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Clinical Index of Stable Febrile Neutropenia

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301. Transplants, Liver (Diagnosis)

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 (...) dysfunction. Acute rejection is represented clinically as jaundice with laboratory evidence of abnormal liver function tests. Bilirubin and alkaline phosphatase levels rise initially, followed by elevations in the hepatocellular enzymes alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Other symptoms may include fever, liver tenderness, and eosinophilia. Acute rejection is most commonly treated with high-dose steroids (prednisolone 200 mg or methylprednisolone 1 g for 3 days) or a high

2014 eMedicine Emergency Medicine

302. Study to Demonstrate That Antibiotics Are Not Needed in Moderate Acute Exacerbations of COPD

was: Recruiting First Posted : July 4, 2013 Last Update Posted : February 23, 2017 Sponsor: Hannover Medical School Collaborator: CAPNETZ Stiftung Information provided by (Responsible Party): Tobias Welte, Hannover Medical School Study Details Study Description Go to Brief Summary: The ultimate goal is to reduce unnecessary antibiotic prescriptions which drive the development of antibiotic resistance in the community. The primary objective of ABACOPD is to demonstrate in a sufficiently sized clinical study (...) 4 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Estimated Enrollment : 980 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment Official Title: Randomized Double Blind Placebo-controlled Study to Demonstrate That Antibiotics Are Not Needed in Moderate Acute Exacerbations of COPD - The ABACOPD Study Study Start Date

2013 Clinical Trials

303. 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

304. Evaluation of Circulating T Cells and Tumor Infiltrating Lymphocytes (TILs) During / After Pre-Surgery Chemotherapy in Non-Small Cell Lung Cancer (NSCLC)

of the last cycle of neoadjuvant chemotherapy Number of subjects undergoing lobectomy having surgery-related mortality Number of subjects experiencing dose-limiting toxicity (DLT) during neoadjuvant therapy. DLT will be defined as treatment-related: ≥ Grade 4 hematologic toxicity (excluding neutropenia without fever or infection) or ≥ Grade 3 non-hematologic toxicity (excluding fatigue, nausea, vomiting, peripheral neuropathy, chemotherapy infusion reaction to carboplatin or paclitaxel) Median Disease (...) increases the number of patients with detectable circulating T cells with specificities against tumor associated antigens (TAA) from zero percent (0%) of patients prior to therapy to 20% of patients after neoadjuvant chemotherapy plus ipilimumab. This is an open label Phase 2 trial. Patients with clinical stage 1B (>4 cm), 2, (N0-2) or 3 non-small cell lung cancer (NSCLC) and no prior therapy for the current diagnosis of lung cancer will be eligible for the study. Subjects will receive 3 cycles

2013 Clinical Trials

305. 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

306. 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

307. A Study of RO5424802 in Patients With Non-Small Cell Lung Cancer Who Have ALK Mutation and Failed Crizotinib Treatment

. Percentage of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (up to 28 days) ] DLTs were to be assessed based on the National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.3 (NCI-CTCAE v 4.3). DLTs: drug-related toxicities that meet any one of the following criteria: Grade 4 thrombocytopenia; Grade 3 thrombocytopenia with bleeding; Grade 4 neutropenia continuing for greater than or equal to (>/=) 7 consecutive days or neutropenic fever; Non (...) weeks after initial documentation. CR was defined as complete disappearance of all enhancing measurable, non-measurable disease; stable or improved non-enhancing lesions; no new lesions; no corticosteroids (or only physiologic replacement dose), and clinically stable or improved. PR was defined as >/=50% decrease compared to screening in the sum of the products of the diameters (SPD) of enhancing measurable lesions; no progression of non-measurable disease (enhancing and non-enhancing lesions

2013 Clinical Trials

308. 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

309. 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

311. 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

312. 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

313. 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

314. Ofatumumab Plus Bendamustine in Frontline and Relapsed Chronic Lymphocytic Leukaemia (CLL)

abnormalities. Cytogenetics (analyzed by fluorescent in situ hybridization [FISH]) of 17p deletion, 11q deletion, 17p or 11q deletions, 6q- or +12q or 13q- deletions, and no aberration at Baseline were summarized by clinical responses after the last dose of study treatment. Clinical responses included complete remission (CR), nodular partial remission (nPR), complete response with incomplete bone marrow Recovery (CRi), partial remission (PR), disease progression (PD), and stable disease (SD (...) at Baseline and who had clinical response after the last dose of study treatment were provided. Clinical responses included complete remission (CR), complete response with incomplete bone marrow Recovery (CRi), nodular partial remission (nPR), and partial remission (PR), disease progression (PD), and stable disease (SD). The participants with a PR, CRi, PR or nPR are called responders and the participants with SD and PD are called non-responders. Number of Participants With the Indicated Immunoglobulin

2012 Clinical Trials

315. 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

316. Study Evaluating ABT-199 in Subjects With Relapsed or Refractory Multiple Myeloma

), diagnosis of fever and neutropenia within 1 week prior to first dose of study drug. Cardiovascular disability status of New York Heart Association Class greater than or equal to 3. Significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular or hepatic disease, within the last 6 months that, in the opinion of the investigator, would adversely affect his/her participation in the study. History of other active malignancies other than multiple myeloma within (...) with dexamethasone in subjects with t(11;14)-positive multiple myeloma. The phase 2 primary objective is to further evaluate the objective response rate (ORR) and very good partial response or better rate (VGPR+) in subjects with t(11;14)-positive multiple myeloma. Condition or disease Intervention/treatment Phase Relapsed/Refractory Multiple Myeloma Drug: Dexamethasone Drug: ABT-199 Phase 1 Phase 2 Expanded Access : An investigational treatment associated with this study is available outside the clinical trial

2012 Clinical Trials

317. 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

318. Duration of Antibiotics for the Treatment of Gram-negative Bacilli Bacteremia

. Immunosuppression, including: HIV infection Hematopoietic stem-cell transplantation Neutropenia on day of randomization or in the 48 hours prior to randomization. Patients with neutropenic fever at presentation that are afebrile and non-neutropenic in the 48 hours before randomization will be included. Clinical instability during the 48 hours before randomization, defined as mean blood pressure<60 mmHg despite adequate fluid resuscitation or vasopressors support. Repeated positive blood cultures for the same (...) for the Treatment of Gram-negative Bacilli Bacteremia - a Randomized Controlled Trial Study Start Date : January 2013 Estimated Primary Completion Date : January 2019 Estimated Study Completion Date : July 2019 Resource links provided by the National Library of Medicine related topics: Arms and Interventions Go to Arm Intervention/treatment Experimental: short-course antibiotic treatment stopped on day 7 if the patient has been afebrile for 48 hours and clinically stable. Continued hospitalization will be left

2012 Clinical Trials

320. Neonatal Sepsis

spontaneous activity Less vigorous sucking Anorexia Apnea Bradycardia Temperature instability (hypothermia or hyperthermia) Fever is present in only 10 to 15% but, when sustained (eg, > 1 h), generally indicates infection. Other symptoms and signs include respiratory distress, neurologic findings (eg, seizures, jitteriness), jaundice (especially occurring within the first 24 h of life without Rh or ABO blood group incompatibility and with a higher than expected direct bilirubin concentration), vomiting (...) 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

2013 Merck Manual (19th Edition)

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