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NCT ID: NCT05827016 Recruiting - Multiple Myeloma Clinical Trials

A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma

Start date: June 22, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effectiveness of iberdomide maintenance to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in participants with newly diagnosed multiple myeloma (NDMM).

NCT ID: NCT05822635 Recruiting - Pancreatic Diseases Clinical Trials

SpyGlass Surgical Study

Start date: December 1, 2023
Phase:
Study type: Observational

- To document the clinical utility of diagnostic and/or therapeutic intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope - To identify specific surgical procedures in which intraoperative use of a thin, single use, flexible cholangiopancreatoscope suggests clinically meaningful benefit and generate a hypothesis for possible subsequent claims-supportive study

NCT ID: NCT05820737 Recruiting - Clinical trials for Gastrointestinal Dysfunction

A Study to Assess the Gut Health Effects of Heat-killed Post-biotics in Overweight and Obese Adults

Start date: April 14, 2024
Phase: N/A
Study type: Interventional

The present study is a randomized, double-blind (Double dummy), placebo-controlled, parallel-group study to assess the gut health effects of heat-killed post biotics in overweight and obese individuals

NCT ID: NCT05817110 Recruiting - Lung Malignancy Clinical Trials

Validating Artificial Intelligence Effectiveness Defined Lung Nodule Malignancy Score in Patients With Pulmonary Nodule.

CREATE
Start date: April 20, 2023
Phase:
Study type: Observational

Artificial intelligence (AI) based algorithms have demonstrated increased accuracy in predicting the risk of Lung Cancer among patients with an incidental pulmonary nodule (IPN) on chest radiographs. Qure.ai, an AI company specializing in the reading of chest X- Rays (CXRs) by a proprietary algorithm and has developed a new model, qXR, that can report the lung nodule malignancy score (LNMS) based on lung nodule features. Our study aims to prospectively validate the lung nodule malignancy score against radiologist assessment of CT scans and Lung CT Screening Reporting and Data System score (Lung-RADS).(lung RADS score explained below) Thus, lung nodule malignancy score (interpreted by qXR as a high or low category) will be compared with radiologist-based assessment probability of CT scan and Lung-RADS assessment. The results of this prospective observational study will pave the way for improved nodule management, leading to better clinical outcomes in patients with incidental pulmonary nodule (IPNs), especially concerning malignancy assessment.

NCT ID: NCT05814965 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Association of Apical Periodontitis With Systemic Level of Inflammatory Markers : A Longitudinal Intervention Study

Start date: April 5, 2023
Phase: N/A
Study type: Interventional

While cross-sectional studies have reported a significant association between diabetes and Apical Periodontics, prospective studies are scarce. This will be the first prospective interventional study to explore the cause-and-effect relation between AP and diabetes by assessment of levels of inflammatory markers in a longitudinal setting. Periapical healing in diabetics and nondiabetics will be compared after root canal treatment to evaluate the role of various physical and metabolic attributes on endodontic outcomes.

NCT ID: NCT05803421 Recruiting - Obesity Clinical Trials

A Study of Daily Oral Orforglipron (LY3502970) Compared With Insulin Glargine in Participants With Type 2 Diabetes and Obesity or Overweight at Increased Cardiovascular Risk

ACHIEVE-4
Start date: April 3, 2023
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to determine safety and efficacy of orforglipron compared with insulin glargine in participants with type 2 diabetes and obesity or overweight at increased cardiovascular risk. The study will last approximately 2 years may include up to 27 visits.

NCT ID: NCT05794230 Recruiting - Healthy Volunteers Clinical Trials

Study of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Given With Routine Pediatric Vaccines in Healthy Infants and Toddlers in India and the Republic of South Africa

MEQ00064
Start date: March 27, 2023
Phase: Phase 3
Study type: Interventional

This open label randomized study will be conducted to evaluate and/or describe the immunogenicity and describe the safety of MenACYW conjugate vaccine when administered in infants and toddlers. It will be conducted in India and the RSA in 2 cohorts: - Cohort I: Infants and toddlers 6 months to 16 months of age - Cohort II: Infants and toddlers 6 weeks to 15 months of age In Cohort I, eligible participants will be randomized in a 1:1 ratio to receive 2 intramuscular (IM) injections (1+1 vaccination schedule) of either MenACYW conjugate vaccine (Groups 1 and 3) or Menactra vaccine (Groups 2 and 4), co-administered with routine pediatric vaccines. In Cohort II, eligible participants will be randomized in a 2:1 ratio to receive either 3 IM injections (2+1 vaccination schedule) of MenACYW conjugate vaccine co-administered with routine pediatric vaccines (Groups 5 and 7) or routine pediatric vaccines only (Groups 6 and 8). The primary objectives of this study are: - To demonstrate the non-inferiority of immunogenicity of 2 doses of MenACYW conjugate vaccine compared to 2 doses of Menactra® vaccine in infants and toddlers 6 months to 16 months of age in terms of serum bactericidal assay using human complement (hSBA) seroprotection (titers ≥ 1:8) in India and the Republic of South Africa (RSA) - To demonstrate the vaccine immune sufficiency of 3 doses of MenACYW conjugate vaccine in infants and toddlers 6 weeks to 15 months of age in terms of hSBA seroprotection (titers ≥ 1:8) in India and the RSA The secondary objectives of this study are: - To describe the antibody titers to the meningococcal serogroups A, C, Y, and W: - before and 30 days post primary series of MenACYW conjugate vaccine and before and 30 days post booster dose of MenACYW conjugate vaccine in infants and toddlers 6 weeks to 15 months of age in India and the RSA when administered concomitantly with other age-recommended vaccines. - before and after 30 days post each dose of MenACYW conjugate vaccine or Menactra vaccine in infants and toddlers 6 months to 16 months of age in India and the RSA when administered concomitantly with other age-recommended vaccines. - To describe the antibody responses against the antigens of the other age-recommended vaccines when administered concomitantly with MenACYW conjugate vaccine: - in infants and toddlers 6 weeks to 15 months of age in India and the RSA. - in infants and toddlers 6 months to 16 months of age in India and the RSA. The duration of each participant's active participation in the study will be approximately 10 to 11 months for Cohort I and 13,5 to 14,5 months for Cohort II.

NCT ID: NCT05789537 Recruiting - Hemophilia B Clinical Trials

A Study of SerpinPC in Participants With Hemophilia B (HemB) With Inhibitors

PRESent-3
Start date: July 28, 2023
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the efficacy, safety, tolerability and pharmacokinetic (PK) profile of prophylactic SerpinPC in participants with Hemophilia B with inhibitors, as part of the SerpinPC registrational program.

NCT ID: NCT05789524 Recruiting - Hemophilia A Clinical Trials

The Efficacy and Safety of SerpinPC in Participants With Severe Hemophilia A or Moderately Severe to Severe Hemophilia B

PRESent-2
Start date: July 6, 2023
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of prophylactic SerpinPC administered subcutaneously (SC) to participants with severe hemophilia A (HemA) (with or without inhibitors) or moderately severe to severe hemophilia B (HemB) (without inhibitors) as part of the SerpinPC registrational program. This study consists of 3 parts: Part 1: dose-justification phase, Part 2: dose-confirmatory phase, Part 3: extension phase for participants who complete either Part 1 or Part 2. This adaptive design study has a randomized dose-justification component to investigate the efficacy and safety of SerpinPC as a therapeutic option, principally for participants with HemB without inhibitors. SerpinPC has a novel mechanism of action compared with marketed treatments and those that are in development.

NCT ID: NCT05786547 Recruiting - Smoking Cessation Clinical Trials

V+PSF-M for Tobacco Cessation in HIV Care in India

Start date: January 2, 2024
Phase: Phase 3
Study type: Interventional

The goal of this research study is to test an intervention to help quit tobacco use in participants with Human Immunodeficiency Virus (HIV). The study interventions used in this research study are: - Positively Smoke Free - Mobile (PSF-M) (mobile behavioral program) - Varenicline (or Chantix, apovarenicline, Champix or Nocrav)