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NCT ID: NCT06195930 Recruiting - Clinical trials for Chronic Heart Failure With Reduced Ejection Fraction

A Study to Learn How Safe Starting Vericiguat at a Dose of 5 Milligrams is in Participants With Chronic Heart Failure With Reduced Ejection Fraction

Start date: April 18, 2024
Phase: Phase 2
Study type: Interventional

Researchers are looking for a better way to treat people who have chronic heart failure with reduced ejection fraction. Chronic heart failure with reduced ejection fraction (HFrEF) is a long-term condition that occurs when the heart is too weak to pump enough blood to the rest of the body. This results in a reduced supply of the oxygen that the body requires to function properly. The common symptoms of HFrEF include breathlessness, weakness, fatigue, and swelling in the ankles and legs. If left untreated, heart failure can lead to other serious health problems, including damage to other organs, which may result in hospital stays or even death. Vericiguat is an approved drug for use in people with chronic HFrEF. It works by activating a protein called soluble guanylate cyclase, which helps dilating the blood vessels and in turn improves heart function. Currently, treatment with vericiguat starts at a daily dose of 2.5 milligrams (mg), which increases to 5 mg after 2 weeks. The dose is then increased to the target dose of 10 mg after another 2 weeks. In this study, researchers are trying to learn how well participants can tolerate and how safe it is to start vericiguat at a dose of 5 mg. Starting directly at the 5 mg dose is expected to help reach the target dose of 10 mg faster. Participants will take vericiguat 5 mg as a tablet by mouth once daily along with their regular heart medications. At the start of the study, study doctors will check participants' medical history and perform full health check-ups to confirm if they can take part in the study. Throughout the study, study doctors will monitor participants' previous and current medications, their heart health, and their overall well-being. This will help researchers assess how safe the study drug is and if they experience adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective of whether they think they are related to the study treatment. Access to study treatment after the end of this study is not planned. Everyone, including study doctors and participants, will know what drug the participants receive during the study. Participants may be in the study for about 4 weeks. Participants may not benefit from the treatment as the study is designed to assess safety and tolerability: the duration of the study is very short and participants will be taking a low dose of vericiguat without moving to the target dose of 10 mg during the study. However, the findings of this study may enable people with chronic HFrEF to safely skip one initial dosing step and reach the target dose of vericiguat faster. Participants may experience medical problems such as low blood pressure, upset stomach, nausea, dizziness, and headache. Researchers will monitor and manage all these, and other, medical problems participants may have during the study.

NCT ID: NCT06195891 Recruiting - Clinical trials for Acute Myeloid Leukemia

Orca-T Following Chemotherapy and Total Marrow and Lymphoid Irradiation for the Treatment of Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia or Myelodysplastic Syndrome

Start date: September 28, 2024
Phase: Phase 1
Study type: Interventional

This phase I trial tests the side effects and best dose of total marrow lymphoid irradiation along with chemotherapy, with fludarabine and melphalan, with or without thiotepa, in combination with Orca-T cells for patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) or myelodysplastic syndrome (MDS). Total marrow and lymphoid irradiation is a targeted form of total body irradiation that uses intensity-modulated radiation therapy to target marrow, lymph node chains, and the spleen. It is designed to reduce radiation-associated side effects and maximize the radiation therapeutic effect. Giving chemotherapy with medications such as thiotepa, fludarabine, and melphalan before a treatment with stem cells helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Orca-T cells take cells from a donor and remove some of the T cells and replace them with partially engineered T cells in order to induce better tolerance in patients. Giving total marrow and lymphoid irradiation and chemotherapy followed by Orca -T cells may be an effective treatment for patients with AML, ALL or MDS.

NCT ID: NCT06195631 Not yet recruiting - Injuries Clinical Trials

Evaluating a Standardized Checklist Bundle for Optimizing Procedural Ergonomics in Endoscopy

Start date: September 2024
Phase: N/A
Study type: Interventional

The goal of this Hybrid Type 2 effectiveness-implementation trial is to test the Standardized Checklist for Optimizing Procedural Ergonomics in Endoscopy (SCOPE-E) bundle-a multicomponent intervention comprised of a pre-procedure ergonomic timeout checklist and evidence-based implementation strategies-as a strategy to mitigate the risk of Endoscopy-related injuries (ERI) during colonoscopy.

NCT ID: NCT06195605 Recruiting - Photoaging Clinical Trials

Investigating Age Dependence of Fibroblast and Extracellular Matrix Responses to Cross-linked Hyaluronic Acid Filler in Human Skin

Start date: May 9, 2024
Phase: N/A
Study type: Interventional

The purpose of the study is to investigate the impact of the injection of dermal filler on the quality of the skin dermal extracellular matrix in persons between the ages of 30-50 years. The quality of the dermal extracellular matrix will be assessed following injection of dermal filler compared to injection of saline vehicle.

NCT ID: NCT06195345 Recruiting - Clinical trials for Hemodynamic Instability

Individual Cerebral Hemodynamic Oxygenation Relationships (ICHOR 1)

ICHOR 1
Start date: November 1, 2018
Phase:
Study type: Observational

This is an observational study in patients who require clinical anesthesia. The main purpose of this study is to understand whether there are differences in the cerebral blood flow, and oxygen metabolism affected by different types of anesthesia. Subjects who require clinical anesthesia for a clinical MRI and for whom the use of anesthetics for the exam are in clinical equipoise are asked to join the study. All eligible subjects will be asked to provide informed consent before participating in the study.

NCT ID: NCT06195319 Completed - Metabolism Clinical Trials

Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-Simufilam Following a Single Oral Dose in Healthy Male Subjects

Start date: February 7, 2024
Phase: Phase 1
Study type: Interventional

To evaluate the absorption, metabolism, and excretion of [14C]-simufilam in healthy male subjects following a single oral administration of 100 mg of (approximately 100 µCi) [14C]-simufilam.

NCT ID: NCT06195306 Not yet recruiting - Breast Carcinoma Clinical Trials

Low Dose Tamoxifen With or Without Omega-3 Fatty Acids for Breast Cancer Risk Reduction

Start date: June 16, 2024
Phase: Phase 2
Study type: Interventional

This phase II trial evaluates tamoxifen, with or without omega-3 fatty acids, for reducing risk of breast cancer among postmenopausal and overweight or obese women who are at increased risk of developing breast cancer. Tamoxifen is a selective estrogen receptor modulator. It works by blocking the effects of the hormone estrogen in the breast. Tamoxifen is approved by the Food and Drug Administration for prevention of breast cancer in women at increased risk. Omega-3 fatty acids have been shown to decrease the amount of fats made in the liver. Omega-3 fatty acids may work to prevent cancer in overweight or obese individuals. Tamoxifen with or without omega-3 fatty acids may be effective at reducing risk of breast cancer among women who are postmenopausal, overweight or obese, and at increased risk.

NCT ID: NCT06195072 Recruiting - Scleroderma Clinical Trials

Platform Clinical Study for Conquering Scleroderma

CONQUEST
Start date: April 1, 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to test efficacy of different investigational products (IPs) compared with placebo on the change from baseline to the end of the treatment period at Week 52 in lung capacity in participants with Interstitial Lung Disease Secondary to Systemic Sclerosis.

NCT ID: NCT06195059 Recruiting - Heart Failure Clinical Trials

Contrast Echocardiography During Exercise to Assess Pulmonary Blood Volume

Start date: July 2024
Phase:
Study type: Observational

The purpose of this study is to evaluate whether pulmonary blood volume (PBV) derived from contrast echocardiography can serve as a non-invasive surrogate for invasive pulmonary artery wedge pressure (PAWP) during exercise. Also, to compare changes in PBV with exercise in patients with and without heart failure and pulmonary vascular disease.

NCT ID: NCT06195046 Recruiting - Clinical trials for Congestive Heart Failure

Baroreflex Activation Therapy in Left Ventricular Assist Device Patients Study

BAT-VAD
Start date: February 1, 2024
Phase: N/A
Study type: Interventional

This study will involve LVAD patients who have already received a clinically-indicated BAT (BAROSTIM) device. After recovery from LVAD implant, we will investigate the effects of BAT in a double-blind cross-over study design.