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* Aim 1:examine whether gamified ABM leads to greater change in the primary and secondary outcomes than sham ABM
* Aim 1: establish that gamified ABM is at least as effective as traditional ABM.
* Aim 2: identify moderators of ABM efficacy and mechanisms responsible for its efficacy.
* Aim 3: Identify the durability of ABM on depression symptoms during short-term follow-up
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: [email protected] role: CONTACT email: [email protected] 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: [email protected] 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: [email protected] name: Timo Nannen role: CONTACT phone: +41 31 632 90 74 email: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] 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: [email protected] name: Helen Green role: CONTACT phone: 44 7825866041 email: [email protected] 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?