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NCT ID: NCT05784246 Recruiting - Ulcerative Colitis Clinical Trials

A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis

SHINE-2
Start date: November 22, 2023
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to investigate efficacy, pharmacokinetics and safety of the drug in pediatric participants with moderately to severely active ulcerative colitis (UC).

NCT ID: NCT05782907 Recruiting - Ulcerative Colitis Clinical Trials

Study to Assess Adverse Events, Change in Disease Activity, and How Oral Upadacitinib Moves Through the Body of Pediatric Participants With Moderately to Severely Active Ulcerative Colitis.

Start date: November 6, 2023
Phase: Phase 3
Study type: Interventional

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess how safe and effective Upadacitinib is in treating pediatric participants with UC. Adverse events and change in disease activity will be assessed. Upadacitinib (RINVOQ) is a drug approved in adults for moderate- to severely active UC and is being developed for moderate- to severely active UC in pediatric participants. This study is conducted in 2 periods: Period 1 is comprised of two phases: an 8-week open-label induction phase which means that the study doctor and patients know that participants will receive UPA Dose-A (or the adult equivalent based on body weight) followed by a 44-week double-blind maintenance phase meaning that neither the participants nor the study doctors will know which dose of upadacitinib will be given(UPA Dose B or Dose C). Period 2 is a 260 week open-label extension (OLE) of Period 1. Approximately 110 pediatric participants with moderate to severely active UC will be enrolled at up to 100 sites worldwide. Participants will receive upadacitinib oral tablets once daily or oral solution twice daily at approximately the same time each day, with or without food. Participants will be followed up for 30 days after each phase (i.e. after induction, maintenance, OLE) and only if a participant doesn't continue into the next phase. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT05782296 Recruiting - Clinical trials for Obstetric Complication

Noninvasive Monitoring of Uterine Activity and Fetal Heart Rate

Start date: February 24, 2022
Phase:
Study type: Observational

A clinical study designed to validate the safety and performance of the TrueLaborâ„¢ device in monitoring labor vs. current standard of care.

NCT ID: NCT05781555 Recruiting - Malignant Tumor Clinical Trials

A Study of Diffusing Alpha Radiation Therapy for Target Treatments of Malignant Tumors

Start date: March 22, 2023
Phase: N/A
Study type: Interventional

This study is a Compassionate clinical study for the treatment of Malignant Tumors. The primary endpoint of the study is to assess the frequency, severity and causality of acute adverse events related to the DaRT treatment. Adverse events will be assessed and graded according to Common Terminology and Criteria for Adverse Events (CTCAE) version 5.0. The secondary endpoint is to assess the tumor response to DaRT treatment assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1) 3 months after DaRT seed insertion.

NCT ID: NCT05774951 Recruiting - Clinical trials for Breast Cancer, Early Breast Cancer

A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy

CAMBRIA-1
Start date: March 31, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer with intermediate or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The planned duration of treatment in either arm of the study is 60 months.

NCT ID: NCT05771948 Recruiting - Knee Osteoarthritis Clinical Trials

Efficacy and Safety of AqueousJoint Intra-Articular Injections in Mild to Moderate Knee Osteoarthritis

Start date: March 16, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evaluate the Efficacy and Safety of AqueousJoint Intra-Articular Injection in Mild to Moderate Knee Osteoarthritis of AqueousJoint. The main questions it aims to answer are: - To demonstrate superior efficacy of AqueousJoint administered via intra-articular injection versus placebo during the study period. - To evaluate the efficacy of two different concentrations of AqueousJoint, administered via single IA injection as compared to control group (placebo) One IA injection of AqueousJoint or Placebo will be injected to participants' knee. Follow up will take place up to six months.

NCT ID: NCT05771545 Recruiting - Clinical trials for Psychiatric Emergency

Telepsychiatry to Enable Expedited Disposition of Psychiatric Emergencies

Start date: July 1, 2023
Phase:
Study type: Observational

The goal of this observational study is to examine the effect of using a video link for evaluation of patients in the psychiatric emergency room. Under current Israeli law, the attending physician must come in to physically examine the patient before they can be admitted involuntarily. Patients often de-compensate and even may become violent while waiting for the attending to arrive. Previous studies have shown that evaluation of such patients via video-link has an extremely high concordance with in person evaluation. This study will compare patients who are evaluated via video-link with historical controls evaluated under usual conditions. This is an observational study, which is taking advantage of a change in practice to collect data on two different ways of delivering care, via chart reviews. If successful, this study will show that the video-link is feasible and acceptable to patients and staff. The following hypotheses will be tested: 1. The intervention will result in shorter ED time compared to historical controls. 2. The intervention will result in fewer violent incidents compared to historical controls. 3. The intervention will result in shorter overall hospital length of stay compared to historical controls.

NCT ID: NCT05767645 Recruiting - Clinical trials for Tricuspid Valve Regurgitation

Mistral Percutaneous Tricuspid Valve Durable Repair Pivotal Study

TRIBUTE
Start date: June 21, 2021
Phase: N/A
Study type: Interventional

The Mistral is an investigational device intended for percutaneous trans-catheter repair in high risk for surgery individuals suffering from functional Tricuspid Regurgitation (TR). The device system is to be used only in accordance with the approved Investigational Plan on subjects who have signed an informed consent form. Device use is limited to the approved study investigators.

NCT ID: NCT05767346 Recruiting - Clinical trials for Obstructive Hypertrophic Cardiomyopathy (oHCM)

Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol Succinate in Adults With Symptomatic oHCM

MAPLE-HCM
Start date: June 19, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of aficamten (CK-3773274) compared with metoprolol succinate in adults with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction

NCT ID: NCT05767047 Recruiting - Clinical trials for Juvenile Psoriatic Arthritis

A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis

Start date: March 23, 2023
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the long-term safety of apremilast in participants 2 years of age or older with oral ulcers associated with Behçets disease or 5 years of age or older with active juvenile psoriatic arthritis that have completed Study 20190530 or Study 20190529.