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NCT ID: NCT04502862 Completed - Asthma Clinical Trials

A Phase 4, Randomized, Double-blind, Placebo-controlled,Multicenter, Parallel-group Study of the Effect of Dupilumab on Sleep Disturbance in Patients With Uncontrolled Persistent Asthma

MORPHEO
Start date: August 10, 2020
Phase: Phase 4
Study type: Interventional

Primary Objective: To assess the effect of dupilumab on sleep Secondary Objectives: - To evaluate the effect of dupilumab on additional patient reported sleep outcomes - To evaluate the effect of dupilumab on objective sleep assessment - To evaluate the effect of dupilumab on asthma symptoms - To evaluate the effect of dupilumab on lung function - To evaluate the safety of dupilumab

NCT ID: NCT04500067 Completed - Covid19 Clinical Trials

Intravenous Immunoglobulin (IVIG, Bioven) Efficacy Assess for COVID-19 / SARS-CoV-2 Severe Pneumonia Complex Treatment

Start date: May 7, 2020
Phase: Phase 3
Study type: Interventional

Pneumonia caused by coronavirus infection COVID-19 is characterized by a combination of several dangerous factors that consistently worsen the patient's condition: viral lung damage early in the disease; a sharp increase in inflammation on the background of an unbalanced immune response ("cytokine storm"); joining a bacterial infection. The condition of patients deteriorates significantly mostly at cytokine storm development. The damaging of a large volume of lung tissue leads to develops of respiratory failure, respiratory distress syndrome, or shock. Ventilatory support becomes ineffective and patients die. There are reports of the effectiveness of Human Normal Immunoglobulin for Intravenous Administration (IVIG) high doses when used as part of complex therapy in patients with pneumonia caused by coronavirus COVID-19. In particular, IVIG has a positive effect on survival rates, overall disease course, duration of stay in the intensive care unit, and ventilatory support duration. The probable mechanism of action of high-dose IVIG therapy is considered to be a regulatory effect on the immune system. Similar is the known and confirmed effectiveness of IVIG for autoimmune diseases (Kavasaky disease, Guillain Barre syndrome, Chronic inflammatory demyelinating polyradiculoneuropathy, Multifocal motor neuropathy). This trial to assesses the Efficacy of IVIG (medication trade name - Bioven, manufactured by Biopharma Plasma LLC) in the High Immunomodulatory Dose in Complex Treatment of Severe Pneumonia Caused by COVID-19 / SARS-CoV-2

NCT ID: NCT04498923 Completed - Postoperative Pain Clinical Trials

Duration of Blockade of Peripheral Nerves With Bupivacaine Depending of the Adjuvants

DBBA
Start date: January 1, 2018
Phase:
Study type: Observational

The main aim of the investigator's study is to propose combination of local anesthetics and adjuvants that provides both adequate anesthesia during surgery and prolonged post-operative analgesia.

NCT ID: NCT04484935 Completed - RSV Infection Clinical Trials

Evaluate the Safety and Tolerability, for Nirsevimab in Immunocompromised Children

MUSIC
Start date: August 19, 2020
Phase: Phase 2
Study type: Interventional

Study D5290C00008 is a Phase 2, open-label, uncontrolled, single-dose study to evaluate the safety and tolerability, pharmacokinetic(s) (PK), occurrence of antidrug antibody (ADA), and efficacy of nirsevimab in immunocompromised children who are ≤ 24 months of age at the time of dose administration. Approximately 100 subjects will be enrolled. Subjects will be followed for approximately 1 year after dose administration.

NCT ID: NCT04456699 Completed - Clinical trials for Metastatic Colorectal Cancer

Efficacy and Safety of Olaparib (MK-7339) With or Without Bevacizumab Compared to Bevacizumab With a Fluoropyrimidine in Unresectable or Metastatic Colorectal Cancer (CRC) (MK-7339-003/LYNK-003)

Start date: August 19, 2020
Phase: Phase 3
Study type: Interventional

This is an efficacy and safety study of olaparib alone or in combination with bevacizumab being compared to bevacizumab with a fluoropyrimidine in participants with unresectable or metastatic colorectal cancer who have not progressed following first-line induction. The primary hypotheses are: Olaparib + Bevacizumab is superior to a fluoropyrimidine + Bevacizumab with respect to progression-free survival (PFS) using Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR); Olaparib is superior to a fluoropyrimidine + Bevacizumab with respect to PFS using RECIST 1.1 as assessed by BICR. As of amendment 5 study enrollment is being discontinued and study participants randomized to one of the two experimental arms (olaparib plus bevacizumab or olaparib monotherapy) must discontinue study intervention. Participants who are still on study treatment will no longer have tumor response assessments by BICR.

NCT ID: NCT04453137 Completed - Plaque Psoriasis Clinical Trials

Pharmacokinetic, Efficacy, Safety, and Immunogenicity of AVT02 With Moderate to Severe Chronic Plaque Psoriasis

Start date: June 30, 2020
Phase: Phase 3
Study type: Interventional

Pharmacokinetic, Efficacy, Safety, and Immunogenicity Between Patients with Moderate to Severe Chronic Plaque Psoriasis Receiving Humira® and Patients with Moderate to Severe Chronic Plaque Psoriasis

NCT ID: NCT04448431 Completed - Clinical trials for Major Depressive Disorder

Comparison of Vortioxetine and Desvenlafaxine in Adult Patients Suffering From Depression

VIVRE
Start date: June 18, 2020
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the efficacy of vortioxetine versus desvenlafaxine after 8 weeks of treatment in patients that have tried one available treatment without getting the full benefit

NCT ID: NCT04436744 Completed - Early Breast Cancer Clinical Trials

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Giredestrant Plus Palbociclib Compared With Anastrozole Plus Palbociclib for Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Untreated Early Breast Cancer (coopERA Breast Cancer)

Start date: September 4, 2020
Phase: Phase 2
Study type: Interventional

This is a randomized, multicenter, open-label, two-arm, Phase II study to evaluate the efficacy, safety, and pharmacokinetics of giredestrant versus anastrozole (in the window-of-opportunity phase) and giredestrant plus palbociclib compared with anastrozole plus palbociclib (in the neoadjuvant phase) in postmenopausal women with untreated, estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, early breast cancer. The study consists of a screening period of up to 28 days, a window-of-opportunity phase for 14 days, followed by a neoadjuvant treatment phase for 16 weeks (four 28-day cycles), surgery, and an end of study visit (28 days after the final dose of study treatment).

NCT ID: NCT04433585 Completed - Clinical trials for Systemic Lupus Erythematosus

A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE)

ISLAND-SLE
Start date: August 19, 2020
Phase: Phase 2
Study type: Interventional

The reason for this study is to see if the study drug LY3471851 (NKTR-358) is safe and effective in adults with systemic lupus erythematosus (SLE).

NCT ID: NCT04428684 Completed - Clinical trials for Dysfunctional Uterine Bleeding

COMPARISON OF A NEW FORMULATION OF GOSERELIN (Pepti 3.6 mg) to Zoladex® 3.6 mg

Start date: October 29, 2018
Phase: Phase 1
Study type: Interventional

The comparator drug (Zoladex 3.6 mg) is approved for use as a thinning agent for the endometrium prior to endometrial ablation. The dosing recommendation is one or two depots with each depot given four weeks apart. When two depots are administered, surgery should be performed within two to four weeks following administration of the second depot.