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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, Soft Tissue Lesions Patient scheduled for clinically indicated conventional Ultrasound examination Age < 18 years | 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, Wart Energy Medecine Magnetism Patients with common warts on hands or feet for over at least 3 months are eligible for the study. Patients fulfilling one or more of the following will not be included: lack of informed consent prior to randomization, younger than 18 years or under judicial protection, treated with oral corticotherapy for more than 6 months, immunosuppressed or with history of transplant surgery, undergoing chemotherapy or suspected to have carcinomatous warts, or patients with infected warts, injured warts or already treated within 90 days with chemical processing, medical device, surgery or ever treated with biofield therapy. Subject will be excluded from the study if its warts was treated by other treatment during protocol ulcerated wart cancerous wart | 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, Myasthenia Gravis Patients between18 to 80 years of age, diagnosed with MG (see below) who have worsening myasthenic symptoms (defined as increasing diplopia, ptosis, dysarthria, dysphagia, difficulty chewing, or limb weakness severe enough to warrant immunoglobulin therapy MG diagnosis will be based upon the clinical evaluation by a neuromuscular expert and meeting any two of the following supportive 1. Abnormal Tensilon test 2. Abnormal repetitive nerve stimulation studies 3. Abnormal single fiber electromyography (EMG) 4. Increased serum acetylcholine receptor or anti-MuSK antibodies 5. Prior response to immunotherapy Respiratory distress requiring ICU admission or a vital capacity <1 L 2. Severe swallowing difficulties with a high risk of aspiration 3. Change in corticosteroid dosage in the 4 weeks prior to screening 4. Known immunoglobulin A (IgA) deficiency 5. Pregnant or breast feeding women 6. Active renal or hepatic insufficiency, clinically significant cardiac disease 7. Patients with worsening weakness associated with an infectious process 8. Previous lack of responsiveness to IVIG 9. History of previous MG crises | 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, Idiopathic Parkinson Disease Diagnosis of idiopathic PD with tremor, rigidity or hypokinesia as major symptoms A two to twenty-five-year history of PD with significant medical management or difficulty in medical management A definite response to levodopa compounds with inadequately relieved of symptoms, or severe secondary effects of the drug Good general health A strong will or desire to have the procedure after being fully informed of its experimental nature History of repeated strokes with stepwise progression of parkinsonian features History of repeated head injury History of definite encephalitis Oculogyric crises (unless drug-induced) Neuroleptic treatment at onset of symptoms Supranuclear gaze palsy Cerebellar signs Babinski sign Presence of cerebral tumor or communicating hydrocephalus on CT scan Sustained remission or negative response to an adequate dose of levodopa | 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, Chronic Ankle Instability History of at least 1 significant ankle sprain (the most recent injury must have occurred more than 3 months prior to study enrolment) or more episodes of the ankle giving way in the last 6 months A score of ≤24 on the Spanish version of the Cumberland Ankle Instability Tool Age range: 18-30 years History of previous surgeries to the musculoskeletal structures in either lower extremity History of a fracture in either lower extremity requiring realignment An acute injury to musculoskeletal structures of other joints of the lower extremity in the previous 3 months that impacted joint integrity and function, resulting in at least 1 interrupted day of desired physical activity | 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): 18.0-99.0, Paget's Disease of Bone for Cases Men and women between the ages of 18-99 years who have evidence of active Paget's disease of bone as clinically and/or radiographically defined by Increased serum alkaline phosphatase or increased serum collagen type 1 c-telopeptide (CTX) or increase in urinary pyridinoline at diagnosis AND history of at least one of the following signs/symptoms: Pagetoid lesions(s) on x-ray/CT/MRI, increased uptake of radioactive substance by bone scan, bone pain, fracture, hearing loss, headache, hypercalcemia, or bony deformity. for controls Men and women between the ages of 18-99 years who match age within 5 years of cases and gender who do NOT have evidence of Paget's disease of bone as defined by No bone pain or bony deformity Normal serum alkaline phosphatase Osteosarcoma or other blastic bony metastases alone Fibrous dysplasia of bone Hyperostosis frontalis interna All men and women < 18 years or > 99 years Pregnancy (women) determined by self-report Current use of oral contraceptive tablets or Depo-Provera™ (women) Current use of hormone replacement therapy Creatinine clearance < 60 ml/min./1.73 m2 by Cockcroft-Gault based on most recent serum creatinine level (if greater than 1 year since last assessment, will be measured on collected blood sample to verify eligibility) Current smoking or tobacco use Alcohol use greater than 3 units daily | 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, Colostomy Ileostomy - Stoma Enterostomy Subject is registered in the Danish Stoma Database Capital Region Is registered as having either ileostomy, jejunostomy, sigmoidostomy, or transversostomy Patients with urostomy or unknown stoma type | 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, Autosomal Dominant Hypocalcemia or OR Primary Hypoparathyroidism Related to Other Cause But Complicated by Hypercalciuria Under Treatment Patients aged from 18 to 80 years, of both sexes Patient with primary hypoparathyroidism related to a genetically proven ADH OR primary hypoparathyroidism related to other cause but complicated by hypercalciuria under treatment Affiliated to a French health insurance system, and who have consented to the study Pregnant and breastfeeding women Women of childbearing age without contraception For men aged from 18 to 20 years, presence of cartilage of growth on X-ray of left knee Anuria Kidney failure with plasmatic creatinine >125 mmol/l and urea >10 mmol/l Long QT interval : QTc > 450 ms (men) or 470 ms (women) Hepatic failure Metabolic bone diseases (Paget's disease of bone) other than primary osteoporosis or glucocorticoid-induced osteoporosis Association to other potassium sparing diuretics Hypokalemia (<3.5 mmol/l) without diuretic therapy | 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, Vertebral Bony Metastases Patients with a histologically confirmed tumor diagnosis, with secondarily diagnosed solitary/multiple metastatic spinal bone metastases Indication for RT of the bone metastasis Age: between 18 and 80 years Karnofsky performance score ≥ 70 Signed Declaration of Informed Consent Bisphosphonate therapy Significant neurological or psychiatric disorders, including dementia and epileptic seizures Lacking or diminished legal capacity foregoing radiotherapy in the planned RT area Any medical of psychological condition that the study director considers a preventive factor for the patient's ability to complete the study or to adequately understand the scope of the study and to give his/her 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): 20.0-85.0, Arthroplasty Recovery of Function Sleep Quality Primary unilateral total hip arthroplasty Patients with hip osteoarthritis,rheumatoid arthritis or femoral head necrosis Able and willing to provide signed informed consent Simultaneously bilateral total hip arthroplasty or revision case Surgical History of the hip joint Hip joint cavity paracentesis in recent 3 months Stiffness with hip Blood coagulation disorders History of deep venous thrombosis Concomitant medical problems such as uncontrolled hypertension, severe cardiovascular disorder, chronic obstructive pulmonary disease, liver or renal failure Allergic to NSAIDs, opioid analgesics, zolpidem Sleep apnea, Parkinson disease, dementia, depression Use of sedatives or hypnotics | 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): 20.0-80.0, Thyroid Diseases Age 20-80 years old Thyroid diseases, including nodular goiter, hyperthyroidism, hypothyroidism and thyroid cancer (before or after operation), consecutive follow-up in outpatient department, and we expected to enroll 800 patients in one year, and follow-up with observation for 5 years N/A | 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): 1.0-31.0, B Acute Lymphoblastic Leukemia Central Nervous System Leukemia Ph-Like Acute Lymphoblastic Leukemia Testicular Leukemia Patients must be enrolled on APEC14B1 and consented to Screening on the Part A consent form prior to enrollment on AALL1131 White Blood Cell Count (WBC) Age 1-9.99 years: WBC >= 50 000/uL Age 10-30.99 years: Any WBC Age 1-30.99 years: Any WBC with Testicular leukemia CNS leukemia (CNS3) Steroid pretreatment Patients must have newly diagnosed B lymphoblastic leukemia (2008 World Health Organization [WHO] classification) (also termed B-precursor acute lymphoblastic leukemia); patients with Down syndrome are also eligible Organ function requirements for patients with Ph-like ALL and a predicted TKI-sensitive mutation: patients identified as Ph-like with a TKI-sensitive kinase mutation must have assessment of organ function performed within 3 days of study entry onto the dasatinib arm of AALL1131 With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or any cancer diagnosed prior to the initiation of protocol therapy on AALL1131; patients cannot have secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy; patients receiving prior steroid therapy may be eligible for AALL1131 Patients with BCR-ABL1 fusion are not eligible for post-induction therapy on this study but may be eligible to enroll in a successor Children's Oncology Group (COG) Philadelphia positive (Ph+) ALL trial by day 15 Induction DS HR B-ALL patients with Induction failure or BCR-ABL1 Female patients who are pregnant are ineligible since fetal toxicities and teratogenic effects have been noted for several of the study drugs Lactating females are not eligible unless they have agreed not to breastfeed their infant Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation | 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): 40.0-999.0, Osteoarthritis hip or knee osteoarthritis (tibiofemoral), uni or bilateral, symptomatic, with confirmed diagnosis according to American College of Rheumatology ACR and European League Against Rheumatism (EULAR) Kellgren and Laurence radiological stage at least 2 knee or hip prosthesis on painful joint preceding osteotomy serious comorbidity (affecting quality of life, or leading to a high care consumption) according to X-ray : knee pain with isolated patello-femoral osteoarthritis (i.e without an associated tibiofemoral osteoarthritis) other pathology on knee or hip adults getting a legal protection or with the incapacity to give their 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, Ostomy Hernia Signs and Symptoms Permanent or temporary active sigmoidostomy, transversostomy, jejunostomy or ileostomy PB diagnosed by stoma care nurse Ability to speak and understand Danish Previous surgical repair for PB Major incisional abdominal hernias | 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, Neoplasm, Trophoblastic Gestational Trophoblastic Disease Hydatidiform Mole Hydatidiform Mole, Invasive Patients are eligible if they have a histologically proven trophoblastic disease, or a diagnosis of gestational trophoblastic neoplasia done on an abnormal evolution of hCG 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): 30.0-70.0, Photosensitivity Disorders Healthy males and females, between ages 30 and 70 Photodamaged skin on upper limbs with IGH lesions meeting aforementioned and excluding differential diagnosis Fitzpatrick skin types III Apt and willing to comply with the entire program as well as appointments, treatment and examination Capable of understanding and providing a written informed consent Fertile women will have to use a viable birth control method for at least 3 months prior to entry and throughout the entire study Pregnancy, intention to become pregnant during the course of the study, less than 3 months after delivery or less than 6 weeks after breastfeeding cessation Uncontrolled comorbidity or any disease that, in the investigator's opinion, may interfere with the treatment, healing or cure Present symptoms of hormonal disturbances, as per the investigator's criteria Constitutional photosensitivity or due to metabolic disfunction, or due to use of external agentes (pharmaco, natural products, etc.) prior to initial treatment or during the study Use of oral isotretinoin 6 months prior to initial treatment or during the course of the study Prior treatment in target área 3 months prior to initial treatment or during the course of the study Adverse reaction to any external agentes (gel, lotions or anesthetic creams) required during the study in case no alternative is available for such agent History of keloids or other type of hypertrophic scar formation or poor wound healing in a previously injured area of skin History of collagen disease Displastic nevus or suspicious carcinogenic lesion in área to be treated | 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, Heart Failure With Normal Ejection Fraction Preserved left ventricular systolic function on echocardiography (LVEF>50%) Evidence of diastolic dysfunction by echocardiography (E/e'>15) Symptoms of heart failure NT-proBNP levels >300 pg/ml absence of permanent atrial fibrillation acute multi-organ failure history of any malignant disease within 5 years diminished functional capacity due to non-cardiac co-morbidities (COPD, PAOD, morbid obesity) pregnancy | 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, Medication-related Osteonecrosis of the Jaw Bisphosphonate-Associated Osteonecrosis of the Jaw Age > 18 years Newly diagnosed patients with osteonecrosis in a facial bone other than the jaw, or Newly diagnosed patients with non-exposed MRONJ (stage 0), or Newly diagnosed patients with exposed MRONJ, i.e Current or previous treatment with antiresorptive or antiangiogenic agents Exposed bone or bone that can be probed through an intraoral or extraoral fistula(e) in the maxillofacial region that has persisted for more than 8 weeks No history of radiation therapy to the jaws or obvious metastatic diseases of the jaw Ability to understand the content of the patient information/ Informed Consent Form Willingness and ability to participate in the clinical investigation according to the Registry Plan (RP) Signed and dated IRB/EC-approved written informed consent Recent history of substance abuse (i. e., recreational drugs, alcohol) that would preclude reliable assessment Pregnancy or women planning to conceive within the registry period Prisoner Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present registry | 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): 10.0-100.0, Osteogenesis Imperfecta Males and females with Clinical diagnosis of OI other than OI type I Individuals 10 years or older Participant of the Brittle Bone Disease (BBD) Longitudinal Study (7701) Individuals who cannot be correctly positioned for valid radiographic analysis (e.g., due to severe scoliosis or short neck secondary to basilar invagination) Women who are pregnant | 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): 1.0-100.0, Wound Infection Sugar Solution Patients conducted surgical operation in the hospital within 2 weeks. The wound had swelling and lots of secretions; 2. Except for the incision, primary surgical site has been recovered smoothly. Patients didn't accept secondary operation in the same site Except for the wound that can't use healthy skin closure in Phase I | 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): 25.0-95.0, Chronic Kidney Disease Patients with severely decreased kidney function (eGRF below 20ml/min) with secondary hyperparathyroidism. In addition a group of healthy volunteers Pregnancy, parathyroidectomy, biphosphonate-medication | 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 Pancreatic Cancer Histologically confirmed metastatic adenocarcinoma of the pancreas (at enrollment) 2. Actively on (or about to initiate) first line therapy for metastatic pancreatic cancer (at enrollment) Patients may have had neo-adjuvant and/or chemotherapy that must have been completed >3 months prior to starting first line therapy Patients may be actively on "maintenance" therapy, such as maintenance capecitabine up to starting first line therapy for metastatic disease 3. Radiographically measurable disease (prior to initiation of second-line therapy) 4. Tumor deposits that are clearly accessible for serial tumor biopsies A patient's biopsied lesion must be at least 1cm in diameter (in at least one dimension) (prior to initiation of second-line therapy) 5. Age ≥ 18 years (at enrollment) 6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Table 6, Appendix D) (at enrollment) 7. Adequate hepatic, bone marrow, and renal function at the time of enrollment AND at initiation of second line therapy Bone Marrow: Absolute neutrophil count (ANC) ≥ 1,500/mm3; Platelets ≥ 75,000/mm3; Hemoglobin ≥ 9.0 g/dL Patients may have a transfusion of red blood cells to meet the hemoglobin requirement Renal function: Serum creatinine ≤ 1.5 X upper normal limit of institution's normal range OR creatinine clearance ≥ 50 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal Hepatic function: Aspartate transaminase (AST) and Alanine transaminase (ALT) ≤ 3 X the upper normal limit of institution's normal range; bilirubin ≤ 1.5 X the upper limit of normal. For patients with known hepatic metastases, AST and ALT ≤ 5 X the upper normal limit of institution's normal range Prothrombin Time and Partial Thromboplastin Time (PTT) must be ≤ 2 X the upper limit of the institution's normal range and International Normalized Ratio (INR) < 2. Subjects on anticoagulation (such as coumadin) will be permitted to enroll as long as the INR is in the acceptable therapeutic range as determined by the investigator 8. Patients must have fully recovered from all effects of surgery (prior to initiation of second-line therapy). Patients must have had at least two weeks after minor surgery and four weeks after major surgery before starting therapy. Minor procedures requiring "Twilight" sedation such as endoscopies or mediport placement may only require a 24-hour waiting period, but this must be discussed with an investigator. 9. Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment and/or postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential (at enrollment). 10. Subject is capable of understanding and complying with parameters as outlined in the protocol and able to sign and date the informed consent, approved by the Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures (at enrollment) Known or suspected brain or central nervous system metastases, irrespective of prior treatment 2. The subject has had another active malignancy within the past three years except for cervical cancer in situ, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin. Questions regarding the of individual subjects should be directed to the Study Chair. 3. Clinically significant peripheral neuropathy at the time of enrollment (defined in the NCI Common Terminology for Adverse Events Version 4.0 [CTCAE v4.0] as grade 2 or greater neurosensory or neuromotor toxicity) 4. Patients receiving any other investigational agents. 5. Active severe infection, or known chronic infection with HIV or hepatitis B virus -Patients with chronic Hepatitis C virus may be enrolled if there is no clinical/laboratory evidence of cirrhosis AND the patient's liver function tests fall within the parameters set in Section 3.2.7.3, Hepatic function 6. Cardiovascular disease problems including unstable angina, therapy for life-threatening ventricular arrhythmia, or myocardial infarction, stroke within the last 3 months, or a diagnosis of congestive heart failure 7. Life-threatening visceral disease or other severe concurrent disease 8. Women who are pregnant or breastfeeding 9. Anticipated patient survival under 2 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): 18.0-100.0, Valvular Heart Disease Stenosis and Regurgitation (Diagnosis) Presence of aortic stenosis, mitral or aortic regurgitation at the time of an echocardiography at the "Cliniques Universitaires Saint Luc" | 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, Umbilical Cyst Pilonidal Sinus no limitation patients followed-up less than 2 years | 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, Sickle Cell Disease Adult patients (18 years and older) Diagnosis of sickle cell disease by hemoglobin electrophoresis (HbSS, hematopoietic blood stem cell [HbSC], Sickle cell b0 Thalassemia, Sickle cell b+ Thalassemia) Able to give informed consent Any race/ethnicity/socioeconomic status Pediatric patient (less than 18 years of age) Unable to give informed consent Untreated primary hyperparathyroidism (ICD9 codes 252.01XX and 252.00XX) hypercalcemia (serum calcium level > 11 mg/dl; ICD9 codes 275.42XX, 259.3XX, 252.00F) Pregnancy: a urine pregnancy test, or a serum pregnancy test, will be obtained at the time of enrollment in addition to reviewing the medical record; pregnant patients will be excluded because they should not undergo DXA scanning Patients taking atorvastatin, thiazide diuretics and digoxin, which are medications that can interact with vitamin D Non-English speakers | 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 Currently scheduled for a bone marrow aspirate concentration (BMAC) procedure Cognitively able to give consent and complete the required questionnaires History of leukemia or lymphoma History of any autoimmune disorders and disease Currently taking immunosuppressive medications Presence of an active or suspected infection, or an infection of the joint in question within the past 6 months Vulnerable populations (pregnant women and breast-feeding women) Cortisone injection into the affected joint within 6 weeks Used NSAIDs within 1 week of the procedure History of bleeding disorders or inflammatory joint disease Surgical intervention on the affected or contralateral joint within 6 months of BMAC injection | 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, Medication-related Osteonecrosis of the Jaw Bisphosphonate-related Osteonecrosis of the Jaw Avascular Necrosis Stage 1, 2, or 3 MRONJ as defined by the AAOMS Position Paper on Medication-Related Osteonecrosis of the Jaw-2014 Update (Ruggiero 2014). 2. History of exposure to antiresorptive medications such as bisphosphonates or RANK-L inhibitors 3. Absence of tumor in the jaw at the time of recruitment 4. Patients with the capacity to give informed consent Patients with history of external radiation therapy to the jaws 2. Patients who underwent any surgical intervention for MRONJ in the past 4 months 3. Patients with past microvascular reconstruction of the head and neck 4. Patients with an expected survival less than 1 year 5. Patients with allergy or hypersensitivity to pentoxifylline, xanthines, or tocopherol 6. Patients with planned invasive dental procedure in the next year 7. Patients taking oral anticoagulants 8. Patients with known hemorrhagic and coagulation disorder 9. Patients with a vitamin K deficiency due to any cause 10. Female patients who are pregnant or lactating 11. Patients with history of serious bleeding or extensive retinal hemorrhage 12. Patients with ischemic heart diseases, including, but not limiting, recent myocardial infarction 13. Patients with serious cardiac arrhythmia 14. Patient with history of prostate cancer 15. Patients with severe liver disease 16. Patients with severe renal failure (Creatinine clearance <30 mL/min) 17. Patients with diagnosed hypotension 18. Patients taking CYP1A2 inhibitors (e.g. ciprofloxacin, fluvoxamine) 19. Diagnosis of MRONJ with no exposed bone 20. Patient cannot tolerate impressions of exposed bone in a clinical setting, if needed. 21. There is a change in the patient's clinical presentation (tooth extraction, sequestrectomy) from alginate impression, if impression is indicated. 22. Any other situation or condition that, in the opinion of the may interfere with optimal in the study 23. A patient who has taken both bisphosphonate and Denosumab | 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, Schistosomiasis Adults, male, 18 to 49 years old (inclusive) at the time of inclusion Living in one of selected villages in Saint-Louis Region (Senegal) Free of obvious/severe health problems except schistosomiasis, as established by clinical examination and blood analysis, i.e. hematological exams, liver and renal function tests Written informed consent to participate obtained Treated with 40mg/kg Praziquantel (PZQ) before (W-5 to W-4 before the first injection) in case of infection with S. mansoni and S. haematobium Residence in the area during the period of the study Adult who does not respond to one of the Current or previous chronic administration (defined as more than 14 days) of immunosuppressive drugs or other immuno-modifying drugs Known hypersensitivity to any component in the Sm14 vaccine or history of allergic disease Knowledge of non-infectious chronic disease Acute disease at time of enrollment Other conditions which in opinion of the PI may potentially represent a danger for the patient to be enrolled Non residence in the study area or intent to move 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): 18.0-65.0, Tooth Impacted cases: bilateral wisdom tooth pathology control: agenesia/previous extraction/no symptoms of the lower third molars younger than 18 years and older than 65 years pregnant or lactating females females using contraceptive methods suffering from any systemic illness undergoing any pharmacological treatment within 30 days prior to the patients affected by periodontal disease (radiographic diagnosis of vertical bone defects or bone resorption equal to 20% of the root length) patients with periapical and periradicular radiolucent areas X-ray detectable patients unable to participate to 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): 21.0-999.0, Systemic Inflammation Cardiopulmonary-bypass Undergoing cardiac surgery with planned cardiopulmonary bypass Additive Euroscore II ≥ 3 OR at least 3 surgical cardiac interventions are planned Ability to provide informed consent (not incapacitated) Already on renal replacement therapy Patients with chronic kidney disease defined as estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2 [ CKD stage > 3 ] Patients who are pregnant Concurrent enrollment in another clinical trial Known allergic reaction to bovine alkaline phosphatase or patient is vegetarian or vegan Patients with ongoing infections or current use of steroids | 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): 18.0-103.0, Missing Teeth Over 18 years old who are able to read and sign an informed consent form. 2. Patient who has good oral hygiene (Full-mouth plaque score <25%). 3. Subject would be available for study monitoring and follow-up visits. 4. Patients with missing teeth in the maxillary posterior region who will require sinus augmentation for implant placement. The patients may be partially or completely edentulous. 5. Patient is a candidate for delayed implant placement approximately 8 months following sinus grafting Alcohol, drug dependency. 2. Signs or symptoms of chronic maxillary sinus disease. 3. Current smoker. 4. History of head and neck radiation treatment. 5. Poor health, conditions like uncontrolled diabetes, uncontrolled hypertension or other uncontrolled systemic disease. 6. Physical or psychological reason that might affect the surgical procedure or the subsequent prosthodontic treatment and/or required follow-up examinations. 7. Also, subjects who are nursing or pregnant will be excluded from 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): 18.0-70.0, HER2 Positive Metastatic Breast Cancer Aged ≥18 and ≤70 years. 2. ECOG performance status of 0 to 1. 3. Life expectancy of more than 12 weeks. 4. According to 1.1, at least one measurable lesion exists 5. Histologically or cytologic confirmed HER2 positive metastatic breast cancer. 6. Prior treatment with trastuzumab (≥2 cycles in metastatic setting, or ≥3 months in adjuvant/neoadjuvant setting) and Taxane(≥2 cycles in any setting or untill unendurable AE or progression during treatment). 7. Previously reveived ≤2 chemotherapy regimens in metastasis setting; 8. Required laboratory values including following parameters: ANC: ≥ 1.5 x 10^9/L; Platelet count: ≥ 90 x 10^9/L; Hemoglobin: ≥ 90 g/L; Total bilirubin: ≤ 1.5 x upper limit of normal (ULN); ALT and AST: ≤ 2 x ULN(patients with liver metastases: ≤5 x ULN); BUN and Creatinine: ≤ 1x ULN;CCR≥50 mL/min;LVEF: ≥ 50%;QTcF: < 450 ms (male)，< 470 ms（female）; 9. Signed informed consent Received capecitabine in metastatic setting; 2. Received HER2 targeted tyrosine kinase inhibitor (including Lapatinib, Neratinib and Pyrotinib); 3. Cumulated dosage of Doxorubincin >400 mg/m^2 or Epirubicin >800 mg/m^2 or equal dosage of other anthracycline drugs in adjuvant/neoadjuvant/metastatic setting ); 4. Received surgery，chemotherapy,radiotherapy or target therapy within 28 days prior to randomization. Received hormone therapy within 7 days prior to randomization; 5. Participated in other clinical trial within 28 days prior to randomization. 6. Known dihydro pyrimidine dehydrogenase（DPD）defect; 7. CT or MRI confirmed brain metastases; 8. Bone or skin lesion as unique target lesion; 9. Second malignancies within 5 years, except for cured skin basal cell carcinoma,carcinoma in-situ of uterine cervix and squamous-cell carcinoma; 10. Factors influencing the usage of oral administration (e.g. unable to swallow, chronic diarrhea and intestinal obstruction, etc.); 11. Uncontrolled third space effusion (such as pleural fluid and ascites) by drainage or other clinical intervention; 12. Receiving any other anti-tumour therapy after informed consent; 13. Unprogressed after or during the last anti-tumour therapy,according to 14. History of any kind of Heart disease,including 1)Angina pectoris; (2) Arrhythmia required medication or with clinical significance; (3) Myocardial infarction; (4) Heart failure; (5) Any other heart disease judged by researcher as not suitable for participating in this study, etc; 15. History of Immunodeficiency, acquired or congenital immunodeficiency (HIV positive) ,history of organ transplantation; 16. History of neurological or psychiatric disorders, including epilepsy or dementia; 17. Concomitant disease judged by investigators that may bring serious harm to the safety of patients or the completion of this study; 18. All female patients in breastfeeding period or in child-bearing period or with positive pregnancy test result or refusing to take a reliable method of birth control during the study; 19. Any other situations judged by investigator as not suitable for participating in 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): 18.0-60.0, Spinal Cord Injuries Osteoporosis Metabolic Syndrome Adult (age 18-60 years) Motor complete SCI (C1-T10 AIS A/B) years post-injury Have a telephone, and ability to attend the study visits Able to take oral medications and swallow independently Can provide free and informed consent Ability to understand instructions in English May report current use of oral alendronate 10mg daily or 70mg weekly or risedronate 5mg daily, 30mg weekly or 150mg monthly These are intended to those in whom; Rosuvastatin would be unsafe, DXA/pQCT measurement or biomarker assessment would be invalid, or in whom other co-morbid health conditions may confound the study results Current and/or one year prior to enrolment treatment with any statin such as atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, simvastatin and rosuvastatin Current treatment with IV bisphosphonate, denosumab, recombinant PTH, ovarian hormone therapy, an oral contraceptive, Immunosuppressants (Including Cyclosporine) and fusidic acid Known allergy to Rosuvastatin, lactose powder, CoQ10, calcium carbonate, vitamin D2 and vitamin D3, or any other ingredient found in rosuvastatin, placebo or study supplements History of Paget's disease, osteomalacia, steroid induced osteoporosis, or untreated parathyroid or untreated thyroid disease Subjects with history of stage 4 chronic kidney disease. (124) Current Weight ≥136 kg Bilateral knee region metal implants (hardware), history of bilateral knee region contracture >30 degrees, fracture or any other bilateral knee region pathology which would preclude accurate DXA assessment of one limb Post-menopausal women (absence of menses for a minimum of 1 year) Women with amenorrhea due to bilateral surgical removal of the ovaries and/or uterus (women with amenorrhea due to spinal cord injury are able to participate) | 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, Delayed Bleeding Post EMR Large Laterally Spreading Lesion in the Colon Endoscopic Mucosal Resection All patients referred for EMR of a LSL 20mm or larger Signed the informed consent Clips used during the EMR procedure to close the defect, totally or partially Inadequate images to adequately assess the defect Use of blood thinners which have not been ceased according to the current guidelines for EMR | 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, Primary Biliary Cholangitis (PBC) Must have provided written informed consent 2. Definite or probable PBC diagnosis as demonstrated by the presence of at least 2 of the following 3 diagnostic factors History of elevated ALP levels for at least 6 months prior to Day 0 (randomization visit) Positive Anti-Mitochondrial Antibodies (AMA) titers (> 1/40 on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies Liver biopsy consistent with PBC 3. ALP >= 1.67x upper limit of normal (ULN) 4. Taking UDCA for at least 12 months (stable dose for ≥ 6 months) prior to screening visit 5. Contraception: Females participating in this study must be of non-childbearing potential or must be using highly efficient contraception for the full duration of the study and for 1 month after the end of treatment History or presence of other concomitant liver diseases 2. Screening creatine phosphokinase (CPK) > upper limits of normal (ULN) 3. Screening alanine transaminase (ALT) or aspartate aminotransferase (AST) > 5 ULN 4. Screening total bilirubin > 2 ULN 5. Screening serum creatinine > 1.5 mg/dl 6. Significant renal disease, including nephritic syndrome, chronic kidney disease (defined as patients with markers of kidney damage or estimated glomerular filtration rate [eGFR] of less than 60 mL/min/1.73 m^2). 7. Patients with moderate or severe hepatic impairment (defined as Child-Pugh B/C) 8. Platelet count <150 X 10^3/microliter 9. Albumin <3.5 g/dL 10. Presence of clinical complications of PBC or clinically significant hepatic decompensation 11. If female: known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating 12. Known history of human immunodeficiency virus (HIV) infection 13. Medical conditions that may cause non-hepatic increases in ALP (e.g., Paget's 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): 18.0-79.0, Osteoarthritis, Knee >=3 months of symptomatic knee OA unresponsive to at least two of the following: activity modification, physical therapy, bracing, assistive devices, acupuncture, non-steroidal anti-inflammatory medications, local steroid injections, and hyaluronic acid injections Radiographically confirmed Kellgren-Lawrence I-II knee OA (mild knee OA; no bone-on-bone) Age 18-79 years Presence of loose bodies on baseline magnetic resonance imaging Clinically and radiologically confirmed anterior/posterior cruciate ligament deficiences History of meniscal injury other than degenerative meniscal tears Previous knee surgery Presence of a degenerative meniscal tear causing mechanical symptoms such as locking, buckling, or give-way Intra-articular injection to affected knee within 6 weeks of intra-articular BMA injection Mechanical axis deviation greater than 7 degrees Intolerance to acetaminophen or hydrocodone (i.e., Vicodin) Use of non-steroidal anti-inflammatory drugs <1 weeks prior to BMA Injection of the joint scheduled for treatment within 3 months of BMA injection | 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, Metastases to Bone Patient is 18 years of age or older and able to provide informed consent Patient with an established tissue diagnosis of cancer Patient with diagnosis of metastatic bone lesion which requires a referral to an Orthopedic Oncology Specialist Patient will receive their care and treatment for this metastatic disease at The Ottawa Hospital Patient does not speak or understand adequate French or English to complete the functional outcome questionnaires Patient has a documented cognitive impairment precluding questionnaire completion (e.g. dementia) | 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, Chronic Oedema Obesity Adults who have capacity to give informed consent Ability to understand the assessment questionnaires in English. Stage 1 all patients accepted for referral. There are no co-morbidities that would people. Stage 2 patients that undergo bariatric surgery Patients under the lower age limit of 18. Stage 2 By-Band-Sleeve study participants who are taking part in the randomisation part 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): 18.0-65.0, Pain, Chronic Musculoskeletal Pain Low Back Pain Neck Pain Over age 18 and report experiencing average daily musculoskeletal pain of moderate intensity (>3/10) in the neck or low back for greater than 4 weeks Report any indication for medical clearance prior to engaging in moderate intensity exercise or if they have any other health limitations to engaging in moderate exercise Additional are the individual is unable to complete any of the data collection protocols, has previously been diagnosed with schizophrenia, dementia or is mentally incapable of providing informed consent or report a previous allergic reaction to kinesiotape or menthol | 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): 15.0-54.0, Pulpitis mature permanent mandibular molars having deep carious lesions involving half or more of the dentine detected by radiographic examination pulp sensibility confirmed using the electric pulp test (Digitest D626D; Parkell Electronics, New York, NY) and the cold test (Endo frost, Coltene, Whaledent) absence of apical and furcal radiolucency determined by radiographic examination absence of clinical symptoms of irreversible symptoms, fistula, swelling and abnormal tooth mobility Clinical diagnosis of vital pulp was made on the basis of radiographic and clinical examination and the pulp sensibility tests • if they presented with signs and symptoms of irreversible pulpitis had negative response to vitality tests before or after ITR diabetic, immunocompromised pregnant had a positive history of antibiotic use in past one month or required antibiotic prophylaxis | 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, Pain, Acute Pain, Chronic Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, age 18 or older 4. Seeking care for a musculoskeletal injury 5. Experiencing pain greater than 3 out of 10 on a visual analog scale 6. English or Spanish speaking 7. Owns a compatible Android or iOS smartphone device (excluding tablets) Unable to understand the goals of the study due to cognitive difficulty 2. Use of a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device or high-frequency surgical equipment. (contraindication for TENS units) 3. Pregnant (contraindication for TENS unit) 4. Current diagnosis of epilepsy, dementia, or other neurological disease that may prevent use of VR hardware or software 5. Hypersensitivity to flashing light or motion 6. Injury to the eyes, face, neck, or arms that prevents comfortable use of VR hardware or software, or safe use of other study hardware (e.g., open sores, wounds, or skin rash on face) | 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, Fibrodysplasia Ossificans Progressiva Key Men and women 18 to 60 years of age at screening Clinical diagnosis of FOP (based on findings of congenital malformation of the great toes, episodic soft tissue swelling, and/or progressive heterotopic ossification (HO)) Confirmation of FOP diagnosis with documentation of any ACVR1 mutation FOP disease activity within 1 year of screening visit. FOP disease activity is defined as pain, swelling, stiffness, and other signs and symptoms associated with FOP flare-ups; or worsening of joint function, or radiographic progression of heterotopic ossifications (increase in site or number of HO lesions) with/without being associated with flare-up episodes Willing and able to undergo PET and CT imaging procedures and other procedures as defined in this study. Key Significant concomitant illness or history of significant illness such as, but not limited to cardiac, renal, rheumatologic, neurologic, psychiatric, endocrine, metabolic or lymphatic disease, that in the opinion of the study investigator might confound the results of the study or pose additional risk to the patient by their participation in the study Previous history or diagnosis of cancer Use of bisphosphonate within 1 year of screening Concurrent participation in another interventional clinical study, or a non-interventional study with radiographic measures or invasive procedures (e.g. collection of blood or tissue samples). Participation in the FOP Connection Registry or other studies in which participants complete study questionnaires are allowed Treatment with another investigational drug, denosumab, imatinib or isotretinoin in the last 30 days or within 5 half-lives of the investigational drug, whichever is longer Pregnant or breastfeeding women Male and women of childbearing potential participants who are unwilling to practice highly effective contraception. Note: Other protocol defined Inclusion/ apply | 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): 14.0-999.0, Post-operative Edema Steroid Use All patients age 14 and over undergoing orthognathic surgery at the Atlantic Centre of Oral and Maxillofacial Surgery in Halifax, Nova Scotia will be included in our study. The clinic is located in the Victoria General Hospital in Halifax, Nova Scotia. Orthognathic surgery includes any combination of Lefort 1, Bilateral Sagittal Split Osteotomy (BSSO) and functional genioplasty procedures Patients with pertinent medical history that precludes the use of high-dose steroids will be excluded from our study. This includes Known hypersensitivity to steroids Type 1 diabetic patients who may have a severe elevation of blood sugars with steroid use Systemic fungal infections Arrested tuberculosis Herpes simplex keratitis Acute psychoses Cushing's syndrome Peptic ulcer disease Pregnant patients and patients with current infections will be excluded Breast feeding mother | 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, Human Papillomavirus HPV-16 High Grade Squamous Intraepithelial Lesion Patients must have vulvar High-Grade Squamous Intraepithelial Lesions (HSIL) as confirmed by pathology report from a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory. 2. Vulvar HSIL must be human papilloma virus (HPV)-16+ by a polymerase chain reaction (PCR), ribonucleic acid (RNA), or in situ hybridization test from a CLIA certified laboratory. 3. Patients must have measurable lesion(s) as defined in section 6.3.2 and one or more of the following 1. Failure of surgery to control disease (i.e. positive margins or recurrence of HSIL after surgery). 2. Multifocal or extensive disease for which surgery would result in major deformity that is not be acceptable to the patient. 3. Disease for which surgery would have a risk of functional impairment that is not be acceptable to the patient (i.e. involve partial or complete excision of the clitoris, anus, vagina, or urethra). 4. Patients may have received any previous therapy, including surgical excision, but must have histologically documented recurrence on new biopsy and a measurable lesion that meets the above criteria. 5. The presence of disease that can be biopsied for research purposes is not an criterion. 6. Patients must have the human leukocyte antigen (HLA)-A*02:01 allele 7. Age greater than or equal to 18 years and less than or equal to 65 years. As age increases, the ability to tolerate the toxicities of aldesleukin decreases, so the patient population for this study will up to and including 60 years of age to increase safety. 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Able to understand and sign the Informed Consent Document. 9. Women of child-bearing potential must have a negative pregnancy test. Women of child-bearing potential are defined as all women who are not post-menopausal or who have not had a hysterectomy. Postmenopausal will be defined as women over the age of 55 who have not had a menstrual period in at least 1 year. 10. The effects of E6 T Cell Receptor (TCR) T Cells on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. 11. Seronegative for human immunodeficiency virus (HIV) antibody. The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune-competence and thus be less responsive to the experimental treatment. 12. Seronegative for hepatitis B antigen and hepatitis C antibody. If hepatitis C antibody test is positive, then the patient must be tested for the presence of antigen by reverse transcription (RT)-PCR and be hepatitis C virus (HCV) RNA negative. 13. Must be willing to participate in Gene Therapy Long Term Followup Protocol (15-C-0141), which will follow patients for up to 15 years per Food and Drug Administration (FDA) requirements. 14. Patients must have normal organ and marrow function as defined below leukocytes greater than or equal to 3,000/mcL absolute neutrophil count greater than or equal to 1,000/mcL platelets greater than or equal to 150,000/mcL hemoglobin greater than or equal to 10.0 g/dL total bilirubin within normal institutional limits except in patients with Gilbert's Syndrome who must have a total bilirubin < 3.0 mg/dL Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT)/alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) Serum ALT/AST < 3 times ULN creatinine less than 1.5 times baseline, < 1.5 times upper limit of normal (ULN) OR -creatinine clearance less than or equal to 60 mL/min/1.73 m(2) for patients with creatinine levels above institutional normal (by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation) Patients who are receiving any other investigational agents 2. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with E6 TCR, breastfeeding should be discontinued if the mother is treated with E6 TCR. These potential risks may also apply to other agents used in this study. 3. Uncontrolled intercurrent illness including, but not limited to, any ongoing or active infection (e.g. requiring anti-infective therapy), coagulation disorders, cardiovascular disorders, respiratory disorders, cancer, or psychiatric illness/social situations (within the last six months) that would limit compliance with study requirements. 4. Any form of systemic immunodeficiency, including acquired deficiency such as HIV or primary immunodeficiency such as Severe Combined Immunodeficiency Disease. The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the treatment. 5. Concurrent systemic steroid therapy if greater than the equivalent of 5 mg prednisone by mouth (PO) daily. Patients previously on steroids must be off steroids for four weeks prior to treatment. 6. Any history of clinically significant cardiac arrhythmia, coronary revascularization, ischemic symptoms, or previously documented left ventricular ejection fraction (LVEF) of less than or equal to 45%. A cardiac stress test is required for all patients greater than 50 years old. A cardiac stress test may also be performed for any clinical concern. Patients with cardiac ischemia are not eligible. 7. Patients with any active invasive cancer are not eligible. 8. Patients vulvar HSIL that is not HPV-16+ or is associated with multiple types of high-risk HPV 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): 40.0-80.0, Osteoporosis Knee Osteoarthritis Age: 40-80 years (inclusive) Gender: male or female (non-pregnant) Fluent in written and spoken English Patients capable of giving informed consent Primary diagnosis of osteoporosis that will be treated with either Forteo® to induce bone anabolism or Prolia® by the study investigator as part of patient's standard of care treatment Symptomatic, medial compartment knee OA with a Kellgren-Lawrence (K-L) score between II-III (documented in the medical record by previously collected knee series radiography). Radiographs to be performed within past two years Age < 40 or >80 years Cognitive impairment Pregnancy Non-English speaking persons History of hyperparathyroidism, hypercalcemia, current/recent renal stones, or malignancy Depression (currently taking home medication) History of inflammatory disease (colitis, rheumatoid arthritis, psoriasis, lupus, scleroderma, spondylitis) Use of immunosuppressants, chemotherapy, or radiotherapy BMI, angular deformity and K-L score of the contralateral knee (if the OA is bilateral) will be noted as covariates | 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): 10.0-90.0, Chronic Migraine Without Aura, Intractable Migraine With Typical Aura Migraine Disorders • Age: 10-90 years Ability to describe headache and its symptoms Ability to read, comprehend, and legibly and reliably record information Ability to provide written, informed consent, and respond to pre and post treatment questionnaires, children's guardian accepts responsibility. Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures Already diagnosed with chronic craniofacial neuralgia and chronic migraine headache Exhausted all or most of available abortive and preventive treatment modalities • Uncontrollable hypertension, acute Myocardial Infarct within last 6 months History of cerebral vascular aneurysm/known atherosclerosis of cerebral system, brain tumor Implanted of neuro-stimulator, trigeminal tractotomy, neurectomy partial or complete, history of gamma knife treatment, microsurgical decompression procedure Hypersensitivity or allergy to any components of De-Novo formula Presence or known anatomic craniofacial deformities or severe spondylosis/spondylolisthesis of cervical spine, profound dental caries, Maxillofacial deformities Pregnancy and current breast feeding status Headaches attribute to acute head and neck injuries, chronicity of cervicogenic headaches Skin infection or micro abscesses dermatogen or dental, ongoing treatment for Methicillin Resistant Streptococcus Aureus ( MRSA) unless treatment completed | 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, Trigger Point Tension-Type Headache Be over 18 years old, they will be present at the time of ordering, not being pregnant and not taking analgesic medication at least 24 hours before the intervention More than 20% of the questionnaire data are incomplete and if during the research the volunteer presents some discomfort | 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): 18.0-84.0, Bone Fracture Patients with fractures of the upper and lower extremities Patients for whom the surgical bone reconstruction are indicated | 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, Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations Confirmed diagnosis of AML according to World Health Organization (WHO) 2016 classification 2. Presence of FLT3-ITD and/or D835 mutation(s) 3. Subjects must be primary refractory or relapsed to 1st line intensive treatment for AML or refractory or relapsed after second line of treatment for AML 4. Age ≥ 18 years and ≤ 75 years 5. Adequate hepatic function 6. Adequate renal functions 7. ECOG performance status ≤ 3 Known clinically active central nervous system(CNS) leukemia 2. Severe liver disease 3. Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) 4. Prior anti-leukemia therapy within the 14 days prior to randomization. Prior use of quizartinib or gilteritinib must be discontinued 21 days prior to randomization. Prior use of hydroxyurea or other palliative treatment for leukocytosis is allowed. 5. Previous treatment with crenolanib or prior participation in clinical trial involving crenolanib | 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, Lymphoma Adult T-Cell Leukemia/Lymphoma Lymphatic Diseases Subjects must meet all of the following to participate in this study: 1. Informed consent and HIPAA authorization for release of personal health information obtained. 2. Age ≥ 18 years at the time of consent. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2. 4. Histological confirmation of biopsy-proven peripheral T-cell leukemia/lymphoma consistent with ATLL Included subtypes will be: acute, lymphomatous, and chronic unfavorable. Chronic unfavorable is defined as the chronic variant with at least one of the following: lactate dehydrogenase (LDH)>upper limit of normal (ULN), blood urea nitrogen (BUN)>ULN, Albumin<lower limit of normal (LLN) Positive human T-lymphotropic virus-1 (HTLV-1) antibody testing with confirmatory testing via Western blot, enzyme-linked immunosorbent assay (ELISA), or molecular testing (PCR). 5. Documented negative serologic testing for human immunodeficiency virus (HIV). 6. If positive for HBV exposure or prior infection, can continue to participate in trial with prophylactic entecavir (for HBV). If positive for hepatitis c virus (HCV) exposure or active infection, can participate in trial with monitoring for liver function abnormalities. 7. Demonstrate adequate organ function as defined below; all screening labs to be obtained within three days prior to study treatment. System: Renal -Calculated creatinine clearance Laboratory Value: ≥ 30 mL/min using the Cockcroft-Gault formula for subjects with creatinine levels > 2.0 x institutional ULN System: Hepatic Bilirubin Laboratory Value: ≤ 3.0 mg/dL System: Hepatic Aspartate aminotransferase (AST) Laboratory Value: ≤ 2.5 × ULN System: Hepatic Alanine aminotransferase (ALT) Laboratory Value: ≤ 2.5 × ULN 8. Females of childbearing potential must have a negative serum pregnancy test within three days (72 hours) prior to initiating study treatment. NOTE: Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months. 9. Females of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 24 weeks (6 months) after treatment discontinuation. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method or an intrauterine device that meets <1% failure rate for protection from pregnancy in the product label. 10. Male patients with female partners must have had a prior vasectomy or agree to use an adequate method of contraception (i.e., double barrier method: condom plus spermicidal agent) starting with the first dose of study therapy through 24 weeks (6 months) after the last dose of study therapy. 11. As determined by the enrolling physician or protocol designee, willingness and ability of the subject to understand and comply with study procedures 12. Prior Treatment: Previously untreated or has received a maximum of one cycle of any combination chemotherapy (e.g. cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP), CHOEP, DA-EPOCH, doxorubicin, cyclophosphamide, cytarabine, vincristine, methotrexate/Etoposide, ifosfamide, cytarabine, methotrexate (CODOX-M/IVAC), HyperCVAD) within 4 weeks of signing the main consent form. Additionally, a patient may have taken antiretroviral therapy (e.g. azidothymidine (AZT) and/or IFN) at any time prior to study enrollment 13. CD30 expression determined by flow cytometry or IHC. NOTE: If CD30 testing was previously done on the biopsy sample from diagnosis, this information will be collected. If CD30 testing was not done, an archival sample from the biopsy used for diagnosis will be requested and tested for CD30. CD30 testing will also be done on the bone marrow tissue collected from the bone marrow exam. If we are unable to obtain an archival sample or if the bone marrow exam is negative, a new biopsy will be performed to confirm the diagnosis and test for CD30 Subjects who meet any of the following should be excluded from study participation: 1. Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study). 2. Has a known additional malignancy that is active and/or progressive requiring treatment; exceptions basal cell or squamous cell skin cancer, in situ cervical or bladder cancer, or other cancer for which the subject has been disease-free for at least five years. 3. Previous exposure to brentuximab vedotin (BV). 4. History of allergic response to BV-CHEP or its components or to any of the required prophylactic medications or reasonable alternatives. 5. Symptomatic cardiac disease including ventricular dysfunction, left ventricular ejection fraction < 40%, symptomatic coronary artery disease or symptomatic arrhythmias 6. Subjects with severe hepatic insufficiency Child-Pugh Score > 6 7. Subjects with severe renal impairment (i.e., creatinine clearance ≤ 30 mL/min; see Appendix B Renal Impairment Guidelines). 8. patients with pre-existing neuropathy grade 2 or higher. 9. Patients receiving prohibited medications listed in the patient handout provided in 11.4 Appendix D: Prohibited Medications or Those to be used with Caution (ie, ketoconazole, itraconazole, ritonavir, macrolide antibiotics, erythromycin phenytoin, phenobarbital, carbamazepine, and valproic acid). 10. Patients with a parenchymal brain lesion thought to be consistent with active lymphoma on screening CT/MRI. Of note, patients with cerebrospinal fluid (CSF) involvement alone are not 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): 0.167-999.0, Tyrosinosis Hepatorenal Tyrosinemia Fumarylacetoacetase Deficiency Fah Deficiency Metabolic Disorders Informed consent will be obtained from the patient or the parents before any study related procedures Patients of both genders older than 2 months The patient has a diagnosis of Tyrosinemia type 1 or a high-grade suspicion for Tyrosinemia type 1 High-grade suspicion present, if one or more are valid Positive family anamnesis for Tyrosinemia type 1 Hepatomegaly Splenomegaly Ascites Coagulopathy No Informed consent from the patient or the parents before any study related procedures Patients of both gender younger than 2 months No diagnosis of Tyrosinemia type 1 or no valid for profound suspicion of Tyrosinemia type 1 | 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): 20.0-60.0, Bone Density Bone Loss Anorexia Nervosa Eating Disorder Atypical Anorexia Nervosa Inclusion/ Female Age 20-60 years, skeletally mature with closed epiphyses Anorexia nervosa or atypical anorexia nervosa defined by DSM-V diagnostic BMD T-score < -1.0 Normal serum 25-OH vitamin D (>30 ng/mL) and calcium levels For women of reproductive age, agree to use an effective contraceptive method. Highly effective methods of birth control Combined (estrogen and progestogen) hormonal methods (pills, vaginal ring, or skin patch) Intrauterine device (IUD) Intraduterine hormonal-releasing system (IUS) Surgery to tie both fallopian tubes (bilateral tubal ligation/occlusion) | 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): 4.0-18.0, Tooth Decay Children of at least 4 years of good general health (ASAI or II) Child with at least two temporary molars of the same type, 1st or 2nd molar, contralateral (fractional mouth), meeting the following The two temporary molars are affected by a cavitary carious lesion or a hypoplastic defect of at least 2 faces the two temporary molars of the pair (54-64, 55-65, 74-84 or 75-85), should or should not be subjected to pulpotomy prior to the realization of the CPP the two molars must have an antagonistic tooth Consent of parents (legal guardians) and child Child and parents (legal guardians) speaking French Child covered by his parents' social security cover Child cooperating in the vigilant or sedated state (cooperation evaluated with a Venham score 0, 1, 2) Child who does not cooperate in care under vigil or under conscious sedation, who must therefore be treated under general anesthesia Child allergic to local anesthetics, chromium or nickel. dental Primary molar whose physiological exfoliation will appear within 24 months or pimary molar with a root resorption of more than a third of the radicular length Severely decayed PM prohibiting the retention and the sealing of the restoration Primary molar with exposed cement or with evidence of swelling in the surrounding tissues Molar with spontaneous pain Primary molar in infraclusion Primary molar whose radiographic examination reveals a widening of the desmodontal space, the presence of radiolucent image on the root furcation and/or apices, internal or external resorption | 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, Burnout, Professional Criteria:Preschool classroom teacher who works in a center that is under the auspice of the School District of Philadelphia and serves exclusively low-income (≤300 % of poverty) children | 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 Patient at the age of 18 or above Patients with clinical diagnosis of prostate cancer Patients diagnosed to have ductal type of prostate 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): 18.0-60.0, Pain Edema Wound Heal Male and female patients with an age of 18 to 60 years; 2. Healthy patients (American Society of Anesthesiologists Physical Status (ASA PS) index ≤ 2); 3. Sole bilateral extractions of IMTMs during the same surgery; 4. Complete root formation of tooth No. 38 and 48 at radiological examination; 5. Absence of acute inflammation and/or infection in the IMTMs area; 6. No history of nonsteroidal anti-inflammatory drug (NSAID) use in the past 4 weeks prior to surgery; 7. Same-difficulty bilateral IMTM extractions, according to both Pederson and Juodzbalys & Daugela classifications; 8. Signed informed consent Smoking patients; 2. IMTM surgery duration difference greater than 10 minutes for each side, seeking to avoid bias; 3. Different surgical manipulations taken at each IMTM surgery site; 4. Presence of any neoplastic lesion (benign or malignant), clinically or radiologically evaluable, at the site or close to the impacted tooth; 5. Presence of any radiolucent lesion >1 cm at impacted tooth level; 6. Absence of the adjacent tooth; 7. Systemic conditions or pharmacological treatments altering oral microbiota or immunologic response; 8. Alcohol or drug abuse; 9. Pregnant or breastfeeding women; 10. Lack of compliance by the patient or any other evidence suggesting that the patient was not likely to follow the study protocol | 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): 40.0-80.0, Salt Hypertension From Excess Dietary Salt Lens Opacities Salt Sensitivity Hypertension patients Non-SSH, salt-resistant HT (SRH) patients Control patients without HT, aged 40-80 years Cataracts Diabetes Mellitus Smoking Hypo/hypercalcemia Hyperparathyroidism Eye trauma Coronary artery disease Cardiac failure Renal failure - | 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): 6.0-18.0, Dental Caries Extending to Pulp Pulp Disease, Dental Patients and parents of the patients who accept to participate and sign the informed consent Patients who have at least one vital permanent molar teeth with irreversible pulpitis symptoms Teeth which can be restorable after the treatment Teeth which has good periodontal health and in the absence of sinus tracts or swelling Patients and parents of the patients who does not accept to participate and sign the informed consent Teeth which have dentoalveolar or extraoral swelling Teeth which have periodontal disease, mobility or alveolar bone loss Teeth which are not restorable Patients who are not cooperative with 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): 25.0-60.0, Maxillary Sinus • Presenting a distance between alveolar crest and maxillary sinus of 2 to 9 millimeters History of periodontal surgery at the area on the last 12 months Use of drugs that affect periodontal tissues (eg: anticonvulsants, calcium channel blockers, cyclosporine, bisphosphonates, hormone-based, contraceptives, steroids) Pregnant Smokers Diabetics History of head and neck 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): 7.0-80.0, Facial Injuries Age 7-80 2. Male or Female Sex 3. Patients who have sustained a facial burn and are now in the chronic phase, or any patient experiencing facial tightness or limited range of motion due to other problems, including patients s/p radiation to the head and neck, trauma, scarring and scleroderma 4. Chief complaint(s) of limited mouth opening, difficulty chewing or speaking, decreased range of motion for oral structures, and/or limited facial expressions 5. Subject or caregiver (parent or guardian, in case of pediatric population) must be able to give informed consent 6. Subject or caregiver (parent or guardian, in case of pediatric population) must be able to perform exercises at home and must be able to record time spent using the devices. 7. Participants who are undergoing other treatment methods such as use of compression garments, skin grafting, radiation or other facial surgery, etc must suspend all of these treatments for the duration of the 2 month trial. 8. Internet access including access to FaceTime, Skype or Zoom and email access if electing telehealth option for enrollment planned or unplanned surgeries for facial skin grafting around lips or nose or oral commissure release during the upcoming 8 weeks 2. completion of any massaging or other stretching exercises or programs not specified by the investigators 3. use of new creams or topical treatments for the duration of enrollment in the study. 4. acutely burn-injured patients 5. incarceration, or pregnancy | 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, Bulging Body Fat Subject must be able to read, understand and sign the Informed Consent Form. 2. Female or Male, 18 to 65 years of age (inclusive). 3. Subject has visible fat bulges in the area to be treated. 4. Non-smoking for at least 6 months and willing to refrain from smoking for the duration of the study. 5. Subject must agree to not undergo any other procedure(s) in the treatment region during the study period. 6. Subject must adhere to the follow-up schedule and study instructions. 7. Subject must adhere to the same diet and/or exercise routine throughout the study, and agree to maintain the same weight throughout the study. 8. Willing to have digital photographs taken of the treatment area and agree to use of photographs for presentation, (educational and/or marketing), publications, and any additional marketing purposes. 9. For female subjects: not pregnant or lactating and is either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study Participation in a clinical trial of another device or drug within 3 months of study participation, or during the study period. 2. Any type of prior cosmetic treatment to the target area within 6 months of study participation. 3. Any prior invasive cosmetic surgery to the target area, such as liposuction. 4. Has a pacemaker, internal defibrillator, implantable cardioverter-defibrillator, nerve stimulator implant, cochlear implant or any other electronically, magnetically or mechanically activated implant. 5. Has metal implant(s) within the body, such as artificial heart valves. 6. Significant uncontrolled concurrent illness that in the opinion of the Investigator would make the subject unsuitable for inclusion. 7. History of any disease or condition that could impair wound healing. 8. History of keloid formation, hypertrophic scarring or abnormal/delayed wound healing. 9. Skin abnormality in the treatment area that in the opinion of the Investigator would make the subject unsuitable for inclusion. 10. Currently undergoing systemic chemotherapy or radiation treatment for cancer, or history of treatment in the target area within 3 months of study participation. 11. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study or a condition that would compromise the subject's ability to comply with the study 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): 45.0-70.0, Hypocalcemia; Dietary Postmenopausal woman Low contribution of elemental calcium in the daily diet Hypersensitivity to the active substances or to any of the excipients Renal insufficiency History of kidney or urinary stones Use in the last month of diuretics (furosemide, ethacrynic acid), aluminum salts and / or thyroid hormones Use of any other drug or experimental device during the 30 days prior to the selection | 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, Bell Palsy years or older exhibiting unilateral facial paralysis progressing to completion in 4 days or less No patients from vulnerable populations as listed above will be included Subjects must be able to travel to continually during the first 12 months following enrollment During the initial visit candidates must have no associated clinical signs or symptoms consistent with other causes of facial palsy. This includes but is not limited to: auricular papules, skin rashes, parotid masses, craniofacial trauma, and the presence of other cranial or distal neuropathies excluding facial numbness, change in taste, and/or hyperacusis Patients with atypical presentations will be referred for cross-sectional imaging and excluded Patients with histories consistent with possible recent tick exposure, rashes, headaches, or excessive fatigue will be serologically tested for Lyme disease and excluded if it returns positive Pneumothorax within the last two years is the only absolute medical (FF) Patients who are epileptics, or are claustrophobic, will be carefully counseled on the risks of HBOT before being allowed to enroll Patients with severe comorbidities will undergo evaluation by their primary care doctor and require physician approval 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): 18.0-999.0, Prostate Cancer Metastatic to Bone Male, 18 years or older Histologically confirmed prostate cancer Bone metastases (≥ 6 lesions) showing pathological uptake at bone scintigraphy WHO performance status of ≤2 Life expectancy of at least 6 months Castration-resistant disease: serum testosterone level of ≤ 1.7 nmol per liter (≤50 ng per deciliter) after bilateral orchiectomy or during maintenance treatment consisting of androgen-ablation therapy with a luteinizing hormone-releasing hormone agonist. During study treatment the maintenance androgen-deprivation therapy must be continued Baseline PSA ≥5 ng/ml with evidence of progressively increasing PSA values Symptomatic disease with either regular use of analgesic medication or treatment with external-beam radiotherapy for cancer-related bone pain within the previous 12 weeks Progression on or after treatment with docetaxel, or inability to receive docetaxel Adequate renal function (serum creatinine level ≤1.5 x ULN) Treatment with chemotherapy within the previous 4 weeks Continuation of treatment with abiraterone or enzalutamide Previous hemibody external radiotherapy Systemic radiotherapy with radioisotopes within the previous 24 weeks Malignant lymphadenopathy ≥3cm in the short-axis diameter Presence of visceral metastases Imminent of established spinal cord compression Active uncontrolled bacterial, viral or fungal infection History of another malignancy within the last five years except adequately treated basal cell carcinoma of the skin Organ allografts requiring immunosuppressive therapy | 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, Greater Trochanteric Pain Syndrome Over 18 years of age 2. Symptoms consistent with GTPS present for at least 6 months 3. Radiological diagnosis of GTPS using MRI, or ultrasound scan if MRI contraindicated 4. Failed conservative management in any other care setting 5. Patient is willing and able to provide written informed consent Lacks capacity to provide consent 2. Has hip joint osteoarthritis requiring treatment on a plain radiograph 3. Presence of confounding pathologies of the hip MRI 4. Any extensive surgery or deformity of the hip on X-ray. 5. Presence of systemic disorders -coagulopathy, active infection, immune system disorders, peripheral neuropathy, malignancy, unresolved fractures. 6. Had any surgical treatment specifically targeted at GTPS e.g. bursectomy/Ilio-tibial band lengthening 7. Pregnancy 8. Anti-coagulant therapy eg warfarin, rivaroxaban, apixaban, dabigatran 9. Haemaglobin <10g/dL or platelets < 150,000/ul 10. Unable to safely stop anti-platelet/NSAID medications eg. Recent cardiac stenting 11. Has lumbar-sacral spine pathology or a recent history of acute hip trauma 12. Has a recent history of acute sciatica 13. Is not able to attend or comply with treatment or follow-up scheduling 14. Participates in any 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): 40.0-999.0, Stenoses, Spinal At least 12 weeks of complaints of INC Magnetic resonance imaging showing LSS Age >40 years of age Sufficient knowledge of the Dutch language Signed informed consent History of lumbar spine surgery >2 lumbar levels operation or needed discectomy Degenerative spondylolisthesis > grade 1 (on a scale of 1 to 4), scoliosis or disc herniation ASA-classification >3 Serious psychopathology Pregnancy Active malignancy Plans to move abroad during 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, Hematologic Neoplasms Patient with malignant haematological pathology 2. Patient who must have an osteo-medullary biopsy for diagnostic purposes 3. Age ≥ 18 years 4. Performance Status < 3 5. Patient with no pelvic bone pain before 6. Patient with normal coagulation balance (TP, Activated Partial Thromboplastin Time, fibrin) and platelet count> 50 G / L 7. Patient affiliated to the social security scheme 8. Patient giving written consent before any specific procedure related to the study Patient regularly taking antalgic treatments from stage 2 or 3 2. Patient with congenital coagulation disorder or acquired or taking anticoagulant therapy such as: fluindione, acenocoumarol, warfarin, dabigatran, apixaban or rivaroxaban 3. Contraindication to a gas mixture composed of 50% Nitrous Oxide, 50% Oxygen administration: true allergy, severe respiratory failure requiring continuous oxygen therapy, emphysema, pneumothorax, history of air embolism or diving accident, epilepsy or uncontrolled neurological disorder, unsubstituted vitamin deficiency B12 and folic acid, abdominal gas distension 4. Any contraindication to the use of the headset: pacemaker or other implanted medical device 5. Pregnancy or breastfeeding 6. Persons deprived of liberty, under guardianship or under guardianship 7. Dementia, mental impairment or psychiatric condition that may compromise patient informed consent and / or protocol compliance and follow-up of the trial 8. Patient unable to undergo protocol monitoring for psychological, social, family or geographical reasons | 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, Edema Planned for total knee arthroplasty BMI ≥30 kg/m2, aged 18 or older Speaks, reads and understands Danish Written informed consent Peripheral Arterial Disease Arterial insufficiency No palpable puls at the arteria dorsalis pedis Severe atherosclerosis Leg ulcers Skin disease Fragile "tissue paper" skin Neuropathy or other cause of sensory impairment Allergy to the stocking material Massive leg edema or pulmonary edema from congestive cardiac failure | 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, Bell's Palsy Facial Nerve Paresis English as primary language Acute unilateral facial palsy without skin lesions which developed within a 72-hour period and is present for 21 days or less Moderate to severe facial palsy [House-Brackmann grade IV or greater] Another cause of facial nerve paralysis that is not idiopathic Otologic disease including otitis media, temporal bone fracture, a previous history of facial nerve palsy in either side, history of otologic surgery, and suspected Ramsay Hunt syndrome Systemic disease including history of tuberculosis, history of head and neck cancer, other neurological disorders, recent use of ototoxic medications, liver or renal dysfunction, and other illnesses that would contraindicate the use of high-dose steroid therapy Pregnancy | 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): 40.0-85.0, Osteoporosis Osteoporosis, Age-Related Osteoporosis Localized to Spine Age Related Osteoporosis Osteoporosis Senile Osteoporosis of Vertebrae Healthy ambulatory male from 40 to 85 years of age (inclusive) with primary osteoporosis or osteoporosis associated with hypogonadism The patient has a BMD T-score (based on the female reference range as assessed by the central imaging vendor) of ≤ -2.5 at the lumbar spine (L1-L4) or hip (femoral neck or total hip) by DXA or ≤-1.5 and with radiologic evidence of vertebral fracture or a documented history of low-trauma nonvertebral fracture sustained in the past 5 years. Men older than 65 years may be enrolled if they have a BMD T-score ≤ -2.0 even if they do not meet the fracture criteria Normal medical history, physical examination, including vital signs, and body mass index (BMI) Hypogonadal patients whose doses of androgens have been stable for at least twelve months before randomization are eligible and may continue therapy during the study Laboratory tests within the normal range including serum calcium (albumin-corrected), PTH, serum phosphorus and alkaline phosphatase, and thyroid stimulating hormone (TSH) values Presence of abnormalities of the lumbar spine that would prohibit assessment of spinal bone mineral density, defined as having at least 2 radiologically evaluable vertebrae within L1-L4 A BMD T-score of ≤-3.5 at the total hip, femoral neck, or lumbar spine based upon the female reference range Unevaluable hip BMD or patients who have undergone bilateral hip replacement Fragility fracture within the prior twelve months History of severe vertebral fracture or >2 moderate vertebral fractures History of bone disorders (e.g., Paget's disease) other than osteoporosis Patients with clinical signs of hypogonadism present at screening who plan to initiate testosterone replacement History of prior external beam or implant radiation therapy involving the skeleton other than radioiodine History of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular, gastrointestinal, endocrine, central nervous system, hematologic or metabolic diseases, or immunologic, emotional and/or psychiatric disturbances to a degree that would interfere with the interpretation of study data or compromise the safety of the patient History of Cushing's disease, growth hormone deficiency or excess, hyperthyroidism, hypo | 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, Rare Diseases Orphan Diseases first contact with the Center for Rare Diseases for unclear diagnosis suspicion of a rare disease but no established diagnosis attending the Center for Rare Diseases as an outpatient written informed consent age <12 years incomplete medical records including summary letters, imaging studies, blood tests etc pre-diagnosed disease(s) explaining all symptoms | 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): 18.0-99.0, Coronary Angiography Sedative Premedication elective coronary angiography planned PCI use of sedative medication at home use of alcohol | 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): 5.0-8.0, Pulp Disease, Dental Cooperative patient 2. Healthy 5-8 years old patient with at least one carious primary molar tooth at each side of the patient's mouth. 3. Presence of at least two-thirds of the root length radiographically. 4. Restorable tooth. 5. No signs of hyperemia and hemostasis will be adequately achieved with moistened cotton pellet within 5 minutes after coronal pulp amputation Teeth showing clinical and radiographic evidence of pulp degeneration such as history of spontaneous or nocturnal pain, tenderness to percussion or palpation, pathologic mobility, swelling or fistulous tract, periodontal ligament (PDL) space widening, internal root resorption, external root resorption, furcal radiolucency/inter- radicular bone destruction and/or periapical bone destruction. 2. Patients eliciting history of known allergy to pollens associated with propolis. 3. Parent or guardian refusal to participate | 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, Chronic Pain Adults over age 18 Have chronic pain (pain on most days or everyday) for the past 3 months or more Able to attend 1 CPSMP workshop a week over 6 weeks Able to attend 3-4 testing sessions for data collection (testing sessions are scheduled before the workshops begin and then six months, one year and, for those assigned to the control group, one and a half years after the start of the study) Chronic pain caused by current cancer diagnosis or an open wound Lack reliable transportation Having surgery for the painful area in the next year Not community-dwelling (i.e., living in a nursing home, assisted living or personal care home, mental hospital, or correctional facility) Not willing to be randomized to either start CPSMP workshop now or in six months Participation in another self-management program (e.g., Diabetes Self-Management Program) in the past 12 months Unable to speak English | 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, Oncology Pain, Acute Pain, Chronic The patient is over 18 years of age Irruptive oncological pain The patient has a mobile phone with Android operating system The patient has the physical ability to use the application The patient does not present psychological and / or cognitive alterations or problems with language that make their participation difficult The patient voluntarily wants to participate and signs the informed consent The patient is under 18 years The patient does not have a mobile phone or has a mobile phone in which Android is not the operating system (the app is currently only available for Android for economic reasons) The patient does not have the physical capacity to use the application The patient does not have the capacity to participate due to psychological and / or cognitive alterations or problems with language The patient does not want to participate | 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): 60.0-75.0, Kinesio Taping Knee Osteoarthritis • Female subjects aged 60 years and over, non-obese (BMI between 18.5 and 24.9 kg / m2), with diagnosis of knee OA according to the of the American College of Rheumatology (Altman et al. , 1986), which are: knee pain most of the day during the last weeks and age greater than 60 years (mandatory criteria), and at least two of the following stiffness after rest less than 30 minutes, crackle in the affected knee , joint increase of firm consistency, absence of temperature increase and painful hypersensitivity to palpation Individuals with radiographic signs of degeneration of the knee joint Individuals with any degree of degeneration according to the Kellgren-Lawrence scale Individuals with a pain scale above 3 according to NPRS Stiffness in the knee for at least 6 months prior to screening Stiffness during the beginning of activities Intermittent swelling Never have used KT Individuals with no history of associated joint disease or systemic rheumatic disease and / or history of surgery in the affected lower limb Individuals who are not under physiotherapeutic treatment during the intervention • Individuals who report pain during the procedure Individuals who do not complete the treatment time or who do not perform the evaluation procedures correctly, making it impossible to collect any of the data investigated Individuals with allergy to bandage or cutaneous injury in the region where KT will be applied Individuals who present hypertensive peak during the evaluations | 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): 40.0-999.0, Chronic Kidney Disease End Stage Kidney Disease Chronic Kidney Disease Mineral and Bone Disorder Renal Osteodystrophy Secondary Hyperparathyroidism Chronic kidney disease stage 3, 4 or 5 Stable dose of vitamin D for 2-months Dialysis Current use or treatment in the past one year with oral or inhaled glucocorticoids for more than 90 days Current use or treatment in the past one year with sex hormone/SERM therapy for more than 30 days Any use of bisphosphonates Use of anti-osteoporosis therapies (denosumab, teriparatide, calcitonin or anti-sclerostin antibodies) in last 2 years Any solid organ transplant or bone marrow transplant (Not including skin or cornea) Patients on non-aspirin anticoagulants that cannot be reasonably held for biopsy Any cancers within 5-yrs of diagnosis that were metastatic to bone, and that are not in complete remission Any history of leukemia, multiple myeloma, lymphoma, amyloid or paraproteinemias Any congenital or acquired collagen of bone diseases other than osteoporosis or renal osteodystrophy (Including but not limited to: Osteogenesis Imperfecta, X-Linked Hypophosphatemic Rickets, Pagets or Cushings 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, Squamous Cell Carcinoma of the Head and Neck Histologically or cytologically confirmed: stage II-IVB oral cavity, stage III-IVB larynx, stage III-IVB hypopharynx, or stage III-IVB HPV and/or p16 negative intermediate-high risk oropharynx head and neck cancer (AJCC 8th edition) 2. Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >10 mm by CT, PET/CT or MRI or >10 mm on visual inspection by clinical exam 3. Patients who are deemed resectable by ENT surgeon without pre-existing medical conditions that could inhibit surgery following neoadjuvant therapy, and do not refuse surgery 4. Written informed consent and HIPAA authorization obtained from the patient prior to performing any protocol-related procedures, including screening evaluations 5. Age > 18 years at time of study entry 6. ECOG performance status ≤ 1 7. Life expectancy ≥ 24 weeks 8. Body weight >30kg 9. Adequate normal organ and marrow function as defined below Hemoglobin ≥9.0 g/dL Absolute neutrophil count (ANC) 1.0 x 109/L (> 1000 per mm3) Platelet count ≥75 x 109/L (>75,000 per mm3) Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician AST (SGOT)/ALT (SGPT) ≤2.5 x institutional upper limit of normal Measured creatinine clearance (CL) >40 mL/min or Calculated creatinine CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance: Males: Creatinine CL (mL/min) = Weight (kg) x (140 Age) 72 x serum creatinine (mg/dL) Females: Creatinine CL (mL/min) = Weight (kg) x (140 Age) x 0.85 72 x serum creatinine (mg/dL) 10. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy) Participation in another clinical study with an investigational product during the last 3 months 2. Patients with active ILD / pneumonitis or with a history of ILD/ pneumonitis requiring steroids 3. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study 4. Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways) 5. Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) 30 days prior to the first dose of study drug for patients who have received prior TKIs [e.g., erlotinib, gefitinib and crizotinib] and within 6 weeks for nitrosourea or mitomycin C. (If sufficient wash-out time has not occurred due to the schedule or PK properties of an agent, a longer wash-out period may be required.) 6. Patients with QTc interval > 470 msec during screening 7. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. The following are exceptions to this criterion Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection) Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) 8. Any concurrent chemotherapy, IP, biologic, or hormonal therapy that is not part of standard NCCN indicated HNSCC adjuvant concurrent CRT. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable. 9. History of allogenic organ or bone marrow transplantation 10. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion Patients with vitiligo or alopecia Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement Any chronic skin condition that does not require systemic therapy Patients without active disease in the last 5 years may be included but only after consultation with the study physician Patients with celiac disease controlled by diet alone 11. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent 12. History of another primary malignancy except for Malignancy treated with curative intent and with no known active disease ≥3 years before the first dose of IP and of low potential risk for recurrence | 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): 18.0-85.0, Talus Fracture diagnosis of a closed, isolated, displaced talar neck or body fracture with 2 or more millimetres displacement, subsequently treated by ORIF age between 18 and 85 years informed consent to participate undisplaced fractures or involvement of both the neck and the body open fractures, talar head and peripheral fractures including posterior process, osteochondral fractures, primary arthrodesis or amputation history of severe neurological deficit previous foot surgery or trauma diagnosis of rheumathological diseases or psoriatic arthritis, foot neuropathy, severe vascular insufficiency and alcohol or drug abuse | 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, Alveolar Osteitis The are cooperative adult patients able to fulfil the study protocol needing surgical extractions of both lower third molars with similar surgical difficulty according to Pederson scale The are refuse to participate in the study failure to attend 24, 48, and 72 hours, as well as, 7 days post-surgical appointment visits smokers systemic diseases as diabetes mellitus or being immunosuppressed patients who take local or systemic antibiotics less than 3 months ago, anti-inflammatory or anticoagulant medication in the previous 4 weeks patients who require antibiotic prophylaxis pregnant or breastfeeding women patients with chronic periodontitis in active phase or | 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 Castration Resistant Prostate Cancer Patients must meet the following for study entry: 1. Patient who are at least 18 years of age who have provided written informed consent. 2. Histologically confirmed adenocarcinoma of the prostate without neuroendocrine or small cell differentiation. 3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 (see Appendix 1). 4. Patients must have progressed on prior enzalutamide, abiraterone and/or apalutamide for treatment of prostate cancer. 5. Determination of disease progression on second generation androgen receptor targeted agent determined by the local investigator. Progressive disease is defined by PCWG3 as any one of the following PSA progression: minimum of two rising PSA values from a baseline measurement with an interval of ≥ 1 week between each measurement. The PSA value at screening should be ≥ 1ng/ml Soft tissue or visceral disease progression as per modified 1.1 (see Appendix 2) Bone progression: ≥ 2 new lesions on bone scan (Appendix 2) 6. At least 2 weeks since the completion of surgery or radiotherapy prior to registration. Any clinically relevant sequelae from the surgery or radiotherapy must have improved to grade 1 prior to registration. 7. Prior surgical orchiectomy or chemical castration maintained on luteinizing hormone-releasing hormone (LHRH) analog (agonist or antagonist). Patients without prior surgical castration must be currently taking and willing to continue luteinizing hormone-releasing hormone (LHRH) analog (agonist or antagonist) therapy throughout the duration of study treatment. 8. Serum testosterone levels ≤ 50ng/dL. (≤ 1.75nmol/L) within 28 days before registration. 9. Imaging evidence of metastatic disease documented with either bone scan or CT scan (Appendix 2). 10. Prior prostate cancer vaccine therapy, radiation therapy, systemic therapies, diethylstilboestrol (DES) or other estrogens are allowed up to 28 days prior to trial registration. Note: bicalutamide flutamide or nilutamide must be discontinued within 4 weeks of registration. 11. Significant PSMA avidity on 68Ga/18F-PSMA PET/CT, defined as a minimum uptake of SUVmax 20 at a site of disease, and SUVmax > 10 at other sites of disease ≥10mm (unless subject to factors explaining a lower uptake, e.g. respiratory motion, reconstruction artefact). 12. Patients must have a life expectancy ≥ 24 weeks. 13. Patients must agree to use a highly effective form of contraception for the entire duration of the study plus an additional 120 days (a spermatogenesis cycle) after the last dose of study treatment and refrain from donating sperm during this period (see section 10.3.3). 14. Patients must be willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled assessments. 15. Patients must have adequate bone marrow, hepatic and renal function documented within 28 days of registration, defined as Haemoglobin ≥90 g/L independent of transfusions (no red blood cell transfusion in last 4 weeks) White blood cells >3x109/L Absolute neutrophil count ≥1.5x109/L Platelets ≥100 x109/L Total bilirubin ≤1.5 x upper limit of normal (ULN) except for patients with known Gilbert's syndrome Aspartate transaminase (AST) (SGOT) and alanine transaminase (ALT) (SGPT) ≤2.5 × ULN or ≤5 × ULN for participants with liver metastases Site(s) of disease that are FDG positive with low PSMA expression defined by PSMA SUVmax < 10. 2. Previous history or presence of brain metastases or leptomeningeal metastases. 3. Any prior exposure to anti-PD-1, anti-PD-L1/L2, anti-CTLA-4 antibody or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathway. 4. Any prior treatment with cabazitaxel. 5. Any prior exposure to 177Lu-PSMA. 6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 7. Patients with active, known or suspected autoimmune disease including Sjogren's syndrome. Patients with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are eligible. 8. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients. 9. Participants must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Participants with ≤ Grade 2 neuropathy may be eligible. 10. Patients with a condition requiring systemic treatment with either corticosteroids (> 10mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of registration. Inhaled or topical steroids, and adrenal replacement doses ≤ 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. 11. Other malignancies within the previous 2-years other than, melanoma in situ, basal cell or squamous cell carcinomas of skin with a > 30% probability of recurrence within 12 months. 12. Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection. 13. Patient has a known history of Human Immunodeficiency Virus (HIV). 14. Patients with symptomatic or impending cord compression unless appropriately treated beforehand and clinically stable for ≥ 4 weeks. 15. Previous history of interstitial lung disease or non-infectious pneumonitis. 16. Recent administration of a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed. 17. Recent administration of the influenza vaccine (within 30 days of 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): 18.0-50.0, Articular Cartilage Disorder of Knee Given written informed consent on the IRB approved consent form specific to the study, prior to study participation 50 years old Male or Female Suspected chondral damage in the following locations where debridement is indicated Medial femoral condyle Lateral femoral condyle Trochlea Patella < 30% joint space narrowing as seen on x-ray (merchant view, AP and PA Rosenberg) or more chondral lesion(s) as noted on MRI Previous chondral treatment in the same compartment (prior debridement and lavage performed more than three months prior to baseline are acceptable) Focal chondral defect indicated for concomitant procedures (i.e., microfracture, ACI, MACI, OATs) Concomitant procedures that are not allowed Lateral retinacular release Excision of osteophytes Subchondroplasty Manipulation under anesthesia ACL reconstruction Quad tendon repair Patellar tendon repair | 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, Bone Metastases Patients who sign the informed consent form and are willing to complete the study according to the plan; 2. Age 18-80 years old; 3. ECOG score ≤ 2 points; 4. CT shows that the main lesion is considered to be ground glass nodular lung cancer; 5. Preoperative examination CEA <5ng/ul 6. There are no bone related symptoms 7. There is no obvious absolute surgical contraindication for preoperative examination History of bone related diseases. 2. History of other kinds of 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): 18.0-65.0, Orofacial Pain When pain attacks, the average unilateral orofacial pain severity >=5 point measured by a 10-point VAS scale Patient with trigeminal neuralgia can be diagnosed according to Trigeminal neuralgia: New classification and diagnostic grading for practice and research (Neurology, 2016) Other kinds of orofacial pain can be diagnosed based on the patient's symptoms Provide written inform consent Free of any other diagnosed psychological conditions with any other diseases such as cardiovascular, renal, neurological, digestive, hepatic, respiratory disease Pregnancy or lactation Participation in a clinical study that may interfere with participation in this study History of or current tobacco, alcohol use Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study Unable to provide written informed consent due to any reason | 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, Quality of Life Parastomal Hernia permanent active sigmoideostomy, transverseostomy, jejunostomi or ileostomy temporary active sigmoideostomy, transverseostomy, jejunostomi or ileostomy age younger than 18 years stoma closure at follow-up death | 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, Wound Heal Healthy patients above 18 years old with mirror image vertical or mesioangular bilateral impacted mandibular third molars Missing second molars or indicated for extraction (un-restorable and remaining roots) Patients under immunosuppressant and patients with acute infection Patients who fail to attend for follow-up appointments | 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): 50.0-85.0, Osteoporosis, Postmenopausal Osteoporosis Osteoporosis Vertebral Osteoporosis Risk Osteoporosis Fracture Osteoporosis Localized to Spine Osteoporosis, Age-Related Osteoporosis Senile Osteoporosis of Vertebrae Subject must meet all of the following to be eligible to participate in this study: 1. The subject is a healthy ambulatory postmenopausal female from 50 to 85 years of age (inclusive) with osteoporosis. 2. The subject has been postmenopausal for at least 5 years. Postmenopausal status will be established by a history of amenorrhea for at least 5 years and by an elevated follicle stimulating hormone (FSH) value of ≥ 30 IU/L. 3. The subject has a BMD T-score ≤ -2.5 at the lumbar spine (L1-L4) or hip (femoral neck or total hip) by DXA or lumbar spine or hip BMD T-score ≤ -2.0 with a history of low trauma vertebral, forearm, humerus, sacral, pelvic, hip, femoral, or tibial fracture sustained within 5 years prior to enrollment. These fractures must be documented by radiograph or hospital report. 4. The subject is in good general health as determined by medical history and physical examination (including vital signs), has a body mass index (BMI) of 18.5 to 33, inclusive, and is without evidence of clinically significant abnormality in the opinion of the Investigator. 5. The subject has serum calcium (albumin-corrected), PTH (1-84), phosphorus, and alkaline phosphatase levels all within the normal range during the Screening Period. Any patient with an elevated alkaline phosphatase value, and who meets all other entry is required to have a normal bone-specific alkaline phosphatase result to be enrolled. 6. The subject has serum 25-hydroxyvitamin D values ≥ 20 ng/mL and within the normal range. Patients with serum 25-hydroxyvitamin D levels < 20 ng/ml may be treated with vitamin D3 and re-tested once. 7. The subject's resting 12-lead electrocardiogram (ECG) obtained during screening shows no clinically significant abnormality. 8. The subject has read, understood, and signed the written informed consent form Subjects with any of the following characteristics are not eligible to participate in the study: 1. Presence of abnormalities of the lumbar spine that would prohibit assessment of lumbar spine BMD, defined as having at least 2 radiologically evaluable vertebrae within L1-L4. 2. Unevaluable hip BMD or patients who have undergone bilateral hip replacement (unilateral hip replacement is acceptable). 3. History of bone disorders (eg, Paget's disease) other than postmenopausal osteoporosis. 4. Clinically significant abnormality of serum hemoglobin, hematocrit, white blood cells (WBC) and platelets, coagulation, or usual serum chemistry: electrolytes, renal function, liver function and serum proteins. 5. Unexplained elevation of serum alkaline phosphatase. 6. History of radiotherapy (radiation therapy), other than radioiodine. 7. History of bleeding disorder that would preclude a bone biopsy, in the opinion of the Investigator. 8. History of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular, gastrointestinal, endocrine, central nervous system, hematologic or metabolic diseases, or immunologic, emotional and/or psychiatric disturbances to a degree that would interfere with the interpretation of study data or compromise the safety of the patient. 9. History of Cushing's disease, hyperthyroidism, hypo or hyperparathyroidism, or malabsorptive syndromes within the past year. 10. History of significantly impaired renal function (serum creatinine > 177 µmol/L or > 2.0 mg/dL). If the serum creatinine is > 1.5 and ≤ 2.0 mg/dL, the calculated creatinine clearance (Cockcroft-Gault) must be ≥ 30 mL/min. 11. History of any cancer within the past 5 years (other than basal cell or squamous cell cancer of the skin). 12. History of osteosarcoma at any time or a history of hereditary disorders which could predispose the patient to osteosarcoma. 13. History of nephrolithiasis or urolithiasis within the past five years. 14. Subjects known to be positive for hepatitis B, hepatitis C, human immunodeficiency virus infection (HIV-1 or HIV-2). Testing is not required in the absence of clinical signs and symptoms suggestive of HIV infection or acute or chronic hepatitis | 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, Periodontal Attachment Loss Periodontal Bone Loss Periodontal Diseases a full-mouth plaque score (FMPS) 25 and a full-mouth bleeding score (FMBS) 26 < 20% at the time of surgery to have at least 20 teeth at least 1 tooth exhibiting vertical bone loss detected by radiographic examination (alveolar crest level [ ACL] bottom of the defect [ BD] distance = Bone defect depth [ BDD]) ≥ 4 mm and a probing pocket depth (PPD) ≥ 5mm when evaluated 12 weeks after phase I non surgical therapy [ scaling and root planing ( SRP)] no systemic diseases no medications affecting periodontal status during the previous 6 months not pregnant or lactating non-smoker no periodontal therapy in the 2 previous years no inadequate endodontic treatment, no dental mobility | 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, Renal Osteodystrophy Patients with reduced renal function: -≥ 18 years estimated Glomerular Filtration Rate (eGFR) ≤ 20 ml/min/1,73m2 PTH < 150 pg/ml or PTH > 300 pg/ml ongoing malignancy Allergy towards tetracyclin Pregnancy Control Group: -≥ 18 years eGFR >= 60 ml/min under examination for c prostata Prostatic Specific Antigen (PSA) total <40 µg/l Former kidney disease ionized calcium or PTH outside normal range Known metabolic bone disease treatment with anticoagulants | 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, Bariatric Surgery Candidate Male Hypogonadism Muscle Loss Eligible for bariatric surgery according to the Danish national (i.e. aged 18-60 years, BMI >35 kg/m2 with specific secondary disease or BMI >40 kg/m2 with significant health issues assessed by the multidisciplinary bariatric team) [42] Caucasian men Total testosterone < 12.0 nmol/l No contraindications for testosterone treatment Previously diagnosed with prostate, mammae or liver cancer. Any other cancer within the last 5 years Hypersensitivity to the active substance or to any of the excipients in Nebido® Symptomatic heart disease NYHA >2 Recently thromboembolic disease <3 months PSA >4.0 ug/l or PSA>3.0 ug/l and lower urinary tract symptoms Disability that severely affect the ability to perform exercise training EVF > 52% | 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, Peripheral Neuropathic Pain Radiculopathy Lower Back Pain History, symptoms and clinical findings consistent with painful radiculopathy in lower extremity(ies) ("probable" or "definite") for at least 3 months, with or without lower back pain. The pain in the extremity(ies) must dominate Understand Norwegian or Swedish language (written and spoken) Usual pain intensity ≥ 3.5 / 10 (NRS 0-10) Absolute Opioid dose > 100 mg morphine equivalents / day Ongoing litigation Mental / psychiatric disorder that may affect treatment Chronic generalized pain Pregnancy Hypersensitivity to local anesthetics Serious or unclear medical condition such as angina pectoris, severe vascular disorder, infection, malignancy disease, bleeding disorders Laminectomy in or above level for planned epidural access Spine surgery the last 3 months Relative | 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): 5.0-8.0, Pulpotomy Children Children aged 5-8 years with at least two bilateral deep carious primary molars indicated for pulpotomy Children who are physically and mentally healthy without any known medical history of systemic conditions contraindicating pulp therapy Children who had "positive" or "definitely positive" behavioral ratings according to the Frankl behavior classification scale (Frankl, 1962) Children whose parents signed an informed consent for the child's participation in the study. Teeth Teeth were selected according to clinical and radiographic criteria. Clinically, the study included Teeth with restorable crowns Teeth with pathologic carious exposure of vital pulps Teeth with no tenderness to percussion, physiologic or pathologic mobility or any clinical evidence of pulp inflammation or degeneration such as history of swelling, pain or presence of sinus tract. Radiographically, the recruited teeth should have Normal radiographic appearance with healthy supporting tissues No pulp calcification Any child complained of clinical signs such as pain, swelling, abnormal mobility, vertical or lateral tenderness to percussion was excluded from the study Radiographically, any child with signs of internal or external root resorption or periapical or inter-radicular pathology was omitted from 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): 8.0-11.0, Schistosomiasis School children, of public schools in villages of Saint Louis region (Senegal), female or male, 8 to 11 years old (inclusive) at the time of inclusion Residence in the area during the period of the study Free of obvious/severe health problems except schistosomiasis, as established by clinical examination Written informed consent to participate obtained from subject's parents or legal guardian Free of obvious/severe health problems except schistosomiasis, established by blood analysis, i.e. hematological exams, liver and renal function tests Treated with 40mg/kg Praziquantel (PZQ) before (W-2 to W-4 before the first injection) in case of infection with S. mansoni and S. haematobium Children of Group 1: not infected, no schistosomiasis history and living in area/village free of Sm and Sh transmission Children Groups 2 & 3: infected with mansoni or/and haematobium schistosomiasis School child who does not respond to one of the Child under 20kg of body weight Vaccination within 90 days preceding the first dose of Sm14 vaccine candidate, or planned use during the study period Current or previous chronic administration (defined as more than 14 days) of immunosuppressive drugs or other immuno-modifying drugs Known hypersensitivity to any component in the Sm14 vaccine or history of allergic disease Knowledge of non-infectious chronic disease Known acute disease Other conditions which in opinion of the PI may potentially represent a danger for the patient to be enrolled | 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): 50.0-999.0, Osteoporosis, Postmenopausal Women at least 50 years of age who are postmenopausal. Postmenopausal is defined as being amenorrheic for at a period of at least 12 months. 2. Diagnosis of osteoporosis by T score of < -2.5 at either lumbar spine or the hip/femoral neck, or osteopenia that qualifies for treatment by FRAX calculation (10-year risk of hip fracture > 3% and/or major osteoporotic fracture of > 20%). 3a. Subjects who have had chronic treatment of denosumab (as defined as > 1 year [at least 3 6-monthly injections]) or zoledronic acid (defined as ≥ 2 years [at least 2 annual injections]) . Note: At the time of treatment initiation, subjects must have met for on-label use (e.g. criterion 2 above). OR 3b. Subjects who are naïve to treatment with denosumab and/or zoledronic acid Renal insufficiency, with glomerular filtration rate (GFR) < 35 ml/min. 2. Hypocalcemia within 6 months of study initiation. 3. Known hypersensitivity to denosumab or zoledronic acid. 4. Medications that could alter bone turnover including prednisone, anti-rheumatic medications, anti-metabolites (Cytoxan). Subjects who have been on stable doses of thyroid replacement or diabetes medications for more than 3 months are eligible. 5. Evidence of untreated oral cavities or oral infections. Preventative dental exams should be performed before starting denosumab or zoledronic acid. Subjects must avoid invasive dental procedures during treatment with denosumab or zoledronic acid | 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 Patients must have histologically confirmed prostate adenocarcinoma that is metastatic and castration resistant (mCRPC) At least 3 metastatic foci avid for PSMA-specific PET agent (CTT1057) uptake on Screening PSMA PET Has received docetaxol, ineligible for docetaxol, or refused docetaxol for the treatment of prostate cancer Has progression by the PCWG3 during or after treatment with either abiraterone or enzalutamide Male Age ≥ 18 years Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (see Appendix 2). Demonstrate adequate organ function Has received previous treatment with radium-223 or another radiopharmaceutical within 3 months prior to first dose of CTT1403 Has received cabazitaxel for the treatment of mCRPC Has received previous treatment with a therapeutic targeting PSMA Has an additional active malignancy requiring therapy that may confound the assessment of the study endpoints Has clinically significant cardiovascular disease Has a history of untreated brain metastases Has a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days before CTT1403 administration Has known positive status for chronic hepatitis B or hepatitis C Known or suspected myelodysplastic syndrome Has any medical condition which in the opinion of the Investigator places the patient at an unacceptably high risk for toxicities | 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): 16.0-70.0, Infection Patient age from 16 to 70 yrs old Patient needs surgical teeth extraction (subject tooth will be removed using osteotomy by motorised drill) Patients refusing the preoperative dose of oral co-amoxiclav, and unwilling to take part Patients who are allergic to co-amoxiclve, amoxicillin or metronidazole Patient are on warfarin medication | 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 Disease Subject that participated in ZiPP Participant willing and able to consent and comply with the study protocol Unable or unwilling to provide 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): 18.0-99.0, Vulvar Paget's Disease Vulvar Paget 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, Dentofacial Deformities Regional Anesthesia Morbidity patients who undergo scheduled bimaxillary surgery the refusal to participate in the study patients who are scheduled for bimaxillary surgery together with another complementary surgical procedure (such as mentoplasty, rhinoplasty, blepharoplasty) age <18 years reinterventions urgent surgeries allergies to local anesthetics allergies to anti-inflammatories agents allergies to opioids American Society of Anesthesiologists Physical Status Classification (ASA) ≥3 | 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): 1.0-31.0, B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Down Syndrome All B-ALL patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to treatment and enrollment on AALL1731. APEC 14B1 is not a requirement for B-LLy patients. B-LLy patients may directly enroll on AALL1731 Age at diagnosis Patients must be >= 365 days and < 10 years of age (B-ALL patients without DS) Patients must be >= 365 days and =< 31 years of age (B-ALL patients with DS) Patients must be >= 365 days and =< 31 years of age (B-LLy patients with or without DS) B-ALL patients without DS must have an initial white blood cell count < 50,000/uL (performed within 7 days prior to enrollment) B-ALL patients with DS are eligible regardless of the presenting white blood cell count (WBC) (performed within 7 days prior to enrollment) Patient has newly diagnosed B-cell ALL, with or without Down syndrome: > 25% blasts on a bone marrow (BM) aspirate OR if a BM aspirate is not obtained or is not diagnostic of B-ALL, the diagnosis can be established by a pathologic diagnosis of B-ALL on a BM biopsy OR a complete blood count (CBC) documenting the presence of at least 1,000/uL circulating leukemic cells Patient must not have secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy. Note: patients with Down syndrome with a prior history of transient myeloproliferative disease (TMD) are not considered to have had a prior malignancy. They would therefore be eligible whether or not the TMD was treated with cytarabine With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B ALL or B LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1731 For patients receiving steroid pretreatment, the following additional apply Non-DS B-ALL patients must not have received steroids for more than 24 hours in the 2 weeks prior to diagnosis without a CBC obtained within 3 days prior to initiation of the steroids DS and non-DS B-LLy patients must not have received > 48 hours of oral or IV steroids within 4 weeks of diagnosis Patients who have received > 72 hours of hydroxyurea B-ALL patients who do not have sufficient diagnostic bone marrow submitted for APEC14B1 diagnostic testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells Patient must not have acute undifferentiated leukemia (AUL) Non-DS B-ALL patients with central nervous system [CNS]3 leukemia (CNS status must be known prior to enrollment) Note: DS patients with CNS3 disease are eligible but will be assigned to the DS-High B-ALL arm. CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment | 0 |
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