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203 results for

Clinical Index of Stable Febrile Neutropenia

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141. Transplants, Liver (Diagnosis)

months, risk of infection is similar to that of the general population. However, a high index of suspicion should always be maintained in transplant recipients. The most common causes of infection in the outpatient setting are the typical community-acquired pathogens, which are treated with the antimicrobials typically prescribed for nonimmunosuppressed patients (with caution regarding drug interactions). Incidence declines after 6-12 months if the recipient is on a stable immunosuppressant regimen (...) is suspected Cultures of blood, urine, pharynx, and/or sputum: Obtain if infection is suspected Imaging studies Chest radiography: Obtain in the presence of fever, cough, dyspnea, or abnormalities on chest examination Abdominal ultrasonography, computed tomography scan, or endoscopic retrograde cholangiopancreatography, as indicated Management of rejection or infection Every clinical complaint by the transplant patient should be taken seriously, and the transplant team should at least know of every

2014 eMedicine Emergency Medicine

142. Transplants, Liver (Follow-up)

months, risk of infection is similar to that of the general population. However, a high index of suspicion should always be maintained in transplant recipients. The most common causes of infection in the outpatient setting are the typical community-acquired pathogens, which are treated with the antimicrobials typically prescribed for nonimmunosuppressed patients (with caution regarding drug interactions). Incidence declines after 6-12 months if the recipient is on a stable immunosuppressant regimen (...) is suspected Cultures of blood, urine, pharynx, and/or sputum: Obtain if infection is suspected Imaging studies Chest radiography: Obtain in the presence of fever, cough, dyspnea, or abnormalities on chest examination Abdominal ultrasonography, computed tomography scan, or endoscopic retrograde cholangiopancreatography, as indicated Management of rejection or infection Every clinical complaint by the transplant patient should be taken seriously, and the transplant team should at least know of every

2014 eMedicine Emergency Medicine

143. Transplants, Liver (Overview)

months, risk of infection is similar to that of the general population. However, a high index of suspicion should always be maintained in transplant recipients. The most common causes of infection in the outpatient setting are the typical community-acquired pathogens, which are treated with the antimicrobials typically prescribed for nonimmunosuppressed patients (with caution regarding drug interactions). Incidence declines after 6-12 months if the recipient is on a stable immunosuppressant regimen (...) is suspected Cultures of blood, urine, pharynx, and/or sputum: Obtain if infection is suspected Imaging studies Chest radiography: Obtain in the presence of fever, cough, dyspnea, or abnormalities on chest examination Abdominal ultrasonography, computed tomography scan, or endoscopic retrograde cholangiopancreatography, as indicated Management of rejection or infection Every clinical complaint by the transplant patient should be taken seriously, and the transplant team should at least know of every

2014 eMedicine Emergency Medicine

144. Shock, Septic (Follow-up)

source of sepsis,” with daily reevaluation of the anti-infective therapy for potential de-escalation. [ , ] Generally, a 7- to 10-day treatment course is followed. Longer treatment regimens may be warranted in the presence of a slow clinical response, undrainable foci of infection, and immunologic deficiencies (eg, neutropenia). The use of procalcitonin or similar biomarkers may facilitate discontinuance of antibiotics in patients with clinical improvement and no further evidence of infection (...) host responses. Source control is an essential component of sepsis management. Venous access In all cases of septic shock, adequate venous access must be ensured for volume resuscitation. When sepsis is suspected, 2 large-bore (16-gauge) intravenous (IV) lines should be placed if possible to allow administration of aggressive fluid resuscitation and broad-spectrum antibiotics. Central venous access is useful when administering vasopressor agents and in establishing a stable venous infusion site

2014 eMedicine Emergency Medicine

145. Study With LDE225 in Combination With Docetaxel in Triple Negative (TN) Advanced Breast Cancer (ABC) Patients

) assessed as possibly, probably or definitively related to study drugs, occurring within the first two cycles of treatment: Neutropenia grade 4 lasting more than one week, febrile neutropenia, thrombocytopenia grade 3 with bleeding more than grade 2, thrombocytopenia grade 4, Increased plasma creatinine phosphokinase (CK) grade 3-4, any non-hematologic grade 4 toxicity, or grade 3 toxicity except nausea and vomiting, Grade 2 GI toxicity (except nausea and vomiting) lasting more than 2 weeks, Inability (...) date. Exclusion Criteria: Have received more than 3 prior chemotherapy regimens for ABC. Patients with untreated brain metastases. However, a patient with Central Nervous System (CNS) metastases may participate in this trial if > 4 weeks from therapy completion (incl. radiation and/or surgery), is clinically stable with respect to the tumor at the time of study entry and is not receiving corticosteroid therapy. Patients with acute or chronic liver or renal disease or pancreatitis. Patients

2013 Clinical Trials

146. A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations

Dose-Limiting Toxicities (DLTs) in Phase 1 [ Time Frame: Cycle 1 (21 days) ] DLT was defined as any of the following adverse events (AEs) attributable to PF-06463922: (1) hematologic: grade 4 neutropenia for >7 days; febrile neutropenia; grade >=3 neutropenic infection; grade >=3 thrombocytopenia with bleeding; grade 4 thrombocytopenia; (2) non-hematologic: grade >=3 pancreatitis; grade >=3 toxicities (excluding grade >=3 laboratory abnormalities not requiring dose modifications) persisting after (...) . Condition or disease Intervention/treatment Phase ALK-positive Non Small Cell Lung Cancer (NSCLC) and ROS1-positive NSCLC Drug: PF-06463922 Drug: Crizotinib Phase 2 Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 334 participants Allocation: Non-Randomized Masking: None (Open Label) Primary Purpose: Treatment Official

2013 Clinical Trials

147. A Study Of PF-06263507 In Patients With Advanced Solid Tumors

Measures : Number of Participants With Dose-limiting Toxicities (DLT) [ Time Frame: Baseline up to Cycle 2 Day 1 (22 days) ] DLT was defined as any of the following adverse events (AEs) occurring in the first cycle of treatment (21 days) which were attributable to PF-06263507: 1) Grade 4 neutropenia lasting >7 days, 2) Febrile neutropenia, 3) Grade >=3 neutropenia with infection, 4) Any grade thrombocytopenia associated with clinically significant or life-threatening bleeding, 4) Grade 4 (...) Neoplasms Drug: PF-06263507 Phase 1 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 26 participants Masking: None (Open Label) Primary Purpose: Treatment Official Title: A PHASE 1, DOSE ESCALATION STUDY OF PF-06263507 IN PATIENTS WITH ADVANCED SOLID TUMORS Actual Study Start Date : August 8, 2013 Actual Primary Completion Date : June 29, 2015 Actual Study Completion Date : June 29, 2015 Resource links provided by the National Library

2013 Clinical Trials

148. Study of Weekly Carfilzomib, Cyclophosphamide and Dexamethasone In Newly Diagnosed Multiple Myeloma Patients (wCCyd)

reduction within Cycle1 Inability to receive Day 1 dose of Cycle2 due to drug related toxicity persisting from Cycle1 or drug related toxicity newly encountered on Day1 of Cycle2. Hematologic: Grade 4 neutropenia (ANC<0.5x109/L) lasting for ≥7days Febrile neutropenia (ANC<1.0x109/L with a fever ≥38.3ºC) Grade 4 thrombocytopenia (platelets<25.0x109/L) lasting ≥7 days despite dose delay Grade 3-4 thrombocytopenia associated with bleeding Any hematologic toxicity requiring a dose reduction within Cycle1 (...) ) patients. Condition or disease Intervention/treatment Phase Multiple Myeloma Drug: Carfilzomib Drug: Cyclophosphamide Drug: Dexamethasone Phase 1 Phase 2 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 63 participants Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A MULTICENTER, OPEN LABEL STUDY OF WEEKLY CARFILZOMIB, CYCLOPHOSPHAMIDE AND DEXAMETHASONE (wCCyd

2013 Clinical Trials

149. Phase I Trial of LCL161 and Gemcitabine Plus Nab-Paclitaxel in Metastatic Pancreatic Cancer

febrile neutropenia (Conroy et al 2011). LCL161 is a biostable, cell-permeable, small molecular weight Smac-mimetic compound. It is an orally bioavailable pan-IAP inhibitor that demonstrates anti-tumor efficacy as a single agent in a small subset of cell lines, and in many more cell lines and xenograft models when given in combination with paclitaxel. Nanoparticle albumin-bound paclitaxel (nab-paclitaxel) is a formulation that is readily soluble in saline, eliminating the need for lipid-based solvents (...) conditions that could increase the patient's risk for toxicity while on the study or that could confound discrimination between disease- and study treatment-related toxicities. Patient has impaired cardiac function or clinically significant cardiac diseases, including any of the following: History or presence of ventricular tachyarrhythmia Presence of unstable atrial fibrillation (ventricular response > 100 bpm); Patients with stable atrial fibrillation are eligible, provided they do not meet any

2013 Clinical Trials

150. A Study Of Oral Palbociclib (PD-0332991), A CDK4/6 Inhibitor, As Single Agent In Japanese Patients With Advanced Solid Tumors Or In Combination With Letrozole For The First-Line Treatment Of Postmenopausal Japanese Patients With ER (+) HER2 (-) Advanced B

medical judgement. Outcome Measures Go to Primary Outcome Measures : Number of Participants With Dose Limiting Toxicities (DLT): Part 1 Phase 1 [ Time Frame: Lead-in period (Day -7) up to Day 28 (Cycle 1) ] DLT was classified as per common terminology criteria for adverse events (CTCAE) version 4.0 as any of the events occurring during 28 days of Cycle 1,attributed to study drug:grade 4 neutropenia(for a duration of greater than [>]7 days); febrile neutropenia (grade greater than or equal to [>=]3 (...) 13, 2018 Sponsor: Pfizer Information provided by (Responsible Party): Pfizer Study Details Study Description Go to Brief Summary: This study is comprised of two portions: a Phase 1 portion and a Phase 2 portion. The Phase 1 portion is a single-country, non-randomized, open label, clinical trial which will evaluate the safety, tolerability, preliminary efficacy, and PK profile of PD-0332991 as a single agent in Japanese patients with advanced solid tumors, and PD-0332991 in combination

2012 Clinical Trials

151. Anti-EGFR Immunoliposomes in Solid Tumors

if no dose limiting toxicity (DLT) occured at a given dose level. The decision to enter a next dose level will be made by the study team after reviewing all available toxicity data of the previous groups. A DLT is defined as any grade 4 toxicity, any grade 3 toxicity lasting more than one week or/and febrile neutropenia grade 3 (defined as neutrophils < 1.0 x 10e9/l and fever > 38.5 °C). Nausea, vomiting, anorexia, and alopecia (grade 2) will be excluded as dose limiting toxicities. Similarly, adverse (...) ) [ Time Frame: after completion of the 1st cycle (day 28) ] The MTD is defined through the occurrence of two dose limiting toxicities (DLTs) at a specific dose level. DLT are defined as any grade 4 toxicity, any grade 3 toxicity lasting more than one week or/and febrile neutropenia grade 3 (defined as neutrophils < 1.0 x 10e9/l and fever > 38.5 °C). Nausea, vomiting, anorexia, and alopecia (grade 2) will be excluded as dose limiting toxicities. Similarly, adverse events that are clearly related

2012 Clinical Trials

152. A Study of Weekly Carfilzomib in Combination With Dexamethasone for Progressive Multiple Myeloma (CHAMPION 1)

baseline or > 4.0 mg/dL) lasting > 72 hours ≥ grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal antiemetic/antidiarrheal therapy Hematologic: grade 4 neutropenia (absolute neutrophil count [ANC] < 500/mm³) for > 7 days febrile neutropenia (ANC < 1000/mm³ with a fever ≥ 38.3ºC) of any duration grade 4 thrombocytopenia (< 25 000/mm³) for > 14 days, despite holding treatment grade 3 or 4 thrombocytopenia (< lower limit of normal) associated with > grade 1 bleeding Overall Response Rate (ORR (...) Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 116 participants Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Phase 1/2 Study of Weekly Carfilzomib in Combination With Dexamethasone for Progressive Multiple Myeloma Study Start Date : July 4, 2012 Actual Primary Completion Date : July 22, 2016 Actual Study Completion Date : October 31, 2018 Resource links provided

2012 Clinical Trials

153. A Study To Evaluate PF-04449913 With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

on when the next chemotherapy cycle was started ] A DLT was any of the following adverse events (AEs) in Cycle 1 and considered by the investigator possibly related to glasdegib in combination with chemotherapy: (1) Grade >= 3 non-hematologic toxicity, excluding Grade >= 3 infection, fever (including febrile neutropenia), infusion related AEs, electrolyte abnormalities and ALT/AST elevation that returned to Grade <= 1 or baseline within 7 days; (2) prolonged myelosuppression that lasted longer than 42 (...) : PF-04449913 Drug: Low dose ARA-C (LDAC) Drug: Decitabine Drug: Daunorubicin Drug: Cytarabine Phase 2 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 255 participants Allocation: Randomized Masking: None (Open Label) Primary Purpose: Treatment Official Title: A PHASE 1B/2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PF-04449913, AN ORAL HEDGEHOG INHIBITOR, IN COMBINATION WITH INTENSIVE CHEMOTHERAPY, LOW DOSE ARA-C OR DECITABINE

2012 Clinical Trials

154. Study of Weekly Cabazitaxel for Advanced Prostate Cancer

castration by orchiectomy or LHRH agonists. Antiandrogen must be discontinued prior to study start. Disease progression, clinically or radiologically documented, during or after treatment with docetaxel, with a minimum cumulative dose of 225 mg/m2. "Unfit" patients defined as patients who satisfy at least one of the following criteria: ECOG 2 Dose reduction due to febrile neutropenia during the previous treatment with docetaxel Radiation therapy affecting more than 25% of bone marrow reserve Documented (...) Detailed Description: The efficacy of three-weekly cabazitaxel is accompanied by an appreciable rate of serious side effects and toxic deaths. The toxicity rates observed, including grade III-IV neutropenia, febrile neutropenia and diarrhea, could be an obstacle to the use and management of a drug that, on the other hand, has demonstrated great activity. In the treatment of patients with prostate cancer, who have a larger number of morbidities than patients with breast cancer, we assume the risk

2012 Clinical Trials

155. Radiation Exposure and Contamination

are electrically neutral particles emitted by a few radionuclides (eg, californium-252) and produced in nuclear fission reactions (eg, in nuclear reactors); their depth of tissue penetration varies from a few millimeters to several tens of centimeters, depending on their energy. They collide with the nuclei of stable atoms, resulting in emission of energetic protons, alpha and beta particles, and gamma radiation. Gamma radiation and x-rays are electromagnetic radiation (ie, photons) of very short wavelength (...) incorporated radionuclides is from radioisotopes of carbon ( 14 C) and potassium ( 40 K), and because these and other elements (stable and radioactive forms) are constantly replenished in the body by ingestion and inhalation, there are approximately 7000 atoms undergoing radioactive decay each second. Internal exposure from the inhalation of radioactive isotopes of the noble gas radon ( 222 Rn and 220 Rn), which are also formed from the Uranium ( 238 U) decay series, accounts for the largest portion (73

2013 Merck Manual (19th Edition)

156. Neonatal Sepsis

infection is generally not associated with perinatal risk factors or demonstrable maternal cervical colonization and may be acquired postpartum. Diagnosis High index of suspicion Blood, CSF, and sometimes urine culture Early diagnosis of neonatal sepsis is important and requires awareness of risk factors (particularly in LBW neonates) and a high index of suspicion when any neonate deviates from the norm in the first few weeks of life. Neonates with clinical signs of sepsis should have a CBC (...) , less vigorous sucking, apnea, bradycardia, temperature instability, respiratory distress, vomiting, diarrhea, abdominal distention, jitteriness, seizures, and jaundice. Diagnosis is clinical and based on culture results. Treatment is initially with ampicillin plus either gentamicin or cefotaxime , narrowed to organism-specific drugs as soon as possible. (See also in adults and .) Neonatal sepsis occurs in 0.5 to 8.0/1000 births. The highest rates occur in Low-birth-weight (LBW) infants Infants

2013 Merck Manual (19th Edition)

157. Combination Trial MSC1936369B With Temsirolimus

; any Grade >=3 non-hematological toxicity except Grade 3 asymptomatic increases in liver function tests, diarrhea, nausea or vomiting with duration <= 48 hours and alopecia; Grade 4 neutropenia of >5 days duration or febrile neutropenia of >1 day duration; Grade 3 thrombocytopenia with bleeding or Grade 4 thrombocytopenia; any treatment interruption >2 weeks due to adverse events; any severe, impairing daily functions or life-threatening, complication or abnormality not defined in NCI-CTCAE (...) : Pimasertib Drug: Temsirolimus Phase 1 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 33 participants Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: Phase I Dose Escalation Trial of MEK1/2 Inhibitor MSC1936369B Combined With Temsirolimus in Subjects With Advanced Solid Tumors Actual Study Start Date : May 27, 2011 Actual Primary Completion Date

2011 Clinical Trials

158. Trial of Docetaxel and Irinotecan (DI) for Recurrent or Refractory Bone and Soft Tissue Sarcomas.

-hematological toxicity occurred on the day when the dose is due. Irinotecan scheduled at D8 will be omitted if diarrhea of grade 2 or higher occurred on the D10. Doses of docetaxel and irinotecan in the subsequent cycles are reduced by 20% for febrile grade 4 neutropenia (ANC<500/μL). Subsequent dose will be reduced by 20% for the recurrent toxicity. G-CSF is allowed if clinically indicated according to the ASCO guideline (22). Dose of docetaxel in the subsequent cycles are reduced by 20% for grade 2 (...) will be discontinued in patients with grade 4 non-hematological toxicities at the discretion of investigators. Dose modification schedule : Docetaxel and Irinotecan (DI) dose adjustment within a cycle will be made following the guidelines shown in Table 1 and 2 based on weekly WBC count and criteria for adverse events v3.0 (CTCAE). Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Estimated Enrollment : 35 participants Intervention Model: Single Group Assignment

2011 Clinical Trials

159. Weekly Paclitaxel and Cyclophosphamide in Metronomic Administration : Dose Escalation Study of Weekly Paclitaxel

:2 blood samples for the correlation between clinical response and biological parameters Outcome Measures Go to Primary Outcome Measures : Determination of the iv paclitaxel maximum tolerated dose and recommended dose in association with a fixed dose of oral cyclophosphamide [ Time Frame: 28 days = cycle 1 ] A DLT is defined below: Hematological toxicity: Polunuclear neutrophils < 500/mm3 for more than 7 days Febrile neutropenia (Polunuclear neutrophils < 1 000/mm3 and fever > or = 38.5°C (...) cycles = 2 months ] Objective response (complete response, partial response and stable disease) according to RECIST 1.1 criteria Estimation of the free-progression median time [ Time Frame: Until disease progression ] Time between the inclusion and the disease progression (clinical or radiological) Calculation of the Growth Modulation Index (GMI) [ Time Frame: Until disease progression ] Time to progression on study treatment and time to progression on prior treatment Evaluation of the correlation

2011 Clinical Trials

160. GSK2251052 in Complicated Urinary Tract Infection

Sponsor: GlaxoSmithKline Information provided by (Responsible Party): GlaxoSmithKline Study Details Study Description Go to Brief Summary: This study is being conducted to evaluate the safety, efficacy (clinical and microbiological), pharmacokinetics/pharmacodynamics of GSK2251052 and to assess whether it would be a suitable antibiotic for the treatment for febrile lower cUTI and pyelonephritis(complicated and uncomplicated). GSK2251052 will be compared to imipenem-cilastatin, which is an antibiotic (...) reticulocyte count of >5% (i.e., reticulocytes >5% of total RBC mass) Subject has known neutropenia or is anticipated to develop neutropenia during the course of the study (i.e., new chemotherapy subject), with absolute neutrophil count less than 1000 cells/mm3 Subject has a known platelet count less than 75,000 cells /mm3 (subjects with platelet counts as low as 50,000 cells /mm3 are eligible if the reduction is historically stable). Subject has an immunocompromising illness; including known human

2011 Clinical Trials

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