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Pulmonary Hypertension in Sickle Cell Anemia

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401. The clinical sequelae of intravascular hemolysis and extracellular plasma hemoglobin: a novel mechanism of human disease. (PubMed)

and hemoglobinemia should be considered as a novel mechanism of human disease.Pertinent scientific literature databases and references were searched through October 2004 using terms that encompassed various aspects of hemolysis, hemoglobin preparations, clinical symptoms associated with plasma hemoglobin, nitric oxide in hemolysis, anemia, pulmonary hypertension, paroxysmal nocturnal hemoglobinuria, and sickle-cell disease.Hemoglobin is released into the plasma from the erythrocyte during intravascular hemolysis (...) and aggregation. Thus, clinical consequences of excessive cell-free plasma hemoglobin levels during intravascular hemolysis or the administration of hemoglobin preparations include dystonias involving the gastrointestinal, cardiovascular, pulmonary, and urogenital systems, as well as clotting disorders. Many of the clinical sequelae of intravascular hemolysis in a prototypic hemolytic disease, paroxysmal nocturnal hemoglobinuria, are readily explained by hemoglobin-mediated nitric oxide scavenging.A growing

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2005 JAMA

402. Correction of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR)

of frequent blood transfusions in the past 6 months Unstable angina or angina pectoris at rest Severe chronic obstructive pulmonary disease requiring routine use of supplemental oxygen Severe liver dysfunction that is defined by an international normalized ratio >2.0, not caused by an anticoagulant Severe malnutrition Active hematological disease (eg, sickle cell anemia, thalassemia) Active malignancy (usually defined as malignancy requiring current chemotherapy or radiotherapy) Patients with current (...) as calculated by the central lab. HB<11 g/dL upon study enrollment. The GFR for assessment of patient eligibility will be determined using the formula derived from the Modification of Diet for Renal Disease (MDRD) Study. Exclusion Criteria: Pregnant or lactating women Presence of uncontrolled hypertension Known hypersensitivity to mammalian cell-derived products or human albumin Active gastrointestinal bleeding Iron overload defined as a transferrin saturation >70% or ferritin >1000 ng/mL History

2005 Clinical Trials

403. Study of Subcutaneously Administered Peginesatide in Anemic Cancer Patients Receiving Chemotherapy

antibodies to other ESAs or history of pure red cell aplasia (PRCA) Acute or chronic leukemia, myelodysplastic syndrome (MDS), or multiple myeloma Any previous or planned radiotherapy to more than 50% of either the pelvis or spine Known intolerance to parenteral iron supplementation Red blood cell transfusion within 4 weeks prior to study drug administration Known hemoglobinopathy (e.g., homozygous sickle-cell disease, thalassemia of all types, etc.) Known hemolysis History of pulmonary embolism or deep (...) or peripheral blood cell transplantation Pyrexia/fever of ≥ 39 °C within 48 hours prior to study drug administration Poorly controlled hypertension, per the Investigator's judgment, within 4 weeks prior to study drug administration (e.g., systolic ≥ 170 mm Hg or diastolic ≥ 100 mm Hg on repeat readings) Epileptic seizure in the 6 months prior to study drug administration Advanced chronic congestive heart failure - New York Heart Association Class IV High likelihood of early withdrawal or interruption

2006 Clinical Trials

404. Effects of Anti-HIV Therapy on Treatment for Hepatitis C in HCV/HIV Infected Adults

within 24 weeks of study entry. Participants who anticipate the need to begin such treatment during the study are not eligible. History of hemoglobinopathy (e.g., thalassemia, sickle cell anemia) Require certain medications Evidence of decompensated liver disease, such as history or presence of ascites, jaundice, bleeding varices, or hepatic encephalopathy Prior opportunistic infection or lowest ever CD4 count less than 200 cells/mm3 Has a pregnant partner Pregnancy or breastfeeding Contacts (...) , rheumatoid arthritis) Chronic pulmonary disease associated with functional limitation Severe cardiac disease within 24 weeks prior to study entry History of severe retinopathy due to diabetes, hypertension, cytomegalovirus, or macular degeneration History of major organ transplantation Severe illness, cancer, or other conditions that would interfere with the study Any systemic antineoplastic or immunomodulatory treatment (except epoetin alfa or granulocyte colony-stimulating factor [G-CSF]) or radiation

2005 Clinical Trials

405. Study of Long-Term Peg Intron Vs. Colchicine in Non-Responders.

or arrhythmia Patients on treatment are eligible as long as they have been symptom free for the previous 6 months. Poorly controlled diabetes mellitus Chronic pulmonary disease (e.g. COAD) Immunologically mediated diseases (e.g. inflammatory bowel disease, SLE, ITP, autoimmune hemolytic anemia, scleroderma, rheumatoid arthritis, severe psoriasis) Clinical gout Patients with clinically significant retinal abnormalities Patients with organ transplants Any other condition, which in the view of the investigator (...) -2b 0.5mcg/kg weekly Active Comparator: Colchicine 0.6mg twice a day Drug: Colchicine 0.6mg twice a day Outcome Measures Go to Primary Outcome Measures : Determination of the Effect of PEG-Intron 0.5mg Per kg Weekly sc Versus Colchicine 0.6mg Bid Daily on: [ Time Frame: 4 years ] number of patients with a liver related outcomes including: mortality, liver transplant, variceal or portal hypertensive bleeding,Development of jaundice, ascites or encephalopathy with an increase in CPT of > 2 points

2005 Clinical Trials

406. Cycle Control and Safety of E2-DRSP

and/or pruritus related to cholestasis -- history of cholestatic jaundice associated with pregnancy or previous COC use Metabolic diseases -- uncontrolled diabetes mellitus with vascular involvement severe dyslipoproteinemia Other diseases: any known or suspected malignant or premalignant disease, uncontrolled thyroid disorder, chronic inflammatory bowel disease, severe renal insufficiency or acute renal failure, hemolytic uremic syndrome, sickle cell anemia, porphyria, history of hypertriglyceridemia (...) the last 6 months before Visit 1) Laboratory values outside inclusion range at Screening - Any disease that may worsen under hormonal treatment or might interfere with the conduct of the study or the interpretation of the results, as e.g.: - Cardiovascular -- presence or a history of venous or arterial thrombotic/thromboembolic events (e.g., deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident, including prodromi (e.g., transient ischemic attack, angina

2008 Clinical Trials

407. Role of Nitric Oxide in Malaria

) ) Study Details Study Description Go to Brief Summary: This study, conducted by NIH, the University of Bamako in Mali, Africa, and Tulane University will examine the relationships between hemolysis (breakdown of red blood cells), nitric oxide (a gas important in regulating blood vessel dilation and blood flow) and pulmonary hypertension in patients with malaria. Malaria is among the leading causes of death in many of the world s poorest countries. It is caused by a parasite that is transmitted (...) following successful therapy. Condition or disease Malaria Pulmonary Hypertension Detailed Description: Malaria is among the leading infectious causes of death in many of the world s poorest countries. This parasitic mosquito-borne illness produces massive hemolysis in many infected human hosts. While much is known about parasite replication and cytoadherence, very little is known about the impact of hemolysis per se on vascular tone and endothelial function. Crossing a number of medical disciplines

2007 Clinical Trials

408. Eltrombopag To Initiate And Maintain Interferon Antiviral Treatment To Benefit Subjects With Hepatitis C Liver Disease

with haemoglobinopathies, e.g. sickle cell anaemia, thalassemia major Any prior history of arterial or venous thrombosis AND two or more of the following risk factors: hereditary thrombophilic disorders (e.g. Factor V Leiden, ATIII deficiency, etc), hormone replacement therapy, systemic contraception (containing estrogen), smoking, diabetes, hypercholesterolemia, medication for hypertension or cancer Pre-existing cardiac disease (New York Heart Association (NYHA) Grade III/IV), or arrhythmias known to involve the risk (...) DAIDS [ Time Frame: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) ] Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low=lymphocytopenia), total neutrophils (low=neutropenia), and white blood cells

2007 Clinical Trials

409. Eltrombopag To Initiate And Maintain Interferon Antiviral Treatment To Subjects With Hepatitis C Related Liver Disease

Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS During the DB Phase [ Time Frame: From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) ] Blood samples for the assessment of hematology parameters were taken at intervals throughout the study. Participants with the worst-case shift from BL during the DB Phase are reported, per severity grades by DAIDS, for levels of hemoglobin (low=anemia), lymphocytes (low (...) severe or poorly controlled psychiatric disorder The following subjects are eligible for study participation, but must be assessed and followed (if recommended) by a mental health professional: Subjects who have had a severe or poorly controlled psychiatric disorder more than 6 months ago but less than 5 years ago Seizure disorder that has not been well controlled History of clinically significant bleeding from oesophageal or gastric varices Subjects with haemoglobinopathies, e.g. sickle cell anaemia

2007 Clinical Trials

410. An Open Label Non-Randomized Dose Escalating Trial to Assess Safety and Tolerability of Alb-Interferon Alfa 2b Every Two Weeks With Ribavirin Among HIV/HCV Coinfected Individuals

/dL, a HbA1C of less than or equal to 7.5%. Coexisting neoplastic disease except for Kaposi's sarcoma, any non-metastatic skin cancer that has been resected, or non-metastatic cervical or anal cancer that has been resected. Severe cardiac disease (Grade 3 or more congestive cardiac failure, symptomatic coronary artery disease, significant arrhythmias, uncontrolled hypertension). Severe chronic pulmonary disease with functional impairment or a DLCO less than or equal to 50% at baseline. Severe (...) psychiatric disorder that would interfere with the adherence to protocol requirements. Preexisting autoimmune disorders including inflammatory bowel diseases, psoriasis, and optic neuritis. Preexisting uncontrolled seizure disorder defined as one episode of seizure within the past 2 years. Chronic pancreatitis. Severe retinopathy as determined by the ophthalmologist. Hemoglobinopathy (e.g., Thalassemia, sickle cell disease). Currently taking didanosine or d4T as part of antiretroviral regimen. Direct

2007 Clinical Trials

411. A Multi-Center, Open-Label, Multiple Dose, Dose Finding Study Exploring the Safety and Tolerability of Beraprost Sodium Modified Release in PAH Patients

of the investigator, may be unable to comply with the study protocol; Has any preexisting disease known to cause pulmonary hypertension (e.g., obstructive lung disease, parasitic disease affecting the pulmonary system, sickle cell anemia, mitral valve stenosis, portal hypertension) other than those listed in the inclusion criteria; Has donated blood or plasma or has lost a volume of blood >450 mL within six weeks prior to the Baseline visit. Has an ongoing hemorrhagic condition (e.g. upper digestive track (...) to continue taking the study drug at their MTD in a separate open-label extension study. Condition or disease Intervention/treatment Phase Pulmonary Arterial Hypertension Drug: Beraprost sodium modified release Phase 2 Detailed Description: This study is an international, open-label, multi-center, Phase II, multiple dose, dose-finding study to investigate the safety, tolerability and pharmacokinetic characteristics of BPS-MR tablets in male and female patients with PAH. All patients will be receiving

2008 Clinical Trials

412. A Safety and Tolerability Study of Peginesatide in Anemic Cancer Patients Receiving Cytotoxic Chemotherapy.

sickle-cell disease, thalassemia of all types, etc). Has known hemolytic condition. Has known blood loss as a cause of anemia, iron deficiency anemia, or anemia caused by gastrointestinal bleeding. Has any previous or planned radiotherapy to more than 30% of active bone marrow. Has donated more than 400 mL of blood within the 90 days preceding the beginning of the study. Has known intolerance to parenteral iron supplementation. Has received IV iron within 1 week of study drug administration. Has (...) history of bone marrow or peripheral blood cell transplantation. Has central nervous system metastases. Has a history of deep venous thrombosis, pulmonary embolism or other thrombotic event (eg, stroke, myocardial infarction, etc.) in the previous 6 months or known history of hypercoagulable disorder. Has uncontrolled, or symptomatic inflammatory disease (eg, rheumatoid arthritis, systemic lupus erythematosus, etc). Has poorly controlled hypertension per the investigator's judgment within 4 weeks

2008 Clinical Trials

413. Bone Marrow Transplantation, Hemoglobinopathies, SCALLOP

Collaborators: Texas Children's Hospital The Methodist Hospital System Information provided by (Responsible Party): Kathryn Leung, Baylor College of Medicine Study Details Study Description Go to Brief Summary: Patients are being asked to participate in this study because they have severe sickle cell anemia (SCD) with or without the beta thalassemia trait. Sickle cell anemia is an illness where the red blood cells change shape and can clog up blood vessels. This keeps the body from getting the oxygen (...) marrow transplants in patients with sickle cell anemia. Condition or disease Intervention/treatment Phase Sickle Cell Disease Hemoglobin SC Drug: Busulfan Biological: Campath 1H Drug: Cyclophosphamide and MESNA Not Applicable Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 8 participants Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: Allogeneic Bone Marrow

2007 Clinical Trials

414. Lansoprazole to Treat Children With Asthma

than 33 weeks gestation or any neonate requiring a significant level of respiratory care, including mechanical ventilation Any major chronic illness, including but not limited to non-skin cancer, cystic fibrosis, bronchiectasis, myelomeningocele, sickle cell anemia, endocrine disease, congenital heart disease, congestive heart failure, stroke, severe hypertension, insulin-dependent diabetes mellitus, kidney failure, liver disorder, immunodeficiency state, significant neuro-developmental delay (...) asthma-related quality of life; questionnaire measures functional impairments that are most troublesome to children as a result of their asthma; number presents an average of the change from baseline to all follow-up points Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Measured at Weeks 0, 4, 8, 12, 16, 20, 24 ] A measure of pulmonary function, specifically the amount of expired air in the first second during a forced expiratory maneuver while seated; test performed

2007 Clinical Trials

415. Safety, Efficacy, and Treatment Satisfaction Switching From Flolan to Remodulin Using the Crono Five Ambulatory Pump in Patients With PAH

) scan must be performed to rule out diffuse interstitial fibrosis or alveolitis History of or evidence of left-sided heart disease Having any other disease that is associated with pulmonary hypertension (e.g. sickle cell anemia, schistosomiasis). Having a musculoskeletal disorder (e.g. arthritis, artificial leg, etc.) or any other disease, which is thought to limit ambulation, or be connected to a machine, which is not portable. Uncontrolled systemic hypertension as evidenced by a systolic blood (...) to intravenous Remodulin therapy. Remodulin (treprostinil sodium) is an approved therapy for pulmonary arterial hypertension (PAH). Unlike Flolan, Remodulin does not need to be mixed daily and is stable at room temperature, so there is no need for ice packs. In addition, Remodulin is changed every 48hrs, instead of every 12-24 (with ice packs) or every 8 hours (without ice packs) with Flolan. Flolan is given using a type of portable medication pump called the CADD Legacy infusion pump. In this study

2007 Clinical Trials

416. The Effect of Epoetin Alfa on Cardiac Function and Quality of Life in Patients With Early Renal ((Kidney) Disease

and Hb show a downward tendency as demonstrated in the patient files and medical history Exclusion Criteria: Presence of clinically significant disease/dysfunction of hepatic, pulmonary, hematological (e.g. sickle cell anaemia, thalassemia, major myelodysplastic syndromes, hemolytic anaemia), neurological, musculo-skeletal, endocrine, gastrointestinal or genitourinary system unrelated to underlying chronic renal failure which in the opinion of the investigator would disqualify the patient from (...) this study Cystic kidney disease Clinical or laboratory evidence of untreated iron, folate or Vitamin B12 deficiency Presence of concomitant malignancy (other than basal cell carcinoma of the skin) Uncontrolled hypertension (i.e. diastolic blood pressure of > 100 mm Hg) History of seizures Administration of medication known to suppress erythropoiesis (e.g. cytotoxic agents, immuno-suppressive) within one month prior to enrolment. Low dose steroid therapy will be permitted Pregnancy or lactation Known

2007 Clinical Trials

417. Inhibition of Disease Progression in Hepatitis C-infected Patients With Compensated Liver Cirrhosis (P03811) (COMPLETED)

thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, etc). Patients with Hemoglobinopathies (thalassaemia, sickle cell anemia) Patients with malignant tumors Patients with organ transplants (other than cornea and hair transplant). Patients with a history of hypersensitivity to interferon preparations, biological products such as vaccine, or nucleoside analogs Female patients who are pregnant or nursing (male patients with partner who are pregnant), and for whom (...) disorder such as depression. Patients with or who have a history of epileptic seizures requiring treatment Patients with or who have a history of angina pectoris, heart failure, myocardial infarction, uncontrollable hypertension (diastolic blood pressure: equal to or more than 110mmHg) or arrhythmia which needs treatment. Patients with chronic pulmonary disease Patients with or who have a history of autoimmune disease (Crohn's disease, ulcerative colitis, chronic rheumatoid arthritis, idiopathic

2008 Clinical Trials

418. Relative Bioavailability of Iron and Folic Acid in New Test Supplement

colitis A history of or current use of IV iron therapy or erythropoietin therapy A history or presence of any clinically significant gastrointestinal pathology (eg. chronic diarrhea, inflammatory bowel disease, partial gastrectomy), unresolved gastrointestinal symptoms (eg. diarrhea or vomiting), steatorrhea, or other conditions known to interfere with the absorption, distribution, metabolism or excretion of iron or folic acid Abnormal hemoglobin electrophoresis ie. sickle cell anemia, thalassemia (...) Accepts Healthy Volunteers: Yes Criteria Inclusion Criteria: Healthy pregnant women between 18 and 45 years of age in the second or third trimester of pregnancy (24-32 weeks of gestational age). Normal Hb (Hb≥110g/L and Hb≤144g/L) Exclusion Criteria: Chronic illness (clinically significant neurological, endocrine, cardiovascular, pulmonary, hematologic, immunologic, psychiatric or metabolic diseases) A history or presence of hemosiderosis, hemochromatosis, peptic ulcer, regional enteritis, ulcerative

2008 Clinical Trials

419. Rapid Switch From Flolan to Remodulin in the Outpatient Clinic

except epoprostenol in the past 3 months. Have an on-going central venous line infection within the past 30 days. Have evidence of predominant left-sided heart disease Have any other disease that is associated with pulmonary hypertension (e.g. sickle cell anemia, schistosomiasis). Have a musculoskeletal disorder (e.g. arthritis, artificial leg, etc.) or any other disease, which is thought to limit ambulation, or be connected to a machine, which is not portable. Have uncontrolled systemic hypertension (...) Hypertension, Pulmonary Drug: treprostinil sodium Phase 4 Detailed Description: Pulmonary arterial hypertension (PAH), which is defined as an elevation in pulmonary arterial pressure and pulmonary vascular resistance, is a severe hemodynamic abnormality common to a variety of diseases and syndromes. Elevation in pulmonary arterial pressure causes an increase in right ventricular afterload, impairing right ventricular function and ultimately leading to inactivity and death. The goal of PAH treatment

2008 Clinical Trials

420. Study of Acid Reflux Therapy for Children With Asthma

than 33 weeks gestation or any neonate requiring a significant level of respiratory care, including mechanical ventilation Any major chronic illness, including but not limited to non-skin cancer, cystic fibrosis, bronchiectasis, myelomeningocele, sickle cell anemia, endocrine disease, congenital heart disease, congestive heart failure, stroke, severe hypertension, insulin-dependent diabetes mellitus, kidney failure, liver disorder, immunodeficiency state, significant neuro-developmental delay (...) asthma-related quality of life; questionnaire measures functional impairments that are most troublesome to children as a result of their asthma; number presents an average of the change from baseline to all follow-up points Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Measured at Weeks 0, 4, 8, 12, 16, 20, 24 ] A measure of pulmonary function, specifically the amount of expired air in the first second during a forced expiratory maneuver while seated; test performed

2007 Clinical Trials

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