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NCT ID: NCT04824092 Active, not recruiting - Clinical trials for Diffuse Large B-cell Lymphoma

Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL Patients

frontMIND
Start date: May 11, 2021
Phase: Phase 3
Study type: Interventional

This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to compare the efficacy and safety of the humanized monoclonal anti CD19 antibody tafasitamab plus lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newly-diagnosed DLBCL

NCT ID: NCT04822181 Recruiting - Clinical trials for Non-alcoholic Steatohepatitis

Research Study on Whether Semaglutide Works in People With Non-alcoholic Steatohepatitis (NASH)

ESSENCE
Start date: April 1, 2021
Phase: Phase 3
Study type: Interventional

Semaglutide is a medicine studied in patients with NASH. Semaglutide is a well-known medicine, which is already used by doctors to treat type 2 diabetes in many countries. Participants will either get semaglutide or a dummy medicine - which treatment participants get is decided by chance. Participants will need to inject themselves with medicine under the skin. Participants will need to do this once a week. The study will last for about 5 years. Participants will have up to 21 clinic visits and 9 phone calls with the clinical staff during the study. Some of the clinic visits may be spread over more than one day. Participants with other chronic liver diseases cannot take part in this study. Women cannot take part in the study if they are pregnant, breast-feeding or plan to become pregnant during the study period.

NCT ID: NCT04821310 Recruiting - Esophagitis Clinical Trials

Protonix Treatment of Maintenance of Healing in Pediatric Participants Aged 1-11 Years and 12-17 Years

Start date: January 13, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to explore the outcomes, tolerability and safety of 2 different doses of oral pantoprazole (full healing dose, half healing dose), assigned based upon weight, for the maintenance of healing of erosive esophagitis in pediatric participants aged 1 to 17 years with endoscopically-confirmed, healed erosive esophagitis.

NCT ID: NCT04811092 Recruiting - Clinical trials for Pulmonary Arterial Hypertension

Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13)

HYPERION
Start date: March 18, 2022
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the effects of sotatercept (MK-7962, formerly called ACE-011) treatment (plus background pulmonary arterial hypertension (PAH) therapy) versus placebo (plus background PAH therapy) on time to clinical worsening (TTCW) in participants who are newly diagnosed with PAH and are at intermediate or high risk of disease progression.

NCT ID: NCT04801914 Recruiting - Clinical trials for Matrix Metalloproteinase

Enzyme Activity of Matrix Metalloproteinases in the Serum of Patients With Malignant Obstructive Hyperbilirubinemia Before and After PTBD

Start date: December 11, 2020
Phase:
Study type: Observational

The purpose of this study is to detect differences in the enzymatic activity of matrix metalloproteinases in patients with malignant obstructive hyperbilirubinemia before and after percutaneous biliary drainage.

NCT ID: NCT04796337 Recruiting - Clinical trials for Pulmonary Arterial Hypertension

A Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004/A011-12)

SOTERIA
Start date: May 12, 2021
Phase: Phase 3
Study type: Interventional

This study is being conducted to assess the long-term safety, tolerability, and efficacy of sotatercept (MK-7962, formerly called ACE-011) in participants with Pulmonary Arterial Hypertension (PAH). This open-label, long-term follow-up (LTFU) study is supported by data from the PULSAR study (Phase 2, NCT03496207) in which treatment with sotatercept resulted in hemodynamic and functional improvements in the study participants, including those receiving maximal PAH therapy with double/triple drug combinations and intravenous prostacyclin. The primary objective of this open-label, LTFU study is to evaluate the long-term safety and tolerability of sotatercept when added to background PAH therapy in adult participants with PAH who have completed prior sotatercept studies. The secondary objective is to evaluate continued efficacy in adult participants with PAH who have completed prior sotatercept studies.

NCT ID: NCT04786873 Active, not recruiting - Clinical trials for Growth Hormone Deficiency

A Research Study of How Well Macimorelin Works to Find Out if Children Have a Lack of Growth Hormone and How Safe it is

DETECT
Start date: November 16, 2021
Phase: Phase 3
Study type: Interventional

This research study will find out if a new growth hormone stimulation test is safe and works as well as other tests to diagnose growth hormone deficiency (GHD) in children. The stimulation test will use a new growth hormone stimulating substance called macimorelin. By now, only adults in the USA can get this new stimulation test. The results of this study are expected to help children and teenagers with suspected GHD to get the macimorelin stimulation test. The macimorelin test will be compared to a clonidine and an arginine test. Both are known standard stimulation tests. Altogether two macimorelin tests are planned to be performed in the study, to show how repeatable macimorelin tests results are (under a set of similar conditions).

NCT ID: NCT04786509 Completed - Clinical trials for ECG Electrode Site Reaction

Wireless ECG Body Sensor During Field Testing

WECG
Start date: June 1, 2018
Phase:
Study type: Observational

Wireless body ECG sensor is a feasible solution for reliable and accurate long-term heart rhythm monitoring. However, there were no studies that delt with usability of this sensor in field testing. Accordingly, the aim of the study is to evaluate the quality of ECG signal measured with wearable wireless ECG body-sensor when used in field test settings and to determine how different types of sensors' fixation affect quality of the ECG signal during submaximal and maximal running settings. Twenty-three participants, 10 females and 13 males, were included in the study (20.56±1.19 years). All subjects performed shuttle run (SR), Cooper 2400 m (C), and 100 m sprint test (S), once wearing the sensor attached to self-adhesive skin electrodes, additionally fixed with self-adhesive tapes, and secondly with the sensor attached to Polar belt and strapped around the chests. Test outcomes were compared applying Student t-test for dependent variables, or non-parametric Wilcoxon test, depending on the results of normality test.

NCT ID: NCT04781543 Recruiting - Clinical trials for Diffuse Cutaneous Systemic Sclerosis

A Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients With Diffuse Cutaneous Systemic Sclerosis

Start date: November 4, 2022
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, repeat-dose, multicenter trial. Participants will be screened within 6 weeks prior to the Baseline (Day 1) Visit. Approximately 300 participants who meet the trial eligibility criteria will be randomized on Day 1 in a 1:1:1 ratio to receive HZN-825 300 mg QD, HZN-825 300 mg BID or placebo for 52 weeks. The trial will include up to a 42-day Screening Period and a 52-week Double-blind Treatment Period. Participants will take their first dose of trial drug at the clinic and will participate in trial visits at Week 4 and every 6 weeks thereafter until Week 52. All participants who complete the Double-blind Treatment Period (Week 52) will be eligible to enter a 52-week extension trial (HZNP-HZN-825-302, NCT05626751). Participants not entering the extension trial will participate in a Safety Follow-up Visit 4 weeks after the last dose of trial drug.

NCT ID: NCT04779242 Active, not recruiting - Clinical trials for Community-acquired Pneumonia

Omadacycline vs. Moxifloxacin for the Treatment of Community-Acquired Bacterial Pneumonia

Start date: February 25, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared to moxifloxacin in the treatment of adults with community-acquired bacterial pneumonia.