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The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Cardiovascular Disease de Novo Coronary Lesions Appropriate Patient Patient is eligible to receive a Boston Scientific TAXUS Stent Inappropriate Patient Known sensitivity to paclitaxel Known allergy to stainless steel Patients in whom antiplatelet and / or anticoagulant therapy is contraindicated Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or delivery device Patients with unresolved vessel thrombus at the lesion site Patients with coronary artery reference vessel diameters less than 2.5 mm or greater than 3.75 mm Patients with lesions located in the left main coronary artery, ostial lesions, or lesions located at a bifurcation Patients with diffuse disease or poor overflow distal to the identified lesions | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-90.0, Osteoporosis 18 years old or greater 2. agree to at least one bone biopsy 3. agree to BMD, blood and urine tests 4. receiving at least 10 mg/day of prednisone for at least three months 5. either be a candidate for alendronate or be taking alendronate (70 mg/week for at least three months) any metabolic bone disorder such as Paget's disease, renal osteodystrophy, parathyroid disease or osteomalacia 2. obesity enough to make a biopsy difficult 3. concurrent use of any tetracycline 4. hypercalcemia 5. kidney stones in the last two years 6. home O2 7. gastric surgery, stapling or bypass 8. inflammatory bowel disease 9. untreated thyroid disease 10. organ transplants 11. malabsorption 12. anticoagulation 13. current infection 14. serious illness 15. allergy to Demerol, Valium, iodine, tetracycline, tape 16. use of anticonvulsant drugs, heparin, Forteo, calcitonin or high-dose fluoride within the past six months | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 0.0-999.0, Gastric Cancer Leukemia Chronic Myelogenous Leukemia Patients with CML in chronic phase, accelerated phase based on cytogenetic abnormalities in addition to Philadelphia chromosome but with less than 5 % blasts, or GIST taking imatinib Patients with life expectancy of at least 12 months; patients must be on imatinib at time of study entry Ability to sign informed consent and/or assent Patients with a known parathyroid disorder; active thyroid disorder except stable, replaced hypothyroidism; Cushing's syndrome; uncontrolled diabetes mellitus (could have unexpected fluid, electrolyte and mineral shifts); sarcoidosis (elevated calcitriol levels from granulomata); hypercalcemia of malignancy (i.e., PTHrP-mediated or extensive bone mets);known tumor-induced osteomalacia; Paget's disease of bone; known X-linged or autosomal dominant hypophosphatemic rickets/osteomalacia; known renal tubular disease (e.g., Fanconi's syndrome); chronic GI malabsorption sydrome Patients taking oral calcium in excess of calcium 750 mg and Vitamin D 400 mg daily (ie, that contained in a single multivitamin). Patients taking more than these amounts may be eligible for this study if vitamin and mineral supplementation in excess of this is stopped for a minimum of 2 weeks prior to study entry Patients taking oral or intravenous steroids, calcitonin, any selective estrogen modulating agent such as tamoxifen or raloxifene, gallium nitrate, and other bone seeking radionuceotides, any calcimimetic agent such as cinacalet Patients who have had prior treatment with cisplatin, carboplatin, oxaliplatin, ifosfamide, or cyclophosphamide | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-110.0, Osseous Lesions From Metastatic Breast Cancer Patients receiving intravenous biphosphonate therapy (zoledronic acid 4 mg or renal dose equivalent) as part of their treatment regimen, who are diagnosed with metastatic breast cancer involving surrounding bone Patients must have had prior treatment zoledronic acid (4 mg or adjusted dose for renal function) within 8 weeks The patients clinical status as assessed by a treating physician must be deemed appropriate for continuing treatment with zoledronic acid The patient's clinical status, as assessed by a treating physician, must be deemed appropriate for an evaluation with a bone scan The patient's medical status as assessed by a treating physician must be medically appropriate to receive zoledronic acid within the study time frame and in association with the study bone scan No evidence of bone metastases, or less than 3 osseous lesions felt to be consistent with bone metastases, on most recent bone scan performed for clinical indications prior to study entry Patients with illnesses, or conditions that would prevent them from understanding the nature of the study and complying with the protocol requirements | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 0.0-999.0, Breast Cancer Osteoporosis Documented histologically or cytologically proven diagnosis of breast cancer Non-metastatic breast cancer tumor with the diagnosis of Tis, T1-T4, N0-3, M0 (Stage 0, I, II or III breast cancer) by the American Joint Committee on Cancer revised tumor-nodal-metastases staging system (Singletary, JCO 2002). DCIS is allowed, but LCIS (only) is not. Adjuvant care is administered as clinically indicated. Adjuvant treatment decisions are not stipulated in this trial Postmenopausal as defined by last menstrual cycle occurring more than 5 years previously. Women who have had a hysterectomy without bilateral oophorectomy will be considered postmenopausal if greater than 55 years of age. Women who have had a bilateral oophorectomy more than 5 years previously will be considered postmenopausal Chemotherapy Arm: Patients about to begin adjuvant, or neoadjuvant, treatment with Doxorubicin (60mg/m2), Cyclophosphamide (600mg/m2) followed by Paclitaxel (175mg/m2) (AC-T) or Doxorubicin (60mg/m2) for 4 cycles followed by Paclitaxel (175mg/m2) for 4 cycles followed by Cyclophosphamide (600mg/m2) for 4 cycles (A-T-C) administered in the dose dense regimen every 2 weeks with growth factor support. The patient may enter this trial within 3 months of initiating adjuvant chemotherapy Observation Arm: Patients begin adjuvant follow up with expectant monitoring (no systemic therapy). The patient may enter this trial within 2 months of initiating adjuvant care Signed informed consent Assessment of the complete blood count and complete biochemical profile must indicate absolute neutrophil count >1000/ul, hemoglobin > 9 g/dl and platelets >100,000/ul and the bilirubin, liver transaminases (AST/ALT) and serum creatinine must be within 2.5 times the institutional upper level of normal at the time of enrollment into the study Any metabolic bone disease (including Paget's disease of the bone) other than postmenopausal osteoporosis or osteopenia Use of systemic gonadal hormonal medications or supplements within the past 24 months. Topical vaginal estrogens such as "Estring" or other vaginal estrogenic compounds not associated with systemic absorption are allowed Prior use of tamoxifen or raloxifene is permitted if the medication was discontinued more then 24 months prior to the diagnosis of breast cancer. No adjuvant antiestrogen, antineoplastic, therapies are permitted on study Chronic use of systemic steroids (equivalent of prednisone 5mg daily for more then 3 months) for disease process other than breast cancer chemotherapy premedications or antiemetics. Inhaled steroids are allowed, as is the occasional use of low to moderate dose short pulse steroids History of rheumatoid arthritis, ankylosing spondylitis, hyperparathyroidism, renal osteodystrophy, moderate to severe inflammatory or autoimmune diseases or newly diagnosed thyroid condition requiring titration of medications (stable dose and minor dose modifications of thyroid medications are acceptable). Other exclusionary comorbid conditions thalassemia, moderate to severe malabsorptive syndromes and HIV. Patients diagnosed with the above conditions or similar comorbid and/or inflammatory diseases associated with changes in BMD either from the disease process or the therapy of such condition(s) during the course of the study will be removed from the study at the point of diagnosis Lobular carcinoma in situ (LCIS) or Stage IV breast cancer and patients with a concurrently active second malignancy other then adequately treated non-melanoma skin cancers or in situ cervical cancer. Patients with non-mammary malignancies, or prior breast cancer, must have been disease free for at least 5 years Participation in other clinical trials that are measuring BMD as a study parameter Patients with conditions that are expected to distort BMD reading and make DEXA results unreliable such as bilateral prosthetic hips, extensive degenerative joint disease, or severe calcification of the aorta Patients with concurrent medical or psychiatric conditions, which at the judgment of the consenting investigator, would prevent them from understanding and complying with this clinical trial | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Plasma Cell Myeloma Patients must have a confirmed diagnosis of symptomatic myeloma; for the original diagnosis of myeloma patients should have met the following at one point in their disease course Bone marrow plasmacytosis with >= 10% plasma cells or sheets of plasma cells or biopsy proven plasmacytoma Patient must have had symptomatic disease at initial diagnosis that prompted the initiation of therapy as well as evidence of end-organ damage at the time of diagnosis namely; at least one of the following: anemia, hypercalcemia, bone disease (lytic bone lesions or pathologic fracture), or renal dysfunction NOTE: Patients with asymptomatic smoldering myeloma (serum m protein >= 3 gm/dL or bone marrow plasma cells >= 10% or greater plus no evidence of anemia, hypercalcemia, lytic bone lesions or renal dysfunction) and monoclonal gammopathy of undetermined significance (serum m protein < 3 gm/dL and bone marrow plasma cells < 10% plus no evidence of anemia, hypercalcemia, lytic bone lesions or renal dysfunction) are not eligible Patients must be > 65 and have declined alternative treatment OR patients who are >= 18 < 65 are eligible if they Are not a candidate for autologous stem cell transplantation in the opinion of the treating physician OR Have declined transplant or other alternative treatment Eastern Cooperative Oncology Group (ECOG) performance status =< 2 All tests below must be performed within 28 days prior to randomization Serum free light chain assay | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Non-Small Cell Lung Cancer Brain Metastasis Histological or cytological documented stage IV NSCLC. Sputum cytology alone is excluded 2. Extracerebral lesions show stable disease after first line chemotherapy. Patient has recovered from CTCAE grade 3/4 toxicity. Patients who had never received EGFR-TKI or EGFR monoclonal antibody. 3. Patients must be at least 18 years. 4. ECOG Performance Status 0, 1 or 2. 5. Life expectancy of at least 12 weeks. 6. Appraisable disease, the presence of at least three lesions if longest diameter <10 mm by brain MRI. 7. Haemoglobin ³ 10.0 g/dl, Absolute neutrophil count (ANC) ³1.5 x 109/L, platelets ³ 100 x 109/L. 8. Total bilirubin £ 1.5 x upper limit of normal (ULN) 9. ALT and AST < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases. 10. Creatinine clearance ³ 60ml/min (calculated according to Cockcroft-gault formula).11. PT-INR/PTT < 1.2 x ULN. 12. Written informed consent.13. Able to comply with study and follow-up procedures Mixed small cell and non-small cell lung cancer histology. 2. Any unresolved toxicity>CTCAE grade 2 from previous anti-cancer therapy. 3. Patients with exposure to biotherapy, immunotherapy within 4 weeks of study entry. 4. Other concurrent anticancer therapy. 5. Patients with exposure to investigational drug therapy outside of this trial. 6. Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease. 7. Any unstable systemic disease (including active infection, hepatic, renal, metabolic disease or seizure disorder requiring medication). 8. Significant cardiovascular event: congestive heart failure >NYHA class 2; unstable angina, active CAD (myocardial infarction more than 1 year prior to study entry is allowed); serious cardiac arrhythmia requiring anti-arrhythmic therapy ( beta blockers or digoxin are permitted) or uncontrolled hypertension. 9. Brain metastases or spinal cord compression, if treated before the start of study treatment, and have any symptoms. Symptoms signs of increased intracranial pressure ,headache,nausea and vomiting,cognitive or affective disturbances,seizures,and focal neurologic symptoms. 10. History of another malignancy within the last 5 years except cured carcinoma in-situ of uterine cervix, cured basal cell carcinoma of skin and superficial bladder tumors [Ta, Tis & T1]. 11. Pregnant or breast-feeding women. 12. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results. 13. Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 0.0-999.0, Osteosarcoma Paget's Disease This is a familial study therefore the only inclusion/ would be that subjects must be a blood relative and over the age of 18 The subjects are proband and father along with unaffected blood relatives. Their peripheral blood will act as a control and provide information to delineate the inheritance from the father, as seen in the son Not part of the family | 2 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-90.0, Colorectal Cancer Signed written informed consent Patients with histologically or cytologically confirmed stage IV colorectal cancer who have failed either irinotecan-based, oxaliplatin-based or both. ECOG performance status of 0-2 Presence of measurable disease by radiographic study (including CT or MRI scan, or chest x-ray) or physical examination At least 3 weeks since last major surgery At least 6 weeks since prior radiotherapy providing that the extent and site of radiotherapy fields are such that marked bone marrow suppression is NOT expected. Patients who have received palliative radiotherapy must have recovered from any reversible toxic effects e.g. nausea and vomiting caused by radiation of fields At least 4 weeks since prior chemotherapy Pt with reproductive potential must use effective BC Required Screening Laboratory Hemoglobin 9.0g/dL WBC 3,500/mm3 [ 3.5 x 109/L] No brain metastases If female of childbearing potential, pregnancy test is negative Concomitant malignancies or previous malignancies other than colorectal cancer within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or low grade prostate cancer Active infection Concurrent severe medical problems unrelated to the malignancy, which would significantly limit full compliance with the study or expose the patient to extreme risk Sexually active patients refusing to practice adequate contraception. (condom plus spermicide, or other form of birth control) Patients with conditions which might affect absorption of an oral drug (for example intermittent obstruction) should be excluded unless discussed and agreed with the principal investigator History of grade 3 or 4 toxicity to fluoropyrimidines Pre-existing neuropathy ≥ NCI CTC grade 2 | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 0.0-999.0, Paget's Disease of the Bone Hypocalcemia Written informed consent As per currently approved Reclast® Package Insert As per currently approved Reclast® Package Insert | 2 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 20.0-60.0, Graves Disease Patients with newly diagnosed hyperthyroid Graves' disease If the patient had been treated previously diabetes, kidney, or liver disease | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-65.0, Bell's Palsy Patients who were diagnosed to have unilateral facial-nerve weakness without any identifiable causes within 168 hours after onset of symptoms; 2. aged 18 to 65 years ： 1. illiterate; 2. the facial paralysis is caused by herpes zoster; 3. recurrent facial paralysis; 4. noticeable asymmetry of the face before the illness which may affect the evaluation; 5. history of peptic ulcer disease, severe hypertension, uncontrolled diabetes, liver and kidney dysfunction, pregnancy, mental illness, or serious systemic diseases which may affect the treatment | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Cystic Fibrosis Vitamin D Deficiency older than 18 years of age 2. diagnosis of CF by sweat testing/genetics 3. vitamin D deficiency defined as a serum 25OHD level < 75 nmol/L 4. on stable baseline vitamin D supplementation for at least 2 months. Standard vitamin D supplementation (cholecalciferol) in CF includes 800 IU daily for individuals with pancreatic insufficiency and 400 IU daily for those with pancreatic sufficiency Individuals with known hypercalcemia or renal stones 2. psychiatric history 3. use of tanning beds/travel to sunny location within the last 2 months 4. lung transplantation 5. pregnancy or lactating women | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 20.0-85.0, Cystic Tumors of the Pancreas uni or oligo-locular cystic tumors indeterminate cystic tumors for which EUS-guided fine needle aspiration (FNA) was required to obtain additional information cystic tumors that increased in size during the observation period cystic tumors which had the typical morphology of serous cystadenomas (i.e., honeycomb appearance) and pseudocysts (i.e., parenchymal changes) evidence of communication between the cystic lesion and the main pancreatic duct according to endoscopic retrograde pancreatograms overt carcinomas with peripancreatic invasion patients with a bleeding tendency (prothrombin time > 1.5 international normalized ratio [INR] or platelet count < 50,000/μL) | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 0.0-999.0, Osteoarthritis, Hip Arthritis Rheumatoid Arthritis Joint Disease Bone Disease Non-inflammatory degenerative joint disease including: Avascular Necrosis, Diastrophic Variant, Fracture of the Pelvis, Fused Hip, Leg Perthes, Osteoarthritis, Slipped Capital Epiphysis, Subcapital Fractures, Traumatic Arthritis Rheumatoid Arthritis Correction of Functional Deformity Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques Revision of previously failed total hip arthroplasty Absolute contraindications Infection, Sepsis, and Osteomyelitis Relative contraindications Uncooperative patient or patient with neurologic disorders that are incapable of following directions Osteoporosis Metabolic disorders which may impair bone formation Osteomalacia Distant foci of infections which may spread to the implant site Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram Vascular insufficiency, muscular atrophy, or neuromuscular disease | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Breast Cancer Postmenopausal women with Stage I, II or IIIa breast cancer being treated with a non-steroidal Aromatase Inhibitor (AI) .Negative bone scan (no bone metastases) Calculated creatinine clearance > 40 ml/min Documented T score of less than or equal to -1.5 on Dual Energy X-ray Absorptiionmetry (DXA) scan at the lumbar spine or femoral neck within 3 months prior to screening Urine NTx > 50 nano moles(nM)based on second morning void Signed informed consent Ambulatory patients at least 18 years of age Eastern Cooperative Oncology Group (ECOG)0-2 Ability to comply with trial requirements Bone Metastases Any woman of child bearing potential Patients with fractures occurring within three months prior to randomization. - Greater than a 2+ protein on urine dipstick without evidence of contamination or bacteriuria (may be repeated one time, at least a day apart) Calculated creatinine clearance less than 30 mL/min at screening Serum calcium > 2.75 mmol/L (11.0 mg/dL) or < 2.00 mmol/L (8.0 mg/dL) Liver Function tests (LFT)> 2.0 x upper limit of normal (ULN) Serum alkaline phosphatase > 1.5 x ULN. History of hypersensitivity to bisphosphonates Evidence of vitamin D deficiency (serum 25-(OH) D of less than 15 ng/ml) History of uveitis or iritis, except when secondary to trauma, and must have resolved > 2 years prior to entry A history of invasive malignancy of any organ system, treated or untreated, within the past 12 months prior to screening; excluding, basal cell or squamous cell carcinoma of the skin, colonic polyps with non-invasive malignancy which have been removed, Ductal Carcinoma in-situ (DCIS) that has been surgically removed, and Carcinoma in-situ (CIS) of the uterine cervix that has been surgically removed | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Venous Thromboembolism Standard surgery for fracture of the upper third of the femur including femoral head and neck Estimated time of injury/fracture > 24 hours before admission to hospital Any major orthopedic surgery in the 3 months prior to study start Multiple trauma affecting more than one organ system Deep vein thrombosis or pulmonary embolism within the last 12 months or known post-phlebitic syndrome High risk of bleeding Known allergy to heparin, or enoxaparin, or pork products End stage renal disease or patient on dialysis; The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 25.0-80.0, Hypoparathyroidism A low endogenous PTH production as verified by low plasma levels of intact PTH, necessitating treatment with 1alpha-hydroxylated vitamin D analogs At least one years of continuous alphacalcidol, calcitriol, or dihydrotachysterol treatment prior to study entry Prior to start of study, participants are required to have received a daily supplement of at least 400 IU (10 microgram) of vitamin D (ergocalciferol or cholecalciferol) for at least 3 months or 25hydroxyvitamin D levels above 50 nmol/l. Subjects may be treated with ergocalciferol or cholecalciferol during a run-in period of three months before entering the study Normal plasma magnesium level (If not, magnesium supplements may be provided during a 3 months run in period) Plasma calcium levels within the normal reference range or slightly below (P-Ca ionized 1.00 to 1.30) Use of safe contraceptive methods (fertile women) Speak and read Danish Known allergic reactions to any of the compounds in the trial medication Severely impaired renal function (plasma creatinine > 200 micromol/l) Severely impaired hepatic function (Plasma alanine aminotransferase (ALAT) > 100 U/l and/or alkaline phosphatase > 400 U/l) Previous or present malignancies (except a treated skin cancer that is not melanoma or treated carcinoma in situ, 2 years since last therapy) Prior radiation therapy involving the skeleton Current treatment with raloxifene, calcitonin, systemic corticosteroids above 5 mg a day, fluoride, lithium, PTH, or digoxin Treatment with anticonvulsant's (within the last 2 years) Immobilization (more than two week within the last 6 months) Granulomatous disease Paget's disease of bone | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 0.0-999.0, Paget's Disease of the Bone Written Informed Consent Patients with Paget's disease randomized to the zoledronic acid arm from the CZOL446K2304 and CZOL446K2305 core studies and who were responders by 6 months Confirmed relapse of Paget's disease of bone (i.e. SAP above ULN, bone scan, worsening clinical symptoms) A patient previously treated with zoledronic acid who relapsed and was retreated with anti-resorptive bisphosphonate or calcitonin therapy within the last 12 months Bisphosphonate Hypersensitivity Patients with suspected/proven metastases at re-treatment Calculated creatinine clearance <35 mL/min at screening Serum calcium level <2.07 mmol/L at screening Active primary hyperparathyroidism, hyperparathyroidism, hypoparathyroidism or hypothyroidism Other protocol-defined inclusion/ | 1 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 19.0-44.0, Lung Inflammation Healthy, man or woman, any race or ethnicity, age 19 years old Screening FEV1 and FVC must be > 80% of predicted Screening oxygen saturation by pulse oximetry is >97% on room air Research volunteer must be capable of lying still and supine within the PET scanner for ~2 ½ hours Research volunteer must be capable of fasting for 6 hours Pregnancy (confirmed by a qualitative urine hCG pregnancy test) Lactation Actively menstruating at time of randomization History of tobacco use or has smoked other illicit drugs (marijuana, cocaine) in the past year Research volunteer is currently taking any prescription medications Research volunteer is at increased risk for radiation exposure (e.g. flight attendants) Research volunteer is enrolled in another research study of an investigational drug Research volunteer has a known allergy to both trimethoprim/sulfamethoxazole and amoxicillin Research volunteer has a known allergy to drugs routinely used during bronchoscopy Research volunteer has a known allergy to lovastatin or rhAPC | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Paget's Disease of Bone Patient aged over 18 years patient who underwent a clinical examination patient who gave its written consent, 1. Each individual (index case) affected by Paget's disease of bone (with diagnosis confirmed by alkalies phosphatases analysis and/or imaging with bone scintigraphy and radiographies on the affected sites with a typical aspect of the disease), and At least one relative affected by Paget's disease of bone with confirmed diagnosis (see above) Or an age at diagnosis < 55 years Or a polyostotic involvement with at least 4 affected bones Or the presence of a bone deformity at the time of the diagnosis. 2. Each relative with established phenotype by imaging (bone scintigraphy and/or radiographies), at first or second degree of relativeness of an index case defined in (a) Index case with not confirmed Paget's disease of bone by biological and/or radiological examinations Index with confirmed Paget's disease but without relative with the same disease, with an age at diagnosis >55 years, with a number of affected bones <4, without any bone deformity at the time of the diagnosis Healthy relatives of a Paget patient who refuse to undergo bone scintigraphy and bone radiographies Individuals < 18 years Pregnant or breast feeding woman-individual living ina sanitary or social establishment individual under guardianship individual in an emergency situation individual unable to give his consent incarcerated individual | 2 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 0.0-999.0, Cancer of the Urinary Tract Patients with suspected transitional cell carcinoma of the upper urinary tract which are deemed surgical candidates Negative visible retroperitoneal or peri-hilar lymphadenopathy on pre-operative radiographic studies. Defined as the absence of suspicious abdominal, retroperitoneal, or pelvic lymphadenopathy (defined as > 1 centimeter [cm]) on pre-operative radiographic imaging (Abdominal and pelvic computed tomography [CT] or magnetic resonance imaging [MRI] if CT contraindicated). Imaging studies can be done at Moffitt or at a local facility of the patient's choice. All imaging studies are going to be reviewed at Moffitt Note: Nodal involvement will depend on the size of the lymph node enlargement; usually nodes of more than 2 cm are associated with malignancy. With a threshold of 1cm, false negative rates for microscopic metastases are low (4%) and false positive rates are between 3 to 43% according to the literature. Because the aim of the study will be to perform a lymph node dissection in patients with non-metastatic disease based on pre-operative evaluation, 1 cm will be the threshold used. Nodes of more than 1 cm will be considered positive and those patients will be excluded as is mentioned in the protocol. Biopsy will not be included as part of the protocol as those potential patients with nodes of more than 1 cm will be excluded No other suspected sites of metastasis on pre-operative radiographic imaging Patients with visible lymph node metastasis on pre-operative radiographic studies. Defined as >1cm abdominal, retroperitoneal or pelvic lymphadenopathy Patients with suspected sites of distant metastasis on pre-operative imaging. (Patients with suspected bony metastases will require a bone scan.) Patients with suspected transitional cell carcinoma of the upper urinary tract with significant comorbidities making them non-surgical candidates Patients with non-transitional cell carcinoma of the upper urinary tract will be excluded from this study | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Osteoarthritis Patients with a pre-operative knee score of < 70 Patients scheduled to undergo primary total knee replacement with any of the following indication: Painful and disabled knee joint resulting from osteoarthritis, Traumatic Arthritis, Rheumatoid Arthritis; One or more compartments are involved Need to obtain pain relief and improve function Ability and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations A good nutritional state of the patient Full skeletal maturity of the patient, patients who are at least 18 years of age Patients of either sex Consent form read, understood, and signed by patient Absolute contraindications the following diagnoses Patients with a pre-operative knee score of >= 70 Infection Osteomyelitis Previous partial or total prosthetic knee replacement on the operative side Patients who are less than 18 years of age Sepsis Patients who had body mass index >= 40 Relative contraindications the following factors Uncooperative patient or patient with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations Osteoporosis or marked bone loss, which may preclude proper fixation of the prosthesis | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Prostate Cancer Bone Metastases Patients with asymptomatic castrate-resistant prostate cancer with bone metastases who have not received any bisphosphonates in the 12 months prior to enrollment years old and over Plan to be on cytotoxic or biologic therapy during study Active dental problems Active heart complications Active infection Patients with moderate to severe swelling due to fluid Other protocol-defined inclusion/ | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Arthritis, Rheumatoid Had a diagnosis of rheumatoid arthritis using American College of Rheumatology of at least 6 months duration A female subject of childbearing potential who is sexually active must agree to use adequate contraception, and must be neither pregnant nor lactating from Screening throughout the duration of the study Had a physical examination at Screening that revealed no clinically significant abnormalities (other than rheumatoid arthritis) in the investigator's opinion Had clinical laboratory test results at Screening that were normal or, if abnormal, were not clinically significant in the investigator's opinion Had a 12-lead electrocardiogram at Screening that was normal or, if abnormal, was not clinically significant in the investigator's opinion Had a chest x-ray within 6 months prior to or during the Pretreatment Period that, in the investigator's opinion, showed no signs of active tuberculosis and was free of clinically significant findings Had a negative purified protein derivative skin test for tuberculosis (less than or equal to 5 mm in duration) during the Screening Period Had been receiving oral or parenteral methotrexate for at least 6 months prior to Baseline and must have been on a stable dose (12.5 to 25 mg per week, inclusive) of methotrexate for at least 4 weeks prior to Baseline. The subject must have been on a dose of folic acid at greater than or equal to 1 mg/day Had at least 6 swollen and 9 tender joints using the 66/68 joint count scale at Screening and Baseline At Screening, the subject must have had a C-reactive protein of at least 1.2 mg/dL or an erythrocyte sedimentation rate of at least 28 mm/hr Had been diagnosed with any type of arthritis at age 16 or younger Had a history of a clinically significant illness, medical condition, or laboratory abnormality within 3 months prior to Baseline that, in the investigator's opinion, would preclude the subject's participation in the study Had a known history of human immunodeficiency virus infection Had a known history of hepatitis B or C Had uncontrolled hypertension Had moderate or severe liver disease at Screening, as defined by at least 1 of the following conditions Aspartate transaminase or alanine transaminase greater than 1.2 times the upper limit of normal Total bilirubin greater than 1.2 times upper limit of normal (excluding subjects diagnosed with Gilbert's disease) Alkaline phosphatase greater than 1.5 times upper limit of normal Had elevated serum creatinine level for age and gender at Screening | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 30.0-999.0, Paget's Disease of Bone Confirmed diagnosis of PDB by radiological reports Serum Alkaline Phosphatase level (SAP) at least two times the upper limit of the normal (ULN) History of hypersensitivity to the active substance or to any of the excipients or to any bisphosphonates History of malignancy of any organ system Severe liver or bladder disease Calculated creatinine clearance < 35 mL/min at baseline Hypocalcaemia Patients with pre-existing dental diseases or who predict to have dental surgeries during the study Evidence of vitamin D deficiency. Other protocol-defined inclusion/ | 2 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-60.0, Risk Factors for or a Diagnosis of Osteoporosis Male or female volunteers 18 to 60 years of age, inclusive Intact normal skin in the area intended for administration Adequate venous access in both upper extremities Dental examination by an appropriately trained professional within 14 days of administration demonstrating no signs, symptoms, or risk factors of osteonecrosis of the jaw (ONJ) Vital signs (BP, HR, temperature, respiratory rate) within normal range or, if out of range, assessed by the Investigator as not clinically significant and it is mutually agreed by both Investigator and Sponsor Medical Monitor that the subject need not be excluded from the study for this reason Electrocardiogram within normal range or if out of range, assessed by the Investigator as not clinically significant and it is mutually agreed by both Investigator and Sponsor Medical Monitor that the subject need not be excluded from the study for this reason Within 14 days prior to administration, metabolic panel (e.g., sodium, potassium, chloride, bicarbonate, BUN, creatinine, glucose, calcium, AST, ALT, alkaline phosphatase, total bilirubin, albumin, and total protein) and complete blood count within the laboratory normal reference range or, if out of range, assessed by the Investigator as not clinically significant and it is mutually agreed by both Investigator and Sponsor Medical Monitor that the subject need not be excluded from the study for this laboratory value A negative serum or urine pregnancy test (if female of child-bearing potential) within 14 days of study drug administration Female subjects of child-bearing potential must agree to be currently practicing effective birth control or abstinence and agree to continue to do so for at least 30 days after duration of their time on study Decision-making capacity and willingness and ability to comply with the requirements for full completion of the trial Lower extremity edema Lower extremity pathology that could interfere with any protocol-specified outcome assessment (e.g., cellulitis, lymphatic disorder or prior surgery, pre-existing pain syndrome, auxiliary lymph node dissection, etc.) Creatinine clearance < 60 mL/min (Cockcroft-Gault formula) Any risk factor for bisphosphonate-related renal toxicity including by not limited to known predisposition to or history of renal insufficiency or renal failure, hypertension, diabetes mellitus, volume depletion, sepsis, paraproteinemia, and subjects receiving known nephrotoxic drugs Dehydration Grade 2 or higher based on NCI CTCAE V3.0 Known parathyroid gland dysfunction or any other disease that could lower blood calcium levels Known history and/or electrocardiographic evidence of atrial fibrillation Known allergy to any hyaluronidase Bisphosphonate treatment within preceding six months Known allergy or intolerance to any bisphosphonate | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 12.0-999.0, Acne Vulgaris Facial acne vulgaris characterized by the following: 25-100 facial inflammatory lesions (papules plus pustules); and 40 or more non-inflammatory lesions (open/closed comedones)); stable disease, non-rapidly regressing facial acne vulgaris; and, 3 or less facial nodules and/or cysts (diameter of 1cm or greater) Female subjects of childbearing potential must have a negative urine pregnancy test at baseline and practice reliable method of contraception throughout the study Non-compliance with washout period Skin disease/disorder that might interfere with diagnosis or evaluation of acne vulgaris Allergy or sensitivity to any component of the test medications Cosmetic or surgical procedure complementary to the treatment of facial acne within 14 days of the baseline visit | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Bone Neoplasm Patients with primary or recurrent benign bone tumor or tumor-like condition that requires operative treatment by means of tumor evacuation and defect filling Pathological fractures of patients in Stratum I are treated by means of conservative treatment for three months before tumor surgery History of acute or chronic local infection History of malignancy (excluding carcinoma basocellular) within past 5 years A history of local radiotherapy A known metabolic skeletal disease (such as osteoporosis, Paget's disease or osteomalacia) Medication affecting bone turnover (oral bisphosphonates, PTH, sodium fluoride, strontium ranelate, calcitonin, testosterone, systemic cortico or anabolic steroids) Any plans to use phenol or other chemical/thermal method of local tumor control Pregnancy Any other condition that in the judgment of the investigator, would prohibit the subject from participating in the study or may hinder the collection of data and interpretation of the results | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Metastatic Colorectal Cancer Liver Metastases Hepatic Lesions Histologically or cytologically confirmed carcinoma of the colon and/or rectum with evidence of liver metastases (new confirmation of metastatic disease is required in case the time interval from last histological diagnosis to enrolment exceeds 3 years) Patient with wild type (WT) KRAS tumor status Patient whose liver metastases are considered to be non resectable with curative intent in medico-surgical staff meeting. In particular patients with at least one of the following which prevent complete local treatment of liver metastasis with surgery alone or surgery plus radiofrequency ablation because less than 30% estimated residual liver after resection disease in contact with liver main vessels documented progressive disease on imaging documents or doubling of serum levels of carcino-embryonic antigen (CEA) or CA19.9 over the past 90 days or less Patient with up to three resectable extrahepatic nodules of <= 10 mm One, two or three prior chemotherapy lines for colorectal cancer Written informed consent Age >=18 years Patient whose primary tumor or metastasis displays mutation of K-Ras (codon 12 and/or 13) Unresectable extrahepatic diseases More than three resectable extrahepatic nodules Size of extra hepatic nodules > 1 cm Prior HAI of the 3 drugs More than 2 prior surgical attempts for metastatic disease Prior radiotherapy for metastatic disease Known documented intolerance or hypersensitivity to any of the drugs used Sensory neuropathy grade 3 (National Cancer Institute-Common Terminology for Adverse Events -NCI-CTCAE, Version 3.0) Past or current history (within the last 2 years prior to treatment start) of malignancy other than colorectal cancer (patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible) | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-80.0, Ankylosing Spondylitis Definitive Ankylosing spondylitis according to the New York At least 18 years old Pregnant Dementia Not able to understand, speak or read Swedish | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Breast Adenocarcinoma DS Stage I Plasma Cell Myeloma DS Stage II Plasma Cell Myeloma Metastatic Malignant Neoplasm to the Bone Pain Musculoskeletal Complication Urinary Complications Histologic documentation of one of the following: breast adenocarcinoma, prostate adenocarcinoma or multiple myeloma At least one site of bone metastasis or bone involvement by radiologic imaging including plain radiograph, computed tomography (CT), positron emission tomography (PET) scan, PET/CT scan, magnetic resonance imaging, bone scan, or skeletal survey; indeterminate lesions should be confirmed by a second imaging method No prior treatment with IV bisphosphonates is allowed; prior treatment with oral bisphosphonates is allowed, but they must be discontinued prior to the initiation of protocol therapy No prior treatment with denosumab No prior treatment with radiopharmaceuticals; prior treatment with radioactive iodine is allowed; prostate cancer patients treated with brachytherapy are eligible Prior radiation therapy to bone is allowed, provided that at least one site of bone metastasis has not been irradiated and radiation is completed prior to registration; there should be no plan for radiation therapy to non-irradiated sites of bone metastases Prior adjuvant and metastatic chemotherapy, biologic therapy, and endocrine therapy is allowed No current treatment with investigational agent(s) Patients with known brain metastases are not eligible; patients who develop brain metastases during the study will be allowed to continue treatment as assigned Not pregnant and not nursing | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Accelerated Phase Chronic Myelogenous Leukemia Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome Acute Undifferentiated Leukemia Adult Acute Lymphoblastic Leukemia in Remission Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Del(5q) Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) Adult Grade III Lymphomatoid Granulomatosis Adult Langerhans Cell Histiocytosis Adult Nasal Type Extranodal NK/T-cell Lymphoma Aggressive NK-cell Leukemia AIDS-related Diffuse Large Cell Lymphoma AIDS-related Diffuse Mixed Cell Lymphoma AIDS-related Diffuse Small Cleaved Cell Lymphoma AIDS-related Immunoblastic Large Cell Lymphoma AIDS-related Lymphoblastic Lymphoma AIDS-related Malignancies AIDS-related Small Noncleaved Cell Lymphoma Anaplastic Large Cell Lymphoma Angioimmunoblastic T-cell Lymphoma Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative Chronic Eosinophilic Leukemia Chronic Myelomonocytic Leukemia Chronic Neutrophilic Leukemia Chronic Phase Chronic Myelogenous Leukemia Clear Cell Renal Cell Carcinoma Cutaneous B-cell Non-Hodgkin Lymphoma de Novo Myelodysplastic Syndromes Essential Thrombocythemia Extramedullary Plasmacytoma Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Hepatosplenic T-cell Lymphoma HIV Infection HIV-associated Hodgkin Lymphoma Intraocular Lymphoma Isolated Plasmacytoma of Bone Light Chain Deposition Disease Mast Cell Leukemia Myelodysplastic Syndrome With Isolated Del(5q) Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable Myeloid/NK-cell Acute Leukemia Nodal Marginal Zone B-cell Lymphoma Noncutaneous Extranodal Lymphoma Osteolytic Lesions of Multiple Myeloma Peripheral T-cell Lymphoma Plasma Cell Neoplasm Polycythemia Vera Post-transplant Lymphoproliferative Disorder Previously Treated Myelodysplastic Syndromes Primary Myelofibrosis Primary Systemic Amyloidosis Progressive Hairy Cell Leukemia, Initial Treatment Prolymphocytic Leukemia Recurrent Adult Acute Lymphoblastic Leukemia Recurrent Adult Acute Myeloid Leukemia Recurrent Adult Burkitt Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Adult Diffuse Mixed Cell Lymphoma Recurrent Adult Diffuse Small Cleaved Cell Lymphoma Recurrent Adult Grade III Lymphomatoid Granulomatosis Recurrent Adult Hodgkin Lymphoma Recurrent Adult Immunoblastic Large Cell Lymphoma Recurrent Adult Lymphoblastic Lymphoma Recurrent Adult T-cell Leukemia/Lymphoma Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Recurrent Marginal Zone Lymphoma Recurrent Mycosis Fungoides/Sezary Syndrome Recurrent Renal Cell Cancer Recurrent Small Lymphocytic Lymphoma Refractory Chronic Lymphocytic Leukemia Refractory Hairy Cell Leukemia Refractory Multiple Myeloma Relapsing Chronic Myelogenous Leukemia Stage IV Renal Cell Cancer T-cell Large Granular Lymphocyte Leukemia Testicular Lymphoma Unspecified Adult Solid Tumor, Protocol Specific Waldenström Macroglobulinemia Biopsy-proven solid tumor or hematological malignancy, including Metastatic renal cell carcinoma A solid tumor malignancy, including an NADC or an AIDS-defining malignancy, if the subject has progressed following standard therapy and/or other curative options are not available A hematologic malignancy, except for blast-phase leukemia, for which effective standard therapy or other curative options are not available Serologic documentation of HIV infection at any time prior to study entry, as evidenced by positive enzyme linked immunosorbent assay (ELISA), positive western blotting (Western Blot), or other federally approved licensed HIV test, or a detectable blood level of HIV ribonucleic acid (RNA), or a positive anti-HIV antibody test On stable anti-retroviral therapy for at least 4 weeks with a protease inhibitor (PI)-based or non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimen of at least three drugs, with no intention to change the regimen within 8 weeks after starting study drug Patients who are on NNRTI and ritonavir PI-based therapy are eligible and will be enrolled in the ritonavir PI-based group (Group 3) Patients who are on NNRTI and non-ritonavir PI-based therapy are eligible and will be enrolled in the non-ritonavir PI-based group (Group 2); NOTE: accrual to Group 2 will be closed upon approval of version 7.0 of the protocol Patients who are on a highly active antiretroviral therapy (HAART) combination that includes neither a PI nor a NNRTI agent are eligible and will be enrolled in the NNRTI-based group (Group 1) CD4 count > 50 cells/uL Concurrent active opportunistic infection (OI) Acute treatment for an infection or other serious medical illness within 14 days prior to study entry Receipt of antineoplastic therapy, including investigational drug or standard treatment, within 2 weeks of study entry; must be able to demonstrate adequate recovery from prior therapy-related toxicities Major surgery or radiation within 3 weeks prior to study entry Concurrent treatment with medications, other than antiretroviral drugs used to treat HIV infection, that are known to inhibit or induce CYP3A4 Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease Clinically significant cardiovascular disease, including uncontrolled hypertension (diastolic blood pressure >= 100 mmHg despite optimal medical therapy) or unstable angina A myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident, transient ischemic attack, or pulmonary embolism within 6 months of study entry Abnormal left ventricular ejection fraction per institutional standards Ongoing ventricular cardiac dysrhythmias of National Cancer Institute (NCI) Common Terminology for Adverse Event (CTCAE) grade >= 2 | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-65.0, Graves' Disease Newly diagnosed of Graves' Disease Pregnancy Allergy to ATD, Alanine aminotransferase (ALT) or asparate aminotransferase (AST) above 2 times of upper normal range Non-compliance because of psychiatric or other serious diseases, or unwillingness to participate in the study | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 0.0-999.0, Neurofibromatosis Type 1 Malignant Peripheral Nerve Sheath Tumor Plexiform Neurofibroma Optic Glioma Neurofibroma Age Less than or equal to 35 years of age for new patients evaluated at NIH No upper age limit for patients previously enrolled on clinical trials at NIH or for patients diagnosed with MPNST, or with clinical concern for MPNST, or with infrequent or unusual NF1 related manifestations. 2. Diagnosis: Patients who are diagnosed with NF1 using the NIH Consensus Conference or have a confirmed NF1 mutation with analysis performed in a CLIA-certified laboratory. NF1 mutation testing to confirm will not be performed on this protocol, but as part of a separate screening study. Histologic confirmation of NF1 related benign tumors is not necessary in the presence of consistent clinical and radiographic findings, but is required for individuals with MPNST who enroll on this study. For the clinical diagnosis of NF1 all study subjects must have at least two or more diagnostic for NF1 listed below (NIH Consensus Conference): 1. Six or more cafe-au-lait spots (greater than or equal to 0.5 cm in prepubertal subjects or greater than or equal to 1.5 cm in postpubertal subjects). 2. Greater than or equal to 2 neurofibromas or 1 plexiform neurofibroma. 3. Freckling in the axilla or groin. 4. Optic glioma. 5. Two or more Lisch nodules. 6. A distinctive bony lesion (dysplasia of the sphenoid bone or dysplasia or thinning of long bone cortex). 7. A first-degree relative with NF1. 3. Prior and current therapy: For NF1 related benign tumor manifestations there is no standard effective medical treatment, and surgery is the only standard treatment. Chemotherapy and radiation therapy are additional treatment options for malignant NF1 related tumors. For the purpose of this study, subjects who have not previously received medical or surgical treatment, patients, who have previously received medical or surgical treatment, and patients who are currently receiving medical treatment and/or radiation for a NF1 related manifestation will be eligible. Prior and current treatment for NF1 related manifestations will be recorded at trial entry and throughout the study. 4. Performance Status: ECOG less than or equal to 3. Subjects who are wheelchair bound because of paralysis will be considered ambulatory when they are up in their wheelchair. Subjects have to be able to travel to the NIH for evaluations. 5. Informed Consent: All patients or their legal guardians (if the patient is less than 18 years old) must sign an IRB-approved document of informed consent to demonstrate their understanding of the investigational nature and the risks of this study before any protocol-related studies are performed. When appropriate, pediatric subjects will be included in all discussions. 6. Durable Power of Attorney (DPA): All subjects greater than or equal to 18 years of age will be offered the opportunity to assign DPA so that another person can make decisions about their medical care if they become incapacitated or cognitively impaired. 7. In addition, subjects participating in evaluation for variation in gene expression must Have at least 1 plexiform neurofibroma and be able to undergo MRI analysis of the plexiform neurofibroma(s) If possible, but not absolutely required, have one or both biologic parents (NF1 affected or not) willing to donate a blood or cheek swab, or mouthwash sample for DNA extraction. A separate informed consent will be obtained from biologic parents In the opinion of the investigator the patient is not able to return for follow-up visits or obtain required follow-up studies. 2. In the opinion of the investigator the patient is not able to obtain an MRI scan. 3. Individuals who are pregnant or breast feeding or who become pregnant while enrolled on this trial will not be excluded from participation, but will not undergo radiographic evaluations or MRI scans requested for research purposes, or other studies which might negatively impact on the pregnancy. FOR TUMOR / FOR 1. Age greater than 12 years, and neurofibroma, cafe-au-lait macule, xanthogranuloma, or other skin area, which is easily accessible, and sufficiently distant from vital structures to allow for biopsy. 2. Platelet count has to be greater than or equal to 100,000/microL, and PT and PTT have to be within normal limits within 1 week of each biopsy. 3. The subject or parent/guardian must sign a separate biopsy consent, and the participant, if minor, must sign a separate assent describing the biopsy. 4. No medical treatment specifically directed at NF1 related tumor within six weeks prior to collection of specimen Biopsies will not be performed if the participant requires general anesthesia. 2. Requirement for medications, which interfere with platelet function, such as aspirin, which cannot be stopped within 1 week prior to the biopsy. (NEUROCOGNITIVE AND QOL 1. Availability of a sibling not affected with NF1 for longitudinal evaluation of neurocognitive function and quality of life evaluation. An assent form will be prepared for unaffected minor siblings, and written informed consent will be obtained from siblings 18 years of age or older A medical condition which would preclude the sibling from participation in the evaluation of neurocognitive function or quality of life. OF (GENETIC 1. Biologic parents (one or both) of patients with NF1 will be eligible if they are willing to provide a blood, cheek swab, saliva, or mouthwash sample for DNA extraction for analysis of gene modifiers. These individuals may be of any gender and ethnicity. Written informed consent will be obtained from each parent willing to participate in this part of the study A medical condition, which would preclude the parent from providing a biologic sample. OF (QUESTIONNAIRES) Parents (one or both) of patients with NF1 will be eligible if they are willing to t complete the questionnaires for NF1 assessment itemized in Section 1.2.8 | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 15.0-999.0, Sinusitis Pain when bending forward, headache, pain in the teeth, purulent nasal secretion, "double worsening" and white blood cell count (WBC) Patients eligible for the study had to meet one of the first three (pain when bending forward, headache, pain in the teeth) and all of the other indicators (purulent nasal secretion, double worsening, a left handed displacement of lymphocytes and a right handed displacement of granulocytes on the WBC as indication of bacterial infection) Subjects over 15 years of age were included Subjects with any kind of antibiotic or allergic treatment within the last three weeks Antibiotic intolerance Pregnant women | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-120.0, Breast Cancer Osteoporosis Patient must be eligible and enrolled in the TEXT-2 trial prior to enrolling in TEXT-Bone Serial bone marrow density (BMD) measurements must be taken within the same institution Hormone receptor positive See Disease Characteristics Premenopausal No bone fracture in the past 6 months that, in the investigator's judgement, could be related to bone fragility No clinical or biochemical malabsorption syndrome, known vitamin D deficiency, active hyper or hypoparathyroidism, or Paget's disease No uncontrolled thyroid disease, Cushing disease, or other pituitary diseases No other bone disease (including osteomalacia or osteogenesis imperfecta) PRIOR | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Unresectable Hepatocellular Carcinoma Written informed consent granted prior to initiation of any study-specific screening procedures year of age or older Histologically or cytologically confirmed HCC Archival, fresh core needle biopsy or fine needle aspiration (FNA) tumor samples Received at least one cycle of prior systemic therapy (at least 3 weeks for continuously administered drugs) and experienced radiographic disease progression or was unable to tolerate therapy. If intolerance was manifested by a Grade 3 or 4 event of such nature that re-challenge is not acceptable, less than 3 weeks of continuous administration will be allowed Discontinued prior treatment for at least 4 weeks, or at least 2 weeks (14 days) if drug was administered continuously and orally (e.g. sorafenib or sunitinib), prior to the study randomization Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤1 Local or loco-regional therapy (i.e., surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation) must have been completed ≥4 weeks prior to randomization Measurable disease as defined by a modified version of the revised Response Evaluation in Solid Tumors (RECIST) version 1.1 (see section 9). Tumor lesions previously treated with local therapy should demonstrate clear dimensional increase by radiographic assessment in order to be selected as target lesion(s) at baseline. (Radiological assessment needs to be redone within 7 days prior to randomization if the pre-study AFP level has increased by more than 30% since the last AFP level taken one to four months prior to randomization) Adequate bone marrow, liver, and renal functions at Pre-Study Visit, defined as More than 1 prior systemic regimen Child-Pugh B-C cirrhotic status Previous or concurrent cancer that is distinct from HCC in primary site or histology, cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated >3 years prior to enrollment is permitted History of congestive heart failure defined as Class II to IV per New York Heart Association (NYHA) classification within 6 months prior to study entry; active coronary artery disease (CAD); clinically significant bradycardia or other uncontrolled, cardiac arrhythmia defined as ≥Grade 3 according to National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE), version 4.0, or uncontrolled hypertension; myocardial infarction occurring within 6 months prior to study entry (myocardial infarction occurring >6 months prior to study entry is permitted) Active clinically serious infections defined as ≥ Grade 3 according to NCI CTCAE, version 4.0 Substance abuse, medical, psychological or social conditions that may, in the opinion of the Investigator, interfere with the patient's participation in the study or evaluation of the study results Any condition that is unstable or which could jeopardize the safety of the patient and his/her protocol compliance Known human immunodeficiency virus (HIV) infection Pregnancy or breast-feeding History of liver transplant | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-55.0, Musculoskeletal Pain Signed and dated informed consent prior to participation Subjects in good health as determined by the Investigator Age 18-55 Willing to abstain from any physical therapy, hard physical work, exercise or sauna during the study observation period (Screening to Final Visit) For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are also allowed for participation Participation in another clinical study within the last 30 days and during the study Subjects who are inmates of psychiatric wards, prisons, or other state institutions Investigator or any other team member involved directly or indirectly in the conduct of the clinical study Pregnancy or lactation Alcohol or drug abuse Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma Skin lesions, dermatological diseases or tattoo in the treatment areas Known hypersensitivity or allergy (including photoallergy) to NSAID´s including celecoxib, sulfonamides and ingredients used in pharmaceutical products and cosmetics including galactose Varicosis, thrombophlebitis and other vascular disorders of the lower extremities Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-skeletal system of the lower limbs | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, HIV Infection Liver Failure Evidence of Liver Transplantation Age ≥ 18 Documented HIV-1 infection, hepatitis B or C co-infection is allowed Plasma viral load at screening visit below 50 copies per mL for at least 6 months Patient with severe liver failure (Meld Score ≥ 15 and/or refractory ascites and/or haemorrhage of digestive tract and/or hepatic encephalopathy) for taking part into period 1 Patient eligible for the liver transplant waiting list or immediate post transplantation for taking part into period 2 Abstinence from alcohol intake for at least 6 months (WHO norm) Withdrawal from intravenous drug use for at least 6 months (methadone substitution is permitted) No ongoing class C opportunistic infection (1993 CDC classification) Patient whose clinical and immunovirological condition allows triple therapy with raltegravir + 2 NRTI or raltegravir + NRTI + enfuvirtide Patient whose HIV population, according to cumulative genotypes carried out on viral RNA together with treatment history (if available and interpreted as per the ANRS-AC11 algorithm version no.19) does not present a profile of mutations associated with resistance to raltegravir and is sensitive to at least two fully active* agents selected among nucleoside/nucleotide reverse transcriptase analogs NRTI (abacavir, lamivudine, emtricitabine, tenofovir) or enfuvirtide *An ARV agent is considered to be fully active if the cumulative genotypes do not show any mutation associated with resistance or any mutation associated with "possible resistance" More than two virological failures during antiretroviral treatment Currently receiving treatment with an agent in development (apart from an authorization for temporary use) Plasma viral load at screening visit ≥ 50 copies per mL during at least the last 6 months Pregnant women, or women liable to become pregnant, breast-feeding women, no contraception, or refusal to use contraception All conditions (including but not limited to alcohol intake and drug use) liable to compromise, in the investigator's opinion, the safety of treatment and/or the patient's compliance with the protocol Patient not having any effective options for NRTI +/ enfuvirtide (defined in the criteria) Ongoing treatment with interferon-alpha or ribavirin for hepatitis C Concomitant medication including one or more agents liable to induce UGT1A1 and reduce raltegravir concentrations anti-infective agents: rifampicin/rifampin | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 0.5-999.0, HIV Infection Rheumatic Disease Cancer Transplant Pediatrics medically recommended influenza A(H1N1) immunization signed informed consent failure or refusal to provide sufficient blood for antibody determination | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-59.0, First Episode Psychosis Aged 18-59 years and meet DSM-IV diagnostic for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version Meeting DSM-IV for another axis I diagnosis, including substance abuse or dependence Needing another nonantipsychotic psychotropic medication at enrollment Having a serious or unstable medical illness Pregnant or lactating women or women without adequate contraception will be also excluded | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Metastatic Melanoma ENTRY Locally advanced or metastatic melanoma Measurable Histologically or cytologically confirmed Surgically incurable HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes PRIOR/CONCURRENT If prior Proleukin treatment, must have had clinical benefit No prior systemic cytotoxic chemotherapy for melanoma No concurrent radiotherapy, chemotherapy, or other immunotherapy More than 4 weeks since prior major radiotherapy | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 21.0-75.0, Prevention of Surgical Site Infections Healthy adult No allergies to cefazolin, metronidazole or lidocaine HIV Hepatitis C Diabetes | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 25.0-53.0, Neck Pain female aged 25 to 53 years office worker permanently employed motivated to continue working motivated for rehabilitation constant or frequently occurring neck pain for more than 6 months severe disorders of the cervical spine disk prolapse spinal stenosis postoperative conditions in the neck and shoulder areas history of severe trauma instability spasmodic torticollis frequent migraine peripheral nerve entrapment fibromyalgia | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Multiple Myeloma History of histologically documented MM with relapsed or progressive disease after at least one line of prior therapy. 2. Patient has measurable disease in which to capture response, defined as one or more of the following: 1. Serum M-protein level > 1.0 gm/dl (10.0 g/L) measured by serum protein electrophoresis or immunoglobulin electrophoresis; or 2. Urinary M-protein excretion > 200 mg/24 hrs; or 3. Bone marrow plasmacytosis of > 30% by bone marrow aspirate and/or biopsy; or 4. Serum Free Light Chains (By the Freelite test) > 2X ULN, in the absence of renal failure 5. Radiographic evidence of disease 3. Performance status of < 2 as per ECOG scale, unless PS of 3-4 based solely on bone pain. 4. Patients must have a platelet count > 100,000/L and an ANC of at least 1,000/μl. 5. Patients must have adequate renal function defined as serum creatinine ≤2.5 mg/dL. 6. Patients must have adequate hepatic function defined as serum transaminases and direct bilirubin < 3 x the upper limit of normal. 7. Male or female adults of at least 18 years of age. 8. Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. 9. Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. 10. Growth factors are allowed during the study 11. Male subject agrees to use an acceptable method for contraception for the duration of the study Platelet count of <100x 10(9)/L within 14 days before enrollment. 2. Absolute neutrophil count (ANC) <1.0 x 10(9)/L 3. Serum creatinine ≥ 2.5 mg/dL within 14 days before enrollment. 4. Patient has >Grade 2 peripheral neuropathy within 14 days before enrollment. 5. Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see section 1.4), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant. 6. Patients with a history of treatment for clinically significant ventricular cardiac arrhythmias. 7. Patient has hypersensitivity to bortezomib, boron or mannitol. 8. Chemotherapy or radiotherapy received within the previous 4 weeks of study enrollment. 9. Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women. 10. Patient has received other investigational drugs with 14 days before enrollment 11. Serious medical or psychiatric illness likely to interfere with participation in this clinical study. 12. Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy. 13. POEMS Syndrome 14. Clinically significant hepatic dysfunction as noted by bilirubin or AST > 3 times the upper normal limit or clinically significant concurrent hepatitis. 15. Uncontrolled, active infection 16. Patients that have taken bisphosphonates within 30 days of screening will not be eligible for this trial. 17. Must not have received 90 days prior to enrolling in this trial | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 21.0-999.0, Shoulder Pain Trial Stage At least 21 years of age Post-stroke shoulder pain Trial Stage Use of habit-forming (narcotic) medications History of recurrent skin infections Bleeding disorder Parkinson's Disease, Spinal Cord Injury, traumatic brain injury, Multiple Sclerosis, or complex regional pain syndrome Heart arrhythmia or artificial heart valves Uncontrolled seizures Implanted Electronic Device Implant Stage Had a "return of pain" defined as an increase in pain of at least 2 points compared to the pain intensity score at Visit 5 and has a pain intensity score of at least 4 | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-40.0, Somatic Dysfunctions of Pelvis Somatic Dysfunctions of Sacrum Somatic Dysfunctions of Lower Lumbar Spine Weight-Bearing Medical students of Nova Southeastern University College of Osteopathic Medicine (NSUCOM) ages 18-40 individuals who have suffered from any type of osseous or soft tissue traumatic injuries in the last three months individuals who have suffered from any type of osseous or soft tissue injuries in the lower extremity joints (knee, ankle, hip) in the last twelve months anyone who has received either osteopathic or chiropractic manipulation within two weeks prior to taking part in the study anyone who has a leg length difference of greater than one-quarter inch | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Muscle Disorder Bone Disorder Male or Female age 18 and older diagnose of Muscle or bone disorders with a combination of medical problems including muscle and bone disease and their family members under 18 year of age unrelated diagnosis | 1 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 19.0-44.0, Lung Inflammation Healthy man or woman, any race or ethnicity, age 19 years old Screening FEV1 and FVC > 90% of predicted Screening oxygen saturation by pulse oximetry >97% on room air Capable of lying still and supine within the PET/CT scanner for ~1.5 hours Capable of following instructions for breathing protocol during CT portion of PET/CT Able and willing to give informed consent BMI < 35 Pregnancy (confirmed by qualitative urine hCG pregnancy test) Lactation Active menstruation History of cardiopulmonary disease Currently taking any prescription medications History of tobacco use or illicit drug use within the past year Presence of implanted electronic medical device Enrollment in another research study of an investigational drug Known allergy to rosiglitazone or zileuton Known allergy to both trimethoprim/sulfamethoxazole and amoxicillin | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 16.0-60.0, Graves' Disease Graves' disease patients. Healthy people Pregnancy. <16 years old or > 60 years old | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Spinal Cord Diseases Spinal Cord Injuries Neuralgia Pain for subjects to be shifted from Study A0081107 Subjects who completed the 18-week study period in Study A0081107 conducted for chronic neuropathic pain after spinal cord injury Subjects who completed assessments of all efficacy endpoints until the end of the treatment phase of the preceding Study A0081107 (V7); for subjects to be new participants in this study Subjects with central neuropathic pain after stroke or multiple sclerosis At least 6 months have passed after the onset of central neuropathic pain Pain VAS at least 40mm in Visit 1 and Visit 2 Creatinine clearance < 60 mL/min Platelet count < 100 × 103/mm3 ; White blood cell (WBC) count < 2500 / mm3; Neutrophil count < 1500/ mm3 Subjects who are expected to require surgery during the trial | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 12.0-75.0, Bone Cyst Bone cyst diagnosed with MRI, CT-scan, or X-Ray Intact cyst wall with high risk for fracture Cysts with minimum diameter of 6mm Diagnostic test performed on cyst fluid Provided written consent form Patients with diagnosis of cancer Patients enrolled in other clinical trial | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-90.0, Bone Marrow Changes Patients with bone marrow changes Pregnacy Age below 18 ys old Contraindications for MRI | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Advanced Solid Tumors With an Alteration of the PIK3CA Gene Estrogen Receptor Positive Breast Cancer Patients with histologically-confirmed, advanced unresectable solid tumors who have progressed within three months before screening/baseline visit Only patients who have confirmed PIK3CA status (wild type, mutation or amplification) will be allowed for screening (patients participating in the combination arm must be eligible for treatment with fulvestrant) Availability of a representative formalin fixed paraffin embedded tumor tissue sample At least one measurable or non-measurable lesion Age ≥ 18 years World Health Organization (WHO) Performance Status ≤ 2 Good organ (hepatic, kidney, BM) function at screening/baseline visit Brain metastasis unless treated and free of signs/symptoms attributable to brain metastasis in the absence of corticosteroid therapy (anti-epileptic therapy is allowed) Prior treatment with PI3K, AKT or mTOR inhibitor and failure to benefit Patient with peripheral neuropathy NCI-CTC Grade ≥ 3 Patient with diarrhea NCI-CTC Grade ≥ 2 Patient with acute or chronic pancreatitis Impaired cardiac function or clinically significant cardiac disease incl. unstable angina pectoris ≤ 3 months prior to starting study drug and Acute Myocardial Infarction (AMI) ≤ 3 months prior to starting study drug Patients with clinically manifest diabetes mellitus, history of gestational diabetes mellitus or documented steroid-induced diabetes mellitus Women who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control Other protocol-defined inclusion/ | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 0.0-24.0, Transient Tachypnea of the Newborn Gestational age at birth 34 and 42 weeks of gestation 2. Admission to the Mount Sinai NICU during the first 24 hours of life 3. Diagnosis during the first 24 hours of life of transient tachypnea of the newborn Gestational age at birth less than 34 weeks or greater than 42 weeks at birth 2. No diagnosis of TTN made in the first 24 hours of life 3. Additional infant diagnosis of major cardiac disease 4. Additional infant diagnosis of major pulmonary disease other than TTN 5. Additional infant diagnosis of meconium aspiration syndrome 6. Additional infant diagnosis of major congenital anomaly with potential to affect respiratory status in the neonatal period 7. Additional infant diagnosis of infectious disease process potentially affecting respiratory status in the neonatal period 8. Observation of thick meconium in the amniotic fluid at delivery. 9. Maternal diagnosis of chorioamnionitis or other infection of the uterus or fallopian tubes pre or peri-partum. for removal from the study: (a) Additional infant diagnosis of major cardiac, pulmonary, or other disease process potentially affecting respiratory status in the neonatal period (i.e., infection, meconium aspiration, pneumothorax, congenital anomaly) present during the study period. (b) Positive test of infection (e.g. blood, CSF, or urine culture; viral DFA; microscopy) drawn from infant at any point during the study period. (c) Maternal diagnosis of chorioamnionitis or other infection of the uterus or fallopian tubes at any point during hospital stay. (d) Objective clinical signs of dehydration: (i) Newborn urine output less than 2 mL/kg/hr over a twelve hour period at any point during the study period. (ii) Newborn serum sodium less than 130 mEq/L or greater than 150 mEq/L at any point during the study period. (iii) Newborn weight loss >10% of birth weight at any point during the study period. (e) Newborn blood glucose by point-of-care testing of less than 40 mg/dL at any point during the study period. (f) Administration of exogenous surfactant at any point during the study period | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Cancer Bone Metastases Patient has cancer Has been referred for evaluation of bone metastases Patient or patient's legal representative can understand and consent to enrollment in the study Must be 18 years or older Can remain still during the scan (approximately one hour) Patient has Medicare Patient does not have Medicare Under the age of 18 Cannot lie still for the necessary time | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 0.0-24.0, Transient Tachypnea of the Newborn gestational age ≥ 35 weeks diagnosis of TTN, defined as respiratory rate >60, presence of subcostal and /or intercostal retractions, nasal flaring, grunting, oxygen saturations 70-93% on room air, and radiological evidence of perihilar streaking and patchy infiltrates admission to the NICU at Mount Sinai hospital within first 24 hours of life gestational age < 35 weeks history of thick meconium stained fluid and/or diagnosis of meconium aspiration syndrome diagnosis of major congenital pulmonary or cardiac anomalies initial CXR demonstrating air leak respiratory distress first occurring after 24 hours of life presumptive diagnosis of RDS as indicated by the need for FiO2 > 40%, severe retractions and grunting with poor air entry, and diffuse alveolar consolidation on chest radiograph | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 20.0-999.0, Chronic Myelogenous Leukemia Acute Lymphoblastic Leukemia Patients who complete CAMN107A1101 and obtained Informed concent by document None | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 16.0-60.0, Osteoarthritis Depression Hip Dysplasia Patients born from 01.01.1950, who are submitted fore primary THA or TKA on Hvidovre University Hospital, Frederiksberg University Hospital or Køge Hospital The patient has to be capable of understanding Danish The patient has to be mental well an capable of understanding the information The patient must not have other major diseases Terminal diseases Lack of ability to follow the department's standard procedures | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 50.0-90.0, Osteoporosis Age 50-90 years old Male or postmenopausal (women who have had no menses for one year) Degenerative joint disease of the hip (osteoarthritis) requiring total hip arthroplasty, based on radiologic and clinical impression Any contraindications to use of TPTD Age younger than 50, greater than 90 years old Metabolic bone disease other than osteoporosis History of hyperparathyroidism without surgical correction Unexplained hypercalcemia Paget's disease (or unexplained elevated bone alkaline phosphatase level) History of any metastatic cancer or osteosarcoma Prior radiation treatment Secondary hyperparathyroidism due to vitamin D deficiency or renal disease. Active hyperthyroidism or excessive thyroid hormone replacement (with TSH below normal range) | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Joint Pain Stiffness Joint pain or swelling for less than 3 months Be able to use the internet Non English speaking Diagnosis of rheumatoid arthritis | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-80.0, Osteoarthritis, Knee Participants with a primary unilateral total knee arthroplasty Age between 18 and 80 years Participants must understand and speak Danish Participants undergo surgery at Copenhagen University Hospital, Hvidovre, and live in the counties of Copenhagen, Brøndby or Hvidovre Disease/Musculoskeletal disorder, which requires special rehabilitation modality Alcohol and drug abuse Lack of wish to participate or unwillingness to sign an informed consent | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Inclusion Body Myopathy With Early-onset Paget Disease and Frontotemporal Dementia Paget Disease of Bone Frontotemporal Dementia Myopathy all individuals with a combination of medical problems including muscle and bone disease and their family members. Because historically VCP related muscle disease has been erroneously diagnosed with the following diagnoses, therefore if these patients also have a personal or family history of bone disease they will be considered eligible for the study: Muscle disorders considered Limb Girdle Muscular Dystrophy Myopathy body myopathy FSH (Facioscapular muscular dystrophy) without the mutation Scapuloperoneal muscular dystrophy Amyotrophic Lateral Sclerosis Non specific muscular dystrophy AND Bone disorders including Paget disease of bone Under the age of 18. Individuals who report a different unrelated diagnosis will be excluded from the study. Testing to confirm different diagnoses will not be performed, instead patient will be questioned for this information and records will be obtained for confirmation of appropriate testing. Those who are unable to provide consent for themselves will be excluded from participating in the study | 2 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 50.0-999.0, Osteoporosis Bone Diseases, Metabolic Hip Fractures STUDY GROUP For the respective groups, individuals need to be either: 1. Diagnosis of Osteoporosis or Osteopenia AND have received bisphosphonate therapy for at least 5 years 2. Diagnosis of Osteoporosis or Osteopenia AND have received bisphosphonate therapy for less than 1 year 3. Diagnosis of Osteoporosis or Osteopenia AND have received bisphosphonate therapy for 1 to 5 years 4. No Diagnosis of Osteoporosis or Osteopenia AND have never received bisphosphonate therapy In Common Will Be: 1. Age 50 or older 2. Ambulatory 3. Living independently STUDY GROUP Will Be: 1. Inability to provide informed consent 2. Cognitive Impairment (MCI/dementia) 3. Current diagnosis of cancer including: breast, prostate, lung, colon, stomach, bladder, uterus, rectum, thyroid, and kidney 4. Previous bilateral hip fractures 5. Pregnancy 6. Small bowel resections 7. Malabsorption 8. Paget s Disease of the Bone 9. Preexisting osteomalacia, active malignancy, prior bone metastasis, osteogenesis imperfecta, fibrous dysplasia, history of kidney failure STUDY GROUP: For the respective groups, individuals need to be either: 1. Diagnosis of atypical femur fracture within the past 10 years, regardless of bisphosphonate use. OR 2. Diagnosis of Osteoporosis or Osteopenia AND have received bisphosphonate therapy for at least 5 years without atypical femur fracture In Common Will Be: 1. Age 45 or older 2. Ambulatory 3. Living independently STUDY GROUP will be: 1. Inability to provide informed consent 2. Cognitive Impairment (MCI/dementia) 3. Current diagnosis of cancer including: breast, prostate, lung, colon, stomach, bladder, uterus, rectum, thyroid, and kidney 4. Pregnancy 5. Small bowel resections 6. Malabsorption 7. Paget s Disease of the Bone The following information pertains to individuals in the Longitudinal Group. Individuals who currently have thigh pain will not be excluded from this study. As the goal of this study is to correlate medication usage with a radiographic feature, individuals concurrently with thigh pain will still be considered, but we will take note of the duration of medication usage and the start of thigh pain per participant history. Duration of thigh pain prior to fracture will likewise be considered. If a current fracture is found on radiographs or suspicion is high for a fracture, selected participants will be sent for MRI of bilateral femurs and participant will be referred back to their primary provider for additional evaluation and treatment. Individuals who have previously had a unilateral hip fracture or arthroplasty will also not be excluded. As several previous studies have shown, bilateral fractures are not uncommon. We will continue to monitor the progress on the contralateral hip. We will query for details regarding history of first fracture and medication usage. These participants will be subanalyzed for medication usage and time between fractures. Individuals with bilateral (but not unilateral) fractures and bilateral arthroplasty initially will be excluded. However, individuals who are found to have unilateral or bilateral fractures during radiographic studies or undergo unilateral or bilateral arthroplasty during their three years of participation will be allowed to remain in the protocol, and we will assess for change in their anatomy. Individuals who are being treated with corticosteroids or other types of medications will not be excluded from this study. These variables will be considered confounders and will be analyzed by univariate analysis. Individuals with anatomical variations such as coxa vara or coxa valga will not be excluded. We will assume that they will be equally distributed into control and treatment groups. These individuals may be at higher risk for atypical fractures, and will be subanalyzed with appropriate femoral-angle matched controls. Controls that choose to begin bisphosphonate during the study will not be excluded from the study, but will be included in a subanalysis of individuals with less than 3 years of bisphosphonate exposure. Likewise, participants who choose to discontinue bisphosphonate usage will also not be dropped from the study. Analysis will be carried through with groups designated by intent to treat. Users who have taken the drug for 5 years and more who are currently on a drug holiday are eligible (because the drug stays in the bone for so long) | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-65.0, Bell's Palsy Patients who were diagnosed to have unilateral facial-nerve weakness without any identifiable causes within 168 hours after onset of symptoms; 2. aged 18 to 65 years ： 1. illiterate; 2. the facial paralysis is caused by herpes zoster; 3. recurrent facial paralysis; 4. noticeable asymmetry of the face before the illness which may affect the evaluation; 5. history of peptic ulcer disease, severe hypertension, uncontrolled diabetes, liver and kidney dysfunction, pregnancy, mental illness, or serious systemic diseases which may affect the treatment | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Acute Rheumatoid Arthritis Male or non-pregnant, non-lactating female patients of any race with an age >18 years. Woman of child-bearing potential must be on regular contraceptives throughout the trial (Pregnancy tests). 1A: RA according to the 1987 revised ARA (Arnett 1987) with an active disease with DAS28>3.2 despite the prior or concurrent use of DMARDs. 2. Patients may be on no active therapy or may be on continuous DMARD therapy including Methotrexate, Sulphasalazine, Leflunomide, Hydroxychloroquine, Myocrisin alone or in combination, or on NSAID treatment, or on steroid (prednisolone not more than 10mg/day). 3. Patients must have a measurable acute phase response: CRP (> 10mg/dl), ESR > 25. (to be measured on routine lab range CRP/ ESR/AP/ standard biochemistry) 4. Patients eligible for treatment with biological TNFα blockers and who are awaiting the administration of such treatment may enroll in the laboratory and safety protocols Data for Clinical Phase observations will be collected but will be handled as last observation carried forward for the final records prior to the administration of TNF blocking agent, should that occur within the 3-month Clinical Phase. The administration of TNFα blockers will not be delayed for the protocol. 5. Patients who have given written informed consent prior to participation in the trial and who undertake to comply with the protocol Patients who are unwilling or unable to be fully evaluated for follow-up. 2. Patients who have an active infection or who are suspected of having systemic infection and or patients that are treated with antibiotics. 3. Patients whose screening blood do not reflect a sufficient cytokine or acute phase response. 4. Patients who have evidence of significant hepatic disease, including history of clinical signs or laboratory values of total bilirubin > 34.2 umol/L (> 2.0 mg/dL), ALT (>120) or AST (>135) corresponding to > 3X upper limit of normal. 5. Alkaline phosphatase levels must be less 145 IU/L (routine clinical method) 6. Patients who received investigational drugs in the 30 days prior to study drug administration, or are currently participating in a study during which the administration of investigational drugs within one month is anticipated. 7. Patients who have renal insufficiency (history of creatinine >177umol/L or >2.0 mg/dL) or chronic renal failure requiring dialysis. 8. Patients with severe neurological deficits (see Appendix I). 9. Patients who have a recent history of drug substance or alcohol abuse. 10. Patients with a diagnosis of idiopathic thrombocytopenia. 11. Patients with a history of cancer who have received chemotherapy or radiation therapy within the past 3 months. Patients receiving only adjuvant hormonal therapy are not excluded. If the cancer has not resolved completely, the patient should not be enrolled without permission of Alloksys. 12. Patients receiving oral glucocorticoids >10mg /day or any IV, IM or Intra articular dosing within 30 days of commencing the protocol. 13. Patients who are vegetarians or veganists or those patients that may be expected not to be tolerant to bovine proteins, or not to wish exposure to bovine proteins for personal reasons. 14. Patients who are, in the opinion of the Investigator or the Sponsor, unsuitable for the study | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-60.0, Fatigue Healthy males who are trained cyclists with a maximal oxygen uptake relative to body weight equal to or greater than 45 ml O2/kg/min Subjects must be in the competitive phase of their annual training cycle Between ages of 18-60 Availability commitment of the subject/expected participation in the study for 97 days Specific allergy to milk proteins (this is different from lactose intolerance) Use of immunosuppressive medication in the case of organ transplants Planned surgeries Kidney disorders Use of antihypertensive medications Cardiovascular disease Abnormal BUN, creatinine, hemoglobin, or hematocrit Body weight greater than 285 pounds A protein-restricted diet Subjects currently using dry whey protein supplements, N-acetylcysteine, or alpha-lipoic acid supplements. The wash-out period is 1 month for any of these supplements | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-70.0, Osteoarthritis Diagnosed with mild to moderate osteoarthritis based on Kellgren-Lawrence radiographic classification Has a history of joint swelling, pain, stiffness, altered gait and loss of motion due to degenerative cartilage Has systemic bone or cartilage disorders Has significant vascular impairment proximal to implant site Has substantial joint destabilization including extensive osteophyte formation Has substantial surface erosion of the weight-bearing articular cartilage Evidence of infection or fractures in or around the joint Contraindication to bone marrow aspiration Any acute or chronic communicable diseases including Hepatitis B, Hepatitis C and HIV Any past history of neoplasia and primary hematological disease Renal impairment indicated by serum creatinine greater than 200mM Liver impairment indicated by serum aspartate transaminase and serum alanine transaminase greater than 120 IU | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Postoperative Thromboembolism Patients who have requested tumescent liposuction Healthy adults ASA Class I, II, or III Known allergy to lidocaine younger than 18 years Positive serology for Hepatitis C, HIV Chronic fatigue Syndrome known bleeding disorder significant psychiatric problems History of seizures Clinically significant cardiac arrhythmia Conditions predisposing to surgical site infections Active bacterial infection | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-49.0, Endometriosis Women 18 years of age or older Women of reproductive age (less than 50 years) undergoing diagnostic laparoscopy for suspected endometriosis Willingness to provide informed consent Pregnancy General health issues that the physician determines would make laparoscopy unsafe | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Post-Extraction Sockets Healing subjects of both genders and ≥ 18 years old Indication of a simple one molar extraction in the mandible Possibility of observation during the follow-up period Unerupted third molars or with horizontal inclination Severe swelling prior to surgery in the areas designated for extraction Suffering an alteration or a serious hematologic disease Be currently undergoing or have received radiotherapy, chemotherapy or immunosuppressive therapy, corticosteroids and/or anticoagulants 30 days prior to In regular treatment with NSAIDs or other anti-inflammatory drugs History of chronic hepatitis or cirrhosis Diabetes mellitus with poor metabolic control (glycosylated hemoglobin >9%) Patients undergoing dialysis Presence of malignant tumors, hemangiomas or angiomas in the extraction area History of ischemic heart disease in the last year | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Blood Loss Elective bilateral knee arthroplasty Must speak and understand Danish Musk be able to gave oral and written consent Females must be post-menopausal, and last menstruation must be minimum of one year ago Alcohol or medicine abuse Treatment with opioids Allergy to local anaesthetics Allergy to active substances i fibrin sealant Age below 18 | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Primary Biliary Cirrhosis Definite or probable PBC diagnosis (consistent with American Association for the Study of Liver Disease [AASLD] and European Association for Study of the Liver [EASL] Practice Guidelines; [Lindor 2009; EASL 2009]), as demonstrated by the presence of ≥ 2 of the following 3 diagnostic factors History of elevated alkaline phosphatase (ALP) levels for at least 6 months Positive antimitochondrial antibodies (AMA) titer or if AMA negative or in low titer (<1:80) PBC specific antibodies (anti-GP210 and/or anti-SP100 and/or antibodies against the major M2 components (pyruvate dehydrogenase complex-E2 [PDC-E2], 2-oxo-glutaric acid dehydrogenase complex) Liver biopsy consistent with PBC 2. At least 1 of the following qualifying biochemistry values ALP ≥ 1.67x upper limit of normal (ULN) Total bilirubin > ULN but < 2x ULN 3. Age ≥ 18 years 4. Taking ursodeoxycholic acid (UDCA) for at least 12 months (stable dose for ≥ 3 months) prior to Day 0, or unable to tolerate UDCA (no UDCA for ≥ 3 months) prior to Day 0. 5. Contraception: Female participants must be postmenopausal, surgically sterile, or if premenopausal, be prepared to use ≥ 1 effective (≤ 1% failure rate) method of contraception during the trial and for 30 days after the end of treatment (EOT) visit. Effective methods of contraception are considered to be Hormonal (for example, contraceptive pill, patch, intramuscular implant or injection); or Double barrier method, that is, (a) condom (male or female) or (b) diaphragm, with spermicide; or Intrauterine device (IUD); or Vasectomy (partner); or History or presence of other concomitant liver diseases including Hepatitis C virus (HCV) infection; participants with active hepatitis B (HBV) infection will be excluded, however, participants who have seroconverted (hepatitis B surface antigen [Hbs Ag] and hepatitis B e antigen [Hbe Ag] negative) may be included after consultation with the medical monitor Primary sclerosing cholangitis (PSC) Alcoholic liver disease Definite autoimmune liver disease or overlap hepatitis Nonalcoholic steatohepatitis (NASH) Gilbert's Syndrome (due to interpretability of bilirubin levels) 2. Presence of clinical complications of PBC or clinically significant hepatic decompensation, including History of liver transplantation, current placement on a liver transplant list or current Model for End Stage Liver Disease (MELD) score ≥ 15 Portal hypertension with complications, including: known gastric or large esophageal varices, poorly controlled or diuretic resistant ascites, history of variceal bleeds or related therapeutic or prophylactic interventions (for example, beta blockers, insertion of variceal bands or transjugular intrahepatic portosystemic shunt [TIPS]), or hepatic encephalopathy Cirrhosis with complications, including history or presence of: spontaneous bacterial peritonitis, hepatocellular carcinoma, bilirubin > 2x ULN | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-90.0, Osteoarthritis of the Knee clinical diagnosis og osteoarthritis of the knee patients must be 18 years or older patients must understand and speak danish must be able to give signed consent severe medical illness documented osteoporosis rheumatoid arthritis prior surgery in the knee neuropathy | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 25.0-999.0, Periodontal Disease General To be eligible to participate in this study, a subject must meet all of the following 1. Ability to understand, and willingness and ability to read and sign, the informed consent form. 2. Age of at least 25 years. 3. Ability to understand and follow directions for study procedures. 4. Minimum of 20 natural teeth, excluding third molar teeth; at least 12 of these teeth must be pre-molars, first molars, or second molars. 5. Willingness not to have professional dental prophylaxis or scaling for the duration of the disease progression and monitoring phase (12 months). 6. Willingness to comply with all study procedures and be available for the duration of the study. 7. For women with reproductive potential, willingness to use highly effective contraception (e.g., licensed hormonal contraception, intrauterine device, abstinence, or vasectomy in partner). Specific Healthy periodontal subjects must have: 1. Any tooth with 3 mm or less PD, irrespective of the attachment level, will be acceptable 2. No teeth with PD of 4 mm or more and concomitant attachment loss, with the exception of the distal of the second molars where a PD of 4 mm and concomitant CAL of up to 2 mm will be acceptable. 3. No radiographic evidence of alveolar bone loss (defined as a distance of greater than 2.0 mm measured radiographically from the CEJ to the crest of the alveolar bone); with the exception of the mandibular incisors where up to 3.0 mm of alveolar bone loss measured radiographically from the CEJ to the crest of the alveolar bone will be accepted. Mild periodontal disease subject: periodontal loss must meet the following and must not meet the minimum for severe periodontal loss: 1. At least 4 teeth with at least 1 site of PD of 5 mm or more and concomitant CAL greater than or equal to 2 mm, and radiographic evidence of mesial or distal alveolar bone loss around at least 2 of the affected teeth. Alveolar bone loss is defined as a distance of > 2.0 mm measured radiographically from the CEJ to the crest of the alveolar bone. Subjects with severe periodontal loss must meet all of the following 1. At least 8 separate teeth with at least 1 site of PD of 5 mm or more and concomitant CAL greater than or equal to 3 mm, and radiographic evidence of mesial or distal alveolar bone loss around at least 2 of the affected teeth. Alveolar bone loss is defined as a distance of > 2.0 mm measured radiographically from the CEJ to the crest of the alveolar bone Presence of orthodontic appliances. 2. The following conditions noted on oral examination Oral lichen planus Candidiasis Clinical leukoplakia Clinical erythroplakia Pemphigus Pemphigoid Other recurrent intraoral or perioral vesiculobullous diseases Aphthous ulcerations (major or minor). Subjects presenting with aphthous ulcers should be rescreened after 2 weeks. They will be eligible if the ulcers have healed and the subject does not have a history of frequent recurrences Herpetic lesions. Subjects presenting with herpes labialis or intraoral herpes should be rescreened after 2 weeks. They will be eligible if the lesions have healed and the subject does not have a history of frequent recurrences. j. Traumatic ulcers. If a subject presents with a traumatic ulcer, he/she can be rescreened in 2-3 weeks. The subject will be eligible if the ulcers have healed. 3. Acute necrotizing ulcerative gingivitis or gross tooth decay, as determined by the investigator. 4. Root fragments, pericoronitis, endo-perio lesions, or other dental abscesses. Subjects may be rescreened after resolution of these dental conditions. 5. Pregnancy or lactation. 6. Requirement for prophylactic antibiotics for dental procedures (e.g., for certain heart and orthopaedic conditions*). 7. Periodontal or systemic antibiotic therapy in the previous 6 months. Routine dental prophylaxis will be allowed. 8. Use of cigarettes or other tobacco products within 1 year before the screening visit. 9. Any medical condition that might influence the course of periodontal disease or treatment (e.g., diabetes [irrespective of level of control], human immunodeficiency virus infection or acquired immunodeficiency syndrome, use of medications associated with gingival hyperplasia). 10. Chronic use of nonsteroidal anti-inflammatory drugs (e.g., for arthritis), defined as the need, or anticipated need, for over 3 weeks of continuous use at the time of enrollment or during the course of the study. The use of low-dose aspirin (81 mg/day) for prophylaxis will be allowed. 11. Current or anticipated use of chronic systemic corticosteroids, cyclosporine, or other systemic immunosuppressive agent. The use of inhaled corticosteroids will be allowed. 12. Hypersensitivity to tetracyclines (e.g., tetracycline, doxycycline, minocycline). 13. Participation in a clinical study testing a drug, biologic, device, or other intervention within the last 30 days. 14. Any condition or circumstance that, in the opinion of the investigator, would place the subject at increased risk or preclude his/her full compliance with or completion of the study | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-30.0, Schistosomiasis Bilharziasis Urinary Schistosomiasis All subjects had to meet the study within 21 days prior to treatment Caucasian volunteers No smoker biological parameters (haematological, biochemical, renal and hepatic) in normal range Health Insurance sign inform consent inflammatory or immunological pathology such as atopic diseases, evidence of inflammation or acute infection (including positive serology to viral hepatitis B and C or HIV) any immunological deficiency any clinically relevant alcohol or drug use (cannabis, opiates, cocaine, amphetamines, benzodiazepines, nicotine, barbiturates, meprobamate or antidepressant drugs according to urine drug and metabolites screen) current immunosuppressor treatment any other medication use within 2 weeks before the study any vaccination within the last 6 months no antibodies against Sh28GST protein | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-80.0, Genetic Hemochromatosis Patients between 18 and 80 years C282 homozygosity corticosteroids during the last 3 months following treatments during the last 6 months : anabolic steroids, growth hormone, hormone therapy for menopause, tibolone, raloxifene following treatments during or in the last 6 month : teriparatide, parathormone, fluor, strontium ranelate, biphosphonate cancer or evolutionary hemopathy (including monoclonal gammopathy) pregnancy at time treated osteoporosis patient in wich follow up seems hard in another study incompatible with this one | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 50.0-80.0, Forearm Fracture written acceptance to participate in the study immobilisation or reposition or surgery demanding Colles fracture (which needs to be fixed with external fixation) age younger than 50 years or older than 80 years treatment with prednisolon NSAIDs treatment previous fracture or surgery at the wrist lack of mental and physical capacity to follow studies' instructions lack of informed consent other diseases can affect bone substance (oncology, endocrine diseases) medical contraindications to NSAIDs use | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 7.0-999.0, Immunosuppression Periodontal Disease Healthy Subjects Healthy Volunteer Patients with Genetic Immune Defects: -Patients with an established monogenic immune defect will be eligible for screening under this protocol Diagnosis of monogenic immune defect Greater than or equal to 7 years old Severe Periodontitis of Suspected Genetic Etiology and Family Members History of severe periodontitis prior to age <30 Willing to allow genetic testing Greater than or equal to 7 years old In good general health Healthy Volunteer Subjects In good general health Greater than or equal to 18 years old Willing to allow genetic testing All Subjects History of Hepatitis B or C History of HIV Prior radiation therapy to the head or neck Have an active malignancy except localized basal or squamous cell carcinoma of the skin Have been treated with systemic chemotherapeutics or radiation therapy within 5 years of screening Pregnant or lactating If participation in the protocol would not be safe or in the subject s best interest in the opinion of either the PI or the primary medical team. Additional Exclusions for Healthy Volunteers Diagnosis of diabetes and/or HbA1C level >6% More than 3 hospitalizations in the last 3years | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 0.0-2.0, Hydronephrosis Kidney Swelling Children 2 years of age and younger Diagnosed with hydronephrosis and scheduled for an ultrasound scan Healthy subjects | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 50.0-90.0, Alzheimer's Disease Mild Cognitive Impairment Frontotemporal Dementia years of age or older (50 years of age or older for frontotemporal dementia patients) Normal memory, mild cognitive impairment (memory loss that does not significantly affect normal daily activities), or clinical diagnosis of Alzheimer's disease or frontotemporal dementia (includes primary progressive aphasia) Right-handed General good physical health History of stroke or neurological disease (other than Alzheimer's disease or frontotemporal dementia) Seizures or head injury with loss of consciousness within the last five years Ferrous (magnetic) or electronic implants (due to the magnet in the MRI scanner) Claustrophobia | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 21.0-70.0, Nasal Polyps The subject must fulfill all of the following conditions or characteristics to be considered for enrollment: 1. Male or female between ages 21 years residing in the Boston area 2. History of chronic rhinosinusitis (symptoms for at least 3 months). Subject must have two or more of the following Facial pain/pressure or headache Nasal congestion Anterior or posterior nasal drainage Hyposmia/anosmia 3. Abnormal CT scan in at least 2 sinuses areas within 3 months 4. Evidence of bilateral polyps or polypoid mucosa (on nasal endoscopy) with minimum polyp/polypoid score of 4 (see scoring system below) History of suggestive of immunodeficiency (i.e. those who have had > one pneumonia in the past 12 months or those with known immune deficiency). 5. History of cystic fibrosis, Kartagener's syndrome, immotile cilia syndrome, hypogammaglobulinemia or bleeding disorder 6. URI within six weeks prior to enrollment 7. Intranasal cocaine use 8. Pregnancy (if applicable 9. History of fainting prior to NP biopsies: 10. Use of prescription blood thinners 11. Use of systemic glucocorticoids for two weeks prior to enrollment 12. Use of intranasal corticosteroids and anticholinergics for three days prior to enrollment 13. Use of an antibiotic for three days prior to enrollment 14. Use of antihistamines for one week prior to enrollment | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-70.0, Hereditary Inclusion Body Myopathy (HIBM) GNE Myopathy Subject is 18-70 years, either gender, inclusive Subject has a diagnosis of HIBM (or IBM2, GNE myopathy, DMRV or Nonaka myopathy) based upon a consistent clinical course and identification of 2 GNE mutations. Molecular confirmation of the diagnosis will be obtained for all subjects in the study Subject must be willing to stop any treatment with ManNAc, sialic acid, IVIG, and/or other supplements containing sialic acid (eg, St John s wort, sialyllactose) 30 days prior to randomization and remain off such treatment for the duration of the trial Subject has the ability to travel to the NIH Clinical Center (CC) for admissions Subject (if a woman of reproductive age) must be willing to use an effective method of contraception for the duration of the trial Subject provides written informed consent Subject has a severe disease manifestation that would interfere with the ability to comply with the requirements of this protocol Subject has a psychiatric illness or neurological disease that would interfere with the ability to comply with the requirements of this protocol. This includes, but is not limited to, uncontrolled/untreated psychotic depression, bipolar disorder, schizophrenia, substance abuse or dependence, antisocial personality disorder, or panic disorder Subject has hepatic laboratory parameters (AST, ALT, GGTP), or renal laboratory parameters (creatinine, BUN) greater than 3 times the upper limit of normal Subject has a QTcB >450 msec (males) or QTcB >470 msec (females) Subject is anemic (defined as two standard deviations below normal for age and gender) Subject shows evidence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, metabolic, or gastrointestinal disease, or has a condition that requires immediate surgical intervention Subject is pregnant or breastfeeding at any time during the study Subject has received treatment with another investigational drug, investigational device, or approved therapy for investigational use within 4 weeks of initial screening Subject has a hypersensitivity to ManNAc or in the judgment of the investigator, has a condition that places the subject at increased risk for adverse effects | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 0.0-999.0, End Stage Renal Failure on Dialysis Periodontitis Chronic Kidney Disease patients, who are receiving hemodialysis therapy for >3 months. of all ages and both gender and are able to give informed consent. 2. Have at least 14 teeth (excluding third molars) in oral cavity shall be included in study Patients have had periodontal therapy <1 year. 2. Diabetes Mellitus 3. Liver disease | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 0.083-83.0, Suppurative Osteomyelitis of Jaw Potential Abnormality of Glucose Tolerance The diagnosis on admission was made on the basis of the presence of sequestra and laminations of periosteal new bone in the pathological area The other diagnostic is that symptoms such as local pain, pyorrhea, fever, swelling, fistula, neuropalsy, odontoseisis, lymphadenopathy, bromopnea, and trismus pain are unresponsive or insensitive to conservative therapy and simple debridement Patients without confirmed evidence of CSOJ and (or) without standard treatment (a combination of antimicrobial therapy and surgery consisting of incision and drainage, debridement or sequestrectomy) were excluded Paget's disease, hypercementosis, fibrous dysplasia, and early stage malignant bone tumor were differentially diagnosed and excluded | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 0.0-85.0, Post Menopausal Osteoporosis Postmenopausal woman, less than 85 years old BMD T-score ≤-2.5 of spine or hip (femoral neck) or ≤-2.0 with previous fracture (within 5 years) Normal physical exam, vital signs, electrocardiogram (ECG), and medical history Laboratory tests within the normal range, including serum calcium, Vitamin D, parathyroid hormone (PTH) (1-84), serum phosphorus, and alkaline phosphatase BMD T-score ≤-5.0 at the lumbar spine or hip History of bone disorders (for example, Paget's disease) other than postmenopausal osteoporosis Significantly impaired renal function History of any cancer | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Prostate Cancer Histologically confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) Metastatic disease as evidenced by the presence of soft tissue and/or bone metastases on imaging studies (computed tomography [CT] of abdomen/pelvis, bone scintigraphy) Castrate-resistant disease, defined as follows All patients must have received standard of care androgen deprivation treatment before trial entry (surgical castration versus gonadotropin-releasing hormone [GnRH] analogue or antagonist treatment), and subjects receiving GnRH analogue or antagonist must continue this treatment throughout the time on this study Patients may have been treated previously with a nonsteroidal antiandrogen, with evidence of disease progression subsequently; subjects must be off use of anti-androgen for at least 4 weeks (for flutamide) or 6 weeks (for bicalutamide or nilutamide) prior to registration ** Subjects who demonstrate an anti-androgen withdrawal response, defined as a >= 25% decline in PSA within 4-6 week of stopping a nonsteroidal antiandrogen are not eligible until the PSA rises above the nadir observed after antiandrogen withdrawal Castration levels of testosterone (< 50 ng/dL) within 2 weeks of registration Progressive disease while receiving androgen deprivation therapy defined by any one of the following as per the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) bone scan or Response Evaluation in Solid Tumors (RECIST) 1.1 during or after completing last therapy PSA: at least two consecutive rises in serum PSA, obtained at a minimum of 1-week intervals, and each value >= 2.0 ng/mL Measurable disease: >= 50% increase in the sum of the cross products of all measurable lesions or the development of new measurable lesions; the short axis of a target lymph node must be at least 15 mm by spiral CT to be considered a target lesion Non-measurable (bone) disease: the appearance of two or more new areas of uptake on bone scan consistent with metastatic disease compared to previous imaging during castration therapy; the increased uptake of pre-existing lesions on bone scan will not be taken to constitute progression, and ambiguous results must be confirmed by other imaging modalities (e.g. X-ray, CT or magnetic resonance imaging [MRI]) Small cell or other variant prostate cancer histology Patients may not be receiving other investigational agents or be receiving concurrent anticancer therapy other than androgen deprivation Symptomatic metastatic disease, as defined by the need for opioid analgesics for the treatment of pain attributed to a prostate cancer metastatic lesion; patients receiving opioids must receive approval from the principal investigator (PI) for Patients may not have been treated with prior sipuleucel-T Treatment with any of the following medications within 28 days of registration, or while on study, is prohibited Systemic corticosteroids (at doses over the equivalent of 1 mg prednisone daily); inhaled, intranasal or topical corticosteroids are acceptable Prostate cancer (PC)-SPES Saw palmetto Megestrol Ketoconazole | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-75.0, Blood Loss, Surgical a) Burn injury requiring debridement and grafting between 5-30% TBSA Head and neck, hand, foot, or genital burns 2. On anticoagulants (except NSAIDs) 3. On monoamine oxidase inhibitor or tricyclic antidepressant 4. Coronary or peripheral vascular disease 5. History of arrhythmias 6. On a Beta-blocker 7. History of vascular abnormality 8. Hypertension | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 50.0-75.0, Headache Volunteers suffering from frequent intermittent headache (either migraine, tension-type headache or cervicogenic headache) at least one per month over a period of 3 months or longer Aged 50 years or older, female or male A score of ≥ 3/10 on visual analogue scale (VAS) of neck pain Evidence of cervical musculoskeletal impairment: restriction in active range of cervical motion in extension and rotation and join tenderness in at least one of the upper joint as detected by manual palpation Headache diagnosed as following: temporal arteritis, trigeminal neuralgia, cluster headache, chronic paroxysmal hemicrania/hemicranias continua, temporomandibular joint dysfunction Other diagnosed disorders: cerebrovascular disease, Parkinson disease, cognitive disturbance Previous history of head or neck surgery Lack of willingness to receive either pragmatic treatment or usual care Physiotherapy or chiropractic treatment for headache in previous 6 months | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 20.0-999.0, Pancreatitis, Chronic Autoimmune Disease Typical CT findings (diffuse sausage-like pancreatic swelling or multifocal pancreatic swelling with or without peripancreatic rim, multifocal biliary stricture, renal lesion, or retroperitoneal fibrosis) Serum level of immunoglobulin G fraction 4 > 135mg/dL Patients under 20 years of age Women who are pregnant, lactating or who are of childbearing potential Patients with any physical or mental status that interferes with the signing of informed consent Patients with a contraindication for MRP or ERP examination | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Breast Cancer Bone Metastasis Pain The patient must be 18 years of age or older 2. The patient must have histologically proven breast adenocarcinoma 3. Radiographic evidence of bone metastasis is required .Acceptable studies plain radiographs, radionuclide bone scans, computed tomography scans and magnetic resonance imaging 4. The patient must have pain that appears to be related to the radiographically documented metastasis 5. Patients receiving systemic therapy with Capecitabine to metastatic disease (according to health basket) 6. Patients must have an estimated life expectancy of 3 months or greater 7. Patients will be eligible for treatment of multiple metastases only if these can be included in no more than two treatment sites 8. Signed study specific informed consent 9. Karnofsky Performance Status > 40 10. Calculated Creatinine Clearance > 50 ml/min 11. ALT and AST no greater than 3 5 times the institutional normal; bilirubin and serum creatinine no greater than 1.5 times normal; ANC greater than 1500, and platelets at least 100,00 Prior radiation therapy or prior palliative surgery to the painful site 2. Impending fracture of the treatment site or planned surgical fixation of the bone 3. Patients with clinical or radiographic evidence of spinal cord or cauda equina compression 4. Patients receiving systemic radionuclides (strontium, samarium, etc.) within 60 days prior to registration | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Fibrous Dysplasia of Bone fibrous dysplasia of bone previously treated with IV bisphosphonates persistent bone pain and increased bone remodeling Chronic renal failure serious infectious diseases liver enzymes abnormality pregnancy dyslipidemia | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-75.0, Cluster Headache Is between the ages of 18 and 75 years. 2. Has been diagnosed with cluster headache, in accordance with the ICHD-2 Classification (2ndEd): o At least 5 attacks fulfilling the following Severe or very severe unilateral orbital, supraorbital and/or temporal pain lasting 15-180 minutes if untreated Headache is accompanied by at least 1 of the following Ipsilateral conjunctival injection and/or lacrimation Ipsilateral nasal congestion and/or rhinorrhea Ipsilateral eyelid edema Ipsilateral forehead and facial sweating Ipsilateral miosis and/or ptosis A sense of restlessness or agitation 3. currently experiencing cluster headaches, and from clinical history is expected to continue experiencing cluster headaches for a period of at least 4 weeks. 4. able to distinguish CH from other headaches (i.e. migraine, tension-type headaches). 5. capable of completing headache pain self-assessments. 6. [Intentionally left blank]. 7. Agrees to use the GammaCore device as intended and follow all of the requirements of the study, including follow-up visit requirements. 8. Agrees to record usage of the GammaCore device, all required study data, and report any adverse device effects to the study center within 24 hours of any such adverse device effects. 9. able to provide written Informed Consent had surgery to treat cluster headache. 2. currently taking prophylactic medication (including chronic opioids and non-prescribed street drugs) for indications other than CH that in the opinion of the clinician may interfere with the study. 3. [Intentionally left blank]. 4. undergone botulinum toxin injections in the head and/or neck in the last 3 months or nerve blocks (occipital or other) in the head or neck in the last month. 5. history of aneurysm, intracranial hemorrhage, brain tumors or significant head trauma. 6. lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal anatomy at the treatment site. 7. structural intracranial, or cervical vascular lesions that may potentially cause headache attacks. 8. other significant pain problem (including cancer pain, fibromyalgia, and trigeminal neuralgia/TAC-cluster) that might confound the study assessments. 9. known or suspected severe atherosclerotic cardiovascular disease, severe carotid artery disease (e.g. bruits or history of TIA or CVA), congestive heart failure (CHF), known severe coronary artery disease or recent myocardial infarction. 10. history of prolonged QT interval or a history of clinically significant arrhythmia. 11. abnormal baseline ECG (e.g. second and third degree heart block, atrial fibrillation, atrial flutter, recent history of ventricular tachycardia or ventricular fibrillation, or clinically significant premature ventricular contraction). 12. previous bilateral or right cervical vagotomy. 13. uncontrolled high blood pressure. 14. currently implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant. 15. history of carotid endarterectomy or vascular neck surgery on the right side. 16. implanted with metal cervical spine hardware or has a metallic implant near the GammaCore stimulation site. 17. recent or repeated history of syncope. 18. recent or repeated history of seizure. 19. known history or suspicion of substance abuse or addiction, or overuse of acute headache medication for headaches other than CH. 20. psychiatric or cognitive disorder and/or behavioral problems which in the opinion of the clinician may interfere with the study. 21. pregnant, nursing, thinking of becoming pregnant in the next 4 months, or of childbearing years and is unwilling to use an accepted form of birth control. 22. participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days. 23. Belongs to a vulnerable population or has any condition such that his or her ability to provide informed consent, comply with follow-up requirements, or provide self-assessments is compromised | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Adenocarcinoma of the Prostate Bone Metastases Hormone-resistant Prostate Cancer Recurrent Prostate Cancer Soft Tissue Metastases Stage IV Prostate Cancer Histologically documented adenocarcinoma of the prostate Life expectancy of >= 6 months, Eastern Cooperative Oncology Group (ECOG) performance status =< 2 Metastatic disease as evidenced by soft tissue and/or bony metastases on baseline bone scan and/or computed tomography (CT) scan or magnetic resonance imaging (MRI) of the abdomen or pelvis Castration resistant prostatic adenocarcinoma; subjects must have current or historical evidence of disease progression despite castrated level of testosterone (< 50 ng/dL) achieved by orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist or antagonist therapy; disease progression has to be demonstrated by PSA progression OR progression of measurable disease OR progression of non-measurable disease as defined below PSA: Two consecutive rising PSA values, at least 7 days apart Measurable disease: >= 20% increase in the sum of the longest diameters of all measurable lesions or the development of any new lesions; the change will be measured against the best response to castration therapy or against the pre-castration measurements if there was no response Non-measurable disease Soft tissue disease: The appearance of 1 or more lesions, and/or unequivocal worsening of non-measurable disease when compared to imaging studies acquired during castration therapy or against the pre-castration studies if there was no response Bone disease: Appearance of 2 or more new areas of abnormal uptake on bone scan when compared to imaging studies acquired during castration therapy or against the pre-castration studies if there was no response; increased uptake of pre-existing lesions on bone scan does not constitute progression White blood cell (WBC) >= 2,500 cells/uL The presence of liver, or known brain metastases, malignant pleural effusions, or malignant ascites Moderate or severe symptomatic metastatic disease, defined as a requirement for treatment with opioid analgesics for cancer-related pain within 21 days prior to registration Eastern Cooperative Oncology Group (ECOG) performance status > 2 Treatment with chemotherapy within 3 months of registration Treatment with any of the following medications or interventions within 28 days of registration Systematic corticosteroids; use of inhaled, intranasal, and topical steroids is acceptable Any other systemic therapy for prostate cancer (except for medical castration) History of external beam radiation therapy to metastatic sites within 1 year of enrollment to the study Participation in any previous study involving sipuleucel-T Pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography > 50%) or spinal cord compression | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Leukemia, Myeloid, Chronic, BCR-ABL Positive CML patients with failure or suboptimal response to imatinib therapy according to established by the European Leukemia Net (ELN) Patients with grade II or higher adverse events CML patients not suitable for stem cell transplantation Patients in blast crisis Pregnant women Patients without a contraception method | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 21.0-80.0, All Type of Cancers With Bony Metastasis Histologically or clinically confirmed solid tumor metastasis with index lesion involving or abutting bone. *Index lesion means an irradiated field covered lesions contoured from CT-Simulation which may generally less than 20cm, 4-5 vertebra bodies, sacrum plus adjacent iliac lesions or a segment of femerol bone. Each patient can only have one index lesion for this study Index lesion with bone destruction either osteolytic or osteoblastic in nature as assessed on CT or MRI imaging If the nature of the metastatic disease has been previously documented, the index lesion to be treated does not require further documentation (i.e., biopsy) ≥ One primary painful metastatic site. The most painful site that need treatment first will be elected as index lesion site for evaluation of response. Additional less painful metastatic sites may be present. Patients who elect to have another course of RT treatment on different metastatic sites after the initial treatment are allowed Worst pain in the last 24 hours must be ≥ 4 on a 0-10 numeric scale Index lesion causing clinical or radiographic evidence of partial spinal cord or cauda equina compression/effacement is allowed Have developed pain or have persistent pain while on a stable chemotherapy, hormonal therapy, target therapy or bisphosphonate therapy regimen is allowed. There will be no change of chemotherapy, hormonal therapy, or bisphosphonate therapy for 4 weeks before and after radiotherapy ECOG performance status 0-3 Life expectancy ≥ 3 months Patients with impending fracture of weight bearing bone or patients with symptoms of spinal cord compression should have surgical opinion before the start of radiotherapy. Patient should not be able to be enrolled in this study if surgery is scheduled Index lesion involves the skull Index lesion has evidence of a pathologic fracture, impending fracture need immediate surgery are not eligible. Those patients had received decompression surgery are not eligible Has undergone prior radiotherapy at the index lesion Those who chemotherapy or systemic treatment will be changed during study period Patients had history of metal implant inside or outside irradiation field are not eligible Patients had history of pacemaker insertion due to arrhythmia are not eligible | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, NSCLC Age>18 years old Cytologically or histologically documented NSCLC PS 0-2 (WHO scale) Measurable disease according to Response Evaluation in Solid Tumors (at least one measurable lesion) Documented disease progression to previous treatment with docetaxel regimen in 1st or 2nd line setting assessed by Response Evaluation in Solid Tumors with at least one visceral or soft-tissue metastatic lesion Brain metastases are allowed, given that are clinically stable and the patient does not present neurologic symptoms Previous radiotherapy, either in the adjuvant setting or for the treatment of bone metastases, is allowed provided that the measurable lesions are outside the radiation fields. Patients who were irradiated to ≥ 40% of bone marrow are not eligible for the study Patients must have a recent (within 7 days prior to treatment start) biochemical and hematogical assessment as defined by adequate bone marrow (absolute neutrophil count ≥1.5 x 109 cells/L, platelets ≥100 x 109cells/L and hemoglobin ≥9 g/dL), liver (AST & ALT ≤ 2.5x ULN, total bilirubin within normal range) and renal (serum creatinine < 1.5 x ULN). If creatinine 1.0 5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance <60 mL/min should be excluded) function tests Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule Persistence of clinically relevant treatment-related toxicities from previous chemotherapy or radiotherapy Treatment with other investigational drugs or treatment in another clinical trial within the past four weeks before start of treatment or concomitantly with this trial Other malignancy within the past five years other than basal cell skin cancer or carcinoma in situ of the cervix Patient with reproductive potential not implementing accepted and effective method of contraception History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs or to docetaxel Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus, hypertension, heart failure ≤ NYHA II, history of myocardial infarction within the past 6 months, angina, chronic obstructive pulmonary disease (COPD), serious infections requiring systemic antibiotic therapy (e.g. antimicrobial, antifungal, antiviral) Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments) (see Appendix A and B) Prior surgery, radiation, chemotherapy, within 4 weeks prior to treatment Active grade ≥2 peripheral neuropathy Active grade ≥2 stomatitis | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-65.0, Multiple Myeloma Man or woman aged 18 to 65 years old; 2. Subjects are newly diagnosed MM patients which are scheduled by the investigators to be treated with vincristine, adriamycin and dexamethasone standard therapy. Stage II/III (according to Durie and Salmon criteria) with skeletal involvement, such as bone pain, bone lytic lesions, diffuse osteoporosis or pathologic fractures; 3. Life expectancy > 3 months; 4. Patient has measurable disease in which to capture response, defined as one or more of the following Serum M-protein level >10.0 g/L measured by serum protein electrophoresis or immunoglobulin electrophoresis; or Urinary M-protein excretion > 1 g/24 hours; or Bone marrow plasmacytosis of > 30% by bone marrow aspirate and/or biopsy; or Serum free light chains (by the Freelite test) > 2 X the upper limit of normal (ULN), in the absence of renal failure. 5. Performance status (PS) of ECOG ≤2.0, unless PS of 3-4 based solely on bone pain; 6. Patients must have a Platelets count≥50×109 cells /L; Absolute neutrophil count (ANC)≥0.75×109 cells /L; 7. Patients must have adequate hepatic function defined as Alanine transaminase(ALT) ≤ 2.5 × upper limit of normal(ULN); Aspartate transaminase (AST) ≤2.5×ULN; Total bilirubin ≤2×ULN; 8. Patients must have adequate renal function defined as creatinine clearance >30 ml /min; 9. Subjects (or their legally acceptable representatives) must have signed a informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study Non-secretory MM, unless the patient has measurable lesions on computed tomography (CT), magnetic resonance imaging (MRI) and/or positron emission tomography (PET); 2. Peripheral neuropathy or neuropathy pain grade 2 or high as defined by National Cancer Institute Common Terminology for Adverse Events(NCI CTCAE) Version 3; 3. Uncontrolled or severe cardiovascular disease, including myocardial infarction (MI ) within 6 months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis; 4. History of allergy reaction attributable to compounds containing boron or mannitol; 5. Any serious, active disease or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol or the investigator's decision; 6. Concurrent treatment with another investigational agent; 7. Female subject who is pregnant or breast-feeding | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Multiple Myeloma Patients with relapsing multiple myeloma according to international defined guidelines: Relapse after having achieved complete remission: 1. Reappearance of paraprotein 2. More than 5% plasma cells in bone marrow. 3. New lytic lesions or progression of old lesions. 4. New hypercalcaeamia. Relapse after having achieved partial remission 1. Increases of paraprotein with more than 25% 2. Increase of urine paraprotein with more than 25% 3. Increase of plasma cells in bone marrow with 10% 4. New lytic lesions or progression of old lesions 5. New hypercalcaemia - Radiotherapy in the last 3 months Ineligible to lay supine during the PET scan Age ≤18 years Pregnancy Claustrophobia Severe kidney dysfunction; serum-creatinine ≥250 µM | 0 |
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