The purpose of the study is to evaluate the safety and how well the medication levosimenden works versus placebo in treating Pulmonary Hypertension and Heart Failure with a Preserved Ejection Fraction measured by a 6 minute walk. This is a condition where the lower left chamber (left ventricle) of the heart is not able to fill properly with blood during the filling phase and the amount of blood pumped out to the body is below normal. The study will also look at information obtained from the tests performed as part of the study to see if subjects have improvement in symptoms of heart failure. Levosimendan is a drug that has been FDA-approved for intravenous (IV) delivery to your body. This study aims to determine if the tablet form of the drug is as effective as the IV route. Tablets are much more attainable for patients to manage their heart failure from home, rather than going to an infusion clinic for treatments. Participation in this study will last approximately 12 weeks with the option to continue to the stage 2 phase of the study. If the stage 2 phase is selected as well, participation will last approximately 26 months or a little over 2 years. These visits will include such activities as blood tests, questionnaires, physical evaluation by a study doctor, echocardiogram, and 6 minute hall walks.
Participants will be randomized to either the treatment group (and receive the medication) or the control group (receive an inactive medication). Subjects will have a 50:50 chance of receiving the study medication during their participation in the trial. The treatment assignment is determined by randomization, where a computer selects at random which treatment group you will be in (like drawing straws). Neither the subject, nor the blinded personnel will know which group subjects are in. Neither the subject nor the study doctor will decide what group subjects are assigned.
VA Principal Investigators plan to gather information about veterans at the VAHCS who are interested in participating in rehabilitation research. Subject information collected will be housed in a centralized Rehabilitation Research Repository. VAHCS investigators may access this repository to quickly identify and recruit individuals who wish to be contacted for current and future VA IRB R&D approved rehabilitation research.
This study is for people newly diagnosed with acute myeloid leukemia (AML). An investigational (not approved by the FDA) drug, Tamibarotene, will be added to the standard of care drugs prescribed. Tamibarotene is a tablet that will be taken daily. The purpose of this study is to determine if the addition of this medication improves the prognosis of these subjects, as this is the first time it has been added to the treatment plan. The most common side effects observed to date include diarrhea, constipation, and vomiting, along with changes in the lab values. Procedures include lab work and bone marrow collections. Participation duration will depend upon how subjects respond to the treatment.
The purpose of this study is to collect information about patients with Arrhythmogenic right ventricular cardiomyopathy(ARVC) and about the disease. ARVC is a rare condition that affects heart muscle and causes abnormal heart rhythms (this is called "arrhythmia"). Participation in this study will take about 5 years. If your study doctor determines you are eligible and you agree to participate, you will be asked to visit the study doctor's office as part of your regular care for a screening visit and about 1 time each year for the length of the study. The majority of the data collected for this study will be part of your regular care, however study related procedures include arrhythmia monitoring, using wearable devices to measure tracing of the electrical activity of your heart, blood work, including genetic testing, and patient questionnaires
Patients with chronic or episodic recurrent dizziness will track their vestibular symptoms with every episode in the iPhone application, Vertige. They will track their symptoms at the conclusion of every episode for a total of six (6) months. The app has a geolocation software that will pair environmental data (barometric pressure, temperature, humidity, etc.) with symptoms. We will then analyze the data to evaluate for associations.
They study is for patients that have have been diagnosed with platinum-resistant or platinum-refractory ovarian cancer (PRROC) which includes fallopian tube cancer and peritoneal carcinomatosis (a form of cancer that affects the thin membrane that surrounds your abdominal organs). The investigational drug used in this study is Olvi-Vec. The main purpose of the study is to determine how women diagnosed with PRROC will best respond to receiving Olvi-Vec followed by platinum-doublet chemotherapy (platinum-based chemotherapy such as carboplatin or cisplatin are given with a non-platinum based chemotherapy, including gemcitabine, paclitaxel, docetaxel, nab-paclitaxel, or pegylated liposomal doxorubicin [PLD]) along with bevacizumab, known as the Experimental Arm. Participants can expect to be in this study for up to 36 months.
This research is all about investigating a potential treatment for a specific type of advanced lung cancer. The cancer cells have a protein called c-Met that's acting a bit too excited, driving the cancer to spread and resist treatment. This study focuses on two treatments: one is called Telisotuzumab Vedotin (ABBV-399), which is a smart combination of an antibody and a drug that can stop this protein's activity. The other treatment is called Docetaxel. The researchers have already found in smaller studies that Telisotuzumab Vedotin could be promising for this type of cancer, especially in patients whose previous treatments didn't work well. Now they want to see if it can really make a difference in the long run. They'll be comparing Telisotuzumab Vedotin and Docetaxel to figure out which one is better at helping patients live longer without their cancer getting worse. In this study, participants will be randomly divided into two groups, like flipping a coin. One group will get a new medicine called telisotuzumab vedotin through a vein in their arm every two weeks. The other group will receive a treatment called docetaxel through a vein every three weeks. People in both groups will keep getting their assigned treatment until their doctors say it's time to stop based on certain criteria. Throughout the study, participants will have scans like X-rays or MRIs to see how their tumors are doing. These scans will happen at the beginning and then every few weeks for the first year, and less often as time goes on.Even if someone stops their treatment for a reason other than their cancer getting worse on these scans, the researchers will keep track of them until their cancer gets worse or until they decide they don't want to be in the study anymore.The whole study is expected to last around 38 months, which is a little over 3 years. They'll keep following up with the participants, either by talking to them, checking their medical records, or other appropriate methods, until the participants decide to leave the study or pass away. This study is a big step towards finding better options for people battling this tough form of lung cancer.
The goal of this research study is to find out if intramuscular sternocleidomastoid (SCM) steroid injections work to reduce cough when compared to superior laryngeal nerve (SLN) steroid injection. Study patients will be randomly assigned to receive injections to numb the sensation within the voice box in one of two possible locations, either a traditional voice box injection or an injection into the neck muscle (a muscle in the neck near the voice box). The injections are composed of a numbing medication (lidocaine) and a medication that helps the numbing medication work longer (steroid). The outcomes studied will include if the treatments help to minimize chronic cough and associated symptoms. By better understanding if this treatment helps improve chronic cough, an additional treatment option could help patients with chronic cough. Voice box injections are usually only performed by fellowship trained laryngologists (an extra specialized year of training after ENT training). However, if neck muscle injections are found to be equivalent in treating chronic cough, general ENT doctors could likely provide this treatment to their patients without the need to see a specialized voice box doctor.
This study aims to investigate innovative approaches to managing chronic pain and opioid use. This study consists of two phases, each offering different treatment options. Participation is voluntary.
This study will sequentially evaluate three novel and scalable interventions for at-risk individuals on long term opioid therapy for chronic pain: (1) low-dose transdermal buprenorphine initiation without a period of opioid withdrawal; (2) a brief Cognitive Behavioral Intervention for pain (CBI); and (3) transcranial magnetic stimulation by examining standardized repeated measures of clinical outcomes at baseline, during treatment, and at follow-up.
Phase 1:
In this initial phase, all participants will have a 1-week open-label trial of buprenorphine (worn as a patch on the arm, shoulder or upper-back). This trial aims to assess the safety and effectiveness of buprenorphine in managing chronic pain and opioid use. During this phase, participants will have the opportunity to experience the effects of buprenorphine under close monitoring.
Phase 2:
After completing Phase 1, participants will have the opportunity to choose their next course of treatment. They can decide to continue with buprenorphine, and undergo a 1-week trial of either real buprenorphine or a placebo (an inactive substance). They will be randomly assigned to receive either real or placebo buprenorphine. If participants respond well to buprenorphine treatment, they may continue the medication under the care of their physician.
Alternatively, participants can explore an alternative treatment called repetitive transcranial magnetic stimulation (rTMS) in Phase 2. If they opt for rTMS, they will receive either real rTMS or a sham version interspersed with cognitive-behavioral therapy for pain. Participants will be randomly assigned to receive either real or sham rTMS.
In both phases, participants will receive close monitoring and attend regular study visits to assess safety and progress. Throughout the study, they will be asked to complete questionnaires about pain, functioning and opioid use, undergo physiological monitoring and blood samples will be collected at specific points.
It's important to note that there are potential risks associated with the study medication, such as difficulty sleeping, nausea, and dizziness. Additionally, for the rTMS arm, there is risk of mild headache, pain at the stimulation site, and there may be unknown risks related to the brain stimulation.
Participants' experience in Phase 1 will involve an open-label trial of buprenorphine, and participants' decisions in Phase 2 will determine the treatment path. While the effectiveness of these treatments is uncertain, participants will receive thorough monitoring throughout the study, and have the option to withdraw at any time. Improvement in participant symptoms is possible but not guaranteed.
The purpose of this study is to evaluate investigational treatments (study drugs) for metastatic esophageal carcinoma to determine if any of these study drugs improve overall survival as compared to standard treatments. The study drugs used in this trial are lenvatinib (E7080/MK‑7902), also called LENVIMA, and pembrolizumab (MK‑3475), also called KEYTRUDA or pembro. Both lenvatinib and pembrolizumab have been approved by the U.S. Food and Drug Administration (FDA) to treat various cancers but may not be approved for your type of cancer. Treatment for this study may be up to 3 years. The procedures include blood and urine samples, questionnaires, infusions, and CT scans. Risks include itchy skin, loose stools, cough, and joint pain. You may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future.