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NCT ID: NCT05350072 Active, not recruiting - Sjogren Syndrome Clinical Trials

Two-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome

NEPTUNUS-1
Start date: July 28, 2022
Phase: Phase 3
Study type: Interventional

A randomized, double-blind, placebo controlled, 2-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjogren's syndrome (NEPTUNUS-1)

NCT ID: NCT05349214 Recruiting - Sjogren Syndrome Clinical Trials

Three-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome

NEPTUNUS-2
Start date: August 4, 2022
Phase: Phase 3
Study type: Interventional

A randomized, double-blind, placebo controlled, 3-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjogren's syndrome (NEPTUNUS-2)

NCT ID: NCT05348733 Recruiting - Clinical trials for Type 2 Diabetes Mellitus

A Study Called FINE-REAL to Learn More About the Use of the Drug Finerenone in a Routine Medical Care Setting

Start date: June 13, 2022
Phase:
Study type: Observational

This is an observational study in people with chronic kidney disease (CKD) and type 2 diabetes (T2D) who will be receiving finerenone. Kidneys filter extra water and waste out of the blood and make urine. CKD is a long-term, progressive, decrease in the kidneys' ability to filter the blood properly. In people with T2D, the body does not make enough of a hormone called insulin, or does not use insulin well enough, resulting in high blood sugar levels that can cause damage to the kidneys. As a result, CKD can occur as a complication of T2D. Finerenone works by blocking certain proteins, called mineralocorticoid receptors. An increased stimulation of these proteins is thought to damage the kidneys and the heart. By lowering their stimulation, finerenone reduces the risk of kidney disease progressively getting worse. Finerenone is available and approved for doctors to prescribe to people with CKD and T2D. Since it has only recently become available for these patients, there is a need for more information about the use of finerenone in the real-world setting. The main purpose of the study is to learn more about treatment patterns in people with CKD and T2D who just started or will start finerenone treatment as decided and prescribed by their doctor as part of their routine medical care. To answer this question, the researchers will collect data on: - Clinical characteristics (e.g., history of CKD and T2D, blood pressure, heart health) of the participants - Reasons for starting finerenone - Reasons for stopping finerenone early - How long participants have been taking finerenone (planned by their doctor compared to actual time it was taken) - Dosing of finerenone - Other medications used while taking finerenone The researchers will also collect data on medical problems (called adverse events) that the participants may have during the study. All adverse events are collected, even if they might not be related to the study treatment. Hyperkalemia, a medical term used to describe a potassium level in the blood that is higher than normal, is of special interest when finerenone is combined with some medications commonly taken to control blood pressure. Researchers want to know how often higher potassium levels occur, and when it leads to: - Stopping finerenone treatment too early - Dialysis (a medical procedure to filter the blood of extra water and waste) - Care in a hospital All data will come from medical records or from interviews study doctors will have with the participants during visits that take place during routine medical care. Participants in the US will be invited to provide voluntary blood and urine samples that could be analyzed later to better understand possible changes in protein or nucleic acid levels over time. Each participant will be in the study for 12 months. This time participating in the study may be shorter if their finerenone treatment is stopped early or the study comes to an end as planned in September 2027.

NCT ID: NCT05348577 Recruiting - Prostate Cancer Clinical Trials

Study of Capivasertib + Docetaxel vs Placebo + Docetaxel as Treatment for Metastatic Castration Resistant Prostate Cancer (mCRPC)

CAPItello280
Start date: March 25, 2022
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy and safety of capivasertib plus docetaxel versus placebo plus docetaxel in participants with metastatic castration resistant prostate cancer (mCRPC), all participants will receive the docetaxel with steroid therapy and receive androgen deprivation therapy. The intention of the study is to demonstrate that the combination of capivasertib plus docetaxel is superior to placebo plus docetaxel with respect to the overall survival of study participants, when overall survival is defined as the time from randomization until the date of death due to any cause.

NCT ID: NCT05348096 Recruiting - Clinical trials for Chronic Graft-versus-host-disease

Efficacy and Safety of Low-dose Ibrutinib and Itraconazole in Chronic Graft Versus Host Disease

Start date: April 1, 2022
Phase: Phase 2
Study type: Interventional

Chronic graft-versus-host disease (cGVHD) affects 30 to 70% of Allogeneic Hematopoietic Cell Transplantation, decreases the quality of life, and increases mortality. First-line treatments for cGVHD are steroids, however, up to 50% of patients do not respond to treatment. There is no well-defined second-line treatment for cGVHD, but ibrutinib, a Bruton tyrosine kinase inhibitor, has been successfully used in phase 2 clinical trials for moderate to severe steroid-refractory cGVHD and has been shown to be safe, showing rates of response of 69% at a median follow-up of 26 months. Therefore, ibrutinib was approved by the FDA for the treatment of steroid-refractory cGVHD. Also, it is known that ibrutinib is metabolized by cytochrome isoenzyme 3A4 and that itraconazole is a potent inhibitor of this hepatic isoenzyme. Therefore, the investigators hypothesized that in subjects with newly diagnosed cGVHD and in patients with steroid-refractory cGVHD, low-dose ibrutinib in combination with itraconazole might be effective and safe.

NCT ID: NCT05347082 Completed - Clinical trials for Postmenopausal Osteoporosis

Frequency of Hyperparathyroidism in Postmenopausal Osteoporosis and Its Treatment

Start date: April 29, 2021
Phase: N/A
Study type: Interventional

Recently, an increase in the prevalence of hyperparathyroidism and hypovitaminosis D in postmenopause women has been occurring in Mexico and the world. Chronic exposure to the parathyroid hormone (PTH) is catabolic for the bone, worsening the state of osteoporosis. However, it is unclear whether these conditions could significantly improve bone mineral density (BMD). In the present work, it was shown that the resolution of hyperparathyroidism in postmenopausal women improves osteoporosis.

NCT ID: NCT05346445 Completed - Hot Flashes Clinical Trials

Comparison of Fluoxetine Versus Citalopram Therapy to Control Postmenopausal Vasomotor Syndrome

Start date: January 20, 2021
Phase: N/A
Study type: Interventional

This study determined the efficacy of non-hormonal therapy with citalopram compared to fluoxetine, for the treatment of menopausal symptoms in Mexican women with vasomotor syndrome (VMS) and urogenital syndrome.

NCT ID: NCT05346419 Completed - Clinical trials for Postmenopausal Osteoporosis

Antiresorptive Effect of Treatment With Risedronate and Vitamin D in Postmenopausal Patients

Start date: July 1, 2021
Phase: N/A
Study type: Interventional

Osteoporosis is defined as a systemic disease of bone mineralization, characterized by a decrease in bone mineral density that causes bone fragility and increases the risk of fractures during menopause. Recently, a high prevalence of hypovitaminosis D has been found worldwide, which could trigger a state of secondary hyperparathyroidism that can worsen the state of postmenopausal patients with osteoporosis. An open-label, clinical trial was conducted in Mexican women with postmenopausal osteopenia-osteoporosis to determine the efficacy of the combined treatment with risedronate and high-dose vitamin D in improving bone mineral density, hyperparathyroidism, and hypovitaminosis D.

NCT ID: NCT05343130 Recruiting - Clinical trials for Cervical Spinal Cord Injury

Efficacy of a Brain-Computer Interface Controlled Functional Electrical Stimulation Therapy for Spinal Cord Injury Neurorehabilitation

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

The study's main goal is to determine the efficacy of a therapy with brain-computer interface controlled functional electrical stimulation for neurorehabilitation of spinal cord injury patients' upper limbs. For this purpose, a randomized controlled trial will be performed to compare the clinical and physiological effects of the brain-computer interface therapy with those of a sham intervention comprised by the application of functional electrical stimulation independently of brain-computer interface control.

NCT ID: NCT05343091 Recruiting - Clinical trials for Pulmonary Hypertension

Prognostic Value of the Right Ventricular Function by Portable Ultrasound in Patients With Pulmonary Hypertension.

Start date: March 1, 2021
Phase:
Study type: Observational [Patient Registry]

Pulmonary arterial hypertension (PAH) is a disease characterized by obliteration and remodeling of small-caliber pulmonary arteries, progressively generating an increase in pulmonary vascular resistance, right heart failure, and death. Current guidelines recommend a multidimensional approach which includes clinical, echocardiographic, exercise and hemodynamic variables to classify patients by risk and thus define a prognosis and guide therapeutic decisions. There is a wide range of studies, which have shown a good correlation between standard echocardiography and portable cardiac ultrasound. There is no doubt about the usefulness of portable cardiac ultrasound in the intensive care unit, emergency department and even during hospital rounds; however, its usefulness during the daily examination in a follow-up consultation of patients at high risk of cardiovascular deterioration, such as patients with PAH, has not yet been demonstrated. There is evidence that a TAPSE measurement <17mm using standard echocardiography by a physician experienced in echocardiography predicts survival in patients with Pulmonary hypertension. We would like to know if patients with low TAPSE will have a higher proportion of morbidity events compared to patients with normal TAPSE measured by portable ultrasound.