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The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
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eligible ages (years): 1.0-30.0, Down Syndrome Recurrent B Acute Lymphoblastic Leukemia Patients must be >= 1 and < 31 years at time of enrollment Patients must have first relapse of CD19+ B-ALL (relapse blasts must express CD19) in one of the following categories Isolated bone marrow relapse Isolated central nervous system (CNS) (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse Combined bone marrow with extramedullary relapse in the CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testes Patients with Down syndrome (DS) are eligible in the following categories Isolated bone marrow relapse Combined bone marrow with CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study Patients with B-lymphoblastic lymphoma (B-LLy) Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia Patients with Philadelphia chromosome positive (Ph+) B-ALL Patients with mixed phenotype acute leukemia (MPAL) Patients with known Charcot-Marie-Tooth disease Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype Patients with active, uncontrolled infection defined as Positive bacterial blood culture within 48 hours of study enrollment Receiving IV or PO antibiotics for an infection with continued signs or symptoms. Note: Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection as long as cultures have been negative for at least 48 hours and signs or symptoms of active infection have resolved. For patients with clostridium (C.) difficile diarrhea, at least 72 hours of antibacterial therapy must have elapsed and stools must have normalized to baseline Fever above 38.2 degrees Celsius (C) within 48 hours of study enrollment with clinical signs of infection. Fever without clinical signs of infection that is attributed to tumor burden is allowed as long as blood cultures are negative for > 48 hours
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0
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The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
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eligible ages (years): 18.0-50.0, Chronic Pelvic Pain Meet the diagnostic of non-cyclic CPP Age 18 to 50 years Have moderate to severe pain in pelvis, anterior abdominal wall, lower back, or buttocks lasting at least six months The mean degree of pelvic pain in the past week rated by Visual Analogue Scale is ≥40 scores Sign informed consent and participate in the study voluntarily Have endometriosis (including adenomyosis), ovarian cyst (larger than 3cm), hysteromyoma (larger than 3cm), severe pelvic adhesion, pelvic malignant tumor (relevant examination must be within the last 6 months) Have acute pelvic/urinary tract infection Have pain after pelvic surgery Have recurrent gastrointestinal or bladder diseases such as irritable bowel syndrome, interstitial cystitis / bladder pain syndrome, etc During pregnancy or in lactation or have a pregnancy plan within 8 months Have heart, lung, liver, kidney, mental disorders or cognitive dysfunction Have acupuncture treatment in recent 3 months
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1
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The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
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eligible ages (years): 18.0-60.0, Abdominal Pain Patients scheduled for elective laparoscopic abdominal surgeries (inguinal hernia repair-missed IUCD extraction-appendectomy-ovarian vein ligation) Patient aged 18-60 years American Society of Anesthesiologists Physical Status I or II Patient refusal Body mass index (BMI) > 40 kilogram/square meter Contraindication to regional anesthesia (coagulopathy, allergy to local anesthetic, sever thrombocytopenia or infection at puncture site) Sepsis Chronic pain condition requiring the intake of opioids at home Any significant neurological, cardiovascular or respiratory disease
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2
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The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
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eligible ages (years): 18.0-35.0, Neurotmesis All females were clinically diagnosed with post caesarean anterior cutaneous branches of iliohypogastric neurotmesis by an Obstetrician. Their ages were ranged from 18 to 35 years old, All patients participated after removal of surgical stitches (after 2 weeks of cesarean delivery), All patients were primiparous, All patients were non-diabetic and all patients received relaxation training. BMI < 30 Multiparous BMI > 30 Diabetic patients Smokers Patients take vitamin B complex Any previous incision in hypogastric region
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1
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The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
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eligible ages (years): 0.0-999.0, Bowel Ischemia Acute Bowel Ischemia / Infarction Referred on the suspicion of acute bowel ischemia Patient not scanned with DECT Patient does not undergo abdominal surgery
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0
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The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
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eligible ages (years): 4.0-90.0, Parasitic Disease All routine examined appendectomy specimens Cases with clinical suspicion of tumor Cases attached to the colectomy specimens
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2
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The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
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eligible ages (years): 18.0-999.0, Osteonecrosis of the Jaw, Bisphosphonate Induced Osteonecrosis of the Jaw, Bisphosphonate Related Diagnosis of stage I or stage II medication related osteonecrosis of the jaws (MRONJ) according to the 2014 AAOMS position paper Coexistence of any medical or social condition that prevents proper adherence to treatment or follow-ups (dependent patients without adequate socio-familiar support, drug addiction, severe psychiatric illness, terminal disease with life expectancy less than 3 months) Coexistence of Brown's Tumor, Paget's Disease or other bone diseases with the exception of Osteoporosis or bone metastases
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0
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The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
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eligible ages (years): 18.0-999.0, Acute Appendicitis clinically and radiologically approved acute appendicitis approved and signed the informed consent form perforated cases cases with peritonitis patient wish for surgical treatment allergy to drugs used in medical treatment of acute appendicitis
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2
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The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
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eligible ages (years): 30.0-85.0, Stage IV Gastric Cancer are age less than 85 years, pre-treatment histological diagnosis of gastric adenocarcinoma, computed tomographic (CT), adjuvant-neoadjuvant chemotherapy regimen, symptoms of GOOS (symptoms of GOOS regular, frequent feeling of bloating or fullness; feeling full after eating less food; nausea and vomiting of undigested food, especially right after eating, abdominal pain) lumen reduction ranging between 70% and 99% at gastroscopy. for are a white blood cells count less than 4,000/L, a platelet count less than 70,000/L, patients with renal failure (i.e. albumin to creatinine ratio > 30 mg/mmol and estimated glomerular filtration rate < 30-44 mL/min/1.73m2), patients with major alterations of liver function tests (i.e. total bilirubin > 25.6 μmol/L, AST > 5 U/L, ALT >5 U/L, PT-INR > 1.5). -
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1
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The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
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eligible ages (years): 17.0-45.0, Chronic Inflammation of Appendix clinical diagnosis of chronic appendicitis -Male or Female patients with chronic appendicitis Patients who are fit for laparoscopy and general anaeshesia Patients who provide a written informed concent Patient who agree to provide short term outcome data and agree to provide -Patients with severe comorbid conditions with high risk for general anesthesia Patients suffering from an ongoing infections including chest infections Patients who didn't give concent Children and pregnant women Cases of complicated appendicitis
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2
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The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
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eligible ages (years): 0.5-18.0, Pain Neuropathic Pain Irritability Children aged 6 months to 18 years with SNI (from any cause) with unexplained pain and irritability and whose cognitive or communication impairments prevent determination of pain location, cause, and type will be eligible to participate Eligible children will have cognitive impairment or be non-verbal and have severe levels of disability equivalent to Gross Motor Functional Classification System (GMFCS) scores of 3, 4 or 5 as well as Communication Function Classification System (CFCS) level 4 or 5 Eligible children will score >3 on two scales administered via an Screening that measures persistence and distress level the child is experiencing as well as identifies the type of pain and irritability as PIUO with no obvious cause or explanation. The score of >3 on the scale measuring pain persistence and distress level confirms that the child is experiencing pain and irritability more than "a little" on "some days" The will be evidence of a comprehensive evaluation of PIUO in the child's medical history, showing no evidence for treatable sources (nociceptive-inflammatory) of pain and/or irritability symptoms Children not within the specified age range Children with communication capabilities and cognitive development to localize their pain Participants whose pain and or irritability is diagnosed through completion of the PIUO Pathway during the enrollment phase of the trial Patients with a known hypersensitivity/allergy to the study medication Patients who are actively participating in another experimental therapy study for pain and/or irritability Patients who are a poor medical risk because of other systemic diseases or active uncontrolled infections Patients who score A or B on the Pain Survey Patients who have an active source of nociceptive-inflammatory pain at the time of enrolment (e.g., post-operative pain) Patients with active renal disease, known renal impairment or glomerular filtration rate < 60 mL/min/1.73 m2 (if known) Patients with known significant hepatic impairment at the discretion of the investigator
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0
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The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
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eligible ages (years): 25.0-999.0, Squamous Intraepithelial Lesions of the Cervix Human Papilloma Virus Infection Cervix Lesion Women aged 25 years old or older With histologically-confirmed cervical intraepithelial lesion 1 only, proven by colposcopy biopsy, done in the most suspiscious area With complete colposcopy, performed less than 3 months prior the With confirmed ASC-US or LSIL cervical-cytology, performed less than 6 months prior the colposcopy Women under guardianship or curatorship Women under the protection of justice Women not affiliated with a social security system Pregnant woman (as vaginal gel has not been evaluated in pregnant women) Urinary dosing of BHCG will be performed on the day of for all women under 55 years of age and effective contraception is recommended during the study for all non-menopausal women Immunodepressed women (HIV, immunosuppressive treatments ...) Woman using vaginal contraceptives (ring, spermicides, cervical cap; because of risk of interaction) NB: Papilocare is compatible with the use of condoms and intrauterine devices Known allergy to one of the components Patients with low-grade histology with HSIL ASC-H AGC smear will not be included. The cyto-colposcopic discordance suggests a high-grade lesion that would not have been biopsied at colposcopy
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0
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The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
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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
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0
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The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
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eligible ages (years): 18.0-999.0, Appendix Abscess Appendicitis Appendix Mass Appendix Cancer Appendix Nec Appendix Tumor Appendix Diseases periappendiceal abscess proven by CT, Mri or US patient declines to participate, complicated appendicitis without periappendiceal abscess
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1
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The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
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eligible ages (years): 18.0-40.0, Cesarean Section Complications Blood Loss, Surgical Misoprostol Tranexamic Acid Women booked for a primary elective cesarean section, not in active labor Aged between 18-40 years BMI 18.5-29.9 kg/ m2 pre-pregnancy weight Term pregnancies (Early term: between 37 weeks, 0 days and 38 weeks, 6 days. Full term: between 39 weeks, 0 days and 40 weeks, 6 days. Late term: between 41 weeks, 0 days and 41 weeks, 6 days) Singleton pregnancies Indication of elective cesarean section (Malpresentation, Malposition, Cephalopelvic disproportion, active herpes) Fetal macrosomia (Macrosomia is defined as birth-weight over 4,000 g irrespective of gestational age) Certain congenital fetal malformation and skeletal disorders (Several congenital anomalies are controversial indications for cesarean delivery; these fetal neural tube defects (to avoid sac rupture), particularly defects that are larger than 5-6 cm in diameter as anterior cystic hygroma vascular sacrococcygeal teratoma, giant omphalocele and hydrocephalus with an enlarged biparietal diameter, and some skeletal dysplasia such as type III osteogenesis imperfecta. (Hamrick et al., 2008) Placenta previa Maternal hypertension and Preeclampsia Diabetes mellitus Severe medical disorder (renal or hepatic) Multiple Fibroid uterus Multiple pregnancies Polyhydramnios Previous uterine surgery as myomectomy Contraindication to spinal anesthesia Blood coagulopathy and bleeding disorder
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0
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The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
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eligible ages (years): 0.0-999.0, Uterine Fibroid Uterine Bleeding Uterine Prolapse Patients suffering from benign gynecological pathology (uterine fibromatosis, abnormal blood loss, complex hyperplasia with atypia, uterine prolapse) with indication for total uterine hysterectomy and consequently need for laparoscopic suture of the vaginal cuff American Society of Anesthesiologists (ASA) class < 3 Patient's informed consent Suspected neoplastic pathology Patients not eligible for surgery Actual pregnancies or pelvic inflammatory disease
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0
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The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
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eligible ages (years): 4.0-7.0, Pulp Disease, Dental Medically free children who will be able and cooperative in all steps of the study. 2 Asymptomatic primary molars with a deep carious lesion. 3 Vital pulp due to dental caries with no clinical sign of pulpal degeneration (spontaneous pain, fistula, mobility) prior to treatment. 3 Preliminary radiographs indicating absence of pathologic internal or external root resorption, or any evidence of inter-radicular bone destruction. 4 Absence of pre-operative pain or they will only have a short-term pain. 5 No tenderness to percussion. 6-Age ranging 4-6 years Excessive bleeding during pulp amputation. 2 Non vital teeth. 3 -History of spontaneous or prolonged pain. 4 Swelling, tenderness, to percussion or palpation, or pathologic mobility. 5 pre-operative radiographic pathology such as resorption (internal, external); periradicular or furcation radiolucency, or a widened periodontal ligament space. 6 Parent or guardians who refuse participating in the study
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0
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The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
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eligible ages (years): 18.0-65.0, Acute Gastroenteritis Abdominal Pain Patients with watery stools starting in the last 2 weeks and 3 times in 24 hours and abdominal pain Peritonitis Hemodynamic instability Pregnancy Inability to give consent Medication given in the emergency room before being included in the study Taking pain medication within 4 hours Diabetes Mellitus and other neuropathic diseases
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1
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The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
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eligible ages (years): 2.0-17.0, Appendicitis Diagnoses Disease Pediatric ALL all children referred with abdominal pain from January 2000 to June 2006 to one surgeon on the pediatric general surgery service at the Health Sciences Centre (HSC)-Children's Hospital in Winnipeg children with abdominal pain > 7 days children with abdominal pain due to other surgical or medical conditions
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1
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The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
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eligible ages (years): 0.0-999.0, Acute Appendicitis male and female patients of all ages who underwent appendectomy of acute appendicitis in a single medical center between December 1, 2006, and December 31, 2016 interval appendectomy incidental appendectomy appendectomy after failed antibiotic treatment for either acute appendicitis or peri-appendicular abscess patients with a non-inflamed appendix those in whom symptom onset before hospitalization was not noted
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2
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The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
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eligible ages (years): 18.0-65.0, Laparoscopic Cholecystectomy Cholelithiasis Postoperative Analgesia Patients undergoing elective laparoscopic cholecystectomy for cholelithiasis ASA (American Society of Anesthesiologists) I-II Patient refusal Perforation of the gallbladder Patients with acute cholecystitis History of the previous gallbladder surgery Pregnancy Morbid obesity Psychiatric disorder Epilepsia Renal insufficiency Coagulopathy
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0
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The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
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eligible ages (years): 18.0-999.0, Abdominal Pain Be at least 18 years of age Initial presenting complaint of moderate to severe abdominal pain (five or higher on numerical rating scale [NRS]) Subjects will be enrolled into the project one (1) time only Under 18 years of age Pregnant patients Inability to provide written consent Evidence of traumatic brain injury Hemodynamic instability Procedures involving laryngeal manipulation History of laryngeal spasm History of adverse reaction to Ketamine or morphine Patients will not be excluded if they had received pain medications prior to enrollment (ie. Received pain medication from triage, non-physician provider (NPP), or emergency medical services (EMS) prior to being seen by physician History of opioid use in the last week, prescription opioid use, recreational opioid use
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2
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The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
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eligible ages (years): 18.0-65.0, Acute Appendicitis Acute Appendicitis With Rupture Presenting to ER with right lower quadrant pain Patients between 18-65 years old Patients receiving immun-suppressive therapy Patients with diagnosed malignancy Presence of mental retardation Patients with previous right hemicolectomy Patients with previous appendectomy Pregnant women
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2
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The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
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eligible ages (years): 18.0-999.0, Appendicitis Acute patients with a diagnosis of appendicitis who are managed laparoscopically Less than 18 year old
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2
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The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
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eligible ages (years): 18.0-75.0, Acute Pancreatitis Chronic Pancreatitis ALL All participants must sign an informed consent indicating that they are aware of the investigational nature of this study and willing to undergo study interventions, and authorizing the use of their protected health information for research purposes ALL Meet one set of group-specific listed below ALL All participants must be >= 18 years old and =< 75 years at the time of enrollment NO No personal history or symptoms of pancreatic disease NO No upper abdominal symptoms NO No family history of pancreatic disorders, celiac disease, cystic fibrosis NO No history of acute infectious or inflammatory conditions requiring medical treatment or evaluation in the preceding 6 months (per provider clinical judgment) NO No history of cancer, except for non-melanoma skin cancers NO No known pregnancy at the time of enrollment NO No solid organ transplant or history of human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) ALL NO History of autoimmune or traumatic pancreatitis, or sentinel attack of acute necrotizing pancreatitis which results in suspected disconnected duct syndrome ALL NO Primary pancreatic tumors pancreatic ductal adenocarcinoma, suspected cystic neoplasm (> 1 cms in size or main duct involvement), neuroendocrine tumors, and other uncommon tumors ALL NO Pancreatic metastasis from other malignancies ALL NO History of solid organ transplant, HIV/AIDS ALL NO Known isolated pancreatic exocrine insufficiency (e.g. in the absence of any eligible criteria) ALL NO Participants must not have medical or psychiatric illnesses or ongoing substance abuse that in the investigator's opinion would compromise their ability to tolerate study interventions or participate in longitudinal follow up ALL NO Patients with known abnormal creatinine (glomerular filtration rate [GFR] < 30) or renal failure (applies to patients with chronic upper abdominal pain of suspected pancreatic origin and suspected CP [yellow] subgroups) ALL NO Failure to agree for longitudinal follow-up ALL NO Known pregnancy. All participants of childbearing potential, except if post-menopausal [i.e. no menses for >= 2 years] or had a hysterectomy, bilateral tubal ligation/clip (surgical sterilization) or surgical removal of both the ovaries), must have a negative urine or serum human chorionic gonadotropin (B-HCG) pregnancy test documented within 2 days prior to any endoscopic or radiologic procedures done for research purposes. Any standard of care tests will follow institutional policies regarding pregnancy test
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0
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The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
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eligible ages (years): 0.0-17.0, Appendicitis Appendix Mass Appendicitis Perforated Eligible for are all children <18 years old that need to undergo treatment for the suspicion of complex appendicitis. Suspicion of complex appendicitis is based upon the following predefined 4 or more points on our scoring system developed to predict complex appendicitis. The diagnostic accuracy of this scoring system is 91% (Range: 84-98%). This scoring system consists of five variables (clinical, biochemical and radiological,each awarded points). In case the total score is 4 or more points, the patient is likely to have complex appendicitis. Variables included in the scoring system are Diffuse abdominal guarding (3 points) CRP level more than 38 mg/L (2 points) Signs on ultrasound / imaging indicative for complex appendicitis (2 points) More than one day abdominal pain (2 points) Temperature more than 37.5 degrees Celsius (1 point) Or High index of suspicion of complex appendicitis by the treating physician. If this is the case, the treating physician will make pre-treatment note upon what clinical, biochemical or radiological variable the high index of suspicion is based Adult patients (=18 years old) Children with a suspicion of simple appendicitis (based upon the previous mentioned scoring system and radiological features)
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1
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The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
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eligible ages (years): 4.0-8.0, Indirect Pulp Treatment Patient 8 years old Healthy Cooperative Had at least two first primary molars or two second primary molars with deep occlusal or proximal caries not approaching the pulp indicated for IPT. Teeth No spontaneous pain No pain on palpation or percussion No signs of fistula or abscess No abnormal mobility No radiolucency at the periapical or interradicular areas Spontaneous pain Pain on palpation or percussion Signs of fistula or abscess Presence of abnormal mobility Radiolucency at the periapical or interradicular areas Loss of lamina dura Radiographic signs of internal resorption No sufficient tooth structure allowing placement of rubber dam Expected to exfoliate within 1 year
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0
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The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
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eligible ages (years): 18.0-999.0, Urothelial Bladder Cancer Gastric Adenocarcinoma Gastro-oesophageal Adenocarcinoma Head and Neck Cancer Biliary Tract Cancer Platinum-sensitive Urothelial Bladder Cancer Clear Cell Renal Cell Carcinoma Age ≥ 18 years Patients must have histologically or cytologically confirmed progressive metastatic or recurrent solid tumor (as defined below for each tumor type). Diagnosis must be stated in a pathology report and confirmed by the physician investigator Evidence of disease progression prior to trial entry To be enrolled in this study, only the tumor types and settings described below are allowed: 4.1 Cohorts 1 A-E: DNA repair deficiency, defined as bi-allelic loss-of-function alteration (mutation and/or deletion) in at least one of the following genes: ARID1A, ARID2, ATM, BARD1, BRCA1, BRCA2, BRIP1, CDK12, CHEK2, FANCA, IDH1, IDH2, NBN, PALB2, PBRM1, RAD51C, RAD51D, FANCA, NBN, RAD51, RAD54L, 4.1.1 Cohort 1A: Urothelial Bladder Cancer Patients must have received at least one line of prior platinum based systemic therapy. No more than 3 lines of previous systemic therapy for metastatic disease are allowed Relapse within 6 months of completion of adjuvant/neoadjuvant chemotherapy containing platinum-based regimen is considered as first-line therapy Previous adjuvant/neoadjuvant chemotherapy is allowed, if completed more than 6 months prior to starting the first-line therapy Participation in another clinical study with an investigational product simultaneously and/or during the last 4 weeks (excepting observational or non-interventional clinical studies). 2. Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) 28 days prior to the first dose of study drug, or five half lives of the previous agent, whichever is the shorter. 3. Participant has had radiation therapy encompassing >20% of the bone marrow within 2 weeks prior to Cycle 0 Day 1; or any radiation therapy within 1 week prior to Cycle 0 Day 1. 4. History of another primary malignancy within 5 years prior to Cycle 0 Day 1 except for Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of study drug and of low potential risk for recurrence Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease Adequately treated carcinoma in situ without evidence of disease (eg, carcinoma in situ of the cervix, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent). 5. Treatment with systemic corticosteroids or other immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and antitumor necrosis factor agents) within 2 weeks prior to Cycle 0 Day 1, or anticipated requirements for systemic immunosuppressive medications during the trial: o The use of inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids for patients with orthostatic hypotension, low-dose supplemental corticosteroids for adrenocortical insufficiency and topical steroids for cutaneous diseases are allowed. 6. Acute toxicities from previous therapies that have not resolved to Grade ≤ 1, with the exception of alopecia. 7. Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE > Grade 1. 8. Participant must not have received a platelet transfusion ≤ 4 weeks prior to Cycle 0 Day 1. 9. Participants must not have received colony stimulating factors (eg, granulocyte colony-stimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin) within 4 weeks prior to Cycle 0 Day 1. 10. Participant has had any known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted > 4 weeks and was related to the most recent treatment. 11. Participant must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). 12. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins. 13. Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or to any component of the TSR-042 formulation, or to niraparib or its components. 14. History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with anti-phospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis or glomerulonephritis Patients with autoimmune hypothyroidism on a stable dose of thyroid replacement hormone are eligible Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen are eligible. 15. Active or prior documented inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis). 16. History of interstitial lung disease, idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia or evidence of active pneumonitis on screening chest CT scan. 17. History of allogeneic organ transplant or prior bone marrow transplantation of double umbilical cord blood transplantation. 18. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection or severe infection requiring hospitalization or IV antibiotics within 2 weeks of starting treatment (with the exception of prophylactic antibiotics) symptomatic congestive heart failure > NYHA II, superior vena cava syndrome, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, pericardial effusion, myocardial infarction within 90 days active peptic ulcer disease or gastritis active bleeding diatheses
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0
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The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
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eligible ages (years): 0.0-999.0, Covid19 Appendicitis appendicitis any other diagnosis
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2
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The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
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eligible ages (years): 17.0-65.0, Cholecystitis, Chronic Morbid obese patients with BMI ≤30 KG/M2 and ≥ 40 9kg/m2 with symptomatic uncomplicated gall stones, ASA 1-3 Acute calcular cholecystitis, BMI ≥45, ASA 4 or higher, length of stay more than 1 day. Patients required additional trocars for patient safety, readmission
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0
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The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
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eligible ages (years): 0.0-999.0, Cancer Pain Patients aged 18 years or older Be able to read Chinese and use a mobile phone Histologically or cytologically confirmed solid tumor Diagnosed chronic cancer pain Could understand the study process and evaluation, agreed to participate in the trial, and signed the informed consent form Illiterate person Incompetence Inability to complete the pain assessment Participation in any other therapies or other study protocols that may have an impact on pain intensity, which were the main outcomes of this study
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0
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The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
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eligible ages (years): 17.0-40.0, Previous Cesarean Section Scar Pregnant women without any medical disorders Gestational age: 36-40 weeks Pregnant woman with singleton pregnancy Clinically adequate pelvis Normal ultrasonographic findings (gestational age, fetal structures and placental site) Cephalic vertex presentation Patients not inlabour Previous repair of ruptured uterus Women with history of long-term treatment for infertility Multiple pregnancies Previous operations in uterus rather than cesarean section Polyhydramnios and Fetal macrosomia Women with bad obstetric history (previous IUFD or difficult delivery) Disturbance of fetal heart rate (determined with the CTG)
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0
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The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
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eligible ages (years): 15.0-999.0, Dysmotility Syndrome Autoimmunity Males and females, Aged>15 Evidence of enteric dysmotility with documented abnormality on objective testing which may high resolution esophageal manometry, gastric emptying scintigraphy, SmartPill Wireless Motility Capsule, Sitz marker studies, antroduodenal manometry or anorectal manometry English proficiency and literacy sufficient to sign consent form and fill out questionnaires Previous Mayo paraneoplastic panel testing Referring gastroenterologist has recommended intravenous immunoglobulin (IVIg) therapy Non-autoimmune causes of enteric dysmotility (diabetes, adrenal insufficiency, Parkinson's, thyroid, electrolytes, drugs, malignancy) Pregnancy as documented in EPIC with serum or urine Human chorionic gonadotropin (hCG) testing If participants believe that they are pregnant, they will need to notify a study physician who will order a serum or urine hCG test for pregnancy within EPIC and remove them from the study if the test results come back positive Previous treatment with IVIg
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0
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The patient is a 31-year-old woman complaining of abdominal pain. The pain started last night as diffuse abdominal discomfort. She had poor appetite as well as malaise. The pain worsened in intensity and became sharp in the morning. The pain became localized to the right lower quadrant in the morning. The temperature is within the normal limits with normal vital signs. Focal tenderness and guarding were observed during palpation of the right lower quadrant. Palpation of the left lower quadrant causes pain on the right. Her lab work is remarkable for leukocytosis. Computed Tomography of the abdomen with contrast shows the presence of a distended appendix with thickened appendiceal wall without perforation, abscess or gangrene. She is a candidate for laparoscopic appendectomy under general anesthesia.
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eligible ages (years): 25.0-65.0, Pain Abdominal Pain Patients who underwent surgery in elective conditions were hospitalized for at least two days after surgery did not develop any serious complications after surgery were operated on under general anesthesia had no previous Reiki or back massage had a pain level of 3 or above according to the Numeric Pain Rating Scale had no cognitive, affective or communication problems used only one type of analgesic (a non-narcotic analgesic) did not use patient-controlled analgesics Patients with chronic disease (such as hypertension, cardiovascular disease) severe complications after surgery (such as bleeding, infection) those who were taking narcotic analgesics
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-75.0, Asthma Lung Diseases Patients with asthma; specific vary for each study
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2
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 0.0-999.0, Asthma Hypersensitivity Male or nonpregnant, non-breastfeeding females age 12-85 years. Diagnosis of persistent asthma for greater than 1 year and currently being treated with short acting beta-2 agonist only. FEV1 50-80% of predicted (must be demonstrated at Day 10 and Day 0). Patients will be stratified into 50-70% or 71-80% cohort at Day 10. Increase of greater than or equal to 15% over baseline FEV1 approximately 15-20 minutes after beta-2 agonist inhalation (2-4 puffs of albuterol via MDI or the nebulized equivalent) documented at baseline. Positive prick skin test to at least two allergens (defined as wheal 3 mm greater than control and erythema greater than control). History of asthma symptoms (wheezing, shortness of breath, cough, chest tightness, or nighttime awakening) on least 3 of the last 7 days. Fulfillment of washout by not using any of the medications listed below for the specified times prior to Day 0 of the study drug treatment: Parenteral corticosteroids for 4 weeks; Oral corticosteroids for 4 weeks; Inhaled corticosteroids for 4 weeks; Cromolyn sodium (Intal), nedocromil (Tilade) for 4 weeks; Theophylline, zileuton (Zyflo), zafirlukast (Accolate), or montelukast (Singulair) for 4 weeks; Astemizole (Hismanal) for 12 weeks; Terfenadine (Seldane), or fexofenadine (Allegra) for 6 days; Cetirizine (Zyrtec) for 6 days; Hydroxyzine (Atarax, Vistaril) for 6 days; Azelastine (Astelin) nasal spray for 6 days; and Salmeterol (Serevent) for 9 days. No clinically significant abnormality in chemistry, hematology, urinalysis: serum creatinine less than or equal to 1.7 mg/dL; total bilirubin less than or equal to 1.5 mg/dL; AST (SGOT), ALT (SGPT) less than or equal to 2 times laboratory's upper limit of normal. No clinically significant abnormality in EKG within 1 month prior to enrollment. No clinically significant abnormality in CXR (other than changes consistent with asthma) within 1 year prior to enrollment. Nonsmoker, for at least 2 years with a smoking history of no more than 10 pack years (e.g., one pack per day for 10 years). Agreement to use medically accepted contraception throughout the study, if sexually active, except females who are postmenopausal for greater than or equal to 2 years. Agreement not to donate blood or blood products throughout the study. Demonstrated ability to follow proper technique in the use of the AERx system. A written, signed, and witnessed consent form. No desensitization therapy within 3 months prior to Day 0 of study drug treatment. No use of any investigational or non-approved drug therapy within 30 days prior to Day 0 of study drug treatment. No occurrence of acute asthma exacerbation requiring emergency room treatment within 6 weeks of Day 0 of study drug treatment. No occurrence of acute asthma exacerbation requiring hospitalization within 12 months of Day 0 of study drug treatment. No occurrence of respiratory infection which affects asthma within 4 weeks prior to Day 0 of study drug treatment. No history of endotracheal intubation for asthma-related exacerbation within 15 years prior to Day 0 of study drug treatment. No presence of significant medical conditions (including obesity affecting respiratory function, congestive heart failure, myocardial infarction, unstable angina, uncontrolled hypertension, severe pulmonary disease, history of cancer [other than resected cutaneous basal or squamous cell carcinoma], insulin-dependent diabetes, autoimmune disease, or known HIV infection). No previous enrollment in a study of soluble IL-4 receptor. No history of alcohol abuse, drug abuse, or psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent. No patients experiencing hypersensitivity to soluble IL-4R
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 16.0-120.0, Pulmonary Complications Quality of Life Unspecified Adult Solid Tumor, Protocol Specific Histologically or cytologically proven diagnosis of cancer FEV-1/FVC at least 80% of predicted OR FEV-1/FVC less than 80% AND improvement in FEV-1 less than 15% after using a bronchodilator Maximum inspiratory pressure no greater than -50 cm of water Oximetry at least 90% Rating of dyspnea "moderate" or "severe" on verbal rating scale (VRS) of "none, mild, moderate, or severe" to describe "usual breathlessness" when walking over the past 24 hours Score for pain of "none" or "mild" on a VRS of "none, mild, moderate, or severe" for "unusual pain" over the past 24 hours Age: 16 and over Performance status: Not specified Life expectancy: Greater than 10 days Hematopoietic: Hemoglobin at least 8.5 g/dL Hepatic: AST/ALT no greater than 2 times upper limit of normal (ULN) No liver disease Renal: Creatinine no greater than 2 times ULN No kidney disease Cardiovascular: No acute congestive heart failure Greater than 3 months since prior myocardial infarction No coronary artery disease where cardiac stimulation might prove harmful (i.e., no unstable angina) No uncontrolled hypertension Pulmonary: See Disease Characteristics Other: Folstein Mini-Mental Status Exam score of at least 24 Able (i.e., sufficiently fluent) and willing to complete quality of life questionnaire and other assessments in either English or French No history of clinically significant allergy or intolerance to theophylline, aminophylline, or other methylxanthines No active peptic ulcer disease No uncontrolled hyperthyroidism PRIOR Biologic therapy: Not specified Chemotherapy: At least 14 days since prior chemotherapy No concurrent chemotherapy Endocrine therapy: At least 2 months since prior initiation of hormonal therapy Hormones as appetite stimulant allowed if received for more than 2 weeks No concurrent oral contraceptives Concurrent steroids allowed if taken for at least 1 week prior to study Concurrent inhaled or oral corticosteroids allowed if taken for at least 1 week prior to study No concurrent initiation of a new hormonal manipulation Radiotherapy: At least 28 days since prior radiotherapy that includes the lung in the treatment field No concurrent radiotherapy that includes the lung in the treatment field Surgery: Not specified Other: No concurrent digitalis glycosides, lithium, coumarin anticoagulants, other xanthines, cimetidine, quinolone antibiotics (e.g, ciprofloxacin and norfloxacin), macrolide antibiotics (e.g., erythromycin), fluvoxamine, and calcium channel blockers Concurrent nebulized or inhaled cromolyn, nedocromil, beta2-agonists, ipratropium, opioids, benzodiazepines, oxygen, and diuretics allowed if dose is stable for more than 1 week prior to study No concurrent paracentesis (i.e., thoracentesis) No concurrent blood transfusion
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-65.0, Lung Diseases, Interstitial Bronchiolitis Obliterans Current employees who have a decline in FEV1 larger than 200cc within the past year will be eligible to participate. All index cases will be eligible to participate
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-999.0, Heart Failure, Congestive Diagnosis of stable asymptomatic heart failure Documented ejection fraction less than 0.40 Must be able to comply with all study procedures Taken B-blocker therapy for longer than 1 week within 6 months prior to randomization Have heart problems that would not allow B-blocker therapy Receiving B-blockers therapy for any medical reason including topical B-blockers that might cause systemic absorption (e.g., glaucoma) Undergone certain heart surgeries, such as, prior heart transplant or cardiomyoplasty Have certain heart diseases Pregnant or breast feeding Unlikely to survive
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 5.0-11.0, Asthma Siblings of a birth cohort recruited 1997-1999 Age less than 11 years Physician diagnosed asthma Active symptoms (wheeze, persistent cough, chest tightness, shortness of breath) or medication use in the 12 months prior to enrollment
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 12.0-999.0, Cystic Fibrosis Key At least 12 years of age Diagnosis of cystic fibrosis with mild to moderate pulmonary impairment Must be receiving ongoing chronic treatment with TOBI (inhaled tobramycin) OR not receiving ongoing chronic treatment with TOBI and no use of TOBI or other inhaled antibiotic within 4 weeks prior to study drug administration· Other specific diagnostic indicators of CF and other factors must meet minimum requirements
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 0.0-999.0, Coronary Artery Disease Adults older than 21 years. Functional class (CCS) 3 or 4 angina attributable to atherosclerotic CAD, despite medical management, not optimal for mechanical revascularization due to coronary anatomy, co-morbidity, or patient preference. Left ventricular ejection fraction greater than 30 percent. Inducible myocardial ischemia by dobutamine stress MRI. No congestive heart failure symptoms within 2 months. No active infection. Normal renal function:creatinine less than 1.5 mg/dl, proteinuria less than 1plus Normal liver function: bilirubin less than 1.5 mg/dl, transaminases within normal limits. Normal blood count: WBC 3000-10000/microliter, granulocytes greater than 1500/microliter; platelet count greater than 150,000/microliter, Hgb greater than 12.5 g/dl. Subject understands protocol and provides written, informed consent in addition to willingness to comply with specified follow-up evaluations Myocardial infarction within 2 months. Crescendo angina: Angina pectoris that is prolonged in duration (greater than 30 minutes), does not respond to nitroglycerin (3 tablets), or is occurring with increasing frequency over the previous two weeks. Significant structural heart disease (e.g. hypertrophic or dilated cardiomyopathy, valvular heart disease) as determined by echocardiography. Patients who are HIV positive, have chronic inflammatory diseases, or are on chronic immunosuppressive medications. Women of childbearing age unless recent pregnancy test is negative. Lactating women. Known active malignancy or prior history of hematologic malignancy. Participation in unrelated research involving an investigational pharmacological agent 30 days before planned G-CSF dosing. Contraindication for MRI. Known hypersensitivity to E. coli-derived proteins or to gadolinium
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 12.0-80.0, Asthma Males and non-pregnant, non-breastfeeding females 12 through 80 years of age FEV1 in the context of this study is greater than 60% and not less or equal to 87% of predicted values at Visit 1 or Visit 2 (and no short-acting agent beta-agonist use within 6 hours prior to spirometry) Improvement in FEV1 of at least 12% of predicted value and at least 200ml within 15 to 30 minutes of inhaling 2 puffs of albuterol 90mcg/actuation demonstrated at study entry OR documented during the previous 12 months at the study site Use of a short-acting, beta-agonist inhaler to treat asthma symptoms on an average of at least 2 days per week during the previous 2 weeks (greater than or equal to 4 days total during the previous 2 weeks, excluding prophylactic use) Otherwise healthy
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 12.0-80.0, Asthma Males and non-pregnant, non-breastfeeding females 12 through 80 years of age FEV1 in the context of this study is greater than 60% and not less or equal to 87% of predicted values at Visit 1 or Visit 2 (and no short-acting agent beta-agonist use within 6 hours prior to spirometry) Improvement in FEV1 of at least 12% of predicted value and at least 200ml within 15 to 30 minutes of inhaling 2 puffs of albuterol 90mcg/actuation demonstrated at study entry OR documented during the previous 12 months at the study site Use of a short-acting, beta-agonist inhaler to treat asthma symptoms on an average of at least 2 days per week during the previous 2 weeks (greater than or equal to 4 days total during the previous 2 weeks, excluding prophylactic use) Otherwise healthy
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 12.0-80.0, Asthma Males and non-pregnant, non-breastfeeding females 12 through 80 years of age FEV1 in the context of this study is greater than 40% and not less or equal to 87% of predicted values for subjects not currently taking ICS and greater than 40% and not less or equal to 95% for those subjects taking ICS at Visit 1 and/or Visit 2 (and no albuterol use within 6 hours prior to spirometry) Improvement in FEV1 of at least 12% of predicted value and at least 200ml within 15 to 30 minutes of inhaling 2 puffs of albuterol 90mcg/actuation demonstrated at study entry OR documented during the previous 12 months at the study site Use of a short-acting, beta-agonist inhaler to treat asthma symptoms on an average of at least 2 days per week during the previous 2 weeks (greater than or equal to 4 days total during the previous 2 weeks, excluding prophylactic use) Otherwise healthy
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 12.0-75.0, Asthma with the diagnosis of allergic asthma >1 year duration who, in addition to the standards of the American Thoracic Society (ATS) meet the following with a positive prick skin test (diameter of wheal > 3 mm) to at least one perennial allergen (e.g. dust mite, animal dander, cockroaches), within the past 5 years or at Visit 1, to which the patient will be exposed on a regular basis (most days) for the duration of the study. A RAST test may be performed for patients with a borderline skin prick test result with total serum IgE level 30 to 700 IU/ml demonstrating 12% increase in FEV1 over baseline value within 30 minutes of taking up to 4 puffs salbutamol (albuterol) or nebulized salbutamol up to 5mg (or equivalent of alternative B-2 agonist) documented within the past year, at screening, during the run-in period or at baseline prior to randomization with FEV1 40-80% of predicted normal value for the patient (demonstrable at least 6 hours after short acting B-2 agonist use or 12 hours after long acting B-2 agonist use) at baseline who have either experienced at least two independent asthma exacerbations requiring unscheduled clinical intervention with a systemic corticosteroid in the past year. or been admitted to hospital (including intensive care unit) or received emergency room (including urgent care centers) treatment in the past 12 months for an asthma exacerbation, which in accordance with the GINA guidelines met all of the following for a severe exacerbation: 1. PEF or FEV1< 60% of predicted/personal best, or patient is too breathless to provide PEF. 2. No improvement after initial treatment and therefore requiring repeated treatment with inhaled B-2 agonist (high dose, spacer or nebulized). 3. Requiring treatment with systemic corticosteroids receiving high dose inhaled corticosteroid (at least 1000ug beclomethasone dipropionate or equivalent) and a regular inhaled long acting B-2 agonist for at least 3 months prior to screening and prior to at least two independent asthma exacerbations requiring unscheduled clinical intervention with a systemic corticosteroid in the past year or the severe asthma exacerbation requiring the hospitalization/ER visit who are receiving an ICS dosage > 1000ug beclomethasone dipropionate or equivalent and a regular inhaled long acting B-2 agonist for the last 4 weeks of the run-in period and at randomization (to be maintained throughout the study) whose asthma medication remains unchanged in the final 4 weeks of the run-in period (to be maintained throughout the study)
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2
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-120.0, Dyspnea Pulmonary Complications Unspecified Adult Solid Tumor, Protocol Specific Diagnosis of cancer Treatment includes the following scenarios May have had prior chemotherapy course(s) Scheduled to receive at least 2 courses of chemotherapy Courses may multiple treatment days such as days 1-5 or day 1-day 8 regimens and may oral regimens Dyspnea as a symptom within the past 5 days (defined by a score of at least grade 2 on the Modified Medical Research Council Dyspnea Scale) All underlying causes of dyspnea have received medical treatment per best clinical judgement of treating physician Age and over Performance status Eastern Cooperative Oncology Group 0-2 Life expectancy Not specified Hematopoietic
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-999.0, Lung Neoplasms Breast Neoplasms Diagnosis of local or metastatic breast or lung cancer Shortness of breath with onset after cancer diagnosis Life expectancy of at least 4 weeks Prior acupuncture Other conditions suspected of causing shortness of breath, such as congestive heart failure, sarcoid disease, pneumonia, or obesity No chest wall deformity Neuromuscular disorders Pulmonary vascular disease Anemia Uncontrolled pain or infection Heart valve dysfunction
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 15.0-75.0, Rhinitis, Allergic, Seasonal Asthma Have at least a two-year history of seasonal allergic rhinitis and an increase in asthma symptoms associated with the allergy season under study Demonstrate an increase in absolute FEV 1 less than 12%, with an absolute volume increase of at least 200 ml, after reversibility testing within the past 12 months Is skin test positive (skin prick test with a wheal diameter at least 3 mm larger than the diluent control or intradermal testing with the wheal diameter at least 7 mm larger than diluent control) at screening, or within 12 months prior to the screening visit, to a seasonal allergen (which may seasonal molds) prevalent during the study period Female participants of childbearing potential use a medically accepted method of birth control and agree to continue its use during the study or be surgically sterilized (eg, hysterectomy or tubal ligation). Females who are not sexually active at time of study agree and consent to use a medically acceptable method of birth control should they become sexually active while participating in the study Female participants who are pregnant, intend to become pregnant during the duration of the study, or are nursing Have asthma symptoms and require chronic use of inhaled or systemic corticosteroids Have current or historical frequent (2 or more episodes per year for the past 2 years), clinically significant sinusitis or chronic purulent postnasal drip Have recent nasal septum ulcers, nasal surgery or nasal trauma, which should not be included until healing occurs Have rhinitis medicamentosa or chronic obstructive pulmonary disease (COPD) Have an upper or lower respiratory tract or sinus infection that requires antibiotic therapy, or have a viral upper or lower respiratory infection Have nasal structural abnormalities, including large nasal polyps and marked septum deviation, that significantly interferes with nasal air flow Are dependent on nasal topical antihistamines, or nasal steroids On immunotherapy (desensitization therapy) and will receive an increase in dose during the study; participants who will receive desensitization treatment within 24 hours prior to a study visit Is a participant who smokes, or is an ex-smoker who has smoked within the previous six months
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-999.0, Heart Failure, Congestive Patient receives all cardiology care at a VISN 11 VAMC Must have chronic heart failure (CHF) secondary to systolic or diastolic dysfunction, as defined by meeting (1) or (2) below: 1. Systolic Dysfunction, defined by a history or documentation of LVEF = 40% (or fractional shortening = 20%-if LVEF not documented) AND at least ONE of the following Current diagnosis or history of CHF and/or Physical findings and/or symptoms of CHF within two months of enrollment and/or Hospitalization for CHF within 12 months OR 2. Diastolic Dysfunction, defined by a history of documentation of LVEF > 40% (or fractional shortening > 20% if LVEF not documented) AND Physical findings and/or symptoms of CHF within two months of enrollment Based on medical record data, patient does not have any co-morbidity other than CHF which, in the opinion of the investigator, limits life expectancy to less than six months (e.g., metastatic CA, hospice care, renal failure with a creatinine above 5.0 mg/dL or on dialysis, HIV)
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 12.0-999.0, Hayfever Rhinitis, Allergic, Seasonal Seasonal Allergic Rhinitis Informed consent Outpatient Females must use appropriate contraception Diagnosis of seasonal allergic rhinitis Adequate exposure to allergen Able to comply with study procedures Literate Significant concomitant medical condition Use of corticosteroids, allergy medications, or tobacco Clinically significant abnormal ECG Laboratory abnormality Positive pregnancy test Allergy to any component of the investigational product
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 12.0-999.0, Rhinitis, Allergic, Seasonal Informed consent Outpatient Females must use appropriate contraception Diagnosis of seasonal allergic rhinitis Able to comply with study procedures Literate Significant concomitant medical condition Use of corticosteroids, allergy medications, or tobacco Clinically significant abnormal ECG Laboratory abnormality Positive pregnancy test Allergy to any component of investigational product
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-50.0, Asthma Confirmed allergy to at least one of the following allergen preparations: house dust mite f; house dust mite p; cockroach; tree mix; grass mix; weed mix; mold mix 1; mold mix 2; rat; mouse; guinea pig; rabbit; cat; or dog Oxygen saturation greater than 94% at baseline Systolic blood pressure between 150 and 90 mm Hg, diastolic blood pressure between 90 and 60 mm Hg Physician-diagnosed asthma or history of episodic wheezing, chest tightness, or shortness of breath consistent with asthma Airway reactivity as determined by either a provocative concentration of methacholine producing a 20% fall in FEV1 (PC20 methacholine) of less than 10 mg/ml by the method used or 12% reversibility of baseline lung function with albuterol therapy for two of the three measures: FVC, FEV1, and FEF25-75% Agree to discontinue use of vitamin supplements for the duration of the study On a stable regimen of maintenance asthma therapy that has not changed within the month prior to participation Chronic medical condition that may make vitamin E and vitamin C treatment medically inadvisable (e.g., significant cardiovascular disease, diabetes requiring medication, chronic kidney disease, chronic thyroid disease, or coagulation defects) History of kidney stones Use of anticoagulants (e.g., warfarin, heparin, or clopindogrel) Pregnant or breastfeeding Use of inhaled steroids, cromolyn, or leukotriene inhibitors (Montelukast or Zafirkulast) for at least one month is not for exclusion
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2
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 21.0-70.0, Asthma COPD Emphysema Chronic Bronchitis Asthmatic patients: 1. Age 21-79 years of both sexes (females will be taking adequate contraceptive measures). 2. Increase in FEV1 >15% and >200ml following beta2 agonist inhalation, either at the time of study or previously documented COPD patients: 1. Stable patients with a post-salbutamol FEV1 30-70% predicted normal of >1L 2. Increase in FEV1 < 15% and < 200 ml following beta2 agonist inhalation, either at the time of study or previously documented 3. Age 21-79 years of both sexes (females will be taking adequate contraceptive measures ) 4. Smokers 5. No history of allergic or respiratory disease. Normal Volunteers 1. Age 21-79 years of both sexes (females will be taking adequate contraceptive measures ) 2. Non-smokers 3. Normal lung function 4. No upper respiratory tract infection within the last 4 weeks 5. No history of allergic or respiratory disease. Healthy Smokers 1. Age 21-79 years of both sexes (females will be taking adequate contraceptive measures ) 2. Smokers 3. Normal lung function 4. No upper respiratory tract infection within the last 4 weeks - Asthmatic patients with FEV1 less than 40% predicted value 2. Alcohol abuse 3. Any history or evidence of hepatic, cardiovascular or renal disease 4. Any history or evidence of neuropsychiatric disease 5. Drug abuse or any other condition associated with poor compliance 6. Pregnancy or breast feeding 7. Patients are unable to provide written informed consent COPD patients: 1. Any other active lung diseases 2. Upper respiratory infection within the last 4 weeks 3. Pregnancy or breast feeding 4. Any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study 5. Subjects unable to give informed consent -
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2
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-75.0, Asthma Mild to moderate persistent asthma (NAEPP/GINA Step 2-3) Reversibility to albuterol at least 12% and 200 mL Any significant co-morbid disease, particularly cardiovascular Use of any maintenance therapy except short acting bronchodilators Smoking history > or = 10 years
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 6.0-999.0, Asthma physician-diagnosed asthma age 6 or older pre-bronchodilator forced expiratory volume (FEV1) of at least 60% of predicted beta-agonist reversibility OR airways hyperreactivity by methacholine challenge Juniper Asthma Control Score of 1.5 or greater if not on daily controller good current health current or past smoking (greater than 20 pack-years) chronic or current oral steroid therapy pregnancy, lack of effective contraception (when appropriate), lactation
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 21.0-75.0, Chronic Obstructive Pulmonary Disease Healthy non-smokers: normal spirometry (forced expiratory volume in 1 second [FEV1] more than or equal to 90% predicted) and normal exhaled NO (between 8 and 24 ppb; flow 50 ml/s) At risk (current or ex-smokers): normal spirometry, with or without chronic symptoms (cough, sputum production) I-II: Mild-moderate COPD FEV1 reversibility of < 15% after inhaled beta2-agonists FEV1/forced vital capacity (FVC) < 70% predicted FEV1 between greater than or equal to 50% and less than 80% With or without chronic symptoms (cough, sputum production) Able to comprehend and grant a written informed consent 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
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-80.0, Asthma Males and non-pregnant, non-breastfeeding females 18 through 80 years of age Clinically acceptable ECG Diagnosis of moderate to severe persistent asthma History or presence of episodic symptoms of airflow obstruction (wheeze, chest tightness, cough, shortness of breath) Airflow obstruction is at least partially reversible FEV1 in the context of this study is <80%of predicted values at visit 1 with no short-acting ß agonist use within 6 hours of spirometry Improvement of at least 12% of predicted FEV1 value and at least 200 ml within 15 to 30 minutes of inhaling nebulized albuterol (up to 5mg) or 2-4 puffs of albuterol (90 mcg/actuation) demonstrated at study entry or documented in the last year Subjects must be able to demonstrate proper technique for use of the MiniWright peak flow meter Subjects must have a negative skin test to the 5 common perennial aeroallergens (D. farinae, D. pteronyssinus, cat, dog, and cockroach) at prick puncture with an adequate histamine control Subjects must have negative RAST to the same 5 common perennial aeroallergens Respiratory tract infection within 14 days prior to Visit 1 Chronic bronchitis, COPD, emphysema and other chronic lung diseases Receiving immunotherapy other than maintenance therapy Current smokers Current use of Xolair® Recent history of drug or alcohol abuse (within 3 years prior to Visit 1) Pregnant or likely to become pregnant during the study Breast-feeding History of hypersensitivity to albuterol, or Xolair, or to drugs with similar chemical structures Treatment with any investigational drug in the last 30 days before enrollment into the study (Visit 1)
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2
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 4.0-11.0, Asthma Main Outpatients Symptoms consistent with the diagnosis of asthma for at least 12 months Forced Expiratory Volume in one Second (FEV) at least 80% of predicted Participants who have a history of reversible airway obstruction Good health with the exception of asthma Main History of life-threatening asthma A hospitalization for asthma within the last 3 months, or more than two hospitalizations for asthma within the last year Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids Participants suffering from relevant lung diseases causing alternating impairment in lung function (e.g. chronic bronchitis or emphysema) Prematurely born children (<36 weeks of gestation) Smokers Pregnancy (or intention to become pregnant during the course of the trial), breast feeding or lack of safe contraception by female of child-bearing potential
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 4.0-15.0, Asthma Main History of persistent bronchial asthma for at least 6 months FEV1 50-90% of predicted Main Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids COPD (chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function Respiratory tract infection or asthma exacerbation within the last 30 days prior to entry into the study History of life-threatening asthma Premature birth Current smoking Smoking history with either equal or more than 10 pack-years Pregnancy Intention to become pregnant during the course of the study Breast feeding
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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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
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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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
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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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 -
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2
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-70.0, Asthma History of asthma for at least one year,confirmed objectively. 2. New or previously reviewed patients where the minimal treatment requirements have not been established within the last six months Smokers or ex-smokers for less than 6 months with a smoking history of more than 10 pack years. 2. Other pulmonary co-morbidity (other than mild or moderate chronic airflow limitation). 3. Subjects having a co-existing illness that precludes them from the study. 4. Inability to give informed consent due to mental or legal reasons. 5. Pregnancy or lactation. 6. Known non-compliance with medications
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2
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-70.0, Asthma Male and female patients with a history of asthma between the ages of 18 and 70 years PC20FEV1 Methacholine ≤ 8.0 mg/mL At least one of the following symptoms, beta agonist use, or FEV1 Asthma symptoms on at least two days per week or Beta agonist use on at least two days per week or FEV1 < 85% predicted Subjects must be non-smokers (patients who have never smoked or patients who have not smoked for 1 year and have a total pack-year smoking history < 15 packs) History of oral or inhaled steroid use in the past 4 weeks FEV1 < 60% predicted Lung disease other than asthma Patients with a history of a respiratory tract infection in the 4 weeks preceding the study Patients who have experienced a significant exacerbation in their asthma in the 6 weeks prior to the study Patients receiving hyposensitization therapy with the exception of those who are on a stable dose for the last three months Patients with cardiovascular disease (active) peptic ulcer disease or diabetes mellitus Females who are lactating or who are pregnant
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-90.0, Asthma Male or female, ages 18 and older Clinical history consistent with asthma For subjects regularly using inhaled corticosteroids, FEV1 50% of predicted, methacholine PC20 FEV1 16 mg/ml or 12% and 200 ml, improvement in FEV1 after 2 puffs of inhaled albuterol For subjects not regularly using inhaled corticosteroids, FEV1 40% of predicted, methacholine PC20 FEV1 8 mg/ml or 12% and 200 ml, improvement in FEV1 after 2 puffs of inhaled albuterol Genotype (determined during screening) Smoker (total smoking history must be less than 10 pack years) Significant unstable medical condition other than asthma History of life-threatening asthma requiring treatment with intubation and mechanical ventilation in the past 10 years Pregnant or lactating
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2
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-65.0, Asthma Exercise-triggered asthmatics defined as asthmatics with exertion as their primary exacerbating factor and experiencing less than two episodes of classic gastroesophageal reflux a week will be the following: 1. Severe asthma (recent or repeated hospitalizations) 2. Severe angina, cardiac arrhythmia's, heart failure, prior MI 3. Respiratory illness e.g. COPD 4. Inability to receive therapy/pH probe 5. Pregnancy 6. Minors, prisoners, individuals unable to give informed consent 7. Prior upper GI surgery (gastrectomy, etc)
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-999.0, Acute Myocardial Infarction Heart Failure Pulmonary Embolism Age 18 and older Visit to the ED is due to a primary complaint of shortness of breath alone or shortness of breath with associated chest pain, cough or edema Blood sample cannot be collected before treatment is initiated, specifically CPR or treatment with i.v. diuretics, injectable anticoagulants, thrombolytics Patient is unwilling or unable to give consent to participate in the study Patient has renal disease requiring dialysis Patients with a clear exacerbation of isolated asthma Patients with trauma that interferes with normal breathing function
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-85.0, Asthma Gastroesophageal Reflux Disease Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent Subjects must be 18 years of age or older Subjects baseline FEV1 must be greater than or equal to 50% of predicted at both Visit 1 and visit 2, when all bronchodilators medications have been withheld for the specified intervals Subjects must have physician-diagnosed asthma at visit 1 and report ongoing chronic or intermittent symptoms that at least one of the following: wheezing, chest tightness, dyspnea, or cough All subjects with a baseline FEV1 greater than or equal to 70% predicted must have a positive methacholine challenge (provocative dose required to reduce FEV1 20% is less than or equal to 10 mg inhaled methacholine) at either visit 1 or visit 2 All subjects with a baseline FEV1 greater than 50% but less than 70% must demonstrate at least 12% improvement in FEV1 after a bronchodilator is administered at visit 1 or visit 2 Subjects must report using rescue inhaled beta adrenergic agonist treatment at least twice weekly for asthma symptoms (e.g. 2 or more nebulized treatments or 4 or more puffs of inhaled albuterol per week) Subjects must experience asthma symptoms (wheezing, shortness of breath, cough, chest tightness, or nocturnal awakening) of at least mild severity on at least 2 days out of each week of run-in (1 week equals 7 days). In addition, the asthma symptom diary card score (over a two week period) must total at least 10 as recorded by the study subject in the run-in diary card. The run-in period may vary in length from 7 days to 28 days, as long as the 10 point score is achieved in a 10 day period Subjects must be free of any clinically significant disease other than asthma Women of childbearing potential must have a negative urine (hCG) pregnancy test at visit 1 or visit 2 and agree, if sexually active, to use medically accepted contraception as defined in ICH guidelines throughout the study Female subjects who are pregnant or lactating Subjects who have required daily or alternate day oral corticosteroid treatment for more than a total of 21 days during the 6 months immediately prior to Visit 1 Subjects who require daily treatment with proton pump inhibitors, H2-receptor antagonists, or OTC anti-reflux medications) Subjects on immunotherapy, unless they are on a stable maintenance schedule for at least 6 months Subjects who have used any investigational drug in the 30 days prior to visit 1 Subjects who have experienced allergic or idiosyncratic reactions to PPI, corticosteroid, or inhaled beta adrenergic agonist agents Subjects demonstrating a change in FEV1 of 20% or more between visit 1 and 2 Subjects who have required ventilatory support for respiratory failure due to asthma within 5 years of Visit 1 Subjects who smoke, have smoked within the past 6 months, or have more than a 15 pack-year history of smoking Subjects who have required hospitalization for asthma in the previous 3 months
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-70.0, Lung Diseases Asthma Kaiser Health Care Program member for more than 1 yr Site: Portland, OR, Honolulu, HI, San Francisco, Oakland, or Richmond, CA Confirmed diagnosis of persistent asthma with currently prescribed medications; no daily or alternate daily oral corticosteroid Evidence of poorly controlled asthma: score of >=1 on ATAQ asthma control questionnaire1 and either overuse of rescue medication vs. controller medications and/or recent emergency visit or hospitalization for asthma COPD not the primary lung disease diagnosis Regular use of Inhaled Corticosteroid (ICS) and current/ex-smokers: >= 8% increase in FEV1 post-bronchodilator; if no routine ICS use +/ smoking HX: >= 12% increase required; non-smokers using ICS regularly not required to reverse
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 8.0-17.0, Asthma Allergy Children and adolescents between 8 and 17 years of age at the start of the trial (born after 01 March '88, but before 01 September '97) Bronchial asthma, diagnosed by a physician, and confirmed by a physician at a paediatric department of a Norwegian Hospital Allergy against dogs, confirmed by skin prick test. Average infiltrate at least 4 millimetres against dog, diagnosed by a new skin prick test at entry. For details about skin prick test, see attachment no. 6 Having had nose or breathing symptoms by contact with dogs, when no drugs against asthma or allergy have been taken Able to co-operate at cold air hyperventilation test and spirometry (see attachment no. 2) Given written consent (by parents of children below 12; by parents and child when above 12, but below 16; by patient when above 16) Positive house dust mite skin prick test, with a more than 3 mm infiltrate Having taken oral beta-2-agonists or theophylline preparations for the last 2 weeks before trial start, or oral steroids for the last 3 months before start of the trial Active smoking Dogs or cats in the home Staying away from the home continuously for more than 14 days in the trial period or during the last month before trial start Being an in-patient in a special department or institution for asthma and allergy in the trial period or the last 3 months before the trial Having another chronic disease that can influence the results of ECP or cold air hyperreactivity tests Other types of mechanical ventilation or air filtration systems in the homes, except for those for kitchen stoves
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-999.0, Asthma Physician diagnosis of asthma Receiving treatment with one or more daily controller (i.e., preventive) medications Age = 18 years Less than 30 pack years of cigarette smoking FEVi greater than 50% of predicted FEVi bronchodilator response of at least 12% Ability to use a telephone without assistance N/A
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2
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 19.0-95.0, Lung Diseases Asthma Diagnosis of asthma Under a provider's care for asthma Prescribed daily inhaled corticosteroids (by metered dose inhaler [MDI]) at least 2 times a day Speaks English Otherwise in good general health N/A
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2
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 20.0-71.0, Bronchial Asthma Main Patients with asthma disease Written informed consent Patients who completed the 24-week evaluation of study APTA-2217-05 Main % FEV1.0 < 60% at both 18 weeks and 24 weeks measurements during APTA-2217-05 Patients with poorly controlled asthma between informed consent day and study starting day: need for oral or intravenous steroid therapy, hospitalization or any emergency visit, PEF value worsened for 2 or more consecutive days Serious diseases
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-999.0, Coronary Artery Disease Chest Pain Referral for cardiac stress testing with SPECT myocardial perfusion imaging refusal to provide written informed consent or lack capacity to provide informed consent
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-999.0, Moderate Asthma A physician diagnosis of asthma 2. Age years old 3. Symptoms consistent with asthma for at least 6 months 4. Current asthma medications: Short-acting inhaled beta agonists as needed for control of asthma symptoms with or without a low to medium dose of an ICS, as defined in the table below and if on a ICS may also be on a long-acting beta agonist provided it is withheld for 24 hours prior to the testing days. Inhaled Corticosteroid Dose less than or equal to: Beclomethasone-HFA 480 µg/day Budesonide-DPI 1000 µg/day Flunisolide 2000 µg/day Fluticasone 500 µg/day Triamcinolone 2000 µg/day 5. FEV1 at screening 50-80% predicted (Hankinson6) 6. Reversibility with albuterol of 12% and 200 ml FEV1FEV1 at 30 minutes
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 19.0-999.0, Asthma asthma plus or minus chronic obstructive pulmonary disease (COPD) ED visit for acute asthma treatment age 19 years or greater COPD without asthma ED visit for asthma prescription renewal only
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-60.0, Asthma Have a diagnosis of moderate asthma as defined by the American Thoracic Society (NIH, 1997) for > 1 year. 2. Men and women, >/= 18 to </= 60 years of age and within 60-140% of desirable height and weight range established by the 1983 Metropolitan Life Insurance Company standards. 3. Non-smoker for at least 1 year and less than a 10 pack year history of smoking. 4. Screening values for haematology, biochemistry and urinalysis should be within clinically acceptable limits for this patient group. 5. Chest radiograph at screening must show no evidence of malignancy, infection, or fibrosis. The chest radiographs should also show no apical scarring, cavitary lesions, or calcified granulomas, as evidence of past tuberculosis infections. 6. Serological assays for hepatitis B and C must be negative for active infection Are pregnant, nursing, or planning a pregnancy within 12 months of enrolment. 2. Diagnosis of chronic obstructive pulmonary disease, cystic fibrosis or other significant respiratory disorder (excluding asthma). 3. Exacerbation of asthma symptoms requiring hospitalisation within the previous 12 weeks. 4. History of clinically significant seasonal allergies will require that the patient is studied outside the allergy season. 5. Have been previously treated with infliximab or any other therapeutic agent targeted at reducing TNF. 6. Have been treated with any anti-CD-4 antibody. 7. Have been treated with any investigational drug within the previous 3 months or within 5 half-lives, whichever is greater. 8. Have previously used cyclophosphamide, nitrogen mustard, chlorambucil, or other alkylating agents. 9. Have a history of any clinically significant adverse reaction to murine or chimeric proteins, including but not limited to allergic reactions. 11. Have had a serious infection during the previous 2 months. 12. Have a chronic or recurrent infectious disease 13. Have a history of opportunistic infections 14. Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease. 15. Have a history of lymphoproliferative disease, including lymphoma 16. Currently have any known malignancy or have a history of malignancy within the previous 5 years. 17. Have had substance abuse (drug or alcohol) problem within the previous 10 years. 18. Use of restricted respiratory medication prior to screening within the following time periods: 1) oral or systemic steroids, 1 month; 2) immunosuppressant therapy, 3 months. 19. Have a history of chronic cough, haemoptysis, weight loss, or pyrexia considered suggestive of possible current tuberculosis infection. 20. Patients with current active tuberculosis (TB) or atypical mycobacterial infection or a previous history of these infections. 21. Be considered at high risk for tuberculosis according to US Centers for Disease Control and Prevention (CDC) 22. A tuberculin (purified protein derivative, PPD) intradermal skin test > 10mm induration. 23. Have demyelinating disease (multiple sclerosis), autoimmune conditions such as systemic lupus
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-90.0, Asthma Moderate to severe persistent asthma Subject is stable on same asthma medications for at least one month If the subject is a woman of child-bearing age, a negative pregnancy test Less than 18 yrs/ age Baseline Forced Expiratory Volume in 1 second (FEV1) <40% predicted Known or suspected allergy to L-arginine Pregnant women, nursing women, or women actively trying to achieve pregnancy Current smokers Subjects with more than a 15 pack-year history of smoking
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 7.0-15.0, Asthma Lung Diseases Diagnosed asthma or history of breathing problems (coughing, wheezing, shortness of breath) in the 12 months prior to study enrollment; 2) Non-Latino white, Puerto Rican or Dominican ethnic background; 3)ages 7-15 years
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-50.0, Asthma Allergy Normal lung function, defined as (Knudson 1976/1984 predicted set) FVC of > 80 % of that predicted for gender, ethnicity, age and height FEV1 of > 80 % of that predicted for gender, ethnicity, age and height FEV1/FVC ratio of > 80 % of predicted values Evidence of allergy to house dust mite Oxygen saturation of > 94 % Normal blood pressure (Systolic between 150 Diastolic between 90-60 mm Hg) Symptom Score (defined in section "f") no greater than 20 (out of a possible 60) for total symptom score with a value no greater than 3 for any one score. No more than one score may be greater or equal than 3 IgE within the following ranges and body weights for omalizumab dosing: IgE ≥30-700 int. units/mL, and weight 30-90 kg A history of significant chronic illnesses (to diabetes, autoimmune diseases, immunodeficiency state, known ischemic heart disease, chronic respiratory diseases such as chronic obstructive pulmonary disease or severe asthma, hypertension) Allergy to any medications which may be used in the course of this study (albuterol, acetaminophen, aspirin or non-steroidal anti-inflammatory agents, corticosteroids, lactose, polyethylene glycol) Positive pregnancy test at time of initial screening Medications which may impact the results of the ozone challenge, interfere with any other medications potentially used in the study (to steroids, beta antagonists, non-steroidal anti-inflammatory agents) or suggest an ongoing illness (such as antibiotics) Mega doses of vitamins and supplements, homeopathic/naturopathic medicines Acute, non-chronic, medical conditions, including (but not limited to) pneumonia or bronchitis requiring antibiotics, febrile illnesses, flu-like symptoms must be totally resolved symptomatically for 2 weeks. Documentation of normal lung function (as defined in "Specific Criteria") must be met Unspecified illnesses, which in the judgment of the investigator increase the risk associated with ozone inhalation challenge, will be a basis for exclusion Physician directed emergency treatment for an asthma exacerbation within the preceding 12 months Use of systemic steroid therapy within the preceding 12 months Use of inhaled steroids, cromolyn or leukotriene inhibitors (Montelukast or zafirkulast) initiated within the past month (except for use of cromolyn exclusively prior to exercise). Patients must be on a stable regimen of therapy and shown to be stable
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 16.0-999.0, Rhinitis Allergic Seasonal Female subject of non-childbearing potential or of childbearing potential agreeing not to become pregnant during the study Have had seasonal allergic rhinitis due to Ragweed for the last 2 consecutive years Subjects who obtain a minimum sum considering SAR related symptoms (mean value) as defined by protocol Any clinically significant condition that might interfere with the treatment evaluation, both for efficacy and safety Have used forbidden concomitant medications as defined by the protocol
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-70.0, Asthma Chronic Obstructive Pulmonary Disease (COPD) Sputum eosinophilia >3% Adults age 18-70 years History of episodic wheeze, chest tightness, dyspnea or cough within the last 12 months FEV1 ≥ 60% predicted Steroid naive or on not more than 500 µg a day of beclomethasone or equivalent Able to give written informed consent Recent asthma or COPD exacerbation (as judged by the clinician) due to respiratory infection within the last month 2. Relevant seasonal allergen exposure within 4 weeks or within the course of the study 3. Treatment with prednisone or antibiotics or hospitalisation within the past 6 weeks 4. Other respiratory diseases 5. Women who are pregnant or unwilling to use appropriate contraception during the study 6. Unable to withhold short-acting ß-agonist treatment for 6 hours before visit
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-999.0, Rhinitis, Allergic, Seasonal Have had seasonal allergic rhinitis due to Ragweed for the last 2 consecutive years Subjects who obtain a minimum sum score, considering Seasonal Allergic Rhinitis (SAR) related symptoms (mean value), as defined by the protocol Any clinically significant condition that might interfere with the treatment evaluation, both for efficacy and safety Have used forbidden concomitant medications as defined by the protocol
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 15.0-999.0, Asthma A subject will be considered eligible for in this study only if all of the following apply Consent: A signed and dated written informed consent must be obtained from the subject or subject's legally acceptable representative prior to study participation. An informed consent must be signed prior to any change in the subject's medication regimen, including withholding medications prior to Visit 1 Gender: Male or female. Females are eligible to participate only if they are currently not pregnant and not lactating. Females of child-bearing potential will be required to use a highly effective method for avoiding pregnancy (i.e., contraception with a failure rate of <1% per year). Female subjects of child-bearing potential will undergo a urine pregnancy test at Visits 1, 2, 3, and 4. Any female who becomes pregnant during the study will be withdrawn. Female subjects should not be enrolled if they plan to become pregnant during the time of study participation Age: 15 years and older Asthma Diagnosis: A diagnosis of persistent asthma, for at least three months, as defined by the following American Thoracic Society definition: Asthma is a clinical syndrome characterized by increased responsiveness of the tracheobronchial tree to a variety of stimuli. The major symptoms of asthma are paroxysms of dyspnea, wheezing, and cough, which may vary from mild and almost undetectable to severe and unremitting (status asthmaticus). The primary physiological manifestation of this hyperresponsiveness is variable airway obstruction. This can take the form of spontaneous fluctuations in the severity of obstruction, substantial improvements in the severity of obstruction following bronchodilators or corticosteroids, or increased obstruction caused by drugs or other stimuli [American Thoracic Society, 1987a]. NOTE: Intermittent and seasonal asthma, as well as exercise-induced bronchospasm alone, are excluded Asthma Therapy: 3 months' prior and current use of one of the following asthma therapies, with no change in regimen during the month prior to Visit 1 Scheduled or as-needed inhaled or oral short-acting beta2-agonist (SABA). Subjects must be able to replace their current short-acting beta2-agonist with albuterol/salbutamol, to be used only on an as-needed basis for the duration of the study Allowed non-corticosteroid controller therapy (e.g., anticholinergics and cromolyn) One of the following inhaled corticosteroids taken at the corresponding daily dose: criteria. Inhaled Corticosteroid (Total Daily Dose) Beclomethasone dipropionate (≤420mcg) Beclomethasone dipropionate HFA (≤240mcg) Budesonide (≤400mcg) Flunisolide (≤1000mcg) Fluticasone propionate inhalation aerosol (≤220mcg) Fluticasone propionate inhalation powder (≤250mcg) Mometasone furoate (≤220mcg) Triamcinolone acetonide (≤1000mcg) Subjects taking 100/50mcg BID are eligible to replace with HFA 110mcg BID for 14 days prior to Visit 1. This change will be at the Investigator's clinical discretion, taking each individual's current and past asthma stability into account. The subject must be aware of the risks and benefits of switching their medication and acknowledge this by signing an informed consent prior to any change in the subject's medication regimen Asthma Severity: An FEV1 between 65% A subject will not be eligible for in this study if any of the following apply Currently Diagnosed with Life-Threatening Asthma: An episode or episodes of asthma requiring intubation associated with hypercapnia, respiratory arrest, or hypoxic seizures Asthma Instability: Hospitalization for asthma within 6 months of Visit 1 Concurrent Respiratory Disease: Current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, chronic bronchitis, emphysema, or any other respiratory abnormalities other than asthma Nasal Obstruction: Severe physical obstruction of the nose (e.g., deviated septum) that could affect the deposition of double-blind intranasal study drug Nasal History: History of nasal septal perforation or recent nasal septal surgery Other Concurrent Conditions/Diseases: Any evidence of rhinitis medicamentosa, history of glaucoma and/or cataracts or ocular herpes simplex, or any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the results if the condition/disease exacerbated during the study. The list of additional excluded conditions/diseases includes, but is not limited to: cardiac arrhythmias; congestive heart failure; coronary artery disease; poorly controlled diabetes, poorly controlled hypertension, poorly controlled peptic ulcer, hematologic, hepatic, or renal disease; immunologic compromise; current malignancy; current or quiescent tuberculosis, and Cushing's or Addison's disease Drug Allergy: Any immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, leukotriene modifier, or any intranasal, inhaled, or systemic corticosteroid therapy, or sensitivity to aspirin or other Subjects with severe milk protein allergies are also excluded from participation Respiratory Tract Infections: Any sinus, middle ear, oropharyngeal, upper or lower respiratory tract infection that has not resolved at least 14 days immediately preceding Visit 1, or for which antibiotic therapy has not been completed at least 14 days prior to Visit 1 Concurrent Medications: Concurrent use of any of the following medications that may affect the course of asthma, rhinitis, or interact with sympathomimetic amines or montelukast
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-999.0, Rhinitis, Allergic, Seasonal Have had seasonal allergic rhinitis due to Ragweed for the last 2 consecutive years Subjects who obtain a minimum sum score, considering SAR related symptoms (mean value), as defined by the protocol Any clinically significant condition that might interfere with the treatment evaluation, both for efficacy and safety Have used forbidden concomitant medications as defined by the protocol
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-60.0, Asthma History of physician-diagnosed asthma Methacholine PC20 less than or equal to 16 mg/ml and/or FEV1 improvement greater than or equal to 12% in response to 180 mcg albuterol Stable asthma for at least 6 weeks prior to study entry FEV1 greater than or equal to 60% of predicted result following 180 mcg albuterol Juniper ACQ score greater than or equal to 1.5 (optimal ACQ score cut-off point for asthma that is "not well-controlled" by NIH/Global Initiative for Asthma [GINA] guidelines) Nonsmoker (less than 10 pack-per-year lifetime smoking history and no smoking in the year prior to study entry) Able to perform spirometry, as per American Thoracic Society adherence with diary cards, fluticasone (monitored with Doser), and placebo pill trial (monitored electronically with Electronic Drug Exposure Monitor [eDEM] pill dose counter) for the final 2 weeks of the four-week run-in period At Visit 1, in steroid-naïve participants, no significant adrenal suppression, defined as a plasma cortisol concentration less than 5 mcg/dL. If adrenal suppression occurs, a 250 mcg corticotropin (ACTH) stimulation test will be performed. Plasma cortisol levels will be collected at baseline, and 30 and 60 minutes after the ACTH stimulation test. Participants must have a cortisol concentration greater than 20 mcg/dL on at least one of the post-ACTH time points Absence of bronchoscopy-induced exacerbation; if bronchoscopy-induced exacerbation has occurred, prednisone therapy must have stopped at least 6 weeks prior to study entry Presence of lung disease other than asthma Presence of vocal cord dysfunction, due to potential confounding of ACQ score Significant medical illness other than asthma History of atrial or ventricular tachyarrhythmia Use of any medication that has a significant interaction with clarithromycin, including herbal or alternative therapies Asthma exacerbation within 6 weeks of the screening visit or during the run-in period prior to bronchoscopy Use of systemic steroids or change in dose of controller therapy within 6 weeks of the screening visit Inability, in the opinion of the study investigator, to coordinate use of dry powder or metered-dose inhaler or to comply with medication regimens Inability or unwillingness to perform required study procedures Prolonged heart rate corrected QT-interval (greater than 450 msec in women and greater than 430 msec in men) on echocardiogram (ECG) at study entry
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-999.0, Rhinitis, Allergic, Perennial Seasonal allergic rhinitis Nasal allergy symptoms during the spring allergy season Prior use of beclomethasone dipropionate or flunisolide Significant concomitant medical conditions Use of corticosteroids Use of allergy and other identified medications during the study Current tobacco use or tobacco use within the past year
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-70.0, Pulmonary Disease, Chronic Obstructive Subjects with a documented history of persistent asthma Current non-smokers Clinically stable persistent asthma FEV1 between 60 and 90% of predicted values Inhaled corticosteroid therapy at a total daily dose between 200-500mcg of fluticasone or equivalent Subjects with significant past or present disease which which may affect their safety Upper or lower respiratory tract infection within 4 weeks of screening History of life threatening asthma, or asthma requiring treatment with oral corticosteroids within 3 months of study Patients taking doses of inhaled corticosteroid >500mcg/day and patients who have changed therapy within 8 weeks of the study Patients weighing less than 50kg
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-59.0, Seasonal Allergic Rhinitis Males and females between 18 and 59 years of age. 2. Seasonal allergic rhinitis by clinical history, with symptoms of impaired olfaction. 3. Positive skin or RAST test to allergen. 4. Symptoms of olfactory dysfunction. 5. No significant history of chronic sinusitis Women of childbearing potential not using the contraception method(s) (Birth control pills, depo Provera, double barrier) as well as women who are breastfeeding. 2. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (heart, lung, kidney, neurological, oncologic or liver disease). 3. Use of any other investigational agent in the last 30 days. 4. Absence of olfactory or nasal symptoms. 5. Use of medications that may affect olfaction. 6. Medical conditions that may affect olfaction. 7. Smoking. 8. URI at the time of screening
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2
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 16.0-999.0, Rhinitis, Allergic, Seasonal Informed consent Outpatient Diagnosis of seasonal allergic rhinitis with symptoms Able to comply with study procedures Significant concomitant medical condition Use of corticosteroids/allergy medications Laboratory abnormality Positive pregnancy test Allergy to any component of investigational product
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-65.0, Bronchitis cough with or without sputum production for less than 30 days duration; were age 18 through 65; and were willing to follow up by phone for a brief interview at 2, 4, and 8 days after enrollment history of COPD; asthma; or other lung disease; had localized lung findings on exam to suggest pneumonia or asthma; chest X-ray (if done) with evidence of pneumonia; purulent nasal discharge or other evidence of bacterial sinus infection; evidence of streptococcal pharyngitis; temperature greater than 101.5 in the preceding 72 hours; treatment of a respiratory tract infection in the last 30 days; pregnancy; breast feeding; actively trying to become pregnant; history of heart failure; history of renal failure or insufficiency with a creatinine greater than 2.0 mg/dl; history of psychiatric illness other than minor depression; currently incarcerated; or were unwilling to sign the consent form
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 12.0-999.0, Asthma Subjects of either sex and any race, at least 12 years of age, with a diagnosis of asthma of at least 12 months Use of medium or high daily dose of ICS (alone or in combination with long-acting beta-agonist [LABA]) for at least 12 weeks prior to Screening and have been on a stable regimen for at least 2 weeks prior to Screening Medium daily doses of ICS > 500 to 1000 mcg beclomethasone chlorofluorocarbon (CFC) > 250 to 500 mcg beclomethasone hydrofluoroalkane (HFA) > 600 to 1000 mcg budesonide dry powder inhaler (DPI) > 1000 to 2000 mcg flunisolide > 250 to 500 mcg fluticasone mcg MF > 1000 to 2000 mcg triamcinolone acetonide A change (increase or decrease) in absolute FEV1 of > 20% at any time from the Screening Visit up to, and including, the Baseline Visit A subject who requires the use of > 12 inhalations per day of short-acting beta-agonist (SABA) MDI or > 2 nebulized treatments per day of 2.5 mg salbutamol, on any 2 consecutive days from the Screening Visit up to, and including, the Baseline Visit A subject who experiences a clinical asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication [other than SABA]) at any time from the Screening Visit up to, and including, the Baseline Visit A subject who has ever required ventilator support for respiratory failure secondary to asthma A subject who is a smoker or ex-smoker and has smoked within the previous year or has had a cumulative smoking history > 10 pack-years
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-50.0, Asthma allergic asthmatic cohort Specific allergy to at least one of the following allergen preparations: (House Dust Mite f, House dust mite p, Cockroach, Tree mix, Grass Mix, Weed Mix, Mold Mix 1, Mold Mix 2, Rat, Mouse, Guinea Pig, Rabbit, Cat or Dog) confirmed by positive immediate skin test response Oxygen saturation of > 94 % at baseline Blood pressure within the following parameters (Systolic between 150 Diastolic between 100-60 mm Hg) Moderate or severe persistent asthma according to NHLBI definitions including history of one of the following: 1)Episodic wheezing, chest tightness or shortness of breath consistent with asthma occurring at least once a week that may affect activity;2)Asthma symptoms occurring at night or during sleep at least 1 time per week; 3)measured FEV1 or FVC is <80% of predicted; OR 4)physician diagnosed moderate or severe persistent asthma which is currently treated or controlled with maintenance medication including moderate or high dose inhaled corticosteroid, or any dose of inhaled corticosteroid and a long-acting inhaled B2-agonist healthy volunteer cohort Oxygen saturation > 94 % at baseline Blood pressure within the following parameters (Systolic between 150 Diastolic between 100-60 mm Hg) Any chronic medical condition considered by the PI as a contraindication to receiving gamma tocopherol, including significant cardiovascular disease, diabetes requiring medication, chronic renal disease, chronic thyroid disease, kidney disease or coagulation defects Use of inhaled steroids, cromolyn or leukotriene inhibitors (montelukast or zafirlukast) which have been used for at least one month are allowed. Patients must be on a stable regimen of maintenance asthma therapy which has not changed in the past month prior to entrance into the study NSAID or ASA use within 48 hours of beginning the study, and inability to suspended use of these medications during the length of the study Use of anticoagulants including warfarin, heparin, or clopidogrel Diagnosis of anemia or abnormal blood counts at screening Pregnancy or nursing a baby. As this is a phase I study, the potential risk to a fetus cannot be justified Children will not be included in this study as the potential risk to a growing child cannot be justified Adults age 51 and older are excluded as the potential for concomitant illness in this population increases the risk for confounding the data Known vagal response to venipuncture Abnormal PT or PTT values at screening
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 6.0-18.0, Asthma Able to perform reproducible spirometry according to American Thoracic Society (ATS) History of asthma symptoms (e.g., cough, wheezing, shortness of breath) and meets at least one of the following 1. Naïve to controller therapy and meeting National Asthma Education and Prevention Program (NAEPP) for mild-moderate persistent asthma (symptoms at least 2 days per week and/or night-time awakenings due to asthma at least 2 nights per month) 2. Current uncontrolled asthma (meets NAEPP for mild-moderate persistent asthma) while receiving an ICS dose greater than or equal to 200 ug per day of fluticasone equivalent or some form of non-ICS controller therapy (e.g., montelukast, theophylline, cromolyn) 3. Asthma is currently under control while receiving an ICS dose between 300 to 400 ug per day of fluticasone equivalent and willing to consider changing current treatment to monotherapy with one dose of ICS (current standard of care) 4. Asthma is currently under control while receiving some form of combination therapy, such as ICS less than or equal to 200 ug per day of fluticasone equivalent in addition to a non-ICS controller therapy (e.g., LABA, montelukast, theophylline, cromolyn), and willing to consider changing current treatment to monotherapy with one dose of ICS (current standard of care) FEV1 reversibility of at least 12% following bronchodilator administration (4 puffs) at study visit 1. Individuals will need to hold albuterol, montelukast, theophylline, ipratropium bromide (or other anticholinergics) and LABAs per study instructions prior to reversibility testing. If an individual is receiving these types of medications prior to study visit 1, he/she may be brought back to the clinical center within 1 week following appropriate medication withholding to attempt qualification by reversibility criteria. If the individual does not meet this requirement, they may qualify for enrollment if their PC20 methacholine FEV1 is less than or equal to 12.5 mg/ml at the time of randomization. If FEV1 is less than 70%, thus precluding the methacholine challenge at this visit, then completion of the visit will be postponed several days and an additional attempt to obtain a methacholine challenge test will be made. If the methacholine challenge still cannot be performed, an individual may still qualify by reversibility at this visit History of clinical varicella or varicella vaccine; individuals needing the vaccine may receive it from their primary care physician prior to study entry Ability of parent to provide informed consent; verbal assent must be obtained from children less than 7 years of age and written assent must be obtained from children between 7 and 18 years of age If female, willing to use an effective form of contraception Prior to being randomly assigned to a treatment group, participants must meet the following to remain in the study Lack of acceptable asthma control during the 8-week screening period as defined by the following 1) On average, on more than 2 days per week, one or all of the following: 1. Diary-reported symptoms 2. The use of inhaled bronchodilator (not including pre-exercise) 3. Peak flows in the yellow zone (less than 80% of post bronchodilator PEF value obtained at study visit 1) OR On average, more than 1 night-time awakening due to asthma, during each 2-week period Corticosteroid treatment for any condition prior to study entry within the following defined timepoints: 1. Oral Use within 2 weeks of the screening visit 2. Injectable Use within 2 weeks of the screening visit 3. Nasal May be used at any time during the study at the discretion of the study investigator or primary care physician Current or prior use of medications known to significantly interact with corticosteroid disposition (within a 2-week period of study visit 1), including but not limited to carbamazepine, erythromycin or other macrolide antibiotics, phenobarbital, phenytoin, rifampin, or ketoconazole Pre-bronchodilator FEV1 less than 60% predicted at study visit 1 More than three hospitalizations for asthma in the year prior to study entry Presence of chronic or active lung disease other than asthma Significant medical illness other than asthma, including thyroid disease, diabetes mellitus, Cushing's disease, Addison's disease, hepatic disease, or concurrent medical problems that could require oral corticosteroids during the study or would place the participant at increased risk while participating in the study History of cataracts, glaucoma, or any other medical disorder associated with an adverse effect to corticosteroids
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-80.0, Pulmonary Diseases age 18-80 referral for pulmonary function evaluation of respiratory symptoms following exposure to WTC dust inability to perform testing
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 20.0-999.0, Asthma Allergic rhinitis symptoms: sneezing, rhinorrhea, obstruction of the nasal passages, itchy nose and throat, and conjunctival Male or female outpatient 20 years of age and older Patients with the following signs and symptoms of asthma and allergic rhinitis: history of cough, wheezing, shortness of breath, positive methacholine bronchoprovocation test Active, acute or chronic, pulmonary disorder (besides asthma) documented by history, physical examination, or chest x-ray. history of anaphylactic or hypersensitive to study drug Requires oral, intravenous, or intramuscular corticosteroids on daily routine basis Started on immunotherapy within six months before the pre-study visit and/or the dose of immunotherapy is expected to change over the course of the study Treated with montelukast within 3 months before enrollment Unable to perform acceptable, reproducible spirometry and peak flow measurement Unresolved symptoms and signs of an upper respiratory tract infection (uri) within 2 weeks prior to visit 1
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 18.0-50.0, Allergic Rhinitis Rhinitis, Allergic, Seasonal The subject is healthy. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history (including family), physical examination, laboratory studies, and other tests They have a history of seasonal allergic rhinitis Exhibit a moderate response to 1500 grass pollen grains per cubic metre after 2 hours in the Vienna Challenge Chamber at screening or within 12 months preceding the screening visit. A moderate response is defined as a total nasal symptom score of at least 6. (Total nasal symptom score is the sum of obstruction, rhinorrhoea, itch and sneeze, each of which has been scored on a scale from 0 to 3) They have a positive skin prick test (wheal size equal to or more than 4mm) for grass pollen at or within the 12 months preceding the screening visit They have a positive RadioAllergoSorbent Test (RAST) (equal to or more than class 2) for grass pollen at or within the 12 months preceding the screening visit They have demonstrated an ability to use the intranasal spray There are no conditions or factors which would make the subject unlikely to be able to stay in the chamber for 5 hours They are capable of giving informed consent which includes compliance with the requirements and restrictions listed in the consent form They are available to complete all study measurements Pregnant or nursing females Female subjects of childbearing potential who are unwilling or unable to use an appropriate method of contraception [i.e. implants of levonorgestrel, injectable progesterone, an acceptable intra-uterine device (IUD) (any IUD with a failure rate of less than 1% per year), oral contraceptives or any other method with a failure rate of <1% per year] for at least two weeks prior to the first dose of study medication and should continue using the same contraceptive measure until the final pregnancy test has been performed (not less than 72 hours after treatment). Alternatively they may be surgically sterilised (refer to section 6.4) or remain abstinent for 2 weeks before exposure to study drug On examination the subject is found to have any structural nasal abnormalities or nasal polyposis, a history of frequent nosebleeds, recent nasal surgery or recent (within 3 weeks) or ongoing upper respiratory tract infection which in the responsible physician's opinion renders the subject unsuitable for participation in the study The subject has any respiratory disease other than mild stable asthma that is controlled with occasional use of as-needed short-acting beta-agonists and associated with normal lung function The subject is likely to be unable to abstain from salbutamol use for 8 hours before a challenge The subject has a history of drug or other allergy that, in the opinion of the responsible physician, contraindicates their participation The subject has participated in a study with a new molecular entity during the previous 3 months or in any clinical study in the previous 2 months The subject is concurrently participating in another clinical study in which the subject is or will be exposed to an investigational or a non-investigational drug or device The subject is currently taking regular (or a course of) medication whether prescribed or not, including steroids, vitamins and herbal remedies (e.g. St. John's Wort). Paracetamol and occasional as needed use of short-acting beta agonists is permitted The subject regularly, or on average, drinks more than 3 units of alcohol per day - where 1 unit = ½ pint of beer (284milliliteres mL), or 1 glass of wine (125mL), or 1 measure of spirit (25mL)
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1
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 1.0-30.0, T Acute Lymphoblastic Leukemia T Lymphoblastic Lymphoma T-ALL patients must be enrolled on AALL08B1 prior to treatment and enrollment on AALL0434 Patients must have newly diagnosed T-ALL or T-lineage lymphoblastic lymphoma (T-NHL) stage II-IV; B-lineage lymphoblastic lymphoma will not be eligible for this study; a diagnosis of T-ALL is established when leukemic blasts lack myeloperoxidase or evidence of B-lineage derivation (cluster of differentiation [CD]19/CD22/CD20), and express either surface or cytoplasmic CD3 or two or more of the antigens CD8, CD7, CD5, CD4, CD2 or CD1a; if surface CD3 is expressed on all leukemic cells, additional markers of immaturity, including transmission disequilibrium test (TdT), CD34 or CD99 will be assessed for expression; cases with uncertain expression will receive additional review within the appropriate Children's Oncology Group (COG) reference laboratory T-NHL For T-NHL patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to T-ALL; for tissue processed by other means (i.e. paraffin blocks), the methodology and for immunophenotypic analysis to establish the diagnosis of T-NHL defined by the submitting institution will be accepted Prior therapy restrictions Patients shall have had no prior cytotoxic chemotherapy with the exception of steroids and/or IT cytarabine IT chemotherapy with cytarabine is allowed prior to registration for patient convenience; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; (Note: the CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment); systemic chemotherapy must begin within 72 hours of this IT therapy Patients diagnosed as having T-NHL or T-ALL with respiratory distress or hyperleukocytosis may require steroids prior to the initiation of additional systemic therapy; they are eligible for AALL0434 and will be stratified, based on the initial complete blood count (CBC); steroid pretreatment may alter the risk group assessment; if the T-ALL patient's clinical status precludes a lumbar puncture within 48 hours of the initiation of steroid therapy, T-ALL patients be classified as low risk and will be Intermediate or high risk based on the results of the day 29 marrow as above; patients with T-NHL who receive steroid pre-treatment will be classified as high risk; the dose and duration of previous steroid therapy should be carefully documented For the management of airway compromise, patients who have received emergent chest irradiation up to 600 cGy will be eligible for this study Patients with a prior seizure disorder requiring anti-convulsant therapy are not eligible to receive nelarabine; in addition, patients with pre-existing grade 2 (or greater) peripheral neurotoxicity, as determined prior to Induction treatment by the treating physician or a neurologist, are not eligible to receive nelarabine; these restrictions in are designed to prevent excessive nelarabine-induced central and peripheral neurotoxicity in at-risk patients; for the purposes of this study, this includes any patient that has received anticonvulsant therapy to prevent/treat seizures in the prior two years Pregnant or lactating females are ineligible Patients with Down syndrome are ineligible to enroll onto this study For T-NHL patients the following additional apply B-precursor lymphoblastic lymphoma Morphologically unclassifiable lymphoma Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma CNS3-positive or testicular involvement
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0
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A 39-year-old man came to the clinic with cough and shortness of breath that was not relieved by his inhaler. He had these symptoms for 5 days during the past 2 weeks. He doubled his oral corticosteroids in the past week. He is a chef with a history of asthma for 3 years, suffering from frequent cough, wheezing, and shortness of breath and chest tightness. The symptoms become more bothersome within 1-2 hours of starting work every day and worsen throughout the work week. His symptoms improve within 1-2 hours outside the workplace. Spirometry was performed revealing a forced expiratory volume in the first second (FEV1) of 63% of the predicted. His past medical history is significant for seasonal allergic rhinitis in the summer. He doesn't smoke or use illicit drugs. His family history is significant for asthma in his father and sister. He currently uses inhaled corticosteroid (ICS) and fluticasone 500 mcg/salmeterol 50 mcg, one puff twice daily.
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eligible ages (years): 0.0-999.0, Pulmonary Disease, Chronic Obstructive Diagnosis of COPD Women who are pregnant or lactating Subjects with a primary diagnosis of asthma. (Subjects with a prior history of asthma are eligible if COPD is currently their primary diagnosis) Has a respiratory disorder other than COPD (e.g., bronchiectasis, sarcoidosis, active tuberculosis, lung fibrosis), including subjects with a diagnosis of alpha-1-antitrypsin deficiency Subjects with lung volume reduction surgery or lung transplant within the previous 12 months Chest X-ray (posterior-anterior) or CT scan reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD. A chest X-ray must be taken if the subject has not had one within 12 months of the Screening Visit Subjects with clinically significant cardiovascular (including clinically significant ECG abnormalities, CHF), neurological, psychiatric, renal, immunological, endocrine(including uncontrolled diabetes or thyroid disease) or hematological abnormalities that is uncontrolled Subjects with carcinoma that has not been in complete remission for at least 5 years. Carcinoma in situ of the cervix, squamous cell carcinoma of the skin and basal cell carcinoma would not be considered if the subject was considered cured in less than 5 years since diagnosis Any adverse reaction including immediate or delayed hypersensitivity to any betaagonist, sympathomimetic drug, or intranasal, inhaled, or oral corticosteroid including any components of the formulations (e.g. lactose or milk protein) Initiation of systemic beta-blocker medications at any time during the study. Systemic beta-blockers and beta-blocker eye drops are allowed for those subjects who have been on a stable regimen for at least 30 days prior to screening and judged capable to continue this regimen until discharged from the study
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0
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