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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): 50.0-999.0, Osteoporosis fracture caused by osteoporosis fifty years or more of age informed consent Physically or mental state that does not participation | 0 |
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): 50.0-999.0, Osteoporosis Osteopenia Postmenopausal women with low trauma distal radius fracture (confirmed by x-ray) Can be taking Didrocal (etidronate), Miacalcin (calcitonin),or hormone replacement therapy Women with fractures of the elbow, mid radius, scaphoid, or injury to wrists (without actual fracture) Significant cognitive impairment (which would preclude them from filling out simple questionnaires) Women already taking osteoporosis therapy, ie. either Fosamax (alendronate), Actonel (risedronate), or the selective estrogen receptor modulator, Evista (raloxifene) | 0 |
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): 25.0-44.0, Osteoporosis women aged between 25 and 44 years of age previous had measurement of bone densitometry thyroid disease renal failure malignancy rheumatoid arthritis history of hysterectomy hormone replacement therapy were pregnant or planning pregnancy within 2 years of study entry lactating | 0 |
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): 0.0-999.0, Hip Fractures Osteoporosis Any North Carolina long-term care facility with ten residents who had had a hip fracture or osteoporosis diagnosis | 0 |
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): 40.0-65.0, Osteoporosis Healthy as assessed by the health and lifestyle questionnaire physical examination results of the pre-study laboratory tests Caucasian women Postmenopausal (≥12 ≤60 months since last menses), determined by interview FSH level ≥ 20 IU/l Body Mass Index (BMI) ≥22 Participation in any clinical trial including blood sampling and/or administration of products up to 90 days before Day 01 of this study Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of products Osteoporosis, determined by Questionnaire (spontaneous bone fractures, use of medication to treat osteoporosis) DXA scans of the lumbar spine between day -14 and day 1 of the study; threshold is set at -2z score of BMD Severe scoliosis (curvature of the spine) that could interfere with the ability of the subject to go through the DXA scanning procedure and/or with a correct reading of the DXA scans Having a history of medical or surgical events that may significantly affect the study outcome, including surgical menopause (including hysterectomy) antecedents and high familiar incidence of breast and/or endometrial cancer gastrointestinal disease (Crohn's, short bowel syndrome, coeliac disease, gastroenteritis episodes the month before the start of the study) | 1 |
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): 65.0-999.0, Post Menopausal Osteoporosis women who have been newly diagnosed with post-menopausal osteoporosis, requiring treatment naive to bisphosphonate treatment,or had bisphosphonate treatment for a maximum of 3 months, at least 5 years before screening patients on HRT within the last 3 months patients on other osteoporosis medication within the last 3 months sCTX below lower limit, or above 3 times the upper limit, of normal premenopausal level hypersensitivity to any component of ibandronate contraindication for calcium or vitamin D therapy history of major gastrointestinal upset malignant disease diagnosed within the previous 10 years (except resected basal cell cancer) | 0 |
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): 18.0-65.0, Vitamin D Deficiency Healthy African-American and Caucasian adults aged 18-65 years Subjects who are not either African-American or Caucasian. The investigators plan to examine racial differences in response to oral vitamin D dosing and, therefore, have chosen the most affected (African-American) and the least affected (Caucasian) racial groups. Including other racial/ethnic groups may confound the results unless they are studied as separate groups Any chronic medical illness including diabetes mellitus, history of myocardial infarction or heart failure, malignancy, hypertension (systolic blood pressure [SBP] > 140), obesity (body mass index [BMI] > 35 kg/m2), history of anemia, leukemia, or other hematologic abnormalities, lupus, rheumatoid arthritis, or other rheumatologic disease, or kidney disease of any kind as determined by history and physical examination Subjects with osteoporosis or taking medications for osteoporosis such as bisphosphonates Pregnancy Use of medication that influences bone metabolism (i.e. anticonvulsant medications, steroids, diuretics) Significant deviation from normal in either history, physical examination, or laboratory tests, as evaluated by the primary investigator Patients with a history of hypercalciuria, hypercalcemia, nephrolithiasis, and active sarcoidosis Participation in another investigational trial in the past 30 days prior to the screening evaluation Unexplained weight loss of > 15% during the previous year or history of anorexia nervosa Medications that interfere with vitamin D metabolism. Oral contraceptive use will be allowed, but will be appropriately documented | 1 |
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): 40.0-999.0, Osteoporosis Postmenopausal women and men over the age of 40 who are starting therapy with teriparatide Patients with diabetes mellitus current smokers patients with a history of organ transplantation Patients currently of previously on glucocorticoid therapy within the past year Patients with serum creatinine above 1.5 mg/dl, patients with uncontrolled hypertension (BP 140/90 or greater) Patients ineligible for teriparatide therapy: History of metabolic bone disease other than osteoporosis History of radiation therapy Patients pregnant or nursing History of bone metastasis or skeletal malignancies History of hypercalcemia | 0 |
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): 0.0-59.0, Osteoporosis Postmenopausal, asthmatic outpatients under 60 years of age on long-term oral or inhaled glucocorticoid treatment for at least one year Hysterectomy, history of breast or endometrial cancer, undiagnosed pelvic or breast mass, untreated hypertension | 0 |
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): 45.0-80.0, Healthy 55 or 70-80 years old History of natural menopause defined by the absence of menses for at least 12 months (or history of surgical menopause defined as bilateral oophorectomy) and a FSH level >26 IU/L On no hormonal medication or herbal supplements and/or over the counter menopause therapy for a minimum of 2 months prior to study Normal TSH, PRL, factor V, and CBC Normal BUN and Creatinine (< 2 times the upper limit of normal) BMI ≤ 30 Non-smokers or smoke less than 10 cigarettes/day Absolute contraindications to the use of physiologic replacement doses of estrogen, including a negative screening mammogram within the past 24 months History of coronary artery disease On medications thought to act centrally on the GnRH pulse generator Past history of hypersensitivity or allergy to narcotics, vancomycin, muscle relaxants, aspirin, and/or anaphylactic reaction(s) to other drugs Prior history of breast cancer and/or blood clots | 0 |
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): 65.0-999.0, Osteoporosis osteoporosis (DXA T-score < -2.5 in hip and/or vertebrae) able to walk at least 15 minutes without an helping device years or older community dwelling at least one fall in the prior year severe cardiac, pulmonary or musculoskeletal disorders pathologies associated with increased fall risks (i.e. stroke or Parkinson's disease) use of psychotropic drugs | 0 |
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): 18.0-80.0, Schizophrenia Alcohol Abuse DSM-IV diagnosis of schizophrenia Onset of illness more than 5 years No severe Medical and endocrinological disorder | 0 |
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): 0.0-999.0, Post-Menopausal Osteoporosis post-menopausal women >=3 months daily or weekly alendronate or risedronate for treatment or prevention of post-menopausal osteoporosis inability to stand or sit in an upright position for at least 60 minutes hypersensitivity to bisphosphonates treatment with other drugs affecting bone metabolism abnormalities of the oesophagus, which delay oesophageal emptying | 0 |
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): 50.0-999.0, Osteoporosis Presented to Modbury Hospital's Accident and Emergency Department with a new bone fracture Residence in nursing home Fracture sustained in motor bike, push bike or motor vehicle accident Fracture sustained due to high trauma, such as fall from roof or ladder Dementia Inability to participate in group settings Inability to understand spoken English Inability to provide informed consent Pathological fracture Usual place of residence outside South Australia | 0 |
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): 50.0-90.0, Osteoporosis Bone Loss, Age Related Postmenopausal Bone Loss Postmenopausal Osteoporosis Female, post-menopausal women aged 50 to 90 Have a bone mineral density (BMD) evaluation resulting in a T-Score of <-1.0 Have a follow-up appointment with a provider in the areas of Family Medicine (FM), Primary Care Internal Medicine (PCIM), or POM Have no major barriers (i.e., severe hearing impairment, dementia, require interpreter, etc.) to participation in shared decision-making (per provider's assessment) Enrollment is open to females of diverse racial backgrounds Currently taking a bisphosphonate Not available for 6 month follow-up phone call | 1 |
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): 18.0-999.0, Osteoporosis Rheumatoid Arthritis Meet American College of Rheumatology for rheumatoid arthritis Taking an oral glucocorticoid equivalent to 5 mg/day of prednisone for at least one month prior to study entry Age 18 or older Existing osteoporosis Pregnancy Breast feeding History of breast cancer Physician recommendation to limit calcium intake Class IV rheumatoid arthritis | 0 |
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): 45.0-55.0, Osteoporosis Female Age 45 (inclusive) to 55 years (inclusive) Race: Caucasian Non-smokers / Smokers up to 10 cigarettes/day Postmenopausal hormone status: 1-3 years since the last spontaneous menstrual bleeding and a follicle-stimulating hormone concentration (FSH) >75 IU/ml and 17-estradiol (E2) of < 20 ng/L Years since menopause between 1-3 years Natural menopause or total hysterectomy with bilateral salpingo-oophorectomy Subjects with E2 results within the range will be assessed on an individual basis if FSH level is less than 75 IU/ml Assessed as age-related healthy, based on a pre-study examination including medical history, physical examination, ECG, vital signs and clinical laboratory. The examination will be performed by a MD at the study site within 1-2 months prior planned study start for the individual subject Willingness and ability to give written informed consent and willingness and ability to understand, to participate and to comply with the study requirements T-score < -2.5 at total hip and spine (either or both) Suspect lack of compliance BMI > 30 or < 21 Use of HRT within the previous 6 months Use of any drug which might interfere with bone-metabolism (bisphosphate, estrogen receptor modulators, calcitonin) within the previous 12 months Systematic practice of high intensity exercise Vegetarian nutrition or any other extreme dietary habits Use of dietary supplements while on study, except multi vitamin. No "wash out" period for supplements must stop before run-in period and refrain until the end of the study Participant in any other study or donation of blood during the last 30 days before start of each dosing phase (T0) | 0 |
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): 55.0-75.0, Osteoporosis Postmenopausal female, 55-75 years old History of Type II diabetes, as defined by the American Diabetes Association for more than 5 years that is either insulin requiring or treated with oral therapies such as sulfonylureas and metformin Body mass index (BMI) of 19-35 Able to move without walkers and without a history of long periods (>3 months) of inactivity Additional for fracture participants Fractures of the proximal humerus and femur as well as the ankle and foot should have occurred after the onset of diabetes and should have been caused by a low energy trauma such as falling from standing height. All fractures will be verified by radiographs Severe neuropathic disease such as neurogenic osteoarthropathies (i.e., Charcot joints) of the foot Steroid users or have disease conditions that could play a significant role in the development of osteoporosis such as idiopathic osteoporosis, immobilization, hyperparathyroidism, or hyperthyroidism Diseases that may affect bone metabolism: alcoholism, chronic drug use, chronic gastrointestinal disease, renal or hepatic impairment Chronic treatment with antacids, estrogen, adrenal or anabolic steroids, anticonvulsants, anticoagulants, or pharmacologic doses of Vitamin A supplements 6 months prior Diabetic patients on rosiglitazone or pioglitazone medications high energy trauma, e.g., due to motor vehicle accidents Pathological fractures of other origin, i.e., tumor, tumor-like lesions as well as focal demineralization visualized on radiographs History of fluoride, bisphosphonate, calcitonin or tamoxifen use History of unstable cardiovascular disease or uncontrolled hypertension MRI contraindications | 2 |
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): 45.0-85.0, Osteoporosis Healthy women aged 45 and above who have been menopausal at least 1 year (absence of menstrual period for a period of 12 months or more) Any chronic medical illness including uncontrolled diabetes mellitus, recent history of myocardial infarction, or heart failure, malignancy, uncontrolled hypertension, obesity (BMI>35 kg/m2), history of anemia, leukemia, or other hematologic abnormalities, lupus, rheumatoid arthritis, or other rheumatologic disease, or kidney disease of any kind as determined by history and physical examination Subjects with osteoporosis of the hip (total hip T-score equal or less than -2.5) or taking medications for osteoporosis such as bisphosphonates will be excluded Pregnancy Use of medication that influences bone metabolism (i.e. anticonvulsant medications, chronic use of steroids and high dose diuretics) Significant deviation from normal in medical history, physical examination, or laboratory tests as evaluated by the primary investigator Patients with a history of hypercalciuria, hypercalcemia, nephrolithiasis, and active sarcoidosis will also be excluded Participation in another investigational trial in the past 30 days prior to the screening evaluation Unexplained weight loss of >15% during the previous year or history of anorexia nervosa Medications that interfere with vitamin D metabolism Patients with a habitual dietary calcium intake that exceeds 800 mg/day | 2 |
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): 18.0-55.0, Osteoporosis Women between the age of 18-55, pre-menopausal by history (regular spontaneous menstrual bleeding every 21-35 days) or documented FSH <10, no current estrogen therapy, undergoing hysterectomy with (ovx) or without ovariectomy (control group) for benign gynecologic disease (fibroid uterus, endometriosis, dysfunctional uterine bleeding, chronic pelvic pain) or for prophylaxis against ovarian cancer (BRCA positive) History of an active cancer including breast and uterine cancer, treatment with chemotherapy or glucocorticoids History of an immune deficiency syndrome including HIV infection History of severe anemia with hematocrit < 25 | 0 |
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): 21.0-70.0, Risk Drinking,Diabetes, Hypertension, Osteoporosis, Infertility has diabetes, hypertension, osteoporosis, or infertility 2. Not currently receiving treatment for alcohol or drug problems or substance related medical illness 3. Not currently experiencing physical dependence on alcohol, requiring medically supervised detoxification 4. Not currently abusing or physically dependent on opiates, cocaine, or other illicit drugs 5. Not currently pregnant. Subjects with infertility may become pregnant during the course of the study Not currently nursing. 7. Able to complete study measures Alcohol screen negative or drinks within NIAAA sensible drinking limits for women Does not agree to randomization and study terms | 1 |
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): 40.0-60.0, Osteoporosis All patients meet the Patients with informed consent Breast Cancer inform possible danger Physical and mental health Menopausal transition meet the Age between 40 ~ 55 years old Women with Menopause syndrome or menstrual disorders The second to fourth lumbar spine bone mineral density to normal Early postmenopause meet the Age between 45 ~ 60 years old Tobacco or alcohol abuser History of various malignant diseases Women with Serious chronic diseases, such as liver and kidney dysfunction Women Suffering from endocrine diseases, such as Thyroid disease, Parathyroid disease,Adrenal disease and Osteomalacia Women with Long-term application of drugs, such as Antiepileptic drug, Adrenocorticotropic hormone, Diuretics and Heparin Women had used estrogen or calcitonin in the past 6 months Women has added higher than the physiological requirements VitD Who had taken bisphosphonates or sodium fluoride in the past 1 year Women had been taking Chinese medicines or other unregistered food in past 3 months Women with one of the following medical history or disease: Thrombophlebitis, estrogen-related thrombosis or thromboembolism, Cerebrovascular accident, with known or suspected estrogen-dependent tumor, undiagnosed vaginal bleeding, Cervical Pap smear graded at 3 or more, Serious uterine disorders, Serious breast disorders, Serious gallbladder disease, Severe hypertension and Hypercholesterolemia | 0 |
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): 65.0-999.0, Type 2 Diabetes Mellitus female >= 65 years old postmenopausal for > 5 years (WHO definition of menopause) currently taking osteoporosis related medication (HRT, SERM, bisphosphonate, PTH, calcitonin, fluoride) had cancer in past 10 years, likely to metastasize to bone (ie: breast, lung) have intrinsic bone disease (ie: Paget's Disease, Cushings syndrome) have untreated malabsorption syndrome (ie: Celiac Disease) renal insufficiency (CrCl <30ml/min) hyperparathyroidism, hypoparathyroidism chronic systemic glucocorticosteroid use > 3mos, dose>2.5mg daily | 0 |
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): 60.0-999.0, Osteoporosis Proximal Femur Fracture Selection of cases: women with hip fracture woman aged 60 years and more clinical suspicion of osteoporosis based on the following: trivial trauma (fall from the standing position), history of vertebral fracture or visualization of a vertebral fracture by CT availability of radiographs of the proximal femur (anteroposterior view of the pelvis mandatory; anteroposterior and lateral views of the fractured hip optional) signature by the patient of the informed consent document patient under 60 years current bisphosphonate, oestrogen, or SERM treatment started more than 3 months earlier; or past treatment with these medications stopped less than 6 months earlier hip arthroplasty on the other side fracture at the site of a bone lesion psychiatric disorder that might prevent the patient from giving informed consent or from remaining completely still for about 15 minutes during the investigations informed consent document not signed by the patient Selection of controls The controls will be women without hip fracture matched on age to the cases woman aged 60 years and more signature by the patient of the informed consent document | 0 |
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): 55.0-999.0, Post Menopausal Osteoporosis Adult patients, >/= 55 years of age Postmenopausal osteoporosis Patients who are in the opinion of the physician eligible to participate in this study | 0 |
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): 40.0-60.0, Hot Flushes Menopause, Premature Obesity Vitamin D Deficiency Women in late menopausal transition or early menopause Age 40-55 BMI >25 kg/m2 Suffer from menopausal symptoms Change in previously regular cycles consisting of at least ≥2 skipped cycles and an interval of amenorrhea (≥60 days) in the last year Negative pregnancy test Vitamin D insufficiency (<30 ng/ml) Weight stability (+/ ) for 3 months No period for >12 months Hormone use (i.e. menopausal hormone therapy, oral contraceptive, other hormonal medications) in last 3 months History of hysterectomy more than 11 months ago Abnormal screening blood tests (i.e. elevated serum calcium level, elevated creatinine) History of medical conditions where Vitamin D supplementation is not indicated (i.e. chronic renal insufficiency, elevated calcium, sarcoidosis or other granulomatous disease, lymphoma, or tuberculosis History of osteoporosis or osteoporosis on baseline DXA (expect less than 4% of screened population)84 Vitamin D deficiency (<10 ng/ml) as we felt it was unethical to withhold supplementation for 12 months in severe deficiency (according to our KPNW survey, this will <2% of population) Consuming more than 400 IU of Vitamin D supplementation daily (we felt such doses taken outside of the study design could confound results) Current smoker (within the last year) Taking medications that affect body weight | 0 |
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): 45.0-54.0, Osteoporosis Osteopenia perimenopausal women willingness to participate in the 6-month study, willingness to undergo testing of bone turnover markers before and after the drug therapies and willingness to provide a self-assessment on quality of life and sleep throughout the program Subjects must be willing to take their treatments right before bed and to not to consume alcohol with this medication will women in whom osteopenia is a result of some other known process such as hyperparathyroidism, metastatic bone disease, multiple myeloma or chronic steroid use Those individuals on osteoporotic drugs, hypnotics, CYP1A2 inhibiting drugs, fluvoxamine or those with severe sleep apnea, severe COPD and those with moderate or severe hepatic impairment will also be excluded Individuals who are lactose intolerant will also be excluded because the placebo and melatonin capsules will contain lactose | 1 |
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): 50.0-90.0, Osteoporosis the risk of osteoporosis the risk of falls | 2 |
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): 18.0-999.0, Osteoporosis, Postmenopausal Who have been diagnosed with postmenopausal osteoporosis by physician Who have received any oral bisphosphonates (weekly or monthly) at least for 2 months to provide answer of OPSAT-QTM questionnaire Who provide informed consent for study participation Do not understand the contents of the questionnaire | 0 |
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): 55.0-85.0, 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 | 0 |
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, 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 | 0 |
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): 18.0-999.0, 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 | 1 |
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): 18.0-999.0, 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 | 0 |
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): 20.0-45.0, 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 | 0 |
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): 65.0-999.0, 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 | 0 |
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): 60.0-999.0, 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 | 0 |
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): 18.0-999.0, 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 | 0 |
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): 30.0-90.0, 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 | 2 |
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): 65.0-999.0, 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 | 0 |
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, 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 | 1 |
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): 40.0-999.0, Type 2 Diabetes Mellitus Osteoporosis inclusion:40-99 years old with type 2 DM patient exclusion:organization people | 1 |
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): 40.0-90.0, 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 | 0 |
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): 50.0-999.0, 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 | 1 |
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): 20.0-75.0, 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) | 0 |
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): 40.0-90.0, 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 | 0 |
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): 20.0-90.0, Osteoporosis Postmenopausal women and men referred for bone density examination Patients unable to sign consent for participation | 1 |
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): 50.0-89.0, 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 | 2 |
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): 50.0-79.0, 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 | 2 |
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): 50.0-80.0, 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 | 0 |
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): 35.0-70.0, 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 | 1 |
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): 20.0-45.0, 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 | 0 |
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): 45.0-70.0, 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 | 1 |
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): 35.0-60.0, 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 | 0 |
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): 40.0-95.0, 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 | 0 |
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): 50.0-999.0, Post Menopausal Osteoporosis Postmenopausal women Age 50 years or greater Previously diagnosed osteoporosis, or receiving treatment for osteoporosis | 2 |
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): 35.0-999.0, 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 | 0 |
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): 50.0-999.0, 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 | 0 |
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): 50.0-75.0, 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 | 2 |
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): 20.0-90.0, 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 | 2 |
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, 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 | 1 |
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, 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 | 0 |
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): 18.0-999.0, 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 | 1 |
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): 3.0-16.0, 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 | 0 |
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, 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 | 0 |
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): 40.0-70.0, 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 | 0 |
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): 6.0-90.0, 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 | 1 |
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): 18.0-999.0, 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 | 1 |
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): 18.0-999.0, 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 | 0 |
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, 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 | 0 |
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): 18.0-999.0, 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 | 2 |
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): 18.0-65.0, 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 | 0 |
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): 20.0-999.0, Lung Neoplasms patients who have solitary pulmonary nodules in CT patients who don't fit the above | 1 |
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): 18.0-999.0, Asthma Chronic Obstructive Pulmonary Disease Physician-diagnosis of asthma, COPD exacerbation, or undifferentiated asthma/COPD exacerbation Admitted to the inpatient medical service at Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center Evidence of airflow obstruction on spirometry (FEV1/FVC<70%) Age 18 years or older History of allergy or other contraindication to macrolides (azithromycin, erythromycin, clarithromycin) Treatment with any macrolide in the 4 weeks prior to study entry Elevated AST or ALT (2 or more times the upper limit of normal) on current admission Elevated alkaline phosphatase (>1.25 times the upper limit of normal) on current admission Elevated total serum bilirubin (more than upper limit of normal) on current admission Previous participation in this study Patients prescribed digoxin (azithromycin may increase digoxin levels) Patients prescribed warfarin (azithromycin may increase INR in patients on warfarin) Patients prescribed pimozide (azithromycin may increase risk of arrhythmias) Patient unable to provide consent (e.g., language difficulty or history of dementia) | 0 |
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): 18.0-999.0, Non-small Cell Lung Cancer lung cancer patients undergoing resection with intent to cure age < 18 years | 0 |
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): 16.0-999.0, Acute Dyspnoea All patients admitted for investigation of acute pulmonary embolus | 0 |
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): 18.0-75.0, 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 | 0 |
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): 40.0-80.0, Chronic Obstructive Pulmonary Disease (COPD) diagnosis of mild COPD OR healthy control subjects 80 years old able to perform all study procedures Smoking history > 10 pack years (for mild COPD) or smoking history < 10 pack years (for healthy control subjects) allergy to atrovent history of asthma, atopy or nasal polyps Oxygen desaturation < 80 % during exercise recent history of CAD (under a year) or any significant diseases that could contribute to dyspnea or exercise limitation | 0 |
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): 18.0-999.0, 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 | 1 |
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): 60.0-999.0, 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) | 0 |
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): 12.0-999.0, Refractory Frontal Lobe Epilepsy Cryptogenic frontal lobe epilepsy Normal cerebral MRI | 0 |
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): 18.0-999.0, 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 | 0 |
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): 0.115-0.308, 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) | 0 |
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): 3.0-25.0, 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 | 0 |
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): 18.0-999.0, 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 | 2 |
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): 18.0-999.0, 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 | 1 |
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): 18.0-999.0, 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.- | 0 |
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): 18.0-999.0, 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 | 0 |
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): 0.0-21.0, 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 | 0 |
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): 18.0-90.0, 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 | 2 |
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): 18.0-999.0, 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 | 0 |
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): 45.0-999.0, 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) | 0 |
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): 18.0-999.0, 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 | 0 |
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): 18.0-999.0, 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) | 0 |
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): 18.0-999.0, 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 +/ | 0 |
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, Lung Cancer Diagnosis of suspected lung cancer or lung cancer Inability to undergo therapy | 2 |
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): 18.0-999.0, 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 | 0 |
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): 0.5-20.0, 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 | 2 |
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): 18.0-999.0, 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 | 2 |
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): 3.0-18.0, 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 | 0 |
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): 19.0-999.0, 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) | 0 |
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