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Pulmonary Hypertension in Sickle Cell Anemia

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261. Tepadina - thiotepa

). In the rats, it induced squamous cell carcinoma of the skin or ear canal in both males and females, and haematopoietic neoplasms in the males. In the mice, it induced lymphoma or lymphocytic leukaemia in both sexes and squamous-cell carcinoma in the skin and associated glands of males. In particular mice strains (A/J and A/He) where increased rates of pulmonary tumours are common, intraperitoneal administration of thiotepa (3x/ week for 4 weeks) was shown to further increase the Page 16 of 78 rate of lung (...) 2008 an application for Marketing Authorisation to the European Medicines Agency (EMEA) through the centralised procedure for Tepadina, which was designated as an orphan medicinal product EU/3/06/424 on 29 January 2007. Tepadina was designated as an orphan medicinal product in the following indication: conditioning treatment prior to haematopoietic progenitor cell transplantation (HPCT). The calculated prevalence of this condition was 0.5 per 10,000 EU population. The applicant applied

2010 European Medicines Agency - EPARs

262. Nivestim - filgrastim

proliferating cells leading to bone marrow damage. Anemia and thrombocytopenia and, most importantly, neutropenia results in impaired host defence, which leaves patients more susceptible to bacterial infections and sepsis. This leads to delays in subsequent chemotherapy cycles. The recovery of bone marrow is stimulated by various growth factors. The most important growth factor for the recovery of neutrophils is granulocyte colony- stimulating factor, G-CSF. Filgrastim is a human G-CSF produced (...) ) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. o The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy. o Filgrastim is indicated for the mobilisation of peripheral blood progenitor cells (PBPC). o In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute

2010 European Medicines Agency - EPARs

263. A Phase 3 Study to Evaluate the Efficacy and Safety of TAK-385 40 mg Compared With Leuprorelin in the Treatment of Uterine Fibroids

has received relugolix (including placebo) in a previous clinical study. The participant is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress. The participant has a previous or current history of blood disorders (eg, thalassemia, sickle cells anemia, folic-acid deficiency, and coagulopathy), excluding (latent) iron-deficiency anemia (...) (up to Week 28) ] Anemia-related measurements consisted of hemoglobin, which were determined at the central laboratory. Numerical Rating Scale (NRS) Score [ Time Frame: From Week 6 to 12, from Week 2 to 6, from Week 18 to 24, and for 6 weeks before the final dose (up to Week 24) ] Pain symptoms were evaluated using the NRS score. NRS score is a self-reported instrument assessing pain from 0 to 10. Higher scores reflect greater level of pain. Change From Baseline in Uterine Fibroid Symptom

2016 Clinical Trials

264. Sildenafil for the Treatment of Lymphatic Malformations

diagnosis of the soft tissue tumor as LM not clinically certain. Participating in another clinical study which may interfere. Has a history of priapism or is diagnosed with sickle cell anemia or any other disorder which may predispose to priapism. 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 using the contact information provided by the sponsor. Please refer to this study by its (...) with sildenafil oral therapy for pulmonary arterial hypertension. We have subsequently evaluated additional subjects who improved with sildenafil. The goal of this clinical research trial is to document the benefit or absence of benefit of sildenafil therapy for LMs and identify which type of patient will benefit from sildenafil. This study is a double-blind placebo-controlled trial which involves precise documentation of volume changes associated with therapy or placebo by using MRI segmentation techniques

2015 Clinical Trials

265. Screening for Alpha Thalassemia in Healthy Volunteers

ulceration,pulmonary hypertension, and cardiac hypertrophy are prevented, delayed or reduced by inheritance of one of more deletions of the alpha globin genes. Our long-term research goal is to understand how deletions of alpha globin protect against the vascular complications of sickle cell disease. Deletions of alpha globin are common and found in approximately 5% of the world s population.They are especially common among Africans and people of African ancestry, as well as in India, China (...) thalassemia trait is when someone has only two out of the normal four alpha globin genes. In some people, they lead to no symptoms. Others have changes that lead to disease, including mild anemia. Researchers want to learn more about alpha thalassemia and blood vessels. This may allow them to develop new treatments for blood diseases such as sickle cell disease. Objective: To better understand how alpha globin deletions in healthy people affect blood vessels. Eligibility: Healthy volunteers ages 18 50 who

2016 Clinical Trials

266. Lorcaserin Intra Venous Cocaine Effects

with aspartate transaminase or Alaine aminotransferase > 40 IU/L). History of priapism or conditions that would predispose to priapism (sickle cell anemia, multiple myeloma, leukemia, Peyronie's disease, or other anatomical deformation of the penis). Currently being treated for erectile dysfunction. Has an unstable medical condition, which, in the judgment of investigators, would make participation hazardous, such as AIDS or active TB. If female, is pregnant or lactating (nursing), not practicing adequate (...) , given the potential for serious adverse events, the FDA has limited its use to patients who are either obese or overweight with a medical complication such as hypertension. Whether or not lorcaserin will become generally accepted as a long-term treatment for obesity will depend on the results of ongoing post-marketing studies of cardiovascular outcome data. Rationale In preclinical studies, agonists for the 5-HT₂cR potently attenuate cocaine-seeking behavior. Lorcaserin is a recently approved

2016 Clinical Trials

267. A Single-Dose Relative Bioavailability Study Of GBT440 300 mg Capsules in Healthy Subjects

: September 2015 Additional relevant MeSH terms: Layout table for MeSH terms Anemia, Sickle Cell Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn (...) Therapeutics Information provided by (Responsible Party): Global Blood Therapeutics Study Details Study Description Go to Brief Summary: The purpose of this study is to evaluate the relative bioavailability of a single 300 mg dose of GBT440 administered as a high strength (1 × 300 mg) capsule versus a low strength (3 × 100 mg) capsule formulation in healthy fasted subjects. Condition or disease Intervention/treatment Phase Sickle Cell Disease Drug: GBT440 Phase 1 Study Design Go to Layout table for study

2015 Clinical Trials

268. Drug Interaction Study of GBT440 With Caffeine, S-warfarin, Omeprazole, and Midazolam in Healthy Subjects

Director: Carla Washington, PhD Global Blood Therapeutics More Information Go to Layout table for additonal information Responsible Party: Global Blood Therapeutics ClinicalTrials.gov Identifier: Other Study ID Numbers: GBT440-003 First Posted: October 5, 2015 Last Update Posted: April 12, 2017 Last Verified: April 2017 Keywords provided by Global Blood Therapeutics: anemia, sickle cell Additional relevant MeSH terms: Layout table for MeSH terms Anemia, Sickle Cell Anemia, Hemolytic, Congenital Anemia (...) : April 12, 2017 Sponsor: Global Blood Therapeutics Information provided by (Responsible Party): Global Blood Therapeutics Study Details Study Description Go to Brief Summary: The purpose of this study to evaluate the effect of concomitant administration of GBT440 on caffeine (a CYP1A2 probe substrate), S warfarin (a CYP2C9 probe substrate), omeprazole (a CYP2C19 probe substrate), and midazolam (a CYP3A4 probe substrate) plasma concentrations. Condition or disease Intervention/treatment Phase Sickle

2015 Clinical Trials

269. Improving Quality by Maintaining Accurate Problems in the EHR

Coronary Artery Disease Congestive Heart Failure Hyperlipidemia Hypertension Myocardial Infarction Sickle Cell Disease Sleep Apnea Smoking Stroke Tuberculosis Other: Problem List Suggestion Not Applicable Detailed Description: The clinical problem list is a cornerstone of the problem-oriented medical record. Problem lists are used in a variety of ways throughout the process of clinical care. In addition to its use by clinicians, the problem list is also critical for decision support and quality (...) Myocardial Infarction Tuberculosis Anemia, Sickle Cell Hyperlipidemias Hyperlipoproteinemias Heart Diseases Cardiovascular Diseases Arrhythmias, Cardiac Pathologic Processes Respiratory Tract Diseases Ischemia Necrosis Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Anemia, Hemolytic, Congenital Anemia, Hemolytic

2015 Clinical Trials

270. Inspiratory Flow Rates Achieved by the COPD Patients Through Breezhaler®, Ellipta® and Handihaler® Inhaler Devices

major chronic illness including but not limited to a diagnosis of non-skin cancer, cystic fibrosis, bronchiectasis, α-1 anti-trypsin deficiency, myelomeningocele, sickle cell anemia, endocrine disease, congenital heart disease, unstable arrhythmia, congestive heart failure, stroke, severe hypertension, insulin-dependent diabetes mellitus, renal failure, liver disorders, immunodeficiency states, significant neurodevelopmental delay or behavioral disorders (excluding mild attention deficit (...) 4, 2015 Results First Posted : June 26, 2018 Last Update Posted : June 26, 2018 Sponsor: Novartis Pharmaceuticals Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals ) Study Details Study Description Go to Brief Summary: The purpose of this study was to compare dynamic inspiratory flow rates achieved by a population of Chronic Obstructive Pulmonary Disease (COPD) patients through the Breezhaler®, Ellipta® and Handihaler® dry powder inhaler (DPI) devices. No active

2015 Clinical Trials

271. 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

272. 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

273. 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

274. 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

275. Late Effects of Treatment for Childhood Cancer

.[ ] With the exception of survivors requiring intensive multimodality therapy, sometimes including hematopoietic cell transplantation, for aggressive or refractory/relapsed malignancies, life-threatening treatment effects are relatively uncommon after contemporary therapy in early follow-up (up to 10 years after diagnosis). However, survivors still frequently experience life-altering morbidity related to effects of cancer treatment on endocrine, reproductive, musculoskeletal, and neurologic function. Mortality Late (...) and pulmonary toxicity.[ - ] An analysis of the CCSS and Surveillance, Epidemiology, and End Results (SEER) data that evaluated conditional survival demonstrated a subsequent 5-year survival rate of 92% or higher among most diagnoses at 5 years, 10 years, 15 years, and 20 years. Among those who had survived at least 5 years from diagnosis, the probability of all-cause mortality in the next 10 years was 8.8% in the CCSS and 10.6% in the SEER study, with neoplasms accounting for cause of death

2012 PDQ - NCI's Comprehensive Cancer Database

276. Wilms Tumor and Other Childhood Kidney Tumors

-year age group, most tumors are renal cell carcinoma. Wilms tumor can affect one kidney (unilateral) or both kidneys (bilateral). Less common types of childhood kidney tumors include , , , , , , , , and . of the kidney is a type of nonmalignant neoplasia.[ , ] References Smith MA, Altekruse SF, Adamson PC, et al.: Declining childhood and adolescent cancer mortality. Cancer 120 (16): 2497-506, 2014. Ahmed HU, Arya M, Levitt G, et al.: Part I: Primary malignant non-Wilms' renal tumours in children (...) CLOVES syndrome PIK3CA X Isolated hemihyperplasia X Perlman syndrome DIS3L2 X Simpson-Golabi-Behmel syndrome GPC3 X Sotos syndrome NSD1 X Bloom syndrome BLM X Denys-Drash syndrome WT1 X Familial Wilms tumor FWT1 X FWT2 Fanconi anemia with biallelic mutations in BRCA2 ( FANCD1 ) or PALB2 ( FANCN ) BRCA2 X PALB2 Frasier syndrome WT1 X Genitourinary anomalies WT1 X Li-Fraumeni syndrome TP53 X CHEK2 Sporadic aniridia WT1 X Trisomy 18 X WAGR syndrome WT1 X For information about the genes associated

2012 PDQ - NCI's Comprehensive Cancer Database

277. A RCT of CenteringPregnancy on Birth Outcomes

preclude prenatal care provision by nurse practitioners or participation in group care Pregestational diabetes, Severe chronic hypertension requiring medication, Morbid Obesity with BMI >49.99 Renal disease with baseline proteinuria >1g/24 hours Any disease requiring chronic immunosuppression (SLE, solid organ transplant) Active pulmonary tuberculosis Sickle cell anemia Human Immunodeficiency Virus Infection Other medical conditions that would exclude women from group care at the discretion of the PI (...) diagnosed with overt diabetes If PG at 1 h after load is ≥140 mg/dL (7.8 mmol/L), proceed to 100-g OGTT (Step 2), performed while patient is fasting GDM diagnosis made when two or more PG levels meet or exceed: Fasting: 95 mg/dL or 105 mg/dL (5.3/5.8) hr: 180 mg/dL or 190 mg/dL (10.0/10.6) hr: 155 mg/dL or 165 mg/dL (8.6/9.2) hr: 140 mg/dL or 145 mg/dL (7.8/8.0) Gestational hypertension [ Time Frame: Measured during pregnancy ] Hypertension (SBP/DBP: above 140/90 mm Hg) occurred during pregnancy

2015 Clinical Trials

278. HSCT For Patients With High Risk Hemoglobinopathies Using Reduced Intensity

Identifier: Other Study ID Numbers: 08057 First Posted: May 6, 2015 Last Update Posted: March 13, 2019 Last Verified: March 2019 Individual Participant Data (IPD) Sharing Statement: Plan to Share IPD: Yes Plan Description: Outcome data to include study findings. Keywords provided by Indira Sahdev, Northwell Health: Reduced Intensity Conditioning Regimen Additional relevant MeSH terms: Layout table for MeSH terms Anemia, Sickle Cell Thalassemia beta-Thalassemia Hemoglobinopathies Anemia, Hemolytic (...) ): Indira Sahdev, Northwell Health Study Details Study Description Go to Brief Summary: This study will evaluate the use of reduced intensity conditioning regimen in patients with high risk hemoglobinopathy Sickle Cell and B-Thalassemia Major in combination with standard immunosuppressive medications, followed by a routine stem cell transplant in order to assess whether or not it is as effective as myeloablative high dose chemotherapy and transplant. Condition or disease Intervention/treatment Phase

2015 Clinical Trials

279. Altitude-Related Disorders (Treatment)

Populations at High Altitude Large numbers of individuals go to high altitudes for work and recreation, and some individuals have special medical problems. Despite similarities to altitude illness in healthy individuals, ascent to high altitude by persons with underlying cardiac disease, [ ] pulmonary disease, and sickle cell anemia deserves special mention. Coronary Artery Disease Unacclimatized persons with coronary artery disease may develop increased anginal symptoms following ascent to altitude (...) in the United States carry at least 1 abnormal hemoglobin gene. Most of these individuals have sickle cell trait and are largely asymptomatic, while a few have a far more severe condition, sickle cell anemia. Those with sickle cell anemia probably already know about their disease, but those with only sickle cell trait may be unaware of the problem and, therefore, are more likely to go to high altitude and experience problems. Exposure to the hypoxia at high altitude may precipitate a sickle cell crisis

2014 eMedicine.com

280. Osler-Weber-Rendu Syndrome (Treatment)

. Patients should be monitored for symptoms and signs of blood loss and anemia with yearly stool guaiac testing and complete blood count (CBC) with differential. Patients should be screened for pulmonary, hepatic, and CNS AVMs at the time of diagnosis and at the onset of any suggestive symptoms and signs. Children who have a parent with HHT carry a 50% chance of harboring the same genetic mutation. Accordingly, pulmonary AVM screening and long-term follow-up are advocated for these children, beginning (...) haemorrhagic telangiectasia associated with mutations in MADH4 (SMAD4). Lancet . 2004 Mar 13. 363(9412):852-9. . Abdalla SA, Letarte M. Hereditary haemorrhagic telangiectasia: current views on genetics and mechanisms of disease. J Med Genet . 2006 Feb. 43(2):97-110. . . Rigelsky CM, Jennings C, Lehtonen R, Minai OA, Eng C, Aldred MA. BMPR2 mutation in a patient with pulmonary arterial hypertension and suspected hereditary hemorrhagic telangiectasia. Am J Med Genet A . 2008 Oct 1. 146A(19):2551-6. . Begbie

2014 eMedicine.com

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