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A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, Metastatic Gastric Cancer Adenocarcinoma of the Gastro-oesophageal Junction Histologically confirmed adenocarcinoma of the stomach or gastro-oesophageal junction with inoperable locally advanced or recurrent and/or metastatic disease not amenable to curative therapy Measurable disease, according to the Response Evaluation in Solid Tumours (RECIST), assessed using imaging techniques (CT or MRI) ECOG Performance status 0, 1 or 2 (see Appendix 2) Life expectancy of at least 3 months Male or female age ≥ 18 years Signed informed consent Assessment of HER2 status (primary tumour or metastasis) by the central laboratory prior to initiation of study treatment (see section 9.1) Able to swallow and retain oral medication LVEF ≥ 50% assessed by multigated radionucleotide angiography (MUGA) or cardiac ultrasound Any of the following will the patient from the study Previous chemotherapy for advanced/metastatic disease (prior peri-operative chemotherapy is allowed if at least 6 months has elapsed between completion of this therapy and enrolment into the study) Previous radiotherapy on the abdomen Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma Patients with active (significant or uncontrolled) gastrointestinal bleeding Residual relevant toxicity resulting from previous therapy (with the exception of alopecia), e.g. neurological toxicity ≥ grade 2 NCI-CTCAE Creatinin clearance <50 mL/min Neutrophil count <1.5 × 109/L, or platelet count <100 × 109/L Serum bilirubin >1.5 × upper limit of normal (ULN); or, AST or ALT >2.5 × ULN (or >5 × ULN in patients with liver metastases); or, alkaline phosphatase >2.5 × ULN (or >5 × ULN in patients with liver metastases, or >10 × ULN in patients with bone but no liver metastases); or, albumin <25 g/L Known dihydropyrimidine dehydrogenase (DPD) deficiency | 1 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, Malignant Dysphagia Esophageal Cancer Age ≥18 years Confirmed esophageal/gastroesophageal (GEJ) cancer (Siewert Type I and Type II only) of any histology on biopsy Dysphagia score ≥2 Stage IV cancer/Metastatic disease Expected life expectancy < 3 months Inability to undergo stent insertion Siewert Type III gastroesophageal cancer Esophageal-Airway fistula | 1 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 20.0-999.0, Metastatic or Recurrent Gastric Adenocarcinoma Her-2 Positive Gastric Cancer Histologically confirmed adenocarcinoma of the stomach or gastro-oesophageal junction with inoperable locally advanced or recurrent and/or metastatic disease, not amenable to curative therapy Measurable disease, according to the Response Evaluation in Solid Tumors (RECIST), assessed using imaging techniques (CT or MRI) HER2 positive tumour (primary tumour or metastasis) defined as either IHC2+ and FISH+ or IHC3+ according to the gastric cancer scoring system for HER2 ECOG Performance status 0, 1 or 2 Life expectancy of at least 3 months Male or female. Age over 20 year Signed informed consent Previous chemotherapy for advanced/metastatic disease (prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study; adjuvant/neoadjuvant therapy with platinum is not allowed) Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (e.g. patients with partial or total gastrectomy can enter the study, but not those with a jejunostomy tube) Patients with active (significant or uncontrolled) gastrointestinal bleeding Residual relevant toxicity resulting from previous therapy (with the exception of alopecia), e.g. neurological toxicity over grade 2 NCI-CTCAE Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal cell carcinoma Neutrophil count < 1.5 × 109/L, or platelet count < 100 × 109/L Serum bilirubin > 1.5 × upper limit of normal (ULN); or, AST or ALT > 2.5 × ULN (or > 5 × ULN in patients with liver metastases); or, alkaline phosphatase > 2.5 × ULN (or > 5 × ULN in patients with liver metastases, or > 10 × ULN in patients with bone but no liver metastases); or, albumin < 25 g/L Creatinine clearance < 60 mL/min. Other Study Drug-Related History of documented congestive heart failure; angina pectoris requiring medication; evidence of transmural myocardial infarction on ECG; poorly controlled hypertension (systolic BP > 180 mmHg or diastolic BP > 100 mmHg); clinically significant valvular heart disease; or high risk uncontrollable arrhythmias Baseline LVEF < 50% (measured by echocardiography or MUGA) | 1 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 12.0-75.0, Laryngopharyngeal Reflux Patients with age of 12-75 years old (inclusive) Patients with at least one symptom consistent with LPR, including hoarseness, throat clearing, throat pain, globus sensation in the throat, or chronic cough ≧ 4 weeks before entering study Patients with a total reflux symptom index (RSI) >10 (based on a self-administered 9-item questionnaire of voice/throat complaints) Patients with a total reflux finding score (RFS) >5 (based on a laryngoscopic examination by investigators) Patients or their legal representatives have signed the informed consent form Patients with viral or bacterial laryngitis, or occupational exposures causing laryngitis Patients with erosive GERD as evidenced by upper GI endoscopy Patients with laryngeal or hypopharyngeal cancer, esophageal or gastric cancer, , or with history of neck radiation therapy Patients with history of uncontrolled hypertension or moderate to severe renal impairment Patients with history of esophageal or gastric surgery Patients with active pulmonary infection (pneumonia, tuberculosis) as evidenced by chest X-ray Patients with endotracheal tube intubation within 2 months before entering study Patients had taken any alginate preparations within 2 days; H2-blocker, prokinetic agent or antacid within 7 days; or proton pump inhibitors (PPIs) within 14 days before screening Patients with a history of allergy to the study drugs or their related compounds Patients with a history of alcohol or drug abuse, or with any psychiatric disease | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, Pharyngitis Healthy, ambulatory, male and female subjects ≥ 18 years of age Presence of sore throat due to upper respiratory tract infection (URTI) Onset of sore throat pain within six days of the screening period Baseline sore throat pain intensity score ≥ 60 mm on the Sore Throat Pain Intensity Scale Have a score ≥ 5 on the Tonsillopharyngitis Assessment Female subjects of childbearing potential who are currently sexually active must be using a medically acceptable form of birth control for at least one month prior to screening (three months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Nuvaring, Depo-Provera, or double-barrier and have a negative pregnancy test at screening/treatment period. Female subjects of non-childbearing potential must be amenorrheic for at least two years or had a hysterectomy and/or bilateral oophorectomy Understand the pain rating assessments History of hypersensitivity to aspirin, salicylates, other nonsteroidal anti-inflammatory drugs, acetaminophen, opioid analgesics, and similar drugs Use of any "cold medication" (i.e. decongestants, antihistamines, expectorants, antitussives) within four hours preceding administration of the investigational product Use of any immediate release analgesic/antipyretic within four hours or use of any sustained release or long-acting analgesic/antipyretic within twelve hours preceding administration of the investigational product Consumption of alcoholic beverages, or foods and beverages containing xanthines within two hours prior to administration of the investigational product Use of any sore throat lozenges, sprays, cough drops, menthol-containing products within one hour preceding administration of the investigational product Presence of cough that causes throat discomfort Presence of mouth-breathing or any respiratory condition that, in the Investigator's judgment, could compromise breathing Evidence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies for which aspirin or acetaminophen is contraindicated Relevant concomitant disease such as medically uncontrolled asthma (exercise induced asthma is permitted), chronic sinusitis or nasal structural abnormalities causing greater than fifty percent obstruction History of gastrointestinal bleeding or perforation related to previous non-steroidal anti-inflammatory therapy | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, Esophageal Cancer All patients with end stage inoperable esophageal cancer deemed candidates for intraluminal esophageal palliative stent insertions Inability to consent for the study Patients less than 18 years old Patients with other benign causes of dysphagia and esophageal obstruction or stenosis Patients with malignant or benign airway esophageal fistulas Patients with cervical esophageal cancer | 1 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-70.0, Oral Health Oral Cancer Gum Disease Submit to a 24 hour urine cotinine test which will be used to determine smoking status Meet one of the following smoking Non-smoker Does not currently smoke or has no history of smoking or using tobacco related products (cigarettes, cigars, pipe, snuff, or chewing tobacco) or smoking any non-tobacco related products and urine cotinine (less than 100 ng/mL Does not currently smoke but has quit smoking for more than 10 years and smoked less than 1 pack/day of cigarettes when they were actively smoking and has a urine cotinine (less than 100 ng/mL) Smoker Smokes habitually at least 10 cigarettes/day and a urine cotinine level of >1000 ng/mL. Cigar and pipe smokers who smoke at least 10 grams of tobacco daily are also eligible Agree to consume a standardized vitamin and mineral supplement and avoid other nutritional, dietary, or alternative medications/supplements for the duration of the study No history of malabsorptive, gastrointestinal or other metabolic disorders requiring special diet recommendations Body mass index (BMI) between 20 and 35 kg/m2 Have a known allergy to strawberries, corn, and wheat products or those who have never consumed any of these products Have active metabolic or digestive illnesses such as malabsorptive disorders (Crohn's, ileus, IBS), renal insufficiency, hepatic insufficiency, hyper or hypothyroidism, cachexia, morbid obesity, or short bowel syndrome Have a history of pituitary hormone diseases that currently require supplemental hormonal administration (thyroid hormones, ACTH, growth hormone, insulin) or other endocrine disorders requiring hormone administration Have significant loss of gastrointestinal organs due to surgery, except for appendix Have altered immunity such as chronic inflammatory disease, autoimmune disorders, cancer, anemia, hemophilia, and blood dyscrasias Heavy alcohol consumers defined as >15 glasses/week (one glass = 1.5 oz. liquor, 5 oz. wine, or 12 oz. beer) Antibiotic use in the last 6 months or on medications that will accelerate or decrease bowel motility Are receiving or in need of dental treatment during the study period Have noticeable open lesions, sores that have not healed for more than 3 months, have had any active oral lesions or maladies within the last month, or have a history of leukoplakia, tumors of the buccal cavity, throat, and lips | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 45.0-999.0, Lung Cancer Smoking >45 years of age Unable to provide informed consent | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 12.0-999.0, Upper Respiratory Infections Subject must have one or more symptoms per category (see also screening assessment of cold symptoms, section 6.1) mild to moderate body pain, headache, fever or sore throat nasal congestion (blocked nose) with or without rhinorrhea (runny nose) or sneezing Baseline sore throat pain of severe intensity, e.g. rated as 3 on a 4-point ordinal scale (0=not present, 1= mild, 2=moderate, 3=severe) Baseline dry cough of severe intensity, e.g. rated as 3 on a 4-point ordinal scale (0=not present, 1= mild, 2=moderate, 3=severe) Subject has a productive cough History of hypersensitivity to any of the study drugs and the listed excipients or to drugs of similar chemical classes Subjects with allergic asthma Use of any inhaler, medicated confectionary, throat lozenges, throat pastilles, sprays, any products with demulcent properties such as chewing gums and boiled sweets or mints, in the 6 hours prior to dosing Use of any medication for sore throat containing a local anaesthetic within the 6 hours prior to dosing Use of paracetamol, any NSAID or any oral nasal decongestant within 6 hours prior to dosing Use of substances of abuse or antihistamines within 24 hours of dosing Drinking of tea, coffee or other caffeinated beverages 1 hour prior to dosing | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, Dysphagia History of dysphagia necessitating a dynamic fluoroscopic swallow study Age > 18 years Ability to complete a comprehensive dynamic fluoroscopic swallow study Ability to provide informed consent for study participation Age < 18 years Pregnant women Prisoner or other institutionalized individual Cognitive disability precluding the ability to provide informed consent or complete a comprehensive swallow study | 2 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-70.0, Esophageal Squamous Cell Carcinoma Resectable Histological or cytologic diagnosis of Esophageal squamous cell carcinoma ECOG performance status 0-2 Age:18-70 years Joined the study voluntarily and signed informed consent form Patients must not have received any prior anticancer therapy Resectable disease, Stage IIA-IIIC, T2N0M0-T3N1M0（AJCC 2009） Target lesions can be measured according to No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥9 g/dL, WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L, platelet count ≥100x 109/L, TBIL<1.5 x ULN, ALT and AST ≦ 2.5 x ULN, creatinine ≦ 1.5 x ULN Use of an effective contraceptive for adults to prevent pregnancy Life expectancy of more than 3 months Not suitable to surgery cervical Esophageal Carcinoma(distance of incisor tooth<19cm) early Esophageal Carcinoma(Stage I) complete esophageal obstruction，Esophageal perforation or hematemesis other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior 11、 History of serious allergic or castor oil allergy 12、 Patients who are not suitable to participate in the trial according to researchers | 1 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-75.0, Esophageal Cancer Patients who have histologically confirmed diagnosis of esophageal cancer without prior palliative treatment or an interval of at least 6 months from the last operation, adjuvant radiation therapy and adjuvant chemotherapy. If patients received adjuvant chemotherapy, paclitaxel and cisplatin must be excluded from the regiment or the total dosage of cisplatin must be less than 300mg/m2 Patients must be 18 to 75 years old and both genders are eligible Patients must have measurable or evaluable disease with at least one tumor mass maximum diameter ≥10mm by multi-slice spiral CT or MR scan. If ordinary CT scan is used the tumor mass maximum diameter must ≥ 2cm. Imaging exam must be performed within 15 days from enrollment Patients must have an expected life expectancy of ≥ 3 months Patients must have a performance status of ≥ 80 on the Karnofsky scale Patients must have normal marrow function and the blood tests must be collected within 7 days from enrollment with a hemoglobin (HGB) of ≥90g/L, an white blood cell (WBC) counts of ≥4.0×109/L，a neutrophil count of ≥2.0×109/L, , a platelet count of ≥100×109/L, a total bilirubin (TBil) of ≤1.0 upper normal limitation (UNL), a creatinine (Cr) of ≤ 1.0 UNL, alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤2.5 UNL, Alkaline phosphatase (AKP) ≤5.0 UNL. For patients with liver metastasis, the ASAT/ALAT must be ≤5.0 UNL Patients must have normal electrocardiogram results and no history of congestive heart failure Patients must be with good compliance and agree to accept follow-up of disease progression and adverse events Patients must give written informed consent signed voluntarily by patients themselves or their supervisors witted by doctors Patients who have received prior palliative treatment or less than 6 months from the last operation, adjuvant radiotherapy, adjuvant chemotherapy Previous treatment regiment involve paclitaxel and S-1 Tumor mass >10mm by CT or MR scan. The total area of metastatic tumor lesions in liver is over 50% of whole liver or the total area of metastatic tumor lesions in lung is over 25% of whole lung Patients without measurable or evaluable disease, for example cavity effusion or diffusive metastasis of organs Patients with history of other tumors except for those of cervical carcinoma in situ or skin basal cell carcinoma who had been completely treated and without relapse in last 5 years Patients with serious diseases such as congestive heart failure, uncontrolled myocardial infarction and arrhythmia, liver failure and renal failure Patients with only brain metastasis or bone metastasis Patients with chronic diarrhea Patients with neurological or psychiatric abnormalities including metastasis of the central nervous system that affect cognitive Pregnant or lactated women (premenopausal women must give urine pregnancy test before enrollment) | 1 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 0.0-1.0, Dysphagia Infants with severe dysphagia on VFFS as defined by dysphagia resulting in aspiration with swallow of at least 2 food textures (e.g. thin and thick liquid) We will children with dysphagia due to a central neurologic deficit. The neurologic diagnosis will be based on the diagnosis from the treating physician Infants with a known or suspected neurodegenerative or peripheral neuromuscular condition or a medical condition that is a contraindication for NMES treatment (tumours in the neck region and neck soft tissue infections) Children with neurodegenerative disorders have been excluded as their natural history of dysphagia would be different from those with a static neurologic disorder | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-65.0, Overweight and Obesity Males and females 65 years old Body Mass Index (BMI) 27-35kg/m2 Overall healthy Weight Stable (<3 kg change in the past 4 months, before the trial) Medical Heavy smokers (more than 10 cigarettes/day) or heavy alcohol consumers (more than 4 alcohol units/day for male and more than 3 alcohol units/day for female) Obesity of endocrine origin Chronic metabolic conditions: diabetes, hepatic disease, gout, kidney, thyroid or coagulation disease Gastrointestinal disorders: celiac disease, ulcerative colitis, irritable bowel syndrome (IBS), Chron's disease, chronic constipation, diverticulitis, history of gastric bezoar. Suspected strictures, fistulas, or physiological GI obstruction Psychiatric disorder: severe depression, bulimia, anorexia, schizophrenia, bipolar disorder Gastrointestinal procedure or surgery in the past three months Disorders of swallowing, severe dysphagia to food or pills Pregnancy Medication | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 20.0-85.0, Stroke age between 20-85 years old first-time stroke confirmed by computed tomography or magnetic resonance image dysphagia > 3 weeks, with preservation of the swallowing reflex currently on a restricted diet, with a Functional Oral Intake Scale (FOIS) score of 5 or less Mini-Mental State Examination (MMSE)> 21 no obvious mental depression, receptive aphasia or cognitive impairment progressive cerebrovascular disease or other neurologic diseases unstable cardiopulmonary status, serious psychologic disorder or epilepsy tumors, extensive surgery or radiotherapy of the head and neck region cardiac pacemakers swallowing therapy within 2 months before participation | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, Oesophageal Adenocarcinoma oesophageal cancer Multidisciplinary team decision to offer neoadjuvant chemotherapy prior to surgery Metastatic disease | 1 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 40.0-72.0, Esophageal Neoplasm Esophageal Cancer TNM Staging Primary Tumor (T) T2 Esophageal Cancer TNM Staging Primary Tumor (T) T3 Esophageal Cancer TNM Staging Regional Lymph Nodes (N) N0 Esophageal Cancer TNM Staging Distal Metastasis (M) M0 Stage T2-3N0M0 disease of TESCC patients confirmed by pathology studies who received R0 operations in Cancer Institute & Hospital，CAMS； KPS≥70 before radiotherapy Did not receive neoadjuvant or adjuvant treatment No clear recurrent or metastatic lesions before radiotherapy Intensity modulated radiation therapy(IMRT) is accepted Regular follow-up Exploratory thoracotomy or palliative surgery No clear recurrent or metastatic sites Recurrence or metastasis is not certain death of no definite cause Irregular follow-up | 1 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, Small Cell Lung Cancer years or older Patients with histologically proven SCLC (all histological subtypes), treated with concurrent chemo and radiotherapy Ability to understand the protocol and willing to provide written informed consent Concurrent participation in a clinical trial in which the subject is taking or receiving any investigational agent that may affect the frequency, severity or duration of mucositis Pre-existent esophagitis Receiving investigational treatment for the prevention or treatment of mucositis Prior irradiation to the lung or head and neck region | 1 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 25.0-80.0, Microbiota Lung Cancer Oral Cancer This study will recruit a convenience sample of 50 volunteers (25 current smokers with at least 5 years of smoking history, 25 never smokers). Current smokers are defined as individuals who have smoked more than 100 cigarettes in their lifetime and have smoked 5 or more cigarettes in the last 24 hours. Recent use of other tobacco products (pipe, cigar, snuff, cigarillos, and chewing tobacco) is an overall but use in the remote past (> 6 month ago) is acceptable in smokers. Never smokers are defined as individuals who have never smoked cigarettes nor used any other tobacco products including pipe, cigar, snuff, cigarillos, or chewing tobacco The ethnic mix of the clinic is roughly 50% Caucasians and 50% African Americans with a small number of unspecified or other racial groups. The median age is about 50 and the gender mix consists of an equal number of men and women. We therefore will select smokers and frequency match to non-smokers based on ethnicity (White, African-American), gender (male, female), and age (above or below the median, estimated to be 50) We will pregnant women and other racial groups because they may represent very small numbers and thus be difficult to match. Hormonal changes associated with pregnancy and unique cultural habits associated with specific ethnic groups could be associated with highly unique or variable microbiome patterns, and therefore reduce the power to detect differences associated with smoking which is our primary goal. We will also subjects with antibiotic usage in the last three months and subjects with previous diagnosed major periodontal disease or cancer because they might be potential confounders | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 0.0-0.827, Dysphagia Infants born prematurely, as defined by birth at less than 37 weeks gestational age, referred for a videofluoroscopic swallow study (VFSS) due to suspected pharyngeal phase dysphagia Infants born prematurely with a corrected gestational age of 43 weeks or greater | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, Cigarette Smoking Overweight Obesity Participating Client Not Re-Enrolling USA Resident Wants to quit in the next 30 days Use Cigarettes (other types ok, but must use cigarettes) years or older Speak English Provide Phone Provide Email Address Use 10 cigarettes per day or more Pregnant or Planning Pregnancy within 3 months Diabetic Previous weight loss surgery or planning weight loss surgery in next 12 months | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 30.0-80.0, Obesity Adults age 30-80 BMI between 30 and 45 prior to starting Weight Watchers Have a documented weight loss of at least 5kg in the past 4-6 months before enrolling Stable health Substance abuse Bulimia nervosa or related behaviors Pregnancy or breast feeding Medical contraindications to counseling about diet, physical activity, or weight reduction Unstable mental illness Screen positive for pathological gambling on the basis of the 10 item DSM-IV (excluded if meets 5 or more criteria) Individuals unable to read consent forms or fill out surveys in English | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 20.0-65.0, Post Operative Sore Throat ASA I-II patients aged between 20 and 65 year undergoing 1 or 2 level posterior spinal fusion in prone position with tracheal intubation preexisting hoarseness or sore throat, upper respiratory tract infection steroid therapy or immunocompromised patients chronic treatment with calcium channel blocker or magnesium allergy to magnesium sulphate Cormack-Lehane grade 3,4 or patients who are expected to difficult intubation fail to tracheal intubation at first trial reduced kidney function Diabetes mellitus | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-25.0, Smoking U.S. participants 18-25 years of age who are part of the Survey Sampling International (SSI) panel Never smoker (never puffed a cigarette) or former smoker (have at least puffed a cigarette but have not smoked in the past 30 days) Less than 18 or greater than 25 years of age For the main study, they must not have participated in the pilot study in which we will test the how convincing these messages are For both studies, they must not have participated in a previous study in which we originally generated these theme sets Current smokers (people who have smoked in the past 30 days) | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, Acute Pharyngitis Sore Throat Primary diagnosis: pharyngitis confirmed by a Tonsillo-Pharyngitis Assessment ≥ 5 Complaint of sore throat with an onset ≤ 4 days prior to randomization Have at least one symptom of upper respiratory tract infection (URTI) on the URTI Questionnaire (e.g., sore throat, runny nose, cough, fever) Have moderate or severe sore throat pain on the Throat Pain Scale Have a baseline Sore Throat Scale (STS) ≥ 6 If the patient is a female of childbearing potential, she has been using effective contraception since the last date of menses and is not breast-feeding or lactating. She is also willing to take adequate contraceptive precautions through 24 hours after the completion of the study If the patient is a female of childbearing potential, the patient must have a negative urine pregnancy test (UPT) result (indicating "not pregnant") obtained on the day of scheduled randomization, prior to the designated time of randomization The patient is willing to remain at the study centre for 3 hours after receiving the dose of study medication During the 3-hour evaluation of the study medication lozenge at the site, the patient is willing to take "nothing by mouth" (e.g., no smoking, food, candy, lozenges, chewing gum, liquids) Known allergy and/or hypersensitivity to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), or any other inactive ingredients such as honey, lemon flavor, menthol, or sucrose History of an upper gastrointestinal ulcer within the past 60 days, current clinically significant upper gastrointestinal complaints, or current regular use (≥ 3 times in the previous week) of any medication for upper gastrointestinal symptoms, including antacids, H2 blockers, proton pump inhibitors or sucralfate History of any hepatic disease or renal dysfunction Other severe acute or chronic medical condition that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study History of chronic analgesic use (≥ 3 times per week over the prior 4 weeks) Use of an antibiotic for an acute disease within the previous 24 hours before randomization. (Chronic antibiotic use, such as for acne, is acceptable.) Use of any quinolone antibiotic such as ciprofloxacin or nalidixic acid within the past week or concurrently is specifically prohibited Use of mifepristone in the 12 days prior to the screening visit Use of inhaled therapy (e.g., inhaled steroids or β-agonists, such as Ventolin) on an acute basis for disease exacerbation in the week prior to the screening visit Use of any immediate release analgesic within 4 hours preceding administration of the study medication Use of any sustained release analgesic within 12 hours preceding administration of the study medication | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 30.0-999.0, Pancreatic Insufficiency Male or female at least 30 years of age Able to read, understand, and sign informed consent Patients with a negligible smoking history (defined as no smoking for the past 7 years, and a total smoking history ≤ 5 pack-years) OR patients with AT LEAST a 20 pack-year smoking history Patients with a prior diagnosis of pancreatic insufficiency Patients who have a current or remote history of acute or chronic pancreatitis or any other primary pancreatic disease or malignancy Patients who have had pancreatic surgery Patients with a diagnosis of small bowel malabsorption or Celiac disease Patients with any other significant systemic disease that is deemed by the investigator as possibly interfering with the conduct or interpretation of the study | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-60.0, Personal Satisfaction availability to give written consent age 18-60, men and women (who are not pregnant or nursing) people in good health able to follow protocol must be experiencing a sore throat or cold at least once a year smokers liver and kidney disease inflammatory bowel disease pancreatitis gallbladder or biliary disease neurolgical/psychological disease bleeding disorders platelet abnormatilies gastrointestinal disorders that could interfere with fat absorption serum triglycerides > 500 mg/dL and/or total cholesterol > 300 mg/dL | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 21.0-999.0, Head and Neck Neoplasms We plan to recruit all patients (controls, precursors, and invasive cancers) at the aforementioned two hospitals. Doctors at these hospitals conduct routine visual and tactile examination as part of Taiwan s national oral cancer screening program. For this screening program, all individuals aged 21 years or older who chew betel-quid or smoke are screened through visual inspection for the presence of precursor lesions or cancer The following individuals will be excluded from the study: subjects younger than 21 years, individuals with a history of cancer, and mentally incompetent individuals | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-35.0, Fatigue healthy, 18 to 35 year old man or woman smoker pregnancy taking part in other research followed a weight loss diet in the previous 6 months history of gastrointestinal, endocrine, cardiovascular disease or diabetes neurological or psychiatric condition that may cause cognitive dysfunction | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, Adenocarcinoma Histologically proven adenocarcinoma of the gastro-oesophageal junction Age 18 years or older International Union Against Cancer (UICC) T2-4 N0-2 M0, potentially resectable disease treated by the CROSS regimen WHO 0-2 Thoracic adenocarcinoma/squamous cell carcinoma Palliative treatment for the oesophageal cancer | 1 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-65.0, Obesity, Morbid Age more than 18 years and less than 65 years BMI more than 40 kg/m2 or more than 35 kg/m2 with comorbidities likely to improve after weight loss Morbid obesity established at least five years Continued failures to adequately supervised conservative treatments Absence of endocrine disorders that are due to morbid obesity Psychological stability No alcohol or drug abuse Absence of major psychiatric disorders (schizophrenia, psychosis), mental retardation, eating disorders (bulimia nervosa) Ability to understand the mechanisms to lose weight with surgery and understand that not always achieved good results Understand that the goal of surgery is to achieve the ideal weight No acceptance Age less than 18 years or more than 65 years Previous bariatric surgery Previous gastric surgery Inflammatory bowel disease | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-75.0, Cigarette Smoking Male or female cigarette smokers, 18-75 years Smoked an average of less than 10 cigarettes per day during past month A personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study Only one subject per household may participate Pregnancy | 2 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, Oropharyngeal Dysphagia (OPD) Dysphagia Profound oropharyngeal feeding tube dependent dysphagia of greater than 12 months duration, as documented by the prevalence of aspiration on fluoroscopic swallow study Must be receiving 100% of nutritional requirements by enterogastric tube years of age and older, acceptable forms of documentation for verification of age birth certificate, passport, and/or driver's license Diminished upper esophageal sphincter opening defined as less than .55 cm for individuals under 65 years of age and less than .40 cm for individuals over 65 years of age on fluoroscopic swallow study Failure of > 3 months of dysphagia therapy within 3 months of study enrollment No documented history of noncompliance with feeding recommendations Cognition that is within normal limits, as evidenced by an Abbreviated Mental Test Score (AMTS) score greater than 6 Manual dexterity that is within normal limits for age, sex, and hand, as evaluated by a Block and Box Test (BBT) Physical strength to pull the SED forward, as evidenced by the ability to lift a 5 lb weight off of a table and keep it elevated for 10 seconds Ability to understand the informed consent and comply with follow-up, as evidenced by appropriate questions, responses, and comments during the initial evaluations and a normal Abbreviated Mental Test Score Profound oropharyngeal feeding tube dependent dysphagia < 12 months duration Esophageal phase dysphagia as defined as personal history and/or documented diagnosis of esophageal dysmotility, hiatal hernia, stricture, eosinophilic esophagitis, erosive peptic esophagitis, and/or systemic disease affecting the esophagus Able to safely consume any food or liquid by mouth, as documented by fluoroscopic swallow study Normal UES opening, as evidenced by UES opening greater than .55 cm for individuals under 65 years of age and greater than .40 cm for individuals over 65 years of age on fluoroscopic swallow study Currently pregnant, as evidenced by a positive result on a pregnancy test if the patient is within child bearing age (younger than 60 years of age) years of age and younger, acceptable forms of documentation for verification of age birth certificate, passport, and/or license Success full receipt of dysphagia therapy or < 3 months of dysphagia therapy within 3 months of study enrollment Lack of manual dexterity to operate swallowing expansion device as determined by a Block and Box Test (BBT) score below the normal limits per age, sex, and hand Inability to lift a 5 lb weight off of a table and keep it elevated for 10 seconds Lack of cognitive ability to operate swallowing expansion device or provide informed consent as evidenced by an Abbreviated Mental Test Score (AMTS) score less than 6 | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-65.0, Wound Infection Elective total thyroidectomy or hemithyroidectomy with lymphadenectomy for thyroid cancer Age > 65 years, < 18 years Thyroid tumor with Grave's disease Thyroid tumor size over 5 cm Second or more than 2 times for thyroid surgery Non-traditional pathway for thyroid surgery ASA > II Pharyngitis Smoking, alcohol drinking history Contraindication or long term use of dexamethasone (allege, ulcer bleeding history, et al) | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 21.0-95.0, Stroke clinical diagnosis of unilateral ischemic strokes by attending physician (according to the National Institute of Health Stroke Scale (NIHSS)) within 6 months of acute stroke diagnosis a score of 3 or higher on the Penetration-Aspiration scale OR a score of 2 on the Residue scale at any location (oral cavity, valleculae, or pharynx) that is instrumentally documented by a participating SLP during a standardized videofluoroscopic swallowing study between the ages of 21 and 95 ability to perform the strengthening protocol independently or with the assistance of a caregiver physician approval of medical stability to participate decision-making capacity to provide informed consent (confirmed through discussion with the subject's primary physician) phone access ability to return to the clinic for required follow-up appointments degenerative neuromuscular disease prior or current diagnosis of bilateral or hemorrhagic stroke prior surgery to the head and neck region that would affect muscles involved in swallowing history of radiotherapy or chemotherapy to the head and neck patient unable to complete the exercise program taking medications that depress the central nervous system allergy to barium (used in videofluoroscopic swallowing assessment) currently pregnant | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, Deglutition Disorders all adult ICU patients post mechanical ventilation (observational analysis) patients prone to die / moribund patients/ or dying patients patients post oesophageal resection / with oesophageal rupture | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 70.0-85.0, Esophageal Cancer Pathologically confirmed esophageal carcinoma Stage I～Iva By EUS and CT/MRI, without contraindication for radical radiotherapy Aged ≥ 70 and < 85 years, behavioral status evaluation ECOG scores 0-2 In 7 days after being screened, subjects should follow the status: WBC ≥ 3.0 x 10^9/L; ANC ≥ 1.5x 10^9/L; PLT ≥ 80 x 10^9/L; Hb ≥ 90 g/L; serum Cr ≤ ULN; serum bilirubin ≤ 1.5 ULN; ALT/AST ≤ 1.5 ULN Subjects should sign for the informed consent Subjects should perform good compliance Patients who have or are currently undergoing additional chemotherapy, radiation therapy or targeted therapy Complete obstruction of the esophagus, or patients who have the potential to develop perforation Patients with a history of malignancy (except that skin carcinomas or in situ breast cancer, oral cancer and cervical cancer with expected survival ≥2 years Patients who have multiple foci esophageal carcinomas Patients who are/were given any other medicine tests currently/in last 4 weeks Experienced hypersensitiveness with similar medicine or other kinds of bio-medicines Patients who have complications as following (1) Uncontrolled angina and heart failure, have a history of hospitalization in 3 months; (2) A history of myocardial infarction in the past 6 months; (3) There is a need for antibiotic treatment of acute bacterial or fungal infection; (4) Chronic obstructive pulmonary disease, or other lung disease requiring hospitalization; (5) Drug addiction, alcoholism and AIDS disease or long-term virus carriers; (6) Uncontrollable seizures, or loss of insight because of mental illness | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, Sore Throat Post-Operative Sore Throat Men and women ages 18 and older American Society of Anesthesiologists physical status classification system I and II (healthy patient or patient with mild systemic disease) Patient coming for elective surgery (except head and neck) requiring general anesthesia Patients staying for at least 24 hours postoperatively Patients provide informed consent Patients presenting for surgery >1 hour in length and <6 hours History of preoperative sore throat, common colds, upper respiratory infections, immune deficiencies Chronic smokers Patients with Mallampati airway grade of more than 2 Patients requiring more than one attempt for intubation or traumatic intubations Patients requiring laryngeal mask Airway (LMA) placement Patients allergic to zinc Patients requiring quinolones or tetracycline antibiotics pre or intraoperatively Patients undergoing head and neck surgeries Pregnancy | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, HER2 Negative Gastric Cancer Patients ≥ 18 years histologically confirmed inoperable locally advanced, recurrent, or metastatic adenocarcinoma of the stomach or gastro-oesophageal junction ECOG (Eastern Cooperative Oncology Group) performance status 0-2 adequate renal, hepatic, and hematologic function measurable or nonmeasurable disease according to the Response Evaluation in Solid Tumors (RECIST). Patients with intraoperatively confirmed intraperitoneal metastases but without detectable disease in radiological studies were also eligible HER2 positive tumors defined as either IHC 3+ or IHC 2+, the latter in combination with FISH+ previous chemotherapy for metastatic or locally advanced disease surgery <3 weeks before the onset of the study treatment congestive heart failure significant dysphagia that would preclude oral administration of capecitabine concurrent malignant disease, except for adequately treated tumors with high likelihood of being cured (e.g. basal cell carcinoma of the skin, cervical cancer) clinical evidence of brain metastases | 1 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-50.0, Obesity Appetite Ability and willingness to come with their twin to the University of Washington (Seattle) Additional for Aim 1 random sample only: Member of randomly selected MZ pair or Additional for Aim 2 random sample only: One member of MZ or same-sex DZ pair with BMI of at least 30 kg/m^2 Additional for Aim 3 sample only: Member of randomly selected MZ pair, and not BMI discordant ≥ 5 kg/m^2 History of weight loss surgery or active participation in weight loss program Major medical problem (e.g., diabetes, cancer) Current use of weight loss medications or other medications known to alter appetite Pregnancy or menopause MRI contraindication (i.e., implanted metal, claustrophobia) Lifetime eating disorder Current smoking Current heavy alcohol use (≥2 drinks per day for females and ≥ 3 drinks per day for males) Self-reported weight >330 pounds at time of phone screening. MRI cannot accommodate all shapes or weights. Inability to have MRI does not subject from participating in other study procedures BMI < 18.5 or > 45 kg/m^2 | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 20.0-80.0, Postoperative Sore Throat patients aged between 20-80 years who were scheduled for surgery under general anesthesia requiring orotracheal intubation history of gastroesophageal reflux disease (GERD) congenital or acquired abnormalities of the upper airway such as tumour, polyp, trauma, abscess, inflammation, infection, or foreign bodies previous airway surgery; increased risk of aspiration coagulation disorders previous history of difficult intubation or conditions with expected difficult airway including Mallampati classification ≥ 3 or thyromental distance < 6.5 cm planned another type of intubation devices such as lighted stylet or fiberoptic bronchoscopy symptoms of sore throat or upper respiratory tract infection expected to place nasogastric tube during perioperative period requiring nasotracheal intubation | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, Smoking Outpatients aged 18 years or above Smoke on at least 1 day in the past 30 days Chinese residents able to communicate in Chinese (Mandarin or Cantonese) Has a telephone Smokers currently receiving smoking cessation interventions Smokers currently enrolled in other smoking cessation trials Smokers who need special care on quitting and are not suitable for AWARD intervention (determined by his/her doctor) Smokers with communication difficulties (physical or cognitive condition) | 0 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-999.0, Esophageal Adenocarcinoma (UICC TNM7) Adenocarcinoma of the Esophagogastric Junction Histologically proven adenocarcinoma of the esophagus according to the Union internationale contre le cancer (UICC) TNM7 definition. Both tumors of the esophagus and tumors of which the epicentre is within 5 cm of the esophagogastric junction and also extend into the esophagus are eligible for into the trial in case of adenocarcinomatous histology. Translated to Siewerts Classification of esophagogastric adenocarcinoma all Type AEG 1 are eligible. Type AEG 2 and Type AEG 3 are eligible in case of tumorous esophageal infiltration Pre-treatment stage cT1N+ M0 or cT2-4a N0/N+, M0 (In case of pre-treatment stage cT4a curative resectability has to be explicitly verified by the local surgical investigator prior to randomisation) Age ≥ 18 years No prior abdominal or thoracic radiotherapy ECOG Performance status 0-2 Adequate cardiac function. Patients with a cardiac history should have a cardiology review and should have a left ventricular ejection fraction > 50% (as determined by echocardiography) Adequate respiratory function (pulmonary function tests completed with FEV1 > 1.5L) Adequate bone marrow function (WBC>3x10^9/l; Hb>9g/dl; platelets >100x10^9/l) Adequate renal function (GFR>60ml/min) and Adequate liver function (Total bilirubin <1.5x Upper level of Normal (ULN); AST <2.5x ULN and ALT <3x ULN Patients with tumors of squamous, adenosquamous or other non-adenocarcinoma histology Patients with advanced inoperable or metastatic esophageal adenocarcinoma Esophageal adenocarcinoma cT1N0 and cT4b Esophageal adenocarcinoma cT4a evaluated as not curatively resectable by the local surgical investigator Gastric carcinoma (according to UICC TNM7) Prior chemotherapy for gastrointestinal cancer Clinically-significant (active) cardiac disease (e.g. symptomatic coronary artery disease or myocardial infarction within last 12 months) Clinically-significant lung disease (FEV1 <1,5l) Peripheral neuropathy Grade >1 Pregnant and lactating women, or patients of reproductive potential who are not using effective birth control methods. If barrier contraceptives are used, they must be continued throughout the study by both sexes | 1 |
A 52-year-old African American man with a history of heavy smoking and drinking, describes progressive dysphagia that began several months ago. He first noticed difficulty swallowing meat. His trouble swallowing then progressed to include other solid foods, soft foods, and then liquids. He is able to locate the point where food is obstructed at the lower end of his sternum. He has lost a total of 25 pounds. | eligible ages (years): 18.0-75.0, Esophageal pathologically or cytology diagnosed phase II-III esophageal carcinoma or IV thoracic segments carcinoma with the supraclavicular lymph nodes metastasis with the measureable lesion of the newly diagnosed the esophageal carcinoma age 18-75 years old ECOG≤2 Expect survival date ≥3 months without serious diseases of important organs signature in the inform consent pregnant or breast-feeding women or using a prohibited contraceptive method with psychiatric diseases with serious diseases or uncontrolled infection with history of other tumors participation other clinical trials within 1 month prior to in the trial not the first antitumor treatment | 1 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 13.0-999.0, HIV Infections Patients may be eligible for this study if they Are 13 years of age or older (consent of parent or guardian required if under the age of 18) Are HIV-positive Have either: (1) no previous experience with anti-HIV treatment (defined as no previous protease inhibitor or nonnucleoside reverse transcriptase inhibitor use, 1 week or less of lamivudine use, and 4 weeks or less of cumulative nucleoside reverse transcriptase inhibitor use) or (2) current or previous enrollment in a qualifying CPCRA study | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 18.0-999.0, Brain and Central Nervous System Tumors Histologically or cytologically confirmed glioblastoma multiforme Some oligodendroglial elements allowed provided they make up < 25% of the tumor Recurrent disease documented by MRI after prior radiotherapy At least 1 bidimensionally measurable target lesion ≥ 2 cm by MRI Undergone prior surgery for recurrent primary brain tumor more than 3 months before study entry Must have a clearly limited target lesion ≥ 2 cm OR evidence of progressive and measurable target lesion OR a second measurable target lesion outside the surgical area Age Over 18 Performance status Karnofsky 70-100% | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 10.0-999.0, Anemia, Sickle Cell Each subject must meet all of the following during the screening process in order to participate in the study Patient must have a diagnosis of SCD (known SS, S-Beta-thalassemia or other hemoglobinopathies causing sickle cell disease). Patients with disease due to Hgb SC are not permitted Must present to the ED/EC or other appropriate unit in VOC Greater than or equal to 10 years old Written informed consent/assent has been obtained Subjects meeting any of the following during baseline evaluation will be excluded from entry into the study Exposure to therapeutic nitric oxide within the past 12 hours Patient has received sildenafil or other phosphodiesterase 5 inhibitors, therapeutic L-arginine, nitroprusside or nitroglycerine within the past 12 hours Patient has received previous ED/EC or other appropriate unit treatment for a vaso-occlusive crisis less than 48 hours or hospitalization less than 14 days ago (patients transferred directly from another ED or clinic may be enrolled) Patient has visited the ED/EC or other appropriate unit greater than 10 times in the past year having a vaso-occlusive crisis Patients presenting with clinically diagnosed bacterial infection (e.g., osteomyelitis, pneumonia, sepsis or meningitis) Patients who are currently enrolled in any other investigational drug study except for hydroxyurea studies Pregnant women (urine HCG + )/ nursing mothers Patients who have received an exchange transfusion (not simple transfusion) in the last 30 days or are on a chronic simple or exchange transfusion program Suspected splenic sequestration | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 18.0-999.0, Candidiasis Non-pregnant subjects >/= 18 years of age; admission to the ICU during the preceding 3 days (minimum of 2 days in ICU) and expected to stay in the ICU a minimum of 2 additional days; subjects must have at least 1 of the following: received at least one other dose of any systemic antibiotic on any one of the ICU days before study entry and continue to receive antibiotics at the time of enrollment, and/or presence of a central venous catheter at the time of enrollment and for one additional day during the current ICU stay, and at least 2 of the following: use of total parenteral nutrition on any of Days 1-4 of ICU stay; any type of dialysis on any of Days 1-4 of ICU stay; any in-patient surgery done under general anesthesia or epidural block in the 7 days prior to or on ICU admission*; pancreatitis (documented by computed tomography (CT) scan or lipase >1,000 u/L) in the 7 days prior to or on ICU admission; more than 1 dose of systemic steroids (prednisone equivalent dose >/=20 mg per dose) in the 7 days prior to or on ICU admission; and/or use of more than 1 dose of other systemic immunosuppressive agents (such as azathioprine, tacrolimus, sirolimus, mycophenolate, monoclonal antibodies, and tumor necrosis factor [TNF] immunomodulators) in the 7 days prior to or on ICU admission Excludes placement of vascular catheters Subjects with an allergy or intolerance to caspofungin or other echinocandin analog; absolute neutrophil count <500/mm3 at entry or likely to develop such a count during therapy; diagnosis of HIV, aplastic anemia, or chronic granulomatous disease; moderate or severe hepatic insufficiency as defined by a Child Pugh score of 7 or greater or cirrhosis due to any cause; pregnancy or breastfeeding; subjects unlikely to survive more than 2 days; subjects who have received systemic antifungal therapy within 7 days prior to study entry; subjects with documented active, proven, or probable invasive fungal infection within 7 days prior to study entry; subjects previously enrolled into this trial; subjects currently receiving another investigational agent or who have received an investigational agent within the 7 days prior to study entry; subjects in the ICU 5 or more days prior to enrollment into this study | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 0.0-999.0, HIV Infections Presently participating, previously participated in, or has given informed consent for participation in a qualifying CPCRA clinical trial Signed informed consent | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 18.0-35.0, Respiratory Tract Infections Chronic Bronchitis Pneumonia Subjects meeting all of the following will be considered for enrollment into the study Male and female adult outpatient subjects diagnosed with AECB or CAP Female subjects must be either postmenopausal for ≥ 1 year or surgically incapable of bearing children. Women of childbearing potential must have a normal menstrual flow ≤ 1 month before study entry, a negative serum pregnancy test immediately prior to study entry, and meet the for acceptable birth control Informed consent must be obtained in writing for all subjects upon enrollment Subjects will have a diagnosis of AECB or CAP, as defined below AECB-Specific Subjects greater than or equal to 35 years of age Subjects with a documented history of chronic bronchitis: with a basal forced expiratory volume in one second (FEV1) < 70% and > 35%; who have had at least one or more AECB in the previous year; and with FEV1/forced vital capacity (FVC) < 70% Subjects with a clinical diagnosis of AECB, presumed to be due to bacterial infection based on increased sputum purulence with either increased dyspnea or sputum volume Subjects producing spontaneous sputum Subjects presenting with any of the following will not be included in the study Subjects with a known history of congenital long-QTc syndrome Subjects who are pregnant or breast-feeding Subjects who have hypersensitivity to telithromycin, azithromycin, or the macrolide classes of antibiotics Subjects who require or receive treatment with rifampin (Rifadin), phenytoin (Dilantin), carbamazepine (Carbatrol, Tegretol), phenobarbital, or St. John's wort (herbal supplement) within 2 weeks prior to Visit 1 or during the study Subjects who require treatment during the study with ergot alkaloid derivatives, cisapride (Propulsid), pimozide (Orap), bromocriptine, cabergoline (Dostinex), or pergolide (Permax) Subjects who have previously participated in this study Subjects with a previous history of myasthenia gravis Subjects with current acute respiratory failure or subjects who require aggressive airway management Hospitalized subjects and subjects from institutional care facilities | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 1.0-5.0, Tick-borne Encephalitis Male and female children will be eligible for participation in this study if they are 1 year (from the 1st birthday) to 6 years (to the last day before the 6th birthday) old they are clinically healthy their legal representative understands the nature of the study, agrees to its provisions and gives written informed consent their legal representative agrees to keep a Volunteer Diary Children will be excluded from participation in this study if they have a history of any previous TBE vaccination have a history of TBE infection or show evidence of a latent TBE infection (as demonstrated by screening ELISA > 126 VIEU/ml and / or neutralization test > 1:10) have a history of allergic reactions, in particular to one of the components of the vaccine have received antipyretics within 4 hours prior to the first TBE vaccination suffer from a disease that cannot be effectively treated or stabilized suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment that can be expected to influence immunological functions suffer from chronic, degenerative and / or inflammatory disease of the central nervous system are known to be HIV positive (a special HIV test is not required for the purpose of the study) suffer from a febrile illness at study entry | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 6.0-15.0, Tick-borne Encephalitis Male and female children will be eligible for participation in this study if they are 6 years (from the 6th birthday) to 16 years old (to the last day before the 16th birthday) they are clinically healthy their legal representative and if older than 8 years the volunteer understands the nature of the study, agrees to its provisions and gives written informed consent their legal representative agrees to keep a Volunteer Diary For safety reasons female volunteers capable of bearing children have to fulfill the following at study start negative pregnancy test at study start they agree to employ adequate birth control measures for the duration of the study Children will be excluded from participation in this study if they have a history of any previous TBE vaccination have a history of TBE infection or show evidence of a latent TBE infection (as demonstrated by screening ELISA > 126 VIEU/ml and / or neutralization test > 1:10) have a history of allergic reactions, in particular to one of the components of the vaccine have received antipyretics within 4 hours prior to the first TBE vaccination suffer from a disease that cannot be effectively treated or stabilized suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment that can be expected to influence immunological functions suffer from chronic, degenerative and / or inflammatory disease of the central nervous system are known to be HIV positive (a special HIV test is not required for the purpose of the study) suffer from a febrile illness at study entry | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 16.0-65.0, Encephalitis, Tick-borne Male and female volunteers were eligible for participation in this study if they Were 16 years (from the 16th birthday) to 65 years (to the last day before the 65th birthday) old Were clinically healthy Had a negative pregnancy test at the first medical examination, if female and capable of bearing children Agreed to employ adequate birth control measures for the duration of the study, if female and capable of bearing children Provided written informed consent For volunteers under 18 years of age written informed consent of the parents / guardian was available Agreed to keep a volunteer diary History of any previous TBE vaccination History of TBE infection or show evidence of latent TBE infection (as demonstrated by screening ELISA > 126 VIEU/ml) History of allergic reactions, in particular to one of the components of the vaccine Previously received volume substitution with a product containing polygeline (stabilizer in Received antipyretics within 4 hours prior to the first TBE vaccination Suffer from a disease that cannot be effectively treated or stabilized Suffering from a disease (e.g. autoimmune disease) or were undergoing any form of treatment that could be expected to influence immunological functions Suffering from chronic, degenerative and/or inflammatory disease of the central nervous system Using any immunosuppressive drugs (e.g. local or systemic corticosteroids, chemotherapeutics) Had a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages) | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 1.0-15.0, Tick-borne Encephalitis Male and female children and adolescents will be eligible for participation in this study if they are aged 1 year (from the 1st birthday) to < 16 years (to the last day before the 16th birthday) they are clinically healthy, (i. e. the physician would have no reservations vaccinating with FSME-IMMUN NEW outside the scope of a clinical trial) their parents/legal guardians understand the nature of the study and agree to its provisions written informed consent is available from both parents/legal guardians for Germany/Austria: additional written informed consent is available for children older than 8 years they or their parents/legal guardians agree to keep a volunteer diary For safety reasons, female volunteers who have reached sexual maturity at study start have to meet the following additional negative pregnancy test at study entry Children and adolescents will be excluded from participation in this study if they have a history of any TBE vaccination have a history of TBE infection have a history of allergic reactions to one of the components of the vaccine suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions are known to be HIV positive (a special HIV test is not required for the purpose of the study) have received banked blood or immunoglobulins within one month of study entry have a history of vaccination against yellow fever and/or Japanese B-encephalitis suffer from hemorrhagic diathesis are participating simultaneously in another clinical trial | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 3.0-18.0, Encephalitis, Tick-Borne Participated in Baxter study 209 and They and/or their parents / legal guardians understand the nature of the study and agree to its provisions Written informed consent is available from the parents / legal guardians according to national law Written informed assent is available from the child/adolescent according to age and capacity of understanding They received the third vaccination with FSME-IMMUN 0.25 ml during the course of Baxter study 209 Blood was drawn after their third vaccination during the course of Baxter study 209 They showed an ELISA concentration > 126 VIE U/ml and / or a NT titer >=10 after the third vaccination in Baxter study 209 They or their parents / legal guardians agree to keep a Subject Diary Received any TBE vaccination since their third vaccination with FSME-IMMUN 0.25 ml Have a history of infection with or vaccination against other flaviviruses (Dengue fever, yellow fever and / or Japanese B-encephalitis virus) since their third vaccination with FSME-IMMUN 0.25 ml Are known to be HIV positive (a special HIV test is not required for the purpose of the study) since their third vaccination with FSME-IMMUN 0.25 ml Received a blood transfusion or immunoglobulins within 30 days of the first and second blood draw (as applicable) Have a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages) Have participated in another Baxter vaccine study within the last six months (with the exception of follow-up studies) Subjects will not be eligible for booster vaccination if they Do not meet the / Are not clinically healthy, (i.e. the physician would have reservations vaccinating with a TBE vaccine outside the scope of a clinical trial) Suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 17.0-66.0, Encephalitis, Tick-borne Male and female subjects who received 2 vaccinations with FSME-IMMUN 0.5 ml during Study 225 understand the nature of the study, agree to its provisions and provide written informed consent are clinically healthy (i.e. the physician would have no reservation vaccinating with FSME-IMMUN 0.5 ml outside the scope of the clinical trial) have a negative pregnancy test result at the first medical examination (if female and capable of bearing children) agree to employ adequate birth control measures for the duration of the study (if female and capable of bearing children) agree to keep a Subject Diary Subjects who have already been administered a third TBE vaccination elsewhere since receiving two vaccinations in Study 225 have a history of infection with, or vaccination against, other flaviviruses since participation in Study 225 (e.g. yellow fever, dengue fever, japanese B encephalitis) have had an allergic reaction to one of the components of the vaccine since participation in Study 225 suffer from a disease (e.g. autoimmune disease, immunodeficiency) or are undergoing a form of treatment (e.g., systemic corticosteroids) that can be expected to influence immunological functions have a known or suspected problem with drug or alcohol abuse (>4 liters wine/week or equivalent doses of other alcoholic beverages) have donated blood or plasma within 30 days of study entry have received a blood transfusion or immunoglobulins within 30 days of study entry are known to be HIV positive (an HIV test is not required specifically for this study) are simultaneously participating in another clinical trial including administration of an investigational product | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 7.0-11.0, Encephalitis, Tick-borne Male and female children who participated in Study 146A if they and/or their parents/legal guardians understand the nature of the study and agree to its provisions written informed consent is available from the child (according to age and capacity of understanding) and the parents/legal guardians they received the complete 3-immunization primary vaccination series with either 0.5 ml or 0.25 ml TicoVac in Study 146A they received FSME-IMMUN 0.25 ml Junior for their first booster vaccination approximately 3 to 4 years after their third vaccination in Study IMAG-146A Subjects who received any further TBE vaccination since their first TBE booster vaccination Subjects with a history of infection with, or vaccination against, other flaviviruses (e.g. dengue fever, yellow fever and/or japanese B encephalitis virus) since their third vaccination in Study 146A Subjects who have suffered from a disease (e.g. autoimmune disease) or have undergone a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions within 30 days before and after their first TBE booster vaccination Subjects who have been known to be HIV positive (a special HIV test is not required for the purpose of the study) since their third vaccination in Study 146A Subjects who have received a blood transfusion or immunoglobulins within 30 days of study entry | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 0.0-999.0, Relapsing Fever, Tick-Borne Jarisch Herxheimer Reaction suspected exposure to tick-borne relapsing fever after returning from field exercise in a tick-borne relapsing fever infected area having a tick bite or staying in field in close proximity to a subject with tick bite sign known sensitivity to tetracycline or doxycycline febrile illness on recruitment | 1 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 1.0-10.0, Encephalitis, Tick-Borne Healthy male and female children, 1 to 10 years of age Subjects with documented evidence of TBE Subjects, who have been previously vaccinated against TBE | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 13.0-999.0, HIV Infections Coenrollment in the SMART study Parent or guardian willing to provide informed consent, if applicable | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 13.0-999.0, HIV Infections Coenrollment in the SMART study Parent or guardian willing to provide informed consent, if applicable | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 18.0-999.0, HIV Infections Coenrollment in the SMART study Unable to comply with all study requirements | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 0.167-4.917, Severe Pneumonia Age: 2 to 59 months Sex: Both boys and girls Severe pneumonia according to WHO (Severe pneumonia is defined as cough or difficult breathing with lower chest wall in drawing with or without fast breathing which is defined as the respiratory rate ≥ 50 breaths per minute for children aged 2-11 months and ≥ 40 breaths per minute for children aged 12-59 months) Attend the Radda Clinic and ICHSH between 8:00 am to 4:00 pm (Sunday through Saturday) Written informed consent by respective parents/guardians Very severe and non-severe pneumonia Nosocomial pneumonia History of taking antibiotics for pneumonia within 48 hour prior to enrollment Chronic illnesses like tuberculosis, cystic fibrosis Congenital deformities/anomalies e.g. Down's Syndrome, congenital heart disease Immunodeficiency Trauma/burn Bronchiolitis Bronchial asthma Lives far away from the Radda Clinic and ICHSH (outside 5 km radius from the respective study site) | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 16.0-999.0, Encephalitis, Tick-Borne Male and female subjects will be eligible for participation in this study if they Understand the nature of the study, agree to its provisions and provide written informed consent (assent if the subjects is under 18 years of age) Provide the written informed consent of their parents / legal guardian (if the subject is under 18 years of age) Are aged >= 16 years (from the 16th birthday) at screening Are clinically healthy, (i.e. the physician would have no reservations vaccinating with FSME-IMMUN 0.5 ml outside the scope of a clinical trial) Have a negative pregnancy test result at the first medical examination (if female and capable of bearing children) Agree to employ adequate birth control measures for the duration of the study (if female and capable of bearing children) Agree to keep a Subject Diary Subjects will be excluded from participation in this study if they Have a history of any previous tick-borne encephalitis (TBE) vaccination Have a history of TBE infection Have a history of infection with or vaccination against other flaviviruses (e.g. dengue fever, yellow fever, Japanese B-encephalitis) Have a history of allergic reactions, in particular to one of the components of the vaccine Suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions Have a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages) Have donated blood or plasma within 30 days of study entry Have received a blood transfusion or immunoglobulins within 30 days of study entry Are known to be HIV positive (an HIV test is not required specifically for the purpose of this study) | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 18.0-55.0, Typhoid Fever Healthy Males or Females aged 18 to 55 years, inclusive Capable of understanding and complying with the protocol requirements and be available for the duration of the protocol History of malignancy, immunocompromised conditions or currently receiving immunosuppressive treatment including systemic steroids History of Typhoid Fever infection, vaccination against typhoid fever or participation in a Clinical Trial using S.typhi organism at any time History of travel to a typhoid endemic region within the last 5 years or history of raising a child from an endemic area. Endemic regions are South and East Asia, the Indian Subcontinent, Africa and Central and South America including Mexico History of persistent diarrhea, blood in stool, peptic ulcer disease, or inflammatory bowel disease Allergies or sensitivities to antibiotics, notably quinolones, penicillins, sulfonamides, cefalosporins and chloramphenicol, and components of the buffer solution, notably aspartame People who are commercial food handlers, day care workers, or health care workers involved in direct patient care. Also people with young children under 2 years of age at home or household contacts who are immunocompromised, pregnant or breast-feeding | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 18.0-999.0, Encephalitis, Tick-Borne Subjects who participated in Study 223 will be eligible for participation in this study if they understand the nature of the study, agree to its provisions and provide written informed consent they received the first booster vaccination with FSME-IMMUN 0.5ml during the course of study 223 blood was drawn after their first booster vaccination in Study 223 Subjects will be excluded from participation in this study if they received any TBE vaccination since their first booster vaccination with FSME-IMMUN 0.5ml have a history of infection with or vaccination against other flaviviruses (e.g. dengue fever, yellow fever, Japanese B-encephalitis) since their first booster vaccination with FSME-IMMUN 0.5ml are known to be HIV positive (a special HIV test is not required for the purpose of the study) since their first booster vaccination with FSME-IMMUN 0.5ml have a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages) Subjects will not be eligible for booster vaccination if they are not clinically healthy, (i. e. the physician would have reservations vaccinating with FSME-IMMUN 0.5ml outside the scope of a clinical trial) suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions are females of childbearing potential and are pregnant or breastfeeding before the booster vaccination (positive pregnancy test result at the medical examination before the booster vaccination) have shown an allergic reaction to one of the components of the vaccine since their first booster vaccination in Study 223 | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 0.75-3.0, Cryptosporidiosis Male and female children aged 9-36 months at the time of enrollment Presence of acute or persistent diarrhea (diarrhea defined as 3 or more loose stool in the previous 24 hours AND not considered normal for that child if the child is exclusively breast fed OR any number of bloody stools in the previous 24 hours; less than or equal to 14 days duration for acute diarrhea; >14 days duration for persistent diarrhea) Child's parent/guardian speaks English or Luganda Parent/guardian provides full and free informed consent for child to participate in study Unknown age Known cardiac, CNS, metabolic or endocrine disorders Moribund children Children with recent history of choking or sudden onset of symptoms with suspected foreign body inhalation | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 0.5-5.0, Pneumonia Malaria Age between 6 months and 5 years Present with history of fever or reported fever Present with cough or difficult breathing Age below 6 months and above 5 years Presence of signs and symptoms of severe illness | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 18.0-45.0, Dengue Fever Dengue Hemorrhagic Fever Dengue Virus Healthy, as determined by medical history, clinical examination, and biological safety parameters Aged 18 to 45 years on the day of inclusion Provision of informed consent signed by the subject or another legally acceptable representative For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to the first vaccination, and until at least 4 weeks after the last study vaccination Able to attend all scheduled visits and to comply with all trial procedures Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia For a woman of child-bearing potential, known or suspected pregnancy or positive serum/urine pregnancy test Breast-feeding woman Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination Planned participation in another clinical trial during the present trial period Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term (at least 2 weeks within the previous 3 months) systemic corticosteroids therapy (at a dose of at least 10 mg). Topical steroids are allowed Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator Current or past alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 35.0-72.0, Irritable Bowel Syndrome Small Intestinal Bacterial Overgrowth Men and women age 32-75 years Rome III for diarrhea-predominant IBS Symptom onset after an apparent episode of acute gastroenteritis Symptoms of > 3 months duration Normal endoscopic appearance of the colonic mucosa Negative markers for celiac disease and inflammatory bowel disease Normal thyroid function and serum calcium levels Must have served in the military or reserves during the time of Operation Desert Storm (August 1990 to May 1991) Clinically significant cardiac, pulmonary, hepatic or renal dysfunction History of/or presence of systemic malignancy Current evidence of any gastrointestinal disorder such as celiac disease or inflammatory bowel disease (i.e. Crohns disease or ulcerative colitis) Current effects of drug or alcohol abuse Investigator perception of patients inability to comply with study protocol Unstable psychiatric disease Recent change in gastrointestinal medications Subjects with a positive pregnancy test Subject is currently participating in another research protocol that could interfere or influence the outcome measures of the present study | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 18.0-70.0, Yellow Fever Able to understand and give informed consent Age 18-45 years or greater than or equal to 55 years If possible, participants agree not to take any vaccines within 30 days before or 30 days after yellow fever vaccination Women of child bearing potential must agree to use effective birth control throughout the duration of the study. A negative urine pregnancy test must be documented prior to vaccination Travel to or having lived in a country/area which is endemic for yellow fever History of previous yellow fever, West Nile, Dengue, St. Louis encephalitis, Japanese encephalitis vaccination or infection Any history of allergy to eggs, chicken or gelatin or to any previous vaccine A history of a medical condition resulting in impaired immunity (such as HIV infection, cancer, particularly leukemia, lymphoma, use of immunosuppressive or antineoplastic drugs or X-ray treatment). Persons with previous skin cancers or cured non-lymphatic tumors are not excluded from the study History of HIV infection, Hepatitis B or Hepatitis C infection History of any chronic medical conditions that are considered progressive (ex, diabetes, heart disease, lung disease, liver disease, kidney disease, gastrointestinal diseases and uncontrolled hypertension). Use of systemic immunosuppressive medications (ex, prednisone) for 2 weeks or more in the past 3 months History of excessive alcohol consumption, drug abuse, psychiatric conditions, social conditions or occupational conditions that in the opinion of the investigator would preclude compliance with the trial Thymus gland problems (such as myasthenia gravis, DiGeorge syndrome, thymoma) or removal of thymus gland or history of autoimmune disorder Recipient of a blood products or immune globulin product within 42 days of the vaccination visit Pregnant women and nursing mothers or women who are planning to become pregnant for the study duration | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 1.0-45.0, Respiratory Sounds Patient and/or parents/guardian signed informed consent Patients with cough or shortness of breath Chest tubes Skin lesions precluding attachment of sensors Respiratory distress Pregnant women | 2 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 18.0-45.0, Dengue Virus Dengue Fever Dengue Hemorrhagic Fever Dengue Diseases Healthy as determined by medical history, clinical examination, and biological safety parameters Aged 18 to 45 years on the day of inclusion Informed consent form signed Able to attend all scheduled visits and to comply with all trial procedures For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to the first vaccination and at least 4 weeks after the last vaccination History of thymic diseases or thymectomy For a woman of child-bearing potential, known or suspected pregnancy or positive pregnancy test Breast-feeding Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent Human Immunodeficiency Virus (HIV), Hepatitis B (HBs Ag) or Hepatitis C (HC) seropositivity in blood sample taken at screening Laboratory abnormalities considered clinically significant upon the Investigator's judgment or above the intensity thresholds (defined in the protocol) in blood sample taken at screening Participation in another clinical trial in the 4 weeks preceding the first trial vaccination Planned participation in another clinical trial during the present trial period Previous residence in or travel of more than 2 weeks to areas with high dengue infection endemicity | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 1.0-11.0, Encephalitis, Tick-Borne Male and female children will be eligible for participation in this study if they are aged >= 1 years (from the 1st birthday) to 11 years (to the last day before the 12th birthday) at screening their parents / legal guardians provide written informed consent children provide written assent to the study according to age and capacity of understanding their parents/guardians understand the nature of the clinical study and will comply with the requirements of the protocol (e.g., completion of the Subject Diary, return for follow-up visits) they are generally healthy, (i.e. the physician would have no reservations vaccinating with a TBE vaccine outside the scope of a clinical study) provide a negative pregnancy test result at the first medical examination (if the subject is a female and capable of bearing children) Subjects will be excluded from participation if they have a history of any previous TBE vaccination they have a history of TBE infection they have a history of infection with other flaviviruses they have a history of vaccination against yellow fever and/or Japanese B encephalitis they have a history of severe allergic reactions, in particular a known sensitivity or allergy to any components of the vaccines they are suffering from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions they have received any blood product or immunoglobulins within 90 days prior to study entry they are known to be Human Immunodeficiency Virus (HIV) positive (an HIV test is not required specifically for the purpose of this study) they have a functional or surgical asplenia | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 0.167-4.917, Acute Respiratory Infections Pneumonia Children aged 2 to 59 months attending the outpatient's clinics of participating sites WHO defined non-severe pneumonia Accessibility for follow-up Written informed consent by a parent or legal guardian WHO signs of severe pneumonia recognised by lower chest wall retraction. Children who present with wheezing will be evaluated for lower chest wall indrawing after treatments with nebulised salbutamol. WHO signs of very severe disease/pneumonia defined as any of the following Cyanosis Inability to drink Convulsions Abnormally sleepy or difficult to wake Severe malnutrition recognised by weight for age less than third percentile by the NCHS (National Child Health Statistics) growth chart and/or oedema (see chart) All patients with a previous history of 3 or more episodes of wheeze or diagnosed to have asthma Known or clinically recognisable congenital heart disease with cyanosis or, congestive heart failure or cardiomegaly Known or clinically recognisable acute/chronic organ system disorders including jaundice, nephrotic syndrome, severe anaemia manifested as extreme pallor etc Other infectious conditions requiring antibiotic therapy at the day of contact including meningitis, tuberculosis, dysentery, osteomyelitis, septic arthritis etc | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 0.0-999.0, Encephalitis, Tick-Borne Subjects who participated in precursor Study 700401 and meet ALL of the following are eligible for participation in this study Subject / parent(s) / legal guardian(s) provide(s) written informed consent (according to national law) Subject provides written assent to the study according to age and capacity of understanding Subject received the first booster vaccination with either FSME-IMMUN 0.25 ml Junior or FSME-IMMUN 0.5 ml during the course of precursor Study 700401 Blood was drawn after the first booster vaccination in precursor Study 700401 Subject / parent(s) / legal guardian(s) understand(s) the nature of the study and is / are willing to comply with the requirements of the protocol (e.g. return for follow-up visits, completion of the Subject Diary) Subjects who participated in precursor Study 700401 and meet ANY of the following are not eligible for participation in this study Subject received any TBE vaccination since his / her first booster vaccination in precursor Study 700401 Subject has a history of infection with or vaccination against other flaviviruses (e.g. Dengue fever, yellow fever, Japanese B encephalitis) since his / her first booster vaccination in precursor Study 700401 Subject is known to be HIV positive since his / her first booster vaccination in precursor Study 700401 (a special HIV test is not required for the purpose of the study) Subject received a blood product or immunoglobulins within 90 days before any blood draw or in the period between the blood draw and the booster vaccination (as applicable) Subject has a known or suspected problem with drug or alcohol abuse (> 4 liters of wine/week or equivalent level of other alcoholic beverages) Subject / parent(s) / legal guardian(s) is / are in a dependent relationship with the study investigator or with a study team member. Dependent relationship includes close relatives (i.e., children or grandchildren, partner / spouse, siblings) as well as employees of the investigator or the site conducting the study | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 1.0-12.0, Pneumonia Children aged 1 to 12 years with acute community-acquired pneumonia (cough, tachypnea, fever and with a chest radiography with lobar, segmental or bronchopneumonia within the first 48 hours) Severely ill patients (hospitalized in intensive care units) Pleural effusion treated with chest drainage Atelectasis detected by x-ray Pneumonia or pleural effusion in the previous six months Other pulmonary underlying disease, heart disease, cerebral palsy or immune deficiency | 2 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 18.0-999.0, Fever Analgesia Age greater than or equal to 18 years Written informed consent by the patients Medical condition necessitating the administration of antipyretic or analgesic medications Αge lower than 18 years Lack of informed consent History of liver cirrhosis Blood creatinine greater than 3mg/dl Blood AST greater than 3 times the upper normal level according to the lab of the participating hospital History of hypersensitivity to non-steroidal ant-inflammatory drugs History of abuse of analgesics Pregnancy or lactation Fulminant hemorrhage of the upper or lower digestive tract Thrombocytopenia defined as less than 50000 platelets/μl | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 18.0-999.0, Respiratory Tract Infection Adults, equal to or more than 18 years years of age Patients with respiratory tract infections, including any of the following Acute tracheitis, acute tracheobronchitis Acute sinusitis Chronic sinusitis Acute tonsillopharyngitis Acute bronchitis Mild community-acquired pneumonia Acute exacerbation of chronic bronchitis Known hypersensitivity to or previously intolerant of macrolides Illness severe enough to warrant hospitalization or parenteral therapy Concomitant use of any of the following medications Drugs metabolized by CYP3A isozyme: alprazolam, astemizole, carbamazepine, cilostazol, cisapride, cyclosporin, disopyramide, ergot alkaloids, lovastatin, methylprednisolone, midazolam, omeprazole, oral anticoagulants (e.g. warfarin), pimozide, quinidine, rifabutin, sildenafil, simvastatin, tacrolimus, terfenadine, triazolam and vinblastine Drugs metabolized by other isozymes within CYP450 system: phenytoin, theophylline and valproate Colchicine, Digoxin, Some antiretrovirals: zidovudine and ritonavir Severe immunodeficiency and chronic disease conditions Renal or hepatic impairment (creatinine clearance under 30 mL/min, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and gamma-glutamyltransferase (GGT) equal or more than 3x higher level in comparison with the norm) Mental condition rendering the subject unable to understand the nature of the study | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 55.0-999.0, Diarrhoea Clostridium Difficile Male/female patients, above 55 years of age Patient has given written informed consent/Assent to take part in the study Patients are receiving antibiotics as inpatients Patients prescribed therapy with single or multiple antibiotics (oral or IV) will be included Antibiotic therapy must be indicated for a minimum of 72 hours Patients must be able to take medication orally in the study is approved by the admitting consultant and validated by a member of the trial team within 48 hours Age less than 55 years Pregnancy Patients on PEG feed. Diarrhoea on admission or within the preceding week Severe life-threatening illness Subjects with allergy or hypersensitivity to any component of the study product (e.g.: allergy or hypersensitivity to milk proteins) Subjects who had any surgery or intervention in the last 4 weeks Subjects enrolled in another clinical study in the last 4 weeks Subjects who are thought not to comply with the clinical study Subjects presenting with a severe evolving or active pathology or infection of the gastrointestinal tract such as inflammatory bowel disease, Crohn's disease or ulcerative colitis, diverticular disease or liver cirrhosis Any condition affecting the pancreas including acute and chronic pancreatitis Patients who had a surgical operation in their bowels in the preceding 3 months A medical condition such that the life expectancy of the patient is predicted at less than 3 months by the admitting consultant and validated by a member of the trial team Immune-suppressed patients (e.g. HIV) Steroid use of Prednisolone greater than 10mg a day (or equivalent of Dexamethasone) for over 2 weeks prior to entering the trial Patients on Cytotoxic drugs Post-transplant patients Any clinical condition affecting the pancreas including acute and chronic pancreatitis Patients with prosthetic heart valves or a history of endocarditis. Patients who have taken probiotic drinks containing live organisms or over the counter probiotic preparations in the past seven days (see Appendix 10) Foreign travel in the last 7 days | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 0.0-999.0, Increased Drug Resistance Infectious Diseases Clinic practices within Denver Health's Webb Center for Primary Care Clinic practices within the University of Colorado Anschutz Campus: General Internal Medicine Clinic Clinic practices within the High Plains Network, and Clinical practices within the Wilmington Health Associates System The antibiotic prescribing patterns of primary care clinicians in these practices will be monitored over a 2 year period. Practices must be willing to assist in tracking Patient records (pediatric and adult) for conditions related to the International Classification of Diseases (ICD-9) codes associated with common infectious conditions (Upper Respiratory Infection, Acute Bronchitis, Pharyngitis, Acute Sinusitis, Otitis Media, Acute Cystitis, Cellulitis or soft tissue abscess, and Community-acquired Pneumonia) will be assessed for antibiotic prescribing 30-day events (hospitalizations Note: Emergency Department (ED) visits, or grade 3 or grade 4 abnormalities), will also be included in this study Ob/Gyn related clinic visits will not be included in this study as these visits are not typically associated with high volumes of antibiotic prescribing for the infectious conditions of interest | 1 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 18.0-45.0, Gastroenteritis Escherichia Coli Male or female ages 18-45, inclusive Provide written informed consent before initiation of any study procedures Healthy as judged by the Principal Investigator (PI) and determined by medical history, physical examination, and medication history Within 45 days of vaccination, have normal screening laboratories for white blood cells (WBC), hemoglobin (Hgb), platelets, absolute neutrophil count (ANC), sodium, potassium, chloride, bicarbonate, blood urea nitrogen (BUN), creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), prothrombin time (PT), partial thromboplastin time (PTT), International Normalized Ratio (INR), C-reactive protein (CRP), and fibrinogen as defined in Appendix B Have normal screening laboratories for urine protein and urine glucose Demonstrate comprehension of the protocol procedures and knowledge of study by passing a written examination (passing grade is at least 70 percent) Capable of understanding, consenting and complying with the entire study protocol including the inpatient period Female subjects must be of non-childbearing potential, (as defined as surgically sterile or postmenopausal for more than 1 year), or if of childbearing potential must be practicing abstinence or using an effective licensed method of birth control (e.g., history of hysterectomy or tubal ligation; use hormonal or barrier birth control such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), cervical sponges, diaphragms, condoms with spermicidal agents, or must have a vasectomized partner) within 2 months of vaccination and must agree to continue such precautions during the study and for 30 days after the Day 28 study visit. Male subjects must agree not to father a child for 90 days after the Day 0 study visit. A woman is eligible if she is monogamous with a vasectomized male Agrees not to participate in another clinical trial during the study period Agrees not to donate blood to a blood bank for 12 months after receiving the vaccine Women who are pregnant or lactating or have a positive serum pregnancy test at screening or positive urine pregnancy test upon admission to inpatient facility Abnormal Vital signs, defined as Hypertension (systolic blood pressure >140 mm Hg or diastolic blood pressure >90 mm Hg) at rest on 2 separate days; or (heart rate <55 at rest on 2 separate days) Respiratory rate >17 Temperature >/= 38.0 C (100.4 F) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within 7 days of administration of dmLT Active positive Hepatitis B, C, and Human Immunodeficiency Virus (HIV) serologies Have a positive urine drug screen Subjects who are unwilling or unable to cease smoking for the duration of the inpatient stay History of antimicrobial treatment in the 2 weeks before ingestion of dmLT Received previous experimental E. coli, LT, or cholera vaccines or live E. coli or Vibrio cholerae challenges; or previous infection with cholera or diarrheagenic E. coli Abnormal bowel habits as defined by fewer than 3 stools per week or more than 2 stools per day in the past 6 months | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 0.231-999.0, Rotavirus Gastroenteritis For cases A male or female child born after 6 March 2006 and at least 12 weeks of age Subject admitted to the study clinics/hospitals for severe gastroenteritis during the study period Onset of severe gastroenteritis ≤ 14 days prior to admission Laboratory confirmed rotavirus positive stool sample at hospital admission or during the first 48 hours of hospitalization Written informed consent obtained from the parent or guardian of the subject For controls Admitted for non-gastroenteritis causes at the same clinic/hospital as the case Living in the same neighbourhood as the case for at least three consecutive months without any symptoms of gastroenteritis or severe gastroenteritis on the day of interview of his/ her parents/ guardians Being born within + For cases Subject has previously participated as case or control in this study Onset of severe gastroenteritis > 48 hours after admission to the hospital (nosocomial infections) For controls For hospital controls: Child who has symptoms of gastroenteritis during current hospitalization or on the day of interview of his/her parent or guardian or for neighbourhood controls: Child who has symptoms of gastroenteritis or severe gastroenteritis on the day of interview of his/her parent or guardian children with the following vaccine preventable diseases: measles, mumps, rubella, diphtheria, pertussis, tetanus, tuberculosis, invasive Haemophilus influenzae type B (Hib) infections (meningitis, bacteraemia, septic arthritis, cellulitis, and epiglottitis) and hepatitis B Child has participated in the past as a case or control in this study Child living in the same house as the case | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 0.0-5.0, Rotaviral Gastroenteritis A male or female < 5 years of age at the time of admission to the study hospital for acute gastroenteritis Written informed consent obtained from the parent or guardian of the subject The diagnosis for treatment at the study site does not acute gastroenteritis The onset of acute gastroenteritis after admission to the hospital i.e. 48 hours after hospital admission | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 0.0-6.0, Nosocomial Rotavirus Gastroenteritis Viral Gastroenteritis Due to Rotavirus A male or female child aged <6 years at the time of admission in hospital. A child will become ineligible on the day of her/his sixth birthday A subject who is hospitalized with any acute gastroenteritis or rotavirus gastroenteritis during the survey period Participants of any kind of rotavirus vaccine clinical trial | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 21.0-40.0, Intestinal Permeability Challenge Test Intestinal Health Inflammation Healthy as assessed by the health and lifestyle questionnaire, (P9067 F02; in Dutch) physical examination results of the pre-study laboratory tests Males, Age >= 21 and <= 40 years at Day 01 of the study Body Mass Index (BMI) >= 20 and < 33 kg/m2. Preferably in high and low body fat mass ranges as to be determined by waist circumference Normal Dutch eating habits as assessed by P9067 F02 Voluntary participation Having given written informed consent Willing to comply with the study procedures, including the ETEC challenge Subjects with one or more of the following characteristics will be excluded from participation Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances Having a history of medical or surgical events that may significantly affect the study outcome, including gastrointestinal illness or surgical operations Use of antibiotics, immunosuppressive drugs, antacids, laxatives or anti-diarrhoeal drugs in the last 3 months before the study Alcohol consumption > 28 units/week for males Reported unexplained weight loss or gain of > 2 kg in the month prior to the pre-study screening Reported slimming or medically prescribed diet Reported vegan, vegetarian or macrobiotic Not willing to be off working as a food handler, in child care or as a healthcare worker with direct patient contact during the week of ETEC contamination | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 0.0-5.0, Infections, Rotavirus A male or female child aged < 5 years at the time of admission. A child becomes ineligible on the day of her/his fifth birthday A subject, who during the study period Is hospitalised for acute gastroenteritis Or Visits an emergency room for acute gastroenteritis Or Has rotavirus positive laboratory results and develops acute gastroenteritis at least 48 hours after hospitalisation | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 0.25-13.0, Kerosene Pneumonitis Ingestion in the preceding 24 hours Presence of respiratory symptoms and/or signs at presentation Informed consent obtained from parent or legal guardian Resident within the Red Cross Hospital drainage area and able to come for two follow-up appointments Asymptomatic and no clinical signs Too ill to be excluded from receiving an antibiotic as judged by Requiring more than 2L/min nasal-prong oxygen Requiring continuous or intermittent positive airway pressure ventilation Fever > 40˚C Needing an antibiotic for another reason e.g. otitis media, tonsillitis Current antibiotic use, prior to kerosene ingestion Allergic to amoxicillin | 1 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 0.0-999.0, Diarrhea Accepting to participate and willing to deliver 2 stool samples With diarrhea: the first 10 children and 10 adults presenting each month at the health facility Without diarrhea: In Bissau matched controls drawn from the registration system at Bandim Health Project. In Finland controls selected at the health facilities participating Not willing or able to deliver the stool samples | 1 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 0.5-6.0, Fever male and female children aged 06 months to 06 years old, weight above 5 kilo and axillary temperature above 37,5 celsius degree patients with a bad general heath state patients with neoplasia, pepic ulcer, gastrointestinal bleeding,history of fever convulsion intolerant to dypirone, ibuprofen, acetaminophen or any other nonsteroidal antiinflammatory drug moderated or severe dehydration conscience state alteration not capable of ingest oral drugs patients being treated with steroids patients treated with antiinflammatory, analgesic and antipyretic drugs in the last 06 hours before the study | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 18.0-999.0, Blastocystis Hominis Infections ≥ 18 years Gastrointestinal symptoms for more than 10 days B. hominis in any quantity in at least one stool specimen out of 3 examined No other pathogenic micro-organism identified Fever > 37.5° bloody diarrhoea weight loss > 10% of usual body weight significant decrease of general condition oncological diseases immune deficiencies known chronic intestinal diseases use of anti-protozoan drugs in the last 2 weeks use of anti-coagulant treatment or antabuse pregnant and lactating women | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 4.0-21.0, Sickle Cell Anemia Acute Chest Syndrome Hemoglobin SS, SC, SB0thal or SBthal Ages ≥ 4-21 years old Patients are admitted to the hematology oncology inpatient service and have been enrolled and consented in the study Meet clinical for ACS an infiltrate on Chest X-ray and one of the following Respiratory symptoms/signs (patients pulse oximetry < 92% or oxygen saturation < 2% below their baseline, tachypnea, cough, and increased work of breathing) Fever Chest pain AND Patients' eligible for a simple transfusion based on one of the following Hypoxemia (patients pulse oximetry < 92% or oxygen saturation < 2% below their baseline) Hemoglobin < 5 gm/dl Increased work of breathing Patient requires exchange transfusion within first 24 hours of admission Patient requires PCCU transfer within first 24 hours of admission Hemoglobin > 9gm/dl secondary to these patients requiring an exchange transfusion | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive Signed and dated written informed consent Male or females ≥ 40 years of age Females must be post-menopausal or using a highly effective method for avoidance of pregnancy Established clinical history of COPD by ATS/ERS definition Post-albuterol spirometry FEV1/FVC ratio ≤ 0.70 and FEV1 ≥30 to ≤ 70% of predicted normal (NHANES III) Former or current smoker ≥10 pack years A history of diagnosed cardiovascular disease or a prior cardiovascular event including any of the following Established (i.e., by clinical signs or imaging studies) coronary artery disease (CAD) Established (i.e., by clinical signs or imaging studies) peripheral vascular (i.e., arterial) disease (PVD) Previous stroke Current diagnosis of asthma Subjects with other respiratory disorders including α1-antitrypsin deficiency as the underlying cause of COPD, active tuberculosis, lung cancer, bronchiectasis (Note: focal bronchiectasis is not exclusionary), sarcoidosis, pulmonary fibrosis (Note: focal fibrotic pulmonary lesions are not exclusionary), pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases Lung volume reduction surgery within previous 12 months Clinically significant abnormalities not due to COPD by chest X-ray or CT scan Hospitalized for poorly controlled COPD within 12 weeks of Screening Poorly controlled COPD 6 weeks prior to Screening, defined as acute worsening of COPD that is managed by the subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician Lower respiratory infection requiring antibiotics 6 weeks prior to Screening A moderate or severe COPD exacerbation and/or a lower respiratory tract infection (including pnuemonia) during the Run-In Period An abnormal, clinically significant finding in any liver chemistry, biochemical, or haematology tests at Screening (Visit 1) or upon repeat prior to randomization An abnormal, clinically significant ECG finding at Screening (Visit 1) or upon repeat prior to randomization | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 40.0-75.0, Lung Cancer ages 40-75 years If ages 40-59, then one of the following needs to be met Current or ex-smoker with >25 pack years and a family history of lung cancer(parent or sibling) OR current or ex-smoker with > 25 pack years and COPD OR current or ex-smoker with a > 35 pack year history If ages 60-75, then one of the following additional needs to be met Current or ex-smoker with >25 pack years and a family history of lung cancer (parent or sibling) OR Current or ex-smoker with >25 pack years and COPD OR Current or ex-smoker with a >30 pack year history Subject is able to return to Cleveland Clinic for annual follow-up screening Current health requires oxygen Have had a chest x-ray or CT of the chest within the last 6 months Previous pneumonectomy Lobectomy of the lung within the last 5 years Diagnosed malignancy within the last 5 years, excluding non-melanoma skin cancer, carcinoma in situ of the cervix and localized prostate cancer A medical condition that would prevent treatment for lung cancer Within the last 6 weeks, one of the following has occured A new cough or chronic cough that has gotten worse Either new shortness of breath, or any worsening of shortness of breath A cough producing blood | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 18.0-999.0, Clostridium Difficile Infection Men / Women aged 18 and over (We will also those adults who lack mental capacity for whom we have a legal representative) Successful treatment of clinically diagnosed CDAD using standard therapy (metronidazole or vancomycin given according to standard local hospital guidelines) Woman of child bearing potential and not willing to use at least one highly effective contraceptive method throughout the study Male with spouse/partner of child bearing potential and not willing to use condoms Pregnant or breast feeding Unable to swallow tablets Life expectancy of <4 weeks Hypersensitivity to the active substance, to any rifamycin (e.g. rifampicin or rifabutin) or to any of its excipients (Tablet core: Sodium starch glycolate type A, glycerol distearate, colloidal anhydrous, silica, talc and microcrystalline cellulose. Tablet coating: hypromellose, titanium dioxide (E171), disodium edentate, propylene glycol and red iron oxide E172) >5 days post standard therapy (metronidazole or vancomycin) for clinically diagnosed CDAD | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 1.0-10.0, Pneumonia children aged 1-10 y presenting to the emergency department must fulfil definition of 'pneumonia', ie any one of fever in the ED a recorded fever at home in the 48h prior to presentation, or WBC > 12 or WBC < 5 in the ED any one of tachypnoea on exam cough on exam or by history increased work of breathing on exam; or or more episodes of emesis in the emergency history of CF, anatomic lung disease, bronchiectasis, congenital heart disease, repeated aspirations, malignancy, immune suppression, recent prolonged admission to hospital, pneumonia diagnosed within the last month, lung abscess within the past six months, > 24 hours of beta-lactam antibiotic therapy prior to presentation, allergy to penicillin, allergy to food colouring evidence of empyaema or necrotizing pneumonia on chest radiograph | 2 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 18.0-999.0, Infectious Keratitis Subjects must be 18 years of age or older Ability to provide written informed consent Likely to complete all study visits Subjects must have one eye that with a diagnosis of infectious keratitis A corneal perforation Descemetocele Pregnancy or breastfeeding Active Herpes corneal disease Patient is unwilling or unable to comply with a medication regimen and follow up appointments | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 18.0-45.0, Gastroenteritis Escherichia Coli Male or female ages 18-45, inclusive Provide written informed consent before initiation of any study procedures General good health, without (a) significant medical illness, (b) clinically significant physical examination findings, including vitals, as determined by the PI, and (c) screening laboratory values outside the site's normal limits Within 46 days of vaccination, have normal screening laboratories, per Appendix B for white blood cells (WBCs), hemoglobin (Hgb), platelets, absolute neutrophil count (ANC), sodium, potassium, chloride, bicarbonate, blood urea nitrogen (BUN), creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST) Have normal screening laboratories for urine protein Trace protein is acceptable HgbA1C <6.5% at screening Demonstrate comprehension of the protocol procedures and knowledge of study by passing a written examination (passing grade is at least 70 percent) Agrees to complete all study visits and procedures Female subjects must be of non-childbearing potential (as defined as surgically sterile or postmenopausal for more than 1 year), or if of childbearing potential, must be using an effective method of birth control (e.g., use hormonal or barrier birth control such as implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], cervical sponges, diaphragms, condoms with spermicidal agents must have a vasectomized partner) within 2 months of vaccination, or practice abstinence and must agree to continue such precautions during the study and for 30 days after the Day 29 study visit. Male subjects must agree not to father a child for 30 days after the Day 29 study visit. A woman is eligible if she is monogamous with a vasectomized male Agrees not to participate in another clinical trial during the study period Women who are pregnant or lactating or have a positive serum pregnancy test at screening or positive urine pregnancy test upon admission to inpatient facility Abnormal vital signs, defined as Hypertension (systolic blood pressure >140 mm Hg or diastolic blood pressure >90 mm Hg) at rest on 2 separate days; or Palpated heart rate <55 or >100 beats/minute at rest on 2 separate days*; or *If heart rate between 45 and 55, subjects may be enrolled with an EKG that demonstrates normal sinus rhythm and does not document conduction disorders Temperature >/= 38.0 degrees C (100.4 degrees F) Symptoms of an acute self-limited illness, including a temperature >/= 38.0 degrees C (100.4 degrees F), such as an upper respiratory infection or gastroenteritis within 7 days of administration of dmLT Positive hepatitis C, or HIV serology or positive hepatitis B serology not consistent with prior hepatitis B immunization Have a positive urine drug screen for opiates Subjects who are unwilling or unable to cease smoking for the duration of the inpatient stay | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 18.0-999.0, Community Acquired Pneumonia age ≥ 18 infiltrate on chest X-ray further cough or production of purulent sputum or pathologic lung auscultation (crackles) or fever hospital inpatient treatment within the last 28 days Immune suppressed patients | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 18.0-999.0, Cough Dyspnea Wheezing Presenting to the Emergency Department with cough, wheezing and/or dyspnea (shortness of breath) Referred for CXR and/or CT scan Life threatening medical condition requiring immediate treatment Unable to sit up for a chest ultrasound Unable to consent Pregnant Unable to speak, read and write in English | 2 |
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