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NCT ID: NCT06075459 Completed - Cataract Clinical Trials

Post Marketing Clinical Evaluation Assessing the Visual Performance of Hanita Lenses "Intensity SL" Intraocular Lens

Post-op
Start date: March 1, 2023
Phase:
Study type: Observational [Patient Registry]

This clinical study will assess the safety and performance of Intensity SL IOL, 1 year post operation. The study will also evaluate the patient satisfaction of the implanted patients.

NCT ID: NCT06075095 Recruiting - Clinical trials for COPD (Chronic Obstructive Pulmonary Disease)

A Study to Investigate the Effect on Lung Function of an Approved COPD Treatment (BGF, With HFA Propellant) Compared to BGF Formulated With a New Propellant (HFO) in Participants 40 to 80 Years of Age With COPD

Start date: January 11, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate that the lung function effect from orally inhaled BGF delivered via HFO propellant is equivalent to the lung function effect from orally inhaled BGF delivered via HFA propellant in participants with COPD. The study duration for each participant will be approximately 15 to 16 weeks and consist of: 1. A screening and placebo run-in period of approximately 2 weeks prior to first dosing 2. Three treatment periods of approximately 4 weeks each (one period for each of 3 study interventions) 3. A final safety follow-up visit via telephone contact approximately 1 to 2 weeks after the final dose administration Participants will be provided with rescue SABA (albuterol or salbutamol) to be used as needed throughout the study. Participants will attend in-clinic study visits approximately weekly during the screening/run-in period (Visits 1, 2, and 3), then every 4 weeks (Visits 4, 5, and 6) to receive take-home study treatment, measure their lung function, and assess their health and safety

NCT ID: NCT06073119 Recruiting - Psoriasis Clinical Trials

A Study to Evaluate Efficacy and Safety of SAR441566 in Adults With Plaque Psoriasis

SPECIFI-PSO
Start date: October 26, 2023
Phase: Phase 2
Study type: Interventional

This is a Phase 2, international, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, 12-week study. It is designed to assess the therapeutic dose, efficacy, and safety of treatment with SAR441566 in male and female adults with moderate to severe plaque psoriasis. Study details include a screening period (4 weeks and not less than 11 days before Day 1), a treatment period (12 weeks ± 3 days) and a post-treatment period (safety follow-up) (2 weeks ± 3 days). The total number of study visits will be 7.

NCT ID: NCT06073093 Recruiting - Clinical trials for Rheumatoid Arthritis

A Study to Evaluate SAR441566 Efficacy and Safety in Adults With Rheumatoid Arthritis

SPECIFI-RA
Start date: November 7, 2023
Phase: Phase 2
Study type: Interventional

This is a parallel group, Phase 2, randomized, double-blind, placebo controlled, 5-arm, international, multicenter, 12-week proof of concept, dose finding study. It is designed to assess efficacy and safety of treatment with SAR441566 for 12 weeks. It will be conducted in male and female adult participants with moderate-to-severe rheumatoid arthritis (RA) not adequately controlled on methotrexate (MTX) and biologic/targeted synthetic disease modifying anti-rheumatic drug (DMARD) naive. Study treatment includes investigational medicinal product (IMP: SAR441566 or placebo) added-on to a background therapy of MTX. Study details include a run-in period (6 weeks ± 3 days) before randomization to determine eligibility, a treatment period (12 weeks ± 3 days) and a post-treatment period (safety follow-up) (2 weeks ± 3 days). The total number of scheduled study visits will be 8.

NCT ID: NCT06068842 Recruiting - Clinical trials for Non Small Cell Lung Cancer

A Study to Assess Prevalence of a Specific Protein Overexpression in Adult Participants With Non-Small Cell Lung Cancer

METRIX
Start date: November 3, 2023
Phase:
Study type: Observational

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for 80%-85% of lung cancers cases of which 60% are non-squamous (NSQ). This study will evaluate the prevalence of mesenchymal epithelial transition (MET) overexpression (OE) in adult participants with advanced or metastatic NSQ NSCLC. Archived tissue biopsies will be tested for MET OE and data from approximately 500 participants will be collected. No participants will be enrolled in this study. Participants' charts will be reviewed. No drug will be administered as a part of this study. The duration of the study will be approximately 15 months. There is no additional burden for participants in this trial.

NCT ID: NCT06067828 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

A Study to Evaluate the Effect of Budesonide, Glycopyrronium, Formoterol Fumarate (BGF) Metered Dose Inhaler (MDI), Budesonide and Formoterol Fumarate (BFF) MDI and Placebo MDI on Exercise Parameters in Participants With Chronic Obstructive Pulmonary Disease (COPD).

ATHLOS
Start date: October 24, 2023
Phase: Phase 3
Study type: Interventional

This study will investigate the effect of Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) metered dose inhaler (MDI) compared with Placebo MDI, and Budesonide and Formoterol Fumarate (BFF) MDI on isotime inspiratory capacity (IC) and exercise endurance time.

NCT ID: NCT06067594 Completed - Clinical trials for Medullary Thyroid Carcinoma

Calcitonin in Needle Wash Using Electrochemiluminescence Method For Diagnosis Of Medullary Thyroid Carcinoma.

Start date: March 1, 2018
Phase:
Study type: Observational [Patient Registry]

Medullary thyroid carcinoma (MTC) is a tumor originating from parafollicular C cells of the thyroid. (1) Representing 1 to 7% of all thyroid carcinoma cases (2, 3, 4). It can occur in two clinical forms, the sporadic or non-hereditary, in 75-80% of patients, and the hereditary form in the remaining 20-25%. It can be part of different clinical syndromes depending on the organs involved: Multiple Endocrine Neoplasia type 2A (MEN2A), Multiple Endocrine Neoplasia type 2B (MEN2B) and Familial Medullary Thyroid Carcinoma (FCM) whose clinical expression is only CMT. A distinctive characteristic of this tumor is its capacity to secrete calcitonin (CT), which, measured in serum, sanctions suspicion of this pathology (5-8) leading to diagnostic studies to confirm CMT. For the preoperative diagnosis of thyroid nodules, ultrasound-guided fine-needle aspiration cytology (FNAC) is a useful and safe procedure; however, its sensitivity to exclude CMT is low (9-15). In 2015, a meta-analysis of 15 studies (16) found that the accuracy of FNAC in diagnosing CMT was around 50%. For this reason, other studies have indicated that the measurement of calcitonin in the fine-needle lavage aspirate fluid of thyroid nodules (CT-guided FNAC), which have suspected medullary carcinoma, can significantly improve the accuracy in the diagnosis of MTC (17 -19). Therefore, clinical practice guidelines recommend its determination in patients with suspected MTC (1,2). The diagnostic importance of pre-surgical medullary carcinoma lies mainly in two points: first, it changes the surgical approach of the patients, and second, it allows one to rule out associated pathologies such as hyperparathyroidism and pheochromocytoma, which are associated when the entity is hereditary. The performance of CT-guided FNAC by the chemiluminescent (CL) method has been widely disseminated. However, to the best of our knowledge, to date there are no data available on the appropriate cut-off value of CT-guided FNAC with calcitonin electrochemiluminescence (ECL) immunometric assay method. As previously stated, it is of particular interest to determine the calcitonin cut-off point in needle washing by electrochemiluminescence method that allows diagnosing medullary carcinoma. Clarifying this point allows improving the approach to patients in whom medullary carcinoma is suspected. This work seeks to determine the cut-off point of CT-guided FNAC for the diagnosis of CMT with the ECL assay method.

NCT ID: NCT06065748 Recruiting - Clinical trials for Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer

A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)

Start date: December 11, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.

NCT ID: NCT06065540 Recruiting - Clinical trials for Type 2 Diabetes Mellitus

A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor

REIMAGINE 2
Start date: September 27, 2023
Phase: Phase 3
Study type: Interventional

The study will look at how well CagriSema helps people lower their blood sugar and body weight. CagriSema is a new weekly medicine that combines two medicines called semaglutide and cagrilintide. CagriSema will be compared to the two medicines semaglutide and cagrilintide, when they are taken alone. CagriSema will also be compared to a "dummy" medicine without any active ingredient. The study will be done in participants who have type 2 diabetes. Participants will take the study medicine together with the current diabetes medicine (metformin with or without an SGLT2 inhibitor).

NCT ID: NCT06064929 Recruiting - Lupus Nephritis Clinical Trials

A Study of Felzartamab in Participants With Lupus Nephritis

Start date: November 1, 2023
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to evaluate the safety and tolerability of felzartamab plus standard of care in participants with refractory Lupus Nephritis (LN).