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Pulmonary Hypertension in Sickle Cell Anemia

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121. Safety and Pharmacokinetics of SANGUINATEâ„¢ in Sickle Cell Disease (SCD) Patients

terms Anemia, Sickle Cell Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn Blood Substitutes (...) Safety and Pharmacokinetics of SANGUINATEâ„¢ in Sickle Cell Disease (SCD) Patients Safety and Pharmacokinetics of SANGUINATE™ in Sickle Cell Disease (SCD) Patients - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding

2011 Clinical Trials

122. Safety Study of MP4CO in Adult Sickle Cell Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT01356485 Recruitment Status : Completed First Posted : May 19, 2011 Last Update Posted : August 19, 2013 Sponsor: Sangart Information provided by (Responsible Party): Sangart Study Details Study Description Go to Brief Summary: Sickle Cell Anemia is caused (...) with a sickle cell crisis, abort a crisis and/or potentially reduce the duration of a crisis. This could mean less time in the hospital and an improved quality of life for patients with sickle cell anemia. Condition or disease Intervention/treatment Phase Anemia, Sickle Cell Sickle Cell Anemia Sickle Cell Disease Sickle Cell Disorders Hemoglobin SC Disease Sickle Cell Hemoglobin C Disease Drug: MP4CO Drug: Sodium chloride solution Phase 1 Detailed Description: To date, no specific agent has been approved

2011 Clinical Trials

123. Ph I/II Study of Allogeneic SCT for Clinically Aggressive Sickle Cell Disease (SCD)

still have aggressive disease despite hydroxyurea treatment. Hydroxyurea therapy also does not seem to prevent the development of pulmonary hypertension. In the pediatric population, patients that have not clinically improved despite optimized hydroxyurea management are offered allogeneic stem cell transplantation. Until recently, the options were more limited in adults with sickle cell disease that had aggressive disease despite hydroxyurea therapy. Most rely on chronic red blood cell transfusions (...) requiring emergency room visits Acute chest syndrome with recurrent hospitalizations, defined as ≥ 2 lifetime events Red-cell alloimmunization (≥ 2 antibodies) during longterm transfusion therapy Bilateral proliferative retinopathy with major visual impairment in at least one eye Osteonecrosis of 2 or more joints Sickle cell nephropathy Stage I or II sickle lung disease Symptoms of pulmonary hypertension and mean pulmonary artery pressure > 25mmHg Age 16-60 years Karnofsky performance status of 70

2011 Clinical Trials

124. Roxadustat in the Treatment of Anemia in End Stage Renal Disease (ESRD) Patients on Stable Dialysis

values, as measured by central laboratory, during the Screening Period. Subject's alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are ≤3 x upper limit of normal (ULN), and total bilirubin (TBL) is ≤1.5 x ULN. Exclusion Criteria: Main Exclusion: Subject has received a red blood cell (RBC) transfusion within 8 weeks prior to randomization. Subject has a known hereditary hematologic disease such as thalassemia or sickle cell anemia, pure red cell aplasia, or other known causes (...) for anemia other than Chronic Kidney Disease (CKD). Subject has had a myocardial infarction, acute coronary syndrome, stroke, seizure, or a thrombotic/thrombo-embolic event (e.g., deep vein thrombosis or pulmonary embolism) within 12 weeks prior to randomization. Subject has had uncontrolled hypertension, in the opinion of the investigator, within 2 weeks prior to randomization. Subject has a history of malignancy, except for the following: cancers determined to be cured or in remission for ≥5 years

2014 Clinical Trials

125. Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease, on Dialysis

., chronic infectious hepatitis, chronic auto-immune liver disease, cirrhosis or fibrosis of the liver) Known hereditary hematologic disease such as thalassemia, sickle cell anemia, a history of pure red cell aplasia or other known causes for anemia other than CKD Known and untreated retinal vein occlusion or known and untreated proliferative diabetic retinopathy (risk for retinal vein thrombosis) Diagnosis or suspicion (e.g. complex kidney cyst of Bosniak Category IIF, III or IV) of renal cell carcinoma (...) on renal ultrasound (or other imaging procedure e.g. CT scan or MRI) conducted at screening or within 12 weeks prior to randomization. Uncontrolled hypertension at the time of randomization (defined as systolic BP ≥180 mmHg or diastolic BP ≥100 mmHg on repeated measurement post-dialysis in hemodialysis patients or at any time in peritoneal dialysis patients), contraindication to epoetin alfa treatment (e.g., pure red cell aplasia, hypersensitivity or know inability to tolerate epoetin alfa) History

2014 Clinical Trials

126. Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease (CKD), Not on Dialysis.

of the liver) Known hereditary hematologic disease such as thalassemia, sickle cell anemia, a history of pure red cell aplasia or other known causes for anemia other than CKD Known and untreated retinal vein occlusion or known and untreated proliferative diabetic retinopathy (risk for retinal vein thrombosis) Diagnosis or suspicion (e.g. complex kidney cyst of Bosniak Category IIF, III or IV) of renal cell carcinoma on renal ultrasound (or other imaging procedure e.g. CT scan or MRI) conducted at screening (...) : human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus antibody (anti-HCV Ab) Chronic inflammatory diseases such as rheumatoid arthritis, systemic lupus erythematosus (SLE), ankylosing spondylitis, psoriatic arthritis or inflammatory bowel disease that is determined to be the principal cause of anemia Known hemosiderosis, hemochromatosis or hypercoagulable condition Any prior organ transplant or a scheduled organ transplantation date Any red blood cell

2014 Clinical Trials

127. Study to Evaluate the Safety and Efficacy of GSK1278863 in Recombinant Human Erythropoietin (rhEPO) Hyporesponsive Hemodialysis-dependent Chronic Kidney Disease Subjects With Anemia

hematological disease including those affecting platelets, white or red blood cells (e.g., antibody-mediated pure red cell aplasia, sickle cell anemia, myelodysplastic syndromes, hematological malignancy, myeloma, hemolytic anemia), coagulation disorders (e.g., antiphospholipid syndrome, Protein C or S deficiency), or any other cause of anemia other than renal disease diagnosed prior to Week -4. Liver disease: Current liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert's (...) Study to Evaluate the Safety and Efficacy of GSK1278863 in Recombinant Human Erythropoietin (rhEPO) Hyporesponsive Hemodialysis-dependent Chronic Kidney Disease Subjects With Anemia Study to Evaluate the Safety and Efficacy of GSK1278863 in Recombinant Human Erythropoietin (rhEPO) Hyporesponsive Hemodialysis-dependent Chronic Kidney Disease Subjects With Anemia - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results

2014 Clinical Trials

128. Childhood Hematopoietic Cell Transplantation (PDQ®): Health Professional Version

Childhood Hematopoietic Cell Transplantation (PDQ®): Health Professional Version Childhood Hematopoietic Cell Transplantation (PDQ®) - PDQ Cancer Information Summaries - NCBI Bookshelf Warning: The NCBI web site requires JavaScript to function. Search database Search term Search NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health. PDQ Cancer Information Summaries [Internet]. Bethesda (MD): National Cancer Institute (US); 2002-. PDQ Cancer Information (...) Summaries [Internet]. Bethesda (MD): ; 2002-. Search term Childhood Hematopoietic Cell Transplantation (PDQ®) Health Professional Version PDQ Pediatric Treatment Editorial Board . Published online: November 15, 2018. Created: February 15, 2012 . This PDQ cancer information summary for health professionals provides comprehensive, peer-reviewed, evidence-based information about the use of hematopoietic cell transplantation in treating childhood cancer. It is intended as a resource to inform and assist

2018 PDQ - NCI's Comprehensive Cancer Database

129. DelIVery for Pulmonary Arterial Hypertension (PAH)

associated with hemoglobinopathies (sickle cell anemia, thalassemia), human immunodeficiency virus (HIV), schistosomiasis, portal hypertension, pulmonary veno-occlusive disease, or pulmonary capillary hemangiomatosis Patient is implanted with electrical stimulation medical device(s) anywhere in the body (e.g., cardiac pacemakers, implantable cardioverter defibrillators (ICDs), spinal cord stimulators). This includes implanted leads and electrodes or abandoned leads and electrodes from an explanted device (...) DelIVery for Pulmonary Arterial Hypertension (PAH) DelIVery for Pulmonary Arterial Hypertension (PAH) - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. DelIVery for Pulmonary Arterial Hypertension (PAH

2011 Clinical Trials

130. Treprostinil Combined With Tadalafil for Pulmonary Hypertension

History of hypersensitivity reaction or adverse effect related to tadalafil Life expectancy < 12 months History of deformed penis shape, an erection that lasted more than 4 hours, or Peyronie's disease. Blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia Pregnant or planning to become pregnant or breast feed. Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff (...) Treprostinil Combined With Tadalafil for Pulmonary Hypertension Treprostinil Combined With Tadalafil for Pulmonary Hypertension - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Treprostinil Combined

2011 Clinical Trials

131. Ferinject® for Iron Deficiency in Idiopathic Pulmonary Arterial Hypertension (IPAH) Patients

ClinicalTrials.gov Identifier: Other Study ID Numbers: CRO1811 First Posted: October 6, 2011 Last Update Posted: January 30, 2018 Last Verified: December 2017 Individual Participant Data (IPD) Sharing Statement: Plan to Share IPD: Undecided Keywords provided by Imperial College London: Idiopathic pulmonary arterial hypertension (IPAH) Iron deficiency Additional relevant MeSH terms: Layout table for MeSH terms Hypertension Familial Primary Pulmonary Hypertension Anemia, Iron-Deficiency Vascular Diseases (...) Cardiovascular Diseases Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Anemia, Hypochromic Anemia Hematologic Diseases Iron Metabolism Disorders Metabolic Diseases Iron Trace Elements Micronutrients Nutrients Growth Substances Physiological Effects of Drugs

2011 Clinical Trials

132. Anemia (Overview)

studies of purportedly healthy subjects show the prevalence of anemia to be 2-5 times greater than that in the United States. Although geographic diseases, such as sickle cell anemia, thalassemia, malaria, hookworm, and chronic infections, are responsible for a portion of the increase, nutritional factors with iron deficiency and, to a lesser extent, folic acid deficiency play major roles in the increased prevalence of anemia. Populations with little meat in the diet have a high incidence of iron (...) deficiency anemia, because heme iron is better absorbed from food than inorganic iron. Sickle cell disease is common in regions of Africa, India, Saudi Arabia, and the Mediterranean basin. The thalassemias are the most common genetic blood diseases and are found in Southeast Asia and in areas where sickle cell disease is common. Race-related demographics Certain races and ethnic groups have an increased prevalence of genetic factors associated with certain anemias. Diseases such as the hemoglobinopathies

2014 eMedicine.com

133. Anemia (Diagnosis)

studies of purportedly healthy subjects show the prevalence of anemia to be 2-5 times greater than that in the United States. Although geographic diseases, such as sickle cell anemia, thalassemia, malaria, hookworm, and chronic infections, are responsible for a portion of the increase, nutritional factors with iron deficiency and, to a lesser extent, folic acid deficiency play major roles in the increased prevalence of anemia. Populations with little meat in the diet have a high incidence of iron (...) deficiency anemia, because heme iron is better absorbed from food than inorganic iron. Sickle cell disease is common in regions of Africa, India, Saudi Arabia, and the Mediterranean basin. The thalassemias are the most common genetic blood diseases and are found in Southeast Asia and in areas where sickle cell disease is common. Race-related demographics Certain races and ethnic groups have an increased prevalence of genetic factors associated with certain anemias. Diseases such as the hemoglobinopathies

2014 eMedicine.com

134. Iron Mediated Vascular Disease in Sickle Cell Anemia Patients

of the problems experienced by sickle cell anemia patients (stroke, kidney failure, pulmonary hypertension, heart disease) result from blood vessel damage. In this trial, iron in the liver, pancreas, and kidney will be measured noninvasively by MRI while vascular function will be measured by ultrasound and tissue Doppler. Patients will be recruited primarily from the greater Los Angeles area, although patients from greater distances will be allowed to participate. Study Design Go to Layout table for study (...) Iron Mediated Vascular Disease in Sickle Cell Anemia Patients Iron Mediated Vascular Disease in Sickle Cell Anemia Patients - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Iron Mediated Vascular Disease

2010 Clinical Trials

135. Phase 2 Study of MP4CO to Treat Vaso-occlusive Sickle Crisis

may alleviate pain associated with a sickling crisis and potentially reduce the severity and duration of a crisis. This may shorten the time in hospital and potentially improve the quality of life for patients with sickle cell anemia. Condition or disease Intervention/treatment Phase Anemia, Sickle Cell Sickle Cell Anemia Sickle Cell Disease Sickle Cell Disorders Hemoglobin SC Disease Sickle Cell Hemoglobin C Disease Drug: MP4CO Drug: Sodium chloride solution Phase 2 Detailed Description: Sickle (...) to Additional Information: Publications: Layout table for additonal information Responsible Party: Sangart ClinicalTrials.gov Identifier: Other Study ID Numbers: SCD-206 First Posted: August 19, 2013 Last Update Posted: October 28, 2013 Last Verified: October 2013 Keywords provided by Sangart: Sickle cell anemia Sickle cell disease Sickling crisis Vaso-occlusive crisis Carboxyhemoglobin Oxygen therapeutic Ischemic rescue therapy Hemoglobin solution Pegylated hemoglobin Additional relevant MeSH terms: Layout

2013 Clinical Trials

136. Childhood Hematopoietic Cell Transplantation (PDQ®): Health Professional Version

Childhood Hematopoietic Cell Transplantation (PDQ®): Health Professional Version Childhood Hematopoietic Cell Transplantation (PDQ®) - PDQ Cancer Information Summaries - NCBI Bookshelf Warning: The NCBI web site requires JavaScript to function. Search database Search term Search NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health. PDQ Cancer Information Summaries [Internet]. Bethesda (MD): National Cancer Institute (US); 2002-. PDQ Cancer Information (...) Summaries [Internet]. Bethesda (MD): ; 2002-. Search term Childhood Hematopoietic Cell Transplantation (PDQ®) Health Professional Version PDQ Pediatric Treatment Editorial Board . Published online: November 15, 2018. Created: February 15, 2012 . This PDQ cancer information summary for health professionals provides comprehensive, peer-reviewed, evidence-based information about the use of hematopoietic cell transplantation in treating childhood cancer. It is intended as a resource to inform and assist

2016 PDQ - NCI's Comprehensive Cancer Database

137. A Study to Evaluate Safety and Efficacy of GSK1278863 in Non-Dialysis Dependent (NDD) Subjects With Anemia Associated With Chronic Kidney Diseases (CKD)

-related exclusion criteria determined at the Screening ophthalmology exam. Inflammatory disease: Active chronic inflammatory disease that could impact erythropoiesis (e.g., scleroderma, systemic lupus erythematosis, rheumatoid arthritis, celiac disease) diagnosed prior to Week -4 Screening through Day 1 (randomization). Hematological disease: Any hematological disease including those affecting platelets, white or red blood cells (e.g. sickle cell anemia, myelodysplastic syndromes, hematological (...) (CHr) at Week 24 [ Time Frame: Baseline and Week 24 ] Reticulocytes are slightly immature red blood cells. Reticulocyte Hgb content is used to differentiate iron deficiency from other causes of anemia. Baseline is the last pre-dose CHr value. Change from Baseline in reticulocyte Hgb was calculated by subtracting the Baseline value from the post-dose value. Change From Baseline in Hematocrit at Week 24 [ Time Frame: Baseline and Week 24 ] Baseline is the last pre-dose hematocrit value. Change from

2013 Clinical Trials

138. Evaluation of Dose Response Relationship, Safety and Efficacy of GSK1278863 in Hemodialysis-dependent Subjects With Chronic Kidney Disease Associated Anemia

criteria Ophthalmology disease: Meeting any ophthalmologic-related exclusion criteria determined at the Screening ophthalmology exam. Inflammatory disease: Active chronic inflammatory disease that could impact erythropoiesis (e.g., scleroderma, systemic lupus erythematosis, rheumatoid arthritis, celiac disease) diagnosed prior to Week -4 Screening through Day 1 (randomization). Hematological disease: Any hematological disease including those affecting platelets, white or red blood cells (e.g. sickle (...) cell anemia, myelodysplastic syndromes, hematological malignancy, myeloma, hemolytic anemia and thalassemia), coagulation disorders (e.g., antiphospholipid syndrome, Protein C or S deficiency), or any other cause of anemia other than renal disease diagnosed prior to Week -4 Screening through Day 1 (randomization). Liver disease: Current liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) or evidence at Screening of abnormal

2013 Clinical Trials

139. Maintenance Treatment of Anemia Associated With Chronic Kidney Disease (CKD) in Hemodialysis Subjects on Epoetin Alfa / Beta Treatment Versus BAY85-3934

hemoglobinopathies (including, but not limited to, sickle cell disease, beta thalassemia, and thalassemia major) which may be the primary cause of anemia Chronic lymphoproliferative diseases Any allograft (including renal allograft) in place and on immunosuppressive therapy, or a scheduled kidney transplant within the next 16 weeks (being on a waiting list does not exclude the subject) Chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus erythematosis, rheumatoid arthritis, celiac (...) infarction, stroke, transient ischemic attack, deep vein thrombosis, pulmonary embolism) within the last 6 months from the initial screening visit Sustained, poorly controlled arterial hypertension or hypotension at screening, defined as a mean BP ≥ 180/110 mmHg or systolic BP < 95 mmHg, respectively Severe rhythm or conduction disorder (e.g., HR < 50 or > 110 bpm, atrial flutter, prolonged QT >500 msec, second or third degree atrioventricular [AV]block if not treated with a pacemaker) New York Heart

2013 Clinical Trials

140. FG-4592 in the Treatment of Anemia in Chronic Kidney Disease (CKD) Patients, Not on Dialysis, in Comparison to Darbepoetin Alfa

to randomization. Subject has received any dose of IV iron within 6 weeks prior to randomization. Subject has received a Red Blood Cell (RBC) transfusion within 8 weeks prior to randomization. Subject has a known history of myelodysplastic syndrome or multiple myeloma. Subject has a known hereditary hematologic disease such as thalassemia or sickle cell anemia, pure red cell aplasia, or other known causes for anemia other than Chronic Kidney Disease (CKD). Subject has a known hemosiderosis, hemochromatosis (...) : NCT02021318 Recruitment Status : Active, not recruiting First Posted : December 27, 2013 Last Update Posted : March 28, 2019 Sponsor: Astellas Pharma Europe B.V. Collaborator: FibroGen Information provided by (Responsible Party): Astellas Pharma Inc ( Astellas Pharma Europe B.V. ) Study Details Study Description Go to Brief Summary: This study is conducted to explore a new therapy for anemia in patients with chronic kidney disease. Anemia is a reduced number of red blood cells or hemoglobin. Hemoglobin

2013 Clinical Trials

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