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NCT ID: NCT03889613 Active, not recruiting - Crohn Disease Clinical Trials

Pillcam Crohn's Capsule for Monitoring of Panenteric Mucosal Healing in Crohn's Disease Patients With Vedolizumab

Start date: April 3, 2019
Phase: N/A
Study type: Interventional

The main aim of the study is to evaluate the lielihood of panenteric mucosal healing in Crohn's disease patients treated with vedolizumab The study will include patients with active Crohn's disease who are starting treatment with vedolizumab. The patients will undergo evaluation with panenteric capsule endoscopy, intestinal ultrasound and inflammatory biomarkers before treatment onset, at week 14 and week 52

NCT ID: NCT03888066 Completed - Hyperkalemia Clinical Trials

Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure (DIAMOND)

DIAMOND
Start date: April 24, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the effects of patiromer compared with placebo on serum K+ in HF patients.

NCT ID: NCT03887520 Completed - Clinical trials for Cardiovascular Disease and Lipoprotein(a)

Lipoprotein(a) in Patients With Cardiovascular Disease (CVD)

Start date: November 27, 2018
Phase: N/A
Study type: Interventional

The study is conducted to improve knowledge about the epidemiology of Lipoprotein(a) in patients with established cardiovascular disease (CVD).

NCT ID: NCT03884790 Terminated - Bone Substitutes Clinical Trials

Pre-market Study to Evaluate Safety and Performance of GreenBone Implant (Long Bone Study)

Start date: January 22, 2019
Phase: N/A
Study type: Interventional

Multi-center, international, prospective, open-label, single-arm, first-in-human clinical investigation. The Patients enrolled in this clinical investigation will undergo a scheduled surgery for the treatment of long bone defects up to 6 cm using GreenBone Implant. After the surgery, the Patients will be monitored at pre-scheduled visits up to 12 months. Adverse events, pain, quality of life and functional parameters, as well as X-ray and CT scan, will be evaluated at scheduled follow-up visits. An independent Data Safety Monitoring Board (DSMB) will review the safety reports at regular intervals and Serious Adverse Events (SAE) as soon as reported, to protect Patients participating in the study. The initial phase of the study contemplates the treatment of bone defects up to 3 cm. An adaptive interim analysis will be performed when the first 7 Patients will have completed the 6-month follow-up visit. The DSMB will review the results of the interim analysis with respect to the primary endpoint (safety), and provide one of the following recommendations to the Sponsor: a) to stop the study for unacceptable frequency and severity of adverse events or b) to continue the study up to 25 Patients recruited and to include at least 5 Patients with a longer bone defect (> 3 cm up to 6 cm).

NCT ID: NCT03884647 Completed - Stroke Clinical Trials

DELPHI in Subjects at Risk for Stroke and Dementia

Start date: April 1, 2020
Phase:
Study type: Observational

The DELPhi system is a software device that is used for the noninvasive evaluation of brain plasticity and connectivity. The DELPhi software uses EEG and TMS devices as accessories. Standard electro-physiological acquisition is performed using TMS to evoke regional neuronal potentials measured as EEG data. TMS-EEG data is analyzed with regards to conventional, well established characteristics of neuronal network plasticity and connectivity.

NCT ID: NCT03884361 Recruiting - Vaginal Microbiome Clinical Trials

Does Elective Amniocentesis Change Vaginal Microbiome?

Start date: April 1, 2019
Phase: N/A
Study type: Interventional

the aim of this study is to check if elective amniocentesis change vaginal microbiome

NCT ID: NCT03884101 Active, not recruiting - Clinical trials for Endometrial Neoplasms

Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001)

LEAP-001
Start date: April 11, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy of pembrolizumab + lenvatinib to chemotherapy in female participants with Stage III, IV, or recurrent endometrial carcinoma. It is hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for progression-free survival (PFS) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR). It is also hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for overall survival (OS). As of Amendment 7 eligible participants on study completion will be able to transition to an extension study, if available, in which they can continue to receive pembrolizumab monotherapy, lenvatinib monotherapy, or a combination of both pembrolizumab and lenvatinib as received in the parent study.

NCT ID: NCT03882918 Terminated - Angelman Syndrome Clinical Trials

An Open-Label Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of OV101 in Individuals With Angelman Syndrome

ELARA
Start date: January 31, 2019
Phase: Phase 3
Study type: Interventional

This open-label study (OV101-18-002) will evaluate the long-term (52 weeks) safety of OV101 in subjects with AS and provide additional OV101 treatment to those subjects who completed Study OV101-15-001 (NCT02996305). Subjects with AS who completed the pharmacokinetic Study OV101-16-001 (NCT03109756) will also be permitted to participate, provided they meet all entry criteria.

NCT ID: NCT03880292 Completed - Spinal Deformity Clinical Trials

Spinal Deformity Intraoperative Monitoring.

Start date: May 15, 2019
Phase: N/A
Study type: Interventional

A multicenter, international prospectively collected patient cohort undergoing high-risk spinal cord level surgery or spinal osteotomy procedures will be enrolled to establish the incidence of intraoperative alerts in high-risk spinal cord cases, and explore factors associated with mitigating injury. Baseline, intraoperative, and postoperative characteristics, including demographics, radiological features, lower extremity motor score (LEMS), procedure, anesthetic agents used, and baseline blood pressure will be recorded for either adult patients or pediatric patients.

NCT ID: NCT03880149 Recruiting - Inflammation Clinical Trials

The Effects of Omega-3 Status and Supplementation on Tendon Structure in Competitive Athletes

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

The study will examine the association between omega-3 status and the effects of omega-3 supplementation on changes in tendon structure and recovery from tendon injuries and inflammatory markers in competitive athletes. Half of the participants will receive omega-3 in combination with vitamin E, while the other half will receive a placebo and vitamin E.