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Application of Surgical Templates in the Surgical Exposure of Impacted Canines

Impacted Tooth

The first choice therapy in case of palatally impacted canines is their exposure and orthodontic eruption to improve facial esthetics and prevent pathologies associated with impacted teeth and Temporomandibular Joint Disorders. Current solutions in digital dentistry allow the registration of three dimensional imaging datasets such as cone beam computed tomography (CBCT) and digital impression of the dentition and soft tissues obtained via intraoral scanning using orthodontic planning software. This allows the surgeon to visualize the position of the impacted canine prior to surgery and to design and manufacture a surgical guide to aid in the localization of the impacted tooth during surgery. The aim of this randomized clinical trial is to assess the feasibility of surgical exposure of palatally impacted upper canines with open-eruption technique using a surgical template. The secondary purpose of this study is to compare this method with the conventional free-hand surgical exposure. Patients included in this study are randomly assigned to two study groups. In Group 1 surgical exposure for open eruption of palatally impacted canines is performed following virtual planning using a surgical template. In Group 2 surgical exposure for open-eruption of palatally impacted canines is carried out using the conventional free-hand method. We hypothesize that guided exposure of the impacted canines will be as successful as the conventional method with shorter surgical intervention and higher associated costs.

Начало: 01.05.2023 Край: 30.06.2028 Възраст: 11–18 г.

Hungary Semmelweis University NCT05909254

Активно (без набиране)

Using NLP and Neural Networks to Autonomously Identify Severe Asthma and Determine Study Eligibility in a Large Healthcare System

Severe Asthma

The study aims to to use new technologies (ML, AI, NLP), to autonomously identify moderate to severe asthma populations within an EHR system, describe differences in treatment patterns across different populations, and determine trial eligibility. Primary Objectives Please ensure you detail primary objectives Aim 1. Determine and validate a diagnosis of severe asthma (SA) using predictive features obtained from the Scripps Health EHR. * Aim 1a: Use ML applied to structured EHR data to predict SA. Use the opinion of 2 specialty-trained physicians and ATS guidelines to determine model accuracy. * Aim 1b: Use NLP applied to unstructured text to predict SA. Determine model accuracy as above in Aim 1a. * Aim 1c: Use a combination of ML applied to structured data to predict SA. Determine model accuracy as above in Aim 1a.

Начало: 01.05.2023 Край: 01.12.2026 Възраст: 6–85 г.

United States San Diego State University NCT06389058

Активно (без набиране)

Clinical Validation of Samsung Smartwatch

Major Depressive Disorder Mood Disorders Mental Health Issue

Objective: Wearable technology holds promising potential for mental health monitoring and detection. Samsung has developed an algorithm that they believe can detect signs of depression and anxiety in smartwatch users. They have used this algorithm to create a "Mindfulness Index," which is an easily understood visual index of mental health. The primary aim of the study is to evaluate the performance of Samsung's Mindfulness Index in identifying those who have received a diagnosis of Major Depressive Disorder (MDD) from a clinician-administered semi-structured diagnostic interview. Research Procedures: The target sample size is 135 individuals diagnosed with current Major Depressive Disorder and 85 healthy controls. To meet this target, the recruitment target is set at 220 participants. Participants will be assigned to the MDD condition, or the healthy control condition based on their score on the Beck Depression Inventory. Each subject will be followed for 3 months. Participants will be provided with a Samsung smartphone and Samsung smartwatch. Participants will be asked to wear the smartwatch 24 hours per day, except while charging. This smartwatch will collect data on heartrate, sleep time, and step count. During the study, each day participants will receive texts prompting a link to a "daily diary." These surveys will ask about depression and anxiety symptoms. Additionally, during the first 3 weeks of the study, participants will participate in ecological momentary assessment; texts will be sent 5 times per day prompting participants to fill out a survey about how they currently feel in that moment. These extra surveys will stop after the first 3 weeks of the study, but the daily diary surveys will continue throughout the study. Furthermore, virtual clinician visits will occur at weeks 4, 8, and 12.

Начало: 27.04.2023 Край: 01.01.2027 Възраст: 18–65 г.

United States Massachusetts General Hospital NCT05767593

Активно (без набиране) Фаза 1

CD19-Car T Cell Therapy for the Treatment of Older Adults With Acute Lymphoblastic Leukemia in First Remission

B Acute Lymphoblastic Leukemia

This phase I trial tests the safety, side effects, and best dose of autologous anti-CD19 CAR-expressing T lymphocytes (CD19-CAR T cells) in older adults with B-cell acute lymphoblastic leukemia. Chimeric antigen receptor (CAR) T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of B-cell acute lymphoblastic leukemia.

Начало: 26.04.2023 Край: 24.07.2026 Възраст: от 55 г.

United States City of Hope Medical Center NCT05707273

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Comparison of Ultrasound and Breast MRI for Breast Cancer Detection

Breast Neoplasms Breast Cancer

The goal of this randomized clinical trial is to compare diagnostic results of secondary breast cancer surveillance using breast ultrasound abbreviated MRI and full protocol MRI.

Начало: 23.04.2023 Край: 28.05.2028 Възраст: 20–75 г.

South Korea Samsung Medical Center NCT05797545

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Prospective Validation of an EHR-based Pancreatic Cancer Risk Model

Pancreatic Adenocarcinoma Predictive Cancer Model

The goal of this prospective observational cohort study is to validate a previously developed pancreatic cancer risk prediction algorith (the PRISM model) using electronic health records from the general population. The main questions it aims to answer are: * Will a pancreatic cancer risk model, developed on routine EHR data, reliably and accurately predict pancreatic cancer in real-time? * What is the average time from model deployment and risk prediction, to the date of pancreatic cancer development and what is the stage of pancreatic cancer at diagnosis? The risk model will be deployed on data from individuals eligible for the study. Each individual will be assigned a risk score and tracked over time to assess the model's discriminatory performance and calibration.

Начало: 21.04.2023 Край: 01.09.2026 Възраст: 40–100 г.

United States Beth Israel Deaconess Medical Center NCT05973331

Активно (без набиране) Фаза 2

TTI-622 in Combination With Pembrolizumab for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Recurrent ALK Positive Large B-Cell Lymphoma Recurrent B-Cell Non-Hodgkin Lymphoma Recurrent Diffuse Large B-Cell Lymphoma Associated With Chronic Inflammation Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified +24

This phase II trial tests the safety, side effects, and best dose of TTI-621 (closed to enrollment) or TTI-622 in combination with pembrolizumab in treating patients with diffuse large B-cell lymphoma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). TTI-621 and TTI-622 are called fusion proteins. A fusion protein includes two specialized proteins that are joined together. In TTI-621 and TTI-622, one of the proteins binds with other proteins found on the surface of certain cells that are part of the immune system. The other protein targets and blocks a protein called CD47. CD47 is present on cancer cells and is used by those cells to hide from the body's immune system. By blocking CD47, TTI-621 and TTI-622 may help the immune system find and destroy cancer cells. Pembrolizumab is a monoclonal antibody directed against human cell surface receptor PD-1 (programmed death-1 or programmed cell death-1) that works by helping the body\'s immune system attack the cancer and may interfere with the ability of cancer cells to grow and spread. Giving TTI-621 (closed to enrollment) or TTI-622 in combination with pembrolizumab may kill more cancer cells in patients with relapsed or refractory diffuse large B-cell lymphoma.

Начало: 19.04.2023 Край: 30.07.2027 Възраст: от 18 г.

United States Mayo Clinic NCT05507541

Активно (без набиране) Ранна Фаза 1

Pilot Study of Imatinib Cetuximab Combo for H & N Cancer

Head and Neck Cancer Squamous Cell Carcinoma of Head and Neck

The goal of this clinical trial is to find if levels of a protein called AXL in tumor cells relate to how tumors respond to cetuximab (CTX) combined with imatinib in participants with head and neck cancer. This interventional study will occur in the time between diagnosis of your cancer and surgery to remove your tumor or radiation or chemoradiation treatment of your primary cancer. Participants will undergo a research blood draw and a research biopsy as part of the screening process, and will be in this research study for approximately 13 to 16 months.

Начало: 18.04.2023 Край: 31.10.2026 Възраст: от 18 г.

United States University of Wisconsin, Madison NCT05816785

Активно (без набиране)

The Ready and Healthy for Kindergarten Study

Parenting Language Development Literacy Health Behavior

The goal of this clinical trial is to test whether a family wellness program enhances child and parenting outcomes among Latino dual language learners entering Kindergarten and their families. The main questions are: (1) To what extent does the family wellness program enhance home health and learning routines, and (2) To what extent does the family wellness program enhance child literacy, language, and social-emotional outcomes. All participants will be asked to complete surveys and assessments. Researchers will compare two groups: (1) Family wellness program that includes (a) 8-weekly summer sessions, (b) text messages, (c) booster sessions, and (2) usual care plus school supplies and list of resources to see if the family wellness program enhances child and parenting outcomes.

Начало: 15.04.2023 Край: 30.11.2026 Възраст: 4–6 г.

United States Rutgers, The State University of New Jersey NCT05760573

Активно (без набиране)

Glycemia and Ischemia Reperfusion Brain Injury in Patients With Acute Cerebral Infarction Treated With Mechanical Thrombectomy

Cerebral Infarction

Postictus hyperglycemia is associated with an accelerated transformation of the ischemic penumbra into an infarct area, with increased infarct size, worse recanalization, reduced cerebral perfusion, increased ischemia reperfusion damage, and worse outcome. Furthermore, when perfusion is reinstated, hyperglycemia causes secondary tissue damage through an increase in ischemic reperfusion damage. Thus, those patients with glycemia values \< 155 mg/dL during mechanical thrombectomy, and especially at the time of reperfusion, will have greater ischemia-reperfusion damage, showing a different profile in miRNA expression, with better neurological and functional outcomes and higher risk of hemorrhagic transformation and cerebral edema. The main objective of the study is to evaluate the association between glycemia values at the time of reperfusion and stroke recovery at 3 months in patients with acute cerebral infarction treated with mechanical thrombectomy.

Начало: 13.04.2023 Край: 15.07.2026 Възраст: от 18 г.

Spain Instituto de Investigación Hospital Universitario La Pa NCT05871502

Активно (без набиране)

Evaluation of My Future Self, an New Teen Pregnancy Prevention Group Intervention for Youth in Non-traditional Settings

Teen Pregnancy

Children's Hospital Los Angeles and ETR will implement and test the effectiveness of a pregnancy prevention intervention, My Future Self, targeting youth ages 16-19 in Los Angeles and San Diego Counties who, for a variety of reasons, are receiving education or training in non-traditional settings. These youth typically experience a combination of needs related to unstable or no housing, extreme poverty, involvement with child welfare or juvenile justice, historical trauma, and/or learning differences. My Future Self is a 5 week program consisting of 5 group sessions. Our study will enroll up to 704 highly mobile youth from various sites in Los Angeles and San Diego. Youth will be randomized to receive the My Future Self intervention in conjunction with their regular services or just their regular services. All youth enrolled will complete baseline, 6 month and 12 month surveys.

Начало: 13.04.2023 Край: 31.01.2027 Възраст: 16–19 г.

United States Children's Hospital Los Angeles NCT05796687

Активно (без набиране) Фаза 2

Inhaled Corticosteroids (ICS) on Pulmonary Endothelial Function in COPD

Chronic Obstructive Pulmonary Disease

The study objective is to determine whether an ICS added for 4 weeks to a baseline treatment with a Long-Acting Beta-adrenergic Agonist (LABA) and Long-Acting Muscarinic Antagonist (LAMA) combination improves pulmonary vascular endothelial function as assessed by the vasodilator response to inhaled albuterol (endothelium-dependent vasodilation) in stable COPD patients treated with a LABA/LAMA without an ICS for at least one month.

Начало: 11.04.2023 Край: 30.06.2026 Възраст: 40–80 г.

United States University of Miami NCT05607719

Активно (без набиране)

Tracking Brain Biomarkers and Renormalization Associated With Antidepressant Transcranial Magnetic Stimulation Therapy

Major Depressive Disorder

This study will attempt to use magnetic resonance imaging (MRI) to take a picture of the brain to learn about changes that occur in the brain during Transcranial Magnetic Stimulation (TMS) in people receiving this treatment for depression.

Начало: 04.04.2023 Край: 01.04.2027 Възраст: 18–65 г.

United States Medical University of South Carolina NCT06043401

Активно (без набиране) Фаза 1

Personalized TCR-T: Study of Adoptively Transferred T-cell Receptor Gene-engineered T Cells (TCR-T)

Malignant Epithelial Neoplasms

This is a phase I/Ib study of adoptively transferred T-cell receptor gene-engineered T cells (TCR-T) targeting tumor-specific antigens, with in vivo CD40 activation and PD-1 blockade, for patients with incurable cancers. The study design is a safety lead-in TCR-T with CD40/PD-1 (3+3), followed by Simon's Two-Stage expansion design, 80% power and 5% one-sided alpha: stage-one futility assessment at n = 10; stage-two assessment at n = 22, (accrual up to 24 to allow for potential study drop-out).

Начало: 03.04.2023 Край: 15.04.2028

United States Providence Health & Services NCT05349890

Активно (без набиране) Фаза 2

Open Label, Long-term Study Evaluating Safety and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis

Dermatitis Atopic

This is a single group, 1-arm, long-term safety study for treatment of participants with moderate to severe atopic dermatitis (AD). The purpose of this study is to characterize the long-term safety and efficacy of amlitelimab in treated participants with age ≥12 years old with moderate to severe AD. The study duration per participant will be up to 284 weeks, including: * A screening period of up to 2 to 4 weeks * An open label treatment period of up to 268 weeks (approximately 5 years) * A post-treatment safety follow-up period of at least 20 weeks after the last dose administration (last IMP administration at Week 264) The planned number of visits will be 35 visits.

Начало: 03.04.2023 Край: 11.06.2031 Възраст: от 12 г. Лечение

Argentina, Australia, Brazil +22 Sanofi NCT05769777

Активно (без набиране)

Relevance of Reversible Causes During OHCA (Rebecca Study)

Out-Of-Hospital Cardiac Arrest Cardiopulmonary Arrest

Management of the reversible causes in cardiac arrest is fundamental for successful treatment of out-of-hospital cardiac arrests. Point-of-care diagnostics as prehospital emergency ultrasound, blood gas analysis and toxicological screening support the diagnostic process of evaluating potential reversible causes. Digital tools provide support of a structured approach. This study aims to evaluate the frequency of reversible causes during OHCA as well as specific interventions due to these findings. Furthermore, CPR performance (hands-off, ROSC, 30-day mortality) and cognitive load of the prehospital emergency physician will be investigated. In total 100 patients with OHCA will be included in this study. Identification of reversible causes will be performed upon a structured protocol using an interactive checklist. Cognitive load of emergency physician as well as CPR parameter (frequency of reversible causes, hands-off, ROSC, 30-day mortality) will be analysed.

Начало: 01.04.2023 Край: 31.12.2026 Възраст: от 18 г.

Austria Medical University of Vienna NCT05784480

Активно (без набиране)

Comprehensive Prospective Comparison Of Two Robotic Platforms In Anatomical Lung Resections: Clinical Outcomes And Cost-utility Analysis

Pulmonary Nodule, Solitary Lung Cancer (NSCLC) Pulmonary Metastases

The goal is to compare clinical outcomes, hospital costs, and cost-utility in patients undergoing anatomical lung resections with DaVinci Xi vs Versius platforms The main questions it aims to answer are: * Do patients that undergo an anatomical lung resection with DaVinci Xi have the same clinical outcomes (complications, stay...) than those who were operated with Versius? * Are anatomical lung resections performed with DaVinci Xi more expensive than those performed with Versius? * Are anatomical lung resection performed with DaVinci Xi more cost-effective than those performed with Versius? Participants already undergoing robotic anatomical lung resection as part of their regular medical care will answer quality of life questionnaires preoperatively, at 1, 3, 6, and 12 months after surgery.

Начало: 01.04.2023 Край: 31.07.2026 Възраст: от 18 г.

Spain Fundacion para la Investigacion Biomedica del Hospital NCT07537556

Активно (без набиране)

Prospective Validation of Liver Cancer Risk Computation (LIRIC) Models

Predictive Cancer Model

The goal of this prospective observational cohort study is to validate previously developed Hepatocellular Carcinoma (HCC) risk prediction algorithms, the Liver Risk Computation (LIRIC) models, which are based on electronic health records. The main questions it aims to answer are: * Will our retrospectively developed general population LIRIC models, developed on routine EHR data, perform similarly when prospectively validated, and reliably and accurately predict HCC in real-time? * What is the average time from model deployment and risk prediction, to the date of HCC development and what is the stage of HCC at diagnosis? The risk model will be deployed on data from individuals eligible for the study. Each individual will be assigned a risk score and tracked over time to assess the model's discriminatory performance and calibration.

Начало: 01.04.2023 Край: 31.03.2027 Възраст: 40–100 г.

United States Beth Israel Deaconess Medical Center NCT06140823

Активно (без набиране)

Utilizing Electronic Clinical Decision Support to Enhance mTBI Care at the Primary Care Point of Entry

Brain Concussion Mild Traumatic Brain Injury

Six primary care practices within a large Philadelphia pediatric care network will use an electronic Clinical Decision Support (eCDS) tool as standard care for concussion evaluation. The eCDS tool will include a prediction rule for children aged 5-18 assessed for mild traumatic brain injury (mTBI). The eCDS tool predicts risk for persistent symptoms and prompts referral to specialty care for those deemed high risk. This research proposes to analyze the clinical and process outcomes in these six practices relative to the rest of the care network, specifically, whether the eCDS tool reduces time to symptom resolution.

Начало: 01.04.2023 Край: 01.09.2026 Възраст: 5–18 г.

United States Children's Hospital of Philadelphia NCT06693778

Активно (без набиране) Фаза 3

Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer

Breast Cancer

This is a Phase III, randomized, double-blind, parallel, multi-center trail to evaluate the efficacy and safety of TQB3616 capsule combined with endocrine compared to placebo compared with endocrine in HR-positive and HER2-negative breast cancer adjuvant therapy. Approximately 1946 female subjects will be randomized to either TQB3616 combined with endocrine group or TQB3616-matching placebo combined endocrine group. Randomization will follow a 2:1 ratio, 1297 subjects in experimental group and 649 in the the Placebo Comparator group.

Начало: 30.03.2023 Край: 01.01.2027 Възраст: 18–75 г.

China Chia Tai Tianqing Pharmaceutical Group Co., Ltd. NCT05780567

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