topic
stringlengths 245
1.29k
| doc
stringlengths 52
16.9k
| label
stringclasses 3
values |
|---|---|---|
A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
|
eligible ages (years): 18.0-65.0, Chronic Hepatitis B Male or female of ages 18 Chronic HBV infection for >/= 6 months Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation Significant fibrosis or cirrhosis History or evidence of drug or alcohol abuse History of intolerance to SC injection History of chronic liver disease from any cause other than chronic HBV infection History of hepatic decompensation Any prior receipt of an interferon product
|
0
|
A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
|
eligible ages (years): 18.0-999.0, Thrombocytopenia Cancer Liver Diseases Patients with history of locally advanced or metastatic solid tumor, with a plan to initiate cancer directed systemic therapy for adjuvant or palliative purposes years of age or greater Known liver disease attributed to one of the following: 1. Chronic HBV and/or chronic HCV with Cirrhosis 2. Alcoholic Cirrhosis 3. Nonalcoholic Fatty Liver Disease with Cirrhosis 4. Primary Biliary Cholangitis 5. Primary Sclerosing Cholangitis 6. Autoimmune Hepatitis 7. Hereditary Hemochromatosis 8. Wilsons Disease 9. Alpha-1 Antitrypsin Deficiency 10. Congestive Hepatopathy 11. Cirrhosis or known pre-existing liver dysfunction of unknown cause, or not otherwise specified No specific Child-Pugh Score will be required for eligibility Patients with liver involvement with primary or metastatic cancer are eligible, if the patient also has a diagnosis from list in Platelet count of < 80,000/mcL at time of enrollment, and no platelet count ≥ 80,000/mcL in the 4 weeks prior to enrollment. A platelet count ≥ 80,000/mcL in the prior 4 weeks within 72 hours of a platelet transfusion will not make a patient ineligible No prior cancer directed therapy that is cytotoxic, marrow suppressive, or has thrombocytopenia as a known common side effect in the past 12 months. a. For purposes of this study, cytotoxic/marrow suppressive systemic cancer therapy drugs will i. Nucleoside Analogue, including gemcitabine and fluorouracil ii. Carboplatin or cisplatin iii. Anthracycline iv. Alkylating agent v. Other cancer directive therapies with thrombocytopenia as a known common toxicity even if not cytotoxic b. If a patient has received cytotoxic systemic cancer therapy at any time in the past, then patients will be evaluated for myelodysplastic syndrome and leukemia prior to enrollment ECOG Performance status ≤ 2 History of immune causes of thrombocytopenia (ITP) Presence of leukemia or myelodysplastic syndrome Known bone metastases sufficient to result in at least one site of cortical bone destruction, osteolytic lesions, or osteoblastic lesions, on radiologic imaging Patients who have previously received thrombopoietin mimetics such as romiplostim, eltrombopag, etc Patients who require emergent systemic cancer therapy will be excluded Patients who require emergent radiation therapy will be excluded. a. Note: Concomitant radiation therapy with systemic cancer therapy is permitted Pancytopenia at enrollment (Hemoglobin <9 g/dL and/or Absolute Neutrophil Count < 1500/mcL). a. G-CSF and Red Blood Cell transfusions to treat anemia and neutropenia and achieve adequate hemoglobin and ANC are permitted Patients with serum sodium ≤130 mEq/L will be excluded Patients with a known bleeding disorder or platelet dysfunction will be excluded 1. Baseline Prothrombin Time (PT) that is greater than 2" above the upper limit of normal. 2. Activated Partial Thromboplastin Time (aPTT) that is greater than 3" above the upper limit of normal Patients with known genetic prothrombotic conditions (Factor V Leiden, Prothrombin 20210A, Antithrombin deficiency or Protein C or S deficiency) or history of antiphospholipid syndrome
|
0
|
A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
|
eligible ages (years): 18.0-999.0, COVID-19 Chronic Liver Disease Confirmed diagnosis of COVID-19 Personal history of either Chronic hepatitis C Chronic hepatitis B Alcoholic liver disease Non alcoholic liver disease Autoimmune hepatitis, Primary biliary cholangitis, Primary sclerosing cholangitis Cryptogenic cirrhosis Hepatocellular carcinoma Non-COVID-19 patient
|
0
|
A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
|
eligible ages (years): 18.0-999.0, Advanced Hepatocellular Carcinoma BCLC Stage B Hepatocellular Carcinoma BCLC Stage C Hepatocellular Carcinoma Must have a histologically confirmed diagnosis of HCC or a non-invasive diagnosis of HCC as per the American Association for the Study of Liver Diseases (AASLD) If available, archival tissue must be submitted Mixed HCC-cholangiocarcinoma is not allowed Patient has Barcelona Clinic Liver Cancer (BCLC) stage C disease, or BCLC stage B disease that is not amenable to locoregional therapy or refractory to locoregional therapy, and not amenable to curative treatment Previous locoregional therapy is allowed (e.g. surgical resection, external beam radiation, catheter-based therapy), and patients must have evidence of disease progression from locoregional therapy Must have measurable disease by v1.1 Lesions that were previously radiated or ablated cannot be target lesions unless there was subsequent radiographic progression at those sites No prior systemic therapy for HCC. Prior chemotherapy given locally into the liver (e.g. transarterial chemoembolization [TACE]) is allowed Must have Child-Pugh class A hepatic function within 7 days prior to first dose of study intervention Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Prior treatment with any systemic therapy for HCC, including anti-VEGF therapy or any systemic investigational agent If the patient previously received systemic treatment for reasons other than HCC: small molecule kinase inhibitors are not allowed within 2 weeks and cytotoxic/biologic agents are not allowed within 4 weeks of study treatment Prior exposure to immune checkpoint inhibitors or other immunotherapeutic agents Currently participating in or has participated in a study of an investigational agent or device within 4 weeks prior to the first dose of study treatment Major surgery within 6 weeks or minor surgery (e.g. dental extraction) within 10 days prior to first dose of study treatment Complete wound healing from major surgery must have occurred at least 1 month before first dose and from minor surgery (e.g. simple excision, tooth extraction) at least 7 days before first dose. Subjects with clinically relevant ongoing complications from prior surgery are not eligible Local liver-directed therapy within 4 weeks of initiating study treatment Palliative radiation for the purpose of symptomatic relief to non-liver and non-central nervous system (CNS) disease within 2 weeks of starting treatment. Other radiation treatments within 4 weeks of starting treatment Patients must have recovered from all radiation-related toxicities, not require corticosteroids, and have not had radiation pneumonitis Prior liver or other allogenic tissue/organ transplantation
|
0
|
A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
|
eligible ages (years): 18.0-999.0, COVID Pneumonia, Viral aged over 18 years old hospitalized for a COVID-19 pneumonia documented by PCR or lung tomodensitometry admitted outside an intensive care unit, in a medicine ward patient opposed to data collected, or who could not consent because of a serious presentation of the pneumonia
|
0
|
A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
|
eligible ages (years): 18.0-999.0, Immune-Mediated Hepatitis Both patient groups and control group: • Able to give written informed consent OR Potential participants who have developed encephalopathy related to ChILI as a response to checkpoint inhibitor therapy, who lack the capacity to give written informed consent and have a consultee (personal or nominated) - for ChILI patient group only ChILI group: Patients who developed checkpoint inhibitor-induced liver injury and meet the following 1. Meets one of the following analytical thresholds at enrolment (visit 1) Alanine transaminase (ALT) exceeding 5 times the upper limit of normal (ULN) OR ALT exceeding 3 times ULN plus bilirubin exceeding 2 times ULN OR Alkaline phosphatase (ALP) exceeding 2 times ULN with accompanying elevations of gamma-glutamyl transferase in the absence of known bone metastases driving the rise in ALP level 2. Absence of other known causes of liver injury after detailed investigations Patients who developed ChILI but did not meet the above at enrolment or who were found to have a different cause for their liver injury after further investigations will be excluded from the analysis Control group: Consecutive patients with cancer who have a clinical indication to start checkpoint inhibitors. A small proportion of patients will develop ChILI following their checkpoint inhibitor treatment and will be classified as cases Patients who are treated with cytotoxic chemotherapy concurrently with checkpoint inhibitors On the judgment of chief investigator that the person has certain alternative explanations to the acute event (rather than ChILI)
|
0
|
A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
|
eligible ages (years): 18.0-999.0, COVID-19 Group with hydroxychloroquine treatment (HC +) LED/SG diagnosed Treatment with Hydroxy-Chloroquine in the 3 months before and during the outbreak at COVID 19, at least in December 2019. Patients may have treatment with Azathioprine or Methotrexate in combination with Hydroxy-Chloroquine COVID19 diagnostic questionnaire and available serology result. Group without hydroxychloroquine treatment (HC-) No Hydroxy-Chloroquine intake for more than 12 months --> HC without an immunosuppressant Viral hepatitis C cured for more than 12 months or primitive bile cholangitis (CBP) whose diagnosis is based on international criteria Non-significant liver fibrosis assessed either by historical histology or by fibroscan with non-significant liver fibrosis Metavir F3 (at last available examination) No Hydroxy-Chloroquine, Azathioprine or Methotrexate or other immunosuppressants have been taken for more than 12 months Anti-CD20 or Cyclophosphamide taken during the six months prior to the completion of the COVID 19 serology Refusal of a blood test for antibodies to COVID-19 Protected adults Pregnant or breastfeeding women Lack of health insurance coverage
|
0
|
A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
|
eligible ages (years): 55.0-999.0, Chronic Subdural Hematoma Must be 55 years of age or greater Have a clinically symptomatic chronic subdural hematoma greater than 1 cm in maximal thickness and be judged clinically to need subdural evacuation Failure to obtain consent Vulnerable study population Any need for chronic anticoagulation Pregnancy (verified by pregnancy testing at screening or medical history of a hysterectomy, oophorectomy, or post-menopausal).Prior surgery for subdural hematoma Glasgow Coma Scale (GCS) less than 8
|
0
|
A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
|
eligible ages (years): 0.0-999.0, Hepatitis C General Practitioners (GP) who have requested a hepatitis C test that leads to new or repeat notification to the Tasmanian Department of Health Not based in Tasmania Practitioner from correctional service Specialist Nurse practitioner who initiated test Sexual health service doctor Family planning Trainee
|
0
|
A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
|
eligible ages (years): 18.0-99.0, Liver Diseases Humans Progression Carcinogenesis Fatty Liver Disease Hepatitis C Hepatitis B Hepatocellular Carcinoma Liver Cirrhoses Treatment Outcome Individuals who visited the gastroenterology clinics of the Tzu Chi Hospitals, Buddhist Tzu Chi Medical Foundation Age younger than 18 or older than 99 years
|
0
|
A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
|
eligible ages (years): 18.0-999.0, COVID-19 All cases positive for COVID-19 Male and non-pregnant female patients years of age or older All moderate and severe caseswith pneuomnia Known allergy or hypersensitivity to the used medications Known severe liver disease Use of medications that are contraindicated with the trial medications and that could not be replaced or stopped during the trial period Pregnancy or breast-feeding or known active HCV infection, because of concerns about the development of resistance History of bone marrow transplant Known G6PD deficiency Chronic hemodialysis or Glomerular Filtration Rate < 20ml/min Psoriasis Porphyria Concomitant use of digitalis, flecainide, amiodarone, procainamide, or propafenone
|
0
|
A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
|
eligible ages (years): 18.0-70.0, Hepatocellular Carcinoma Hepatoma Liver Cell Carcinoma Hepatitis C Hepatitis C diagnosed as the HCV RNA (≥ 10,000 IU/mL in peripheral blood) at the time of screening Genotype inclusions Have documented chronic HCV GT1 or GT4, (with no evidence of nontypeable or mixed genotype) infection HCC diagnosed on the basis of histology or according to AASLD radiological Written informed consent granted prior to initiation of any study-specific screening procedures Patients aged 18 to 70 years-old Child-Pugh ≤≤ A6 BCLC stage 0, A HCC or no detectable HCC in a patient who has undergone a curative form of treatment (liver transplantation, surgical resection of local ablative therapy with curative intent) OR BCLC-B disease but clinically stable with non-evidence of disease progression as demonstrated by either Triphasic CT or contrast MRI at least 3 months after the last HCC treatment Enrolment in other investigation / experimental therapies Prior or current use of Sorafenib or other systemic chemotherapy Life expectancy < 12 months (unless transplantation eligible) Unable to provide informed consent Previous or concurrent cancer that is distinct from HCC in primary site or histology, cervical carcinoma in situ, treated basal cell carcinoma, and superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 3 years prior to enrollment is permitted Any condition that in the opinion of the investigator would impair participation in the trial Coinfected with human immunodeficiency virus (HIV) infection or Hepatitis B virus (e.g. HBsAg positive) History of congestive heart failure defined as Class II to IV per New York Heart Association (NYHA) classification within 6 months prior to study entry; active coronary artery disease (CAD); clinically significant bradycardia or other uncontrolled, cardiac arrhythmia defined as ≥ Grade 3 according to National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE), version 4.03, or uncontrolled hypertension; myocardial infarction occurring within 6 months prior to study entry (myocardial infarction occurring > 6 months prior to study entry is permitted) Active clinically serious infections defined as ≥ Grade 3 according to NCI CTCAE, version 4.03 6. Any medical, psychological, or social conditions, particularly if unstable, including substance abuse, that may, in the opinion of the Investigator, interfere with the subject's safety or participation in the study, protocol compliance, or evaluation of the study results Concomitant interferon therapy or therapies for active Hepatitis C Virus (HCV) infection. Prior interferon and/or ribavirin therapy is not a contraindication to enrolment however previous treatment with direct acting antiviral treatment is an
|
1
|
A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
|
eligible ages (years): 0.0-999.0, Pneumonia, Viral Covid19 ARDS Oxidative Stress Patients admitted to the UTC in the Temporary COVID-19 Citibanamex Center with suspected or diagnosed severe pneumonia due to SARS-COV2 with or without septic shock Patients who accept and sign informed consent. If the patient is clinically unable to authorize, acceptance by a first-degree relative will be requested Diagnosis of septic shock in the last 24 hours characterized by refractory hypotension and vasopressor requirement despite adequate fluid resuscitation (20 mL/kg of colloids or 40 mL/kg of crystalloids) to maintain a blood pressure ≥ 65 mmHg with lactate> two mmol / L Patients with an advance directive format Chronic use of steroids in the past six months or recent Use of statins before admission Patients who are under some antioxidant treatment Any contraindication for the use of Vit C, Vit E, NAC, and melatonin Pregnant women
|
0
|
A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
|
eligible ages (years): 12.0-999.0, Hepatitis C Virus (HCV) Direct-acting antiviral treatment-experienced participants with confirmed chronic hepatitis C (CHC) genotype 1, receiving combination therapy with the all oral glecaprevir/pibrentasvir (GLE/PIB) regimens according to standard of care, international guidelines and in line with the current local label Participants can enroll up to 4 weeks after starting treatment Participating or intending to participate in a concurrent interventional therapeutic trial
|
1
|
A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
|
eligible ages (years): 15.0-999.0, Hepatitis C Cross-sectional assessment of prevalence Patients with all the following characteristics can be included Patient admitted to one of the inpatient or outpatient adult psychiatric units of the hospitals participating in the study Patient accepting the realization of the HCV RDT (or patient with positive HCV serology performed less than 3 month ago) 2. Cohort follow-up of HCV positive patients: Patients who are included in the cross-sectional assessment of prevalence of the SaPHIR study and having a positive HCV RDT (or positive HCV serology performed less than 3 months ago) will participate in the follow-up of the study Cross-sectional assessment of prevalence: Patients with at least one of the following characteristics cannot be included Minors under 15 years of age (all units involved in the recruitment are adult psychiatry units, for which the minimum age limit is 15 years and 3 months) Pregnant or lactating woman Participating simultaneously in another interventional research on a drug (so as not to interfere with the biological assays) Not mastering the reading and writing of the French language well enough Patient placed under judicial protection 2. Cohort follow-up of HCV positive patients Patients who are included in the cross-sectional assessment of prevalence of the SaPHIR study, with negative RDT HCV (or negative HCV serology performed less than 3 months ago) cannot participate in the follow-up of the study
|
0
|
A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
|
eligible ages (years): 18.0-80.0, Hepatitis C Chronic HCV infection, positive HCV RNA 2. Aged 18 to 80 3. Willingness and capacity to provide informed consent, or consent is provided by a substitute decision maker Presence of or history of decompensated cirrhosis (evidence of decompensation with history of either ascites, variceal hemorrhage, or hepatic encephalopathy) 2. Platelets < 75,000/mm3, total albumin <35 g/L, total bilirubin >34 μmol/L, INR >1.5 3. History of current or past hepatocellular carcinoma. 4. HBV (HBsAg +ve) co-infection or untreated HIV co-infection 5. Prior HCV antiviral therapy with DAA with or without peginterferon/ribavirin 6. Chronic liver disease other than mild nonalcoholic or alcoholic fatty liver disease from a cause other than HCV 7. Pregnancy/breastfeeding/inability to use contraception 8. Use of concomitant contraindicated medications
|
0
|
A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
|
eligible ages (years): 18.0-999.0, Gram Negative Infections more than or equal to 18 years of age 2. Admitted to hospital with documented gram negative infection 3. Has received treatment for atleast 48 hours (complete) with Ceftazidime-Avibactam as a part of his routine clinical management The patient is enrolled in any clinical trial of an investigational product 2. Age <18 years 3. Received Ceftazidime avibactam for less than 48 hours. 4. Patient with documented Acinetobacter infection. 5. Patient was a part of named access program or any other interventional study
|
0
|
A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
|
eligible ages (years): 18.0-999.0, Chronic Pain Have a complex, prolonged axial neck pain or lower back pain Have been followed by a pain management specialist for at least 3 months or have a history of chronic pain for at least 3 months as recorded by physician Be >18 years of age Have a goal and motivation that is adequate in relation to the program offered Be medically prepared Have no major change in interventional treatment or be a surgical candidate Own a smart phone, tablet or computer or have the knowledge to use one Chronic pain requiring imminent surgical intervention Reported severe or acute psychiatric illness, severe anxiety or depression Current history of substance abuse Serious health risks or scheduled major health interventions for other medical reasons Pain related to malignancy Pain duration <3 months Other areas of pain exceeding the amount of back or neck pain Not currently involved in lawsuit or pending litigation
|
0
|
A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
|
eligible ages (years): 18.0-999.0, HCV adult patients (≥18 years old) with chronic HCV infection that were HCV RNA positive have received DAA treatment would like to adhere to the follow-up lack of HCV treatment information
|
2
|
A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
|
eligible ages (years): 18.0-999.0, Safety Issues Written informed consent 2. Male or Female patient 3. Age of patient ≥18 years 4. Patients already diagnosed with HCV and on DAAs therapy Written informed consent 2. Male or Female patient 3. Age of patient ≥18 years 4. Patients already diagnosed with HCV and on DAAs therapy
|
2
|
A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
|
eligible ages (years): 18.0-75.0, Hepatocellular Carcinoma The diagnosis of HCC was based on the diagnostic for HCC used by the European Association for the Study of the Liver (EASL) Seropositive for hepatitis B surface antigen (HBsAg) Received concurrent antiviral prophylaxis and at least one cycle of PD-1 inhibitor treatment. Prior use of antiviral therapy was allowed Adherence to antiviral therapy A life expectancy of 3 months or more An Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2 other positive viral markers, including IgM antibodies to hepatitis A virus, the hepatitis C virus viral load, IgG antibodies to hepatitis D virus, IgM antibodies to hepatitis E virus Antibodies to human immunodeficiency virus A lack of HBV DNA and liver function testing before the first immunotherapy and during the follow-up period
|
0
|
A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
|
eligible ages (years): 18.0-999.0, Inguinal Hernia Adult patients Underwent uni-or bilateral groin hernia repair in the period March 2015 March 2020 Groin hernia repair via robotic assisted laparoscopy or open surgery History of abdominal prostatectomy before the groin hernia repair Age below 18 Groin hernia repair via conventional laparoscopy Groin hernia repair via open surgery other than Liechtenstein method Groin hernia repair without mesh placement
|
0
|
A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
|
eligible ages (years): 20.0-999.0, Hepatitis C Virus Infection Hepatitis C Virus Infection, Response to Therapy of Human Immunodeficiency Virus (HIV) Coinfection Age old than 20 years old Patients with human immunodeficiency virus coinfection (HIV) during IFN-based or IFN-free antiviral therapy for hepatitis C virus (HCV) infection Patients achieving SVR, defined as undetectable serum HCV RNA at week 12 off-therapy Poor access to sites for venipuncture
|
0
|
A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
|
eligible ages (years): 18.0-999.0, Chronic Liver Disease Subjects with chronic liver disease (CLD) at the Humanity and Health Medical Group and eligible for the HK government vaccination programme; 2. Able to understand and sign informed consent.; 3. Underlying CLD defined as patients with chronic hepatitis B or C infections, liver cirrhosis, metabolic associated liver disease, hepatocellular carcinoma, alcoholic liver disease, autoimmune hepatitis, hemochrombtosis Patients contraindicated for the COVID -19 Vaccination Program due to uncontrolled co-morbitities; 2. Past allergies to other vaccines; 3. Pregnant subjects
|
0
|
A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
|
eligible ages (years): 18.0-999.0, Rheumatoid Arthritis Psoriatic Arthritis Spondyloarthritis Crohn Disease Ulcerative Colitis Autoimmune Hepatitis Liver Transplant; Complications An established clinical diagnosis of one of the following immune-mediated diseases: rheumatoid arthritis (RA), spondyloarthritis (SpA), psoriatic arthritis (PsA), ulcerative colitis (UC,) Crohns disease (CD), autoimmune hepatitis (AIH) or patients who have undergone a liver transplantation 2. Treatment with relevant immunosuppressive and/or immunomodulating medication * 3. Adult patients (> 18 years) 4. Patient intends to obtain vaccination against COVID-19 during the next 6 months * The following drugs are considered relevant immunosuppressants and/or immunomodulators and patients using them may be eligible for this study: Rituximab, infliximab, adalimumab, golimumab, certolizumab, etanercept, tocilizumab, abatacept, secukinumab, vedolizumab, ustekinumab, risankizumab, methotrexate, sulfasalazine, leflunomide, azathioprine, 6-mercaptopurine, tofacitinib, filgotinib, baricitinib, upadacitinib, tacrolimus, mycophenolate, prednisolone Allergy or intolerance to elements of the COVID-19 vaccines -
|
0
|
A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
|
eligible ages (years): 18.0-999.0, Hepatitis, Drug-Induced Histologically confirmed solid cancer Treatment with cytotoxic T-lymphocyte-associated protein-4 (CTLA-4) or Programmed Cell Death-1 (PD-1)/Programmed Cell Death Ligand-1 (PD-L1) inhibitor or a combination of CTLA-4 plus PD-1 inhibitors within 6 months Abnormal liver parameters equal to ≥ grade 3 ir-hepatitis defined as; AST/ALT >5 x upper level of normal (ULN), International Normalised Ratio (INR) ≥ 2.5 x ULN, or bilirubin > 3.0 x ULN Age: ≥ 18 years Women of childbearing potential: Negative serum pregnancy test and must use effective contraception. This applies from screening and until 6 months after treatment. Birth control pills, spiral, depot injection with gestagen, subdermal implantation, hormonal vaginal ring and transdermal depot patch are all considered effective contraceptives Men with female partner of childbearing potential must use effective contraception from screening and until 6 months after treatment. Effective contraceptives are as described above for the female partner. In addition, documented vasectomy and sterility or double barrier contraception are considered effective contraceptives Signed statement of consent after receiving oral and written study information Willingness to participate in the planned treatment and follow-up and capable of handling toxicities Concomitant chemotherapy treatment or tyrosine kinases or angiogenesis inhibitors Concomitant immunosuppressive medication except prednisolone Patients with hepatocellular carcinoma Known hypersensitivity to one of the active drugs or excipients Uncontrolled infection Acute viral hepatitis Any medical condition that will interfere with patient compliance or safety Simultaneous treatment with other experimental drugs or other anticancer drugs Pregnant or breastfeeding females Phenylketonuria
|
0
|
A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
|
eligible ages (years): 18.0-65.0, Hepatitis B, Chronic Male or female ages 18 <66 years Chronic HBV infection for >/= 6 months On NRTI therapy for >/= 2 months at the time of screening Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation Significant fibrosis or cirrhosis History or evidence of drug or alcohol abuse History of chronic liver disease from any cause other than chronic HBV infection History of hepatic decompensation History of anaphylaxis History of allergic reactions to monoclonal antibodies or antibody fragments History of immune complex disease Active infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis Delta virus (HDV)
|
0
|
A 53-year-old man presents with chronic HCV infection for the past 2 years. His past medical history is only significant for inguinal hernia surgery when he was 20 years old. He is on IFN (100 mg/week) plus RBV (400 mg/day) combination therapy for the past 9 months. Direct antiviral drugs were added to his treatment 6 months ago. His medical record shows previous positive HCV RNA tests as well as positive enzyme immunoassay for anti-HCV-antibodies. The recent biopsy was negative for hepatocellular carcinoma and was only remarkable for chronic inflammation compatible with a chronic viral hepatitis. There is no evidence of alcoholic liver disease, bleeding from esophageal varices, hemochromatosis, autoimmune hepatitis or metabolic liver disease. He is an alert male with no acute distress. His BP: 130/75, HR: 90/min and BMI: 27. His abdomen is soft with no ascites or tenderness. The lower extremities are normal with no edema.
|
eligible ages (years): 21.0-70.0, NAFLD Male and female subjects with age ≥ 21 years old and < 70 years old. 2. BMI ≥ 30 kg/m2 and ≤ 50 kg/m2 3. Abnormal sex-specific ALT (female ≥ 32 U/L; male ≥ 41 U/L), but less than 100 U/L within the last 3 months 4. Negative tests for viral hepatitis C (hepatitis C antibody) and autoimmune hepatitis (anti-smooth muscle antibody) 5. Elastography result positive for fibrosis grade F2 through F4 (that is, LSM between 8 and 124 kPa) and/or steatosis grade S1 through S3 (that is, CAP ≥ 248 dB/m) within the last 3 months Type 1 diabetes mellitus 2. Subjects with type 2 diabetes mellitus who use insulin 3. Heart failure NYHA stage 3 or 4 4. Myocardial infarction within last 6 months 5. Unstable angina 6. Chronic kidney disease with eGFR ≤ 30 mL/min/1.73 m² 7. Chronic obstructive pulmonary disease requiring O2 supplementation 8. Coexisting liver disease or end-stage liver disease 9. Severe or uncontrolled mental health disease 10. Gout 11. History of uric acid nephrolithiasis 12. Porphyria 13. Conception attempts, confirmed pregnancy or breast feeding 14. Past or active cholecystitis without cholecystectomy 15. Uncontrolled hyperthyroidism 16. Uncontrolled hypothyroidism with TSH ≥ 10 mcIU/mL 17. Excessive alcohol consumption (that is, an AUDIT-C score ≥ 4 for men and ≥ 3 for women) 18. Use of medicines for weight loss within last 3 months 19. Use of warfarin, lithium, chronic use of prednisone (20mg or more daily)
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 35.0-60.0, Lung Diseases Lung Diseases, Obstructive Chronic Obstructive Pulmonary Disease Men and women who were cigarette smokers and between the ages of 35 and 60
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-999.0, Chronic Obstructive Lung Disease Age greater than or equal to 40 years 2. Cigarette smoking greater than or equal to 30 pack years 3. Obstructive Spirometry 4. First degree relative with smoking history willing to participate
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 0.0-75.0, Emphysema Post-bronchodilator FEV I < 40% and > 15% of predicted 2. TLC > 120% of predicted* 3. Carbon monoxide diffusing capacity by the single breath technique (DLCOSB) < 50% of predicted 4. PaCO2 < 55 mmHg 5. Age 75 years or younger TLC will be determined by body plethysmography using slow inspiratory effort to determine thoracic gas lume because of the overestimation of lung volumes by high frequency panting in patients with COPD
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 50.0-999.0, Pulmonary Disease, Chronic Obstructive Bronchitis, Chronic > 50 years old > 20 pack-year of smoking Diagnosed with COPD and chronic bronchitis Patients with bronchiectasis, cystic fibrosis, tuberculosis, asthma, alpha-1 antitrypsin deficiency, CHF Require oxygen therapy Uncontrolled hypertension HIV or Hepatitis Recent history of COPD exacerbation Patients with cancer Recent history of infection
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 50.0-999.0, Benign Prostatic Hyperplasia Participants must be men, aged 50 years or older with moderate-to-severe BPH Participants must not have a history of prostate cancer, prior surgery on the prostate, kidney failure, or taking furosemide (Lasix), warfarin (Coumadin), or hormone medications. Individuals taking medicine for their BPH must stop them for one month (prazosin, terazosin (Hytrin), doxazosin (Cardura), tamsulosin (Flomax)) or six months (saw palmetto, finasteride (Proscar or Rogaine)) prior to entering the study
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive Patients with chronic obstructive pulmonary disease
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 45.0-80.0, Prostatic Hyperplasia Have an enlarged prostate by DRE (digital rectal examination) Have a diagnosis of BPH Have documented symptoms (frequency; urgency; nighttime urination; reduced flow) Have a documented urinary flow rate as required
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Pulmonary Emphysema Chronic Bronchitis Able to commit to a 12-week yoga class in San Francisco, California Moderate to severe COPD, clinically stable for at least 1 month prior to study entry Forced Expiratory Volume at one minute (FEV1) < 49% predicted after inhaled bronchodilator Activities of daily living limited by shortness of breath Ability to speak English and sign consent Patients receiving supplemental oxygen will be acceptable if their O2 saturation can be maintained at > 85% on < 6 L/min of nasal oxygen Symptomatic illness (e.g., cancer, left heart failure, ischemic heart disease, neuromuscular disease, psychiatric illness) Formal pulmonary rehabilitation training within 1 year prior to study entry
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-85.0, Ischemic Stroke Diagnosis of acute ischemic stroke with planned start of intravenous tPA. Acute ischemic stroke is defined as a measurable neurological deficit of sudden onset, presumed secondary to focal cerebral ischemia. Stroke onset will be defined as the time the patient was last known to be without the new clinical deficit. If the stroke started during sleep, stroke onset will be recorded as the time the patient was last known to be at baseline. 2. Disabling neurological deficit attributable to acute ischemic stroke. 3. NIHSS less than or equal to 21 for left hemisphere strokes, NIHSS less than or equal to 16 for others. 4. Age 18-85 years, inclusive. 5. Body weight greater than 50 kg. For MRI Arm only: 6. Screening MRI diagnostic of focal cerebral ischemia corresponding to the clinical deficits. The MRI evaluation must involve echo planar diffusion weighted imaging, magnetic resonance angiography(MRA),and MRI perfusion. A normal appearing MRA with an appropriate perfusion deficit is eligible. An apparent stenosis or occlusion on MRA with normal appearing perfusion distally will not be eligible. Poor quality or uninterpretable MRA will not make patient ineligible. Patients who have a normal appearing diffusion weighted image (DWI) are eligible. 7. Evidence on perfusion weighted image (PWI) MRI or a perfusion defect corresponding to the acute stroke syndrome. The PWI will be assessed by relative mean transit time (MTT) images obtained prior to the start of tPA therapy Current participation in another study with an investigational drug or device within, prior participation in the present study, or planned participation in another therapeutic trial, prior to the final (day 30) assessment in this trial. 2. Symptoms suggestive of subarachnoid hemorrhage, even if CT or MRI scan is negative for hemorrhage. 3. Evidence of acute myocardial infarction defined as having at least two of the following three features: 1) Chest pain suggestive of cardiac ischemia; 2) EKG findings of ST elevation of more greater than 0.2 millivolts (mV) in 2 contiguous leads, new onset left bundle branch block, ST segment depression, or T-wave inversion; 3) Elevated troponin I. 4. Acute Pericarditis. 5. Women known to be pregnant, lactating or having a positive or indeterminate pregnancy test. 6. Patients who would refuse blood transfusions if medically indicated. 7. Neurological deficit that has led to stupor or coma (NIHSS level of consciousness [item I a] score greater than or equal to 2). 8. High clinical suspicion of septic embolus. 9. Minor stroke with non-disabling deficit or rapidly improving neurological symptoms. 10. Baseline NIHSS greater than 21 for left hemisphere stroke or greater than 16 for others. 11. Evidence of acute or chronic ICH by head CT or MRI. 12. CT or MRI evidence of non-vascular cause for the neurological symptoms. 13. Signs of mass effect causing shift of midline structures on CT or MRI. 14. Persistent hypertension with systolic BP greater than 185 mmHg or diastolic BP greater than 110 mmHg (mean of 3 consecutive arm cuff readings over 20-30 minutes), not controlled by antihypertensive therapy or requiring nitroprusside for control. 15. Anticipated need for major surgery within 72 hours after start of study drugs, such as a carotid endarterectomy or hip fracture repair. 16. Any intracranial surgery, intraspinal surgery, or serious head trauma (any head injury that required hospitalization) within the past 3 months. 17. Stroke within the past 3 months. 18. History of ICH at any time in the past. 19. Major trauma at the time of stroke, such as a hip fracture. 20. Blood glucose greater than 200 milligrams per diluent (mg/dl). 21. Presence or history of intracranial neoplasm (except small meningiomas) or arteriovenous malformation. 22. Intracranial aneurysm, unless surgically or endovascularly treated more than 3 months before. 23. Seizure at the onset of stroke. 24. Active internal bleeding. 25. Major hemorrhage (requiring transfusion, surgery or hospitalization) in the past 21 days. 26. Major surgery, serious trauma, lumbar puncture, arterial puncture at a non-compressible site, or biopsy of a parenchymal organ in last 14 days. Major surgical procedures but are not limited to the following: major thoracic or abdominopelvic surgery, neurosurgery, major limb surgery, carotid endarterectomy or other vascular surgery, and organ transplantation. For non-listed procedures, the operating surgeon should be consulted to assess the risk. 27. Presumed or documented history of vasculitis. 28. Known systemic bleeding or platelet disorder, e.g., von Willebrand's disease, hemophilia, idiopathic thrombocytopenia purpura (ITP),thrombotic thrombocytopenic purpura (TTP), others. 29. History of heparin induced thrombocytopenia. 30. Platelet count less than 100,000 cells/microliter. 31. Congenital or acquired coagulopathy (e.g. , secondary to anticoagulants) causing either of the following: 1. Activated partial thromboplastin time (aPTT) prolongation greater than 2 seconds above the upper limit of normal for local laboratory, except if due to isolated factor twelve (XII) deficiency. 2. International normalized ratio (INR) greater than or equal to 1.4. Patients receiving warfarin prior to entry are eligible provided INR is less than 1.4 and warfarin can be safely discontinued for at least 48 hours. 32. Life expectancy less than 3 months. 33. Other serious illness, e.g., severe hepatic, cardiac, or renal failure; acute myocardial infarction; or complex disease that may confound treatment assessment. 34. Severe renal failure: Serum creatinine greater than 4.0 mg/dL or dependency on renal dialysis. 35. Aspartate aminotransferase (AST) or Alanine transaminase(ALT) greater than 3 times the upper limit of normal for the local laboratory. 36. Treatment of the qualifying stroke with any thrombolytic, anti-thrombotic or glycoprotein inhibitor(GPIIbIIIa)outside of this protocol. 37. Any administration of a thrombolytic drug in the prior 7 days. 38. Treatment of the qualifying stroke with intravenous heparin unless aPTT prolongation is no greater than 2 seconds above the upper limit of normal for local laboratory prior to study drug initiation. 39. Treatment of the qualifying stroke with a low molecular weight heparin or heparinoid. 40. Known hypersensitivity to alteplase, aspirin, tinzaparin, eptifibatide, heparin, sulfites, benzyl alcohol, or pork products. 41. Anticoagulation (evidenced by abnormal INR, aPTT, or platelet count) caused by herbal therapy. 42. Known history of alcohol or illicit drug use (e.g. prior to study drug administration) FOR non-MRI arm only (items 43-44): 43. Ischemic changes on screening CT of greater than approximately one third of the territory of the middle cerebral artery territory by qualitative assessment. 44. Patients who were excluded by screening MRI, except for exclusions item 45 (contraindication to MRI) and item 46 (PWI was not obtained or is uninterpretable) and item 51 (MRI not obtainable because it would have put the patient out of the 3 hour time window for tPA). FOR MRI arm only (items 45-51): 45. Contraindication to MRI scan. 46. PWI not obtained or uninterpretable. 47. No MTT defect corresponding to acute stroke deficit. 48. Satellite DWI hyperintensity with corresponding hyperintensity on T2 weighted image or FLAIR in a vascular territory different than the index stroke 49. DWI abnormality larger than approximately one third of the territory of the middle cerebral artery territory by qualitative assessment. 50. Evidence of multiple microbleeds on gradient echo MRI (GRE). 51. Patient has a contraindication to gadolinium contrast agent: prior adverse reaction to gadolinium or estimated glomerular filtration rate(GFR) less than 60 milliliters per minute (mL/min)
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-999.0, Chronic Obstructive Pulmonary Disease COPD Main Clinical diagnosis of COPD (Chronic Obstructive Pulmonary Disease) Currently stable COPD with no change in COPD treatment in the prior 4 weeks Main Clinical diagnosis of asthma Poorly controlled COPD Regular need for daily oxygen therapy
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 0.0-999.0, Granulomatous Disease Chronic The recipient fulfills by study design the The patient however, would be considered ineligible for the study only If his donor is unable to participate. DONOR Pregnant or lactating Donor unfit to receive G-CSF and undergo apheresis. (Uncontrolled hypertension, history of congestive heart failure or unstable angina, thrombocytopenia) HIV positive
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-99.0, Secondary Pulmonary Arterial Hypertension Pilot: The pilot study will enroll two groups of individuals: 1) patients who have either IPAH or a secondary form known to have similar histopathology (PAH), and 2) age, gender, and race matched control subjects for each patient. Main: The main study will enroll three groups of individuals: 1) patients who have either IPAH or a secondary form known to have similar histopathology (PAH), 2) patients with PH ascribed to a nonvascular injury process, and 3) age, gender, and race matched control subjects for each PAH patient. Subjects must be at least 18 years of age and must be able to provide informed, written consent for participation in this study. There is no based on race or gender. FOR The for this study are as follows: 1. Patients diagnosed with IPAH 2. Patients diagnosed with secondary pulmonary hypertension known to have histopathology similar to the primary form or PAH. Clinical conditions causing pulmonary hypertension with histopathology similar to the primary form are listed below. i. Eisenmenger Syndrome ii. Collagen vascular disease iii. Liver disease with portal hypertension iv. Toxin induced injury (anorexic agents, rapeseed oil) v. HIV disease vi. Sickle cell disease FOR WITH 1. Pregnant women (all women of childbearing age will be required to have a screening urine or blood pregnancy test) 2. Age less than 18 years 3. Inability to provide informed written consent for participation in the study 4. Mean PA less than or equal to 25mmHg or PVR less than 3 wood units 5. PCW greater than 16 mmHg unless increase accounted for by increased transpulmonary gradient greater than or equal to 10 mmHg 6. Patients receiving more than 1 year of oral therapy or more than 6 months of IV therapy. FOR WITH The are as follows: Patients diagnosed with pulmonary hypertension not known to have histopathology similar to the primary form. Etiologies are listed below. 1. Congenital or acquired valvular or myocardial disease 2. Pulmonary parasitic diseases 3. Arterial hypoxemia with hypercapnea 4. COPD with hypoxemia and forced expiratory volume/forced vital capacity (FEV1/FVC) greater than 2 standard deviations from normal 5. Interstitial lung disease with reduced total lung capacity greater than 2 standard deviations from normal and infiltrates on chest x-ray 6. Pulmonary thromboembolic disease as evidenced by lung perfusion scan or pulmonary angiogram, or intravenous drug abuse 7. Pulmonary hypertension due to congenital abnormalities of the lungs, thorax and diaphragm FOR WITH 1. Pregnant women (all women of childbearing age will be required to have a screening urine or blood pregnancy test) 2. Age less than 18 years 3. Inability to provide informed written consent for participation in the study 4. Mean PA less than or equal to 25mmHg or PVR less than 3 wood units FOR MRI IN WITH 1) Implanted cardiac pacemaker or defibrillator 2) Central nervous system aneurysm clips 3) Cochlear implants 4) Neural stimulator 5) Ocular foreign body (e.g. metal shavings) 6) Insulin pump 7) Metal shrapnel or bullets 8) Claustrophobia. Furthermore, the following patient groups will be excluded from studies involving the administration of MRI contrast agents: 1) lactating women 2) renal disease (CrCl less than 20 ml/min) The creatinine clearance (CrCl) will be calculated using the Cockroft formula where age is in years, kg is weight in kilograms, and Cr is the serum creatinine. If there is no history of kidney disease from the patient or referring physician, additional testing will not be performed. If a patient has a history of renal insufficiency, a recent blood Cr will be used unless the physician performing the test believes the Cr may have changed since the last test. If the Cr may have changed, a blood sample will be obtained for Cr or the subject will be excluded from receiving gadolinium. CrCl = (140-age) (wt in kg)/72 X serum Cr (mg/dl) for men CrCl = (0.85) (140-age) (kg)/72 X serum Cr (mg/dl) for women FOR 1. Any healthy man or woman who is the appropriate age, race, and gender for matching to a PAH patient 2. No history of HIV infection 3. EKG and echocardiogram with no evidence of clinically relevant heart disease 4. Spirometry with no evidence of clinically relevant lung disease 5. No history of causes of pulmonary hypertension such as collagen vascular disease, chronic liver disease with ALT or AST greater than 2 times the upper limit of normal or cirrhosis of the liver, chronic thromboembolic disease, congenital heart defects, or pulmonary parenchymal disease with hypoxemia 6. No history of diseases thought to be related to development of endothelial dysfunction including systemic hypertension or diabetes requiring drug therapy, hypercholesterolemia and obesity 7. No history of anemia, thrombocytopenia or coagulopathy 8. No history of renal insufficiency 9. No medical conditions requiring chronic medication use with the exception of: a. Heartburn, GERD b. Environmental allergies, post nasal drip or non-allergic rhinitis c. Asthma with no history of oral steroid use, weekly inhaled steroids, or hospitalization for asthma exacerbation d. Dermatologic conditions that do not require the use of oral steroids or other immunosuppressants e. Treated and stable thyroid disease, depression, or anxiety. 10. No more than 20 cigarettes per years for the previous 2 years and no cigarette use for 30 days prior to the screening evaluation until completion of the study FOR 1. Current pregnancy, lactation or women not currently using medically acceptable birth control. (All women of childbearing age will be required to have a screening urine or blood pregnancy test) 2. Contraindication to MRI scanning including individuals with the following devices: A) Implanted cardiac pacemaker or defibrillator B) Central nervous system aneurysm clips C) Cochlear implants D) Implanted Neural stimulator E) Ocular foreign body (e.g. metal shavings) F) Insulin pump G) Metal shrapnel or bullet H) Claustophobia 3. Contraindications to MRI contrast agent administration 4. Inability to provide informed written consent for participation in the study 5. Chronic, medically refractory atrial tacharrhythmias 6. Symptoms of heart failure. 7. Mean PA greater than 25mmHG or PVR greater than 1.5 wood units, or PCWP greater than 15 mmHg 8. History of recreational drug use with the exception of marijuana. No marijuana use within 3 months of protocol screening through completion of the study. 9. Intravenous drug abuse. Volunteers may be excluded if in the opinion of the study investigators they have a condition that may adversely affect the outcome of the study or the safety of the volunteer
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease Diagnosis of COPD, clinically stable for 1 month Spirometry results showing at least mild disease (FEV1/FVC < 70% and FEV1 < 80% predicted after bronchodilator) ADL limited by dyspnea Ability to speak English and sign consent form Actively use computer and the Internet Maintain O2 saturation > 85% on < 6 L/min of nasal oxygen during the six minute walk Understands and is able to rate shortness of breath during exercise Active symptomatic illness other than COPD Formal pulmonary rehabilitation training in the past 6 months
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive Male or female of African descent years of age or older Diagnosis of COPD History of smoking at least one pack per day for at least 10 years Currently experiencing shortness of breath at least with exertion Asthma Recent myocardial infarction or hospitalization for congestive heart failure
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-90.0, Chronic Obstructive Pulmonary Disease A clinical diagnosis of COPD and meeting the American Thoracic Society's definition of COPD Age 55 years of age or older A history of 10 pack-years or more of cigarette smoking FEV1 to FVC ratio of less than 70% and a postbronchodilator FEV1 of less than 50% of predicted (at baseline and after the run-in) PaC02 of 45 mm Hg or greater measured at rest on room air (at baseline and after run-in) Coexisting medical conditions that make survival for at least 6 months unlikely Refusal to participate Cognitive impairment which makes it impossible to obtain informed consent Patient on a lung transplant list Clinical history of left ventricular heart failure Body mass index of 35 kg/m2 or greater (Obstructive) apnea-hypopnea index (AHI) of > 15 on polysomnography Evidence of Cheyne-Stokes respiration on polysomnography Impaired left ventricular ejection (LVEF of < 40% as determined on 2-D echocardiography) Patients who require rehospitalization, or an emergency visit for COPD during the run-in phase
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 45.0-80.0, Lung Diseases, Obstructive Diagnosis of COPD (history, spirometry, symptoms including chronic cough and/or shortness of breath that is worse on exertion and/or excess sputum production) Aged 45 years Have pre-bronchodilator FEV1 > 1.4 litres and at least 60% of predicted for height, age and gender and a post-bronchodilator FEV1 <80% of predicted for height, age and gender Post-bronchodilator FEV1/FVC < 70 % ≥ 10 pack years smoking history As determined by the investigator, are capable and willing to perform all of the techniques necessary to measure lung function administer the dry powder mannitol Are capable of, and have given informed consent to, participating in this study in accordance with local regulations Investigators, site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biologically or legally adopted Subjects receiving treatment with inhaled corticosteroids (including combination therapies, e.g. Seretide®, Symbicort®) or oral corticosteroids within the last 6 weeks Subjects who have had an exacerbation or a chest infection within the 2 weeks prior to the study Subjects receiving antibiotic treatment for respiratory infection Known diagnosis of asthma or allergic rhinitis Myocardial infarction in the six months prior to enrolment Cerebral vascular accident in the six months prior to enrolment Ocular surgery in the three months prior to enrolment Abdominal surgery in the three months prior to enrolment Active tuberculosis (TB)
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 45.0-999.0, Chronic Obstructive Pulmonary Disease All patients must have a clinical diagnosis of chronic obstructive pulmonary disease according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines Patients must have a cigarette smoking history of more than 10 pack-years Patients must be clinically stable and at least 4 weeks from last acute exacerbation (and return to baseline level of symptoms) Patients must have an FEV1 of less than 80% of predicted values with FEV1 to FVC ratio of less than 0.70 (post-bronchodilator values) Men or women ≥ 45 years of age
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-999.0, Heart Failure, Congestive Clinical diagnosis of heart failure Under age of 18 years Unable to give consent
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-999.0, Smoking COPD COPD patients (FEV1/FVC<70% and FEV1<90 % predicted) Smoking 1 cigarette daily or more Willing to follow the protocol Used NRT or bupropion the last week Not able or willing to adhere to the protocol Estimated survival < 1 year
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive Patients who have signed an written informed consent consistent with ICH GCP guidelines and local legislations prior to participation in the trial. 2. Patients with a diagnosis of COPD. COPD is defined as a disease state characterised by the presence of airflow obstruction often due to chronic bronchitis or emphysema; the airflow obstruction is generally progressive, may be accompanied by airway hyperreactivity, and may be partially reversible. 3. Patients 40 years of age or older without any restriction to sex. 4. Patients who currently smoke or who are ex-smokers with a cigarette smoking history of >10 pack-years. 5. Patients who have a relatively stable airway obstruction (at least 4 weeks free of COPD exacerbations) with a post bronchodilator FEV1 ? 60% of predicted normal, a post bronchodilation FEV1 < 70% of FVC, and a MRC symptom score minimum of 2 at Visit 1 Patients with a history of asthma, allergic rhinitis, atopy, or who have a total (absolute) blood eosinophil count ? 600 per mm3 (= 0.6 * 109/L) of the first determination at Visit 1 2. Patients with known moderate or severe renal insufficiency. 3. Patients with a recent history (i.e., 6 months or less prior to Visit 1) of myocardial infarction. 4. Patients with any unstable or life threatening cardiac arrhythmia, including patients with a newly diagnosed, clinically relevant arrhythmia on the electrocardiogram (ECG) performed at Visit 1 as well as patients with cardiac arrhythmia requiring an intervention (i.e., hospitalisation, cardioversion, pacemaker placement, and automatic implantable cardiac defibrillator (AICD) placement) or a change in drug therapy during the last year prior to Visit 1. 5. Patients who regularly use oxygen therapy. 6. Patients with known active tuberculosis. 7. Patients with a history of cancer within the last 5 years. Patients with treated basal cell carcinoma are allowed. 8. Patients with a history of life threatening pulmonary obstruction or a history of cystic fibrosis or clinically evident bronchiectasis. 9. Patients who have undergone thoracotomy with pulmonary resection. 10. Patients who are currently in a pulmonary rehabilitation program or who have completed a pulmonary rehabilitation program in the 6 weeks prior to the screening visit (Visit 1). 11. Patients with known hypersensitivity to anticholinergic drugs, lactose or any other components of the inhalation capsule delivery system. 12. Patients with known symptomatic hyperplasia or bladder neck obstruction. Patients being treated for prostatic hyperplasia and report minimal symptoms may be included and should continue their medications. 13. Patients with known narrow-angle glaucoma
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive Written informed consent Male or female patients 40 years of age or older Smoking history of at least 10 pack years Diagnosis of COPD with post bronchodilator FEV1 less than or equal to 70% of predicted normal and FEV1<70% of FVC and on stable respiratory medication Significant diseases other than COPD which in the opinion of the investigator may put the patient at risk or influence the patients ability to participate Myocardial infarction in past 6 months Unstable or life threatening arrhythmia in past year Hospitalization for NYHA heart failure class III or IV in past year Active tuberculosis Asthma Pulmonary resection Malignancy treated with radiation or chemotherapy in past 5 years Respiratory infection in 4 weeks prior to screening Known hypersensitivity to anticholinergic drugs or components
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 21.0-70.0, COPD Emphysema Chronic Bronchitis Healthy Non-Smoking Subjects. All normal volunteers will meet the following Age 21-70 years No history of respiratory or allergic disease Normal baseline spirometry as predicted for age, sex and height Non-smokers No history of upper respiratory tract infection in the preceding six weeks Not taking regular medication COPD Subjects. COPD is diagnosed according to American Thoracic Society, European Respiratory Society and British Thoracic Society guidelines. All COPD volunteers will meet the following Age between 40-75 years A smoking history of at least 20 pack years. (1 pack year = 20 packs of cigarettes per day for 1 year) Subjects will not be included in this study if they meet any of the following Clinically significant findings in the medical history or on physical examination other than those of COPD in the COPD group Pregnant women or mothers who are breastfeeding Subjects who are unable to give informed consent
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-999.0, Head and Neck Cancer Patients must have documented advanced, locally recurrent, or metastatic head and neck carcinoma, which is untreatable by surgical resection or radiation therapy Prior chemotherapy for advanced/metastatic disease is allowed (1 regimen only) Patients must be taxane-naïve (no prior docetaxel or paclitaxel) Patients who have received chemoradiation as a primary therapy for advanced head and neck cancer are eligible Patients must have measurable or evaluable disease. Pre-study imaging for disease assessment must be done within 28 days of registration Patients with brain metastases are eligible if they have been stable for at least six weeks post-radiation therapy Aged 18 years or older Performance status of 0-2 by Zubrod criteria Life expectancy of at least 12 weeks Hematologic: absolute neutrophil count (ANC) equal to or > 1,500/mm3; hemoglobin equal to or > 8.0 g/dl; platelets equal to or > 100,000/mm3 Patients with congestive heart failure, second or third degree heart block or recent myocardial infarction within 12 months from registration are not eligible Peripheral neuropathy equal to or greater than grade 2 Patients with a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80 Use of standard chemotherapy or investigational agents for treatment of head and neck cancer within 28 days of 1st dose of study drug Any medical or psychiatric illness which, in the opinion of the principal investigator, would compromise the patient's ability to tolerate this treatment regimen Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil Pregnant or lactating women, women of childbearing potential with either a positive pregnancy test (PPT) at baseline, or sexually active females not using a reliable contraceptive method while on study and for at least six months after chemotherapy. (Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.) Sexually active patients not using a reliable contraceptive method while on study and for at least six months after chemotherapy Patients with malabsorption syndromes will be excluded. Administration of capecitabine through feeding tubes is permitted Serious concurrent infections
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-80.0, Lung Diseases, Obstructive (COPD Smokers) Smokers currently on at least 5 cigarettes per day, with a history of >10 pack years Post-bronchodilator FEV1 >30% of predicted and < 80% of predicted Pre-bronchodilator FEV1/FVC of <70% With or without chronic simple bronchitis (COPD Smokers) History of asthma, allergy (including rhinitis/eczema) Reversibility : an increase in FEV1 that is >400ml from the baseline pre- bronchodilator value (bronchodilate with salbutamol 400g delivered from a metered dose inhaler (MDI) into a spacer). (for "Healthy" Smokers) Smokers currently on at least 5 cigarettes per day, with a history of >10 pack years FEV1 >90% of predicted, FEV1/FVC of >70% Cannot have chronic simple bronchitis Age, sex, smoking history matched to COPD Smokers (for "Healthy" Smokers) History of asthma, allergy (including rhinitis/eczema Reversibility: an increase in FEV1 that is both >400ml from the baseline pre-bronchodilator value (bronchodilate with salbutamol 400mcg delivered from a metered dose inhaler (MDI) into a spacer)P
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-85.0, Chronic Obstructive Pulmonary Disease Chronic Obstructive Pulmonary Disease Aspirin therapy Cardiac Pacemaker -
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-999.0, Critical Illness Severe Sepsis Two of four for the systemic inflammatory response syndrome; and one of the following systolic blood pressure =< 90 mm Hg; or a blood lactate concentration => 4 mmol/l; or skin marbling; or impaired consciousness; or urine output < 30 ml/h Age < 18 years Pregnancy Do-not-resuscitate status Advanced directives restricting implementation of the protocol Obesity (body mass index [BMI] > 30) Anasarca
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-80.0, Chronic Obstructive Pulmonary Disease Emphysema Chronic Bronchitis stable symptoms of COPD in the previous 3 months before study entry; forced expiratory volume in one second (FEV1) after bronchodilation with 400 mcg salbutamol that was 25 to 90% of predicted, a change of less than 20% of predicted FEV1, 30 minutes following bronchodilation, and a FEV1/forced vital capacity (FVC) of less than 75%; history of at least 10 pack-years of smoking or prolonged exposure (>10 years) to noxious gases (e.g. diesel fumes) active malignancy; unable to follow instructions; patients taking any anti-inflammatory medications
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 50.0-75.0, Osteoporosis Prostate Cancer Biopsy-confirmed early stage prostate cancer Disease localized within the capsule No evidence of regional or distant spread (i.e., T1-2, N0, M0 disease) A cohort of patients must have undergone a prior radical prostatectomy Prostate specific antigen < 12 ng/mL Gleason score ≥ 6 Creatinine clearance ≤ 2.0 mg/dL No Paget's disease No hyperthyroidism or hypothyroidism No Cushing's disease
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 21.0-70.0, Chronic Obstructive Pulmonary Disease Healthy non-smokers Normal spirometry (FEV1 >90 % predicted; exhaled NO bigger than or equal to 10 ppb; flow 50 ml/s) At risk (current smokers) Normal spirometry, with or without chronic symptoms (cough, sputum production) FEV1 reversibility of <15% after inhaled beta2-agonists* Moderate COPD FEV1 greater than or equal to 30% and < 80% FEV1/FVC < 70% predicted FEV1 reversibility of <15% after inhaled beta2-agonists With or without chronic symptoms (cough, sputum production, dyspnea) Concomitant use or pre-treatment within the last 4 weeks with oral steroids Respiratory infection within 4 weeks prior to entry into the trial Females who are pregnant or lactating History of current or past drug or alcohol abuse
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-60.0, Asthma The final diagnosis of severe asthma will be made according to the screening steps we have set up. The definition will require the presence of one or both major (treatment with continuous or near continuous oral corticosteroids and/or requirement for treatment with high dose inhaled steroids) and two minor criteria. Patients who do not fit the of severe asthma will not be entered into the study. Age 18-60; both sexes. For the investigation of fiberoptic bronchoscopy, other additional will be imposed: 1. Post-bronchodilator FEV1 greater than 40% on the day of the bronchoscopy 2. No evidence of an exacerbation of asthma within the past 4 weeks. 3. Ability to cooperate with procedures 4. Ability to give consent 5. Current smokers, and ex-smokers with greater than 10 pack years history of smoking Pregnancy or unreliable contraceptive measures in child-bearing woman. he bronchoscopist has determined the subject is clinically appropriate for bronchoscopy -
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 21.0-75.0, Chronic Obstructive Airway Disease Healthy Volunteers Healthy non-smoking subjects: All normal volunteers will meet the following Age 21-70 years No history of respiratory or allergic disease Normal baseline spirometry as predicted for age, sex and height Non-smokers No history of upper respiratory tract infection in the preceding six weeks Not taking regular medication COPD subjects: COPD is diagnosed according to American Thoracic Society, European Respiratory Society and British Thoracic Society guidelines by the doctors in Professor Barnes' COPD clinic. All COPD volunteers will meet the following Age between 40-75 years A smoking history of at least 20 pack years. ( 1 pack year = 20 cigarettes per day for 1 year) FEV1:FVC ratio of <0.7, post-bronchodilator FEV1 of <85% predicted, reversibility with inhaled b2-agonist of <15% of predicted FEV1: all three are required Subjects will not included in this study if they meet any of the following Clinically significant findings in the medical history or on physical examination other than those of COPD in the COPD group Pregnant women or mothers who are breastfeeding Subjects who are unable to give informed consent
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-999.0, Asthma Chronic Obstructive Pulmonary Disease Physician-diagnosis of asthma, COPD exacerbation, or undifferentiated asthma/COPD exacerbation Admitted to the inpatient medical service at Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center Evidence of airflow obstruction on spirometry (FEV1/FVC<70%) Age 18 years or older History of allergy or other contraindication to macrolides (azithromycin, erythromycin, clarithromycin) Treatment with any macrolide in the 4 weeks prior to study entry Elevated AST or ALT (2 or more times the upper limit of normal) on current admission Elevated alkaline phosphatase (>1.25 times the upper limit of normal) on current admission Elevated total serum bilirubin (more than upper limit of normal) on current admission Previous participation in this study Patients prescribed digoxin (azithromycin may increase digoxin levels) Patients prescribed warfarin (azithromycin may increase INR in patients on warfarin) Patients prescribed pimozide (azithromycin may increase risk of arrhythmias) Patient unable to provide consent (e.g., language difficulty or history of dementia)
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 16.0-999.0, Sepsis Critical Illness Group 1: healthy control patients Patients undergoing elective total hip replacement will be eligible for enrollment in Group 1 after written informed consent has been obtained. Only 1 blood sample and 1 fat and muscle biopsy will be taken intra-operatively Group 2: non-septic, critically ill patients Patients requiring intensive care within 48 hours of admission to hospital from home, for a non-septic/non-inflammatory pathology will be eligible for enrollment in the study after informed agreement has been obtained from the closest family member (see Consent below). At enrolment, Group 2 patients must have received mechanical ventilation commencing within 48 hours of admission to intensive care, should be likely to require mechanical ventilation for at least 48 hours, and must not fulfil the 2001 International Sepsis Definition Conference for severe sepsis or septic shock Group 3: patients with severe sepsis or septic shock Patients requiring intensive care within 48 hours of admission to hospital from home, and evidence of severe sepsis (organ dysfunction due to infection) or septic shock as defined by the 2001 International Sepsis Definition Conference will be eligible for enrollment in the study after informed agreement has been obtained from their next-of-kin. Patients with underlying chronic liver disease are excluded from this group, and will be enrolled separately into Group 4. Group 4: patients with severe sepsis and underlying chronic liver disease Patients requiring intensive care admission, with underlying Child-Pugh Class A or B, biopsy-proven liver cirrhosis, within 24 h of the onset of severe sepsis (organ dysfunction due to infection) or septic shock as defined by the 2001 International Sepsis Definition Conference criteria), will be eligible for enrollment in the study after informed agreement has been obtained from their next-of-kin Age <18 years Child-Pugh Class C liver disease Chronic dialysis-dependent renal failure Hepatitis B or C infection Immunosuppression (e.g. haematological malignancy, neutropenia, HIV infection) Immunosuppressive drug therapy within past 6 months Patient receiving oral or IV steroid therapy for greater than 1 week, within 6 months prior to ICU admission Muscle biopsy contraindicated in presence of coagulopathy (INR >2, platelet count < 30,000)* Next-of-kin declines agreement / patient declines consent Patient receiving thyroid hormone therapy prior to ICU admission *This does not enrolment into the study, particularly in the case of Group 4 patients who frequently develop a coagulopathy as part of their underlying liver dysfunction
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-999.0, Chronic Illness Child 2-11 years of age, with diagnosed chronic illness Parent at least 18 years of age, able to speak and read English at 4th grade level and able to attend a 7 week two-hour class program Child in active hospice treatment
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 55.0-999.0, Heart Failure Chronic Obstructive Lung Disease diagnosis of Chronic Heart Failure diagnosis of Chronic Obstructive Pulmonary Disease living in a nursing home inability to give informed consent involved in other studies of CHF or COPD
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-80.0, Chronic Obstructive Pulmonary Disease (COPD) diagnosis of mild COPD OR healthy control subjects 80 years old able to perform all study procedures Smoking history > 10 pack years (for mild COPD) or smoking history < 10 pack years (for healthy control subjects) allergy to atrovent history of asthma, atopy or nasal polyps Oxygen desaturation < 80 % during exercise recent history of CAD (under a year) or any significant diseases that could contribute to dyspnea or exercise limitation
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-80.0, Chronic Obstructive Pulmonary Disease FEV1 less than/equal to 70 % predicted, FEV1/FVC ratio less than/equal to 70%, and FRC greater than/equal to 120 % predicted Moderate to severe chronic activity-related dyspnea (modified Baseline Dyspnea Index focal score less than/equal to 6) Clinically stable as defined by no changes in medication dosage or frequency of administration with no exacerbations or hospital admissions in the preceding four weeks Males or females greater than 40 years of age A cigarette smoking history of at least 20 pack-years Able to perform all study procedures and sign informed consent History of asthma, atopy or nasal polyps Recent history of cardiovascular disease (< 1 year) or other significant disease that could contribute to dyspnea or exercise limitation Oxygen saturation less than 80% during exercise on room air
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-999.0, Urolithiasis Patients 18 years old and above with urolithiasis scheduled for shock wave lithotripsy Contraindications to Flomax Patients with renal impairment (serum creatinine above 2.0) Patients with hepatic impairment (liver enzymes 2.5 times the upper limit of normal) Use of other oral alpha blockers
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 0.0-18.0, Multivessel Pulmonary Vein Stenosis Diagnosis can be based on clinical and radiographic grounds or at the time of biopsy or prior surgical procedures. The diagnosis must be consistent with multivessel pulmonary stenosis There must be evidence of severe pulmonary vein stenosis in at least two pulmonary veins Must give written informed consent according to institutional guidelines Mechanism of pulmonary venous obstruction due to obvious anatomic cause, such as extrinsic compression
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 50.0-999.0, COPD -History of COPD and cigarette smoking Clinical diagnosis of asthma Chest X-ray that is diagnostic of a significant pulmonary disease other than COPD Disease of other major organ systems
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-999.0, COPD Medical diagnosis of COPD Current or prior history of cigarette smoking Medical diagnosis of asthma Chest X-ray diagnostic of significant disease other than COPD Significant condition or disease other than COPD
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-999.0, COPD Medical diagnosis of COPD Current or prior history of cigarette smoking Medical diagnosis of asthma Chest x-ray (CXR) prior to Day 1 diagnostic of significant disease other than COPD Significant condition or disease other than COPD
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 50.0-999.0, Benign Prostatic Hyperplasia (BPH) Males in good general health and at least 50 years of age, with symptoms of moderate to severe benign prostatic hyperplasia Medical conditions that would confound the efficacy evaluation Medical conditions in which it would be unsafe to use an alpha-blocker The use of concomitant drugs that would confound the efficacy evaluation The use of concomitant drugs that would be unsafe with this alpha-blocker
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 50.0-999.0, Benign Prostatic Hyperplasia Males in good general health and at least 50 years of age, with symptoms of moderate to severe BPH Medical conditions that would confound the efficacy evaluation Medical conditions in which it would be unsafe to use an alpha-blocker The use of concomitant drugs that would confound the efficacy evaluation The use of concomitant drugs that would be unsafe with this alpha-blocker
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-999.0, COPD Diagnosed with COPD, with symptoms of cough and chronic sputum production and/or dyspnea Post-bronchodilator FEV1 at no more than 65% and at least 30% of the predicted normal value Pre-bronchodilator FEV1/FVC ratio of less than 70% Current or ex-smokers with a smoking history of at least 10 pack years History of asthma, atopy or allergic rhinitis Other serious respiratory or other medical conditions which may interfere with the outcome of the study
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 0.0-5.0, Type 2 Gaucher Disease The patient is eligible because he has Type 2 Gaucher disease The patient may not be eligible to receive CED of glucocerebrosidase if he: 1. Is not healthy enough to undergo surgery or general anesthesia. 2. Has an uncorrectable bleeding disorder. 3. Is not able to undergo magnetic resonance (MR)-imaging
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 0.0-999.0, COPD COPD patients (male/female)given long-term oxygen treatment Able to perform two separate walking tests Severe heart failure
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease Patients with chronic obstructive pulmonary disease and an acute exacerbation After the acute treatment a simple pulmonary function test shows a value of 30%-60% of the predicted normal value Patients, who, based on the clinical examination after the initial acute treatment, are candidates for a course of oral steroids for the treatment of acute symptoms due to chronic obstructive pulmonary disease Diagnosis/history of asthma Oxygen uptake (saturation) is <92% after the initial acute treatment A requirement for regular use of oxygen therapy Regular treatment with any inhaled steroid >1 000 µg/day at study entry Additional and will be evaluated by the investigator
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 45.0-80.0, Prostate Cancer Patients Undergoing External Radiation and Seed Implantation Males age 45-80 years Diagnosis of prostate cancer Status post IMRT and Palladium-103 seed implantation and initiated alpha blocker therapy with alfuzosin10mg daily or tamulosin 0.4mg bid at time of seed implantation Baseline AUA score< or =12 May be on antiandrogenand/or alpha reductase therapy Patients receiving IMRT followed by Palladium-103 Brachytherapy implantation as the primary therapy for prostate cancer with curatives intent - History of insulin-dependent diabetes Uncontrolled hypertention History of symptomtic hypotension (including syncope and dizziness) Pre-existing obstructive uropathy based on history of BPH and or Acute Urinary Retention Pre-existing prostatitis either continuous or intermittent Concurrent use of any other anticholinergics previous or concurrent usage of LHRH agonist
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-999.0, Shortness of Breath Acute Exacerbation Acute shortness of breath of unknown etiology as presentation to the emergency room 2. Possible acute exacerbation of known heart failure None -
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-999.0, COPD Medical diagnosis of COPD Current or prior history of cigarette smoking Medical diagnosis of asthma Chest X-ray diagnostic of significant disease other than COPD Significant condition or disease other than COPD
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 50.0-999.0, Prostatic Hyperplasia Acute Urinary Retention Male aged over 50 years Having given his written consent Presenting with a first episode of painful acute urinary retention related to BPH With a catheterized urine volume between mL and mL at the time of retention Associated urological diseases / troubles (e.g. infection or surgery of prostate, urinary retention f neurogenic origin Iatrogenic causes of urinary retention
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive participation in the trial 2. All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric ? Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 =< 70% of predicted normal* and FEV1 =< 70% of FVC (Visits 1 and 2). *: Predicted normal values will be calculated according to the formulas for Japanese predicted normal values (R05-0607) (see below). Males: FEV1 predicted (L) = 0.036 x (height (cm)) ? 0.028 x age (years) ? 1.178 Females: FEV1 predicted (L) = 0.022 x (height (cm)) ? 0.022 x age (years) ? 0.005 ? Patients must maintain stable COPD medications for 1 month prior to Visit 1. 3. Male or female patients 40 years of age or older. 4. Patients must be current or ex-smokers with a smoking history of more than 10 pack years. Pack Years = [Number of cigarettes/ day / 20] x years of smoking 5. Patients must be able to perform technically acceptable pulmonary function tests. 6. Patients must be able to inhale medication in a competent manner from the Respimat inhaler and the HandiHaler. Patients with/who: 1. Significant diseases except COPD 2. Clinically relevant abnormal haematology, blood chemistry, or urinalysis 3. Recent history of MI 4. Any cardiac arrhythmia requiring drug therapy or who have been hospitalised for heart failure within the past 3 yrs 5. Cancer within the last 5 yrs 6. Symptomatic prostatic hypertrophy or bladder neck obstruction 7. Narrow-angle glaucoma 8. History of asthma, allergic rhinitis, atopic disease, or who have a total blood eosinophil count >= 600 mm3 9. History of life-threatening pulmonary obstruction, or cystic fibrosis or clinically evident bronchiectasis 10. Active tuberculosis 11. History of and/or active significant alcohol or drug abuse 12. Underwent thoracotomy with pulmonary resection 13. Completed a pulmonary rehabilitation program within the 6 weeks prior to the Scr. Visit or who are currently in a pulmonary rehabilitation program 14. Regularly use daytime oxygen for more than 1 h/day and in the investigator?s opinion unable to abstain from the use of oxygen 15. Took an investigational drug within 1 m or 6 half lives prior to Scr. Visit 16. Beta-blockers 17. Anti-allergic drugs or antihistamines for asthma, allergic rhinitis, atopic disease, or other allergic disease with a total blood eosinophil count >= 600 mm3 18. Oral corticosteroids at unstable doses or at doses in excess of the equivalent of 10 mg of prednisone/day or 20 mg every other day 19. Hypersensitivity to anticholinergic drugs, or components of the Respimat delivery system, to lactose or any other component of the inhalation capsule deliver system 20. Pregnant or suspect of pregnant or women who are willing to become pregnant during the study period or nursing women 21. Who are currently participating in another study 22. The randomisation of patients with any respiratory infection or COPD exacerbation in the 6 weeks prior to the Scr. Visit or during the scr. period should be postponed
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-75.0, Pulmonary Disease, Chronic Obstructive COPD Subjects A COPD subject will be eligible for in this study only if all of the following apply Male or female subjects, aged 40-75 years inclusive A baseline (post-bronchodilator) FEV1 <80% of predicted normal and a baseline (post-bronchodilator) FEV1/FVC ratio 70% Current or ex-smokers with a smoking history of at least 10 pack-years (number of pack years = (number of cigarettes per day / 20) x number of years smoked e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years) A signed and dated written informed consent is obtained prior to participation Able to comply with the requirements of the protocol and be available for study visits over 3 years Control Subjects Current/Ex Smokers A control subject will be eligible for in this study only if all of the following apply Male or female subjects, aged 40-75 years inclusive, who are free from significant disease as determined by history, physical examination and screening investigations COPD Subjects A COPD subject will not be eligible for in this study if any of the following apply Known respiratory disorders, or disorders identified at screening/visit 1 (including identification on the first CT scan), other than COPD (e.g.: lung cancer, sarcoidosis, tuberculosis, lung fibrosis, cystic fibrosis) Known history of significant inflammatory disease, other than COPD (e.g. rheumatoid arthritis and Lupus) Known to be severely alpha-1-antitrypsin deficient (PI SZ or ZZ) Having undergone lung surgery (e.g. lung reduction, lung transplant) Have cancer or have had cancer in the 5 years prior to study entry Serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study or impact on subject safety Is enrolled in a long term blinded drug study (subjects in open label studies may be considered and subjects in short blinded studies (approx less than 12 weeks may be considered following consultation with sponsor) or a study where there is significant radiation exposure (e.g.: CT scans) Have, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 21.0-75.0, Chronic Obstructive Pulmonary Disease Emphysema Chronic Bronchitis Healthy non-smoking subjects: All normal volunteers will meet the following Age 21-75 years. No history of respiratory or allergic disease. Normal baseline spirometry as predicted for age, sex and height. Non-smokers. No history of upper respiratory tract infection in the preceding six weeks. Not taking regular medication COPD subjects: COPD is diagnosed according to American Thoracic Society, European Respiratory Society and British Thoracic Society guidelines by the doctors in Professor Barnes' COPD clinic. All COPD volunteers will meet the following Age between 35-75 years. A smoking history of at least 10 pack years. ( 1 pack year = 20 cigarettes per day for 1 year) FEV1:FVC ratio of <0.7, post-bronchodilator FEV1 of <85% predicted, reversibility with inhaled beta2-agonist of <15% of predicted FEV1: all three are required Subjects will not included in this study if they meet any of the following Clinically significant findings in the medical history or on physical examination other than those of COPD in the COPD group. Pregnant women or mothers who are breastfeeding. Subjects who are unable to give informed consent.-
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-999.0, Chronic Prostatitis Pelvic Pain Male subjects aged 18 and older. 2. Male subjects with at least 3 months of symptoms of CP/CPPS who are refractory to other therapies 3. Subjects with a minimum score of 15 on the CPSI. 4. Male subjects must give written informed consent. 5. Male subjects must be willing an able to comply with the most recent version of the FDA-mandated S.T.E.P.S.â Program to He understands and can reliably carry out all instructions He is capable of complying with the mandatory contraceptive measures that are appropriate for male patient registration, and patient surveys as described in the S.T.E.P.S.â program He has received both oral and written warning of the hazards of taking thalidomide and exposing a fetus to the drug He has received both oral and written warning of the risk of possible contraception failure and of the presence of thalidomide in semen. He has been instructed that he must always use a late condom during any sexual contact with a woman of childbearing potential, even if he has undergone a successful vasectomy He acknowledges in writing his understanding of these warning and of the need to use a latex condom during any sexual contact with women of childbearing potential, even if he has undergone a successful vasectomy He agrees NOT to be a sperm or blood donor while being treated with thalidomide - Subjects who are female. 2. Subjects with a documented positive urine culture (>100,000 CFU/mL) within the past six months 3. Subjects with duration of symptoms less than three months 4. Subjects with active genital infections 5. Subjects with prior urologic surgeries 6. Subjects with known active or prior genitourinary cancers including renal, ureteral, bladder or prostate 7. Subjects having received prior radiation to the abdominal or pelvic area 8. Subjects with known bladder or ureteral calculi 9. Subjects unable to complete a voiding diary 10. Subjects diagnosed with neuropathy 11. Subjects with neutropenia 12. Subjects with a history of deep venous thrombosis, pulmonary embolism, or hypercoagulable state 13. Any patient who is not willing to comply with the most recent version of the FDA-mandated S.T.E.P.Sâ program 14. Subjects with orthostatic hypotension 15. Subjects with known malignancies in the last 2 years
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-55.0, Influenza Healthy male and female subjects between 18 and 55 years of age. Male subjects should use appropriate contraception (e.g. condoms) during the time interval between dosing until 3 months after dosing. Female subjects should be of non-child bearing potential. Female subjects 50 years of age or less must be surgically sterile or post-menopausal (defined as at least two years post cessation of menses and/or follicle-stimulating hormone (FSH) >18 mIU/mL and serum oestradiol <110 pmol/L), non-lactating and have a negative serum pregnancy test. Female subjects of more than 51 years of age must be surgically sterile or post menopausal (defined by a value of FSH >18 mIU/mL and no spontaneous menstruation for at least one year before investigational product administration), non-lactating and have a negative serum pregnancy test Vital signs within normal limits: systolic BP between 90 and 150 mmHg, diastolic BP between 40 and 90 mmHg, pulse rate between 35 and 100 bpm (confirmed as sinus rhythm if between 35 and 40 bpm), oral temperature between 35.5°C and 37.7°C and oxygen saturation of at least 98% Normal physical examination and laboratory findings. Grade 1 laboratory abnormalities for non-essential tests and clinical findings considered not clinically significant or a variant of normal may be acceptable following discussion between the Investigator and the Sponsor No abnormality in the ECG; specifically QTc <450 ms and PR 120-200 ms None of the following abnormal laboratory findings AST >51 IU/L (males) or >46 IU/L (females) [based on 1.25 x ULN] ALT >61 IU/L (males) or >48 IU/L (females) [based on 1.25 x ULN] Serum creatinine >104 micro mol/L (males) or >84 micro mol/L (females) Glucose <3.8 or >5.5 mmol/L Potassium <3.9 or >5.3 mmol/L (males) or <3.8 or >5.4 mmol/L (females) Subjects who have taken any prescription medication (with the exception of hormone replacement therapy (HRT)) within 14 days or any non-prescription (with the exception of vitamin/mineral supplements) within the last 7 days prior to the administration of the investigational product (Day 1) Intake of any investigational drug within 4 months (new chemical entity) or 3 months (marketed compounds) prior to the intake of investigational product (Day 1) History of allergy or serious adverse reaction to the excipient or neuraminidase inhibitor A history or clinical evidence of significant cerebrovascular, cardiovascular, gastrointestinal, or haematological disease, or myocardial infarction, or a previous history of any other serious underlying disease (including immunocompromised subjects and/or neutropenic subjects) that, in the opinion of the Investigator would interfere with the conduct of the study A history or clinical evidence of significant respiratory disease (including asthma, hyper-reactive lung disease, COPD, cystic fibrosis and/or recurrent lower respiratory tract infection) and/or upper respiratory tract infection within the last month or lower respiratory tract infection within the last three months A history or clinical evidence of renal disease (including renovascular occlusive disease), nephrectomy and/or renal transplant, and/or previous clinically significant laboratory abnormalities of renal function parameters. All subjects with serum creatinine outside the normal laboratory reference range at screening and before randomization that are regarded by the Investigator as clinically significant A history or clinical evidence of hepatic disease and/or previous clinically significant laboratory abnormalities of liver function parameters. All subjects with alanine transaminase (ALT) and/or aspartate transaminase (AST) outside the normal laboratory reference range at screening and before randomization, that are regarded by the Investigator as clinically significant. Subjects known to have experienced elevated liver enzyme values in previous clinical studies will also be excluded Psychiatric or emotional problems that would limit the ability of the subject to comply with study requirements Body Mass Index (BMI) <18.5 kg/m squared or >30.0 kg/m squared FEV1 less than or equal to 85%, FEV (1.0%) less than or equal to 70%, and/or FVC less than or equal to 80% of the predicted value, as calculated from standard age and height formula
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease (COPD) Main History of COPD for at least 12 months prior to baseline visit FEV1/FVC ratio (post-bronchodilator) ≤ 70% FEV1 (post-bronchodilator) between ≥ 40% and ≤ 70% of predicted Main COPD exacerbation indicated by a treatment with systemic glucocorticosteroids and/or antibiotics not stopped at least 4 weeks prior to baseline visit
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 0.0-999.0, Chronic Obstructive Pulmonary Disease Admission for chronic obstructive pulmonary disease Other severe acute or chronic diseases
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive Clinical diagnosis of at least moderate Chronic Obstructive Pulmonary Disease (COPD), as defined by the following Global Initiative for COPD (GOLD) 1. Post-bronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio of less than 70% 2. Post-bronchodilator FEV1 less than 80% predicted, with or without chronic symptoms Cigarette consumption of 10 pack-years or more (may or may not be active smokers) Meets one or more of the following four conditions: 1. Current, or history of, supplemental O2 use 2. Received a course of systemic corticosteroids for respiratory problems within 1 year prior to study entry 3. Visited an emergency department for a COPD exacerbation within 1 year prior to study entry 4. Hospitalized for a COPD exacerbation within 1 year prior to study entry Willing to make return visits Available by telephone for duration of study Minimum of 4 weeks from the most recent acute exacerbation (have not received a course of systemic corticosteroids, an increased dose of chronically administered systemic corticosteroids, and/or antibiotics for an acute exacerbation for a minimum of 4 weeks from the time of study entry) Diagnosis of asthma Diagnosis other than COPD that results in the patient being either medically unstable, or having a predicted life expectancy less than 3 years Special patient groups (i.e., prisoners, pregnant women, or institutionalized patients) Women who are at risk of becoming pregnant during the study (pre-menopausal) and who refuse to use acceptable birth control (i.e., hormone-based oral or barrier contraceptive) for the duration of the study History of hypersensitivity to any macrolide antibiotic Taking any of the following medications: 1. Cisapride 2. Ergot derivatives 3. Pimozide 4. Disopyramide 5. Cyclosporin 6. Tacrolimus 7. Nelfinavir 8. Bromocriptine 9. Hexobarbital Corrected QT interval (QTc) on electrocardiogram exceeding 440 ms Taking rifabutin or rifampin Chronic hepatic insufficiency Chronic renal insufficiency
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 0.0-999.0, Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Expiratory airflow limitation such that FEV1/FVC is less than or equal to 70% and the FEV₁ is greater than or equal to 20% of the predicted amount Physical disability, including self-reported difficulty with walking a city block, climbing stairs, lifting and carrying groceries, performing household activities such as cleaning and doing yard work, or getting out of a chair Currently lives within a 35-mile radius of Wake Forest University Plans to reside in Forsyth County, North Carolina for the entire study Willing and able to participate in all aspects of the trial Undergoing treatment for cancer Severe congestive heart failure Stroke Peripheral vascular disease Coronary artery disease Valvular heart disease Major psychiatric disease Severe anemia Liver or kidney disease Uncontrolled diabetes or hypertension
|
2
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-80.0, Chronic Obstructive Pulmonary Disease 80 years stable COPD FEV1 < 60 % predicted severe chronic breathlessness (Baseline Dyspnea Index < 6) SpO2 at rest < 90% or a a sustained decrease of > 4% in arterial O2 saturation during the ergometer test, as determined by pulse oximetry a body mass index (BMI) < 19 or > 30 chronic oral steroid therapy other medical conditions which could cause or contribute to breathlessness, i.e., heart disease or other respiratory diseases other problem which could interfere with carrying out of exercise testing, i.e., neuromuscular diseases, orthopedic diseases, etc
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 65.0-999.0, Hypertension Male or female outpatients ≥ 65 years old Patients with essential hypertension with an msSBP ≥ 140 mmHg and < 180 mmHg, and msDBP < 110 mmHg at Visits 2 and 3. (Visit 201 was deleted by the Administrative Changes document.) Patients must have had a difference in msSBP of ≤ 20 mmHg between Visit 3 and the visit immediately prior to Visit 3 Patients who were eligible and able to participate in the study, and who consented to do so after the purpose and nature of the investigation had been explained to them (written informed consent) History of renal artery stenosis Known Keith-Wagener grade III or IV hypertensive retinopathy History of hypertensive encephalopathy Current diagnosis of heart failure (New York Heart Association Class III-IV) History of transient ischemic cerebral attack or cerebrovascular accident within 6 months History of myocardial infarction, bypass surgery, or any percutaneous coronary intervention within 6 months Current unstable angina pectoris. Patients on a stable dose of oral or topical nitrates or beta blockers for angina were acceptable Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia Clinically significant valvular heart disease Concurrent use of any antihypersensitive medications except a stable dose 3 months prior to visit 1 of alpha adrenergic blockers for benign prostatic hypertrophy (e.g., Flomax for BPH), beta blockers for angina, or beta blockers ophthalmic preparations
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-999.0, Benign Prostatic Hyperplasia years of age or older Clinically diagnosed with mild to moderate BPH (AUA symptom score <20) Patient with severe BPH (AUA symptom score >21) Currently using any other forms of medical therapy, prescription finasteride, terazosin, tamsulosin or propecia (for hair loss) Prior Transurethral resection of the prostate (TURP) Using non-prescription supplements such as Saw Palmetto, B-sitosterol, vitamin E, and quercetin
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 18.0-999.0, Asthma Chronic Obstructive Pulmonary Disease Adult patients with orders for routine 2.5 mg albuterol sulfate nebulizer therapy ordered either Q4 or Q6 hours who consent to the study Adults with nebulizer therapy ordered more frequently than Q4 hours Adults with nebulizer therapy ordered less frequently than Q6 hours Pregnant patients are excluded Adults with orders for albuterol sulfate > 2.5 mg Adults in the ICU or Emergency Department
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 0.0-999.0, Chronic Obstructive Pulmonary Disease Exertional dyspnea Activity limitation COPD Recent exacerbation (< 4 wks) Supplemental O2 Significant cardiovascular/musculoskeletal abnormalities
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-75.0, Pulmonary Disease, Chronic Obstructive COPD Lung Diseases, Obstructive Male and females aged 40-75 years with COPD and symptoms such as cough, sputum production, and shortness of breath Smoking history of at least 10 pack years FEV1 less than 65% of the predicted normal value and at least 0.75 L Pre-bronchodilator FEV1/FVC less than 70% A history of asthma or COPD diagnosis before the age of 40 Hospitalization for COPD exacerbation within the previous 6 weeks Respiratory tract infection within 6 weeks Use of long-term oxygen therapy Diabetes type I or uncontrolled diabetes type II Clinically relevant laboratory abnormality or clinically significant condition Corrected QT interval (QTc) above 430 ms for males and 450 ms for females, or a history of QTc prolongation. Other protocol-defined inclusion/
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 21.0-65.0, Chronic Illness 21 years of age or older; 2. Resident of one of the following Maryland counties: Caroline, Cecil, Kent, Queen Anne's, Talbot, Dorchester, Somerset, Wicomico, Worcester, Allegheny, Frederick, Garrett, Washington, Calvert, Charles, or St. Mary's; or 3. Chronic medical condition(s) identified by ACG Case Mix software (e.g. an ACG score => 0.10) as likely to incur high costs in the following year; and 4. Substance use problem in the past 27 months as indicated by an ICD-9 code or CPT code on DHMH list for Special Needs Population. Criterion. 1) Enrolled in or eligible for enrollment in a Special Needs disease management program at JHHC: HIV/AIDS, Partners with Mom, Omega Life. It is necessary to these programs because PPMCO members are already receiving intensive care management
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 0.0-999.0, Esophageal Perforation male with esophageal perforation man with COPD Iatrogenic perforation
|
0
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 0.0-999.0, Chronic Obstructive Pulmonary Disease moderate to severe COPD (according to GOLD classification) oxygen saturation >= 92 KPa symptomatically stable habitually low fruit and vegetable intakes (<=2 portions daily) exercise limited by shortness of breath (rather than e.g. angina, arthritis) diabetes taking antioxidant supplements or drugs oxygen saturation <8KPa
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive Male or female ≥40 years of age Current or previous cigarette smoker with a history of cigarette smoking of ≥10 pack/years Self reported symptoms of chronic bronchitis where chronic bronchitis is defined as the presence of productive cough for at least 3 months in each of the successive 2 years Completion of written informed consent prior to study participation Subject must be able to read, comprehend, and record information in English Regular use (i.e., prescribed for use on a daily basis) of the following respiratory medications for the six months prior to the study visit: ipratropium, ipratropium/albuterol combinations, tiotropium, salmeterol, formoterol, inhaled corticosteroids, inhaled corticosteroid/long-acting beta-agonist combinations, theophyllines, oral beta-agonists. - Previous lung surgery, including, lung transplant, lung resection, lung volume reduction surgery, etc Current diagnosis of a significant lung condition other than chronic bronchitis, including, asthma, lung cancer, cystic fibrosis, pulmonary fibrosis, bronchiectasis, active tuberculosis, sarcoidosis, or alpha-1-antitrypsin deficiency Any medical or physical condition that would interfere with the adequate performance of spirometry Evaluation and/or treatment by a pulmonary specialist (e.g., pulmonologist or allergist) within 3 years of the study visit A spirometrically confirmed diagnosis of COPD Have, in the opinion of the investigator, evidence of current alcohol, illegal drug or solvent abuse Limited ability to provide a valid informed consent due to serious uncontrolled psychiatric disease, intellectual or cognitive deficiency, poor motivation or other relevant condition which in the opinion of the site principal investigator will interfere with the subject's participation in the study Pregnant females. - Participating investigator, sub-investigator, study coordinator, employee of the participating investigator or family members of the aforementioned site staffs
|
1
|
The patient is a 60-year-old Spanish man presenting with shortness of breath about a day before. The symptoms began acutely and progressively worsened. He is a known case of COPD since 2 years ago. The spirometry revealed post-bronchodilator FEV1/FVC = 60% of predicted values. He smokes 20 cigarette per day. His past medical history is remarkable for BPH and he is using Flomax for that. His family history is positive for HTN in his brother. His medication includes Duo-Neb inhaled q4 hr PRN, Vit D3 1000 units per day and Flomax for his PBH. He is an obese man who is acutely ill but oriented and conscious. The vital signs are as bellow: BP: 135/80 RR: 25/min HR: 75 bpm BMI: 40 O2sat: 90%
|
eligible ages (years): 40.0-999.0, Chronic Obstructive Pulmonary Disease (COPD) Participants will have: 1. a diagnosis of COPD which is clinically stable (including medications) for at least one month; 2. spirometry results showing at least mild obstructive disease defined as post bronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio <0.70 with FEV1<80% predicted or post-bronchodilator FEV1/FVC ratio <0.60 with FEV1>80% predicted; 3. ADL limited by dyspnea; 4. a designated primary care physician; 5. ability to speak English and sign consent form; 6. actively using a computer and the Internet; 7. no formal pulmonary rehabilitation training for at least 12 months; 8. patients receiving supplemental oxygen will be acceptable if their O2 saturation can be maintained at >80% on <6L/min of nasal oxygen; 9. understands how to and is able to rate their shortness of breath during exercise; 10. age > 40 years Subjects will be excluded if they have active symptomatic illness (e.g., cancer, left heart failure, ischemic heart disease with known coronary artery or valvular heart disease, psychiatric illness, and neuromuscular disease)
|
1
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.