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NCT ID: NCT04657991 Active, not recruiting - Melanoma Clinical Trials

A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma

Start date: January 15, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to learn about the effects of three study medicines (encorafenib, binimetinib, and pembrolizumab) given together for the treatment of melanoma that: - is advanced or metastatic (spread to other parts of the body); - has a certain type of abnormal gene called "BRAF"; and - has not received prior treatment. All participants in this study will receive pembrolizumab at the study clinic once every 3 weeks as an intravenous (IV) infusion (given directly into a vein). In addition, half of the participants will take encorafenib and binimetinib orally (by mouth) at home every day. Participants may receive pembrolizumab for up to two years. Those participants taking encorafenib and binimetinib can continue until their melanoma is no longer responding. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.

NCT ID: NCT04657289 Recruiting - Clinical trials for Neovascular Age-related Macular Degeneration (nAMD)

A Study of the Efficacy, Safety, and Pharmacokinetics of A 36-Week Refill Regimen for the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration (Velodrome)

Start date: July 14, 2021
Phase: Phase 3
Study type: Interventional

Study WR42221 is a Phase IIIb, global, multicenter, randomized, visual assessor-masked study designed to assess the efficacy, safety, and pharmacokinetics of the Port Delivery System with ranibizumab (PDS) 100 mg/mL delivered every 36 weeks (Q36W) compared with every 24 weeks (Q24W) in patients with neovascular age-related macular degeneration (nAMD).

NCT ID: NCT04657224 Active, not recruiting - Clinical trials for Chronic Lymphocytic Leukemia

A Study of JNJ-64264681 and JNJ-67856633 in Participants With Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

Start date: February 25, 2021
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to determine: the recommended Phase 2 doses (RP2Ds) of JNJ-64264681 and JNJ 67856633 when administered together in participants with B cell non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL) (Part A - Dose Escalation); and the safety of the RP2Ds for this combination in different histologies/participant populations (Part B - Cohort Expansion).

NCT ID: NCT04656418 Completed - Clinical trials for Hereditary Angioedema

CSL312 (Garadacimab) in the Prevention of Hereditary Angioedema Attacks

Start date: January 27, 2021
Phase: Phase 3
Study type: Interventional

This is a multicenter, double-blind, randomized, placebo-controlled, parallel-arm study to investigate the efficacy and safety of subcutaneous administration of CSL312 (garadacimab) in the prophylactic treatment of hereditary angioedema.

NCT ID: NCT04654546 Recruiting - Anatomy Clinical Trials

Conversion of Ultrasound Images to CT Format Imaging Using Artificial Intelligence-based Learning

Start date: August 24, 2021
Phase: N/A
Study type: Interventional

Background: Ultrasound imaging is an imaging method that uses sound waves to characterize the structure and function of various organs in health and disease conditions. This technique is widely used in clinical day-to-day life and has many advantages, such as real-time imaging, availability for imaging at the patient's bedside, and lack of ionizing radiation. Aside from the mentioned advantages, the ultrasound test also has notable drawbacks. These include the absence of sound wave penetration through a medium containing air such as intestinal loops, dependence on operator skill, and the need for the subject's cooperation during the test. Compared to the ultrasound examination, the CT scan allows for a broader anatomical view and is not limited by physiological factors such as bones and air. on the other hand, the test requires ionizing radiation that inevitably carries a direct and indirect danger to the patient's health, and requires more financial resources. Objectives of the study: Using artificial intelligence to bridge the gap between ultrasound and CT scans, and to create a uniform system that takes advantage of them. This is to allow for better spatial orientation as well as a better characterization of the anatomical structures being scanned. Participants: Women and/or men over the age of 18, who performed an abdominal CT scan during the previous month for the ultrasound examination in the experiment. Methods: The study is a prospective open-label research, in which both the physician and the patient are aware of the manner and purposes of the scan. Participants who meet the threshold conditions will be summoned for examination in the rooms of the Imaging Institute at Haemek medical center, during which the participants will undergo a complete ultrasound scan of the abdominal organs using a clinical ultrasound device. The ultrasound images will be visually coupled to previous CT images of the same patient at the time of the examination, using a Fusion system located in the ultrasound device mentioned above. The conjugated CT and ultrasound images will be encoded and will be sent without identifying details to the SAMPL laboratory, to be used as a learning platform for the artificial intelligence system. The images will be transferred after the subject's personal details have been encoded in an EXCEL file and saved by the principal investigator.

NCT ID: NCT04653961 Recruiting - Type1diabetes Clinical Trials

Evaluation of a Decision Support System for People With Diabetes Who Use Multiple Daily Insulin Injections- Feasibility and Proof of Concept Studies

Start date: June 1, 2020
Phase: N/A
Study type: Interventional

The study comprises of two segments: a feasibility segment and a Proof of Concept segment. The study is open label, prospective study that will include up to 72 subjects in segment 1 and up to 40 subjects in segment 2. Participants are people with Type 1 or type 2 Diabetes treated with Multiple Daily Injections ( MDI) and Self Monitoring of Blood Glucose (SMBG) or intermittent Continuous Glucose Monitoring (CGM). The study will include screening, a 2-4-week run-in period and 10-12 weeks intervention period. Subjects will be asked to record their insulin delivery during basal/bolus insulin treatment (using dedicated apps ) and their daily activities (meals, physical activity etc.) using electronic log (implemented on Dedicated Apps), for a total period of 12-16 weeks. The goal of this study is to evaluate the safety of a decision support system for adjustment of insulin treatment plan for people with diabetes using multiple daily injections and monitoring glucose by SMBG or intermittent CGM

NCT ID: NCT04653831 Completed - Covid19 Clinical Trials

Treatment With Pirfenidone for COVID-19 Related Severe ARDS

Start date: November 8, 2020
Phase: N/A
Study type: Interventional

A randomized, open label, two arm, pilot trial of Pirfenidone 2,403 mg administered per nasogastric tube or orally as 801mg TID for 4 weeks in addition to Standard of Care (SoC), compared to SoC alone, in a population of COVID-19 induced severe ARDS. Patients will be randomized according to 1:1 ratio to one of the trial arms: Pirfenidone (intervention arm) or SoC (control arm).

NCT ID: NCT04653506 Completed - Pain Clinical Trials

Paracetamol / Ibuprofen for Postpartum Pain in the Early Postpartum Period

Start date: November 28, 2020
Phase: N/A
Study type: Interventional

The investigators will examine the effectiveness of non-opioid analgesia (Paracetamol versus Ibuprofen) in the early postpartum period

NCT ID: NCT04652726 Active, not recruiting - Clinical trials for Familial Hypercholesterolemia - Heterozygous

Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Heterozygous Familial Hypercholesterolemia

ORION-16
Start date: January 27, 2021
Phase: Phase 3
Study type: Interventional

This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein cholesterol (LDL-C).

NCT ID: NCT04651309 Completed - Pregnancy Related Clinical Trials

Assessment of Labour Progress by Intrapartum Ultrasound

Start date: August 27, 2019
Phase: N/A
Study type: Interventional

Assessment of labor progress via digital exams is considered the standard of care in most delivery rooms. However, this method can be stressful, painful and imprecise and multiple exams increase the risk for chorioamnionitis. Trans-perineal ultrasound (TPUS) was found to be an objective noninvasive way to monitor labor progress. The study aim is to investigate whether, in nulliparous women, the use of TPUS during labor can reduce the number of vaginal exams and the incidence of chorioamnionitis.