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NCT ID: NCT05096845 Active, not recruiting - COVID-19 Pandemic Clinical Trials

Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) Phase III

COVID-19
Start date: August 25, 2021
Phase: Phase 3
Study type: Interventional

A Global, Multi-center, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in Adults Aged 18 Years and Older

NCT ID: NCT05093933 Active, not recruiting - Clinical trials for Chronic Heart Failure With Reduced Ejection Fraction

A Study of Vericiguat (MK-1242) in Participants With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-035)

VICTOR
Start date: November 2, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of vericiguat in participants with chronic heart failure with reduced ejection fraction (HFrEF), specifically those with symptomatic chronic HFrEF who have not had a recent hospitalization for heart failure or need for outpatient intravenous (IV) diuretics. The primary hypothesis is that vericiguat is superior to placebo in reducing the risk of cardiovascular death or heart failure hospitalization.

NCT ID: NCT05083169 Active, not recruiting - Multiple Myeloma Clinical Trials

A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma

MajesTEC-3
Start date: October 14, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy of teclistamab daratumumab (Tec-Dara) with daratumumab subcutaneously (SC) in combination with pomalidomide and dexamethasone (DPd) or daratumumab SC in combination with bortezomib and dexamethasone (DVd).

NCT ID: NCT05071664 Active, not recruiting - Clinical trials for Arthritis, Psoriatic

A Study of Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis

AFFINITY
Start date: October 25, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy of guselkumab plus golimumab combination treatment in participants with active psoriatic arthritis (PsA) and inadequate response (IR) to prior anti-tumor necrosis factor-alpha (anti-TNF-alpha) therapies by assessing clinical response compared with guselkumab monotherapy.

NCT ID: NCT05071053 Active, not recruiting - Clinical trials for Gastrooesophageal Cancer

Tusamitamab Ravtansine (SAR408701) in Combination With Ramucirumab in Pretreated Participants With Gastric Cancer

CARMEN-GC01
Start date: November 16, 2021
Phase: Phase 2
Study type: Interventional

Primary Objectives: Part 1: to confirm the recommended tusamitamab ravtansine loading dose Q2W in combination with ramucirumab in advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma population Part 2: to assess the antitumor activity of tusamitamab ravtansine loading dose Q2W in combination with ramucirumab in advanced gastric or GEJ adenocarcinoma Secondary Objectives: - To assess safety - To assess durability - To assess progression-free survival (PFS) - To assess the disease control rate (DCR) - To assess the pharmacokinetics (PK) - To assess the immunogenicity

NCT ID: NCT05064059 Active, not recruiting - Colorectal Cancer Clinical Trials

A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007)

Start date: November 10, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of coformulated favezelimab/pembrolizumab (MK-4280A) in participants with metastatic colorectal cancer. The study will also compare MK-4280A with the standard of care treatment of regorafenib and TAS-102 (trifluridine and tipiracil). The primary study hypothesis is that coformulated favezelimab/pembrolizumab (MK-4280A) is superior to standard of care with respect to overall survival.

NCT ID: NCT05062044 Active, not recruiting - Clinical trials for Prevention of Vitamin Deficiency During and/or Before Pregnancy

A Study to Gather Information About the Progress and Outcomes of Pregnancy in Women Using Various Vitamin Support Plans Before and During Pregnancy

Start date: December 2, 2021
Phase:
Study type: Observational

This is an observational study in which data from the participants who will be taking different vitamin supplementation regimes before and during pregnancy. Vitamin deficiency is a condition where there is not enough vitamins in the body. During pregnancy, a woman's body may require more vitamins than usual. When the body does not get enough vitamins, people can take vitamin supplements to help increase the amount of vitamins in the body. It is already known, that polyvitamins can decrease risks of anemia (low level of red cells in the blood), neural tube defects (severe congenital anomaly of neural system) or other malformations, but also on several pregnancy complications. Nevertheless, a significant amount of evidence on the use of vitamins during pregnancy has been obtained in countries with low and middle level of living standards. Countries with higher living standards may have different prevalence of vitamin insufficiency, thereby it is not clearly known how vitamin supplementation may help to reduce pregnancy complications in these population. So, researchers think it is important to do more studies. Elevit contains many different vitamins and minerals. These vitamins and minerals are important to help women before and during pregnancy. In this study, the researchers want to collect more data about how well pregnancies progress and the outcomes of the pregnancies in women who are taking different vitamin treatment or supplements, including elevit. To do this, the researchers will review information collected from the participants to: - calculate how many women give birth without any complications between weeks 37 and 42 of their pregnancies - calculate how many women have low levels of red blood cells in the blood during the third trimester of their pregnancies - calculate how many women have a serious condition called preeclampsia during their pregnancy, a condition in which pregnant women have a sudden rise in blood pressure and swelling in the hands, feet and face - calculate how many women give birth to babies who weigh less than expected at the time of their birth - give the women a questionnaire to complete during each trimester to see how they are feeling The participants will have decided with their doctor to start their vitamin treatment or supplements before getting pregnant or during their pregnancy. During the study, the researchers will collect the women's information from their medical records taken during their regular medical appointments. The study will include women who are pregnant and who are planning to get pregnant. The study will include both women who have vitamin deficiency and women who do not have vitamin deficiency. Each participant will be in this study for up to 18 months., The whole study will last about 2 years and 10 months. During this time, the participants will visit their doctor 5 times as part of their usual care. The study is planned to collect data from October 2021 until June 2024.

NCT ID: NCT05061823 Active, not recruiting - Cancer Clinical Trials

Bintrafusp Alfa Program Rollover Study

Start date: December 1, 2021
Phase: Phase 3
Study type: Interventional

This study is designed to provide continuous access to treatment with bintrafusp alfa for eligible participants from ongoing bintrafusp alfa parent studies (NCT02517398, NCT03840902, NCT02699515, NCT04246489, NCT04489940, NCT03840915, NCT03631706, NCT04551950, NCT03833661 and NCT04066491) and to collect long-term safety and efficacy data. Study Duration: All participants in this rollover study will be treated with bintrafusp alfa until meeting defined criteria in the protocol for discontinuation, until study intervention is commercially accessible and provisioned via marketed product, or until end of study. The study also includes a 5 years survival follow-up after last dose of the study treatment. Treatment Duration: Treatment under the rollover protocol according to the interval and dosing schedule in the parent protocol until discontinuation.

NCT ID: NCT05059522 Active, not recruiting - Ovarian Cancer Clinical Trials

Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing

Start date: September 29, 2021
Phase: Phase 3
Study type: Interventional

This Master Protocol for Avelumab Continuation Sub-Studies is to provide continued treatment access, safety follow-up, and when applicable, overall survival follow-up for eligible participants who continue to derive a benefit from study intervention in the Pfizer-sponsored Avelumab parent studies.

NCT ID: NCT05049798 Active, not recruiting - Clinical trials for Arthritis, Psoriatic

A Study of Guselkumab and Interleukin-17 (IL-17) Inhibitor Therapies in Participants With Psoriatic Arthritis in Routine Clinical Practice

PsABIOnd
Start date: August 25, 2021
Phase:
Study type: Observational

The purpose of this study is to evaluate treatment persistence with guselkumab and interleukin-17 inhibitor (IL-17i) initiated at enrollment into this study (PsABIOnd).