The purpose of this study is to research and evaluate safety and effectiveness of the administration of bone marrow mesenchymal stem cell (bmMSC) derived extracellular vesicles product, DB-3Q, the study drug for perianal fistulizing Crohns disease. The study will enroll up to 36 participants across multiple sites. Your participation in this study will be…
The Takeda study drug used in this study is vedolizumab, a monoclonal antibody. Monoclonal antibodies are proteins made in laboratories that act like proteins in our bodies called antibodies. Vedolizumab acts specifically in the gut and works by preventing certain immune cells from going to the gut and helps reduce inflammation that can cause the symptoms (…
If your doctor has determined that you have a diagnosis of Ulcerative Colitis (UC), you may qualify for treatment with Sacral Nerve Stimulation (SNS). The purpose of this study is to evaluate the safety and effectiveness of SNS in study participants who have UC. While the investigational medical device used in this research study has been studied and…
Lymphangioleiomyomatosis (LAM) is a rare lung disease primarily affecting young women. Currently, LAM is often diagnosed in patients with radiology imaging (CTs) and/or lung biopsies; however, these methods can be imprecise, invasive, and/or can carry significant risks. The current study aims to devise a less invasive tool for diagnosis of this rare…
The purpose of this study is to identify genetic causes of lung diseases and to develop a research repository so that we can better understand, prevent and treat these conditions. You should consider joining this study if you have been diagnosed with a lung disease that has a genetic cause or if other family members have been diagnosed with a similar lung…
The purpose of this study is to compare the efficacy and safety of two standard-of-care drugs, Risankizumab (Skyrizi) versus Vedolizumab (Entyvio), over 48 weeks to compare how well these drugs work in patients with moderate to severe Ulcerative Colitis (UC). This study is being conducted at approximately 285 research centers worldwide and is expected to…
The purpose of this study is to assess the safety and effectiveness of GIE Medical's ProTractX3 TTS drug coated balloon (DCB) for the treatment of benign stricture in the bowel. This study is conducted to see whether this new drug coated balloon dilation device can treat strictures and reduce the rate of recurrence. Up to 215 subjects will participate…
The purpose of this study is to compare the effects, good or bad, of RO7790121 versus placebo inpatients with ulcerative colitis. In this study, you will get either RO7790121 or placebo. You will have the opportunity to participate in an open-label extension phase (getting the active drug - RO7790121), if your condition has not improved. RO7790121 is an…
The main purpose of the study is to determine whether the study drug, ONC-392, together with a standard of care drug PLUVICTO (Lutetium Lu 177 Vipivotide Tetraxetan), are safe and well tolerated, and whether two drugs are effective in treating prostate cancer, in comparison with the standard of care PLUVICTO alone. ONC-392 has not yet been approved by the…
This research study will look at a newer treatment option for Barrett's Esophagus (BE) which uses nitrous oxide to freeze unwanted tissue. The most commonly used treatment method is Radiofrequency Ablation (RFA) which uses heat to destroy the pre-cancerous tissue. Nitrous Oxide ablation using the C2 CryoBalloon Focal Ablation System, an FDA-cleared…
The purpose of this study is to help researchers understand more about the possible effectiveness and safety of apalutamide when given to patients with or without intermittent Androgen Deprivation Therapy (ADT) to treat metastatic Castration-Sensitive Prostate Cancer (mCSPC). Apalutamide is a type of drug that blocks the action of testosterone. By blocking…
The purpose of this study is to identify genetic causes of lung diseases and to develop a research repository so that we can better understand, prevent and treat these conditions. You should consider joining this study if you have been diagnosed with a lung disease that has a genetic cause or if other family members have been diagnosed with a similar lung…
The purpose of this study is to evaluate the safety and performance of sacral nerve stimulation (SNS) using an FDA-approved device called InterStim Neurostimulator (InterStim) in study participants with active moderate to severe ulcerative colitis. The goal of the study team is to reduce inflammation and symptoms associated with these conditions. This…
The purpose of this study is to determine whether HB-302/HB-301 therapy is safe and well tolerated. This will be the first time HB-302/HB-301 will be tested in humans. HB-302/HB-301 has not yet been approved by the Food and Drug Administration (FDA).
The use of electronic cigarettes, also known as e-cigs or vaping, has increased among former smokers and young adults who have never smoked. Relatively little is known, however, about their health effects (whether they are adverse, have no effect, or are beneficial). The purpose of this research study is to evaluate (1) the association of e-cig use with…
The purpose of this research study is to help us understand whether blood markers of lung injury are worse in adult patients with interstitial lung disease and obstructive sleep apnea compared with patients with interstitial lung disease who do not have obstructive sleep apnea.
We are asking you to participate in a research study to determine if we can detect minor lung injury that we cannot currently measure with available tests. This injury can occur when somebody is smoking for a long time or when somebody has COPD (chronic obstructive pulmonary disease). We want to compare the results of people who have never smoked, people…
We are asking you to participate in a research study to determine if we can detect changes in enzymes in the blood that may influence lung function decline in COPD (chronic obstructive pulmonary disease), in particular after COPD exacerbations. The procedures of the study include a pulmonary function test (breathing test), a short questionnaire, and blood…
This study aims to investigate ADXS-504 as a possible treatment for biochemically recurrent prostate cancer. ADXS-504 is a type of cancer treatment that is designed to stimulate your immune system to attack prostate cancer cells. ADXS-504 is made of bacteria that have been weakened to remove their ability to cause an infection. The bacteria have also been…
The purpose of this study is to find out whether delivering SBRT to the prostate, combined with the study drug atezolizumab, is a safe and effective treatment when given in combination with abiraterone, prednisone, and Lupron (the standard treatment for this disease). In addition, the researchers want to find out whether the study treatment works better…
Capnography-Assisted, Learned, Monitored (CALM) Breathing is a mind-body intervention for COPD that uses breathing exercises and biofeedback with the goal of reducing shortness of breath, anxiety symptoms and improving overall quality of life. The intervention is a 4-week (1 hour, twice weekly) program taking place in-person at New York Presbyterian…
The purpose of this study is to assess the effectiveness and safety of combining an investigational drug called BMS-986218 (also known as Anti-CTLA4-NF monoclonal antibody), or BMS-986218 plus nivolumab, with standard of care docetaxel (chemotherapy), in men who have metastatic castration-resistant prostate cancer (mCRPC) that progressed after a second-…
The purpose of this study is to determine if the addition of immunotherapy to the current standard of care for metastatic prostate cancer, chemotherapy, and hormonal therapy, is safe and improves your response to therapy. People who usually have metastatic prostate cancer to their bones and organs are usually treated with combination of chemotherapy (…
The purpose of this study is to see whether immunotherapy with BMS-986218 added to degarelix (which suppresses your testosterone) given prior to surgery can decrease the chance that your cancer will come back compared to degarelix alone. People who usually have this type of prostate cancer usually do not receive any additional therapy prior to surgery.
In Phase 1b, the purpose is to learn how well patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) tolerate the treatment when PLX2853 is added to ongoing treatment with abiraterone acetate and prednisone. We are looking for the highest dose of PLX2853 that can be given safely to patients with your type of disease who are already on…
This is a global prospective, observational, multi-center registry to evaluate the long-term safety profile for patients with short bowel syndrome (SBS) who are treated with teduglutide in a routine clinical setting. The registry will also evaluate the long-term clinical outcomes in patients with SBS. SBS patients treated and not treated with teduglutide…
The purpose of this study is to test the effectiveness and safety of an experimental drug known as HPN424 (also known as study drug) in patients with advanced prostate cancer. This drug has been tested in animals but not yet in people. This study tests different doses of HPN424. We want to find out how good the drug is at treating prostate cancer. We also…
This study is for patients with prostate cancer and that require treatment because their disease is now growing. The purpose of this study is to see whether immunotherapy with nivolumab added to degarelix or nivolumab and BMS-986253 added to degarelix is safe and can decrease the chance that the cancer will come back. Degarelix is a standard of care drug…
This study is for subjects with Idiopathic Pulmonary Fibrosis (IPF). IPF is an uncommon long-term disease that causes scar tissue to build up in the lungs, damaging the lung tissue. Idiopathic means that there is no known cause. Subjects with IPF have symptoms such as cough, shortness of breath, and reduced ability to exercise. The purpose of this study is…
The goal of this study is to evaluate how the results of a novel laboratory developed and validated urine test which predicts the likelihood of high grade prostate cancer will impact the decision on whether you will have a prostate biopsy to rule out prostate cancer. Approximately 1,000 subjects will be enrolled in this study. The study is expected to last…
The purpose of this study is to find out if a new investigational drug, called tofacitinib (also known as tofacitinib citrate or CP-690,550), can help people with Ulcer Colitis (UC). The purpose of this research study is to compare the effects of tofacitinib to a placebo in patients with Ulcer Colitis (UC). A placebo looks like the study drug but does not…
New medical therapy for pediatric Crohn's disease (CD) or pediatric ulcerative colitis (UC). We are currently recruiting pediatric participants (aged 2 to 17 years) who have received a diagnosis of UC or CD but who do not tolerate or respond to standard treatments, including corticosteroids, immunomodulators and TNF-alpha antagonists. The hubble study…
The purpose of this study is to see if 18FDCFPyL (PyL) PET/CT scans are able to find prostate cancer tumors. PyL is a radioactive drug (tracer) that targets prostate specific membrane antigen (PSMA). Because PSMA is a protein found mostly on the surface of prostate cancer cells, we are testing to see if PyL will be able to correctly identify prostate cancer…
The purpose of this study is to find out if you can take the prescribed dose of VX-371 without problems, and whether VX-371 is safe and helps subjects with PCD. VX-371 is called an investigational or experimental drug because it has not been approved for use in people by the Food and Drug Administration (FDA), the branch of U.S. government which approves…
This study is for patients who have been diagnosed Idiopathic Pulmonary Fibrosis (IPF). The purpose of the IPF-PRO registry is to collect data and biological samples that will support future research studies. The IPF-PRO Registry is actively enrolling patients to collect information regarding the natural history of IPF and healthcare interactions. The…
The main purpose of this study is to see if ustekinumab is useful for treating patients with moderately to severely active ulcerative colitis. The safety of ustekinumab will also be studied.
The purpose of this study is to find a more effective treatment as well as to gain a better understanding of prostate cancer. This study includes investigational study drugs which are specific for your prostate cancer (module). Treatment in each module will include an investigational medication called AZD4635 as well as another module-specific study drug(s…
The purpose of this clinical research study is to evaluate the safety and effectiveness of INS1007 as a treatment for non-CF bronchiectasis and to measure the concentration of INS1007 in the blood after treatment. INS1007 is taken as tablets and has been studied in animals and humans. Patients like you, with non CF bronchiectasis, may have problems with…
Our clinic is seeking patients with nontuberculous mycobacterial, or NTM, lung disease caused by Mycobacterium avium Complex (MAC), ages 18 years and older, for possible participation in a clinical trial. The CONVERT Study is evaluating the safety and effectiveness of an inhaled investigational drug called Liposomal Amikacin for Inhalation, or LAI
The purpose of this study is to find out if ODM-201 is effective at keeping hormone-sensitive prostatecancer under control when given in addition to standard treatment which includes androgen deprivation therapy (ADT) and docetaxel chemotherapy for six cycles. A total of approximately 1,300 men will take part in this study at a number of different locations…
The purpose of this study is to evaluate a new technique called Wide Area Transepithelial Sample 3-Dimensional Esophageal Biopsy (WATS) with computer assisted method of analysis of brush biopsy. This study will assess whether performing standard biopsies in addition to the WATS brush biopsies identifies more patients with dysplasia than does performing…
The purpose of this study is to characterize the pharmacokinetics (PK) and safety of intravenous (IV) pantoprazole in patients 1 to 16 years old who are candidates for acid suppression therapy.
The purpose of the ELEVATE CF study is to evaluate an oral investigational medication called VX-440 tosee if it is safe, effective, and well-tolerated when taken alone or with two other oral medications(VX-661 tezacaftor and ivacaftor) in people with cystic fibrosis (CF). This triple combination(TC) is being tested to see if it improves chloride transport (…
The purpose of this research study is to gather information about how respiratory syncytial virus (RSV) disease affects babies who were born earlier than their full-term due date, and how the hospitalization for RSV disease affects the parents/guardians daily routine activities. Information about the cost of healthcare and other costs related to the RSV…
C2 Therapeutics is currently enrolling patients to participate in the Coldplay 3 clinical trial. Coldplay 3 is evaluating the effectiveness of the Coldplay CryoBalloon Focal Ablation System in patients with Barrett's esophagus who have not yet received treatment. Participants will undergo treatment with the Coldplay CryoBalloon Focal Ablation System…
This is a clinical research study designed to determine the safety and effectiveness of the TIVUS system, an investigational device used in the treatment of PAH. The TIVUS System is intended to treat patients with pulmonary artery hypertension by injuring the sympathetic nerves surrounding the pulmonary vasculature (denervation) using ultrasonic energy. The…
The purpose of this study is to find out if subjects can take the prescribed dose of GBT440 without problems, and whether GBT440 is safe and helps subjects with IPF. GBT440 is called an investigational or experimental drug because it has not been approved for use in people by the Food and Drug Administration (FDA), the branch of U.S. government which…
We are doing this study to test a drug called MGD009. MGD009 is like an antibody, which is a protein in your blood that helps get rid of germs in your body. MGD009 is made to attach to cancer cells and to T-cells, which are a part of your immune system. Certain T cells have the ability to kill other cells, including cancer cells. By attaching to cancer…
You are being asked to participate in this research study because you have been diagnosed with metastatic castrate resistant prostate cancer (mCRPC) and are scheduled to start a new treatment. The purpose of this study is to see if changes in 18FDCFPyL (PyL) PET/CT scans before starting your new treatment and after 6 weeks on treatment is associated with…
The purpose of this study is to assess how effective the study drug Pulmaquin is in the management of chronic lung infections with Pseudomonas aeruginosa in subjects with non cystic fibrosis (nonCF) bronchiectasis by evaluating the time to first pulmonary exacerbation. A pulmonary exacerbation is defined as the new appearance or worsening in 4 or more of…
The purpose of this study is to see how safe and effective study drug GS-5745 is in treating people with moderate to severe Ulcerative Colitis. This is a randomized, double-blind, placebo-controlled study. Placebo-controlled means that you may receive an injection with no medicine in it, but looks like GS-5745. Randomized means you will be selected by…
The purpose of the study is to compare two types of endoscopic treatments in patients with Barretts esophagus (BE) with abnormal cells (dysplasia); radiofrequency ablation (RFA) and hybrid argon plasma coagulation (H-APC). H-APC is a newer technique in the treatment of BE and has not been adequately studied and is not approved by the FDA for routine use.…
This research study is investigating a new treatment for cancer that uses your immune system (a type of white blood cell called T cells or T lymphocytes) to try to attack your cancerous cells. T cells fight infections, and may attack cancer cells, in some cases. Currently, your T cells may not able to attack your cancerous cells. The use of these modified T…
The purpose of this study is to investigate the safety of adding nentedanib to treatment with pifenidone in patients with Idiopathic Pulmonary Fibrosis (IPF). Eligible patients must be receiving consistent treatment with pifenidone for at least 16 weeks on a stable dose. Nintedanib will be added as an additional treatment for IPF (combination treatment) for…
The purpose of this clinical research study is to test the effects of an investigational (being tested) study medication, GED-0301, in order to find out if GED-0301 can or cannot improve the symptoms of Crohns disease. The study will test 2 doses of GED-0301 compared to placebo. The placebo is a dummy pill that contains no study medication (or GED-0301),…
This study is being done to learn more about the safety and effectiveness of VX-440 used in combination with tezacaftor and ivacaftor in patients with cystic fibrosis. VX-440 given in combination with tezacaftor and ivacaftor is an investigational drug; investigational means the drug is not approved by the Food and Drug Administration (FDA), and is still…
You are being asked to join this study because you have either been diagnosed with prostate cancer and will be having surgery to remove your prostate or you will be having a prostate biopsy to look for prostate cancer. This study is looking to see if a new imaging device, diffuse optical tomography (DOT), can detect prostate cancer. We will also see if DOT…
The purpose of this study is to find out whether the study drug altaluren can help lung function and can reduce the symptoms associated with cystic fibrosis (CF), and decrease the number of hospitalizations and the use of antibiotics for CF-related lung infections. The study will also investigate whether the drug can help improve overall patient quality of…
This study is for patients that have been diagnosed with Crohn's Disease, which is an inflammatory disease of the gastrointestinal tract (stomach and intestines). The purpose of this study is to see if study drug GS-5745 is effective in treating people with Crohn's Disease.
This study will enroll participants with prostate cancer that were treated by removing the prostate or by giving radiation (or both), but whose blood prostate specific antigen (PSA) level is going up. PSA is produced by the prostate and other tissues, and when it goes up, it means that the prostate cancer is coming back. In this study, participants will…
The objective of the Block-COPD Study is to determine if beta-blockers are safe and effective at reducing the number of exacerbations or flare-ups that people living with Chronic Obstructive Pulmonary Disease (COPD) experience. A beta-blockers is a drug that is taken by mouth and is currently used to treat a wide range of diseases including high blood…
This study is for patients with systemic sclerosis (SSc) and associated Interstitial Lung Disease. Systemic sclerosis or systemic scleroderma is a disease that causes thickening of the skin and the internal organs which often includes the kidneys, heart, lungs and gastrointestinal tract. Your disease affects the skin but also it affects the lungs. As the…
This study is being done to see how safe and effective this investigational drug is and how well it is tolerated in subjects with ulcerative colitis. This study will study the safety of LY3074828 and any side effects one might have when they take it and how much LY3074828 should be given to subjects.
This research is being done to look at how a medicine called Losartan helps people with Chronic Obstructive Pulmonary Disease (COPD) with emphysema, a disease of the lungs. COPD is often caused by cigarette smoking. It includes the symptoms of emphysema and chronic bronchitis. Although some medications for COPD reduce symptoms and prevent exacerbations, few…
This research study will look at whether computer tools (also called decision aids) help prostate cancer patients better understand their treatment options and help patients talk about their treatment preferences with their doctors
The purpose of this study is to study the effects of a new study drug known as Riociguat in people diagnosed with pulmonary hypertension (PH) associated with idiopathic interstitial pneumonia (IIP). Patients will be in the study for approximately 26 weeks in which they will take the pill Riogciguat three times a day.
The purpose of the study is to determine if the experimental use of an antibiotic called rifaximin for upto one year can improve the symptoms of Crohns disease (like abdominalpain and liquid/very soft stools), and if rifaximin can improve the inflammation in the intestines causedby Crohns disease. The study is trying to determine if rifaximin, unlike other…
The purpose of this study is to compare the clinical benefit (i.e., does it help to improve or slow down the cancer) of adding study drug JNJ-56021927 to combined treatment of abiraterone acetate plus prednisone to treat patients with metastatic Castration-resistant Prostate Cancer (mCRPC). This study will also evaluate the possible side effects of study…
We are currently recruiting pediatric patients ages 7-17 who suffer from Irritable Bowel Syndrome with Constipation (IBS-C) for our Linaclotide clinical trial. Study will involve 6 visits and will last anywhere from 10-12 weeks after the patient qualifies.
The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug called nivolumab when combined with rucaparib, docetaxel or enzalutamide in participants with late stage prostate cancer that was unable to be surgically removed. These three combinations: nivolumab plus rucaparib, nivolumab…
The Families At-Risk for Interstitial Lung Disease (FAR-ILD) study is designed to detect and study the earliest stages of ILD in adults with a family history of ILD. FAR-ILD is a non-interventional study. This means that FAR-ILD is not involved in testing any new interventions or therapies. The purpose of FAR-ILD is to gather data on family members of…
This study is for patients who have been prescribed tobramycin inhalation powder (TOBI Podhaler) or another inhaled medication used to treat cystic fibrosis patients whose lungs contain bacteria called Pseudomonas aeruginosa. The purpose of this research study is to assess how well TOBI Podhaler works on treating Pseudomonas aeruginosa in the lungs of…
This study is for patients with Gastroesophageal Reflux Disease or GERD which may cause reflux or heartburn. Symptoms are often caused by a weak valve, or sphincter, between the esophagus (the swallowing tube that leads from your mouth to your stomach) and the stomach. This structure is called the lower esophageal sphincter (LES). Normally, when liquid and…
The main purpose of this study is to look at the effectiveness, safety, and tolerability of study drug CTX-4430 when compared to a placebo (sugar pill) taken once-daily for 48 Weeks in adult patients with CysticFibrosis (CF).
This study is being conducted to evaluate the performance of the ConfirmMDx and SelectMDx tests for Prostate Cancer to identify patients with increased risk for clinically significant disease, to ultimately lower the rate of repeat biopsies. Approximately 1000 people are expected to take part in this study.
The purpose of this Registry is to develop a database to store information from subjects who haveundergone an examination of the esophagus with the NvisionVLE Imaging System. This is done bythe collection and analysis of the medical record information, imaging data, and physicianquestionnaires. The information is then stored in a database and may be used at…
Auriculotherapy is a type of Eastern medicine that has been used for thousands of years involving the ear. The ear has nerve connections to the whole body, and therefore using non-invasive techniques can be used to treat a wide variety of problems. This study is looking to see if auriculotherapy might be used to treat abdominal pain and find areas on the…
This study involves two infusions of either rituximab or placebo, two right heart catheterizations (6 months apart), and a variety of other clinical study procedures and exams.
This study is being done to learn more about the safety and effectiveness of study drug VX-661 in combination with ivacaftor in patients aged 12 years and older with Cystic Fibrosis (CF). In this Study there are two treatment groups. If the patient meets all the rules for being in the Study, they willbe in one of the two treatment groups. The patient will…
This research study is testing an investigational medication called AMG 714 for people with refractory celiac disease Type II. If youre at least 18 years of age, diagnosed with celiac disease, and you are still experiencing persistent or recurrent intestinal atrophy and gastrointestinal symptoms despite following a strict gluten-free diet for at least 6 12…
The purpose of this clinical trial to find out if the investigational medication pembrolizumab in combination with enzalutamide + Androgen Deprivation Therapy (ADT) is safe and works to slow down or stop the growth of metastatic prostate cancer compared to enzalutamide + ADT alone. Pembrolizumab is a type of immunotherapy, which may help the bodys immune…