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Pulmonary Hypertension in Sickle Cell Anemia

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341. Management of Priapism

(CBC) with special attention to the white blood count (WBC), white blood cell differential and platelet count. Acute infections or hematologic abnormalities that can cause priapism, such as sickled red blood cells, leukemia and platelet abnormalities, may be suggested or identified by the CBC. The reticulocyte count is often elevated in men with sickle cell anemia. Hemoglobin electrophoresis identifies the presence of sickle cell disease or trait as well as other hemoglobinopathies. Because (...) and selective embolization of the pudendal artery for high flow priapism refractory to medical and surgical treatments. J Urol, 146: 1361, 1991. 15. Gbadoe, A. D., Assimadi, J. K., and Segbena, Y. A. Short period of administration of diethylstilbestrol in stuttering priapism in sickle cell anemia. Am J Hematol, 69: 297, 2002. 16. Virag, R., Bachir, D., Lee, K., and Galacteros, F. Preventive treatment of priapism in sickle cell disease with oral and self-administered intracavernous injection of etilefrine

2010 American Urological Association

342. Practice Parameters for the Respiratory Indications for Polysomnography in Children

children with suspected SRBDs. Findings indicate that PSG may be particularly useful in the evaluation of children with chronic health conditions such as obe- sity, metabolic syndrome, overt or evolving hypertension, and other conditions associated with cardiovascular risk. There is a need for further investigation of SRBD in children with neuro- developmental and neuromuscular disorders, sickle cell anemia, craniofacial disorders, and certain infants who experience ALTEs. The clinical utility and cost (...) treatment of children for obstructive sleep apnea syndrome with rapid maxillary expansion (2) Clinical parameters may be unreliable for predicting OSAS. (3) Children with certain medical disorders are at higher sur- gical risk (e.g., sickle cell anemia, HIV , coagulopathies, con- genital heart disease). (4) Children with severe OSAS have a higher risk for certain postoperative complications including respiratory compromise. The task force identified 30 papers pertaining to the clinical utility of PSG

2010 American Academy of Sleep Medicine

343. Biopoin (epoetin theta)

and differentiation of red blood cell progenitors, leading to more red blood cells and increased oxygen-carrying capacity. Epoetin for clinical use is produced by recombinant DNA technology using mammalian cells as expression systems. All Epoetins in clinical use have a similar amino acid sequence as endogenous erythropoetin but differ in their glycosylation pattern. Glycosylation influences pharmacokinetics and may affect efficacy and safety. Biopoin containing the active substance epoetin theta, is obtained (...) by recombinant DNA technology and has the same biological effects as endogenous epoetin. It is produced by mammalian cells into which the human epoetin gene has been introduced. It contains r-HuEPO as the active active substance and is structurally similar to Epoetin alfa, Epoetin beta, and Epoetin delta. Epoetin theta belongs to the pharmacological class of chemically defined anti-anaemic drugs. Biopoin has been developed as a stand alone product. The Applicant is seeking approval for the indication

2009 European Medicines Agency - EPARs

344. Kombiglyze XR (saxagliptin/metformin extended release) fixed dose combination tablets

hormones are released from the gastrointestinal tract during meals and stimulate insulin release from the pancreatic beta-cell in a glucose-dependent manner. DPP4 inhibitors increase the levels of intact glucagon-like peptide-1 (GLP-1). The intact GLP-1 regulates blood glucose via stimulation of glucose-dependent insulin secretion, delaying of gastric emptying, inhibiting of glucagon secretion, and as a result of all these actions, improves the pre-prandial and postprandial glycemic profile. Metformin (...) . For discussion of the results and conclusions from the bioequivalence studies please refer to the clinical pharmacology review. Mechanism of Action Saxagliptin: Saxagliptin is DPP4 inhibitor that decreases the inactivation of the incretin hormones glucagon- like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) which are released into bloodstream from the small intestine in response to meals. These hormones cause insulin release from pancreatic beta cells in a glucose-dependent manner

2009 FDA - Drug Approval Package

345. Study to Determine How Cialis Effects the Renal Function in Response to Volume Expansion in Preclinical Diastolic Cardiomyopathy (Aim3)

. Patients taking the following selective alpha blockers and who are unable to stop for the duration of the study; Alfuzosin Prazosin Doxazosin Tamsulosin Terazosin Silodosin Patients with retinitis pigmentosa, previous diagnosis of nonischemic optic neuropathy, untreated proliferative retinopathy or unexplained visual disturbance Patients with sickle cell anemia, multiple myeloma, leukemia or penile deformities placing them at risk for priapism (angulation, cavernosal fibrosis or Peyronie's disease (...) ) Patients with an allergy to iodine. Patients on PDEV inhibition for pulmonary hypertension Patients on PDEV inhibition for erectile dysfunction who are not willing to stop the medication for the duration of the study Valve disease (> moderate aortic or mitral stenosis; > moderate aortic or mitral regurgitation) Obstructive Hypertrophic cardiomyopathy Infiltrative or inflammatory myocardial disease (amyloid, sarcoid) Pericardial disease Have experienced a myocardial infarction or unstable angina

2014 Clinical Trials

346. Study to Evaluate the Efficacy and Safety of GX-E2 in the Anemic Patients Diagnosed With Chronic Kidney Disease (CKD)

findings or previously taken chest x-ray findings Uncontrolled hypertension Congestive heart failure more severe than NYHA functional class III; unstable Coronary artery disease (CAD); myocardial infraction within 3 months Uncontrolled arrhythmia High risk of thrombosis and embolism Systemic blood diseases (e.g. Pure red cell anemia, sickle cell anemia, myelodysplastic syndromes, hematologic malignancy, myeloma, hemolytic anemia) Absolute neutrophil count below 1,500 per microliter (uL) within (...) : January 24, 2014 Last Update Posted : October 16, 2017 Sponsor: Genexine, Inc. Information provided by (Responsible Party): Genexine, Inc. Study Details Study Description Go to Brief Summary: The primary objective of study is Part A : To explore the optimal fixed starting dose and dosing interval of GX-E2 Part B : To evaluate the proof of concept (POC) of GX-E2 Condition or disease Intervention/treatment Phase Anemia Chronic Kidney Disease Drug: GX-E2 Drug: NESP Drug: MIRCERA Phase 2 Detailed

2014 Clinical Trials

347. Optimal Oxygenation in the Intensive Care Unit

or hypothermia <36 deg.C Heart rate >90 bpm Respiratory rate >20 /min or pCO2 <32 mmHg (4.3 kPa) Number of leucocytes >12 x 10^9/l of <4 x 10^9/l of >10% bands Within 12 hours of admittance to the ICU Expected stay of more than 48 hours as estimated by the attending physician Exclusion Criteria: Elective surgery Carbon monoxide poisoning Cyanide intoxication Methemoglobinemia Sickle cell anemia Severe pulmonary arterial hypertension (WHO class III or IV) Known severe Acute Respiratory Distress Syndrome (ARDS (...) , an increasing number of studies not only confirm the known negative pulmonary effects of chronic oxygen oversupply, but also important and more acute circulatory effects, characterised by decreased cardiac output (CO), increased systemic vascular resistance (SVR), and impaired microvascular perfusion. These phenomena can impair perfusion of organs, which may outweigh higher arterial oxygen content, resulting in a net loss of oxygen delivery and perturbed organ function. This may for example be responsible

2014 Clinical Trials

348. Safety Evaluation of the KLOX BioPhotonic System in Venous Leg Ulcers

0.7 and 1.3, inclusive). Exclusion Criteria: Venous leg ulcer present for more than 12 months; The ulcer to be treated is planned for operative debridement; The ulcer has significant necrotic tissue (e.g., more than 20% of the ulcer area); Major uncontrolled medical disorder(s) such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia; Severe or significant hypoalbuminemia (albuminemia < 30 g/L, and/or pre-albumin < 5 mg/dL), or hypoproteinemia (...) leg ulcer, clinically defined and confirmed by duplex, refilling time or venous hypertension; Open venous leg ulcer present for more than 4 weeks prior to study entry (Screening/Visit 1); Ulcer area between 5 and 100 cm2 inclusive, with a maximum depth of 1 cm. The maximum diameter of the wound must not exceed 10 cm; Wound area has not changed by more than +/- 30% between Screening visit and Week 1/Visit 1 (before treatment). Adequate arterial blood perfusion (ABI (ankle brachial index) between

2014 Clinical Trials

349. Oxygen: the poison is in the dose. (PubMed)

Oxygen: the poison is in the dose. Cell-free hemoglobin (Hb) has been blamed for a spectrum of problems, including vasoconstriction pancreatitis, myocardial infarction, and pulmonary hypertension in hemolytic anemia, malaria, and sickle cell anemia, and from Hb-based oxygen carriers (HBOCs). Toxicities have been attributed to scavenging of nitric oxide (NO). However, while NO scavenging may explain many in vitro effects, and some effects in animal models and clinical trials with HBOCs, key (...) inconsistencies in the theory require alternative explanations. This review considers the hypothesis that cell-free Hb oversupplies oxygen to tissues, leading to oxygen-related toxicity, possibly through formation of reactive oxygen species and local destruction of NO. Evidence for this hypothesis comes from various sources, establishing that tissue oxygen levels are maintained over very narrow (and low) levels, even at high oxygen consumption. Tissue is normally protected from excessive oxygen by its

2013 Transfusion

350. SCD-Haplo: Phase II Study of HLA-Haploidentical SCT for Aggressive SCD

with major visual impairment in at least one eye Osteonecrosis of 2 or more joints Sickle cell nephropathy, defined by a GFR < 90mL/min/1.73m2 or the presence of macroalbuminuria (urine albumin > 300 mg/g creatinine) Pulmonary hypertension, defined by a mean pulmonary artery pressure > 25mmHg Age 16-60 years Karnofsky performance status of 60 or higher Adequate cardiac function, defined as left ventricular ejection fraction ≥ 40% Adequate pulmonary function, defined as diffusion lung capacity of carbon (...) with this protocol. The acute complications include vaso-occlusive pain episodes, acute chest syndrome, stroke, and priapism. The chronic complications include nephropathy, retinopathy, osteonecrosis, pulmonary artery pressures, cardiomyopathy, and chronic lung disease. Overall & Disease-Free Survival [ Time Frame: Up to one year post-transplant. ] To determine the overall and disease-free survival of patients with sickle cell disease receiving HLA-haploidentical hematopoietic stem cell transplantation

2013 Clinical Trials

351. Reduced Intensity Conditioning in Patients Aged ≤35 With Non-Malignant Disorders Undergoing UCBT, BMT, or PBSCT

Inflammatory Conditions Crohn's Disease/Inflammatory Bowel Disease Exclusion: Allogeneic hematopoietic stem cell transplant within the previous 6 months. Any active malignancy or MDS. Severe acquired aplastic anemia. Uncontrolled bacterial, viral or fungal infection (currently taking medication and with progression of clinical symptoms). Pregnancy or nursing mother. Poorly controlled pulmonary hypertension. Any condition that precludes serial follow-up. Contacts and Locations Go to Information from (...) mannosidosis Gaucher Disease Other inheritable metabolic diseases where hematopoietic stem cell transplantation may be beneficial. Hereditary anemias Thalassemia major Sickle cell disease (SCD) - patients with sickle disease must have one or more of the following: Overt or silent stroke Pain crises ≥ 2 episodes per year for past year One or more episodes of acute chest syndrome Osteonecrosis involving ≥ 1 joints Priapism Diamond Blackfan Anemia (DBA) Other congenital transfusion dependent anemias

2013 Clinical Trials

352. New Treatment Response in People With and Without Cirrhosis From Chronic Hepatitis C

) History of hemoglobinopathies (e.g., thalassemia major or sickle cell anemia), diagnoses associated with an increased baseline risk for anemia (e.g., spherocytosis), hemolytic anemia, or diseases in which anemia would be medically problematic, or hemophilia; c) Pre-existing ophthalmologic disorders considered clinically significant on eye exam, including retinal, examination. Note: all subjects with a history of diabetes or hypertension must have a documented eye exam within 12 months prior (...) , sarcoidois, etc; f) History of cardiomyopathy, coronary artery disease (including angina), interventional procedure for coronary artery disease (including angioplasty, stent procedure, or cardiac bypass surgery), ventricular arrhythmia, congestive heart failure, pulmonary hypertension, cardiomyopathy, or other clinically significant cardiac disease; g) Historical or current ECG findings indicative of cardiovascular instability, including but not limited to evidence of significant myocardial ischemia

2013 Clinical Trials

353. The Effects of Adding TCM-700C on the Standard Combination Treatment for HCV Genotype 1 Patients(Phase III)

than cornea or hair transplant or skin graft); Severe concurrent medical disease such as severe hypertension, significant coronary heart disease, poorly controlled diabetes mellitus (glycated hemoglobin A1c [HbA1c] >8.5%), not adequately controlled thyroid dysfunction, chronic obstructive pulmonary disease, severe infections (bacterial, viral, fungal, including acute tuberculosis), or hemoglobinopathies (thalassemia major or sickle cell anemia); Autoimmune hepatitis or other autoimmune conditions (...) <1500 cells/mm3; Hemoglobin <12 g/dL for women and <13 g/dL for men; Creatinine >1.5 mg/dL; Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >10 x upper limit of normal (ULN); Total serum bilirubin >1.5 x ULN; Subjects without cirrhosis and AFP >50 ng/mL must have an ultrasound between the screening and baseline visit with no findings suspicious for HCC. Medical conditions which are contraindications for PegIFNα 2a or RBV therapy: Psychiatric disorders; Organ transplant (other

2013 Clinical Trials

354. A Phase 1, Open-Label Study of Intravenous Sildenafil in Patients With Cirrhosis

, myocardial infarctus, life-threatening arrhythmia or stroke within 6 months before enrollment History of retinitis pigmentosa Anatomical deformation of the penis (Peyronie's disease, angulation, cavernosal fibrosis) History of sickle cell anemia, multiple myeloma or leukemia Renal failure treated with dialysis Cognitive impairment based on IRB "evaluation to sign consent form" Transjugular intrahepatic porto-systemic shunt placement Previous kidney or liver transplantation Contacts and Locations Go (...) Eligible for Study: All Accepts Healthy Volunteers: No Criteria Subjects will be eligible for the study if they meet the following inclusion criteria: Cirrhosis. Diagnosis of cirrhosis will be based on either liver biopsy OR clinical characteristics (e.g. history of ascites or encephalopathy or esophageal varices or gastric varices or splenomegaly or spider angioma or any clinical sign of portal hypertension/cirrhosis), laboratory (e.g. history of thrombocytopenia or history of APRI (Reference: Wai CT

2013 Clinical Trials

355. Study to Determine How Cialis Effects the Renal Function in Response to Volume Expansion in Preclinical Systolic Cardiomyopathy (Aim2)

taking the following selective alpha blockers and who are unable to stop for the duration of the study; Alfuzosin Prazosin Doxazosin Tamsulosin Terazosin Silodosin Patients with retinitis pigmentosa, previous diagnosis of nonischemic optic neuropathy, untreated proliferative retinopathy or unexplained visual disturbance Patients with sickle cell anemia, multiple myeloma, leukemia or penile deformities placing them at risk for priapism (angulation, cavernosal fibrosis or Peyronie's disease) Patients (...) with an allergy to iodine. Patients on PDEV inhibition for pulmonary hypertension Patients on PDEV inhibition for erectile dysfunction who are not willing to stop the medication for the duration of the study Valve disease (> moderate aortic or mitral stenosis; > moderate aortic or mitral regurgitation) Obstructive Hypertrophic cardiomyopathy Infiltrative or inflammatory myocardial disease (amyloid, sarcoid) Pericardial disease Have experienced a myocardial infarction or unstable angina, or have undergone

2013 Clinical Trials

356. Study of PPI-668, BI 207127 and Faldaprevir, With and Without Ribavirin, in the Treatment of Chronic Hepatitis C

at Screen. Clinically significant, unstable cardiovascular or pulmonary disease, including cardiovascular or pulmonary disease requiring pharmacologic intervention other than anti-hypertensive medications, statins, and/or prophylactic aspirin (or similar anticoagulant). Red blood cell disorder, including (but not limited to): thalassemia major or minor, sickle cell anemia. Diabetes Mellitus treated with insulin or hypoglycemic agents History of asthma requiring hospital admission within the preceding 12 (...) ) No clinically significant abnormalities in the 12-lead electrocardiogram at Screen Signed informed consent prior to trial participation. Exclusion Criteria: Seropositive for HIV antibody or Hepatitis B Surface Antigen at Screen Liver disease due to causes other than chronic HCV infection Symptoms or signs of decompensated liver disease, or evidence of cirrhosis Any medical condition that may interfere with the absorption, distribution or elimination of study drugs Poorly controlled or unstable hypertension

2013 Clinical Trials

357. Non-Myeloablative Conditioning and Bone Marrow Transplantation

. Patients with an HLA-matched related donor will proceed to a matched BMT. Age 2-70 years Good performance status (ECOG 0 or 1; Karnofsky and Lansky 70-100) Patients and donors must be able to sign consent forms. First degree relative should be willing to donate Patients must be geographically accessible and willing to participate in all stages of treatment. Eligible diagnoses: Patients with sickle cell anemia such as sickle cell anemia (Hb SS), Hb Sβ° thalassemia, Hb Sβ+thalassemia, Hb SC disease, Hb (...) Center Investigators Layout table for investigator information Principal Investigator: Adetola A Kassim, MD Vanderbilt-Ingram Cancer Center More Information Go to Additional Information: Layout table for additonal information Responsible Party: Adetola A. Kassim, Associate Professor of Medicine; Clinical Director, Sickle Cell Anemia Program; Medical Oncologist, Vanderbilt-Ingram Cancer Center ClinicalTrials.gov Identifier: Other Study ID Numbers: VICCNC BMT 12108 First Posted: May 9, 2013 Last Update

2013 Clinical Trials

358. Pregnancy Related Causes of Deaths in Ghana: A 5-Year Retrospective Study (PubMed)

%) and genital tract sepsis (2.5%). The remaining 20.5% (130) resulted from indirect obstetric causes, including: infections outside the genital tract, (9.2%), anemia (2.8%), sickle cell disease (2.7%), pulmonary embolism (1.9%) and disseminated intravascular coagulation (1.3%). The top five causes of maternal death were: haemorrhage (21.8%), abortion (20.7%), hypertensive disorders (19.4%), infections (9.1%) and ectopic gestation (8.7%).Ghana continues to have persistently high levels of preventable causes (...) statistical software (Version 19).Of 5,247 deaths among women aged 15-49, 12.1% (634) were pregnancy-related. Eighty one percent of pregnancy-related deaths (517) occurred in the community or within 24 hours of admission to a health facility and 18.5% (117) occurred in a health facility. Out of 634 pregnancy-related deaths, 79.5% (504) resulted from direct obstetric causes, including: haemorrhage (21.8%), abortion (20.8%), hypertensive disorders (19.4%), ectopic gestation (8.7%), uterine rupture (4.3

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2013 Ghana Medical Journal

359. Trial of HQK-1001 in Beta Thalassemia Intermedia in Lebanon

, an innate type of hemoglobin which is normally made but is suppressed in infancy. Fetal globin (HbF) can perform the function of the missing beta globin and reduce anemia in beta thalassemia, when it is produced in higher amounts than normal. In this trial, 10 patients with beta thalassemia intermedia in Lebanon will all receive the study drug for 6 months at a dose which has been previously shown to be safe in normal volunteers and in beta thalassemia and sickle cell patients and to stimulate fetal (...) Exclusion Criteria: Red blood cell transfusions within 3 months prior to administration of study drug QT Segment corrected (QTc)> 450 msec Use of Erythropoiesis Stimulating Agents(ESAs)within 9 days of first dose Hydroxyurea treatment within 6 months of first study drug History of significant arrythmias, syncope, or resuscitation Alanine Transaminase (ALT)> 4x upper limit of normal Serum creatinine > 1.5 mg/dl Sse of iron chelating agents within 7 days of first dose Pulmonary hypertension requiring

2012 Clinical Trials

360. Clinical Trial of Group ACYW135 Meningococcal Polysaccharide Vaccine 003

application of antibiotics or anti-virus treatment in the whole body within the past 1 week; History of fever within the past 3 days (axillary temperature ≥38.0℃); Participating in another clinical trial; History of allergy, eclampsia, epilepsy, encephalopathy and mental disease or family disease; Thrombopenia or other coagulopathy that may cause contraindication to intramuscular injection; Acute chronic disease (such as Down syndrome, diabetes, sickle cell anemia or neurologic disease, Guillain-Barre (...) 3 months and vaccination with other products within the last 2 weeks; Axillary temperature ≤37.0℃. Exclusion Criteria: Any acute disease, such as: tumor, autoimmunity disease, progressive atherosclerotic disease or diabetes with complication, chronic obstructive pulmonary disease need oxygen uptake, acute or progressive hepatopathy or nephropathy, congestive heart-failure, etc.; Allergic to vaccines or drugs (history of allergy to any vaccine in the past); History of neurologic symptom or signs

2012 Clinical Trials

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