eligible ages (years): 55.0-85.0,  All  Post-Menopausal Osteoporosis in the cross-sectional part of the study which involves assessment of vitamin K status Informed consent to screening stage : assessment of vitamin K status serum vitamin K concentration < 0.15 ug/ml into the randomised controlled trial ambulatory post-menopausal women aged between 55-85 years 2. Post-menopausal osteoporosis ( history of previous fragility fractures or BMD evidence of osteoporosis or osteopenia with at least one clinical risk factors such as low BMI, positive family history of osteoporosis) 3. Treatment with a bisphosphonate and calcium/vitamin D supplements for at least 12 months 4. Informed written consent 5. e GFR >30 ml/min 6. normocalcaemia  Age <55 years, or > 85 years Male gender severe renal impairment (CKD stage 4 and 5) poor mobility (inability to walk 100 yards unaided) malabsorption (extensive bowel surgery, short bowel) generalised carcinomatosis glucocorticoid therapy inflammatory disorders (e.g. active rheumatoid arthritis, inflammatory bowel disease requiring oral glucocorticoids) endocrine diseases (e.g. primary hyperparathyroidism, hyperthyroidism) chronic liver disease


A 51-year-old woman is seen in clinic for advice on osteoporosis. She has a past medical history of significant hypertension and diet-controlled diabetes mellitus. She currently smokes 1 pack of cigarettes per day. She was documented by previous LH and FSH levels to be in menopause within the last year. She is concerned about breaking her hip as she gets older and is seeking advice on osteoporosis prevention.

eligible ages (years): 40.0-80.0,  All  Chronic Obstructive Pulmonary Disease age 40-80 years old cases: spirometry (post-bronchodilator) based diagnosis of COPD (GOLD criteria) + smoking history of at least 10 pack-years and active smoking behavior till at least 10 years from the moment of enrollment smoking controls: no COPD (spirometry based) + smoking history of at least 10 pack-years and active smoking behavior till at least 10 years from the moment of enrollment non-smoking controls: no COPD (spirometry based) + < 1 pack year  Respiratory disorder other than COPD α1-antitrypsin deficiency Known history of significant inflammatory disease other than COPD COPD exacerbation within 4 weeks prior to study Lung surgery Recent diagnosis of cancer Therapy with oral corticosteroids in the last 6 weeks Significant cardiovascular comorbidity Significant orthopedic/musculoskeletal problems


eligible ages (years): 18.0-999.0,  All  Type 2 Diabetes Mellitus Have been diagnosed with type 2 diabetes mellitus Have an HgbA1c value ≥ 7% and ≤17% Are on basal insulin, with or without oral agents Are not on basal bolus insulin therapy Have had no severe hypoglycemic episodes in the 6 months prior to enrollment in the study. Severe hypoglycemia will be defined as any hypoglycemia that is both neurologically impairing and absolutely requires assistance from a third party in the form of carbohydrates, glucagon shots, or attention from a paramedic or other healthcare professional Have no known allergy to medical tape or sensors Are capable of and willing to test their blood glucose (BG) on an average of 4 times per day Are willing to not use Acetaminophen while enrolled in the study Are willing not to undergo a MRI procedure while wearing the CGM sensor Are willing and capable of performing self insertions of the device sensor  Have been on pump therapy in the 6 months prior to enrollment in the study Are receiving basal bolus insulin therapy Are taking any medication that is not approved to be taken with insulin Are pregnant or have intentions of becoming pregnant during the duration of the study Have any skin condition that would inhibit the proper wearing of the CGM sensor including severe psoriasis, burns, eczema, scarring, excessive tattoos, etc Have a hematocrit ≤30% or ≥55% Are currently enrolled in another clinical study (subjects must have ended participation in other studies at least 30 days prior to enrolling in this study Are employed by any company that manufactures or is developing a CGM device Are deemed incapable of participating in the study by the Primary Investigator for any reason


eligible ages (years): 18.0-999.0,  All  Osteoporosis inherited low-turnover osteoporosis lumbar spine or hip BMD T-score ≤ -2.5 a written informed consent  age less than 18 years generally accepted contraindications for the treatment


eligible ages (years): 20.0-45.0,  All  Adult Idiopathic Generalized Osteoporosis Premenopausal women, aged 20-45, with regular menses and no historical or biochemical secondary cause of osteoporosis Documented adult fractures judged to be low-trauma Must be willing to use effective contraception throughout the period of study drug administration vary slightly based on age category Premenopausal women ages 20-35 years must have at least one major osteoporotic fracture (excluding fractures of fingers, toes and face) AND low Bone Mineral Density(BMD) Premenopausal women above the age of 35 years should have a history of fracture AND/OR low BMD  History of any condition that increases the risk of osteosarcoma Early follicular phase serum Disorders of mineral metabolism Suspicion of osteomalacia Vitamin D deficiency Pregnancy or lactation within past 12 months Prolonged amenorrhea (> 6 months) during reproductive years (except pregnancy or lactation) Prior eating disorder Malignancy, except cured basal or squamous cell skin carcinoma Endocrinopathy: new onset untreated hyperthyroidism, hypothyroidism, Cushing's syndrome, prolactinoma


eligible ages (years): 65.0-999.0,  All  Fall Fractures Aged over 65 years with normal renal function Normal transaminase levels Normal calcium blood levels Not homebound (not immobilized) nor in socio-healthcare institutions  Need for medical treatment with calcium or vitamin D Hypersensitivity to or contraindication for calcium or vitamin D Medical treatment that includes calcium or vitamin D Physical disability that impedes their collaboration Taking thiazide diuretics Oral anticoagulants Hormone replacement therapy Digitalis drugs Anticonvulsants or barbiturates Having any of the following diseases


eligible ages (years): 60.0-999.0,  All  Osteoporosis Postmenopausal women or men > 60 years DXA T-Score at lumbar spine, total hip or femur neck <-2,0 before the start of the bisphosphonate therapy or at baseline or at least one low trauma vertebral fracture grade 2-3 or multiple low trauma vertebral fractures independent of bone mineral densitiy Pretreatment with bisphosphonates for at least four years Risk for hip and vertebral fractures min. 30% according to DVO-guideline for osteoporosis 2009 Signed informed consent  Other pharmacological treatment of osteoporosis during the last 48 months Other bone diseases Malabsorption syndromes Renal insufficiency with a calculated creatinine clearance < 35 ml/min Diseases of the esophagus, delayed esophageal clearance UUnability to realise the intake instructions Hypocalcemia


eligible ages (years): 18.0-999.0,  All  Cervical Disc Degeneration Cervical Stenosis virgin spines no emergency operation age above 18 sufficient knowledge of the German language indication for anterior cervical discectomy and fusion absence of concomitant spinal disease  prior cervical surgery indications other than ACDF concomitant neoplastic, metabolic, severe general or infectious disease


eligible ages (years): 30.0-90.0,  All  Osteoporosis Females Postmenopausal women Outpatients screened for osteoporosis Women > 45 years Women < 45 years under menopause Women obtained their consent to be measured  Premenopausal females Women without any symptom of menopause Women not obtained their consent to be measured


eligible ages (years): 65.0-999.0,  All  Fall and Fracture Prevention. > age 65 Patient of the Centre for Family Medicine Family Health Team (CFFM FHT) Have at least one of the following or more falls in the past 12 months age 75 + high risk of fracture based on the CAROC difficulty with walking or balance as determined by attending physician acute fall history of a fragility fracture after the age of 50  moderate to severe cognitive impairment moderate to severe neurologic impairment not able to communicate in English contraindications to exercise as determined by physician uncontrolled hypertension palliative care, current cancer, on dialysis participation in a similar exercise program including resistance training at least 3 times a week


eligible ages (years): 40.0-80.0,  All  Smoking Cessation COPD Active smokers over 40 years and more than 10 pack-years  Previous diagnosis of respiratory disease (asthma, COPD, interstitial lung disease) that cause alteration of spirometric pattern Patients with limitations in performing spirometry Age greater than 80 years Institutionalized patients Patients with a life expectancy less than 1 year Spirometry in the past 2 years


eligible ages (years): 40.0-999.0,  All  Type 2 Diabetes Mellitus Osteoporosis inclusion:40-99 years old with type 2 DM patient exclusion:organization people


eligible ages (years): 40.0-90.0,  All  Osteoporosis Postmenopausal women Diagnosis of osteoporosis in the medical record At least one prescription drug to treat osteoporosis in the last 5 years Insured by "Clalit" Health Services Hebrew-speaking capability and readiness to answer a questionnaire  Premenopausal women No diagnosis of osteoporosis in the medical record No treatment for osteoporosis in the last 5 years Women who do not speak Hebrew or are unable to answer a questionnaire


eligible ages (years): 50.0-999.0,  All  Diabetes Mellitus Osteoporosis Osteopenia Type 1 or type 2 diabetes Age ≥ 50 years Unaltered treatment of diabetes during the previous six months (no changes in drugs, but an increase or decrease in dose is accepted) and HbA1c is stable with a level of ± 1 in the same period HbA1c level≥ 7 % through the previous six months BMI between 19 og 35 Specific for type 2 diabetes Either treatment with metformin, sulfonylureas, dipeptidyl peptidase IV (DPP IV) inhibitors or glucagon-like peptide 1 (GLP-1) analogs Treatment with insulin and insulin in the combination with metformin, sulfonylureas, DPP IV inhibitors or GLP-1 analogs  HbA1C > 10% Pregnancy Metal implanted at both ankles and wrists Patients treated with: Antiresorptive (incl. hormone replacement therapy) or bone anabolic treatment, glucocorticoids, lithium and anticonvulsives Patients with a bone disease other than osteoporosis Vertebral fracture visible by vertebral fracture assessment (VFA) Patients with renal disease defined by estimated glomerular filtration rate(eGFR) < 50 Other medical disease in unstable phase (fx. cancer, hyperthyroidism) Heart failure; New York Heart Association (NYHA) class IV Patients which the investigator does not believe is fit to participate in the study


eligible ages (years): 20.0-75.0,  All  Healthy Men and non-pregnant women who are at least 20 years and under 75 years of age; and Female subjects cannot be pregnant or breast feeding Patients who are, in the opinion of the Investigator, able to comply with the requirements of the study; and Patients who have been adequately informed of the nature and risks of the study and who have given written informed consent prior to receiving study medication  Women who are pregnant, as determined by a urine pregnancy test, or breast-feeding Presence or history of congestive heart failure (NYHA class III/IV) within the prior 12 weeks Recent myocardial infarction (within the prior 12 weeks) Unstable angina pectoris Known or suspected renal insufficiency defined as creatinine>1.5mg/dl Known or suspected hepatic insufficiency defined as abnormal liver function tests (GOT/GPT) >3x upper normal limit (i.e., 120 U/l) Known hypomotility syndrome: (such as hypothyroidism or scleroderma) Recent major trauma within the prior 12 weeks Recent surgery requiring anesthesia including coronary artery bypass graft (within 12 weeks) Recent hospitalization (within 12 weeks)


eligible ages (years): 40.0-90.0,  All  Osteoporosis Adults between the ages of 40 to 90 Adults who been fractures prior to assessment Adults who have ability, well conscious to complete the questionnaires  Adults who have treatment currently will not in this study


eligible ages (years): 20.0-90.0,  All  Osteoporosis Postmenopausal women and men referred for bone density examination  Patients unable to sign consent for participation


eligible ages (years): 50.0-89.0,  All  Osteoporosis Female sex Age 50 to 89 years  Those who have opted out of being contacted for research on their general Park Nicollet clinic consent will not be recruited by mail Inability to sign consent form due to cognitive impairment. Those with dementia (ICD-9 diagnosis codes 331.0, 294.1, 294.10, 294.11, or 294.8) will excluded from mailed recruitment Measurement of hip BMD is not feasible (for example, those who have had bilateral hip replacement surgeries or who cannot have central DXA because of their body weight) Open leg or arm wounds at sites where ultrasound measurements are supposed to be taken, precluding such measurements


eligible ages (years): 50.0-79.0,  All  Osteoporosis Osteoporosis suspicion Age: 50 years (n = 500) and 60-79 years (n = 500) Post-menopausal status At least one of the clinical risk factors for fracture Low body mass index (< 19kg/m2) Previous fragility fracture Parental history of hip fracture Glucocorticoid treatment (≥ 5mg prednisolone daily or equivalent for 3 months or more) Current smoking  Treatment: osteoporosis medication Obesity: body mass index BMI > 30kg/m2 a refusal to participate in the study Healthy Age: 50 years (n = 50) and 60-79 years (n = 50) Post-menopausal status No diseases or treatments which may affect to bone health Treatment: osteoporosis medication a refusal to participate in the study


eligible ages (years): 50.0-80.0,  All  Osteoporosis Women between 50 and 80 years Hospitalized In health services, orthopedics, gynecology, surgery Able to respond to an easy questionnaire Able to give their agreement to participate in the study  Patients with dementia Patients can not express Patients at end of life Patients previously treated for osteoporosis or recent densitometry (BMD) <3 years Patients could not be seen in time by the nurse during their hospitalization Patients receiving a measure of legal protection


eligible ages (years): 35.0-70.0,  All  Hypertension Diabetes Smoking Cardiovascular Diseases All individuals between the ages of 35 and 70 and residing in the area allotted to the CHW will be offered screening Of the screened individuals, those with at least 1 cardiovascular risk factor (either one of Hypertension (BP>140/90), Diabetes (FBG >126) or current daily smoker (self-reported) will be enrolled in the study  Individuals who are bed-bound because of acute illness, or have a chronic condition that makes them bed-bound Individuals who refuse consent Individuals who do not reside in the community and are only visiting, therefore being unlikely to be available for continuous follow up. Individuals who have stayed less than 6 months in the study area, or whose name is not on the voter list of the area will be excluded Individuals who are not able to participate in the intervention due to significant disabilities, such as blindness, deafness or the intellectually disabled


eligible ages (years): 20.0-45.0,  All  Polycystic Ovary Syndrome PCOS diagnosis to three of the Rotterdam  pregnancy lactation taking vitamin d or calcium supplement in excess of a regular multivitamins diabetes mellitus uncontrolled hypertension liver disease renal disease secondary causes of hyperandrogenism metabolic bone disease thyroid dysfunction taking oral contraceptives taking hypoglycemic agents (metformin or thiazolidinediones) medication to affect plasma sex steroids for >/3 months before the study smokers


eligible ages (years): 45.0-70.0,  All  Osteoporosis Osteopenia Periodontal Disease Women between 45-70 years with Absorptiometry Dual Energy X-ray (DEXA) Control group: post-menopausal women with periodontal disease and normal osseous condition Study group: post-menopausal womens with periodontal disease and osteoporosis/osteopenia with and without bisphosphonate treatment (risedronate or ibandronate 150 mg) for longer than 3 months before the study and another  Patients with history of aggressive periodontitis and had received any periodontal treatment when they entered the study Patients with any systemic illness (except osteopenia/osteoporosis) Patients who received antibiotic or non-steroidal anti-inflammatory therapy in the 6 months prior to the study


eligible ages (years): 35.0-60.0,  All  Generalized Chronic Periodontitis Osteoporosis Male and Female Patients aged between 35.00 Year(s) to 60.00 Year(s) diagnosed with Osteoporosis and Chronic Periodontitis who are willing to participate in the study  Patients who are Systemically compromised and under medications such as steroids Patients who smoke.Pregnant and lactating mothers are excluded from the study


eligible ages (years): 40.0-95.0,  All  Post Menopausal Osteoporosis post menopausal osteoporosis women in whom a decision has been made to treat with Prolia in the last 4 weeks received their first prescription of Prolia in the last 4 weeks patient has provided informed consent before enrolling in the study  patients participating in ongoing or previous Denosumab clinical trials


eligible ages (years): 50.0-999.0,  All  Post Menopausal Osteoporosis Postmenopausal women Age 50 years or greater  Previously diagnosed osteoporosis, or receiving treatment for osteoporosis


eligible ages (years): 35.0-999.0,  All  Osteoporosis, Postmenopausal Osteoporosis, Steroid Induced Female patients with postmenopausal osteoporosis (T-score ≤-2,5 SD at any skeletal site) under osteoporosis treatment (except teriparatide) for at least one year with a history of ≥ low-energy fracture during the last 10 years prior the study Male patients ≥ 50 years old with idiopathic osteoporosis (T-score ≤-2,5 SD at any skeletal site) under osteoporosis treatment (except teriparatide) for at least one year with a history of ≥ low-energy fracture during the last 10 years prior the study Male and female patients with steroid-induced osteoporosis (T-score ≤-2,5 SD at any skeletal site) under osteoporosis treatment (except teriparatide) for at least one year with a history of ≥ low-energy fracture during the last 10 years prior the study  Prior use of teriparatide or PTH(1-84) Hypersensitivity to teriparatide regimen Pregnancy and lactation Hypercalcamia Renal deficiency (eGFR < 30 ml/min) Other bone metabolic diseases (including hyperparathyroidism and Paget's disease) except primary osteoporosis or steroid induced osteoporosis  Uninterpretable increases of alkaline phosphatase (ALP) Prior skeletal radiotherapy Skeletal malignancies or bone metastases


eligible ages (years): 50.0-999.0,  All  Hypovitaminosis D Spinal Disease Osteoporosis (Part 1, Retrospective Study) 50 years old or older Patients with any form of spinal fusion surgery performed by Dr. Daniel Fassett, MD, MBA, Neurosurgeon at OSF-INI from November 1, 2012 to October 31, 2014  Subjects diagnosed with chronic renal disease Stage IV or V, metastatic spinal disease, bariatric surgery, malabsorption syndrome, seizure medication and chronic steroid use greater than 3 months at time of surgery (Part 2, Observational Study) (Screening period July 1, 2015-June 30, 2016) 50 years old or older Serum Vitamin D level checked prior to or at surgery BMD exam performed anytime within 2 years prior to surgery Patients with any form of spinal fusion cervical, thoracic, lumbar, surgery performed by Dr. Daniel Fassett, MD, MBA, Neurosurgeon at OSF-INI from July 1, 2015 to May 31, 2016 Subjects diagnosed with Chronic Renal Disease with a GFR < 45 at Stage IV Metastatic Spinal Disease


eligible ages (years): 50.0-75.0,  All  Type 2 Diabetes Mellitus Bone Fractures presence of type 2 diabetes for at least 3 years (history of treatment for type 2 diabetes)  immobility coexisting metabolic bone disease or comorbidities affecting bone health previous treatment with osteoporosis medication or intake of medications known to affect bone metabolism (e.g. steroids) within 6 months prior to enrolment thiazolidinedione use


eligible ages (years): 20.0-90.0,  All  Osteoporosis age of at least 20 years, able to read and fill out the questionnaire, and willingness to participate  severe liver, heart, or kidney impairment, and tumor. Procedures of the study were in accordance with the Declaration of Helsinki and were approved by the local ethics committee


A 58-year-old nonsmoker white female with mild exertional dyspnea and occasional cough is found to have a left lung mass on chest x-ray. She is otherwise asymptomatic. A neurologic examination is unremarkable, but a CT scan of the head shows a solitary mass in the right frontal lobe.

eligible ages (years): 0.0-999.0,  All  Cerebellar Disease Dementia Healthy Parkinson's Disease Right handed normal volunteers (18-65 years old) Patients with Parkinson's disease off medication Patients with cerebellar deficits Patients with frontal lobe lesions Patients with frontal lobe dementia  Subjects with personal or family history of seizures or other neurological disorders Pregnant women Volunteers or patients with severe coronary artery disease Metal in the cranium except mouth Intracardiac lines Increased intracranial pressure as evaluated by clinical means Cardiac pacemakers Intake of neuroleptics


eligible ages (years): 0.0-999.0,  All  Dementia Characterized as having behavioral manifestations using a standardized neuropsychiatric scale and interview FLD patients' frontal cognitive sysfunctions characterized using a short neurobehavioral test battery Patients must be able to be tested and cooperative with the procedures required in this protocol No contraindications to the use of Sertraline No medical conditions that can reasonably be expected to subject the patient to unwarranted risk (e.g., cancer) or require frequent changes in medication. Well-controlled medical conditions such as hypertension and diabetes will not be excluded Patients must not be pregnant or nursing and must be using effective contraception, if still at child-bearing age No history of prior severe traumatic brain injury or other severe neurologic or psychiatric condition, such as psychosis, stroke, multiple sclerosis, or spinal cord injury Not using any psychotropic medication which cannot be stopped 4 weeks before the study


eligible ages (years): 18.0-999.0,  All  Lung Cancer Histologically confirmed stage IIIB with metastatic pleural effusion or metastatic stage IV non-small cell lung cancer Large cell Adenocarcinoma Squamous cell Bronchioalveolar carcinoma Undifferentiated No small cell or carcinoid histologies At least 1 bidimensionally measurable or evaluable indicator lesion Measurable or evaluable indicator lesion(s) must be completely outside the radiation portal or there must be proof of disease progression No current CNS metastases at study entry No meningeal carcinomatosis Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: Greater than 12 weeks Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) SGOT and/or SGPT no greater than 2.5 times ULN if alkaline phosphatase less than ULN, OR alkaline phosphatase no greater than 4 times ULN if SGOT and/or SGPT less than ULN Renal: Creatinine clearance at least 50 mL/min Other: No concurrent illness that would effect assessment of this study Not pregnant or nursing Effective contraception required of all fertile patients PRIOR Biologic therapy: Not specified Chemotherapy: No prior systemic chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Prior radiotherapy for non-small cell lung cancer allowed Radiotherapy for new brain metastases (other than leptomeningeal disease) is allowed during study, but chemotherapy is stopped during and for 2 weeks following radiotherapy Concurrent radiotherapy to other sites allowed if there is no objective for disease progression Surgery: Not specified Other: No other concurrent experimental drug


eligible ages (years): 3.0-16.0,  All  Brain and Central Nervous System Tumors Histologically proven primitive neuroectodermal tumors of the central nervous system No metastatic disease within or outside the central nervous system Must have survived 1 week following surgery Postoperative CT scan and myelogram required Age: 3 to 16 Performance status: Not specified Life expectancy: Not specified Hematopoietic: No concurrent hematological disorder Hepatic: Not specified Renal: Renal dysfunction allowed Other: No prior history of malignant disease PRIOR Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics


eligible ages (years): 0.0-999.0,  All  Carcinoma, Non-Small-Cell Lung Histologically confirmed locally advanced NSCLC (squamous, large cell undifferentiated or adenocarcinoma) Disease limited to the thorax, adjacent mediastinum and neurovascular structures, and supraclavicular or scalene lymph node area, as defined by the AJCC Staging System. This includes patients with Stage IIIA and IIIB disease Performance status of 0-2 by Southwest Oncology Group criteria Medically inoperable patients (Stage I or II) Locoregional recurrent tumor following surgery will be eligible provided they meet other criteria


eligible ages (years): 40.0-70.0,  All  Lung Cancer Patients at high risk for the development of lung cancer as defined by the following: At least 40 pack years smoking (may have stopped smoking within past 10 years) at time of study entry FEV-1/FVC ratio less than 70% predicted OR FEV-1 less than 80% predicted obtained from 3 serial performances with less than 5% difference Normal or stable current chest x-ray Age: 40 to 70 Performance status: Not specified Life expectancy: At least 5 years Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Pulmonary: See Disease Characteristics Other: No other comorbidity that limits life span to less than 5 years No prior cancer except nonmelanomatous skin cancer or carcinoma in situ of the cervix Not pregnant Negative pregnancy test Fertile patients must use effective contraception PRIOR Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified


eligible ages (years): 6.0-90.0,  All  Intracranial Central Nervous System Disorder Mental Disorder Healthy AND  Controls: Healthy normal controls matched to specific patient groups for age, education, gender, and race to be recruited by advertisement from the community or from among friends and relatives of the patient. Individuals with a neurological or psychiatric history or medical condition that would compromise our interpretation of the test results will not be included Patients: Patients will be selected from referrals to the Cognitive Neuroscience Section, the NIH Clinical Center, and from referrals recruited through approved advertisement in appropriate media and medical journals All patients must have a diagnosed CNS disorder with lesions localization (when suspected) verified by CT or MRI scanning available from the referring physician or completed at the NIH Clinical Center. Subjects without neurological, neuropsychological, and imaging evidence compatible with one of the recruited diagnoses will be excluded from the study as will subjects who cannot cooperate with neuropsychological testing (based on family report and the report of the referring healthcare professional) The bulk of the patients recruited for this protocol will have focal or degenerative lesions of the HPFC. We also will recruit patients with non-frontal lesions in order to determine the specificity of the deficit we observe in patients with HPFC lesions. These patients will undergo the same testing but are not expected to have marked cognitive deficits on tests of frontal lobe function Patients with different basal ganglia disorders or limbic system lesions are included because their lesions involve differing subsets of subcortical structures that are thought to play an important role in the automatic activation of stored plans and social behavior. Another prediction from the SEC model is that patients with basal ganglia disorders will have deficits primarily on over-learned components of tasks that require visuomotor interaction (e.g., a visuomotor serial reaction time task) but have spared performance on higher level cognitive planning tasks that don't require simple visuomotor responses The bulk of the patients will be patients with focal penetrating head injuries who will be seen here at the NIH as part of a newly funded study to be conducted primarily, but not solely, at the National Naval Medical Center. Patients with dementing disorders (e.g., frontotemporal dementia) are suitable for assessment of the structure of knowledge, and in particular, the systematic general breakdown of social and non-social SEC knowledge representation. Patients with focal lesions (e.g., dorsolateral frontal) will be studied to assess damage to specific sub-components of the structured event complex model. Occasionally, single cases will be intensively studied due to a unique behavioral presentation (see above for a lengthier description) A durable power of attorney will be appointed if the patient is unable to make decisions about any or all aspects of this protocol. In the past in our protocols, this has almost always been the spouse The age range of the brain-damaged patients will be determined on entrance into the protocol. An equal number of left and right unilateral lesions will be sought for determination of laterality differences. Patients with lesions limited to (rather than simply including) the frontal lobe will also be especially sought Minors (ages 6-17) are included in this protocol in order to examine 3 specific questions: (1) What is the distinction in retrievable SEC knowledge (e.g., plans or social rules) learned prior to adolescence from that subsequent to adolescence?; (2) Does learning and development of all aspects of social cognition require an intact prefrontal cortex?; and (3) Will some effects of early prefrontal cortex lesions only appear after the age of 14? The first question will be addressed by studying healthy normal children before the age of 14 on experimental social cognition and planning tasks slightly modified from those used with adults (see the six studies described above). The second question will be addressed by studying single cases and groups of children with prefrontal cortex lesions on social cognition tasks before and after the age of 14. The third question will be addressed by studying children with prefrontal cortex lesions incurred before the age of 14 both before and after the age of 14 on social cognition, meta-cognition, and planning tasks


eligible ages (years): 18.0-999.0,  All  Carcinoma, Non-small-cell Lung Histologically confirmed non-small cell bronchogenic carcinoma, including squamous cell carcinoma, undifferentiated carcinoma, adenocarcinoma, mixed (adenocarcinoma with squamous cell carcinoma), bronchoalveolar carcinoma, or large cell carcinoma Stage IV or Stage IIIB Progressed during or after first-line therapies with platinum-containing regimens in the advanced or metastatic treatment regimen At least 18 years of age Good performance status (ECOG 0 to 1) Adequate liver, renal, and bone marrow function  Pregnant or lactating women Treatment with more than one cytotoxic therapy Prior radiation to the whole pelvis Unstable medical conditions such as uncontrolled cardiac arrhythmia Patients with known history of severe hypersensitivity reactions to docetaxel or other drugs formulated with polysorbate 80


eligible ages (years): 18.0-999.0,  All  Adenocarcinoma of the Lung Adenosquamous Cell Lung Cancer Bronchoalveolar Cell Lung Cancer Large Cell Lung Cancer Squamous Cell Lung Cancer Stage IB Non-small Cell Lung Cancer Stage IIA Non-small Cell Lung Cancer Stage IIB Non-small Cell Lung Cancer Stage IIIA Non-small Cell Lung Cancer Patients must have histological proof of a primary non-small cell lung cancer (bronchoalveolar carcinomas presenting as a discrete solitary radiological mass or nodule are eligible) Patients must be classified post-operatively as stage IB, II or IIIA on the basis of pathologic At the time of resection a complete mediastinal lymph node resection or at least lymph node sampling should have been attempted; if a complete mediastinal lymph node resection or lymph node sampling was not undertaken, any mediastinal lymph node which measured 1.5 cm or more on the pre-surgical computed tomography (CT)/magnetic resonance imaging (MRI) scan or any area of increased uptake in the mediastinum on a pre-surgical positron emission tomography (PET) scan must have been biopsied; note: a pre-surgical PET scan is not mandatory The nodal tissue must be labelled according to the recommendations of the American Thoracic Society; surgeons are encouraged to dissect or sample all accessible nodal levels; the desirable levels for biopsy are Right upper lobe: 4, 7, 10 Right middle lobe: 4, 7, 10 Right lower lobe: 4, 7, 9, 10 Left upper lobe: 5, 6, 7, 10 Left lower lobe: 7, 9, 10 Surgery may consist of lobectomy, sleeve resection, bilobectomy or pneumonectomy as determined by the attending surgeon based on the intraoperative findings; patients who have had only segmentectomies or wedge resections are not eligible for this study; all gross disease must have been removed at the end of surgery; all surgical margins of resection must be negative for tumor  Prior or concurrent malignancies; patients who have had a previous diagnosis of cancer, if they remain free of recurrence and metastases five years or more following the end of treatment and, in the opinion of the treating physician do not have a substantial risk of recurrence of the prior malignancy, are eligible for the study; patients who have been adequately treated for non-melanomatous skin cancer or carcinoma in situ of the cervix are eligible irrespective of when that treatment was given A combination of small cell and non-small cell carcinomas or a pulmonary carcinoid tumor More than one discrete area of apparent primary cancer (even if within the same lobe, T4, IIIB) Clinically significant or untreated ophthalmologic (e.g. Sjogren's etc.) or gastrointestinal conditions (e.g. Crohn's disease, ulcerative colitis) Any active pathological condition that would render the protocol treatment dangerous such as: uncontrolled congestive heart failure, angina, or arrhythmias, active uncontrolled infection, or others A history of psychiatric or neurological disorder that would make the obtainment of informed consent problematic or that would limit compliance with study requirements Patient, if female, is pregnant or breast-feeding Neoadjuvant chemotherapy or immunotherapy for NSCLC; however, patients may have received pre-operative limited field, low dose (less than 1000 cGy) external beam radiation therapy or endobronchial brachytherapy or laser therapy for short term control of hemoptysis or lobar obstruction; full dose pre-operative radiotherapy of curative intent is a cause for exclusion; patients may have received post-operative adjuvant platinum-based chemotherapy however non-platinum-based chemotherapy is a cause for History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used on this trial; patients with ongoing use of phenytoin, carbamazepine, barbiturates, rifampicin, or St John's Wort are excluded Incomplete healing from previous oncologic or other major surgery


eligible ages (years): 0.0-999.0,  All  Healthy Participants will be right-handed volunteers, aged 20 to 70, without history of any disorder of the central nervous system  Current serious medical or psychiatric condition of any kind History of any significant trauma or medical condition affecting the brain or skull History of epileptic seizure Current use of neuroactive medications, medications affecting the cerebral circulation, or recreational drugs Presence of metal in the head (other than dental hardware) or body, such as pacemakers, aneurysm clips, metallic prostheses (including heart valves or cochlear implants), patches with metallic foil backing, such as nicotine patches, permanent eyeliner or shrapnel fragments History of welding or metal work Broken skin in the area of the stimulating electrodes Pregnancy/breastfeeding


eligible ages (years): 18.0-999.0,  All  Neoplasm Metastasis Brain Neoplasm Single presumed brain metastasis on contrast magnetic resonance imaging (MRI) scan within two weeks before commencement of treatment Systemic cancer diagnosed histologically or cytologically synchronous with, or within 5 years of treatment of the presumed brain metastasis (other than non-melanoma skin cancer and cancer in-situ of the cervix, neither of which would be reasonably attributable as the primary site). Exception melanoma diagnosed > 5 years previously is allowable in view of the extremely variable natural history of melanoma Age >= 18 (no upper age limit) Considered suitable for both S and RS by the neurosurgeon and radiation oncologist (see exclusions) Patient must agree to adjuvant WBRT RTOG RPA Class 1 or 2 (Karnofsky Performance Status [KPS] >= 70 after adequate trial of corticosteroids) RPA Class 3 patients (KPS < 70) eligible if it is considered that the poor performance status is due primarily to the solitary metastasis, aggressive local treatment of which may be expected to restore good performance status. This would ordinarily be associated with minimal systemic disease burden Accessible for treatment and follow-up Patient is infertile or is aware of the risk of becoming pregnant or fathering children and will use adequate contraception  Previous history of brain metastasis(es) Surgery indicated to relieve life-threatening raised intracranial pressure or excision required for tissue diagnosis (no extra-cranial site to biopsy ie unknown primary). However, prior diagnostic (non-excisional) biopsy is allowable it is acknowledged that the 50% probability of a repeat surgical procedure on subsequent randomisation would not be acceptable to many patients and clinicians Surgery contraindicated by site (e.g. thalamus, brain stem) or medical co-morbidities Leptomeningeal disease Primary is small cell lung cancer, germ cell tumour, lymphoma, leukaemia or myeloma Prior cranial RT (including RS) Patient is pregnant


eligible ages (years): 18.0-65.0,  All  Brain Neoplasms Histopathologically confirmed newly diagnosed base of skull benign tumour Karnofsky Performance Status (KPS) equal to or greater than 70  Brain metastases or recurrent tumour Prior radiotherapy (RT) to head or neck No prior chemotherapy or radiosensitizer


eligible ages (years): 20.0-999.0,  All  Lung Neoplasms patients who have solitary pulmonary nodules in CT  patients who don't fit the above


eligible ages (years): 18.0-999.0,  All  Asthma Chronic Obstructive Pulmonary Disease Physician-diagnosis of asthma, COPD exacerbation, or undifferentiated asthma/COPD exacerbation Admitted to the inpatient medical service at Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center Evidence of airflow obstruction on spirometry (FEV1/FVC<70%) Age 18 years or older  History of allergy or other contraindication to macrolides (azithromycin, erythromycin, clarithromycin) Treatment with any macrolide in the 4 weeks prior to study entry Elevated AST or ALT (2 or more times the upper limit of normal) on current admission Elevated alkaline phosphatase (>1.25 times the upper limit of normal) on current admission Elevated total serum bilirubin (more than upper limit of normal) on current admission Previous participation in this study Patients prescribed digoxin (azithromycin may increase digoxin levels) Patients prescribed warfarin (azithromycin may increase INR in patients on warfarin) Patients prescribed pimozide (azithromycin may increase risk of arrhythmias) Patient unable to provide consent (e.g., language difficulty or history of dementia)


eligible ages (years): 18.0-999.0,  All  Non-small Cell Lung Cancer lung cancer patients undergoing resection with intent to cure  age < 18 years


eligible ages (years): 16.0-999.0,  All  Acute Dyspnoea All patients admitted for investigation of acute pulmonary embolus


eligible ages (years): 18.0-75.0,  All  Oral Cancer Histologically proven T1 or T2 N0 M0 (clinical) squamous cell carcinoma of the buccal mucosa, lower alveolus, oral tongue and floor of mouth Surgery is the preferred treatment and the primary tumor can be excised with clear margins via the per-oral route No history of a prior malignancy in the head and neck region No prior malignancy outside the head and neck region in the preceding 5 years Patient will be reliable for follow-up Age> 18 years and < 75 years No significant co-morbid conditions ASA grade II and I Understands the protocol and is able to give informed consent  Prior radiotherapy or surgery for malignancy in the head and neck region Non squamous cell carcinomas of the oral cavity Upper alveolus and palatal lesions where there is a possibility of retropharyngeal node involvement Per-oral excision of tumor will compromise margins in the opinion of the treating surgeon Significant co-existing pre-malignant conditions like erytho-leucoplakia and oral sub mucous fibrosis that in the opinion of the clinician would interfere in the planned treatment management of the patient


eligible ages (years): 40.0-80.0,  All  Chronic Obstructive Pulmonary Disease (COPD) diagnosis of mild COPD OR healthy control subjects 80 years old able to perform all study procedures Smoking history > 10 pack years (for mild COPD) or smoking history < 10 pack years (for healthy control subjects)  allergy to atrovent history of asthma, atopy or nasal polyps Oxygen desaturation < 80 % during exercise recent history of CAD (under a year) or any significant diseases that could contribute to dyspnea or exercise limitation


eligible ages (years): 18.0-999.0,  All  Lung Cancer Metastatic Cancer Histologically or cytologically confirmed malignant pulmonary neoplasm New lung lesion(s) with definitive clinical and imaging features of primary or metastatic disease allowed Imaging findings compatible with localized treatment failure after prior cryotherapy allowed Malignant pleural effusion allowed provided it is associated with a distinct measurable pulmonary mass amenable to cryotherapy Metastatic disease must meet all of the following Primary tumors have been resected or have been deemed controlled by other therapies No other widespread metastases evident (e.g., multiple hepatic or brain metastases) Each pulmonary mass must be amenable to CT-guided percutaneous cryotherapy approach No more than 5 targeted masses for study therapy Target mass defined as pulmonary, hilar, mediastinal, and/or chest wall mass > 1 cm, but < 10 cm in average diameter


eligible ages (years): 60.0-999.0,  All  Depression DSM-IV of major depressive disorder (MDD) Score of greater than 20 on the MADRS (score of greater than 17 for atypical depression) Score of greater than 20 on the Mini Mental State Examination (MMSE)  Any condition that may make having an MRI medically inadvisable Any severe or unstable medical conditions Any known primary neurological disorders, including history of stroke Any other simultaneous Axis I disorder History of substance or alcohol abuse disorder within 6 months prior to study entry Currently at risk for suicide History of failed prior adequate trials of two antidepressants for the current depressive episode History of failed prior adequate trial of sertraline Current use of any other psychoactive medications (medication washout will be required)


eligible ages (years): 12.0-999.0,  All  Refractory Frontal Lobe Epilepsy Cryptogenic frontal lobe epilepsy Normal cerebral MRI


eligible ages (years): 18.0-999.0,  All  Renal Cell Carcinoma Confirmation of metastatic or recurrent renal cell carcinoma  Certain types of previous anti-cancer therapy for Renal Cell Carcinoma Patients with type I insulin-dependent diabetes or poorly-controlled type II insulin-independent diabetes Patients with a history of poorly controlled high blood pressure


eligible ages (years): 0.115-0.308,  All  Pneumonia & AOM Caused by S. Pneumoniae & H. Influenzae A male or female between, and including, 6 and 16 weeks of age at the time of the first vaccination. Pre-term born infants can be included in the study starting from 8 weeks of chronological age at the time of first vaccination and up to 16 weeks of chronological age Subjects should be living in the area covered by the surveillance system for community acquired pneumonia (CAP), invasive disease and acute otitis media (AOM) •Written informed consent obtained from the parent or guardian of the subject Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study), that would contraindicate the initiation of routine immunizations outside a clinical trial context Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol  Use of any investigational or non-registered drug or planned use during the study period Use or planned use of any investigational or non-registered vaccine other than the study vaccine(s) Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis A and/or Streptococcus. pneumoniae . Locally recommended EPI vaccines to be given at birth are allowed, but should be administered at least one month before the first dose of the study vaccine .Other locally recommended vaccines are always allowed, even if concomitantly administered with the study vaccines. •Previous or planned vaccination with a registered pneumococcal vaccine such as Prevnar is not allowed. If Prevnar immunization needs to be initiated, due to the presence of a high risk disease for pneumococcal infections for which the Prevnar vaccine is made locally available, the subject can not be enrolled in the study and should be referred to the specific Prevnar immunization program History of allergic disease or reactions likely to be exacerbated by any component of the vaccines History of any neurologic disorders or seizures Acute disease at the time of enrolment For Colombia: infants with low birth weight ( less than (<) 2.500 grams)


eligible ages (years): 3.0-25.0,  All  Low Grade Gliomas Craniopharyngioma Ependymomas Meningiomas Patients with primary intracranial tumours such as low-grade glioma, meningioma, craniopharyngiomas, ependymomas and other benign tumours considered for radical focal radiotherapy Tumours measuring upto 7 cms on maximum dimension on the CT/MRI Age 3 to 25 years NPS of 0-3 Informed consent from patients or parents as appropriate Long-term follow up expected  Previous radiotherapy Planned adjuvant chemotherapy Expected median survival of less than two years Patient not cooperative for planning and execution of SCRT


eligible ages (years): 18.0-999.0,  All  Lung Cancer Subjects undergoing EUS evaluation of a mediastinal mass, or suspected/known lung cancer Subjects with a prior history of lung cancer Subjects referred to thoracic surgery for evaluation of a suspected/known lung cancer  Altered mental status that would prohibit the giving and understanding of informed consent Dementia Psychiatric illness that would preclude adequate compliance with communication for this protocol Prisoners


eligible ages (years): 18.0-999.0,  All  Lung Cancer Non Small Cell Have pathologically confirmed non-small cell lung cancer Have measurable primary pulmonary tumors ≥ 1cm Have plans for a clinically indicated non-contrast CT scan of the chest All patients must be ≥ 18 years old  Pregnant or lactating women


eligible ages (years): 18.0-999.0,  All  Inoperable Stage I/II Non-small Cell Lung Cancer Histologically confirmed non-small cell cancer by biopsy or cytology. Squamous cell carcinoma, adenocarcinoma, large cell carcinoma, bronchioalveolar carcinoma, or non-small cell carcinoma (not otherwise specified) are allowed Staging studies must identify patient as AJCC Stage I or II based on only 1 of following combinations of TNM staging T1, N0, M0 T2 (<=7cm), N0, M0 T3 (<=7cm), N0, M0 Primary tumor must be arising in one of the following central chest locations Within or touching the zone of the proximal bronchial tree (a volume 2cm in all directions around the proximal bronchial tree [carina, R & L main bronchi, R & L upper lobe bronchi, intermedius bronchus, R middle lobe bronchus, lingular bronchus, R & L lower lobe bronchi]) Adjacent to (within 5 mm) or invading the mediastinal pleura Adjacent to (within 5 mm) or invading the parietal pericardium To differentiate T3 lesions involving the mediastinal pleura from T4 lesions involving major vessels or organs, a chest MRI will be obtained. If any uncertainty remains, the patient will have four-dimensional CT scans (4DCT) in an effort to determine the degree of tumor motion. A freely mobile tumor during ventilation will be judged to be T3 disease  There is no associated with this protocol. Please see the above criteria.-


eligible ages (years): 18.0-999.0,  All  Undiagnosed Pulmonary Nodules Lung Nodules Referral to the pulmonary or thoracic surgery service for undiagnosed pulmonary nodules History of smoking exceeding 10 pack-years (pack year defined as number of packs of cigarettes per day multiplied by the number of years smoked) Age >18 Nodule size 5 to 15 mm in diameter  Clinical indication for immediate biopsy via bronchoscopy, fine needle aspiration, or video-assisted thoracoscopic Surgery (VATS) Active lung cancer or metastasis to the lung Contraindication to needle biopsy Pneumonectomy Need for supplemental oxygen Radiation pneumonitis Interstitial lung disease


eligible ages (years): 0.0-21.0,  All  Pulmonary Nodules Participant has a known or clinically suspected solid malignancy (excluding brain tumor) Nodule must be discovered at the time of diagnosis of the primary malignancy or after the completion of therapy  Participant has not been off therapy for at least 3 weeks before undergoing PET-CT


eligible ages (years): 18.0-90.0,  All  Ulcer Within 24 hours of admission to Neurosurgical ICU after neurosurgery with ventilator support  Less than 18 y/o Pregnancy Not suitable for medication from NG route Had GI bleeding at admission to ICU


eligible ages (years): 18.0-999.0,  All  Non-small Cell Lung Cancer Patient must be over the age of 18 years Pulmonary nodule with maximum diameter ≤ 5 cm Histological confirmation of primary NSCLC The following stage of NSCLC patients are eligible Stage I: T1 N0 M0 or T2 N0 M0 (Tumor size ≤ 5 cm) Stage II: T3 N0 M0 (Chest wall invasion only, Tumor size ≤ 5 cm) ECOG/Zubrod status of 0, 1 or 2 Thoracic surgery consultation should be obtained from a Board Certified Thoracic surgeon who in collaboration with a radiation oncologist should determine that the patient is not a surgical candidate In order to be considered medically inoperable, the patient must meet at least one major or a minimum of 2 minor as described below MAJOR  Excluding the primary cancer targeted for this treatment, the patient has a prior history of cancer (within the last 5 years) or concurrent cancer other than basal cell or squamous skin cancer Visible endobronchial lesion seen in the trachea, carina, major bronchus, lobar or segmental bronchus on bronchoscopy or microscopic disease detected in the trachea, carina, major bronchus, lobar or segmental bronchus The patient's weight exceeds the tolerances of the institution's imaging and CyberKnife platform/couch The patient has received thoracic radiation therapy in the same field as the planned treatment area in the past The patient has completed chemotherapy within less than 30 days of treatment T2: Tumor size > 5 cm, T3 tumors (except T3 by virtue of chest wall invasion and ≤ 5 cm), T4 tumors. Presence of N1, N2 or N3 disease per previously described would be excluded Pancoast tumors would be excluded Current distant metastatic disease (M1) (preferably biopsy proven) The patient is a female with child-bearing potential who refuses to take a pregnancy test prior to treatment The patient is pregnant or a female who is nursing an infant


eligible ages (years): 45.0-999.0,  All  Emphysema Pulmonary Disease, Chronic Obstructive for All Participants Able to read and write English At least 30 pack-year smoking history (the equivalent of smoking a pack a day for 30 years) Able to participate in the informed consent process Relatively stable clinical status for the past six weeks (i.e., no illness in the 6 weeks before study entry) for Participants with Emphysema Global Initiative for Chronic Obstructive Lung Disease (GOLD) class II, III, or IV COPD, as determined by post-bronchodilator spirometry values OR More than minimal emphysema on an acceptable-quality chest CT scan for Participants without Emphysema GOLD class I COPD or GOLD class 0 (2005 classification), as determined post-bronchodilator spirometry values AND  Pregnant Prisoner Vulnerable populations Recent illness (defined as increased cough, sputum production, worsening malaise, or need for unscheduled physician visit in the 6 weeks prior to enrollment) Coexisting active chronic inflammatory or collagen vascular disease, immunodeficiency of any kind, non-cutaneous malignancy (melanoma is an exclusion), or previous organ transplant Congenital abnormalities of the lung or previous lung surgery Known active hepatitis B, hepatitis C, or HIV/AIDS (not prospectively evaluated) CT evidence of lung disease other than emphysema (including significant fibrosis, bronchiectasis, consolidation, or indeterminate nodules)


eligible ages (years): 18.0-999.0,  All  Stomach Ulcer those recieved major abdominal surgery (estimated admission to sirgical ICU more than 7 days); give written consent and was randomized within 24 hours of admission  age less than 18 y/o; pregnant; allergy to famotidine or pantoprazole; have had GI bleeding


eligible ages (years): 18.0-999.0,  All  Lung Cancer Histologically confirmed non-small cell lung cancer Stage I or II disease (T1-3, N0, M0) T2 or T3 tumor ≤ 5 cm No T3 tumors involving the central chest or mediastinum (only chest wall involvement allowed) Tumor deemed technically resectable, in the opinion of an experienced thoracic surgeon, AND patient deemed "medically inoperable" Patients with FDG-avidity in mediastinal lymph nodes are eligible provided they are able to undergo mediastinoscopy to confirm N0 status ECOG performance status 0-2 Not pregnant or nursing Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment  No history of contrast allergy No psychological issues that would preclude the completion of study treatment No prior radiotherapy or chemotherapy No suspected nodal metastasis that cannot be falsified by mediastinoscopy (i.e., hilar or mediastinal nodes that are either fludeoxyglucose F 18 [FDG]-avid or measure > 1 cm in short axis diameter on CT scan) No tumor within or touching the proximal bronchial tree, defined as a volume of 2 cm in all directions around the proximal bronchial tree (carina, right and left main stem bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi)


eligible ages (years): 18.0-999.0,  All  Neoplasms, Unknown Primary Carcinoma Histologic or cytologic proven, non-resectable carcinoma of unknown primary (adenocarcinoma or non-differentiated carcinoma) Measurable tumor lesion(s) according to WHO PS 0 to 1 Paclitaxel/Carboplatin with or without Cetuximab in Adeno and Undifferentiated CUP (PACET-CUP) Signed written informed consent ≥ 18 years of age Effective contraception for both male and female subjects if the risk of conception exists Adequate bone marrow function Neutrophiles blood cell count (NBC) ≥ 1,5x109/L  Previous exposure to epidermal growth factor receptor-targeting therapy Previous chemotherapy except adjuvant treatment with progression of disease documented > 6 months after end of adjuvant treatment Radiotherapy or major abdominal or thoracic surgery within the last 4 weeks before Concurrent chronic systemic immunotherapy, chemotherapy or hormone therapy Investigational agents or participation in clinical trials within 30 days before treatment start in this study Clinically relevant coronary disease or myocardial infarction within 12 months before study entry Possibility of a curative local treatment (surgery and/or radiotherapy) Women with axillary node metastasis as predominant tumor site Women with peritoneal carcinomatosis as predominant tumor site Men < 50 years old with retroperitoneal or mediastinal lymph node +/


eligible ages (years): 0.0-999.0,  All  Lung Cancer Diagnosis of suspected lung cancer or lung cancer  Inability to undergo therapy


eligible ages (years): 18.0-999.0,  All  Esophageal Neoplasms Histologically documented squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (> 20 cm from the incisors) or gastroesophageal junction are included No distant metastases (M0) Patients will be stratified by stage (clinical N0 versus clinical N1), and surgeon Patients with tumours within 3 cm distal spread into gastric cardia as detected by esophagogastroscopy Resectable mediastinal nodes are eligible No prior chemotherapy for this malignancy No prior radiotherapy that would overlap the field(s) treated in this study Patients with other malignancies are eligible only if > 5 years without evidence of disease or completely resected or treated non-melanoma skin cancer Age > 18 years and able to tolerate tri-modality therapy at the discretion of the treating thoracic surgeon, medical and radiation oncologists. Tumours must be resectable after assessment by the thoracic surgeon  Cancers of the cervical esophagus (< 20 cm are excluded) Tumours that have > 3 cm of spread into cardia of the stomach are considered gastric cancers and are ineligible Patients with biopsy (by endoscopic ultrasound, laparoscopy, or laparotomy ) proven metastatic supraclavicular nodes are ineligible Patients with biopsy proven metastatic celiac nodes are ineligible


eligible ages (years): 0.5-20.0,  All  Neuroblastoma Brain Tumors Solid Tumors Histologically or cytologically confirmed neuroblastoma, brain tumor or other solid tumor (at diagnosis) Relapsed or refractory tumors in which correct standard treatment approaches have failed No more than 2 lines of prior chemotherapy Measurable primary and/or metastatic disease on CT/MRI at least one bi-dimensionally measurable lesion For patients with neuroblastoma, measurable disease will be defined by the modified International Neuroblastoma Staging System (Brodeur et al.1993) completed with MIBG scoring Age at 6 months to ≤ 20 years Lansky play score ≥ 70% or ECOG performance status ≤ 1 Life expectancy ≥ 3 months Adequate organ function Adequate haematological function: haemoglobin ≥ 80 g/l, neutrophil count ≥ 1.0 x 109/L, platelet count ≥ 100 x 109/L; in case of bone marrow disease: neutrophils ≥ 0.5 x 109/l and platelets ≥ 75 x 109/l  Concurrent administration of any other anti-tumour therapy Serious concomitant systemic disorder (for example, active infection including HIV or cardiac disease) that in the opinion of the investigator, would compromise the patient's ability to complete the study History of allergic reaction to the compounds or their solvents History of allergic reaction to Dacarbazine (DITC) Galactosemia, Glucose-galactose malabsorption or lactase deficiency Pregnant or breast feeding young women Presence of symptomatic brain metastases in patients with solid non-CNS tumors


eligible ages (years): 18.0-999.0,  All  Pulmonary Nodule, Solitary Multiple Pulmonary Nodules Scheduled for chest CT as part of their needed medical care If available, individuals who have had previous imaging to suggest they fulfill the needs of the study years of age, or older In good enough physical condition to stand motionless and hold their breath during the image acquisition procedures  Children under 18 years of age Women who are pregnant or who suspect they may be pregnant Individuals who on previous imaging are shown to have objects in or around the lungs that might produce substantial artifacts that would obscure pulmonary nodules Individuals who on recent imaging had active lung or pleural disease that would obscure pulmonary nodules Individuals with more than 5 pulmonary nodules between 5mm and 20mm in diameter in either right or left lung Individuals suspected to have more than 15 total nodules between 3mm and 20mm. NOTE that up to 20 nodules between 3mm and 20mm will be allowed in the final study sample


eligible ages (years): 3.0-18.0,  All  Pneumonia Subject's parent or legal guardian, is able and willing to read the Informed Consent, understands the Informed Consent, and provides written Informed Consent for the subject; if the minor child is in fact able to give consent, the minor's consent must be obtained in addition to the consent of the minor's legal guardian Boy or girl in the age range of 3-18 years Patient presented with acute respiratory complaints, acute cough, onset of shortness of breath, or fever Patient referred by ED physician and presented for CXR  Body habitus or skin condition that might prevent the placement of the sound sensors on the back (e.g. severe scoliosis, kyphosis, chest wall deformation, skin lesion on the back or compression fracture) Potentially contagious skin lesion on the back Subject has had lung surgery Subject was prescribed the CXR for monitoring or follow up of a lung condition that pre-existed the current, acute symptoms


eligible ages (years): 19.0-999.0,  All  Lung Cancer Patients will be evaluated for using the following All newly diagnosed patients with small lung nodules < 1cm that require excision with no history of prior ipsilateral thoracotomy The nodules must be located in parts of the lung that are amenable to thoracoscopic wedge excision of the nodules.The external surface of the lesion must be at least 2 cm from the major pulmonary arteries, veins, and main bronchi to allow safe and adequate thoracoscopic excision of the lesion Patients must be mentally competent to give written, informed consent Patients must be capable of independently completing standard English-language QOL instruments  Patients will be excluded from the trial if they do not consent to participate in the study, or if the radiologist and surgeon agree that the nodule is located too centrally to be safely excised using thoracoscopic wedge techniques Patients with more than three nodules will be excluded from the study Patients with a positive diagnosis of non-small cell lung cancer obtained from sputum cytology, bronchoscopy, or CT guided needle biopsy will be excluded from the study If the patient is excluded, he/she will receive the current standard treatment, which may needle biopsy, continued observation of the nodule at three to six monthly intervals, or excisional surgery (thoracoscopy or open thoracotomy)


eligible ages (years): 18.0-85.0,  All  Lung Abscess Adult 18-85 years of age Patients referred to pulmonologists, oncologists, or thoracic surgeons for the evaluation of peripheral lung nodules found on CT scan Repeat CT scans, biopsy or surgical excision are clinically indicated to determine the etiology of the nodule One or more lung nodules must be between 8 mm and 30 mm in the greatest diameter Patients must be fully informed of the investigational nature of the procedure and sign an informed consent  Lung nodules or masses greater than 30 mm in the greatest dimention Lung nodules that have solid calification Lung nodules or masses with CT evidence of partial or complete obstruciton of a lobar bronshus, mainstem bronchus or the trachea No prior cancer with the exception of non-melanoma skin cancer Life expectany of < t months Any indifidual who does not give oral and written consent for participation -


eligible ages (years): 18.0-45.0,  All  Schizophrenia, Undifferentiated Type For patients Men and women, right handed, 18 to 45 years Having given their written informed consent Presenting a diagnosis of schizophrenia made by DMS IV, hospitalized or followed regularly in a hospital proper, and whose symptoms are stable for at least 6 weeks, at the discretion of the psychiatrist Receiving antipsychotic treatment (risperidone or aripiprazole) monotherapy stable (treatment and dose) for at least than 6 weeks Showing no contra-indication for fMRI Patients whose physical examination is unremarkable clinically significant Patients without serious somatic pathology Affiliated to a social security system For women of childbearing potential, an appropriate contraception is mandatory and an negative pregnancy test  For patients Patients in menstruation without effective contraception (oral, intramuscular hormonal, intrauterine device, or surgical) Patients who are pregnant or breastfeeding Patients not meeting for schizophrenia according to DSM IV or those with resistant schizophrenia (Kane criteria) Introducing a somatic disease or serious neurological, particularly Parkinson's disease, epilepsy, tardive dyskinesia and disabling cardiovascular disease, liver or kidney disease Presenting a contra-indication to MRI Having a history of alcoholism or drug addiction during the past year Participating in another clinical trial or are in a period of from a previous protocol Patients likely to have behavioral self aggression from the trial investigators During the study


eligible ages (years): 18.0-80.0,  All  Lung Cancer Chronic Obstructive Airway Disease age 18-80 competent confirmed lung cancer  history of other cancers


eligible ages (years): 18.0-999.0,  All  Solitary Pulmonary Nodule Age> 18 years in patients with solitary pulmonary nodule who had percutaneous needle biopsy for diagnosis of lung nodule  patients who do not agree the study enrollment


eligible ages (years): 18.0-999.0,  All  Lung Cancer Patients undergoing elective, open and thoracoscopic thoracic surgery for any indication  Age < 18 years old Inability to consent for the study Chest wall anatomy precluding SATS Inability to sit upright


eligible ages (years): 18.0-999.0,  All  Melanoma Histologically documented cutaneous malignant melanoma which is recurrent or metastatic and is not curable by surgical or other means Patients must have tumour tissue from their primary and/or metastatic tumour available to assess putative molecular markers of response (paraffin block or 12 unstained slides) Presence of clinically and/or radiologically documented disease. At least one site of disease must be unidimensionally measurable as follows Chest X-ray > 20 mm, CT scan (with slice thickness of < 5 mm) >10 mm (longest diameter), Physical exam (using calipers) > 10 mm, Lymph nodes by CT scan > 15 mm measured in short axis All radiology studies must be performed within 21 days prior to randomization (Exception: Within 28 days if negative) Patients must have either maximum tumour lesion size of ≤ 50 mm OR if tumour lesion is > 50 mm, LDH must be ≤ 2.5 x ULN Patients must have a life expectancy of at least 12 weeks Age > 18 years ECOG performance status of 0-1 Previous Therapy  Patients with known HIV, Hepatitis B or Hepatitis C infection History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for > 5 years Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, myocardial infarction, other interventional cardiac procedure within the past 12 months, autoimmune conditions requiring chronic immunosuppressive therapy, or psychiatric illness/social situations that would limit compliance with study requirements Patients may not have received any other investigational agents within 28 days of study entry, and may not receive concurrent treatment with other anti-cancer therapy or investigational agents while on protocol therapy Patients with known brain metastases or history of CNS metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. A head CT or MRI is required on all patients to rule out brain metastases Pregnant or lactating women. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with rIL-21 or dacarbazine, breastfeeding should be discontinued if the mother is treated with protocol therapy Prohibited Medications: Long Term (> 7 days) Systemic Corticosteroids (e.g. prednisone, dexamethasone, etc.) because these may counteract the stimulatory effects of rIL-21 on lymphocytes. (Note: Topical steroids are allowed)


eligible ages (years): 18.0-999.0,  All  Lung Cancer All patients with CT identified pulmonary nodules not deemed to be visualizable during VATS who are candidates for VATS resection  Inability to consent for the study Patients less than 18 years old Patients with pulmonary nodules easily located during VATS Patients with tumours extending to visceral pleura or chest wall Patients who have chest anatomy precluding VATS resection


eligible ages (years): 40.0-80.0,  All  Yield of Cryo Biopsy in Lung Cancer Solitary Pulmonary Nodule solitary pulmonary nodule < 4 cm no endobronchial lesion indication for bronchoscopy  coagulopathy pulmonary hypertension pregnancy


eligible ages (years): 0.0-18.0,  All  Craniopharyngioma Obesity Diagnosed with craniopharyngioma for the first time Age at diagnosis 18 years or less of age Agreement from patient's parents or legal guardian as well as the patient for in randomization study Histological diagnosis of craniopharyngioma Age at diagnosis 18 years or less of age Age at primary surgery over 5 years of age Incomplete primary resection Reference radiological confirmation of an incomplete resection Agreement from patient's parents or legal guardian as well as the patient  Age at diagnosis over 18 years of age No QoL measurement for randomization (3 months after surgery)


eligible ages (years): 18.0-999.0,  All  Incisional Hernia age ≥18 years asymptomatic/ oligosymptomatic incisional hernia  no hernia detectable by physical examination acute incarcerated hernia emergency hernia repair pain or discomfort associated with the hernia during normal activities local or systemic infection ASA score >3 inability to complete or comprehend the preoperative questionnaire repair with biologic prothesis


eligible ages (years): 4.0-22.0,  All  Medulloblastoma Age at diagnosis at least 4 years or 5 years (according to the policy of the National Brain Tumour Group) and less than 22 years Histologically proven medulloblastoma, including the following variants(WHO classification : classic medulloblastoma, nodular / desmoplastic medulloblastoma, melanotic medulloblastoma, medullomyoblastoma No CNS metastasis on MRI supratentorial, arachnoid of the posterior fossa or spine No clinical evidence of extra-CNS metastasis No tumour cells on the cytospin of lumbar CSF. Central Review of CSF cytology is recommended but not mandatory. It will be left to national policy Radiotherapy to start no more than 40 days after surgery Ability to receive twice daily radiotherapy Vital functions within normal range for their age group CTC grades < 2 for liver, renal, haematological and audiological function  One of the is lacking Brainstem or supratentorial primitive neuroectodermal tumour Atypical teratoid rhabdoid tumour Medulloepithelioma Ependymoblastoma Large cell médulloblastoma Metastatic medulloblastoma (on CNS MRI and/or positive cytospin of postoperative lumbar CSF) Patient previously treated for a brain tumour or any type of malignant disease Patients who are pregnant Females who are sexually active and not taking reliable contraception


eligible ages (years): 18.0-90.0,  All  Bronchiectasis Bronchiolitis All patients with bronchiectasis or bronchiolitis  All patients with severe lung disease other than bronchiectasis Active lung infection Active infection other site except the lung


eligible ages (years): 18.0-999.0,  All  Lung Cancer Participant is a lung cancer patient  Participant is under 18 years old Participant is not a lung cancer patient


eligible ages (years): 50.0-999.0,  All  Solitary Pulmonary Nodules Multiple Pulmonary Nodules Renal Neoplasms Adrenal Gland Neoplasms Aortic Aneurysm, Abdominal Liver Neoplasms Adnexal and Skin Appendage Neoplasms Lymphadenopathy Pancreatic Neoplasms No participant sub-populations will be excluded prior to selection (the E1 population will be matched to the Case Group populations) Data from the 15 participating sites from the ACRIN 6664 trial provide a study data set of 2531 participants, broken down into a total target study data set of 520 participants. Participants will be distributed into one of three cohorts as follows The Case Group will target consenting 141 participants from the cases with indeterminate but potentially significant findings (E3/E4s) other than pulmonary nodules The Pulmonary Nodules Case Group will comprise 119 cases with E3/E4 ECFs characterized as pulmonary nodules The E1 Control Group will be drawn from the 866 E1 ECF cases to create a cohort of 260 E1ECF cases. The Control Group for comparison with the Case Group and the Pulmonary Nodules Case Group will be selected at the Biostatistics and Data Management Center (BDMC). The BDMC will match E1 141 controls to the 141 case-group participants with indeterminate but potentially significant findings (E3/E4s). The BDMC will also match 119 E1 controls to the 119 E3/E4 pulmonary nodules cases. Controls will be matched by site, age caliper (5 years), and sex where possible. Where an appropriate match cannot be obtained, the matching will be relaxed. If potential participants decline study consent, we will then best-match additional cases for the appropriate group to maintain target populations. Any additional cases beyond the initial 520 participants identified for medical record collection will be matched as feasible


eligible ages (years): 18.0-999.0,  All  Small Bowel Obstruction Gastrointestinal Hemorrhage Patients 18 years and older Patient or proxy willing to provide informed consent Patients who require placement of a nasogastric/orogastric tube, in the ED or ICU, as standard of care, AND a member of the study staff is available and present for NG/OG tube placement It is anticipated that the patient will remain in the ED/ICU in order to obtain RightSpot pH Indicator reading and verifying CXR  Patients less than 18 years of age Patient or proxy unwilling or unable to provide informed consent Patient with known or suspected pregnancy


eligible ages (years): 18.0-999.0,  All  Solitary Pulmonary Nodule Multiple Pulmonary Nodules Subjects who meet all of the following may be enrolled in this Study Subject is male or female, age 18 or older Subject has undergone CT scan of the lung(s) that indicates one or more nodules or lesions suspicious for lung cancer Subject's pulmonary nodule or lesion is greater than 4mm. Size is determined by the largest nodule or lesion dimension identified from CT imaging Subject meets one or more of the following conditions indicated for a tissue biopsy of the lung indicated for surgical resection of the lung being followed by CT for nodule growth within a 1-year time frame* subject must receive at least one follow-up CT by their 1-year enrollment anniversary or within 60 days after their 1-year enrollment anniversary to continue in the Study Subject must be able to receive a ProLung Test  The following will disqualify a subject from enrollment into this Study Subject has an implanted electronic device in the chest Subject receiving therapy for suspected chest infection such as fungal infection or tuberculosis Subject with diagnosed malignancy other than lung cancer who has 2 or more suspicious pulmonary nodules Subject has received an invasive medical or surgical procedure within the thoracic cavity within 30 days prior to the ProLung Test or within the previous 14 days for a bronchoscopic procedure Subject presents with an anomalous physical or anatomical condition that precludes ProLung Test measurement Subject will have undergone unusually strenuous exercise within 24 hours Subject who has significant systemic diseases such as uncontrolled diabetes, advanced heart failure, or a recent myocardial infarction, or other medical condition such as severe morbid obesity that in the judgment of the Principal Investigator would make him/her unsuitable for the Study


eligible ages (years): 16.0-999.0,  All  Hypotension Arterial pressure <100 mm/Hg at presentation At least one of the following symptoms Unresponsive Syncope Impaired mental status Respiratory distress Severe malaise and fatigue  Patients undergoing cardiopulmonary resuscitation Trauma patients Electrocardiographic and clinical diagnosis of STEMI or Clear cause of shock that needs immediate intervention (hemorrhage, gastrointestinal bleeding, drugs overdose) Late evolution of shock state in a patient already treated with known diagnostic tests


eligible ages (years): 16.0-90.0,  All  Pneumothorax Radiologic diagnosis of pneumothorax Clinical need to perform a CT scan Ability to perform the lung ultrasound imaging within 20 minutes from the CT study  age less than 16 years


eligible ages (years): 18.0-999.0,  All  Metastatic Pancreas Cancer Histologically documented metastatic pancreatic adenocarcinoma not previously treated with palliative systemic therapy Metastatic disease based on the presence of clinically and/or radiologically documents Measurable disease base on Adequate tissue (core biopsy) available for IHC testing of hENT1. This may be from primary tumour or metastatic site. Fine needle aspiration biopsies will not be allowed. Histological/cytological confirmation of tissue to ensure sufficient material is available for hENT1 analysis by the Cross Cancer Institute is required prior to starting a patient on study. Biopsies from metastatic sites must be obtained ≥ 3 months after any adjuvant chemotherapy (if applicable). If a patient has had previous surgical resection of their primary tumours, that tissue can be utilized. Tissue sufficient for preparing ≥ 10 unstained slides for central storage and testing is required ECOG performance status of 0 Age ≥ 18 years Life expectancy of at least 3 months based on discretion of treating oncologist Adequate hematologic function defined by the following laboratory parameters Hemoglobin ≥ 100 Platelet count ≥ 100 Absolute granulocyte count ≥ 1.5  Patients who have received prior palliative chemotherapy for their metastatic pancreatic adenocarcinoma Radical pancreatic resections (e.g. Whipple procedure) are not allowed < 6 months prior to randomization. Exploratory laparotomy, palliative (e.g. bypass) surgery, or other procedures (e.g. stents) are not allowed < 14 days prior to randomization. In any of the above cases, patients must be adequately recovered and stable prior to randomization Prior treatment with > 6 cycles of traditional alkylating agent-based chemotherapy, > 2 cycles of carboplatin-based chemotherapy, prior treatment with irinotecan or oxaliplatin chemotherapy, or concurrent treatment with other experimental drugs or anti-cancer therapy Curative radiation treatment to the pelvis or radiation therapy to ≥ 25% of bone marrow stores Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, short gut syndrome, or history of bowel obstruction due to peritoneal metastases Previous or concurrent malignancies, excluding curatively treated in situ carcinoma of the cervix or non-melanoma skin cancer, unless at least 5 years have elapsed since last treatment and the patient is considered cured Any serious medical condition within 6 months prior to study entry such as myocardial infarction, uncontrolled congestive heart failure, unstable angina, active cardiomyopathy, unstable ventricular arrhythmia, cerebrovascular diseases, uncontrolled hypertension, uncontrolled diabetes, uncontrolled psychiatric disorder, serious infection, active peptic ulcer disease, or other medical condition that may be aggravated by treatment Known dihydropyrimidine dehydrogenase (DPD) deficiency Pre-existing neuropathy ≥ grade 2 from any cause Patients with unstable metastasis to the central nervous system are excluded. Patients who have treated brain metastasis and are off steroids, anticonvulsants, and have documented stability of lesions for at least 3 months may be eligible. A CT scan or MRI is NOT required to rule out brain metastases unless there is clinical suspicion of CNS involvement


eligible ages (years): 18.0-999.0,  All  Primary Graft Dysfunction All consecutive bilateral lung transplant recipients  Immediate need for extracorporeal life support following transplant (those requiring ECLS four hours after intensive care admission can be included as the investigators would have obtained some ELWI measurements) Contraindications to femoral artery catheterization (eg, abdominal aortic aneurysm)


eligible ages (years): 20.0-40.0,  All  Assess the Efficacy of Differentiated and Undifferentiated Stem Cell Therapy in Improving Endometrial Receptivity. ICSI candidates with repeated implantation failure and history of development of good embryos in previous ICSI cycles Advanced maternal age above 38 years Poor endometrial response to ovulation induction drugs Endometrial atrophy  Presence of infection in the form of vaginitis, cervicitis or hydrosalpinx Presence of uterine abnormality as uterine septum Presence of any pathology distorting the uterine cavity as submucus polyp or submucus myoma Marked sperm morphology abnormality High FSH > 12 IU


eligible ages (years): 0.0-999.0,  All  Pneumonia All patients who present to the ED with respiratory symptoms suspicious for pneumonia In whom the treating physician believes would benefit from diagnostic imaging  Patients who arrive at the ED with a previously performed CXR Unstable patients with life-threatening injuries who require ongoing resuscitation


eligible ages (years): 40.0-75.0,  All  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


eligible ages (years): 18.0-999.0,  All  Transitional Cell Carcinoma Written informed consent Age ≥ 18 Life expectancy ≥ 12 weeks Patients with histology/cytology confirmed Transitional Cell Carcinoma (TCC) including mixed pathology with predominantly TCC, with locally advanced (T4b) or metastatic (lymph node or visceral) TCC arising from bladder or upper urinary tracts Treated patients with incidental prostate cancer (pT2, Gleason ≤ 6) and PSA (Prostate Specific Antigen) ≤ 0.5 ng/mL are eligible Measurable disease as per 1.1 ECOG Performance Status 0-1 Previously received first line platinum based treatment Recurrence within 12 months (by version 1.1) from last cycle of chemotherapy  Previous therapy with a taxane Pure non TCC histologies Grade II or more peripheral neuropathy Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrolment in the study Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus) Inadequate organ and bone marrow function as evidenced by Hemoglobin < 9.0 g/dL Absolute neutrophil count < 1.5 x 109/L Platelet count < 100 x 109/L AST/SGOT and/or ALT/SGPT > 2.5 x ULN


eligible ages (years): 18.0-48.0,  All  Cerebral Oxygen Saturation During Spinal Anesthesia for Cesarean Delivery Term healthy parturients  Body Mass Index > 35 preeclampsia neurological,cardiovascular, respiratory disease


eligible ages (years): 8.0-17.0,  All  Persons With Frontal Lobe Damage With no Specific Language Disorder frontal lobe damage at least one year after injury native hebrew speaker  specific language disorder premorbid learning disability


eligible ages (years): 55.0-74.0,  All  Lung Carcinoma   Men and women who at the time of randomization are less than 55 or greater than or equal to 75 years of age Individuals undergoing treatment for cancer at this time, excluding basal-cell and squamous-cell skin cancer Individuals with known prior cancer of the colon, rectum, lung, prostate (men only) or ovary (women only) This includes primary or metastatic PLCO cancers Individuals with previous surgical removal of the entire colon, one lung, or the entire prostate (men only) Until October 1996, women with previous surgical removal of both ovaries were excluded from the trial. In order to increase the enrollment of women into the trial, beginning in October 1996, these women were no longer excluded for this reason Individuals who are participating in another cancer screening or cancer primary prevention trial Males who have taken Proscar/Propecia/finasteride in the past 6 months NOTE: Individuals who are already enrolled in the trial when their physician prescribes finasteride are not prevented from taking this medication. As a result, these participants will continue to be screened and followed just as those participants who are not on finasteride NOTE: Men who are taking Tamoxifen are not excluded from any part of the PLCO Screening Trial


eligible ages (years): 50.0-75.0,  All  High Risk of Developing Lung Cancer Smokers or former smokers At least 20 pack year history of smoking Ages 50  Had a CT scan of chest within last 24 months History of any cancer within 10 yrs (except skin cancer or cervical cancer) A serious illness that decreases life expectancy to less than 5 years Any current use of Oxygen Uncontrolled congestive heart failure or cardiac arrhythmia that would prevent surgery for a lung lesion Severe COPD or dyspnea that would prevent lung surgery or stereotactic body radiotherapy


eligible ages (years): 21.0-999.0,  All  Lung Cancer All patients aged above 21 years, capable of giving consent and suspected of lung cancer with radiological lung nodules and masses  Patients with contra-indications to bronchoscopy and CT-TTNA that active myocardial ischemia, uncorrected coagulopathy, severe respiratory distress, uncontrollable cough, and pregnancy will be excluded. Before females in the reproductive age are recruited, urine pregnancy test will be performed and confirmed negative


eligible ages (years): 0.0-999.0,  All  Soft Tissue Sarcoma cases of undifferentiated sarcomas from ARST0332 (additional cases may be ascertained as eligible for this current project that also fall under ARST0332 to be requested later if necessary)


eligible ages (years): 18.0-999.0,  All  Non-small Cell Lung Cancer Metastasis From Other Cancers Histological confirmation of malignancy, unless the risks of biopsy are unacceptable and the lesion has grown on serial CT scan and/or is PET positive Eligible patients must have staging studies (e.g. chest radiograph, CT scan, MRI/CT Brain/Bone Scan) identifying them as patients with stage I or II, non-metastatic NSCLC (T1, N0, M0; T2, N0, M0; or T3, N0, M0 chest wall primary tumors only) patients with a non-lung primary that is controlled and which has metastasized to the lungs alone, in whom potentially curative surgery would otherwise be an option (e.g. colorectal, breast, sarcoma…etc) the subset of patients with limited (low) volume metastatic NSCLC or other primary site tumors whom it is felt may derive benefit from highdose SBRT treatment to the primary or metastatic lung tumor. And in whom other sites of metastatic disease are being treated with the desire to achieve long term control. Lesions must meet size in 4.1.2.1 Patients who have potentially resectable disease should be considered medically inoperable, or else in the judgement of the thoracic surgeon and lung team, surgery is not considered the preferred management option Early stage lung cancer: ≤3 parenchymal lung lesions, Metastatic disease to lungs: ≤5 parenchymal lung lesions Patients with early stage primary NSCLC should have hilar or mediastinal lymph nodes that are considered N0 on clinico-radiological grounds (i.e. no clinico-radiological evidence of lymph node spread) In patients with early stage primary NSCLC and a co-existing malignancy, the co-existing malignancy must have an expected prognosis better than primary lung lesion Adequate lung function to tolerate the planned stereotactic radiation  Patients with active systemic, pulmonary or pericardial infection No concurrent systemic therapy (chemotherapy, immunotherapy or biological therapy), apart from hormone therapy, is allowed History of active auto-immune diseases, including systemic lupus erythematous, rheumatoid arthritis, C.R.E.S.T., systemic sclerosis,scleroderma Potential candidate for concurrent chemo-radiation therapy Patient enrollment on other studies may be permissible. This will depend on patient and study characteristics


eligible ages (years): 18.0-999.0,  All  Lung Cancer peripheral lung nodules < 3cm in size Surgical candidate  Non surgical candidate


eligible ages (years): 18.0-45.0,  All  Multiple Sclerosis (MS) Must be between the ages of 18 and 45 years, inclusive Must have a body mass index (BMI) of 19 to 28 kilograms/height (m)2, inclusive, and have a minimum body weight of 50 kilograms (at screening and baseline) Must give written informed consent  History of severe allergic or anaphylactic reactions History of hypersensitivity to acetaminophen (paracetamol) or ibuprofen. Subjects in Part III of the study will also be excluded for history of hypersensitivity to human albumin History of any clinically significant (as determined by the investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease History of asthma, as defined by wheezing, dyspnea, or cough requiring treatment with either inhaled beta-2-agonists, inhaled corticosteroids, inhaled cromolyn sodium, or oral steroids or history of chronic obstructive pulmonary disease (including chronic bronchitis, bronchiectasis, or emphysema) Abnormal screening full pulmonary function tests (PFTs) or baseline spirometry (predicted values are those of the European Coal and Steel Community (Quanjer, 1983)) or abnormal screening or baseline oximetry, as defined by any one of the following <80% predicted Forced expiratory volume (FEV1) <80% predicted forced vital capacity (FVC) <70% FEV1/FVC ratio <80% predicted total lung capacity (TLC) <80% predicted diffusion capacity, corrected for hemoglobin (DLCOcorr)


eligible ages (years): 18.0-999.0,  All  Metastatic Melanoma At least 18 years of age Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's Regional Ethics Board/Independent Ethics Committee (REB/IEC) Histologically documented cutaneous or mucosal malignant melanoma, which is recurrent or metastatic and is not curable by surgical or other means Adequate tumour tissue (greater than 0.5cm3 preferred, 3 X core biopsy acceptable) available and agreement from subjects that this tissue from their primary and/or metastatic tumour be made available for assessment of potential biomarkers Ability and availability to complete all prescribed biomarker studies (Screening and after Cycle 2) Recovered to Grade 1 from reversible toxicities of prior therapy Presence of clinically and/or radiologically documented disease. At least one site of disease (which will not be removed during the course of the study) must be uni-dimensionally measurable as per 1.1 or clinically quantifiable (such as in the case of skin disease) ECOG performance status of 0 Prior treatment with any number of immunotherapies (e.g., IL2, ipilimumab), targeted therapies (e.g., vemurafenib) are permitted but no more than one 1 prior chemotherapy Acceptable liver function  Anticancer treatment with radiation therapy, targeted therapies, chemotherapy, immunotherapy, hormones or other antitumour therapies within 28 days prior to first dose of TH-302 Subjects who have received any other investigational drug or agent within 28 days of first dose of TH-302 Current use of drugs with known cardiotoxicity Significant cardiac dysfunction Seizure disorders requiring anticonvulsant therapy Progressing brain metastases (unless previously treated and stable disease for a period of greater than or equal to 3 months on repeat MRI following definitive treatment) History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for greater than 2 years Severe chronic obstructive or other pulmonary disease with hypoxemia (requires supplementary oxygen, symptoms due to hypoxemia or oxygen saturation less than 90% by pulse oximetry after a 2 minute walk) or in the opinion of the investigator any physiological state likely to cause hypoxia of normal tissue Major surgery, other than diagnostic surgery, within 4 weeks prior to Cycle 1 Day 1, without complete recovery Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy


eligible ages (years): 40.0-999.0,  All  Emphysema Chronic Obstructive Pulmonary Disease (COPD) Willing and able to provide informed consent and to participate in the study Age > or = 40 years at the time of the screening Advanced lower or lower and upper lobe predominant heterogeneous emphysema by CT scan Minimum of 2 subsegments appropriate for treatment MRCD questionnaire score of 2 or greater at screening Failure of medical therapy to provide relief of symptoms Spirometry 15 minutes after administration of bronchodilator (BOTH) FEV1 < 50 % predicted FEV1/FVC ratio <70 % Lung volumes by plethysmography (BOTH)  Prior lung volume reduction surgery, prior lobectomy or pneumonectomy, or prior lung transplantation Requirement for ventilator support (invasive or non-invasive) Three (3) or more COPD exacerbations requiring hospitalization within 1 year of Screening visit or a COPD exacerbation requiring hospitalization within 8 weeks of Screening visit Pulmonary hypertension, defined as Echocardiogram with estimated peak systolic pressure > 45 mmHg in the presence of tricuspid valve regurgitation stated in the echocardiogram report If the echocardiogram shows peak systolic pressure > 45 mmHg, right heart catheterization is required to rule out pulmonary hypertension, defined as peak systolic pressure > 45 mmHg or mean pressure > 35 mmHg Clinically significant asthma (reversible airway obstruction) or bronchiectasis CT scan: Presence of the following radiologic abnormalities Pulmonary nodule on CT scan greater that 1.0 cm in diameter (Does not apply if present for 2 years or more without increase in size or if proven benign by biopsy/PET) Radiologic picture consistent with active pulmonary infection, e.g., unexplained parenchymal infiltrate


eligible ages (years): 18.0-999.0,  All  Malignant Solid Tumour Patients with confirmed diagnosis of advanced, non resectable and / or metastatic solid tumours, who have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment Evaluable tumour deposits by one or more techniques (X-ray, CT, MRI, ultrasound) Age 18 years or older Life expectancy of at least three months Patients had to give written informed consent (which must be consistent with International Conference on Harmonization Good Clinical Practice (ICH-GCP) and local legislation) Eastern Cooperative Oncology Group (ECOG) performance score < 2 Full recovery from all therapy-related toxicities from previous chemo-, hormone-,immuno-, or radiotherapy  History of relevant surgical procedures during the last four weeks prior to treatment with the trial drug, or active ulcers, or injuries with incomplete wound healing Pregnancy or breastfeeding Active infectious disease Brain metastases requiring therapy Absolute neutrophil count less than 1500 / mm3 Platelet count less than 100 000 / mm3 Bilirubin greater than 1.5 mg / dl (> 26 μmol / L, International System of Units (SI unit) equivalent) Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than three times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal) Serum creatinine greater than 1.5 mg / dl (> 132 μmol / L, SI unit equivalent) Uncontrolled, severe hypertension