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NCT ID: NCT06241664 Recruiting - Clinical trials for Diabetic Retinopathy, DR

Efficacy and Safety of AEYE Diagnostic Screening (AEYE-DS) Software Device for Detection of Diabetic Retinopathy From Digital Funduscopic Images

Start date: January 31, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn about the performance of the AEYE-DS Software Device to automatically detect more than mild Diabetic Retinopathy (mtmDR) in adult participants diagnosed with Diabetic Mellitus (DM) using fundoscopic images of the eyes. The main question it aims to answer is if the software is effective in diagnosing more than mild Diabetic Retinopathy (mtmDR) in patients with known diabetes using digital funduscopic images, acquired from each of the participating fundoscopy devices and based on one macula centered image per eye. Participants: - will have an eye exam in which photographic images of each eye will be taken by a novice operator, using four different FDA approved/registered fundoscopy cameras. These images will be sent to and analyzed by the AEYE-DS software device. - will have additional eye imaging taken using a different FDA approved desktop camera system by a professional ophthalmic photographer. These images will be sent to an independent reading center for analysis. - will have dilation drops put in their eyes (either during or after the imaging with the fundoscopy cameras), wait about 30 minutes for the pupils to dilate and continue the eye imaging exams. The outcome results with the AEYE-DS Software will be compared to the analysis of the eye images processed by the reading center to see if the investigational software device was accurate in its diagnosis.

NCT ID: NCT06241456 Recruiting - Clinical trials for Advanced Solid Tumor

FT825/ONO-8250, an Off-the-Shelf, HER2 CAR-T, With or Without Monoclonal Antibodies in Advanced Solid Tumors

Start date: January 5, 2024
Phase: Phase 1
Study type: Interventional

This is a phase 1 study designed to evaluate the safety, tolerability, and antitumor activity of FT825 (also known as ONO-8250) with or without monoclonal antibody therapy following chemotherapy in participants with advanced human epidermal growth factor receptor 2 (HER2)-positive or other advanced solid tumors. The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT825 in indication-specific cohorts.

NCT ID: NCT06241430 Not yet recruiting - Clinical trials for Heart Failure With Reduced Ejection Fraction

The CardioClip Study

CardioClip
Start date: February 2024
Phase: N/A
Study type: Interventional

The CardioClip study is exploring the use of a wireless sensor to monitor pressure in the pulmonary artery. This sensor is inserted much like the mTEER procedure, a non-surgical method through a vein in the groin. The investigators want to find out if the sensor, by constantly sending information about heart function, can help improve patient outcomes. This means doctors could adjust medications based on real-time pressure changes detected by the sensor. The results from this study will help pave the way for future trials, asking if using these wireless sensors could benefit people with valve disease and heart failure.

NCT ID: NCT06241300 Recruiting - Executive Function Clinical Trials

Executive Function and Parenting in Childhood

EPIC
Start date: November 20, 2023
Phase: N/A
Study type: Interventional

Deficits in executive functioning (EF) disproportionately impact children living in poverty and increase risk for psychopathology, particularly disruptive behavior disorders. This randomized clinical trial seeks to determine whether childhood EF, assessed across neural and behavioral units of analysis, is an experimental therapeutic target that can be directly modified through caregiver participation in the Chicago Parent Program (CPP), if increases in EF predict reduced disruptive behavior trajectories in low-income children over a short-term follow-up period, and identify which CPP-driven parenting skill improvements are the most influential in modifying EF. This work will contribute new knowledge as to whether a cost-efficient parenting intervention, developed for and with low-income families raising young children in poverty, can modify EF, a neural behavioral mechanism implicated in risk for childhood disruptive behavior problems.

NCT ID: NCT06241183 Recruiting - GERD Clinical Trials

Famotidine and Antacids for Treatment of Dyspepsia

Start date: November 9, 2023
Phase: Phase 4
Study type: Interventional

The aim of this study is to compare intravenous famotidine, an H2 receptor antagonist, and Maalox/ Mylanta, an oral antacid, in treatment of dyspepsia in the emergency department. The goal of this study is to reduce patients' pain based on the verbal numerical pain scale. The anticipated outcome is for pain levels in both groups to decrease. It is expected that antacids will improve symptoms more quickly and to a greater degree within an hour of taking medication based on the results of similar studies.

NCT ID: NCT06241118 Recruiting - Dermatitis Atopic Clinical Trials

A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor

AQUA
Start date: February 29, 2024
Phase: Phase 3
Study type: Interventional

This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm study for treatment of participants diagnosed with moderate-to-severe AD on background TCS who have had inadequate response to prior biologic or oral JAKi therapy. The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for subcutaneous (SC) injection compared with placebo in participants with moderate-to-severe AD aged 12 years and older on background TCS and have had an inadequate response to prior biologic or an oral JAKi therapy. Study details include: At the end of the treatment period, participants will have the option to enter the Long-Term Safety Study LTS17367 (RIVER-AD). The study duration will be up to 56 weeks for participants not entering the long-term safety study (LTS17367 [RIVER-AD]) including a 2 to 4-week screening, a 36-week randomized double-blind period, and a 16-week safety follow-up. The study duration will be up to 40 weeks for participants entering the long-term safety study (LTS17367 [RIVER-AD]) including a 2 to 4-week screening and a 36-week randomized double-blind period. The total treatment duration will be up to 36 weeks. The total number of visits will be up to 13 visits (or 12 visits for those entering the long-term safety study LTS17367 [RIVER-AD] study).

NCT ID: NCT06240871 Completed - Clinical trials for Pulmonary Hypertension

Contrast Enhanced PA Pressure Measurements

Start date: September 2013
Phase:
Study type: Observational

Pulmonary hypertension (PH) is an abnormal increase of the pressure inside the lung circulation. This condition can be caused by many different diseases. If PH persists for a long period of time, irreversible damage to the lung circulation and to the heart may ensue. A definitive diagnosis of PH requires direct measurement of the pressure within the lung circulation with a procedure called right heart catheterization (RHC). While overall safe, RHC is an invasive procedure and is associated with a small risk of complications (~1.1%) and, very rarely, death (0.055%), even when performed in experienced laboratories. Therefore, alternative diagnostic approaches are often employed such as an ultrasound technique called Doppler echocardiography which is non-invasive, relatively inexpensive and widely available technique. It is suitable not only as a screening tool but also for serial monitoring of disease progression in PH. However, the accuracy of Doppler echocardiography in measuring pressure in the lung circulation appears to be modest in patients with suspected PH. To improve the performance of Doppler echocardiography it is common practice to inject a small amount of agitated saline or an echocardiographic contrast medium (usually composed of microbubbles of fat containing a minuscule amount of a gas) into a vein. However, the accuracy of using agitated saline or a contrast agent in the measurement of pressures inside the lung circulation has not been established. The proposed study will assess the accuracy of Doppler echocardiographic measurements of pressures in the pulmonary circulation by simultaneously comparing the pressures collected during a RHC. The investigators will enroll 100 consecutive patients undergoing RHC in the Catheterization Laboratory of Northwestern Memorial Hospital. The investigators will measure pulmonary pressures by RHC and by Doppler echocardiography at baseline and following the injection of agitated saline as well as Optison®, an FDA-approved contrast agent commonly used in the echo laboratory. The investigators will then determine the accuracy of the Doppler echocardiography measurement without and with the use of agitated saline or Optison® with the measurements obtained during the RHC which is the gold standard. The results of this study will allow determination whether the use of echo contrast improves the accuracy of Doppler echocardiography and whether contrast-enhanced Doppler measurements are a clinically useful alternative to RHC measurements.

NCT ID: NCT06240780 Not yet recruiting - Clinical trials for Anterior Cruciate Ligament Reconstruction

Incrediwear ACL MCL Arthroscopic Surgery Recovery Study

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to assess the benefits of using the Incrediwear knee products after anterior cruciate ligament arthroscopic surgery or anterior cruciate ligament and medial collateral ligament (ACL+MCL) arthroscopic surgery, on the postoperative pain, range of motion and effusion. Participant population includes female or male patients in relative good health, 18 to 65 years old. The investigators will compare participants with Incrediwear and placebo Incrediwear products during the first 6-month postoperative period. The main question it aims to answer are: - Will the Incrediwear products help participants to decrease postoperative pain and swelling? - Will the Incrediwear products help the participants by increasing the range of motion in a shorter amount of time than the placebo group? Participants will be asked to maintain a journal documenting surgical site pain, pain medication type and quantity taken. Researcher will compare 90 participants enrolled in one of six groups, double blinded and randomly assigned, to see if the Incrediwear products assist in controlling postoperative swelling, and increase range of motion in a shorter amount of time. - ACL participants randomly assigned the Incrediwear product, placebo product, or none - ACL+MCL participants randomly assigned the Incrediwear product, placebo product, or none

NCT ID: NCT06240754 Not yet recruiting - Clinical trials for Clonal Cytopenia of Undetermined Significance

Enasidenib for Patients With Clonal Cytopenia of Undetermined Significance and Mutations in IDH2A Decentralized Trial

Start date: June 30, 2024
Phase: Phase 2
Study type: Interventional

Study researchers think that a drug called enasidenib may help people with clonal cytopenia of undetermined significance (CCUS) because the drug blocks the mutated IDH2 protein, which may improve blood cell counts. The purpose of this study is to find out whether enasidenib is a safe and effective treatment for CCUS.

NCT ID: NCT06240728 Recruiting - Clinical trials for Metastatic Malignant Neoplasm

A Study of NPX887 for Participants With Solid Tumors Known to Express HHLA2/B7-H7

Start date: January 22, 2024
Phase: Phase 1
Study type: Interventional

NPX887 is a human, antagonistic immunoglobulin G1 (IgG1) monoclonal antibody targeting HHLA2 (B7-H7) that may potentiate an anti-tumor immune response. The goal of this first-in-human study is to learn whether NPX887 is safe and tolerable in participants whose cancers are known to express HHLA2 (B7-H7).The main questions it aims to answer are: - what is an appropriate dose to be given to participants? - are the side effects of treatment manageable? Participants who are treated will receive an intravenous (IV) infusion of NPX887 if their disease has not progressed, and be closely monitored by the treating physicians.