the database Generation of a biobank of urines and DBS from rare diseases (IEMs) \& from a large reference population useful for other research applications conditions: Inborn Errors of Metabolism conditions: Rare Diseases studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: 3 groups:
1. Control subjects
2. Confirmed patients (rare diseases)
3. Suspected patients (rare diseases) primaryPurpose: DIAGNOSTIC masking: NONE count: 2286 type: ESTIMATED name: High resolution mass spectrometry measure: Uncover new biomarkers in dried blood spots and urines samples able to improve the diagnosis of rare diseases sex: ALL minimumAge: 1 Day maximumAge: 99 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Hôpital Universitaire des enfants Reine Fabiola (HUDERF-ULB) status: NOT_YET_RECRUITING city: Brussels zip: B-1020 country: Belgium name: Lionel Marcélis, MSc, Ph.D. role: PRINCIPAL_INVESTIGATOR name: Aurélie Empain, M.D., Ph.D. role: PRINCIPAL_INVESTIGATOR name: Corinne De Laet, M.D., Ph.D. role: SUB_INVESTIGATOR name: Ebru Surgun, M.D. role: SUB_INVESTIGATOR name: Céline Morelli, M.D. role: SUB_INVESTIGATOR lat: 50.85045 lon: 4.34878 facility: Cliniques universitaires Saint Luc status: RECRUITING city: Brussels zip: B-1200 country: Belgium name: Joseph P. Dewulf, M.D., Ph.D. role: PRINCIPAL_INVESTIGATOR name: Marie-Cécile Nassogne, M.D., Ph.D. role: PRINCIPAL_INVESTIGATOR name: Xavier Stephenne, M.D., Ph.D. role: SUB_INVESTIGATOR name: Nicole Revencu, M.D., Ph.D. role: SUB_INVESTIGATOR name: Stéphanie Paquay, M.D. role: SUB_INVESTIGATOR lat: 50.85045 lon: 4.34878 facility: Institut de Pathologie et de Génétique (IPG) status: NOT_YET_RECRUITING city: Charleroi zip: B-6041 country: Belgium name: Dominique Roland, M.D. role: PRINCIPAL_INVESTIGATOR name: Damien Lederer, M.D., Ph.D. role: SUB_INVESTIGATOR name: Isabelle Maystadt, M.D., Ph.D. role: SUB_INVESTIGATOR lat: 50.41136 lon: 4.44448 facility: CHU Liege status: NOT_YET_RECRUITING city: Liège zip: B-4000 country: Belgium name: François-Guillaume Debray, MD PhD role: PRINCIPAL_INVESTIGATOR name: François Boemer, Pharm D PhD role: PRINCIPAL_INVESTIGATOR name: Caroline Dadoumont, MD role: SUB_INVESTIGATOR lat: 50.63373 lon: 5.56749 hasResults: False
<\|newrecord\|> nctId: NCT06360900 id: 2024P000849 briefTitle: Synergistic Gut-brain Axis Modulation Via Vagal Stimulation and Cognitive Behavioral Therapy in Functional Dyspepsia overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2029-03 date: 2029-03 date: 2024-04-11 date: 2024-04-11 name: Spaulding Rehabilitation Hospital class: OTHER briefSummary: The primary aims of this randomized, single-blinded, 2x2 sham-controlled trial are to 1) evaluate synergistic impact of 8-weeks of transcutaneous auricular vagus nerve stimulation (taVNS) + cognitive-behavioral therapy (CBT) on post-meal gut-brain communication; 2) determine the sequential relationship between treatment-associated changes in gastrointestinal-related anxiety and both clinical functional dyspepsia (FD) improvements and meal-induced physiological outcomes; 3) investigate whether post-treatment changes in gut-brain physiology mediate improvements in FD clinical outcomes. Using a fully non-invasive framework including gastric and brain magnetic resonance imaging (MRI) and taVNS, the investigators aim to evaluate the potential synergy of taVNS and CBT in FD, by assessing the gut-brain physiological response to prandial challenge, linking physiological with symptom improvements. conditions: Functional Dyspepsia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: FACTORIAL primaryPurpose: TREATMENT masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: taVNS name: CBT name: Education Control name: Sham taVNS measure: Nepean Dyspepsia Index (NDI) measure: Visceral Sensitivity Index (VSI) measure: Gastric peristaltic velocity sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06360887 id: DRKS00030614 briefTitle: Management of Proximal Humerus Fractures in Adults: a Clinical Trial overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-01-31 date: 2028-01-31 date: 2024-04-11 date: 2024-04-12 name: Regional Hospital of Bolzano class: OTHER briefSummary: Prospective patient registry examining the outcome of three different treatment methods for proximal humerus fractures in elderlies: conservative treatment, open and minimal invasive surgical treatment. conditions: Shoulder Fractures studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 351 type: ESTIMATED name: Conservative name: ORIF name: CRPP measure: Oxford Shoulder Score measure: The visual analogue scale measure: Rate of complications sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Academic Hospital of Bolzano (SABES-ASDAA) city: Bolzano state: Alto Adige zip: 39100 country: Italy name: Malte Nikolas Witte, Dr. role: CONTACT phone: 00393885787726 email: maltewitte@posteo.de lat: 46.49067 lon: 11.33982 hasResults: False
<\|newrecord\|> nctId: NCT06360874 id: ND003-I-06 briefTitle: A Study to Evaluate Safety, Tolerability and Pharmacokinetic of ND-003 Tablets in Healthy Adults overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2024-12 date: 2025-02 date: 2024-04-11 date: 2024-04-11 name: Shenzhen NewDEL Biotech, Co., Ltd class: INDUSTRY name: Shenzhen Innovation Center for Small Molecule Drug Discovery Co., Ltd. briefSummary: The purpose of this study is to evaluate Safety, Tolerability and Pharmacokinetic of ND-003 tablets in Healthy Adults conditions: Healthy studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE maskingDescription: Double-blind whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 104 type: ESTIMATED name: ND-003 40mg name: ND-003 placebo 40mg name: ND-003 80mg name: ND-003 placebo 80mg name: ND-003 160mg name: ND-003 placebo 160mg name: ND-003 240mg name: ND-003 placebo 240mg name: ND-003 300mg name: ND-003 placebo 300mg name: MAD_ND003_Dose 1 name: MAD_placebo_Dose 1 name: MAD_ND003_Dose 2 name: MAD_placebo_Dose 2 name: MAD_ND003_Dose 3 name: MAD_ placebo_Dose 3 name: Food effect_Cohort 1 name: Food effect_Cohort 2 measure: Adverse Events (AE) measure: maximum concentration (Cmax) measure: Time to maximum concentration (Tmax) measure: Elimination Half-life (t1/2) measure: Clearance (CLz/F) measure: AUC from time 0 to last time of quantifiable concentration (AUC0-t) sex: ALL minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT hasResults: False
<\|newrecord\|> nctId: NCT06360861 id: 1400-1-233-51589 id: IR.TUMS.MEDICINE.REC.1400.197 type: OTHER_GRANT domain: Tehran University of Medical Sciences briefTitle: Evaluate the Safety and Feasibility of Allogeneic Mesenchymal Stem Cells in Patients With Multiple Sclerosis acronym: MS overallStatus: COMPLETED date: 2019-07-23 date: 2024-03-04 date: 2024-03-06 date: 2024-04-11 date: 2024-04-11 name: Tehran University of Medical Sciences class: OTHER briefSummary: To assess the safety and of a single dose of IV infusion of placenta derived Mesenchymal Stem Cells (PLMSCs) in patients with secondary progressive Multiple Sclerosis (SPMS) disease.
Monitoring will be encompassed baseline assessments and follow-ups over subsequent months, evaluating clinical signs, Expanded Disability Status Scale (EDSS), cytokines, diffusion tensor imaging (DTI), functional MRI (fMRI), cognitive \& psychological evaluations, and flow cytometry for B cell markers. conditions: Multiple Sclerosis conditions: Secondary-Progressive Multiple Sclerosis conditions: Mesenchymal Stem Cells studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Open-label phase 1, single-center, pre-post comparison study primaryPurpose: TREATMENT masking: NONE count: 5 type: ACTUAL name: Allogenic placenta derived mesenchymal stem cells measure: Number of participants with Treatment-Emergent Adverse Events [Safety and Tolerability]. measure: Number of participants with a change in disability as measured by Expanded Disability Status Scale . measure: Number of participants with a change in cognitive function as measured by the Paced Auditory Serial Addition Test . measure: Number of participants with a change in cognitive performance as measured by Persian version of minimal assessment of cognitive function in MS battery. measure: Number of participants with a change in brain connectivity as measured by Functional magnetic resonance imaging . measure: Number of participants with a change in white matter integrity as measured by quantitative diffusion tensor imaging . measure: Number of participants with a change in processing and motor speed as assessed by the Symbol Digit Modalities Test . measure: Number of participants with evaluation of verbal learning and memory deficits as measured by the California Verbal Learning Test second edition . measure: Proportion of patients with change in CD20 / CD19 B cells surface markers measure: Biological Assessments including IL-10, IL-6, IL-17, and TNFα levels of cytokines. measure: Proportion of patients with change in T2 lesion volume on brain MRI. measure: Proportion of patients with change in brain volume on MRI. measure: Proportion of patients for assessment of visuospatial learning as measured by the Brief Visuospatial Memory Test-Revised . measure: Proportion of patients for assessment of visuospatial ability as measured by Judgment of Line Orientation Test . measure: Proportion of patients for evaluation of executive functions as measured by the Delis-Kaplan Executive Function System Sorting and descriptive tests. measure: Proportion of patients for measuring verbal fluency as measured by the Controlled Oral Word Association Test . measure: Proportion of patients for psychological assessment as measured by the validated Persian version of Symptom Checklist-90-Revised . measure: Proportion of patients for evaluation of fatigue as measured by was examined by the Persian version of Fatigue Severity Scale . measure: Proportion of patients for assessment of visuospatial ability as measured by the brief visuospatial memory test-revised test. measure: Proportion of patients for assessment of visuospatial ability as measured by the California Verbal Learning Test Second Edition test. sex: ALL minimumAge: 17 Years maximumAge: 45 Years stdAges: CHILD stdAges: ADULT facility: Tehran University of Medical Sciences,Tehran, Iran city: Tehran country: Iran, Islamic Republic of lat: 35.69439 lon: 51.42151 hasResults: False
<\|newrecord\|> nctId: NCT06360848 id: IRB00001192 briefTitle: Surgical Treamtment of Pseudarthrosis of the Humerus (Study of a Series of 53 Cases) overallStatus: COMPLETED date: 2005-01-01 date: 2021-01-01 date: 2021-01-01 date: 2024-04-11 date: 2024-04-11 name: Ibn Jazzar Hospital class: OTHER briefSummary: Pseudarthrosis of the humerus is a serious complication of humerus fractures, of particular interest to subjects young working people with pseudoarthrogenic risk factors (tobacco++). It represents a real problem therapeutic given the long period of treatment, its disabling socio-professional repercussions and the cost which resulting.
The aim of our work is to evaluate the anatomical and functional results of different surgical techniques. used. conditions: Humerus Fracture studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 53 type: ACTUAL name: surgery measure: Distribution of atrophic pseudarthrosis according to technique surgical procedure used (in Number of patients) measure: Distribution of hypertrophic pseudarthrosis according to technique surgical procedure used (in Number of patients) measure: Time to consolidation depending on the type of pseudarthrosis (in months) measure: Average Constant score postoperatively according to the means of restraint sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06360835 id: IRB00001193 briefTitle: Our Experience in the Management of Therapeutic Failures of Fractures of the Proximal End of the Femur (About 35 Cases) overallStatus: COMPLETED date: 2015-01-01 date: 2021-12-01 date: 2021-12-02 date: 2024-04-11 date: 2024-04-11 name: Ibn Jazzar Hospital class: OTHER briefSummary: Osteosyntheses employed in treating fractures at the upper end of the femur play a critical role in facilitating a swift recovery by minimizing immobilization periods and enabling early rehabilitation of the affected joints, thereby promoting a speedy return to normal walking function.
Osteosynthesis alters the mechanical dynamics of the bone segment, which undergoes continual changes during the consolidation and mobilization phases of recovery. Throughout these stages, a range of mechanical complications may arise, posing challenges despite the successful prevention of infections. Non-infectious complications associated with the presence of osteosynthesis materials, especially in weight-bearing areas like the lower limb, remain a concern.
In light of these considerations, surgeons must exercise meticulous care in selecting synthetic materials to mitigate the risk of osteosynthesis failures. In cases where internal fixation fails, the standard recourse often involves converting to total hip arthroplasty (THA).
However, it is essential to note that THA subsequent to complications arising from proximal femur osteosynthesis presents a higher incidence of both intraoperative and postoperative complications compared to the implantation of primary total hip prostheses. Thus, while osteosynthesis remains a valuable intervention for femur fractures, careful attention to material selection and postoperative management is crucial in optimizing patient outcomes and minimizing complications. conditions: Proximal Femur Fractures studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 35 type: ACTUAL name: total hip arthroplasty measure: Surgical Approach measure: Preparation of the Patient measure: Anesthesia measure: Type of Surgical Revision measure: Types of Prosthesis measure: Age Distribution measure: Distribution by Sex measure: Distribution According to Affected Side measure: Distribution According to Circumstances of Trauma sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: IBN jazzar hospital city: Kairouan zip: 3190 country: Tunisia lat: 35.6781 lon: 10.09633 hasResults: False
<\|newrecord\|> nctId: NCT06360822 id: 19317 briefTitle: Increasing Equity in Lung Cancer Screening acronym: LUCARE overallStatus: RECRUITING date: 2023-12-01 date: 2027-02-01 date: 2027-02-01 date: 2024-04-11 date: 2024-04-11 name: Indiana University class: OTHER name: Eskenazi Health briefSummary: The overall objective of this mixed methods study is to: 1) Refine the Emergency Department Lung Cancer Screening (ED-LCS) intervention using qualitative interviews among key stakeholders; 2) pilot test the ED-LCS intervention evaluating the intervention efficacy, acceptability, and feasibility; and 3) provide an in-depth description of stakeholders' experiences with the ED-LCS intervention for future refinement. conditions: Lung Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: HEALTH_SERVICES_RESEARCH masking: NONE count: 144 type: ESTIMATED name: ED-LCS measure: Rate of patients receive Lung Cancer Screening measure: Patients ratings of intervention sex: ALL minimumAge: 50 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Eskenazi Health status: RECRUITING city: Indianapolis state: Indiana zip: 46202 country: United States name: Nicholas Pettit, MD role: CONTACT phone: 317-962-5975 email: nrpettit@iu.edu lat: 39.76838 lon: -86.15804 hasResults: False
<\|newrecord\|> nctId: NCT06360809 id: 2024 PARINEFC 00001 briefTitle: Prehabilitation Exercise Program in Breast Cancer: Effects on Quality of Life and Tumor Microenvironment (PEP_BC) acronym: PEP_BC overallStatus: RECRUITING date: 2024-03-22 date: 2025-06 date: 2025-06 date: 2024-04-11 date: 2024-04-11 name: Institut Nacional d'Educacio Fisica de Catalunya class: OTHER name: ICFO - The Institute of Photonics Sciences name: Hospital Clinic of Barcelona name: Institut d'Investigacions Biomèdiques August Pi i Sunyer name: Universidad San Jorge briefSummary: To improve the health and quality of life of breast cancer (BC) patients, researchers are focusing on prehabilitation strategies like physical exercise, preparing patients both mentally and physically for clinical and surgical procedures, potentially reducing complications. Physical exercise is also recognized as pivotal in optimizing chemotherapy. It can improve blood flow and oxygen supply in the microenvironment of the tumor (MT), potentially enhancing chemotherapy effectiveness. Although previous research has shown the benefits of preoperative exercise combined with chemotherapy in various cancer types, including BC, further investigation is needed into the exact effects of prehabilitation exercise (PE) on MT physiology.
This study aims to provide valuable insights into the potential benefits of PE for BC patients and its impact on the tumor microenvironment. The hypothesis is that PE in BC patients will improve their quality of life, reduce fatigue, increase muscle mass, decrease fat mass, and enhance physical fitness. Additionally, beneficial acute hemodynamic changes, particularly increased blood flow following PE sessions, and hemodynamic adaptations involving higher levels of oxygenated hemoglobin, increased blood flow, greater oxygen saturation, and a higher metabolic rate of oxygen, are expected.
The study will include 76 participants aged 18-65 years, meeting specific criteria such as a diagnosis of hormone receptor-positive BC, no medical contraindications for exercise, no metastatic cancer, and no structured exercise in the last six months. These participants will be randomly assigned to a PE group or a control group. The study will consist of three phases: Phase 1 involves pre-intervention assessments, Phase 2 includes a 4-week PE intervention with three weekly sessions, and Phase 3 encompasses post-intervention and post-surgery assessments. The 4-week PE intervention in Phase 2 will include strength and aerobic training. Quality of life and fatigue assessments will use questionnaires, and measurements will be made for fat mass, lean mass, bone density, and cardiorespiratory fitness. Strength measurements will be taken, and shoulder mobility will be evaluated. Hemodynamics of the MT will be assessed using a hybrid device combining Near-Infrared Spectroscopy and Diffuse Correlation Spectroscopy with ultrasound. conditions: Breast Cancer studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 76 type: ESTIMATED name: Prehabilitation exercise program measure: Quality of life score measure: Cancer quality of life score measure: Cancer-related fatigue measure: Body composition measure: Bone density measure: Cardiorespiratory fitness measure: Maximum isometric manual grip strength measure: Upper body maximum strength measure: Lower body maximum strength measure: Shoulder range of motion measure: Relative oxyhemoglobin concentration ([02Hb]) in the microenvironment of the tumor measure: Relative deoxyhemoglobin concentration ([HHb]) in the microenvironment of the tumor measure: Oxygen saturation (StO2) in the microenvironment of the tumor measure: Blood flow (BF) in the microenvironment of the tumor measure: Height measure: Body mass measure: Body mass index measure: Wait circumference measure: Anthropometric measurements measure: Bioimpedance measurements measure: Maximal heart rate sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Hospital Clínic status: RECRUITING city: Barcelona zip: 08036 country: Spain name: Eduard Mension, MD role: CONTACT email: mension@clinic.cat name: Albert Busquets, PhD role: PRINCIPAL_INVESTIGATOR name: Lucia Sagarra-Moreno, PhD role: PRINCIPAL_INVESTIGATOR name: Esther Valera, MSc role: SUB_INVESTIGATOR name: Graciela Martínez-Pallí, MD role: SUB_INVESTIGATOR name: Raquel Sebio, PhD role: SUB_INVESTIGATOR name: Blai Ferrer-Uris, PhD role: SUB_INVESTIGATOR name: Turgut Durduran, PhD role: SUB_INVESTIGATOR name: Mireia Mora, MD role: SUB_INVESTIGATOR name: Eduard Mension, MD role: SUB_INVESTIGATOR name: Helena Castillo, MD role: SUB_INVESTIGATOR name: Rosa Angulo-Barroso, PhD role: SUB_INVESTIGATOR name: Alfredo Irurtia, PhD role: SUB_INVESTIGATOR name: Marta Carrasco-Marginet, PhD role: SUB_INVESTIGATOR name: Alex Cebrián-Ponce, MSc role: SUB_INVESTIGATOR name: Ferran Faixat role: SUB_INVESTIGATOR name: Quim Rosales role: SUB_INVESTIGATOR name: Raquel Martinez-Reviejo, MSc role: SUB_INVESTIGATOR name: Paula Bonay, BS role: SUB_INVESTIGATOR lat: 41.38879 lon: 2.15899 hasResults: False
<\|newrecord\|> nctId: NCT06360796 id: 2023-ADC189-I-010 briefTitle: Study of Pharmacokinetics and Metabolism on [(14)C]ADC189 overallStatus: RECRUITING date: 2023-11-24 date: 2024-06-30 date: 2024-07-30 date: 2024-04-11 date: 2024-04-11 name: Jiaxing AnDiCon Biotech Co.,Ltd class: INDUSTRY briefSummary: This study is designed to determined the metabolism, excretion, and substance balance of almonertinib of ADC189. The pharmacokinetic characteristics and safety profile of ADC189 was investigated following a single oral dose (45 mg/100 µCi) in healthy Chinese male participants. conditions: Pharmacokinetics conditions: Metabolism studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: BASIC_SCIENCE masking: NONE count: 6 type: ESTIMATED name: [(14)C]ADC189 measure: The Area Under the Curve (AUC) of [(14)C]ADC189 and its metabolites measure: The Maximum Plasma Concentration [Cmax] of [(14)C]ADC189 and its metabolites measure: The whole blood and serum concentrations of total radioactivity of [(14)C]ADC189 (about 100 μCi) measure: The urinary and fecal recovery of total radioactivity of [(14)C]ADC189 (about 100 μCi) sex: MALE minimumAge: 18 Years maximumAge: 45 Years stdAges: ADULT facility: The First Affilicated Hospital of Bengbu Medical University status: RECRUITING city: Bengbu state: Anhui zip: 233004 country: China name: Huan Zhou role: CONTACT phone: +8613665527160 email: zhouhuanbest@vip.163.com lat: 32.94083 lon: 117.36083 hasResults: False
<\|newrecord\|> nctId: NCT06360783 id: Pro00111388 briefTitle: COVID-19 Quick Start - Test and Treat in Africa overallStatus: ACTIVE_NOT_RECRUITING date: 2023-02-01 date: 2024-06 date: 2024-06 date: 2024-04-11 date: 2024-04-26 name: Duke University class: OTHER name: Duke Clinical Research Institute name: Clinton Health Access Initiative, Nigeria briefSummary: Duke University and the Clinton Health Access Initiative (CHAI), in partnership with the Ministries of Health (MoH) of Ghana, Malawi, Rwanda, Zambia, and Zimbabwe, aim to assess the implementation and impact of COVID-19 test -and -treat (T\&T) demonstration programs conditions: COVID-19 studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: RETROSPECTIVE count: 1000 type: ESTIMATED measure: Stakeholder Perspectives sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Duke Global Health Institute city: Durham state: North Carolina zip: 27705 country: United States lat: 35.99403 lon: -78.89862 hasResults: False
<\|newrecord\|> nctId: NCT06360770 id: NIRSCovidSBCelje briefTitle: Assessement of Microcirculation With NIRS Predicts Sepsis Development in Patients With Severe Covid-19 Pneumonia overallStatus: COMPLETED date: 2021-12-01 date: 2023-02-28 date: 2023-04-30 date: 2024-04-11 date: 2024-04-12 name: General and Teaching Hospital Celje class: OTHER briefSummary: Sepsis and septic shock are among main causes of death in patients with severe Covid-19 pneumonia. A few factors are proven to predict sepsis in these patients. WIth near infrared spectroscopy it is possible to detect microcirculatory changes typical for sepsis early in the course of disease. The hypothesis that changes in tissue oxygene saturation during vasoocclusive test predict sepsis as well as mortality in mechancally ventilated patients withe severe Covid-19 pneumonia will be tested. conditions: Sepsis studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 35 type: ACTUAL measure: sepsis development measure: mortality sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: SB Celje city: Celje zip: 3000 country: Slovenia lat: 46.23092 lon: 15.26044 hasResults: False
<\|newrecord\|> nctId: NCT06360757 id: DHF-21-2141-1 briefTitle: Clinical Evaluation of the NeuMoDx SARS-CoV-2 Assay (COVID-19) overallStatus: RECRUITING date: 2024-02-06 date: 2024-09-01 date: 2024-09-01 date: 2024-04-11 date: 2024-04-11 name: QIAGEN Gaithersburg, Inc class: INDUSTRY briefSummary: A multicenter study, using prospectively collected, fresh (Category I) and frozen (Category II), residual/leftover nasopharyngeal (NP) swab in UTM/UVT specimens obtained from symptomatic individuals suspected of COVID-19 infection. This study will evaluate the NeuMoDx SARS-CoV-2 Assay's clinical performance on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems. conditions: SARS-CoV-2 Acute Respiratory Disease studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 1432 type: ESTIMATED name: NeuMoDx SARS-CoV-2 Assay measure: Sensitivity as compared to the comparator method measure: Specificity sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: QIAGEN Gaithersburg, Inc status: RECRUITING city: Manchester zip: M130BH country: United Kingdom name: Sarah G Johnson role: CONTACT phone: 44 7825866041 email: Sarah.Johnson@qiagen.com name: Helen Green role: CONTACT phone: 44 7825866041 email: Helen.Green@qiagen.com lat: 53.48095 lon: -2.23743 hasResults: False
<\|newrecord\|> nctId: NCT06360744 id: ENFORCE PLUS briefTitle: A Phase IV Vaccine Study Under the National Cohort Study of Effectiveness and Safety of SARS-CoV-2 (COVID-19) Vaccines. overallStatus: COMPLETED date: 2021-07-05 date: 2023-12-31 date: 2023-12-31 date: 2024-04-11 date: 2024-04-11 name: Jens D Lundgren, MD class: OTHER name: Ministry of the Interior and Health, Denmark briefSummary: A phase IV study to assess if the SARS-CoV-2 vaccine from Johnson \& Johnson/Janssen (J\&J) results in change in number and activation of platelets and anti-PF4 Level. As well as compare whether the vaccine is causing a greater activation of platelets and anti-PF4 than the mRNA vaccines.
The Danish Medicines Agency has approved the vaccine from J\&J for use in Denmark, however it is not currently part of the national vaccine programme.
The design is an open-labelled, non-randomised, parallel group, phase IV study with historical controls. A sub-study will be embedded within this master protocol addressing basic and translational research questions requiring additional sampling of biological material (under separate participant informed consent). conditions: SARS CoV 2 Infection studyType: INTERVENTIONAL phases: PHASE4 allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: The design is an open-labelled, non-randomised, parallel group, phase IV study with historical controls. primaryPurpose: OTHER masking: NONE count: 25 type: ACTUAL name: Johnson & Johnson measure: Assessment of the J& J vaccine sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Aarhus Universitetshospital, Skejby city: Aarhus state: Aarhus N zip: 8200 country: Denmark lat: 56.15674 lon: 10.21076 facility: Aalborg Universitetshospital Syd city: Aalborg zip: 8000 country: Denmark lat: 57.048 lon: 9.9187 facility: Hvidovre Hospital city: Hvidovre zip: 2600 country: Denmark lat: 55.65719 lon: 12.47364 facility: Odense Universitetshospital city: Odense zip: 5000 country: Denmark lat: 55.39594 lon: 10.38831 facility: Sjællandsuniversitetshospital city: Roskilde zip: 4000 country: Denmark lat: 55.64152 lon: 12.08035 hasResults: False
<\|newrecord\|> nctId: NCT06360731 id: 1018 briefTitle: The Effect of 4-7-8 Breathing Exercise Technique on Tinnitus overallStatus: ACTIVE_NOT_RECRUITING date: 2024-03-18 date: 2024-05-31 date: 2024-05-31 date: 2024-04-11 date: 2024-04-23 name: Ege University class: OTHER briefSummary: The goal of this study is to evaluate the effect of 4-7-8 breathing exercise on tinnitus handicap, psychological factors and sleep quality.
There will be a parallel-group randomized controlled trial study and consists of two groups.
Both groups will receive 1 hour of informative session on tinnitus and the experimental group will also perform 4-7-8 breathing exercises for 6 weeks. Visual analog scale, tinnitus handicap inventory, insomnia severity index, trait anxiety inventory, and perceived stress scale will be applied before and after the application. conditions: Tinnitus, Subjective studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: This study employs a parallel group randomised controlled trial design. primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE maskingDescription: In the study, patients do not know which group they were in. Therefore, blinding is performed among the participants. To prevent bias in the study, blinding is also performed between the researchers. Researchers (S.B. and A.O. from both clinics) make the pre- and post-test evaluations without knowing which group the patients are in. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 60 type: ACTUAL name: 4-7-8 breathing exercise technique and informative session on tinnitus name: Informative session on tinnitus measure: Visual Analog Scale (VAS) measure: Visual Analog Scale (VAS) measure: Tinnitus Handicap Inventory (THI) measure: Tinnitus Handicap Inventory (THI) measure: Insomnia severity index (ISI) measure: Insomnia severity index (ISI) measure: Perceived stress scale -10 (PSS-10) measure: Perceived stress scale -10 (PSS-10) measure: Trait Anxiety Scale (TAS) measure: Trait Anxiety Scale (TAS) sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Gokce Saygi Uysal city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 facility: Audiology Unit of the Department of Otorhinolaryngology, Ege University Faculty of Medicine Hospital city: Izmir country: Turkey lat: 38.41273 lon: 27.13838 hasResults: False
<\|newrecord\|> nctId: NCT06360718 id: CHLA-23-00170 briefTitle: Effects of Using a Storybook, to Explain Leukemia to Children Versus the Standard Child Life Intervention, on Parental Stress. overallStatus: RECRUITING date: 2024-02-03 date: 2025-05-15 date: 2025-05-15 date: 2024-04-11 date: 2024-04-19 name: Children's Hospital Los Angeles class: OTHER briefSummary: The goal of this clinical trial is to measure the effects of using a storybook versus standard child life intervention with parents of children newly diagnosed with leukemia on parental stress.
The main questions it aims to answer are:
* What effect will the storybook have on parent/legal guardian stress at three timepoints: baseline, discharge, and follow up?
* Will this storybook impact parent/legal guardian comfort levels and improve their child's understanding?
Participants will be asked to complete surveys at three timepoints, prior to and following child life intervention and about 3.5 months later. During child life interventions, participants will receive resources and support to explain leukemia to their school aged, 3-16-year-old, child (patient or sibling).
Researchers will compare Intervention and Control Groups to see if parental stress is lower in those who received the storybook in addition to the standard child life intervention versus the standard child life intervention alone. conditions: Leukemia studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 140 type: ESTIMATED name: "Who is Luke Eemia?" Storybook measure: Parental Stress, prior to and following child life intervention measure: Parent perception of the child's stress measure: Parent's Comfort Explaining Aspects of Leukemia Diagnosis measure: Parent comfort, readiness, and importance, explaining aspects of the diagnosis at the discharge (1-week post baseline). measure: Parental Impression of the Storybook Tool using a Likert scale (1-week post baseline). sex: ALL minimumAge: 3 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Children's Hospital Los Angeles status: RECRUITING city: Los Angeles state: California zip: 90027 country: United States name: Erin Shields, MA role: CONTACT lat: 34.05223 lon: -118.24368 hasResults: False
<\|newrecord\|> nctId: NCT06360705 id: CVVD003 briefTitle: StrataMGT for the Treatment of Vulvar Lichen Sclerosus overallStatus: RECRUITING date: 2024-04 date: 2024-09 date: 2024-10 date: 2024-04-11 date: 2024-04-19 name: Center for Vulvovaginal Disorders class: OTHER name: Stratpharma AG briefSummary: This study is designed to evaluate the efficacy and safety of StrataMGT for the treatment of vulvar lichen sclerosus. conditions: Vulvar Lichen Sclerosus studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 5 type: ESTIMATED name: StrataMGT measure: Histopathologic Inflammation sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Centers for Vulvovaginal Disorders status: RECRUITING city: New York state: New York zip: 10036 country: United States name: Andrew Goldstein, MD role: CONTACT phone: 4102790209 email: obstetrics@yahoo.com name: Andrew Goldstein, MD role: PRINCIPAL_INVESTIGATOR name: Leia Mitchell, PA-C, MMSc, MSc role: SUB_INVESTIGATOR lat: 40.71427 lon: -74.00597 hasResults: False
<\|newrecord\|> nctId: NCT06360692 id: Marta Lluesma Vidal Carden briefTitle: Impact of Nipple Micropigmentation in Mastectomized Women overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2024-10-30 date: 2025-12-31 date: 2024-04-11 date: 2024-04-11 name: Cardenal Herrera University class: OTHER briefSummary: This will be a multicenter prospective descriptive case series study following a cohort.
The micropigmentation/tattoo procedure will be carried out following the protocol established in each center (see annex x). The present investigation only involves measuring the impact that this technique has on the patients by collecting data in digital format before and after the CAP micropigmentation/tattoo that motivated their visit to the clinical service.
CAP micropigmentation/tattooing is usually performed between 6 and 12 months after the breast reconstructive surgery has been completed, sufficient time for healing to complete and the breast to stabilize, although it can be performed from 2 months after the intervention. Nurses are responsible for performing micropigmentation/tattooing of the areola and nipple in mastectomized women. conditions: Body Image conditions: Female Sexual Function conditions: Self Esteem conditions: Intimacy With Your Partner studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 30 type: ESTIMATED measure: Body imagen measure: Self-esteem measure: Sexual Function measure: Intimacy with the partner sex: FEMALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False
<\|newrecord\|> nctId: NCT06360679 id: CIP000004 briefTitle: Clinical Feasibility Study of the BariTon™ System in Obese or Overweight Patients. overallStatus: RECRUITING date: 2024-01-29 date: 2024-10-01 date: 2025-06-01 date: 2024-04-11 date: 2024-04-11 name: BariaTek Medical class: INDUSTRY briefSummary: Safety and efficacy evaluation of the BariTon™, BariaTek Medical gastric restriction and biliodigestive diversion device. conditions: Obesity studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 10 type: ESTIMATED name: Endoscopic gastric restriction and biliodigestive diversion measure: Safety of the BariTon™ measure: Safety of the BariTon™ measure: Safety of the BariTon™ measure: Safety of the BariTon™ measure: Efficacy of the BariTon™ measure: Efficacy of the BariTon™ measure: Efficacy of the BariTon™ measure: Efficacy of the BariTon™ measure: Efficacy of the BariTon™ measure: Efficacy of the BariTon™ sex: ALL minimumAge: 25 Years maximumAge: 60 Years stdAges: ADULT facility: BMI Clinic Double Bay status: RECRUITING city: Sydney state: New South Wales zip: 2028 country: Australia name: Adrian Sartoretto, Dr role: CONTACT phone: 0290534688 phoneExt: 61 email: info@bmiclinic.com.au lat: -33.86785 lon: 151.20732 facility: BMI Clinic Liverpool status: RECRUITING city: Sydney state: New South Wales zip: 2170 country: Australia name: Adrian Sartoretto, Dr role: CONTACT phone: 0290534688 phoneExt: 61 email: info@bmiclinic.com.au lat: -33.86785 lon: 151.20732 hasResults: False
<\|newrecord\|> nctId: NCT06360666 id: Neurax1 briefTitle: Clinical Outcomes in Adult Patients Undergoing Laparoscopic Surgery Under Neuraxial Anesthesia acronym: NEURAX overallStatus: ENROLLING_BY_INVITATION date: 2022-10-01 date: 2024-01-31 date: 2024-12-31 date: 2024-04-11 date: 2024-04-11 name: Asst Melegnano e Martesana class: OTHER_GOV briefSummary: The goal of this observational study is to learn about postoperative mortality and postoperative length of stay outcomes after abdominal laparoscopic major surgery. The main question it aims to answer is:
Does general anesthesia lower complications compared to loco-regional anesthesia (keeping the patient spontaneously breathing and sedated) in laparoscopic abdominal major surgery? Participants are followed for neurological sequelae for 90 days following surgery conditions: Mortality conditions: Surgical Complication conditions: Neurological Complication conditions: Respiratory Complication conditions: Cardiovascular Complication conditions: Nephrotoxicity conditions: Metabolic Complication studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: RETROSPECTIVE count: 70 type: ESTIMATED measure: Mortality measure: Morbidity measure: Surgical revisions measure: organ dysfunctions sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ASST Melegnano e Martesana - Ospedale Vizzolo Predabissi city: Vizzolo Predabissi state: Milan zip: 20070 country: Italy lat: 45.35587 lon: 9.34815 hasResults: False
<\|newrecord\|> nctId: NCT06360653 id: 76CIVICO2023 briefTitle: a SIngle Center Study of Post-operative STEReotactic RAdiotherapY for Endometrial Cancer acronym: SISTER-RAY overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-06 date: 2026-06 date: 2024-04-11 date: 2024-04-11 name: ARNAS Civico Di Cristina Benfratelli Hospital class: OTHER briefSummary: The primary endpoint of the present prospective study is to assess the outcomes in terms of acute toxicity of post-operative stereotactic radiotherapy for endometrial cancer conditions: Endometrial Cancer studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 60 type: ESTIMATED name: Stereotactic Post-operative Radiotherapy for Endometrial Cancer measure: Acute G3 or higher Gastrointestinal and Genitourinary Toxicity measure: Late Gastrointestinal and Genitourinary Toxicity measure: Distant Progression Free Survival measure: Local Control measure: Overall Survival measure: Overall Quality of Life sex: FEMALE minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: ARNAS Civico Hospital city: Palermo state: PA zip: 90100 country: Italy name: FRANCESCO CUCCIA, MD role: CONTACT phone: +393334393336 email: francesco.cuccia@arnascivico.it lat: 38.13205 lon: 13.33561 hasResults: False
<\|newrecord\|> nctId: NCT06360640 id: APC148-001 id: 2023-507939-38-00 type: OTHER domain: EU Trial no briefTitle: A First-in-human Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of APC148 in Healthy Adults overallStatus: NOT_YET_RECRUITING date: 2024-06 date: 2025-03 date: 2025-03 date: 2024-04-11 date: 2024-04-11 name: AdjuTec Pharma AS class: INDUSTRY name: CTC Clinical Trial Consultants AB briefSummary: The purpose of this first-in-human trial is to investigate the safety, tolerability, and pharmacokinetics of APC148 after intravenous (IV) infusion of single ascending doses in healthy adults. conditions: Healthy Subjects studyType: INTERVENTIONAL phases: PHASE1 allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Placebo-controlled, 6 sequential cohorts. primaryPurpose: BASIC_SCIENCE masking: DOUBLE maskingDescription: This is a double-blind trial. whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 46 type: ESTIMATED name: APC148 and Placebo measure: Incidence and intensity of adverse events (AEs) measure: Incidence and intensity of serious adverse events (SAEs) measure: Incidence and intensity of infusion-related AEs measure: Time course of local tolerability reactions measure: Changes from baseline in blood pressure measure: Changes from baseline in respiratory rate measure: Changes from baseline in body temperature measure: Changes from baseline in heart rate measure: Changes from baseline in PQ/PR interval measure: Changes from baseline in QRS interval measure: Changes from baseline in QT interval measure: Changes from baseline in QTcF interval measure: Changes from baseline in Clinical Laboratory Profile measure: Changes from baseline in physical examination measure: APC148 plasma concentrations measure: APC148 urine concentrations measure: Pharmacokinetic (PK) parameter in plasma - Area under curve (AUC) 0-24 measure: PK parameter in plasma - AUC0-inf measure: PK parameter in plasma - AUC0-last measure: PK parameter in plasma - Cmax measure: PK parameter in plasma - Tmax measure: PK parameter in plasma - T1/2 measure: PK parameter in plasma - Clearance (CL) measure: PK parameter in plasma - Vz measure: PK parameter in plasma - Vss determination of plasma concentrations will be collected. measure: PK parameters in urine - A(e) measure: PK parameters in urine - fe measure: PK parameter in urine - renal clearance (CLr) sex: ALL minimumAge: 18 Years maximumAge: 60 Years stdAges: ADULT facility: Clinical Trial Consultants AB city: Uppsala country: Sweden name: Erik Rein-Hedin, MD role: PRINCIPAL_INVESTIGATOR lat: 59.85882 lon: 17.63889 hasResults: False
<\|newrecord\|> nctId: NCT06360627 id: 2022_D0008 briefTitle: Ultra Low Dose CT and Use of Iomeron 400 in PCD-CT overallStatus: RECRUITING date: 2023-02-20 date: 2027-03-31 date: 2027-12-01 date: 2024-04-11 date: 2024-04-11 name: University of Zurich class: OTHER briefSummary: Evaluation of ultra low dose protocols and Iomeron 400 contrast in PCD-CT conditions: Radiation Exposure conditions: Lung Embolism conditions: Lung Cancer conditions: Pneumonia studyType: INTERVENTIONAL phases: NA allocation: NON_RANDOMIZED interventionModel: PARALLEL primaryPurpose: DIAGNOSTIC masking: NONE count: 100 type: ESTIMATED name: Computed Tomography measure: Dose Reduction by new scanner measure: stable Image Quality in reduced dose scans sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Hospital Zurich - Diagnostic Radiology status: RECRUITING city: Zurich zip: 8091 country: Switzerland name: Thomas Frauenfelder, PD MD role: CONTACT phone: 0041442551111 email: thomas.frauenfelder@usz.ch name: Marga Rominger, Prof MD role: CONTACT phone: 0041442551111 email: marga.rominger@usz.ch name: Thomas Frauenfelder, PD MD role: PRINCIPAL_INVESTIGATOR lat: 47.36667 lon: 8.54999 hasResults: False
<\|newrecord\|> nctId: NCT06360614 id: 2024s01 briefTitle: The Effect of Hand Massage Applied to Palliative Care Oncology Patients overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2025-06-01 date: 2024-04-11 date: 2024-04-15 name: murat koç class: OTHER_GOV name: Istanbul Sultanbeyli State Hospital briefSummary: World Health Organization (WHO) palliative care is defined as "an approach that aims to reduce or prevent suffering by early identification, evaluation and treatment of the physical, psychosocial and spiritual problems of patients and families accompanying life-threatening diseases, and thus to increase their quality of life." Palliative care is a multidisciplinary approach that provides appropriate health care for oncology patients, who have a wide variety of medical, functional, social and emotional needs. Pharmacological approaches are generally used in symptom management of palliative care patients. In addition to pharmacological approaches, non-pharmacological approaches are also preferred. Massage is a preferred intervention among professional nursing practices because it is reliable, has no side effects, has a direct effect on patients, and is easy to apply.
Massage is the stimulation of the skin, subcutaneous tissue, muscles, internal organs, metabolism, circulation and lymph systems for therapeutic purposes through mechanical and neural means. The presence of sufficient mechanoreceptors in the hands, which stimulate painless nerve endings, shows that the hands should be chosen as the appropriate area for massage. Among the effects of hand massage: ensuring the regeneration of cells, facilitating the elimination of accumulated toxins, providing relaxation, helping to reduce pain by facilitating the release of endorphins, helping to increase circulation, regulating respiratory functions, providing stress and anxiety control, creating a state of well-being, strengthening the immune system, increasing general comfort, improving sleep quality. is located. Studies in the literature have found that hand massage reduces anxiety levels, stress and agitation levels, pain levels, and increases comfort and sleep levels. As seen in the literature, the effectiveness of hand massage applied to different sample groups on anxiety, stress, agitation, pain, comfort and sleep parameters was evaluated. There are very few studies evaluating the effectiveness of hand massage applied to oncology patients. In addition, no study has been found that evaluated the effects of hand massage on pain, comfort and sleep in palliative oncology patients, who constitute the majority of palliative care patients. conditions: Hand Massage studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Before the application, data will be collected and recorded through a face-to-face interview (8-10 minutes) by a nurse who does not know which group the patients are in. Sleep times of patients will be measured with a smart bracelet. At this stage, the same procedure will be continued for the intervention and control groups.
Hand massage will be applied to the intervention group for 4 weeks, 2 days a week (Monday and Friday), 2 sessions each day. The control group will receive routine monitoring and nursing care for 4 weeks.
In the intervention and control groups, VAS-Pain, General Comfort Scale and Pittsburgh Sleep Quality were assessed by a face-to-face interview by a nurse who did not know which group the patients were in, on the 7th day (Monday), 14th day (Monday) and 28th day (Monday). Index measurement tools will be applied and patients' sleep times will be measured with a smart bracelet. primaryPurpose: SCREENING masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 80 type: ESTIMATED name: Hand massage application name: routine monitoring and nursing care measure: İndividual Information Form measure: Patient Follow-up Form measure: General Comfort Scale measure: Pittsburgh Sleep Quality Index measure: Smart Bracelet sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Sultanbeyli State Hospital city: Istanbul zip: 34000 country: Turkey name: Murat Koç role: CONTACT phone: +905436725093 email: mrtkoc49@gmail.com lat: 41.01384 lon: 28.94966 hasResults: False
<\|newrecord\|> nctId: NCT06360601 id: 36264PR589/3/24 briefTitle: Intravenous Labetalol Versus Hydralazine in Preeclampsia overallStatus: ACTIVE_NOT_RECRUITING date: 2024-04-01 date: 2024-09 date: 2024-09 date: 2024-04-11 date: 2024-04-11 name: Tanta University class: OTHER briefSummary: We study the effect of intravenous labetalol versus hydralazine in sever preeclampsia patients on cerebral blood flow and neurological outcome conditions: Preeclampsia Severe studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: PREVENTION masking: TRIPLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 40 type: ESTIMATED name: Labetalol Injection name: HydrALAZINE Injection measure: Cerebral blood flow sex: FEMALE minimumAge: 25 Years maximumAge: 45 Years stdAges: ADULT facility: Faculty of Medicine city: Tanta zip: 3511 country: Egypt lat: 30.78847 lon: 31.00192 hasResults: False
<\|newrecord\|> nctId: NCT06360588 id: NCI-2024-01141 id: NCI-2024-01141 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: EAY131-Z1G type: OTHER domain: ECOG-ACRIN Cancer Research Group id: EAY131-Z1G type: OTHER domain: CTEP id: U10CA180820 type: NIH link: https://reporter.nih.gov/quickSearch/U10CA180820 briefTitle: Testing Copanlisib as Potentially Targeting Treatment in Cancers With PTEN Loss (MATCH - Subprotocol Z1G) overallStatus: ACTIVE_NOT_RECRUITING date: 2018-06-19 date: 2024-11-15 date: 2024-11-15 date: 2024-04-11 date: 2024-04-22 name: National Cancer Institute (NCI) class: NIH briefSummary: The phase II MATCH treatment trial tests how well copanlisib works to treat patients with cancer with PTEN loss. Copanlisib may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for cell growth. conditions: Malignant Solid Neoplasm studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 35 type: ESTIMATED name: Biopsy name: Biospecimen Collection name: Copanlisib name: Radiologic Examination measure: Objective response rate (ORR) measure: Overall survival (OS) measure: 6-month progression-free survival (PFS) rate measure: Progression free survival sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: ECOG-ACRIN Cancer Research Group city: Philadelphia state: Pennsylvania zip: 19103 country: United States lat: 39.95233 lon: -75.16379 hasResults: False
<\|newrecord\|> nctId: NCT06360575 id: NCI-2024-01127 id: NCI-2024-01127 type: REGISTRY domain: CTRP (Clinical Trial Reporting Program) id: EAY131-C2 type: OTHER domain: ECOG-ACRIN Cancer Research Group id: EAY131-C2 type: OTHER domain: CTEP id: U10CA180820 type: NIH link: https://reporter.nih.gov/quickSearch/U10CA180820 briefTitle: Testing Crizotinib as Potentially Targeted Treatment in Cancers With MET Exon 14 Deletion Genetic Changes (MATCH - Subprotocol C2) overallStatus: ACTIVE_NOT_RECRUITING date: 2016-05-30 date: 2024-11-15 date: 2024-11-15 date: 2024-04-11 date: 2024-04-22 name: National Cancer Institute (NCI) class: NIH briefSummary: This phase II MATCH treatment trial tests how well crizotinib works to treat patients with cancers with MET exon 14 deletion genetic changes. Crizotinib is in a group of medications called tyrosine kinase inhibitors. It works by blocking enzymes that cancer cells need to grow and spread. It may also prevent the growth of new blood vessels that tumors need to grow. conditions: Advanced Lymphoma conditions: Advanced Malignant Solid Neoplasm conditions: Refractory Lymphoma conditions: Refractory Malignant Solid Neoplasm conditions: Refractory Multiple Myeloma studyType: INTERVENTIONAL phases: PHASE2 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 35 type: ESTIMATED name: Biopsy name: Biospecimen Collection name: Crizotinib name: Radiologic Examination measure: Objective response rate (ORR) measure: Overall survival (OS) measure: 6-month progression-free survival (PFS) rate measure: Progression free survival sex: ALL stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: ECOG-ACRIN Cancer Research Group city: Philadelphia state: Pennsylvania zip: 19103 country: United States lat: 39.95233 lon: -75.16379 hasResults: False
<\|newrecord\|> nctId: NCT06360562 id: 2020P002418 briefTitle: Reconnecting to Ourselves and Others in Virtual Meetings (ROOM) overallStatus: RECRUITING date: 2020-09-15 date: 2025-01-30 date: 2025-04-25 date: 2024-04-11 date: 2024-04-11 name: Massachusetts General Hospital class: OTHER briefSummary: This study aimed to determine the feasibility and acceptability of delivering Resilience Training in multi-user virtual reality. conditions: Mood Disorders conditions: Anxiety Disorders conditions: Psychotic Disorders studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 174 type: ESTIMATED name: Resilience Training measure: Discomfort with Others measure: Intervention Feasibility and Acceptability measure: Penn Emotion Recognition Test measure: Stop Distance Paradigm measure: Beck Depression Inventory measure: Spielberger State-Trait Anxiety Inventory measure: Prodromal Questionnaire- Brief measure: Connor-Davidson Resilience Scale sex: ALL minimumAge: 14 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Massachusetts General Hospital status: RECRUITING city: Charlestown state: Massachusetts zip: 02129 country: United States name: Daphne J Holt, MD, PhD role: CONTACT phone: 617-726-7618 email: dholt@mgh.harvard.edu name: Nicole DeTore, PhD role: CONTACT phone: 617-726-2065 email: ndetore@mgh.harvard.edu lat: 42.37787 lon: -71.062 hasResults: False
<\|newrecord\|> nctId: NCT06360549 id: TJ-IRB202403019 briefTitle: Effect of Percutaneous Acupoint Electrical Stimulation on Delirium overallStatus: RECRUITING date: 2024-03-01 date: 2024-12-30 date: 2025-06-30 date: 2024-04-11 date: 2024-04-11 name: Qin Zhang class: OTHER name: National Natural Science Foundation of China briefSummary: This study is a multicenter, prospective, randomized controlled clinical trial that aims to observe the impact of Transcutaneous Electrical Acupoint Stimulation (TEAS) on plasma TK/MMP3 in a randomized controlled setting. The intervention group received percutaneous acupoint electrical stimulation, whereas the control group underwent conventional treatment. The primary objective is to enhance the management of postoperative delirium, specifically focusing on the occurrence and severity of delirium following thoracoscopic pulmonary resection. Additionally, various perioperative inflammatory markers, cognitive function, recovery quality, pain levels, anxiety, sleep patterns, postoperative complications, and overall hospital stay duration were monitored to elucidate the mechanisms through which percutaneous acupoint electrical stimulation improves postoperative delirium. conditions: Delirium, Postoperative studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: The intervention group was percutaneous acupoint electrical stimulation treatment group, and the control group was conventional treatment group.
Inclusion criteria:
1. Voluntarily sign informed consent;
2. Age ≥18 years old;
3. Patients undergoing thoracoscopic pneumonectomy;
4. ASA Grade I-III; primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 238 type: ESTIMATED name: Transcutaneous Electrical Acupoint Stimulation measure: Delirium (using the Delirium Rating Scale, DRS) measure: Mini-Mental State Examination (MMSE) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Guangdong Hospital of Traditional Chinese Medicine status: NOT_YET_RECRUITING city: Guangzhou state: Guangdong zip: 510000 country: China name: Jiemin Deng role: CONTACT phone: 2780 email: qin4298@sina.com name: Jiemin Deng role: CONTACT lat: 23.11667 lon: 113.25 facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology status: RECRUITING city: Wuhan state: Hubei zip: 430030 country: China name: Qin Zhang, phd role: CONTACT phone: 15717154768 email: qzhang8@tjh.tjmu.edu.cn name: Qin Zhang, phd role: PRINCIPAL_INVESTIGATOR lat: 30.58333 lon: 114.26667 hasResults: False
<\|newrecord\|> nctId: NCT06360536 id: IRB-300012634 id: P50MD017338 type: NIH link: https://reporter.nih.gov/quickSearch/P50MD017338 briefTitle: Remotely Delivered Resistance Training for Cardiometabolic Health Among Black Women acronym: OVERCOME-IT overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2026-06-01 date: 2026-06-30 date: 2024-04-11 date: 2024-04-11 name: University of Alabama at Birmingham class: OTHER name: National Institute on Minority Health and Health Disparities (NIMHD) briefSummary: The purpose of this study is to collect preliminary data on the feasibility, acceptability, and potential effects of a novel, remotely delivered resistance training program. conditions: Overweight or Obesity conditions: Prediabetes or Diabetes conditions: Prehypertension (Elevated Blood Pressure) or Hypertension conditions: Resistance Training studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 36 type: ESTIMATED name: Resistance Training measure: Feasibility of recruitment measure: Feasibility of retention measure: Intervention adherence measure: Change in resistance training behaviors measure: Change in blood pressure measure: Change in HbA1C measure: Change in body composition measure: Change in handgrip strength measure: Change in the number of chair stands sex: FEMALE minimumAge: 30 Years maximumAge: 64 Years stdAges: ADULT facility: University of Alabama at Birmingham city: Birmingham state: Alabama zip: 35294 country: United States name: Jackie Grant role: CONTACT phone: 205-975-7108 email: jroche@uabmc.edu name: Amber Kinsey role: CONTACT phone: 205-934-9851 email: akinsey@uabmc.edu name: Amber W Kinsey, PhD role: PRINCIPAL_INVESTIGATOR lat: 33.52066 lon: -86.80249 hasResults: False
<\|newrecord\|> nctId: NCT06360523 id: CRE-2024.141 briefTitle: To Evaluate an MRI-based Optimized Prostate Cancer Diagnostic Pathway Powered by Artificial Intelligence overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-31 date: 2025-07-20 date: 2024-04-11 date: 2024-04-11 name: Chinese University of Hong Kong class: OTHER briefSummary: It is a prospective paired-cohort study for diagnostic test evaluation. The study aim to determine the accuracy of AI review and investigate whether AI review could detect MRI visible significant cancer as effective as radiologist review. MRI image of about 102 men recommended for biopsy will be reviewed by an AI model and an experienced radiologist, respectively. AI review (index) and radiologist review (standard) will be blinded to each other, while biopsy urologists will be well-informed of the findings of both AI review and radiologist review and make personalized biopsy plan by combining both findings. The pathological results of MRI-ultrasound fusion biopsy (reference) will serve as the gold standard to assess the diagnostic accuracy. conditions: Prostate Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 102 type: ESTIMATED name: AI modal measure: Prostate Cancer detection rate of ISUP grade group ≥2 measure: Diagnosis of any grade of prostate cancer sex: MALE minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Prince of Wales Hospital, Chinese University of Hong Kong city: Hong Kong country: Hong Kong lat: 22.27832 lon: 114.17469 hasResults: False
<\|newrecord\|> nctId: NCT06360510 id: 44 briefTitle: Comparison of %5 Dextrose and Betamethasone Injections in Patients With Carpal Tunnel Syndrome overallStatus: ACTIVE_NOT_RECRUITING date: 2023-05-05 date: 2024-05-05 date: 2024-05-05 date: 2024-04-11 date: 2024-04-11 name: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital class: OTHER briefSummary: The aim of the study is to compare the effectiveness of ultrasound-guided betamethasone and 5% dextrose injection, which is routinely applied in clinical practice, in patients with mild and moderate carpal tunnel syndrome (CTS). conditions: Carpal Tunnel Syndrome studyType: OBSERVATIONAL observationalModel: OTHER timePerspective: PROSPECTIVE count: 30 type: ACTUAL name: %5 dextrose injection name: betamethasone injection measure: vas measure: boston carpal tunnel syndrome questionnaire measure: median nerve cross sectional area measure: tinnel test positivity measure: phalen test positivity measure: duruöz hand index measure: global evaluation of treatment outcomes sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital city: Ankara country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False
<\|newrecord\|> nctId: NCT06360497 id: 202206090070 briefTitle: The Effect of Mindfulness Meditation and Loving-kindness and Compassion Meditation on Psychological Distress overallStatus: COMPLETED date: 2022-06-03 date: 2022-10-09 date: 2022-10-09 date: 2024-04-11 date: 2024-04-11 name: Beijing Normal University class: OTHER briefSummary: The purpose of the study is to explore the effect of of mindfulness meditation and loving-kindness and compassion meditation on psychological distress (i.e., anxiety, depression, stress), and explore the mechanism from the perspective of reinforcement sensitivity theory. conditions: MM Group conditions: LKCM Group conditions: Waitlist Group studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: OTHER masking: NONE count: 152 type: ACTUAL name: mindfulness meditation intervention and loving-kindness and compassion meditation intervention measure: The Depression Anxiety Stress Scale measure: The Philadelphia Mindfulness Scale measure: The Sensitivity to Punishment and Sensitivity to Reward Questionnaire measure: The Emotional Word Lists sex: ALL minimumAge: 18 Years maximumAge: 56 Years stdAges: ADULT facility: Xianglong Zeng city: Beijing state: Beijing zip: 100875 country: China lat: 39.9075 lon: 116.39723 typeAbbrev: Prot_SAP hasProtocol: True hasSap: True hasIcf: False label: Study Protocol and Statistical Analysis Plan date: 2024-03-27 uploadDate: 2024-03-27T06:37 filename: Prot_SAP_000.pdf size: 125410 hasResults: False
<\|newrecord\|> nctId: NCT06360484 id: PrevelanceHDVSudan briefTitle: Prevalence and Clinical Characterization of Hepatitis D Virus (HDV) Infection Among Sudanese Patients With Hepatitis B Virus overallStatus: COMPLETED date: 2022-06-01 date: 2022-09-01 date: 2022-09-10 date: 2024-04-11 date: 2024-04-11 name: National Center for Gastroentestinal and Liver Disease class: OTHER briefSummary: Background: Sudan has a high prevalence of hepatitis B surface antigen (HBsAg), exceeding 8%. The prevalence of hepatitis B varies across different regions of Sudan, ranging from 6.8% in central Sudan to as high as 26% in southern Sudan. Hepatitis B virus (HBV) infection can lead to various complications, including cirrhosis, liver failure, and hepatocellular carcinoma (HCC). Hepatitis D virus (HDV) relies on HBV for replication and can accelerate the progression of HBV-related liver diseases, leading to more severe outcomes. This study aims to determine the prevalence of HDV infection among Sudanese patients with HBV-related liver diseases and to investigate the clinical characteristics of patients with HBV/HDV co-infection.
Design/Method: This descriptive cross-sectional hospital-based study was conducted at Ibn Sina Specialized Hospital in Sudan between June and September 2022. Ninety HBV patients aged 16 years and above were included. Patients were interviewed using a structured questionnaire, and medical histories and examinations were recorded. Investigations included liver function tests, abdominal ultrasounds, and ELISA for Ant-HDV-IgG conditions: Hepatitis B conditions: Hepatitis D conditions: Viral Hepatitis studyType: OBSERVATIONAL observationalModel: CASE_ONLY timePerspective: CROSS_SECTIONAL count: 90 type: ACTUAL name: investigations for Hepatitis D virus measure: the prevalence of hepatitis D infection among Sudanese patients with HBV-related liver diseases. sex: ALL minimumAge: 16 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: National Center for Gastrointestinal and Liver Diseases city: Khartoum zip: 15004 country: Sudan lat: 15.55177 lon: 32.53241 hasResults: False
<\|newrecord\|> nctId: NCT06360471 id: FS-FMC briefTitle: Fertility Preservation and Pregnancy and Offspring Health Outcomes in Female Cancer overallStatus: RECRUITING date: 2023-10-01 date: 2027-10-01 date: 2032-10-01 date: 2024-04-11 date: 2024-04-16 name: The First Affiliated Hospital with Nanjing Medical University class: OTHER briefSummary: To explore whether there is a significant difference in the cumulative live birth rate and maternal and child health outcomes between cancer patients who undergo or do not undergo fertility preservation before receiving anti-tumor treatment and non-cancer patients who undergo assisted reproductive technology treatment/natural pregnancy.
This study will be conducted in the Clinical Center of Reproductive Medicine, First Affiliated Hospital of Nanjing Medical University. 2800 women diagnosed with malignant cancers who has desire to reproduce will be enrolled in this study.
Statistical analysis of the data will be performed. conditions: Fertility Issues conditions: Cancer studyType: OBSERVATIONAL observationalModel: COHORT timePerspective: PROSPECTIVE count: 2800 type: ESTIMATED name: fertility preservation measure: 5-year cumulative live birth rate measure: Ovarian function(AMH levels) measure: Ovarian function(AFC counts) measure: Newborn malformation rate measure: Tumor recurrence rate measure: Tumor survival rate sex: FEMALE minimumAge: 20 Years maximumAge: 40 Years stdAges: ADULT facility: Clinical Center of Reproductive Medicine of First Affiliated Hospital with Nanjing Medical University status: RECRUITING city: Nanjing state: Jiangsu zip: 210000 country: China name: Xiang Ma, MD. PHD role: CONTACT phone: +8618001581878 email: sxmaxiang@126.com name: Nan Lu role: CONTACT phone: +8615950476023 email: nancylu1993@126.com lat: 32.06167 lon: 118.77778 hasResults: False
<\|newrecord\|> nctId: NCT06360458 id: MRCTA,ECFAH of FMU[2024]368 briefTitle: Methylprednisolone Adjunctive to Endovascular Treatment for Stroke overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2025-05-01 date: 2028-03-01 date: 2024-04-11 date: 2024-04-11 name: Wan-Jin Chen class: OTHER briefSummary: The efficacy and safety of methylprednisolone in acute ischemic stroke patients with large infarct cores (ASPECTS score \< 6) due to anterior circulation large vessel occlusion have not been clearly established. This is a multi-center, randomized, double-blind, placebo-controlled trial to investigate early combination therapy with methylprednisolone for reperfusion in acute large core infarction. conditions: Acute Ischemic Stroke studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 735 type: ESTIMATED name: Methylprednisolone measure: Mortality at 90 days sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT hasResults: False

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