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NCT ID: NCT05187793 Active, not recruiting - COVID-19 Clinical Trials

Study of Efficacy of Different Treatment Regimens of Olokizumab

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Start date: July 8, 2021
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to evaluate the efficacy and safety of Artlegia (INN: olokizumab) new dosing regimen in patients with moderate coronavirus infection (COVID-19) with signs of hyperinflammation. This study is a multicentre, open-label, randomized, comparative, parallel group, active-controlled clinical trial.

NCT ID: NCT05173987 Active, not recruiting - Clinical trials for Endometrial Neoplasms

Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma (MK-3475-C93/KEYNOTE-C93/GOG-3064/ENGOT-en15)

Start date: February 3, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of treatment with pembrolizumab (MK-3475) compared to a combination of carboplatin and paclitaxel in women with mismatch repair deficient (dMMR) advanced or recurrent endometrial carcinoma who have not previously been treated with prior systemic chemotherapy. The primary study hypotheses are that pembrolizumab is superior to the combination of carboplatin and paclitaxel with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and Overall Survival (OS).

NCT ID: NCT05170607 Active, not recruiting - Atrial Fibrillation Clinical Trials

Investigation of Specific Biomarkers in Patients With Atrial Fibrillation Who Undergo Interventional Treatment

Start date: January 1, 2021
Phase:
Study type: Observational

The two main mechanisms for atrial fibrillation (AF) recurrence after cryoablation include Pulmonary vein (PV) reconnection and the presence of non-PV associated arrhythmic focuses. The aim of this study is to reveal the specific biomarkers by antibody microarrays.

NCT ID: NCT05166005 Active, not recruiting - Clinical trials for COVID-19 Respiratory Infection

Severity of COVID-19 and Vitamin D Supplementation

Start date: April 1, 2020
Phase: Phase 4
Study type: Interventional

Purpose of the study: to analyze the interlinks between serum 25(OH)D level and severity of new coronavirus infection (COVID-19) in hospitalized patients, as well as the effect of adding colecaciferol to standard therapy for patients in the acute period of the disease. The study will involve at least 300 hospitalized patients with confirmed COVID-19. All study participants will be twice assessed for serum 25 (OH) D levels: baseline and 8-10 days of hospitalization. Following a baseline examination, patients will be randomized into 2 groups. Group I (No. 1), vitamin D therapy begins with a dosage of 50,000 IU in the first and second weeks. Group II (No. 2), vitamin D therapy is prescribed at a dosage of 2000 IU / day. On 8-10 days of vitamin D supplementation, all participants will be retested for serum 25 (OH) D levels to assess the effectiveness of therapy. On 14-21 days we assessed severity of the course, ICU hospitalization, duration of hospitalization, outcome of the disease, duration of glucocorticoid therapy, the need for specific therapy (inhibitors IL-6), changes in cytokine/chemokine, APPs concentration.

NCT ID: NCT05143723 Active, not recruiting - Infertility Clinical Trials

Luteal Phase Support With Daily Administration of Gonadotropin-releasing Hormone Agonist Compared to Progesterone/Estradiol in IVF/ICSI Cycles With Ovulation Triggering With GnRH-a

Start date: January 20, 2020
Phase: Phase 2
Study type: Interventional

Purpose: To determine the efficacy and safety of daily injections of gonadotropin-releasing hormone agonist in comparison with the standard strategy of supporting the luteal phase in protocols with gonadotropin-releasing hormone antagonists, in patients at risk of developing ovarian hyperstimulation syndrome and changing the trigger to a gonadotropin-releasing hormone agonist. Materials and Methods: This prospective, controlled, randomized study, conducted at the Clinic of the Federal State Budgetary Educational Institution of Higher Education of the KubSMU of the Ministry of Health of Russia, included 102 patients at risk of developing ovarian hyperstimulation syndrome, who were on protocols with gonadotropin-releasing hormone antagonists and changing the ovulation trigger to a gonadotropin-releasing hormone agonist. All patients underwent blastocyst transfer on day 5. Patients of the first group (n = 51) received as support for the luteal phase gonadotropin-releasing hormone agonist daily 0.2 mg, subdermally, patients of the second group (n = 51) progesterone 10 mg 3 times a day, orally and estradiol 1 mg 3 times a day, transdermal. The level of progesterone on the day of transfer, the incidence of clinical pregnancy, and the incidence of ovarian hyperstimulation syndrome in both groups were compared.

NCT ID: NCT05123898 Active, not recruiting - Soft Tissue Atrophy Clinical Trials

Clinical and Histological Outcomes of Using Collagen Matrix or Soft Tissue Graft Around Implants

Start date: January 14, 2020
Phase: N/A
Study type: Interventional

This was an interventional prospective randomized clinical trial (RCT) in parallel groups. The sample size is 35 patients who were randomly divided into two groups depending on the surgical intervention used. First group - patients underwent increasing the thickness of the mucous membrane using free connective tissue graft from tuberosity area of the upper jaw. Second group - patients used collagen matrix "Fibromatrix" (LLC "Cardioplant", Russia; registration in Russia 20/05/2019 No FSZ 2019/83671). In the postoperative period the value of soft tissue thickness gain, duration of surgery, severity of pain syndrome and quality of life were assessed. Also, after 3 months simultaneously with installation of gingiva formers biopsy specimens were sampled with mucotome in the area of the intervention followed by histomorphometric analysis of the obtained biopsies.

NCT ID: NCT05116189 Active, not recruiting - Ovarian Cancer Clinical Trials

Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65)

Start date: December 13, 2021
Phase: Phase 3
Study type: Interventional

The primary objective is to compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab, with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the investigator. The hypotheses are that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for participants with programmed cell death ligand 1 (PD-L1) positive tumors (Combined Positive Score [CPS] ≥1) and that pembrolizumab plus paclitaxel with or without bevacizumab is superior to placebo plus paclitaxel with or without bevacizumab, with respect to PFS per RECIST 1.1 as assessed by the investigator for all participants.

NCT ID: NCT05113251 Active, not recruiting - Breast Cancer Clinical Trials

Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer

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

This study will look at the efficacy and safety of trastuzumab deruxtecan (T-DXd) in a neoadjuvant setting, in high-risk, HER2-positive early non-metastatic breast cancer.

NCT ID: NCT05104866 Active, not recruiting - Breast Cancer Clinical Trials

A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)

Start date: October 18, 2021
Phase: Phase 3
Study type: Interventional

The study will evaluate the safety and efficacy of datopotamab deruxtecan (also known as Dato-DXd, DS-1062a), when compared with Investigator's choice of standard of care single-agent chemotherapy (eribulin, capecitabine, vinorelbine, or gemcitabine) in participants with inoperable or metastatic HR-positive, HER2- negative breast cancer who have been treated with one or two prior lines of systemic chemotherapy.

NCT ID: NCT05101148 Active, not recruiting - Clinical trials for Neurofibromatosis Type 1

Phase I Study to Assess the Effect of Food on the PK and Gastrointestinal Tolerability of Selumetinib in Adolescent Children With Neurofibromatosis Type 1 Related Plexiform Neurofibromas

Start date: July 21, 2021
Phase: Phase 1
Study type: Interventional

This study in adolescent participants with NF1 who have inoperable PN is designed to evaluate the effect of a low fat meal on steady state selumetinib exposure; to assess the effect on GI tolerability when selumetinib is dosed under fed and fasted conditions; and potentially, to confirm an appropriate dosing recommendation of selumetinib with a low fat meal that maintains efficacy with acceptable safety. These results may support labelling statements with regard to posology and food.