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NCT ID: NCT04728919 Active, not recruiting - COVID-19 Clinical Trials

Nasal and Pulmonary Nitric Oxide Output in COVID-19 Infection

Start date: January 15, 2021
Phase:
Study type: Observational

A Study of the relation of COVID-19 infection and its severity to upper and lower airway nitric oxide, upper airway viral load and lung function.

NCT ID: NCT04725188 Active, not recruiting - Clinical trials for Metastatic Non Small Cell Lung Cancer

Pembrolizumab/Vibostolimab Coformulation (MK-7684A) or Pembrolizumab/Vibostolimab Coformulation Plus Docetaxel Versus Docetaxel for Metastatic Non Small Cell Lung Cancer (NSCLC) With Progressive Disease After Platinum Doublet Chemotherapy and Immunotherapy (MK-7684A-002, KEYVIBE-002)

Start date: April 20, 2021
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to compare pembrolizumab/vibostolimab coformulation (MK-7684A) plus docetaxel or pembrolizumab/vibostolimab coformulation to normal saline placebo plus docetaxel. Participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and treatment with one prior anti- programmed cell death 1 (PD-1)/ programmed cell death ligand 1(PD-L1) monoclonal antibody (mAb). MK-7684A is a coformulation product of pembrolizumab/vibostolimab. The dual primary hypotheses of the study are pembrolizumab/vibostolimab coformulation plus docetaxel and pembrolizumab/vibostolimab coformulation is superior to normal saline placebo plus docetaxel with respect to progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).

NCT ID: NCT04722250 Active, not recruiting - Clinical trials for Aortic Valve Stenosis

SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial

SMART
Start date: April 2, 2021
Phase: N/A
Study type: Interventional

The purpose of this trial is to generate clinical evidence on valve safety and performance of self-expanding (SE) versus balloon-expandable (BE) transcatheter aortic valve replacement (TAVR) in subjects with a small aortic annulus and symptomatic severe native aortic stenosis. Additionally, a stress echocardiography sub-study will be conducted as part of the SMART Trial at select sites. The purpose of the sub-study is to evaluate performance of SE versus BE TAVR in subjects with a small aortic annulus and symptomatic severe native aortic stenosis after undergoing exercise stress echocardiographic testing.

NCT ID: NCT04714762 Active, not recruiting - Clinical trials for Gestational Diabetes

eHealth in Treatment of Gestational Diabetes (eMOMGDM)

eMOMGDM
Start date: March 10, 2021
Phase: N/A
Study type: Interventional

The overall aim of the eMOM GDM-project is to develop and evaluate a novel system to clinical decision making and patient behavior change in treatment of GDM, combining diet, physical activity, sleep, heart rate (e.g. stress), and glucose monitoring within a single system (the eMOM GDM application), and linking the developed application tool for the normal health care system in a new way. In this second phase of the project, the effect of eMOM GDM application on maternal and neonatal outcomes will be evaluated in a randomized controlled study design. The follow-up study continues until 3 months postpartum.

NCT ID: NCT04702425 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia (AML)

VOB560-MIK665 Combination First in Human Trial in Patients With Hematological Malignancies (Relapsed/Refractory Non-Hodgkin Lymphoma, Relapsed/Refractory Acute Myeloid Leukemia, or Relapsed/Refractory Multiple Myeloma)

Start date: June 23, 2021
Phase: Phase 1
Study type: Interventional

The purpose of the study is to identify doses and schedules of VOB560 and MIK665 that can be safely given and to learn if the combination can have possible benefits for patients with Non-Hodgkin lymphoma (NHL), Multiple Myeloma (MM) or Acute Myeloid Leukemia (AML). VOB560 and MIK665 are selective and potent blockers respectively of the B-cell lymphoma 2 (BCL2) protein and of the myeloid cell leukaemia 1 (MCL1) protein, proteins that may protect tumor cells from undergoing cell death. VOB560 and MIK665 are designed to block the functions of the BCL2 and MCL1 proteins, so that the tumor cells that rely on these proteins undergo cell death. Preclinical data suggest that concomitant treatment with VOB560 in combination with MIK665 induces robust anti-tumor activity.

NCT ID: NCT04698200 Active, not recruiting - Type 2 Diabetes Clinical Trials

Type 2 Diabetes, Cardiovascular Comorbidity and Environmental Temperature

DiabColdHeat
Start date: January 1, 2021
Phase: N/A
Study type: Interventional

Both high and low environmental temperatures are associated worldwide with higher morbidity and mortality and an estimated 8% of the mortality is estimated to relate to non-optimum temperatures. The majority of the adverse health effects occur at to low, and not high temperatures, and already with a modest change in temperature. Persons with type 2 diabetes can be sensitive to the effect of temperature due to their altered neural, metabolic and circulatory functions. The pathophysiological responses of type 2 diabetes in a cold and hot environment are not known. The aim of the study is to examine how advanced type 2 diabetes (disease progression >10 years) alone, an in conjunction with coronary artery diseases and hypertension affect neural, cardiovascular and metabolic responses in a cold and hot environment. Type 2 diabetes is associated with altered neural regulation, weakened cardiovascular function, structural changes in blood vessels, altered blood constitution and metabolic disturbances. These affect thermoregulation and result in increased susceptibility to cold (lesser heat production, increased heat loss) and heat (lesser sweating and heat loss). The patients are exposed under controlled conditions in a random order to both cold (+10°C) and heat (+44°C) while resting and lightly clothed for 90 min at a time. The exposure itself is preceded by baseline measurements of the parameters of interest, and followed by repeating the same measurements after the exposure. The topic of the research is very relevant due to the worldwide epidemic of type 2 diabetes. Simultaneously, the comorbid conditions associated with diabetes become more common and are related to a higher occurrence of cardiac events. The research information is useful for all individuals with type 2 diabetes in their protection and self-management of the disease, and enabling to maintain functional ability in a cold or hot environment. The research knowledge can be utilized when developing weather warning systems for the identification of susceptible populations. Health care personnel may utilize the research information while advising their patients and for proper care. An increased awareness of the health effects of both low and high temperatures improve the functional ability of individuals and reduced help reducing morbidity and mortality from weather conditions.

NCT ID: NCT04697628 Active, not recruiting - Cervical Cancer Clinical Trials

Tisotumab Vedotin vs Chemotherapy in Recurrent or Metastatic Cervical Cancer

innovaTV 301
Start date: February 22, 2021
Phase: Phase 3
Study type: Interventional

This trial is being done to find out whether tisotumab vedotin works better than chemotherapy to treat cervical cancer. People in this study have cervical cancer that has spread to other parts of the body (metastatic) or has come back after being treated (recurrent). Participants in this trial will be randomly assigned to one of two groups. One group will be treated with tisotumab vedotin. Participants in the other group will get one of five different chemotherapy drugs (topotecan, vinorelbine, gemcitabine, pemetrexed, or irinotecan). Participants and their doctors will know which group they are in. Participants in the chemotherapy group will decide with their study doctor which drug they will take.

NCT ID: NCT04680052 Active, not recruiting - Follicular Lymphoma Clinical Trials

A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma.

InMIND
Start date: April 15, 2021
Phase: Phase 3
Study type: Interventional

This is a Phase 3 double-blind, placebo-controlled, randomized study designed to investigate whether tafasitamab and lenalidomide as an add-on to rituximab provides improved clinical benefit compared with lenalidomide as an add-on to rituximab in patients with R/R FL Grade 1 to 3a or R/R MZL.

NCT ID: NCT04662619 Active, not recruiting - Healthy Clinical Trials

A Study of a Probiotic Food Supplement Containing B. Infantis (EVC001) in Healthy Breastfed Infants at Risk of Developing Atopic Dermatitis

Start date: December 18, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the effect of B. infantis (EVC001) versus placebo supplementation, in healthy breastfed infants at risk of developing atopic dermatitis (AD), on cumulative incidence of physician-diagnosed AD during the first year of life.

NCT ID: NCT04657991 Active, not recruiting - Melanoma Clinical Trials

A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma

Start date: January 15, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to learn about the effects of three study medicines (encorafenib, binimetinib, and pembrolizumab) given together for the treatment of melanoma that: - is advanced or metastatic (spread to other parts of the body); - has a certain type of abnormal gene called "BRAF"; and - has not received prior treatment. All participants in this study will receive pembrolizumab at the study clinic once every 3 weeks as an intravenous (IV) infusion (given directly into a vein). In addition, half of the participants will take encorafenib and binimetinib orally (by mouth) at home every day. Participants may receive pembrolizumab for up to two years. Those participants taking encorafenib and binimetinib can continue until their melanoma is no longer responding. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.