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NCT ID: NCT03627572 Active, not recruiting - Clinical trials for Respiratory Syncytial Virus Infections

RESCEU Study: Defining the Burden of Disease of Respiratory Syncytial Virus in Europe in Infants

Start date: July 21, 2017
Phase:
Study type: Observational

The REspiratory Syncytial virus Consortium in EUrope (RESCEU) is an Innovative Medicine Initiative (IMI) effort funded by the EU under the H2020 framework to define and understand the burden of disease caused by human respiratory syncytial virus (RSV) infection. RSV causes severe disease in individuals at the extremes of the age spectrum and in high risk groups. It was estimated that RSV was associated with 34 million cases of acute respiratory tract infection (ARTI), 3.4 million ARTI hospitalizations and 55,000 to 199,000 deaths in children <5 years in 2005 worldwide. These estimates were based on limited data and there is a substantial gap in knowledge on morbidity and associated healthcare and social costs in Europe. New vaccines and therapeutics against RSV are in development and will soon be available on the European market. RESCEU will deliver knowledge of the incidence and burden of disease RSV in young children and older adults in Europe, which is essential for stakeholders (governments, etc) to take decisions about prophylaxis and treatment. Objective: To determine the burden of disease due to RSV in young children. Study design: Prospective epidemiological, observational, multi-country, multicenter cohort study. Study population: Birth cohort of healthy infants (follow-up from birth until the age of 3 years maximum): - Passive birth cohort (n=9,000). - Active birth cohort (n=1,000). Main study parameters/endpoints: The primary endpoint of the study is the incidence of RSV infection-associated ARTI, RSV associated medically attended (MA) ARTI (active birth cohort) and RSV related hospitalization (passive birth cohort) in infants (< 1 year) during 3 RSV seasons. In addition, a major secondary endpoint is RSV attributable burden of wheezing.

NCT ID: NCT03625323 Active, not recruiting - NSCLC Clinical Trials

Combination Study With Soluble LAG-3 Fusion Protein Eftilagimod Alpha (IMP321) and Pembrolizumab in Patients With Previously Untreated Unresectable or Metastatic NSCLC, or Recurrent PD-X Refractory NSCLC or With Recurrent or Metastatic HNSCC

TACTI-002
Start date: February 18, 2019
Phase: Phase 2
Study type: Interventional

Evaluate the safety and efficacy of the combination of eftilagimod alpha with pembrolizumab in non-small cell lung carcinoma and head and neck carcinoma patients.

NCT ID: NCT03625037 Active, not recruiting - DLBCL Clinical Trials

First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma

EPCORE™ NHL-1
Start date: June 26, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this trial is to measure the following in participants with relapsed and/or refractory B-cell lymphoma who receive epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20): - The dose schedule for epcoritamab - The side effects seen with epcoritamab - What the body does with epcoritamab once it is administered - What epcoritamab does to the body once it is administered - How well epcoritamab works against relapsed and/or refractory B-cell lymphoma The trial consists of 3 parts: - a dose-escalation part [Phase 1, first-in-human (FIH)] - an expansion part (Phase 2a) - a dose-optimization part (OPT) (Phase 2a) The trial time for each participant depends on which trial part the participant enters: - For the dose-escalation part, each participant will be in the trial for approximately 1 year, which is made up of 21 days of screening, 6 months of treatment (the total time of treatment may be different for each participant), and 6 months of follow-up (the total time of follow-up may be different for each participant). - For the expansion and dose-OPT parts, each participant will be in the trial for approximately 1.5 years, which is made up of 21 days of screening, 1 year of treatment (the total time of treatment may be different for each participant), and 6 months of follow-up (the total time of follow-up may be different for each participant). Participation in the study will require visits to the sites. During the first month, participants must visit every day or every few days, depending on which trial part the participant enters. After that, participants must visit weekly, every other week, once a month, and once every 2 months, as trial participation ends. All participants will receive active drug, and no participants will be given placebo.

NCT ID: NCT03621930 Active, not recruiting - Bronchiolitis Clinical Trials

RESCEU Study, Defining the Burden of Disease of RSV in Older Adults

Start date: August 1, 2017
Phase:
Study type: Observational

The REspiratory Syncytial virus Consortium in EUrope (RESCEU) is an Innovative Medicine Initiative (IMI) funded by the EU under the H2020 framework to define and understand the burden of disease caused by human respiratory syncytial virus (RSV) infection. RSV causes severe disease in individuals at the extremes of the age spectrum and in high risk groups. It was estimated that RSV was associated with 34 million cases of acute respiratory tract infection (ARTI), 3.4 million ARTI hospitalizations and 55,000 to 199,000 deaths in children <5 years in 2005 worldwide. The estimated burden of disease in older adults is comparable with non-pandemic influenza A (for which a vaccine is available). These estimates were based on limited data and there is a substantial gap in knowledge on morbidity and associated healthcare and social costs in Europe. New vaccines and therapeutics against RSV are in development and could soon be available on the European market. RESCEU will deliver knowledge of the incidence and burden of RSV disease in young children and older adults in Europe, which is essential for stakeholders (governments, etc.) to take decisions about prophylaxis and treatment. Objective: To determine the burden of disease due to RSV in older adults. Study design: Prospective epidemiological, observational, multi-country, multicenter cohort study. Study population: Adults aged 60 years and up (n=1,000) of which approximately 50% is above 75 years of age. Main study parameters/endpoints: The primary endpoints of the study are; - The incidence of RSV infection-associated ARTI. - RSV associated medically attended (MA) ARTI. - RSV related hospitalization.

NCT ID: NCT03621215 Active, not recruiting - Gout Flare Clinical Trials

The Effect of Tart Cherry Juice on Risk of Gout Attacks

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

The purpose of this study is to determine whether consuming tart cherry juice daily for 12 months reduces the risk of gout attacks during this period. Individuals with an existing gout diagnosis and who have experienced at least one gout flare in the past year will be recruited to participate in this study.

NCT ID: NCT03620643 Active, not recruiting - Gastric Cancer Clinical Trials

Crizotinib in Lobular Breast, Diffuse Gastric and Triple Negative Lobular Breast Cancer or CDH1-mutated Solid Tumours

ROLo
Start date: May 9, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to find out how effective the combination of crizotinib and fulvestrant is in shrinking lobular breast cancer tumours. The investigators will also be assessing the side effects of the combination of crizotinib tablets and fulvestrant injections. The side effects and the doses of crizotinib and fulvestrant have already been evaluated in large clinical trials, but this is the first time these two drugs will be combined together.

NCT ID: NCT03617666 Active, not recruiting - Hodgkin Lymphoma Clinical Trials

Avelumab in the Frontline Treatment of Advanced Classical Hodgkin Lymphoma - a Window Study

AVENuE
Start date: September 27, 2019
Phase: Phase 2
Study type: Interventional

This is a phase II, non-randomised, multicentre study to assess the safety and efficacy of the PD-L1 inhibitor, avelumab, in a previously untreated fit population of high risk stage II, stage III and stage IV classical Hodgkin lymphoma.

NCT ID: NCT03616587 Active, not recruiting - Clinical trials for ER+ HER2- Advanced Breast Cancer

Study of AZD9833 Alone or in Combination in Women With Advanced Breast Cancer.

SERENA-1
Start date: October 11, 2018
Phase: Phase 1
Study type: Interventional

A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination in Women with ER Positive, HER2 Negative Advanced Breast Cancer (SERENA-1)

NCT ID: NCT03616470 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia

Study to Determine the Efficacy of Uproleselan (GMI-1271) in Combination With Chemotherapy to Treat Relapsed/Refractory Acute Myeloid Leukemia

Start date: October 15, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy of uproleselan (GMI-1271), a specific E-selectin antagonist, in combination with chemotherapy to treat relapsed/refractory AML, compared to chemotherapy alone. The safety of uproleselan when given with chemotherapy will also be investigated in patients with relapsed/refractory AML

NCT ID: NCT03615326 Active, not recruiting - Clinical trials for Gastroesophageal Junction Adenocarcinoma

Pembrolizumab/Placebo Plus Trastuzumab Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-811/KEYNOTE-811)

Start date: October 5, 2018
Phase: Phase 3
Study type: Interventional

The study will compare the efficacy and safety of pembrolizumab plus trastuzumab in combination with standard of care (SOC) chemotherapy versus trastuzumab in combination with SOC chemotherapy in participants with HER2-positive gastric cancer. The primary hypotheses of the study are that pembrolizumab plus trastuzumab in combination with chemotherapy is superior to trastuzumab plus chemotherapy in terms of 1) progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), and 2) overall survival (OS).