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NCT ID: NCT04435613 Completed - ARDS Clinical Trials

Clinical and Physiological Assessment of a Nearly Ultra-protective Lung Ventilation Strategy: A Quasi-experimental Preliminary Study in ARDS Patients

Start date: September 4, 2019
Phase: N/A
Study type: Interventional

This study aims to determine whether a protective mechanical ventilator strategy generates a reduction in the Bohr´s dead space in patients with moderate or severe acute respiratory distress syndrome (ARDS). Commonly used ventilatory strategies in the clinical practice were applied sequentially to assess their impact. Data obtained from volumetric capnography will be recorded after each ventilatory strategy is applied

NCT ID: NCT04429373 Recruiting - Clinical trials for Dental Implant Failed

Effect of Platelet-rich Plasm (PRF) on Two-implant Mandibular Overdenture: a Split Mouth

PRF
Start date: November 30, 2020
Phase: N/A
Study type: Interventional

Implant retained overdentures are a cost-effective treatment for elderly patients suffering from complete tooth loss. Despite the high success rate of implants in the general population, older adults lacking all teeth are a challenging population for implant therapy, often presenting limited bone disponibility, narrow alveolar ridges, diminished bone density, scarce inserted gingiva and several co-morbidities.Thus, improving their possibility of success in implant therapy avoiding further surgical interventions is key. Platelet-rich fibrin (PRF) is a blood derivate that can be easily and economically obtained from patients and that has shown promise of reducing the complications and improving the success of implant therapy, nevertheless its benefits in patients receiving implant retained overdentures has not been stablished. It is possible that PRF can improve the results and diminish the complications of implant therapy in older adults. The investigation aims to demonstrate that the use of platelet-rich fibirn (PRF) is safe and beneficial for implant treatment in older adults suffering from complete tooth loss.

NCT ID: NCT04426695 Completed - COVID-19 Clinical Trials

Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for Hospitalized Adult Patients With COVID-19

Start date: June 10, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objectives are: Pooled Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) - To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2 - To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation Phase 1/2 (Cohort 1) - To exclude futility of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation - To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo

NCT ID: NCT04424316 Completed - Clinical trials for Respiratory Tract Infection

A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.

Start date: June 17, 2020
Phase: Phase 3
Study type: Interventional

This randomized, double-blinded, placebo-controlled Phase 3 study is designed to evaluate the efficacy and safety of maternal immunization with RSVpreF against medically attended lower respiratory tract illness (MA-LRTI) in infants.

NCT ID: NCT04422028 Completed - Bioequivalence Clinical Trials

Bioavailability of Desogestrel 0.075 mg Tablets With Regards to Reference Product

Start date: January 11, 2020
Phase: Phase 1
Study type: Interventional

This Pivotal study investigated the bioavailability in women of 2 tablet formulations containing Desogestrel 0.075 mg. The Pivotal study was performed at a single site with 30 subjects. Participants took 2 tablets of the test product and reference product in 2 periods and 2 sequences (either test after reference or reference after test). There was a washout of 14 days between each study period.

NCT ID: NCT04419506 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

A Study to Test How Taking BI 1015550 for 12 Weeks Affects Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)

Start date: July 28, 2020
Phase: Phase 2
Study type: Interventional

This study is open to adults with idiopathic pulmonary fibrosis (IPF) who are at least 40 years old. People taking standard medicines for IPF, including antifibrotic medicines, can continue taking them throughout the study. The purpose of the study is to find out whether a medicine called BI 1015550 can slow down the worsening of lung function. Participants are in the study for about 4 months. During this time, they visit the study site about 7 times. At the beginning, they visit the study site every 2 weeks. After 1 month of treatment, they visit the study site every 4 weeks. The participants are put into 2 groups by chance. 1 group gets BI 1015550. The other group gets placebo. Placebo tablets look like BI 1015550 tablets but contain no medicine. The participants take BI 1015550 or placebo tablets twice a day. The participants have lung function tests at study visits. The results of the lung function tests are compared between the BI 1015550 group and the placebo group. The doctors also regularly check the general health of the participants.

NCT ID: NCT04418661 Terminated - Metastatic Neoplasm Clinical Trials

Safety and Efficacy Study of SAR442720 in Combination With Other Agents in Advanced Malignancies

Start date: June 9, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Primary Objectives: - Part 1 - To characterize the safety and tolerability of SAR442720 in combination with pembrolizumab in participants with advanced solid tumors. - To define the MTD and RP2D for the combination of SAR442720 and pembrolizumab in participants with solid tumors. - Part 2 - To determine the anti-tumor activity of SAR442720 in combination with pembrolizumab. - Part 3A - To define the MTD and RP2D for the combination of SAR442720 and adagrasib in participants with KRAS G12C NSCLC - To characterize the safety and tolerability of SAR442720 in combination with adagrasib in participants with KRAS G12C NSCLC - Part 3B - To determine the anti-tumor activity of SAR442720 in combination with adagrasib in participants with KRAS G12C NSCLC - Part 4 - To evaluate the impact of food on the PK of SAR442720 when dosed with pembrolizumab. - To evaluate the impact of the formulations (formulation 1 and formulation 2) on the PK of SAR442720 when dosed with pembrolizumab. Secondary Objectives: - Part 1 - To assess the PK of SAR442720 with pembrolizumab, and the PK of pembrolizumab with SAR442720. - To estimate the anti-tumor effects of SAR442720 with pembrolizumab. - Part 2 - To assess the safety profile of SAR442720 combined with pembrolizumab. - To assess other indicators of anti-tumor activity. - To assess the PK of SAR442720 with pembrolizumab, and the PK of pembrolizumab with SAR442720. - Part 3A - To characterize the PK of SAR442720 with adagrasib, and the PK of adagrasib with SAR442720. - To estimate the anti-tumor effects of SAR442720 with adagrasib - Part 3B - To assess the safety profile of SAR442720 with adagrasib in participants with KRAS G12C NSCLC. - To assess other indicators of anti-tumor activity. - To assess the PK of SAR442720 with adagrasib, and the PK of adagrasib with SAR442720. - Part 4 - To assess the safety and tolerability of SAR442720 formulations with pembrolizumab - To estimate the anti-tumor effects of SAR442720 with pembrolizumab.

NCT ID: NCT04417478 Completed - Obesity Clinical Trials

Effect of Periodontal Debridement on Leptin Levels in Obese

Start date: December 2016
Phase: N/A
Study type: Interventional

The main purpose of the study is to quantify of Leptin hormone in patients with normal weight, class I obesity, class II obesity and periodontitis, before and after scaling and root planning (SRP) and correlate the Body mass index (BMI) with Leptin levels. A double-blind, controlled, clinical trial was conducted. The sampling method was probabilistic stratified and the sample size 27 subjects in total, divided in 3 groups of: 9 normal weight patients, 9 class I Obesity patients and 9 class II Obesity patients and history of Generalized Periodontitis Stage II,III or IV, Grade B or C, who met the inclusion and exclusion criteria and signed an informed consent. All patients received SRP and clinical monitoring at baseline and 3 months post-therapy by the same examiner.Probing depth (PD), Clinical Attachment Level (CAL), Biofilm Index (BI) and Bleeding on Probing (BoP), Tooth Mobility and Suppuration were evaluated as clinical variables. Serum levels of leptin were evaluated by enzyme-linked immunosorbent assay (ELISA) at baseline and 3 months post SRP.

NCT ID: NCT04413617 Completed - Clinical trials for Rheumatoid Arthritis

TO ASSESS THE EFFICACY AND SAFETY OF PF-06650833, PF-06651600, AND TOFACITINIB ALONE AND IN COMBINATION IN PARTICIPANTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE

Start date: July 29, 2020
Phase: Phase 2
Study type: Interventional

Dual objectives of increased efficacy compared to currently available SoC RA drugs and maintaining a favourable benefit - risk relationship.

NCT ID: NCT04410991 Active, not recruiting - Clinical trials for Relapsing Multiple Sclerosis

Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2)

GEMINI 2
Start date: June 11, 2020
Phase: Phase 3
Study type: Interventional

Primary Objective: To assess efficacy of daily SAR442168 compared to a daily dose of 14 mg teriflunomide (Aubagio) measured by annualized adjudicated relapse rate (ARR) in participants with relapsing forms of MS Secondary Objective: To assess efficacy of SAR442168 compared to teriflunomide (Aubagio) on disability progression, MRI lesions, cognitive performance and quality of life To evaluate the safety and tolerability of daily SAR442168 To evaluate pharmacodynamics (PD) of SAR442168