17 Clinical Trials for Various Conditions
This is a multi-site, multi-group study that obtained two sets of ultrasound scans from all enrolled participants. Participants underwent limited ultrasound scanning by both cardiac sonographers and abdominal sonographers. Algorithm's performance on the view identification task and the object labeling task is computed.
This clinical registry study aims to evaluate the safety and effectiveness of the AE05ML device for ligating vessels and tissue structures during laparoscopic surgery using Hem-o-lok® Medium Large (ML) polymer clips. The primary objective is to assess the device's safety and performance, with secondary objectives focusing on device performance characteristics and operator feedback.
Hypothesis: The severity of portal hypertension in compensated advanced chronic liver disease (cACLD) can be assessed using vibration controlled transient elastography (VCTE) via the FibroScan® 502 Touch by measuring SS (splenic stiffness) Specific Aims: SS by VCTE will be measured in this single center clinical study comprising of 200 patients with cACLD (defined by LSM ≥10 kilopascals (kPa) according to the Baveno VI recommendations) who have not had a liver transplant and 100 subjects who are post-liver transplant. The association between baseline SS values will be examined in relation to the manifestations of portal hypertension such as esophageal or gastric varices. Specific Aim: To examine the relationship between SS and the presence of esophageal and gastric varices in patients with compensated advanced chronic liver disease (cACLD). Proposed Study Design: This is a cross sectional study that evaluates the relationship between SS by VCTE in patients with cACLD and manifestations of portal hypertension.
This is a study that will evaluate the utility of measuring liver and spleen stiffness before and after a meal by a non invasive ultrasound based technologies called Fibroscan (Transient elastography) and acoustic radio-frequency impulse (ARFI) in diagnosing or excluding cirrhosis in patients with chronic liver disease who will be getting a liver biopsy.
A growing number of people are being diagnosed with fatty liver disease, also known as metabolic-dysfunction associated liver disease (MASLD). Fatty liver disease can unknowingly progress to serious liver disease and even permanent scarring (cirrhosis).The purpose of this research is to learn the best way to detect serious liver disease as early as possible in patients with fatty liver disease by measuring the stiffness of the spleen. Secondarily, the study hopes to understand how the stiffness of the spleen relates to the severity of liver disease.
The goal of this study is to assess the physician and patient experience of radio frequency (RF) track cautery in patients undergoing needle biopsy of the liver, kidney, or spleen who have one or more risk factors for biopsy-related bleeding. RF track cautery involves inserting a bipolar electrode through the same introducer needle used for the biopsy, and heating the tissues along the path of the biopsy needle to prevent bleeding. This study primarily aims to assess the operator and patient experience during the use of track cautery. Secondary aims are to assess the technical success rate and procedure adverse events. Participants who enroll in the study will undergo track cautery as part of their clinically indicated liver, kidney, or spleen biopsy. After the procedure, they will fill out a brief survey asking about their experience during the procedure. Physician operators who perform track cautery as part of the study will also fill out a survey after each procedure asking about their experience using this technique.
The primary purpose of this project is to determine if acute monitoring of shunt patency via ultrasound elastography measurements of splenic stiffness before and after TIPS placement results in reduced morbidity and mortality from shunt failure.
Treatment for patients with autoimmune destruction of blood cells is poor. The part of the body that fights infections is called the immune system and white blood cells (WBCs) are part of the immune system. Normally, a person's body creates WBCs to fight infections and eliminates WBCs which have stopped helping the body function. Patients with autoimmune destruction of blood cells have difficulty eliminating old WBCs. The abnormal WBCs build up and can damage other healthy cells, which can lead to anemia, fatigue, jaundice, internal bleeding, infection, and cancer. Few effective medications exist for treatment for patients with autoimmune cytopenias and those commonly used are fraught with side effects. Nevertheless, as scientific understanding of autoimmune diseases has improved, more directed and less toxic therapies are becoming available. A number of groups have been studying the efficacy of a medication called sirolimus in patients with autoimmune diseases. This medicine has been FDA-approved for over 20 years. Sirolimus is a medicine used in children with other diseases. Sirolimus works, in part, by eliminating old and abnormal WBCs. Our group and others have shown that sirolimus is effective in mice with autoimmunity and in children with a rare condition called Autoimmune Lymphoproliferative Syndrome (ALPS). We believe sirolimus will help children with autoimmune cytopenias. We believe it will improve their symptoms and make them less sick. We propose to study sirolimus in children with chronic and/or refractory autoimmune cytopenias.
The ELASTO-SURGERY study aims to evaluate the prognostic role of portal hypertension evaluated by non-invasive methods in predicting post-operative morbidity (at 90 days) and mortality (at 365 days) in patients with advanced chronic liver disease undergoing elective extrahepatic surgery.
Background: COVID-19 is a new disease caused by SARS-CoV-2 that was identified in 2019. Some people who get sick with COVID-19 become ill requiring hospitalization. There are some medicines that may help with recovery. Researchers want to see if a drug called fostamatinib may help people who are hospitalized with COVID-19. Objective: To learn if fostamatinib is safe in patients who are hospitalized with COVID-19 and gain earlier insight into whether it improves outcomes. Eligibility: Adults age 18 and older who are hospitalized with COVID-19. Design: Participants will be screened with a physical exam, including vital signs and weight. They will have a blood test and chest x-ray. They will have a COVID-19 test as a swab of either the back of the throat or the back of the nose. They will take a pregnancy test if needed. Participants will be randomly assigned, to take either fostamatinib pills or a placebo twice daily for up to 14 days in addition to standard of care for COVID-19. If they can swallow, they will take the pills by mouth with water. If they cannot swallow or are on mechanical ventilation, the pills will be crushed, mixed with water, and given through a tube placed through the nostril, or placed in the mouth, down the esophagus, and into the stomach. Blood samples will be taken daily. Participants will return to the Clinical Center for safety follow-up visits. At these visits, they will have a physical exam and blood tests. If they cannot visit the Clinical Center, they will be contacted by phone or have a telehealth visit. Participation will last for about two months
Unrecognized abdominal and pelvic injuries can result in catastrophic disability and death. Sporadic reports of "occult" injuries have generated concern, and physicians, fearing that they may miss such an injury, have adopted the practice of obtaining computed tomography on virtually all patients with significant blunt trauma. This practice exposes large numbers patients to dangerous radiation at considerable expense, while detecting injuries in a small minority of cases. Existing data suggest that a limited number of criteria can reliably identify blunt injury victims who have "no risk" of abdominal or pelvic injuries, and hence no need for computed tomography (CT), without misidentifying any injured patient. It is estimated that nationwide implementation of such criteria could result in an annual reduction in radiographic charges of $75 million, and a significant decrease in radiation exposure and radiation induced malignancies. This study seeks to determine whether "low risk" criteria can reliably identify patients who have sustained significant abdominal or pelvic injuries and safely decrease CT imaging of blunt trauma patients. This goal will be accomplished in the following manner: All blunt trauma victims undergoing computed tomography of the abdomen/pelvis in the emergency department will undergo routine clinical evaluations prior to radiographic imaging. Based on these examinations, the presence or absence of specific clinical findings (i.e. abdominal/pelvic/flank pain, abdominal/pelvic/flank tenderness, bruising abrasions, distention, hip pain, hematuria, hypotension, tachycardia, low or falling hematocrit, intoxication, altered sensorium, distracting injury, positive FAST imaging, dangerous mechanism, abnormal x-ray imaging) will be recorded for each patient, as will the presence or absence of abdominal or pelvic injuries. The clinical findings will serve as potential imaging criteria. At the completion of the derivation portion of the study the criteria will be examined to find a subset that predicts injury with high sensitivity, while simultaneously excluding injury, and hence the need for imaging, in the remaining patients. These criteria will then be confirmed in a separate validation phase of the study. The criteria will be considered to be reliable if the lower statistical confidence limit for the measured sensitivity exceeds 98.0%. Potential reductions in CT imaging will be estimated by determining the proportion of "low-risk" patients that do not have significant abdominal or pelvic injuries.
Background: People who have a blood stem cell transplant can sometimes develop cytopenia. This means that their levels of one or more types of blood cell, such as the red cells or platelets, are lower than they should be. This can occur because a person s immune system might attack these cells after a stem cell transplant. Up to 20% of people who have blood stem cell transplants develop cytopenias, which can lead to anemia, severe bleeding, infections, and other problems. Treatments are needed to help keep blood cell levels stable after blood stem cell transplant. Objective: To evaluate the long-term effects of a study drug (fostamatinib) in people with cytopenia after a blood stem cell transplant. Eligibility: People who responded well to fostamatinib in an earlier study. Design: Participants will be screened. They will have a physical exam and blood tests. Fostamatinib is an oral tablet taken by mouth. Participants will take the pills at the same dose and frequency as they did during the previous study. They will take the pills for up to 21 months. The dosage of the drug may be reduced over time if their blood cell levels are stable. Participants will have a medical assessment every month. This can be with their local doctor or at the NIH clinic. Participants will have blood tests every 3 months. Participants will have a follow-up visit after they stop taking the drug. Their vital signs will be taken, and they will have blood drawn. They will answer questions about their health.
Background: People who have a blood stem cell transplant can sometimes develop cytopenia. This means that their levels of one or more types of blood cell, such as the red cells or platelets, are lower than they should be. This can occur because a person s immune system might attack these cells after a stem cell transplant. Cytopenia can lead to anemia, severe bleeding, infections, and other problems. Treatments are needed to help keep blood cell levels stable after blood stem cell transplant. Objective: To test a study drug (fostamatinib) in people who have cytopenia after a blood stem cell transplant. Eligibility: People aged 18 to 75 years who have cytopenia after a blood stem cell transplant. Design: Participants will be screened. They will have a physical exam. They will have blood, urine, and stool tests. Fostamatinib is an oral tablet taken by mouth. Participants will take the pills 2 times a day for 12 weeks. Participants will have a medical assessment every 2 weeks; their vital signs will be checked, and they will have blood and stool tests. Participants must come to the NIH clinic for these visits in weeks 4 and 12. Other visits may be done by telephone or telehealth; the blood and stool tests can be sent to the researchers from a local lab. After 4 weeks, some participants may begin taking a higher dose of the drug. Participants will return for a final medical assessment 2 weeks after they finish taking the drug. Participants who complete this study and show evidence that fostamatinib has increased their blood cell counts may enroll in an extension study to continue taking fostamatinib.
This study (study ID PAC203 North America; PAC303 ex-North America) is evaluating 200 mg BID of pacritinib compared to physician's choice (P/C) therapy in patients with MF and severe thrombocytopenia (platelet count \<50,000/μL). Approximately 399 patients in total will be enrolled, randomized 2:1 to either pacritinib (approximately 266 patients) or to P/C therapy (approximately 133 patients) Condition or disease: Primary Myelofibrosis/Post-Polycythemia Vera Myelofibrosis/ Post-essential Thrombocythemia Myelofibrosis Intervention/treatment: Drug-Pacritinib
Phase 3, randomized, controlled study to evaluate the safety and efficacy of oral pacritinib compared to Best Available Therapy (BAT) in patients with thrombocytopenia and primary or secondary myelofibrosis.
Phase 3, randomized, controlled study to evaluate the safety and efficacy of oral pacritinib compared to Best Available Therapy (BAT) in patients with primary or secondary myelofibrosis.
This study will examine whether PET imaging can reveal what is happening in lymph nodes of patients with systemic lupus erythematosus, or lupus, during periods of active disease. Patients may have periods of active disease when they may feel sick with fever, fatigue, and aching or swollen joints. Their blood tests are abnormal and their kidney, lungs or heart may be affected. At other times, the disease is inactive, and patients feel well, their blood is normal, and there is no evidence of organ disease. In lupus, like other autoimmune diseases, the body's immune system attacks it own healthy tissues. Activated lymphocytes (a type of immune cell) lead to the production of antibodies and chemical signals that contribute to the disease process. In animals with lupus, these cells are activated in the lymphoid organs, such as the lymph nodes or spleen. It is not known exactly where these cells are activated in humans. Because some lymph nodes are located deep inside the chest and abdomen; surgery is currently the only way to examining them. PET imaging may provide an alternative, non-invasive, means of obtaining information on lymph node activity in humans. This test uses a radioactive sugar molecule called F18-FDG to find areas of increased cellular activity in the body. (Cells use sugar for fuel, so active cells, such as active lymphocytes, uses more FDG than other body tissues.) This study will determine whether PET can detect these areas of increased activity in lupus during active disease. Patients with active or inactive lupus may be eligible for this study. Candidates are screened with a history, physical examination, and routine blood and urine tests. Women who are pregnant or breastfeeding may not participate. Participants will undergo PET scanning. On the day of the scan they have a brief medical history and physical examination and a blood sample is drawn to check blood count and look for markers of lymphocyte activation. Then, a small plastic tube (catheter) is placed into a vein in the patient's arm, the FDG is injected through the catheter, and the patient rests for an hour. For the scan, the patient lies flat in a cradle that is moved into the central hole of the doughnut-shaped PET camera, and pictures are taken over the next 2 hours, with the patient lies quietly, without moving the head or arms. After the scan is finished, the patient empties the bladder approximately every hour for 6 hours to excrete the radioactive sugar.