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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, Inadequate Bone Height in Maxillary Posterior Area Over 18 years old who are able to read and sign written consent form. 2. Patient who has good oral hygiene (Full-mouth plaque score <25%). 3. Subject would be available for study monitoring. 4. Patients with missing teeth in the maxillary posterior region who will require sinus augmentation f or implant placement. The patients may be partially or completely edentulous. 5. Delayed implant placement approximately 8 months following sinus grafting A medical history that will complicate the outcome of the study such as: 1. alcohol, drug dependency, 2. signs or symptoms of maxillary sinus disease, 3. current smoker, 4. history of head and neck radiation treatment, 5. poor health or any other medical, physical or psychological reason that might affect the surgical procedure or the subsequent prosthodontic treatment and/or required follow-up examinations | 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): 18.0-89.0, Atypical Facial Pain Persistent Idiopathic Facial Pain Atypical Trigeminal Neuralgia Neuropathic Orofacial Pain Neuropathic Facial Pain The patient is at least 18 years but no more than 89 years of age The patient has atypical facial pain/persistent idiopathic facial pain, as diagnosed by the 2nd Edition of The International Headache Classification (ICHD-2), section 13.18.4 The patient has constant pain in the face, persisting for all or most of the day (four or more hours per day) and present four days or more per week, with a severity of 5 or more (11-point scale, 0 = no pain, 10 = worst pain imaginable) The pain is chronic, present for at least six months The patient's pain is confined at onset to a limited area on one side of the face, and is deep and poorly localized The patient's pain is not associated with sensory loss or other physical signs, and diagnostic studies of face and jaws do not demonstrate any relevant abnormality Patient must be willing to refrain from opioid medications during the course of the trial Patients entering the study on other approved concomitant medications for pain (e.g., anticonvulsants, antidepressants) must continue them as a stable regimen for at least two weeks prior to Pre-Screening and throughout the study period The patient must agree to limit their rescue medications to APAP (Paracetamol/ acetaminophen) The patient must understand and be willing to cooperate with the study instructions, including attendance of all scheduled office visits and returning unused medication and vials The patient has predominantly paroxysmal facial pain consistent with the diagnosis of classical trigeminal neuralgia or symptomatic trigeminal neuralgia The patient's facial pain has an identifiable cause The patient has a positive urine drug screen during the screening visit The patient has a history of substance abuse and/or dependency (including but not limited to opioid and/or alcohol dependence) The patient has been on chronic opioid therapy or has taken opioid medication ≤ 7 days prior Pre-Screening The subject has a history of significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, or metabolic disease. The subject has acute hepatitis or liver failure The subject has a history of left ventricular hypertrophy, recent MI, angina, palpitations, dyspnea, or arrhythmia The subject has used MAO Inhibitors within 30 days of enrollment The patient has a history of an allergic reaction to the components in the trial medication The patient is pregnant or breastfeeding | 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, Bladder Cancer TNM Staging Primary Tumor (T) Ta Bladder Cancer TNM Staging Primary Tumor (T) T1 Bladder Cancer Transitional Cell Grade histologically proven primary stage pTa-pT1 urothelial bladder cancer adequate bone-marrow reserve (ie, white-blood-cell count ≥4000 × 10⁶ cells per L; platelet count ≥120 × 10⁹/L) normal renal function (ie, serum creatinine ≤123·76 μmol/L) normal liver function (ie, serum glutamic-oxaloacetic aminotransferase ≤42 U/L, serum glutamic-pyruvic aminotransferase ≤48 U/L, and total bilirubin ≤22 μmol/L) Eastern Cooperative Oncology Group performance status between 0 and 2 non-urothelial carcinomas of the bladder previous or concomitant grade G3 urothelial and/or carcinoma in situ of the bladder urothelial carcinoma of the upper urinary tract and urethra, or both previous intravesical treatment with chemotherapeutic and immunotherapeutic drugs known allergy to mitomycin bladder capacity less than 200 mL untreated urinary-tract infection; severe systemic infection (ie, sepsis) treatment with immunosuppressive drugs urethral strictures that would prevent endoscopic procedures and catheterisation | 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): 20.0-90.0, Breast Cancer 18F-FDG PET Age：20-90 years old 2. Histological proven breast cancer, with known metastatic bone lesion(s) 3. written informed consent signed pregnant or intend to be pregnant 2. other malignancies known | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Adenocarcinoma of the Prostate Hormone-resistant Prostate Cancer Recurrent Prostate Cancer Stage IV Prostate Cancer Documentation of Disease Progressive castration-resistant metastatic prostate cancer with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features 2. Patients must have measurable or non-measurable disease: 1. Measurable Disease For visceral or extra nodal lesions to be considered measurable, they must be ≥ 10 mm in one dimension, using spiral CT. For lymph nodes to be considered measurable (ie, target or evaluable lesions), they must be ≥ 20 mm in at least one dimension, using spiral CT. 2. Non-Measurable Disease All other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly non-measurable lesions. Lesions that are considered non-measurable bone lesions (only). 3. Patients with node only disease (ie, no presence of visceral, extra nodal lesions or bone lesions) must have node(s) that measure ≥ 15 mm in short axis. 3. Progressive Disease Patients must have progressive disease at study entry defined as one or more of the following three that occurred while the patient was on androgen deprivation therapy. For patients enrolling on the basis of soft tissue or bone progression, the baseline scan must show progression relative to a comparison scan. If the comparison scan is not available, the baseline scan report must reference the previous scan to document progression. 1. PSA progression defined by a minimum of two rising PSA levels with an interval of ≥ 1 week between each determination. Patients who received an anti-androgen must have progression documented by a minimum of two rising PSA levels with an interval of ≥ 1 week between each determination such that at least the second of these rises is ≥ 4 weeks since last flutamide, bicalutamide or nilutamide. The PSA value at the screening should be ≥ 2 µg/L (2 ng/mL) . 2. Soft tissue disease progression defined by the protocol 3. Bone disease progression defined by the Prostate Cancer Working Group 2 (PCWG2) with two or more new lesions on bone scan 4. Prior Treatment 1. No treatment with prior taxane-based chemotherapy for metastatic disease Patients who received prior taxane-based chemotherapy as neoadjuvant or adjuvant therapy for local disease, or who received taxane-based therapy in the PSA clinical (non-metastatic) state is allowable provided that the total duration of exposure was six cycles or less and chemotherapy was completed more than 6 months prior to registration Taxane-based chemotherapy that was aborted due to allergic reactions or intolerance to chemotherapy and therefore received one cycle of prior therapy is allowable 2. No prior enzalutamide, abiraterone or other novel antiandrogen or androgen synthesis inhibitor 3. No treatment with any of the following for prostate cancer within 4 weeks prior to enrollment Hormonal therapy (e.g., androgen receptor [AR] antagonists, 5 alpha reductase inhibitors, estrogens) Note: Treatment with bicalutamide and nilutamide within 4 weeks prior to enrollment is not allowed. Treatment with flutamide within 4 weeks prior to enrollment is not allowed. Treatment with all other gonadotropin releasing hormone (GnRH) analogues or antagonists is allowed Chemotherapy | 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, The Focus of the Study is the Quality and Amount of Regenerated Articular Cartilage. Participant is willing and able to give informed consent for participation in the study Male or Female, aged 18 years to 65 years Diagnosed with articular cartilage defect in the knee (ICRS/Outerbridge grade III/IV cartilage lesions as assessed on MRI scan) No other significant medical co-morbidities, as assessed by pre-operatively, that could interfere with surgery results of trial eg. Hypertension, COPD etc Participant has clinically acceptable laboratory and ECG tests at pre-assessment clinic Able (in the Investigators opinion) and willing to comply with all study requirements Up to 3 lesions of sizes 2-8 cm2 Generalized and/or inflammatory arthritis Active joint inflammation More than 5 degrees of varus or valgus deformity Age below 18 and over 65 years More than 4 lesions Lesions more than 8 cm2 Significant co-morbidities or classified as ASA grade 3/4 | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 19.0-999.0, Chronic Pain Pain Widespread Chronic Pain Chronic Pain Syndrome Chronic Pain Due to Injury Must be at least 19 yrs-old in order to consent to treatment. 2. Must have received at least one diagnosis consistent with chronic pain by a physician at one of the participating primary care clinics. 3. Must have experienced pain most days of the month for 3 months, and although pain may have more than one pain source, all pain must be non-malignant (e.g., not cancer or HIV-related). 4. Must be able to speak and understand English. 5. Must have a telephone or other avenue of communication for contact regarding the study Must not demonstrate significant cognitive impairment (based on results of a cognitive screener). 2. Must not have current, uncontrolled serious psychological disturbance (e.g., schizophrenia, bipolar disorder) or active substance abuse (based on responses to a structured diagnostic interview). 3. Must have minimal literacy skills (i.e., read at the 1st grade level). 4. Must have been stabilized for at least 4 weeks on current pain and psychotropic medication regimen to reduce potential confounds to treatment results. 5. Must not have a surgery scheduled for the intervention period (~3 months). 6. Must neither be currently receiving a psychosocial treatment for pain (though they may be receiving psychotherapy for non-pain difficulties) nor be a participant in our previous treatment studies | 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): 40.0-65.0, Adult Lymphoblastic Lymphoma Disease ALL in complete remission (CR) at the time of transplant. Remission is defined as "less than 5.0% bone marrow lymphoblasts by morphology," as determined by a bone marrow aspirate obtained within 2 weeks of study registration Philadelphia chromosome positive ALL is allowed Lymphoid blastic crisis of CML will be included (provided that patients achieve CR) Age Equal or above age 40 and up to 65 years. If younger than 40, there must be comorbidities which preclude the patient to undergo CyTBI conditioning regimen Organ Function All organ function testing should be done within 28 days of study registration Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA (Multi Gated Acquisition) scan or echocardiogram Pulmonary: FEV1 (Forced expiratory volume in 1 second) and FVC (Forced vital capacity) ≥ 50% predicted, DLCO (alveolar diffusion capacity for carbon monoxide) (corrected for hemoglobin) ≥ 50% of predicted Renal: The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula: CrCl = (140-age) x weight (kg) x 0.85 (if female)/72 x serum creatinine (mg/dL) Hepatic Non-compliant to medications No appropriate caregivers identified HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive Active life-threatening cancer requiring treatment other than ALL Uncontrolled medical or psychiatric disorders Uncontrolled infections, defined as positive blood cultures within 72 hours of study entry, or evidence of progressive infection by imaging studies such as chest CT scan within 14 days of registration Active central nervous system (CNS) leukemia Preceding allogeneic HSCT Receiving intensive chemotherapy within 21 days of registration. Maintenance type of chemotherapy will be allowed | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Breast Cancer Nos Metastatic Recurrent Women Aged 18 years and over With an invasive breast cancer diagnosed by cytology or histology Tumors cT0 to cT3, CN0-3 No clinical evidence of metastasis at the time of Untreated including scored for breast cancer surgery in progress Patient receiving a social security system Patient mastering the French language Free and informed consent for additional biological samples, different questionnaires and collecting information on resource usage Metastatic breast cancer Local recurrence of breast cancer History of cancer within 5 years prior to entry into the trial other than basal cell skin or carcinoma in situ of the cervix Already received treatment for breast cancer ongoing Blood transfusion performed for less than six months Persons deprived of liberty or under supervision (including guardianship) | 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, Thyroid Cancer Newly diagnosed with a first occurrence of thyroid cancer <2-4 weeks of diagnosis (i.e., histologically confirmed thyroid cancer (papillary, follicular, or medullary type; TNM classification system) Willing to participate in the EG meetings >18 years Alert and capable of giving free and informed consent Able to speak and read English or French Anaplastic thyroid cancer Karnofsky Performance Status (KPS) score <60 (rated by the Research Coordinator (RC) or referring physician) or expected survival <6 months according to clinical judgment | 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, Chronic Pain Women Clinical diagnosis of chronic pelvic pain More than eighteen years Non-menstrual or noncyclic pelvic pain Duration of pain of at least 6 months Duration of pain less than 6 months Women who were pregnant in the last 12 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): 18.0-999.0, Coronary Artery Stenosis Age ≥ 18 years Patient with an indication for PCI including angina (stable or unstable), silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present), or recent STEMI. For STEMI the time of presentation to the first treating hospital, whether a transfer facility or the study hospital, must be >24 hours prior to randomization and enzyme levels (CK-MB or Troponin) demonstrating that either or both enzyme levels have peaked Non-target vessel PCI are allowed prior to randomization depending on the time interval and conditions as follows: a. During Baseline Procedure: i. PCI of non-target vessels performed during the baseline procedure itself immediately prior to randomization if successful and uncomplicated defined as: <50% visually estimated residual diameter stenosis, TIMI Grade 3 flow, no dissection ≥ NHLBI type C, no perforation, no persistent ST segment changes, no prolonged chest pain, no TIMI major or BARC type 3 bleeding. b. Less than 24 hours prior to Baseline Procedure: i. Not allowed (see #3). c. 24 hours-30 days prior to Baseline Procedure: i. PCI of non-target vessels 24 hours to 30 days prior to randomization if successful and uncomplicated as defined above. ii. In addition, in cases where non-target lesion PCI has occurred 24-72 hours prior to the baseline procedure, at least 2 sets of cardiac biomarkers must be drawn at least 6 and 12 hours after the non-target vessel PCI. If cardiac biomarkers are initially elevated above the local laboratory upper limit of normal, serial measurements must demonstrate that the biomarkers are falling. d. Over 30 days prior to Baseline Procedure: iii. PCI of non-target vessels performed greater than 30 days prior to procedure whether or not successful and uncomplicated Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule. Angiographic (visual estimate) Treatment of up to three de novo target lesions, maximum of one de novo target lesion per vessel Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥2.5 mm to ≤4.25 mm and diameter stenosis ≥50% to <100% Lesion must be ≤28 mm long and can be covered by a single study stent with maximum length of 33 mm (note: multiple focal stenoses may be considered as a single lesion and be enrolled if they can be completely covered with one stent) TIMI flow 2 or 3 If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria Planned procedures after the baseline procedure in either the target or non-target vessels STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital or in whom enzyme levels (either CK-MB or Troponin)have not peaked PCI within the 24 hours preceding the baseline procedure and randomization Non-target lesion PCI in the target vessel within 12 months of the baseline procedure History of stent thrombosis Cardiogenic shock (defined as persistent hypotension (systolic blood pressure <90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including IABP Known LVEF <30% Subject is intubated Relative or absolute contraindication to DAPT for 12 months (including planned surgeries that cannot be delayed, or subject is indicated for chronic oral anticoagulant treatment) Hemoglobin <10 g/dL | 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, Cluster Headache Informed and written consent Cluster headaches defined in ICHD-2 duration of periods of attacks normally more than 2 months and insufficient effect of available prophylactic treatment Heart or lung disease Any kind of systematic or local disease or illness that may significantly increase the risk of complications for the procedure, related to injection or anesthesia Psychiatric illness that hinders participation in the study Known pregnancy or breast feeding Inadequate use of contraceptives Overuse or abuse of opioids Abuse of medications, narcotics or alcohol Allergy or any other hypersensitivity reactions against marcain, lidocaine, xylocain or adrenalin, botulinum toxin type A, Botox or any of it's constituents or any other related medication Treatment with medication that can interact with botulinum toxin type 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): 25.0-70.0, Pre-diabetes Obesity Age 25 years and 55 years Overweight or obesity status BMI>25 kg/m2 Pre-diabetes. The from WHO/IDF (International Diabetes Foundation) for assessing pre-diabetes will be used as the formal i.e. having: Impaired Fasting Glucose (IFG): Fasting venous plasma glucose concentration 5.6 9 mmol/l or Impaired Glucose Tolerance (IGT): Venous Plasma glucose concentration of 7.8 0 mmol/l at 2 h after oral administration of 75 g glucose (oral glucose tolerance test, OGTT), with fasting plasma glucose less than 7.0 mmol/l. Due to potential between-lab variation (local assessments), HbA1c is not used as an in the screening Informed consent required Ethnic group No restrictions Based on interview and/or questionnaire, individuals with the following problems will be excluded Medical conditions as known by the subjects: Diabetes mellitus (other than gestational diabetes mellitus); Significant cardiovascular disease including current angina; myocardial infarction or stroke within the past 6 months; heart failure; symptomatic peripheral vascular disease; Systolic blood pressure above 160 mmHg and/or diastolic blood pressure above 100 mmHg whether on or off treatment for hypertension. If being treated, no change in drug treatment within last 3 months; Advanced chronic renal impairment; Significant liver disease e.g. cirrhosis (fatty liver disease allowed); Malignancy which is currently active or in remission for less than five years after last treatment (local basal and squamous cell skin cancer allowed); Active inflammatory bowel disease, celiac disease, chronic pancreatitis or other disorder potentially causing malabsorption; Previous bariatric surgery; Chronic respiratory, neurological, musculoskeletal or other disorders where, in the judgement of the investigator, participants would have unacceptable risk or difficulty in complying with the protocol (e.g. physical activity program); A recent surgical procedure until after full convalescence (investigators judgement); Transmissible blood-borne diseases e.g. hepatitis B, HIV; Psychiatric illness (e.g. major depression, bipolar disorder) Medication: Use currently or within the previous 3 months of prescription medication that has the potential of affecting body weight or glucose metabolism such as glucocorticoids (but excluding inhaled and topical steroids; bronchodilators are allowed), psychoactive medication, epileptic medication, or weight loss medications (either prescription, over the counter or herbal). Low dose antidepressants are allowed if they, in the judgement of the investigator, do not affect weight or participation to the study protocol. Levothyroxine for treatment of hypothyroidism is allowed if the participant has been on a stable dose for at least 3 months Personal/Other: Engagement in competitive sports; Self-reported weight change of >5 % (increase or decrease) within 2 months prior to screening; Special diets (e.g. vegan, Atkins) within 2 months prior to study start. A lacto-vegetarian diet is allowed; Severe food intolerance expected to interfere with the study; Regularly drinking > 21 alcoholic units/week (men), or > 14 alcoholic units/week (women); Use of drugs of abuse within the previous 12 months; Blood donation or transfusion within the past 1 month before baseline or CID's; Self-reported eating disorders; Pregnancy or lactation, including plans to become pregnant within the next 36 months; No access to either phone or Internet (this is necessary when being contacted by the instructor's during the maintenance phase); Adequate understanding of national language; Psychological or behavioral problems which, in the judgement of the investigator, would lead to difficulty in complying with the protocol Laboratory screening: If all of the above are satisfied, the participant is eligible for a glucose tolerance test (blood at 0 and 120 mins), and blood glucose concentrations are analyzed immediately (Haemocue). In addition full blood count, urea, and electrolytes may be analyzed as a further safety evaluation ONLY IF the glucose tolerance test meets the entry for the study, the remaining samples are sent to the local laboratory for a safety check, with the following Hemoglobin concentration below local laboratory reference values (i.e. anemia); Creatinine >1.5 times Upper Limit of Normal (local laboratory reference values); Alanine Transaminase (ALT) and/or Aspartate Transaminase (AST) >3 times the Upper Limit of Normal (local laboratory reference values); Or any other significant abnormality on these tests which in the investigators opinion may be clinically significant and require further assessment Electrocardiography (ECG). Any abnormality which in the opinion of the investigator might indicate undiagnosed cardiac disease requiring further assessment (e.g. significant conduction disorder, arrhythmia, pathological Q waves). This is done in adults 55-70 years of age After LCD phase (in adults): Failure to reach at least 8% weight reduction during the LCD phase. This leads to from the intervention | 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, Prostatic Diseases Men who be referred a new urological outpatient and satisfy the following Wanted examined because of elevated PSA Not strong family history of prostate cancer It is taken biopsy as part of routine investigation. 2. Control group: Men referred to urological outpatient clinic, and who satisfy the following urination complaints Normal PSA examination shows prostate size> 40cc 3. Control group: Men first time referred urological / gastroenterological outpatient clinic, and which satisfy the following - symptoms that might indicate cancer suspicion in colorectum 4. Age> 40 years and <75 years known prostate cancer 2. Reduced consent 4 Familial occurrence of prostate cancer (one or more 1st degree relatives with CaP) | 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, Healthy Volunteer Key Healthy male and female, ages ≥ 18 to ≤ 65 years (inclusive) Body weight > 60 to < 100 kg at time of screening Clinically acceptable physical exams and laboratory tests (blood hematology, blood chemistry, urinalysis) and no history or evidence of any clinically significant medical disorder that would pose a risk to subject safety or interfere with study evaluations or procedures Normal or clinically acceptable electrocardiogram (ECG) (12-lead reporting heart rate and PR, QRS, QT, and QTc intervals) at screening Willing to be confined to the research facility for 2 consecutive nights Subject will be available for follow-up assessments Prior diagnosis of bone disease, or any condition that will affect bone metabolism such as, but not limited to: osteoporosis, osteogenesis imperfecta, hyperparathyroidism, hyperthyroidism, hypothyroidism, osteomalacia, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, current flare-up of osteoarthritis and/or gout, active malignancy, renal disease (defined as glomerular filtration rate [GFR] < 45 mL/min), Paget's disease of the bone, recent bone fracture (within 6 months), malabsorption syndrome Presents with any psychiatric disorder, which may prevent the subject from completing the study or interfere with the interpretation of the study results Significant changes in physical activity during the 6 months before study drug administration or constant levels of intense physical exercise Prior use of any non-Amgen approved medications within 4 weeks or 5-half lives (whichever time period is longer) of study drug administration and for the duration of the study. This includes medications such as, but not limited to: bisphosphonates, fluoride, hormone replacement therapy (ie, estrogen) or selective estrogen receptor modulator, such as ralaxofene, calcitonin, strontium, parathyroid hormone or derivatives, supplemental vitamin D [>1000 IU/day], glucocorticosteroids, anabolic steroids, calcitriol, diuretics, over the counter medications, herbal supplements Positive for human immunodeficiency virus (HIV) at screening or known diagnosis of acquired immune deficiency syndrome (AIDS) Positive hepatitis B surface antigen (HepBsAg) (indicative of chronic hepatitis B) or detectable hepatitis C virus ribonucleic acid (RNA) by polymerase chain reaction (PCR) at screening (indicative of active hepatitis C screening is generally done by hepatitis C antibody [HepCAb], followed by hepatitis C virus RNA by PCR if HepCAb is positive) Known sensitivity to any of the products to be administered during the study Prior denosumab administration Receiving or has received any investigational drug (or is currently using an investigational device) within 30 days before receiving study drug, or at least 10 times the respective elimination half-life (whichever period is longer) and for the duration 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): 18.0-999.0, Gaucher Disease Type 1 Age: >18 Gaucher disease type 1 Able to undergo a DEXA test Minors | 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, Traumatic Subarachnoid Haemorrhage All patients of traumatic subarachnoid haemorrhage Metabolic disorder Altered coagulation profile Cardiac disease morbid illness | 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 Malignant Neoplasm in the Brain Recurrent Non-Small Cell Lung Carcinoma Stage IIA Non-Small Cell Lung Carcinoma Stage IIB Non-Small Cell Lung Carcinoma Stage IIIA Non-Small Cell Lung Cancer Stage IIIB Non-Small Cell Lung Cancer Stage IV Non-Small Cell Lung Cancer Pathologically proven (either histologic or cytologic) diagnosis of NSCLC with any of the following stages (according to the American Joint Committee on Cancer [AJCC] Staging Manual, 7th edition) Stage IIIA or IIIB Stage II NSCLC with medical contraindication to curative surgical resection Stage IV disease with solitary brain metastasis that has been treated radically (eg: with surgical resection or stereotactic radiosurgery) and thoracic disease that would be classified as stage II-III Appropriate diagnostic/staging workup, including Complete history and physical examination Whole body PET/computed tomography (CT) scan within 42 days prior to study entry demonstrating hypermetabolic pulmonary lesion(s) and/or thoracic lymph node(s), with a maximum standardized uptake volume (SUV) > 6 for at least one lesion; if PET/CT was obtained more than 42 days prior to study entry and is not repeated, CT scan of the chest within 28 days prior to study entry demonstrating stable disease is required Magnetic resonance imaging (MRI) of the brain or CT scan of the head with contrast within 42 days prior to study entry Biopsy confirmation of suspected metastatic disease identified by PET/CT is recommended Pulmonary function tests (PFTs) within 6 weeks of study entry are highly recommended but not required Pleural or pericardial effusion A patient with pleural effusion may be enrolled the effusion is sampled by thoracentesis and cytology is negative or the effusion is seen on axial imaging but not on chest x-ray and deemed too small to tap under CT or ultrasound guidance Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness Women who Are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after cessation of study therapy Have a positive pregnancy test at baseline Are pregnant or breastfeeding Poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL) despite attempts to improve glucose control by fasting duration and adjustment of medications; patients with diabetes will preferably be scheduled for PET/CT imaging in the morning, and instructions for fasting and use of medications will be provided in consultation with the patients' primary physicians | 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, Relapsed or Refractory Acute Myeloid Leukemia (AML) Untreated AML Other IDH1-mutated Positive Hematologic Malignancies Myelodysplastic Syndromes Key Subject must be ≥18 years of age Subjects must have documented IDH1 R132 gene-mutated advanced hematologic malignancy based on local or central evaluation Subjects must be amenable to serial bone marrow biopsies, peripheral blood sampling, and urine sampling during the study Subjects must have ECOG PS of 0 to 2 Platelet count ≥20,000/µL (Transfusions to achieve this level are allowed) Subjects must have adequate hepatic function as evidenced by: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤3.0 × ULN, unless considered due to leukemic disease and serum total bilirubin ≤1.5 x upper limit of normal (ULN), unless considered due to Gilbert's disease or leukemic disease Subjects must have adequate renal function as evidenced by a serum creatinine ≤2.0 × ULN or creatinine clearance >40mL/min based on Cockroft-Gault glomerular filtration rate (GFR) Subjects must be recovered from any clinically relevant toxic effects of any prior surgery, radiotherapy, or other therapy intended for the treatment of cancer Female subjects with reproductive potential must have a negative serum pregnancy test within 7 days prior to the start of therapy and on the first day of study drug administration. Key Subjects who have undergone hematopoietic stem cell transplant (HSCT) within 60 days of the first dose of AG-120, or subjects on immunosuppressive therapy post HSCT at the time of screening, or with clinically significant graft-versus-host disease (GVHD). (The use of a stable dose of oral steroids post HSCT and/or topical for ongoing skin GVHD is permitted.) Subjects who received systemic anticancer therapy or radiotherapy <14 days prior to their first day of study drug administration. (Hydroxyurea is allowed prior to enrollment and after the start of AG-120) Subjects who received an investigational agent <14 days prior to their first day of study drug administration Subjects who are pregnant or breastfeeding Subjects with an active severe infection or with an unexplained fever >38.5°C during screening visits or on their first day of study drug administration (at the discretion of the Investigator, subjects with tumor fever may be enrolled) Subjects with New York Heart Association (NYHA) Class III or IV congestive heart failure or LVEF <40% by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan within approximately 28 days of C1D1 Subjects with a history of myocardial infarction within the last 6 months of screening Subjects with a known unstable or uncontrolled angina pectoris Subjects with a known history of severe and/or uncontrolled ventricular arrhythmias Subjects with known unstable or uncontrolled angina pectoris | 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, Relapsed or Refractory Multiple Myeloma Patients with relapsed/refractory multiple myeloma based on standard Renal function assessed by calculated creatinine clearance as follows Phase I subjects must have calculated creatinine clearance >=30ml/min by Cockcroft-Gault formula Phase II subjects must have calculated creatinine clearance >=30ml/min by Cockcroft-Gault formula Progressed (>25% increase in evaluable disease) or non response on Revlimid or within 60 days of stopping Revlimid > 1 prior regimen Total bilirubin <=1.5 x Upper limit of normal (ULN) AST (aspartate aminotransferase) or serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT) or serum glutamic-pyruvic transaminase (SGPT) <=3 x ULN All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of Revlimid REMS® Females of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL (milli-International unit/milliliter) within 10 > grade 2 neuropathy > Cr (complete response) 2.5 LFTs (liver function test) > 2x nl (normal limit) Patient had myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG (electrocardiogram) abnormality at screening must be documented by the investigator as not medically relevant Known hypersensitivity to thalidomide or Revlimid (if applicable) The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible Female subject is pregnant or lactating. Confirmation that the subject is not pregnant must be established by a negative serum -human chorionic gonadotropin (hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for postmenopausal or surgically sterilized women Female patients who are lactating or have a positive serum pregnancy test during the screening period, or a positive urine pregnancy test on Day 1 before first dose of study drug, if applicable Serious medical or psychiatric illness likely to interfere with participation in this clinical study | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 0.0-999.0, Chronic Total Occlusion of Coronary Artery Subject shows the presence of at least one coronary chronic total occlusion (CTO), either with or without the presence of one or more other diseased coronary arteries. This CTO must be located in a native coronary artery and have a visually estimated stenosis of 100%, corresponding with Thrombolysis in Myocardial Infarction (TIMI) flow 0. Following the operators judgment, this occlusion is present for more then 3 months Subject will be/is treated percutaneously for one or more CTOs via the hybrid techniques Subject (or legal guardian) understands the study requirements and the treatment procedures and provides written informed consent before any study-specific procedures are performed Subject is willing to comply with all protocol-required follow-up evaluation (patient will be followed during 1 month after PCI procedure to assess any complications and clinical status) The occlusion is considered to be less than 3 months present Subject is treated via PCI without application of the hybrid algorithm and/or use of the CrossBoss™ and Stingray™ technology (Bridgepoint Medical, Inc.) Subject is participating in another investigational clinical trial that may cause non-compliance with the protocol or confound data interpretation Subject intends to participate in another investigational clinical trial that may cause non-compliance with the protocol or confound data interpretation | 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): 0.0-30.0, Relapsed Pediatric Solid Tumors Refractory Pediatric Solid Tumors Rhabdomyosarcoma Ewing Sarcoma Osteosarcoma Neuroblastoma Wilms Tumor Hepatic Tumor Germ Cell Tumor Desmoid Tumor AGE: ≤ 30 years of age. Histologically confirmed malignant solid tumors, which may but are not limited to rhabdomyosarcoma and other soft tissue sarcomas, Ewing's sarcoma family of tumors, osteosarcoma, neuroblastoma, Wilms' tumor, hepatic tumors, germ cell tumors, and desmoid tumors. TUMOR Target lesion(s) must be located in bone or soft tissue in close proximity to bone. Target lesions must be reachable within the normal safety margins of HIFU as specified in the instructions for use. Radiographically evaluable or measurable solid tumor target lesion(s). Malignant Tumor: The patient's cancer must have relapsed after or failed to respond to frontline curative therapy and there must not be other potentially curative treatment options available. Curative therapy may surgery, radiation therapy, chemotherapy, or any combination of these modalities. PRIOR Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering on this study. No limitation on the number of prior chemotherapy regimens that the patient may have received prior to study entry. Myelosuppressive chemotherapy: The last dose of all myelosuppressive anticancer drugs must be at least 3 weeks prior to study entry. Immunotherapy: The last dose of immunotherapy (monoclonal antibody or vaccine) must be at least 4 weeks prior to study entry. Biologic (anti-cancer agent): The last dose of all biologic agents for the treatment of the patient's cancer (such as retinoids or tyrosine kinase inhibitors) must be at least 7 days prior to study entry. Radiation therapy: The last dose of radiation to more than 25 % of marrow containing bones (pelvis, spine, skull) must be at least 4 weeks prior to study entry. The last dose of all other local palliative (limited port) radiation must be at least 2 weeks prior to study entry. Stem Cell Transplantation. At least 2 months post-autologous stem cell transplant or at least 3 months post-allogeneic transplant and recovered from toxicities without evidence of graft versus host disease and on stable doses of immunosuppressive medications if required. Growth Factors. The last dose of colony stimulating factors, such as filgrastim, sargramostim, and erythropoietin, must be at least 1 week prior to study entry, the last dose of long-acting colony stimulating factors, such as pegfilgrastim, must be at least 2 weeks prior to study entry. No other anti-cancer therapy (chemotherapy, biological therapy, radiation therapy) is permitted during HIFU treatment and post treatment follow up for tolerability (see section 3.3). Patients > 16 years old must have a Karnofsky performance level ≥ 50%, and children ≤ 16 years old must have a Lansky performance level ≥ 50% (See Appendix I). Patients who are unable to walk because of paralysis or motor weakness, but who are up in a wheelchair will be considered ambulatory for the purpose of calculating the performance score Peripheral absolute neutrophil count (ANC) of ≥750/µL 2. Platelet count ≥75,000/µL (may receive transfusions) RENAL Age-adjusted normal serum creatinine OR a creatinine clearance ≥60 mL/min/1.73 m2 Defined as no dyspnea at rest, and a pulse oximetry >94% on room air if there is clinical indication for determination Normal PT, PTT and INR < 1.5 x ULN (including patients on prophylactic anticoagulation) Clinically significant unrelated systemic illness, such as serious infections, hepatic, renal or other organ dysfunction, which in the judgment of the Principal or Associate Investigator would compromise the patient's ability to tolerate the general anesthetic required for the procedure. Implant or prosthesis or scar tissue within the path of the HIFU beam. Target <1 cm from nerve plexus, spinal canal, bladder, bowel Target in contact with hollow viscera Lesion in the skull Inability to undergo MRI and/or contraindication for MRI Inability to tolerate stationary position during HIFU Patients currently receiving other anticancer agents. Patients currently receiving other investigational agents | 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, Stroke Subjects with a pure unilateral motor paresis after a stroke (ischemic or hemorrhagic). All subjects should have sufficient cognition to follow simple instructions as well as understand the content and purpose of the experiment, and also should be able to sit up for 1 hour Excessive spasticity of the affected arm Participation in any therapeutic treatment ("outside therapy") performed with the paralyzed arm during the planned study including baseline and follow up | 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, Postpartum Hemorrhage At least one risk for postpartum hemorrhage and lack of hypersensitivity to oxytocin and carbetocin Patients' refusal to cooperate, major therapeutic side effects, history of cardiac and renal disease or preeclampsia | 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, Carcinoma, Non-small Cell Lung For all Parts: The participant must have stage IV non-small cell lung cancer (NSCLC) For Part A (abemaciclib + pemetrexed): Non-squamous subtypes only. The participant must have received at least one but no more than three prior therapies for advanced/metastatic NSCLC For Part B (abemaciclib + gemcitabine): Any subtype. The participant must have received at least one but not more than three prior therapies for advanced/metastatic NSCLC For Part C (abemaciclib + ramucirumab): Any subtype. The participant must have received at least two but not more than three prior therapies for advanced/metastatic NSCLC For Part D (abemaciclib + LY3023414): Any subtype. The participant must have received at least two, but not more than three prior therapies for advanced/metastatic NSCLC. The participant must not have received prior treatment with any phosphoinositide 3-kinase (PI3K) or mammalian target of rapamycin (mTOR) inhibitor For Part E (abemaciclib + pembrolizumab): Any subtype. The participant must have received at least one but no more than three prior therapies for advanced/metastatic NSCLC Have either measureable or nonmeasurable disease as defined by the Response Evaluation in Solid Tumors (RECIST v1.1) Have adequate organ function including Hematologic: Absolute neutrophil count (ANC) 1.5 x 109/liter (L), platelets 100 x 109/L, and hemoglobin 8 gram/deciliter (g/dL) Hepatic: Bilirubin 1.5 times upper limits of normal (ULN), alanine aminotransferase (ALT) and aspartate transaminase (AST) 3.0 times ULN. For participants with tumor involvement of the liver, AST and ALT equaling ≤5.0 times ULN are acceptable. Alkaline phosphatase ≤5.0 times ULN for participants with tumor involvement of the bone is acceptable Have a personal history of any of the following conditions: presyncope or syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest. Exception: Participants with controlled atrial fibrillation for >30 days prior to study treatment are eligible Parts A, B, D and E: Have central nervous system (CNS) metastasis with development of associated neurological changes 14 days prior to receiving study drug Have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix or breast), unless in complete remission with no therapy for a minimum of 3 years Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 3 to 4 months after the last dose of trial treatment (as appropriate) Have active bacterial, fungal, and/or known viral infection (for example, human immunodeficiency virus [HIV] antibodies, hepatitis B surface antigen [HBSAg], or hepatitis C antibodies). Screening is not required for enrollment Parts A, B, C, and E: Have QTc interval of > 470 millisecond (msec) on screening electrocardiogram (ECG). Part D participants have QTc interval of >450msec on screening ECG. Additional For Part C History or evidence of cardiovascular risk including any of the following History of acute coronary syndromes (including myocardial infarction and angina), coronary angioplasty, or stenting within 6 months prior to enrollment History or evidence of current ≥Class II congestive heart failure as defined by New York Heart Association | 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, Stroke Patients First stroke Patients must be able to sit independently on a chair with arm support during 30 minutes No shoulder problems prior to stroke No severe cognitive problems that make it impossible to understand brief commands | 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, Osseous Paget's Disease Osseous Paget's disease patients treated with sodium risedronate tablets 17.5 mg | 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): 19.0-75.0, Chronic Pancreatitis Osteopenia Osteoporosis Age 19-75 years Diagnosis of Chronic Pancreatitis, as defined by specific clinical Refusal to complete the consent process in it's entirety 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): 20.0-90.0, Cancer Bone Bone Tumors Patient with metastatic cancer bone lesions | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-75.0, Pain Myofascial Pain Temporomandibular Disorder Syndrome Therapeutic Exercise Facial Pain more than 18 years old have diagnosis of myofascial pain according RDC/TMD signed the informed consent people under 18 years old | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-65.0, Muscle Spasm Between the ages of 18 and 65 years Has acute trapezius muscle pain that has been assessed by a health care practitioner Has a NRS pain severity score of 3.0 or higher in the trapezius muscle 3-4 times over the past week prior to enrolling in the trial Subjects must be willing and able to self-administer treatment daily within their place of residence or during normal daily activity, excluding bathing, showering, or other water activities which may result in submersion of the device under test Not taken any prescription pain medications or muscle relaxers in the 5 days prior to the study and agree not to take any during the study and to maintain any dosage of NSAIDs (nonsteroidal antiinflammatory drug) or non-prescription pain medications constant during the study Has access to a mobile phone or camera and the help of another individual to take a picture of the upper back area immediately after use of the device Subjects with known neuropathy will be excluded from the study Women who are pregnant may not participate Prisoners Smokers Subjects with Type I or Type II Diabetes Subjects who have had surgery in the target area within the last 6 months will be excluded from the study Subjects who are non-ambulatory (i.e. who cannot walk) will be excluded from the study Subjects who refuse to agree to not increase current use or initiate new use of pain medication during the course of the trial unless medically necessary to ensure patient safety Subjects who refuse to agree to not use any cream, gel, or topical solution during the administration of treatment other than the approved ultrasound gel provided to the subject at the initiation of the study Subjects who refuse to discontinue massage therapy or spinal manipulation during the duration of this study | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Carpal Tunnel Syndrome Local Steroid Injection Wrist Splinting patients attending the medical clinic of Kwong Wah Hospital with clinical and electrophysiological features of CTS any recognized causes of CTS including inflammatory arthritis, diabetes mellitus, hypothyroidism, renal failure, polyneuropathy and history of significant local trauma previous treatment of CTS pregnancy patients with motor impairment or thenar muscle atrophy | 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): 19.0-44.0, Lung Inflammation Healthy man or woman, any race or ethnicity, age 19-44 years old Screening FEV1 and FVC greater than or equal to 90% of predicted Screening oxygen saturation by pulse oximetry greater than or equal to 97% on room air Capable of lying still and supine with arms raised above the head within PET/CT scanner for 2-2.5 hours Capable of following instructions for breathing protocol during CT portion of PET/CT scans Able and willing to give informed consent Body Mass Index (BMI) < 35 Pregnancy (confirmed by qualitative serum hCG pregnancy test) Lactation History of cardiopulmonary disease Currently taking any prescription medications History of tobacco use or illicit drug use within the past year Presence of implanted electronic medical device Enrollment in another research study of an investigational drug Known allergy to both trimethoprim/sulfamethoxazole and amoxicillin, Penicillin, Lidocaine, Demerol, Versed, and/or Fentanyl Inability to lie flat for 2-2.5 hours for PET/CT scans or follow breathing protocol instructions for the CT portion of the PET/CT Prior research-related radiation exposure within the past year such that participation in this study would result in exposures that exceed the limits as defined by the FDA RDRC regulations (21 CFR 361.1) | 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): 18.0-75.0, Primary Sclerosing Cholangitis (PSC) Male or female aged 18 to 75 years Must provide written informed consent and agree to comply with the trial protocol Must have a diagnosis of PSC (based on cholangiography at any point in time) Alkaline phosphatase (ALP) at Screening ≥ 2x ULN Total bilirubin at Screening < 2.5x ULN For subjects with concomitant inflammatory bowel disease (IBD): 1. Colonoscopy (if subject has a colon) or other appropriate endoscopic procedure within 12 months of Day 0 confirming no dysplasia or colorectal cancer 2. Subjects with Crohn's Disease (CD) must be in remission as defined by a Crohn's Disease Activity Index (CDAI) <150. 3. Subjects with ulcerative colitis (UC) must either be in remission or have mild disease. Remission is defined as a partial Mayo score of ≤2 with no individual sub-score exceeding 1. Mild disease is defined as a partial Mayo score ≤3 with no individual sub-score exceeding 1 point For subjects being administered UDCA as part of their standard of care, the dose must have been stable for ≥ 3 months prior to, and including, Day 0 and must not have exceeded 20 mg/kg/day during this time Subjects being administered biologic treatments (eg, anti-tumor necrosis factor (TNF) or anti-integrin monoclonal antibodies), immunosuppressants, systemic corticosteroids, or statins, must have been on a stable dose for ≥ 3 months prior to, and including, Day 0 and should plan to remain on a stable dose throughout the trial Contraception: female subjects of childbearing potential must use ≥ 1 effective method (≤1% failure rate) of contraception during the trial and until 4 weeks following the last dose of IP (including long term safety extension doses) Evidence of a secondary cause of sclerosing cholangitis at Screening Immunoglobulin G4 (IgG4) > 4x ULN at Screening or evidence of IgG4 sclerosing cholangitis Small duct cholangitis in the absence of large duct disease Presence of clinical complications of chronic liver disease or clinically significant hepatic decompensation, including Current Child Pugh classification B or C History of, or current diagnosis or suspicion of, cholangiocarcinoma or other hepatobiliary malignancy, or biliary tract dysplasia History of liver transplantation, or current model of end stage liver disease score ≥ 12 History of, or current, cirrhosis with complications, including history or presence of spontaneous bacterial peritonitis hepatocellular carcinoma or hepatic encephalopathy (as assessed by the investigator) Current known portal hypertension with complications, including known gastric or large esophageal varices, poorly controlled or diuretic resistant ascites, history of variceal bleeds, or related therapeutic or prophylactic interventions (e.g., beta blockers, insertion of variceal bands or transjugular intrahepatic portosystemic shunt [TIPS]) History of, or current, hepatorenal syndrome (type I or II) or Screening serum creatinine > 2 mg/dL (178 μmol/L) | 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, Acute Porphyrias Male or female aged 18 years Willing to provide written informed consent Acute symptoms (7 days duration or less to time of enrollment) such as abdominal, back and/or limb pain, diagnosed by the investigator as caused by porphyria after initial evaluation has excluded other causes Diagnosis of acute porphyria documented by a substantial increase in urinary or serum porphobilinogen (PBG) Type of acute porphyria confirmed by additional testing (in addition to increased PBG), which may be completed before or after treatment begins using pretreatment samples For acute intermittent porphyria (AIP): Normal or only slight increases in plasma and fecal porphyrins. Most (~90 percent) will have deficient activity of erythrocyte porphobilinogen deaminase (PBGD), and almost all (>95 percent) will have a demonstrable disease-causing PBGD mutation For hereditary coproporphyria (HCP): Substantial increases in fecal porphyrins (almost entirely coproporphyrin III). In the absence of skin photosensitivity, most will have normal or only slight increases in plasma porphyrins. Almost all (>95 percent) will have a demonstrable disease-causing coproporphyrinogen oxidase (CPO) mutation For variegate porphyria (VP): Substantial increases in fecal porphyrins (mostly coproporphyrin III and protoporphyrin), increased plasma total porphyrins and a fluorescence emission maximum of diluted plasma at neutral pH near 626 nm. Almost all (~95 percent) will have a demonstrable disease-causing protoporphyrinogen oxidase (PPO) mutation Symptoms such as abdominal, back or limb pain are explained by another condition, as judged by the investigator Therapy with hemin within 7 days prior to enrollment in this study Known or suspected allergy to Panhematin™ or related products Preexisting coagulation defect or concurrent treatment with an anticoagulant Previously documented renal impairment defined as a serum creatinine above 1.7 mg/dL or 150 mmol/L A diagnosis of diabetes mellitus, which might increase the risk of glucose infusion Heart failure, significant chronic anemia or any disease or condition that the investigator judges would lead to an unacceptable risk to the patient or interfere with the successful collection of date for the trial Previous randomization in this trial | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 16.0-85.0, Pain During and After Endovenous Laser Obliteration of Large Saphenous Vein Based on Lidocaine Tumescent Concentration Large Saphenous Vein treatment 85 years old, good health Able to understand informed consent Eligible for EVLT determined by physician Patients with know lidocaine sensitivity Bleeding disorders Pregnancy Congestive heart failure Liver dysfunction Patient ineligible for EVLT | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Prostate Cancer Histologically confirmed diagnosis of prostate adenocarcinoma: 1. Asymptomatic or mildly symptomatic (defined as no opioids and Brief Pain Inventory score) 2. Metastatic to bone with ≥ 2 bone metastases (area of increase uptake on 99mTC BS (Technetium-99m bone scintigraphy) confirmed by standard X-Ray, Computed tomography (CT), or Magnetic resonance imaging (MRI)) with or without additional lymph node metastases. Visceral metastases are not allowed 3. Progressive Castration-resistant prostate cancer (CRPC) according to Prostate Cancer Working Group 2 (PCWG2) i.e. either of For patients who manifest disease progression solely as a rising Prostate-specific antigen (PSA) level. PCWG2 require documentation of a sequence of rising PSA values at a minimum of 1-week intervals with the last value ≥ 2 ng/ml For patients with disease progression manifest in the bone, irrespective of progression by rising PSA, PCWG2 guidelines require appearance of 2 or more new lesions. Ambiguous results should be confirmed by other imaging modalities than bone scan and x-ray (e.g.: CT-scan or MRI) For patients with disease progression manifest at nodal sites, irrespective of progression by rising PSA, PCWG2 requires progression according to 1.1 Ongoing androgen deprivation therapy with LHRH (Human luteinizing hormone-releasing hormone) agonist or antagonist or bilateral orchiectomy Patients must be at least 18 years old WHO Performance status 0-1 Charlson score ≤ 3 Castrate serum levels of testosterone (< 50 ng/dL) Biochemistry and hematology: 1. Adequate bone marrow function (absolute neutrophil count 1.5109/L; platelets 100 109/L, and hemoglobin > or = 10.0 g/dl.). 2. Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN), except for patient with Gilbert's disease 5.0 ULN 3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < or = 2.5 x ULN 4. Creatinine < or= 1.5 x ULN 5. Albumin > 25 g/L No known history of central nervous system metastases or leptomeningeal tumor spread No significant cardiovascular disease including: 1. Myocardial infarction within 6 months prior to screening 2. Uncontrolled angina within 3 months prior to screening 3. Congestive heart failure New York Heart Association (NYHA) class III or IV, or patients with history of congestive heart failure NYHA class III or IV in the past, unless a screening echocardiogram or multi-gated acquisition scan (MUGA) performed within 3 months results in a left ventricular ejection fraction that is ≥ 45% 4. History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes) 5. History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place 6. Uncontrolled hypertension as indicated by a resting systolic blood pressure > 170 mm Hg or diastolic blood pressure > 105 mm Hg at screening 7. Hypotension as indicated by systolic blood pressure < 86 millimeters of mercury (mm Hg) at screening 8. Bradycardia as indicated by a heart rate of < 45 beats per minute on the screening ECG and on physical examination patients having received docetaxel for CRPC are excluded No prior treatment with enzalutamide or Ra223 No prior and concomitant treatment with Cyp17 inhibitors (abiraterone, orteronel) and ketoconazole No prior hemibody external radiotherapy. Patients who received other types of prior external radiotherapy are allowed provided that the bone marrow function is assessed and meets the protocol requirements for hemoglobin, absolute neutrophil count and platelets No prior therapy with other radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188) No involvement in another therapeutic trial involving an experimental drug No anticancer therapy or treatment with another investigational agent within the last 4 weeks prior to randomization No known hypersensitivity to compounds related to enzalutamide or Ra223 | 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 Acute Pain be informed of the nature of the study and must give written informed consent be able to communicate effectively with study personnel be diagnosed with a condition for which the physician has prescribed a compounded pain cream History of allergy or adverse reaction to pain cream ingredients History of psychiatric disorders | 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, Bisphosphonate-Associated Osteonecrosis of the Jaw patients taking bisphosphonates whatever the indication, the type, the administration and the duration of treatment (we patients taking or having taken bisphosphonates, even several years ago) And who need tooth extraction (not recoverable in conservative dentistry and symptomatic tooth: dental and periodontal infections, symptomatic traumatic tooth fracture) pregnant women younger than 50 years old jaw's radiotherapy history of jaw osteonecrosis jaw metastasis from an other 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): 0.0-75.0, Osteoarthritis undergoing primary, simultaneous bilateral knee arthroplasty for osteoarthritis no neurological, vascular or cardiac problems that limit function or any unstable orthopaedic conditions that limit functional performance | 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, Oral Hygiene Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral/dental examination A minimum of 20 permanent gradable teeth Moderate gingivitis present at the screening visit in the opinion of the investigator A total of 20 bleeding sites or greater at baseline visit Positive response to bleeding on brushing present at the screening visit Pregnant or breast feeding women Tobacco chewers Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any other medical condition (e.g. Diabetes Mellitus) that would make the participant unlikely to fully complete the study or any that increases the risk to the participant or undermines the data validity Recent history (within the last year) of alcohol or other substance abuse Participants requiring prophylactic antibiotic treatment prior to dental therapy Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients Have current active caries or any medical conditions which may directly influence gingival bleeding Use of concomitant or any systemic medication that, in the opinion of the investigator, might interfere with the outcome of the study or have an effect on gingival conditions within 14 days of gingival examinations Excessive calculus present that interferes with the probing examination for Gingival Bleeding Index Participation in another clinical study or receipt of an investigational drug or oral care product within 30 days of the screening visit | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-65.0, Oral Hygiene Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral/dental examination A minimum of 20 permanent gradable teeth Moderate gingivitis present at the screening visit in the opinion of the investigator A total of 20 bleeding sites or greater at baseline visit Positive response to bleeding on brushing present at the screening visit Pregnant or breast feeding women Tobacco chewers Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any other medical condition (e.g. Diabetes Mellitus) that would make the participant unlikely to fully complete the study or any that increases the risk to the participants or undermines the data validity Recent history (within the last year) of alcohol or other substance abuse Participants requiring prophylactic antibiotic treatment prior to dental therapy Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients Have current active caries or any medical conditions which may directly influence gingival bleeding Use of concomitant or any systemic medication that, in the opinion of the investigator, might interfere with the outcome of the study or have an effect on gingival conditions within 14 days of gingival examinations Excessive calculus present that interferes with the probing examination for Gingival Bleeding Index Participation in another clinical study or receipt of an investigational drug or oral care product within 30 days of the screening visit | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 20.0-999.0, Graves Disease Patients with Graves 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, Bisphosphonate-related Osteonecrosis of the Jaw Study Group (all of the following): 1. Subject is ≥18 years old 2. Subject is or was a Multiple Myeloma and/or other cancer patient who is or has been IV treated with the BP zoledronic acid and/or pamidronate disodium; Or; Subject is or was a Multiple Myeloma and/or other cancer patient who is or has been IV treated with the BP zoledronic acid and/or pamidronate disodium and was also treated by oral BP such as sodium alendronate, and in the opinion of the PI, IV treatment was significant enough to be considered as the cause for BRONJ 3. Subject has been diagnosed with BRONJ at stages 1 or 2 or 3 according to AAOMS (American Association of Oral and Maxillofacial Surgeons) 4. Subject has signed the informed consent or consent can be waived Control Group (all of the following): 1. Subject is ≥18 years old 2. Subject is or was a Multiple Myeloma and/or other cancer patient who is, or has been IV treated with the BP zoledronic acid and/or pamidronate disodium for at least two (2) years (continuously or cumulatively) 3. Subject has not developed any signs or symptoms of BRONJ 4. Subject has signed the informed consent or consent can be waived Subject has been treated with irradiation to the jaws or head and neck at levels exceeding 35 Gy 2. Pregnant or lactating women 3. Subject has been treated with either bevacizumab or sunitimib 4. Subject has been treated with Allogeneic hematopoietic stem cell transplantation (HSCT) | 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): 5.0-999.0, Hypophosphatasia Bone Disease Documented informed consent/assent prior to video collection and data abstraction Documented informed consent/assent in Study ALX-HPP-502 Patients with juvenile-onset HPP and was selected as a historical-control for Study ENB-006-09 Patients with at least 2 videos of basic mobility that were recorded at 2 different clinic visits when the patient was ≥5 to ≤15 ye There are no for 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): 0.0-999.0, Hypophosphatasia Patients or their legal representative must provide written informed consent or, if applicable, qualify for waiver of consent Patients must have a pre-established clinical diagnosis of HPP, as indicated by one or more of the following Serum alkaline phosphatase (ALP) below the age-adjusted normal range Plasma PLP at least twice the upper limit of normal (no vitamin B6 administered for at least 1 week prior to determination) Evidence of osteopenia or osteomalacia on skeletal radiographs Genetic analysis fof the ALPL gene Any patient without confirmation of clinical diagnosis of HPP | 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, Cervical Dysfunction asymptomatic and healthy participants with not contraindications to HVLA no local metastases no osseous or ligamentous disruption no apprehension on the part of the participant contraindications to HVLA diagnosis of fibromyalgia syndrome neck or back or cervical spine pain herniated nucleus pulposus bone diseases (such as osteoporosis) rheumatoid arthritis Down Syndrome prior surgery on back any cervical radiculopathy if rotation of the head and neck causes dizziness, lightheadedness or pain | 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, Monoclonal Gammopathy of Undetermined Significance (MGUS) Chronic Lymphocytic Leukemia (CLL) Myelodysplastic-Myeloproliferative Diseases Hematological Malignancies B-cell Malignancy, Low-grade Myelodysplastic Syndrome With Low-grade Lesions IgG Monoclonal Gammopathy of Uncertain Significance Smoldering Multiple Myeloma Waldenstrom Macroglobulinemia Patients with Known or Suspected Precursor Hematological Cancer Including the following subgroups of diseases Early MDS, including pathologically-confirmed MDS (IPSS Low/Int-1; IPSS-R Very Low/Low) and idiopathic cytopenias of undetermined significance (ICUS) Myeloproliferative neoplasms (MPN) Asymptomatic Multiple Myeloma and Waldenstrom Macroglobulinemia such as monoclonal gammopathy of undermined significance (MGUS) or Smoldering Multiple Myeloma (SMM or SWM) Monoclonal B cell lymphocytosis (MBL) Early stage asymptomatic low-grade lymphomas; or Other precursor conditions or clonal genetic abnormalities of the blood/bone marrow that do not meet for symptomatic hematological malignancy, or patients exposed to prior chemotherapies (e. g., alkylating agents, platinum derivatives, taxanes, topo-2 inhibitors, anti-metabolites, systemic radioisotopes) Patients must be at least 18 years of age to participate in this research of Women and Minorities - Patients with Known or Suspected Precursor Hematological Cancer are NOT Evidence of symptomatic or active hematological malignancy. Patients enrolled on clinical trials for precursor diseases are NOT excluded from this study | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-80.0, GERD A medical diagnosis of GERD 2. Awakening with a taste of refluxed stomach acid in the mouth 3. Heartburn during sleep 4. Voice hoarseness upon awakening 5. Antacid use at night 6. Dry mouth at bedtime or during the night 7. Experience difficulty chewing, swallowing, and speaking because of dry mouth Under 18 2. Prior history of any of these conditions: 1. coronary artery disease 2. gallbladder disease 3. gastric or esophageal cancer 4. peptic ulcer disease 5. esophagitis, whether eosinophilic, infectious, or pill based 6. esophageal motility disorders 3. A history of thoracic, esophageal, or gastric surgery 4. No medical examination in the prior year | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Otitis Media With Effusion Eustachian Tube Disorder Patients > 18 years old Referred to ENT clinic at Rikshospitalet for evaluation and treatment of OME, tympanic membrane peroration or tympanic membrane retraction Dysfunction of the ET is suspected by the ENT surgeon The patient is a candidate for balloon dilation of the ET Previous serious allergic reaction to iodine based contrast medium Increased risk of bleeding Serious heart disease Diabetes I Previous ENT-surgery (t-tubes excluded) Middle ear disease, which requires other type of treatment Chronic rhino sinusitis or nasal polyposis 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): 16.0-60.0, Molar, Third Wisdom Teeth any patients requiring bilateral lower third molars extracted of similar technical difficulty under general anaesthesia any intra-operative complications any post-operative complications, including infection if the extractions end up being too dissimilar surgically any contra-indication to the Hilotherm mask patients with any immune system-affecting diseases patients with allergies to pharmaceutical drugs (eg. analgesics or antibiotics) | 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 Male and female subjects >18 years old Complaining functional discomfort associated to joints and/or muscles disorders, motility disorders and/or initial SMFA score higher or equal to 15 Able to give a written or verbal informed consent Affiliated or beneficiary of social security IMC>30kg/m Acute or chronic, progressive joint disorders (arthrosis, rheumatoid arthritis, acute articular rheumatism) of first or second degree and correlated treatments Subjects refusing of giving their written or verbal informed consent Subjects deprived of freedom following an administrative or judicial decision Participation to another clinical trial in the last four weeks People who already participated to another research that comprises an period still ongoing at the time of | 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, Parkinson Disease Impulse Control Disorders Case Group 1. Age upper or equal to 30 years 2. Caucasian European (2 parents and 4 grandparents born in Europe) 3. Parkinson's disease according to the of 4. With a behavioral addiction defined as A score greater than or equal to 2 or 3 scores greater than or equal to 2 at hyperdopaminergic following items of Ardouin's scale (ECMP): eating behaviors, creativity, hobbyism, risk-taking behaviors, compulsive shopping, pathological gambling, hypersexuality, cyber-addiction, and Punding Onset under dopamine agonist or under L-DOPA Present at the visit OR in the past (<6 years). For these patients, the scale of Ardouin must have been passed at the time of behavior trouble or within 3 months after its disappearance. 5. Affiliation to a social security 6. Signature of the consent form Control Group 1. Age upper or equal to 30 years 2. Caucasian European (2 parents and 4 grandparents born in Europe) 3. Parkinson's disease according to the of 4. Time evolution of the disease than or equal to 5 years 5. Having taken during its evolution a dopamine agonist dose at least equivalent to 300 mg of L-DOPA for at least 12 months. 6. Not having behavioral addiction Not current, defined as a score of 0 or 1 and at most two items with a score of 1 on all items above and addiction to L-DOPA Neither passed, given authenticated by the semi-structured interview retrospective finding a score of 0 or 1 on all items hyperdopaminergic of Ardouin's scale (see above) AND no more than two items with a score of 1 and addiction to L-DOPA. 7. Affiliation to a social security 8. Signature of the consent form Case Group 1. No Parkinson's disease or atypical parkinsonian syndrome 2. Taking neuroleptic except clozapine for patients with AC 3. Behavioral Addiction having started taking the antiparkinsonian treatment Control Group 1. No Parkinson's disease or atypical parkinsonian syndrome 2. Taking neuroleptic included clozapine for control patients 3. Behavioral Addiction having started taking the antiparkinsonian treatment 4. Patient with guardianship, deprived of his liberty by judicial decision | 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, Knee Injuries for implanted subjects Implanted with a Journey II BCS At least 3 months post-operative with no other surgical procedures within the past 6 months Body Mass Index (BMI) < 40 Body weight < 250 lbs Not pregnant Knee Society score (KSS) of > 90 Must be able to walk on level ground without aid of any kind Must be able to perform deep knee bend activity without aid of any kind Must be able to perform chair-rise activity without aid of any kind for implanted subjects Other surgical procedures performed within the past 6 months < 3 months post-operative Pregnant Severe cardiopulmonary or neurologic disease Body weight > 250 lbs BMI > 40 KSS < 90 Unable to perform 3 required activities unassisted Unwilling to sign both Informed Consent and HIPAA forms | 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, Cardiac Catheterisation Indication for cardiac catheterization Suitable candidates for transradial approach AMI Intubated patients Complications during procedure (cardiac arrest, pulmonary edema, cardiogenic shock, stroke) Prior in this trial | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 8.0-17.0, Migraine Present to the emergency department with a migraine headache as defined by the modified Irma criteria. The modified Irma are as follows: Headache episodes of 1-168 hours (7 days) presenting with at least 3 of the following 6 moderate to severe episode of impaired daily activities; focal localization of headache; pulsatile description; nausea or vomiting or abdominal pain; photophobia or phonophobia or avoidance of light and noise; symptoms increasing with activity or resolving by rest Headache severity of moderate to severe pain (i.e. at least 4/10 on the Faces Pain Scale Revised) Requiring IV fluids and any IV medication (for example: ketorolac, metoclopramide, prochlorperazine, ondansetron) as part of their headache treatment, as per their treating attending physician Contraindication to receiving ketorolac Receipt of an NSAID within six hours of study drug administration Presence of an intranasal obstruction that cannot be readily cleared Inability to speak English or Spanish Unable to complete self-report measures of pain or questionnaires Critical illness Frequent use of drugs for headache (i.e. regular intake of analgesics for acute headaches on more than 10 days per month) | 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, Lymphedema years of age or older Patients undergoing a primary elective total knee arthroplasty The patient is able to understand the study and is willing to give written informed consent to the study Allergy against one of the used materials Severe systemic diseases causing peripheral oedema Acute superficial or deep vein thrombosis Arterial occlusive disease (stadium II, III or IV) ABPI<0,8 Local infection in the therapy area auto-immunological disorders or vasculitis use of systemic corticosteroids Inability to don, doff, and adjust the device | 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 Male or female over 18 years old Subject needing to undergo extraction of one impacted mandibular third molar For woman of childbearing potential and woman in post menopausal period under hormonal substitution treatment, she must accept to plan the extraction of the impacted mandibular third molar only during the last week of the menstrual cycle Affiliated to a social security system, or is a beneficiary (if applicable in the national regulation) Existence or history of parotid gland disorders Acute or history of recent acute pericoronitis at any tooth Extraction of more than 1 third molar in the same surgical procedure Subject at high risk of bacterial endocarditis (prosthetic heart valve, history of bacterial endocarditis, congenital cyanogenic heart disease) Coagulation or haemostatic disorder or use of anticoagulants Hypersensitivity to chlorhexidine or any of the excipients Hypersensitivity to any anesthetic agent Hypersensitivity to corticosteroids, analgesics including opioid drugs used for post-surgery pain relief Intake of systemic vasodilator or vasoconstrictor Intake of systemic or local (in the mouth) antibiotics within 7 days before Day 1 and/or any pre | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Paget Disease, Extramammary Non-invasive vulvar Paget's disease, primary or recurrence after earlier surgery Willing and able to comply with the protocol and to provide informed consent in accordance with institutional and regulatory guidelines Invasive vulvar Paget's disease Underlying adenocarcinoma Treatment of the vulva with topical 5% imiquimod cream during the last 6 months Participation in a study with another investigational product within 30 days prior to enrolment in this study Hypersensitivity to any component of topical 5% imiquimod cream (methylhydroxybenzoate (E218), propylhydroxybenzoate (E216), cetylalcohol, atearylalcohol) Patients with autoimmune disorders Immune compromised patients (e.g. HIV patients, patients with a history of transplantation) Insufficient understanding of the Dutch or English language Pregnant women Lactating women | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Thyroid Cancer Affiliated to a social security regimen ; 2. Patients with histologically confirmed differentiated thyroid cancer (papillary, follicular including Hurthle cell or poorly differentiated) ; 3. Iodine refractory disease defined by the absence of radioiodine uptake in at least one lesion or progression of the disease within 14 months after a radioactive iodine (RAI) treatment or persistent disease after the administration of a cumulative activity of 22GBq I 131 ; 4. Age ≥18 years ; 5. Eastern Cooperative Oncology Group performance status 0-2 ; 6. Life expectancy longer than 3 months ; 7. Presence of at least one bone metastasis visible on CT scan or axial skeleton (AS) MRI and not requiring urgent locoregional treatment ; 8. Presence of at least one bone metastasis with uptake on FDG PET/CT ; 9. Presence of at least one bone metastasis with increased uptake on 99mTc HMDP bone scintigraphy or FNa PET/CT 10. Low likelihood of an indication for systemic treatment within the next 6 months, as defined by the absence of soft tissue distant metastases or by the presence of only small (<1cm) soft-tissue metastases, or larger (>1 cm) but stable soft tissue metastases within 6 months prior to in the present protocol ; 11. Adequate haematological (neutrophils ≥1,5×109/L; platelets ≥100×109/ L; haemoglobin > 9g/dL), renal (creatinine <1,5×upper limit of normal range), and hepatic (total bilirubin < 1.5 institutional upper limit of normal), aspartate aminotransferase and alanine aminotransferase <2,5×upper limit of normal range in the absence of liver metastases or <5×upper limit of normal range in case of liver metastases) functions ; 12. Patients receiving bisphosphonates or anti-RANK ligand (Denosumab) are allowed but patients should have received at least 2 administrations prior to Radium-223 administration and these treatments will be continued during Radium-223 treatment ; 13. Blood negative pregnancy test in women of childbearing potential within 30 days prior to treatment initiation. Both men and women (of childbearing potential) who are sexually active must use adequate contraception during and for at least 6 months post-treatment ; 14. Patient who is fully informed, able to comply with the protocol and who signed the informed consent Patients with another malignancy that is not in remission for at least 2 years (except for in situ cervix uterine cancer, basocellular skin cancer) ; 2. Treatment with any investigational drug or with a TKI within the previous 4 weeks, or planned during the treatment period ; 3. Treatment with cytotoxic chemotherapy within the previous 4 weeks, or planned during the treatment period, or failure to recover from adverse events due to cytotoxic chemotherapy administered more than 4 weeks before the study initiation ; 4. Previous systemic therapy with radionuclides, including strontium-89, samarium-153, rhenium-186, rhenium-188 or radium-223 ; 5. Patients with imminent or established spinal cord compression based on clinical findings and/or MRI and/or immediate need for local radiotherapy ; 6. Patients with progressive visceral metastases according to 1.1 assessed by CT scan and/or symptomatic brain metastases within 6 months prior to study initiation ; 7. Patient already included in other clinical trial ; 8. Pregnant or breast feeding women ; 9. Fecal or urinary unmanageable incontinence ; 10. Bone marrow dysplasia, uncontrolled diabetes or infection, NYHA Class III or IV cardiac disorders, fecal incontinence and symptomatic intestinal disease (such as Crohn disease or ulcerative colitis) | 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, Arthritis Tendonitis Gout Radiculopathy Muscle Spasms Synovitis Migraine Headache 1.1 Primary complaint or clinical findings of arthritis, tendonitis, gout, synovitis, radiculopathy, muscle spasms, migraines, and/or idiopathic pain. 4.1.2 No new pain medications of any kind in the last 4 weeks. 4.1.3 Between the ages of 18-85yrs 2.1 Current or history of disease or disorders of the liver, kidneys, gastrointestinal system, or cardiovascular system. 4.2.2 Blood test indicating kidney, liver, or cardiovascular function outside of normal clinically accepted ranges. Blood test must be performed in the last 7 days. 4.2.3 Broken or inflamed skin, burns, open wounds, atopic dermatitis or eczema in the area of pain where the compound cream and transdermal patch would be applied. 4.2.4 Women who are pregnant, nursing, or planning to become pregnant in the next 52-weeks. 4.2.5 Allergy/sensitivity to study drugs or their formulations. 4.2.6 Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. 4.2.7 Serious illness (requiring systemic treatment and/or hospitalization) until subject either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 14 days prior to study entry. 4.2.8 Inability or unwillingness of subject to give written informed consent | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Ischemic Preconditioning Patients with aneurysmal subarachnoid hemorrhage whose initial angiogram show an aneurysm and patients with clipped aneurysm will be eligible for enrollment Patients will be enrolled within 96 hours of bleeding onset, if informed consent is obtained from the participant or health care proxy, as appropriate Hunt Hess Scale > 4 Inability to undergo limb preconditioning due to local wound or tissue breakdown, history of peripheral extremity vascular disease or patient discomfort Inability to obtain informed consent from the patient or a health care proxy Ankle-brachial index < 0.7 Inability to start limb preconditioning within 4 days of bleeding Inability to precondition a leg that is not-plegic (that is preserved anti gravity strength) and has not been accessed for catheter angiography Age<18 years Pregnant women Prisoners | 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, Total Atherosclerotic Occlusion of Radial Artery Patients referred for cardiac catheterization. - Absence of informed consent. 2: Known allergy to nitroglycerin. 3: Ad-hoc PCI 4: Previous ipsilateral TRA. 5: Warfarin or NOAC therapy. 6: Systolic blood pressure < 100 mmHg. 7: Critical aortic stenosis (AVA < 0.6 sq.cm) 8: Inability to administer unfractionated heparin. 9: Need for post-procedural use of heparin (UFH, LMWH) 10: Raynaud's disease. 11: Sheathless technique or use of > 11 cm sheath. 12: History of intractable headache of any cause OR Migraine headache | 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, Inherited Cardiac Arrythmias Long QT Syndrome (LQTS) Brugada Syndrome (BrS) Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) Early Repolarization Syndrome (ERS) Arrhythmogenic Cardiomyopathy (AC, ARVD/C) Hypertrophic Cardiomyopathy (HCM) Dilated Cardiomyopathy (DCM) Muscular Dystrophies (Duchenne, Becker, Myotonic Dystrophy) Normal Control Subjects All patients and family members 18 years of age or older with inherited cardiac arrhythmias including LQTS, Brugada Syndrome (BrS), cathecholaminergic polymorphic ventricular tachycardia (CPVT) or early repolarization syndrome (ERS) are eligible for enrollment All enrolled patients will have undergone clinically indicated genetic testing Age <18 years >85 years pregnant women life-limiting co-morbidities immunocompromise | 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, HER2 Positive Metastatic Breast Cancer Aged ≥18 and ≤70 years ECOG performance status of 0 to 1 Life expectancy of more than 12 weeks At least one measurable lesion exists.(RECIST 1.1) Histologically or cytologic confirmed HER2 positive advanced breast cancer which failed prior therapies Required laboratory values including following parameters: ANC: ≥ 1.5 x 10^9/L;Platelet count: ≥ 100 x 10^9/L;Hemoglobin: ≥ 9.0 g/dL;Total bilirubin: ≤ 1.5 x upper limit of normal (ULN);ALT and AST: ≤ 1.5 x ULN;BUN and creatine clearance rate: ≥ 50 mL/min;LVEF: ≥ 50%;QTcF: < 470 ms for female and < 450 ms for male Signed informed consent Received previous therapy with lapatinib, neratinib, pyrotinib or any other HER2 directe tyrosine kinase inhibitor Received previous therapy with capecitabine within 3 months | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 0.0-999.0, Liver Cirrhosis Muscle Cramps Cirrhosis Muscle cramps( ≥3 cramps per week ) • Allergy to orphenadrine Renal impairment Pregnant and lactating women Peripheral vascular disease Peripheral neuropathy Medications as calcium channel blockers, conjugated estrogens and naproxen. Glaucoma Prostatic enlargement | 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, Oral Surgery Patients 18+ years requiring surgical removal of a single (unilateral) mandibular wisdom tooth 2. Tooth requiring full mucoperiosteal flap and bone removal for removal of tooth 3. Written informed consent Patients refusing to give written informed consent 2. Clinically significant or unstable physical or mental disability rendering the participants incapable of complying with the study protocol as judged by the investigator 3. Pregnant women 4. Patients taking long-term anti-microbial or anti-inflammatory drugs 5. Patients requiring pre-operative antibiotics for surgery 6. Patients requiring concomitant extractions or contralateral lower 3rd molar removal | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Multiple Myeloma Newly diagnosed with Multiple Myeloma requiring treatment The patient must be able to speak and understand Danish and be able to give his/her informed consent Patients with spinal cord compression Unstable vertebral fracture (SINS score >12) (52) Untreated cardiac failure and untreated cardiac arrythmia Severe chronic cardiac failure (NYHA 3-4) Other severe comorbidity that will not allow physical training, e.g. neurological or uncompensated liver failure and psychological or psychiatric disorder that will not allow compliance in physical training | 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, Bronchopulmonary Dysplasia Very Low Birth Weight very low birthweight infant (<1500g) gestational age at birth <32 weeks age 14 or more days and corrected to 28w0d to 33w6d gestational age continuing to require respiratory support and/or supplemental oxygen chromosomal abnormalities major congenital anomalies congenital heart disease, except atrial septal defect and patent ductus arteriosus clinical providers determine subject too unstable to undergo pulmonary function testing | 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, Quality of Life diagnosed by a neurologist, with headache characteristics as established by the International Headache Society and Controlled pharmacologically Patients with infrequent ETTH, or with probable frequent and infrequent forms of TTH They can never have vomiting or headache episodes during the treatment ETTH patients may experience very occasionally photophobia or phonophobia during their episodes of headache, CTTH patients may experience very occasionally photophobia, phonophobia or mild nausea during headache episodes. Pain aggravated by movement of the head, Metabolic or musculoskeletal problems with similar headache symptoms, Previous trauma to the cervical spine, Active vertigo history Poorly controlled hypertension, Joint stiffness, atherosclerosis, or advanced osteoarthritis, Patients undergoing pharmacological adaptation, Excessive emotional stress, Patients with heart devices Joint instability, Neurological disorders, Laxity of cervical soft tissues, Radiographic abnormalities Generalized hyperlaxity or hypermobility, 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, Prostate Cancer Written informed consent provided prior to initiation of study procedures 2. Age ≥ 18 years 3. Histologically documented adenocarcinoma prostate cancer confirmed by a pathology report from prostate biopsy or a radical prostatectomy specimen. If prostatic tumor is of mixed histology, > 50% of the tumor must be adenocarcinoma 4. Bone metastases as manifested by one or more lesions on a bone scan performed within 2 months of screening 5. Castrate-resistant prostate cancer, in the setting of castrate levels of testosterone (≤ 50 ng/dL), defined as current or historical evidence of disease progression concomitant with surgical castration or androgen deprivation therapy (ADT), as demonstrated by two consecutive rises in PSA OR new lesions on bone scan PSA progression will be defined as 2 rising PSA values compared to a reference value, measured at least 7 days apart and the second value is ≥ 2 ng/mL [1]. It must be documented within 2 months of screening Appearance of one or more new areas of abnormal uptake on bone scan when compared to imaging studies acquired during castration therapy or against the precastration studies if there was no response. Increased uptake of pre-existing lesions on bone scan does not constitute progression. It must be documented within 4 months of screening 6. Serum PSA ≥ 2.0 ng/mL 7. Screening ECOG perf status ≤ 1 8. Asymptomatic or minimally symptomatic disease (no narcotic analgesic; other analgesics use is allowed) 9. Prior abiraterone and enzalutamide are permitted, but not required 10. Concurrent osteoclast-inhibitory therapies (zoledronic acid, denosumab) are permitted if patients have been on a stable dose for at least 1 month 11. Adequate screening hematologic, renal, and liver function as evidenced by laboratory test results within the following ranges ≤ 28 days prior to registration Absolute neutrophil count (ANC) ≥ 1.5 x109/L Platelet count ≥ 100 x109/L Hemoglobin ≥ 10.0 g/dL Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN Creatinine ≤ 1.5 x ULN Albumin > 25 g/L The presence of known lung or liver metastases greater than 1.0 cm in the long axis diameter 2. The presence of lymphadenopathy greater than 3 cm in the short-axis diameter 3. The presence of known brain metastases 4. Spinal cord compression, imminent long bone fracture, or any other condition that, in the opinion of the investigator, is likely to require radiation therapy and/or steroids for pain control during the active phase 5. Previous treatment with chemotherapy for mCRPC (adjuvant chemotherapy is permitted), or chemotherapy for any reason within 2 years prior to registration 6. Intention to receive chemotherapy within 6 months after enrollment in protocol therapy 7. History of radiation therapy, either via external beam or brachytherapy within 28 days prior to registration 8. Systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within previous 24 weeks 9. Prior history of other cancers (except non-melanoma skin cancers or low-grade low-stage urothelial cancers) 10. Use of prednisone or equivalent systemic corticosteroid within 2 weeks of treatment. Use of inhaled, intranasal, intra-articular, and topical steroids is allowed. Oral or IV steroids to prevent or treat IV contrast reactions are allowed 11. Use of opioid analgesics for cancer-related pain 12. Use of experimental drug within 4 weeks of treatment 13. Uncontrolled medical conditions including diabetes, heart failure, COPD, ulcerative colitis, or Crohn's disease 14. Uncontrolled fecal incontinence 15. Any medical intervention, any other condition, or any other circumstance which, in the opinion of the investigator, could compromise adherence with study requirements or otherwise compromise the study's objectives | 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, Abdominal Aortic Aneurysms Diagnosed abdominal aortic aneurysm with indication for endovascular repair. 2. Intention to electively implant the Aorfix™ Stent Graft System Does not comply with the indications for Aorfix™ in the Instructions for Use (IFU). 2. Unwillingness or inability to comply with the recommended follow-up assessments according to the standards of care at the investigative site. 3. Unwillingness or inability to provide informed consent to both the Registry and the EVAR procedure. 4. Patients in whom Aorfix™ is being placed as a secondary procedure to a previous surgical or endovascular treatment of an AAA other than with another Aorfix™ graft | 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, Ankle Fractures All patients operated on Nordsjællands Hospital, department of Orthopaedic surgery, during the period, for mono-, bi and trimalleolar fracture, according to the AO-principles Age above 18 years Sub study 1 Age under 18 Dementia Need for external fixation Known or suspected DVT or pulmonary embolism Patients without Danish CPR-number, or address in Denmark Patients who doesn´t want to participate or who are not able to give written or oral consent No palpable pulse in the foot in the affected leg (the posterior tibial or dorsal artery) Multi-traumatized patients and patients with fractures of more than one extremity Sub study 2 | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-90.0, Pain Age > 18;-90 2. A localized pain complaint to the back, neck, face, groin, buttocks, abdomen, chest, or up to two extremities 3. Average pain score ≥ 4/10 over the past week; 4. Pain duration > 6 weeks 5. DEERS eligibility Previous prescription for a compounded pain cream. 2. Cannot read or understand English. 3. Allergic reaction to Ketamine, Gabapentin, Diclofenac, Baclofen, Cyclobenzaprine, Ketoprofen, Clonidine or lidocaine. 4. Pregnancy. Ruling out pregnancy will be done in accordance with our standard procedures, which is to obtain a urine HCG in any female of child-bearing age who may be pregnant prior to starting any new medications | 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, Surgical Site Infections Venous Thromboembolism Subjects greater than 18 years of age scheduled for surgical procedure considered to have a high risk for a surgical site infection (SSI) such as 1) secondary repair of a ventral hernia, 2) open bariatric surgery, 3) open abdominal colorectal surgery, 4) trauma surgery, 5) burn surgery or 6) sternotomy. 2. Patients must have one of the following risk factors for surgical site infection: emergency surgery, obesity, diabetes mellitus, cancer surgery, be immune-compromised or otherwise be at an increased risk for SSI. 3. Only adults will participate as research subjects 4. This study will involve both males and females 5. Patients in ASA (American Society of Anesthesiology) class I or II or III or IV will be included. Treatment assignment will be stratified with respect to ASA classification. 6. Abdominal wound classifications: Clean-Contaminated, Contaminated, or Dirty are eligible to participate. Treatment assignment will be stratified with respect wound classification. Similarly, trauma and burn patients will be classified. 7. Patient must be able to understand the same written and spoken language as either the surgeon or nurse who provides informed-consent information to the patient. 8. Patients must be appropriately screened for the proposed surgery Procedures involving only simple ostomy closures 2. Known allergy to cefazolin or metronidazole or an antibiotic preferred and routinely used by the surgeon 3. Persons less than 18 years old 4. Emergency operation as designated by the surgeon will be included only with the appropriate approval by the institutional IRB at an individual research site 5. Pregnant or breast-feeding women 6. A known bleeding/hemorrhagic/thrombotic disorder is exclusionary unless there is a written clearance chart-note or clearance letter from a primary care physician or hematologist 7. Significant psychiatric problems which might impair ability to give truly informed consent or which may impair follow-up communication with the surgeon and staff 8. Clinically significant cardiac arrhythmias are exclusionary unless there is a written clearance chart-note or clearance letter from a cardiologist 9. Heart/liver/kidney disease, neuropsychiatric disease classifying patient as ≥ ASA V 10. Major concomitant infections such as pneumonia or sepsis 11. In non-emergency surgery, pre-existing active bacterial skin infection at the time of the surgical incision; however, pre-existing bacterial infections are not exclusionary in burn or trauma patients. 12. Foreign material in the incision that cannot be removed 13. Recent systemic antimicrobial therapy 14. Clinically significant renal impairment or a creatinine clearance < 30 mL/min. Vulnerable Subjects are excluded 1. Pregnant women 2. Nursing home residents, or other institutionalized persons are not fully alert, not cognizant or and not able to give informed consent are not eligible to participate as a research subject 3. Children < 18 years of age | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Joint Instability chronic anterior instability requiring bone grafting (Instability Severity Index Score>3) Patient refusal | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Breast Neoplasm Females or males, aged >=18 years at the time of signing the informed consent form (ICF). 2. mTNBC (confirmed from most recent tissue sample) meeting the following 1. Estrogen receptor (ER) and progesterone receptor negative (a tumor is ER and/or progesterone receptor positive if at least 1 percent (%) of the cells examined have estrogen and/or progesterone receptors) and human epidermal growth factor receptor 2 (HER2) negative (defined as immunohistochemistry [IHC] less than (<) 2+ or fluorescence in situ hybridization [FISH] negative). 2. Previously treated with 0 to 2 lines of systemic anticancer therapy (cytotoxic or targeted anticancer agents) in the metastatic setting. Hormonal therapy and bone metastases treatment (example, bisphosphonates, denosumab, etc) are not considered forms of systemic anticancer therapy. 3. Presence of measurable disease meeting the following 1. At least 1 lesion of >=10 millimeter (mm) in long axis diameter for nonlymph nodes or >=15 mm in short axis diameter for lymph nodes that is serially measurable according to Response Evaluation in Solid Tumors version 1.1 (RECIST 1.1) using computerized tomography (CT) or magnetic resonance imaging (MRI) or panoramic and close-up color photography. 2. Lesions that have had radiotherapy must show subsequent radiographic evidence of increased size to be deemed a target lesion. 4. Life expectancy of >=3 months. 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. 6. Adequate renal function as evidenced by serum creatinine less than or equal to (<=) 1.5 milligram per deciliter (mg/dL) or calculated creatinine clearance >=50 millimeter per minute (mL/min) according to the Cockcroft and Gault formula. 7. Adequate bone marrow function, defined as: 1. Absolute neutrophil count (ANC) >=1.5*10^9/L. 2. Hemoglobin (Hb) >=10.0 gram per deciliter (g/dL) (can be corrected by growth factor or transfusion). 3. Platelet count >=100*10^9/L. 8. Adequate liver function, defined as: 1. Total bilirubin <=1.5*upper limit of normal (ULN). 2. Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) <=3*ULN unless there are bone metastases, in which case liver specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of the total alkaline phosphatase. ALT and AST <= 5*ULN if participant has liver metastases. 9. Resolution of all chemotherapy-related or radiation-related toxicities to Grade 1 severity or lower, except for stable sensory neuropathy (<= Grade 2) and alopecia. 10. Archived tissue sample or new biopsy sample. 11. Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative beta-human chorionic gonadotropin [B-hCG] (or human chorionic gonadotropin [hCG]) test with a minimum sensitivity of 25 International units per litre (IU/L) or equivalent units of B-hCG [or hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug. 12. All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (that is, bilateral tubal ligation, total hysterectomy or bilateral oophorectomy, all with surgery at least 1 month before dosing). 13. Females of childbearing potential must not have had unprotected sexual intercourse within 30 days before study entry and must agree to use a highly effective method of contraception (example, total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], a contraceptive implant, a combination oral contraceptive (estrogen/progesterone), or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for 120 days after study drug discontinuation. If currently abstinent, the participant must agree to use a double barrier method as described above if she becomes sexually active during the study period or for 120 days after study drug discontinuation. Females who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 28 days before dosing and must continue to use the same contraceptive during the study and for 120 days after study drug discontinuation. 14. Males who have had a successful vasectomy (confirmed azoospermia) or they and their female partners meet the above (that is, not of childbearing potential or practicing highly effective contraception throughout the study period or for 120 days after study drug discontinuation). No sperm donation is allowed during the study period or for 120 days after study drug discontinuation. 15. Willing and able to comply with all aspects of the treatment protocol. 16. Provide written informed consent Previous treatment with eribulin mesylate or any anti-programmed death receptor-1 (anti-PD-1), programmed death receptor ligand-1 (PD-L1), or PD-L2 agent. 2. Active autoimmune disease that has required systemic treatment in the past 2 years (that is, with use of disease modifying agents, corticosteroids, or immunosuppresive drugs). Replacement therapy (example, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc) is not considered a form of systemic treatment. 3. Less than 6 months since prior adjuvant chemotherapy. 4. Current enrollment in another interventional clinical study or used any investigational drug or device within the past 28 days preceding informed consent. 5. Treatment with chemotherapy or biological therapy within the previous 3 weeks, radiation or small molecule targeted therapy within the previous 2 weeks. 6. Known central nervous system (CNS) disease, except for those participants with treated brain metastasis who are stable for at least 1 month, having no evidence of progression or hemorrhage after treatment and no ongoing requirement for corticosteroids, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. 7. Known history of human immunodeficiency virus (HIV) positive. 8. Known active hepatitis B (example, HBsAg reactive) or hepatitis C (example, hepatitis C virus ribonucleic acid (HCV RNA) detected). 9. Existing anticancer treatment-related toxicities of Grades >= 2 (except for alopecia and Grade 2 sensory neuropathy) according to Common Terminology for Adverse Events (CTCAE v4.03). 10. Any other malignancy that required treatment or has shown evidence of recurrence (except for nonmelanoma skin cancer, or histologically confirmed complete excision of carcinoma in situ) during the 5 years prior to enrollment in this study. 11. History of significant cardiovascular disease, defined as: 1. congestive heart failure greater than New York Heart Association (NYHA) Class II according to the NYHA Functional Classification. 2. unstable angina or myocardial infarction within 6 months of enrollment. 3. serious cardiac arrhythmia. 12. Clinically significant electrocardiogram (ECG) abnormality, including a marked Baseline prolonged QT interval/corrected QT interval ([QT/QTc], example, a repeated demonstration of a QTc interval >500 millisecond [ms]). 13. History of concomitant medical conditions or infectious diseases that, in the opinion of the investigator, would compromise the participant's ability to safely complete the study. 14. Hypersensitivity to the active substance or any other excipients of the eribulin mesylate drug product, or severe hypersensitivity (>=Grade 3) to pembrolizumab and/or any of its excipients. 15. Scheduled for major surgery during the study. 16. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. The use of physiologic doses of corticosteroids may be approved after consultation with the sponsor. 17. Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis. 18. Has a history of interstitial lung disease. 19. Has an active infection requiring systemic therapy. 20. Has received a live-virus vaccination within 30 days of planned start of study therapy. Seasonal flu vaccines that do not contain live virus are permitted. 21. The investigator's belief that the participant is medically unfit to receive eribulin mesylate and pembrolizumab or unsuitable for any other 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): 18.0-60.0, Impacted Third Molar Tooth Impacted lower third molar not in use of NSAID or opioids in the last one month Local anesthetics allergy History of gastrointestinal bleeding or ulcers Kidney disease Asthma Allergy or sensitivity to aspirin or any other NSAID or opioids Pregnant or nursing woman Patients using antidepressant, diuretic or aspirin Patients under treatment to quit drugs | 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, Neck Pain No current history or past history of neck pain; able to lie on back or stomach without difficulty 'Red flag' items indicated in your Neck Medical Screening Questionnaire such as history of a tumor, bone fracture, metabolic diseases, Rheumatoid Arthritis, osteoporosis, severe atherosclerosis, prolonged history of steroid use, etc. 2. History of neck whiplash injury 3. Diagnosis from your physician of cervical spinal stenosis (narrowing of spinal canal) or presence of symptoms (pain, pins and needles, numbness) down both arms 4. Presence of central nervous system involvement such as exaggerated reflexes, changes in sensation in the hands, muscle wasting in the hands, impaired sensation of the face, altered taste, and presence of abnormal reflexes 5. Evidence of neurological signs consistent with nerve root entrapment (pinched nerve in the neck) 6. Prior surgery to your neck or upper back 7. A medical condition which may influence assessment of pain or pressure pain thresholds (i.e. taking analgesics, sedatives, history of substance abuse, or cognitive deficiency) 8. Diagnosis from your physician of fibromyalgia syndrome 9. Currently pregnant, or could be 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): 18.0-999.0, Renal Osteodystrophy Patients with kidney disease who have an indication for a bone biopsy, based on clinical, laboratory and radiologic findings known malignant bone or bone marrow 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, Pain; Bone Neoplasms; Neoplasm Metastasis Adults at least 18 years of age Malignant bone disease due to multiple myeloma or cancer of the lung, prostate, gastrointestinal (GI) tract, ovary, or bladder Bone pain defined as a Brief Pain Inventory (BPI) most acute pain score greater than or equal to 4 Radiologically confirmed bone disease disease Previous treatment with ibandronate (Bondronat) within previous 2 months Severely impaired renal function Known brain metastases | 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): 7.0-75.0, Bone Cyst Patients admitted to the hospital for surgical treatment of benign bone lesion requiring bone grafting Patient below 6 years of ageIrreversible coagulopathy or bleeding disorder. Note regarding reversible coagulopathies: Patients on coumarin or other anticoagulants may participate. Investigators should follow routine practices for perioperative discontinuation and re-initiation of anticoagulants A pre-existing calcium metabolism disorder (e.g. hypercalcemia) | 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, Castration-Resistant Prostate Cancer Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 Adenocarcinoma of the prostate; either non-metastatic castrate resistant prostate cancer (NM-CRPC) with high risk disease (defined as PSA Doubling time equal or less than (<=) 10 months) or metastatic CRPC Be surgically or medically castrated with testosterone levels of less than (<) 50 nanogram per deciliter If treated with a gonadotropin releasing hormone analog (ie, patient who has not undergone bilateral orchiectomy), then this therapy must have been initiated at least 4 weeks prior to Cycle 1 Day 1 and must be continued throughout the study Electrocardiogram (ECG) showing a QT interval corrected for heart rate, using Fridericia formula (QTcF) <= 470 milliseconds (based on the average of a triplicate ECG set collected during the screening visit) Left ventricular ejection fraction (LVEF) of more than 45% as determined by multiple uptake gated acquisition (MUGA) or echocardiography at the screening visit Abnormal cardiac function at screening Known brain metastases Has received an investigational drug within 4 weeks, or within a period < 10 times the drug's half-life, whichever is longer, of Cycle 1 Day 1 Has received chemotherapy or immunotherapy for the treatment of prostate cancer within 4 weeks of Cycle 1 Day 1 Prior treatment with enzalutamide and apalutamide Use of therapies that must be discontinued or substituted within at least 4 weeks prior to Cycle 1 Day 1 including medications to lower seizure threshold, inducing/inhibiting metabolizing enzymes or prolonging the QT interval History or condition that may predispose to seizures, or evidence of severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events within 12 months prior to Cycle 1 Day 1, New York Heart Association (NYHA) Class II to IV heart 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, Atopic Dermatitis Key 1. Non-immunocompromised male or non-pregnant, non-lactating female, 18 years of age or older with a clinical diagnosis of moderate to severe AD. 2. Have confirmed diagnosis of atopic dermatitis for at least 3 months using the diagnostic features as described by Hanifin and Rajka 3. Have an IGA score of 3 (moderate) or 4 (severe). 4. Have an affected Body Surface Area (BSA) of at least 20% at baseline. 5. Treated with a bland emollient for at least 7 days. Key Active cutaneous bacterial or viral infection in any treatment area at baseline. 2. Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at baseline. 3. History of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, or ichthyosis. 4. History or presence of Netherton's Syndrome, immunological deficiencies or diseases, HIV, diabetes, malignancy, serious active or recurrent infection, clinically significant severe renal insufficiency or severe hepatic disorders. 5. Known allergy or hypersensitivity to tacrolimus or any other component of the Study products | 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, Defective Mineralization IInclusion Informed consent will be obtained from the patient or the parents before any study related procedures Patients of both genders older than 2 month The patient has a diagnosis of Hypophosphatasia disease or a high-grade suspicion for Hypophosphatasia disease High-grade suspicion present, if one or more are valid Positive family anamnesis for Hypophosphatasia disease Frequent fractures Bone pain Tooth loss Osteopenia/Osteoporosis No Informed consent from the patient or the parents before any study related procedures Patients of both gender younger than 2 month No diagnosis of Hypophosphatasia disease or no valid for profound suspicion of Hypophosphatasia 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): 2.0-21.0, Simple Bone Cyst Arm 1 Simple Bone Cyst Patients 1. Patients ≥ 2 and ≤ 21 years 2. Patients with a diagnosis of simple bone cyst located in a long bone confirmed by imaging within 3 months prior to registration 3. All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines Patients with implants to stabilize the bone where the cyst is located. 2. Patients with bone disease (i.e. osteogenesis imperfecta, cancer, osteoporosis, Paget's disease) 3. Patients who are pregnant or breastfeeding 4. Patients with a simple bone cyst crossing the growth plate Arm 2 Healthy Controls 1. Patients ≥ 2 and ≤ 21 years 2. All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines Patients with bone disease (i.e. osteogenesis imperfecta, cancer, osteoporosis, Paget's disease) 2. Patients receiving any bone-modifying agents (i.e. steroids, bisphosphanates, etc.) 3. Patients who are pregnant or breastfeeding Arm 3 Fracture patients 1. Patients ≥ 2 and ≤ 21 years 2. Patients who have undergone any type of casting or surgical treatment for their fracture 3. All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines Patients with bone disease (i.e. osteogenesis imperfecta, cancer, osteoporosis, Paget's disease) 2. Patients receiving any bone-modifying agents (i.e. steroids, bisphosphanates, etc.) 3. Patients who are pregnant or breastfeeding | 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, Lung Cancer Age between 18 and 70 years of age, male or female 2. histologically or cytologically confirmed stage IIIB or IV lung cancer at diagnosis 3. no evidence of bone metastatic lesions was radiographically confirmed by bone scintigraphy 4. life expectancy of ≥6 months 5. adequate renal, hematologic, and hepatic 6. Eastern Cooperative Oncology Group(ECOG) performance status≤2 7. All patients provided written informed consent Treatment with other bisphosphonates 2. Presence of brain metastases 3. Be allergic to ZOL 4. attending other unlisted drug clinical trials,currently | 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, Prostatic Neoplasms Patients with histologically proven prostate cancer. 2. Hormonal treatment (either surgical orchiectomy or medical castration with LHRH agonist or antagonist). 3. Proven castration levels (serum Testosterone< 50 ng/dl) 4. Radiological evidence of metastatic disease. 5. Uptake of the radiotracer 68Ga-DOTATET in at two least to metastases Participation in another trial | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-75.0, Primary Sclerosing Cholangitis Participants with chronic cholestatic liver disease for at least 6 months Clinical diagnosis of Primary Sclerosing Cholangitis (PSC) as evident by chronic cholestasis of more than six months duration with either a consistent magnetic resonance cholangiopancreatography (MRCP)/endoscopic retrograde cholangiopancreatography (ERCP) showing sclerosing cholangitis, or a liver biopsy taken at any time consistent with PSC in the absence of a documented alternative etiology for sclerosing cholangitis. If diagnosis of PSC was made by histology alone, it must require the presence of fibro-obliterative lesions (i.e., onion skin lesions) Participants with or without Inflammatory Bowel Disease (IBD) are allowed. If participant has IBD, documented evidence of IBD either by prior endoscopy or in previous medical records, for ≥ 6 months. In addition, participants will be required to enter the study with a Partial Mayo Risk score of 0-3, inclusively In participants receiving treatment with ursodeoxycholic acid (UDCA), therapy must be stable for at least 3 months, and at a dose not greater than 20 mg/kg/day Serum ALP greater than 1.5 × upper limit of normal (ULN) Ability to understand and sign a written informed consent form (ICF) Participants receiving allowed concomitant medications need to be on stable therapy for 28 days prior to the Baseline Visit with the exception of UDCA in which participants need to be on stable therapy for ≥ 3 months Presence of documented secondary sclerosing cholangitis (such as ischemic cholangitis, recurrent pancreatitis, intraductal stone disease, severe bacterial cholangitis, surgical or blunt abdominal trauma, recurrent pyogenic cholangitis, choledocholithiasis, toxic sclerosing cholangitis due to chemical agents, or any other cause of secondary sclerosing cholangitis) on prior clinical investigations Small duct PSC Presence of percutaneous drain or bile duct stent History of cholangiocarcinoma or high clinical suspicion over dominant stricture within 1 year by MRCP/ERCP or clinical judgment Ascending cholangitis within 60 days prior to Screening Alcohol consumption greater than 21 units/week for males or 14 units/week for females (one unit of alcohol is ½ pint of beer [285 mL], 1 glass of spirits [25 mL] or 1 glass of wine [125 mL]) Prior or planned liver transplantation Presence of alternative causes of chronic liver disease, including alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, autoimmune hepatitis History of cirrhosis and/or hepatic impairment (Child-Pugh classes A, B and C) and/or hepatic decompensation including ascites, encephalopathy or variceal bleeding. Participants who show evidence of significant worsening of hepatic function will be excluded Participants with fibrosis evidence of cirrhosis, as determined by local transient elastography (TE, e.g., Fibroscan) values of ≥ 13.0 kPa, taken within the last 6 months. If TE has not been conducted within the 6 months prior to screening, then one will be conducted during the screening period and can be used as the Baseline value | 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): 14.0-19.0, Orthodontic Anchorage Procedures Mild to moderate skeletal Class II Super eruption of maxillary posterior segment Erupted full set of maxillary permanent teeth except 3rd molar Increased lower facial height Previous orthodontic treatment Any hormonal disorders or syndromes Systemic Disease Facial Asymmetry Para-functional habits | 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, Neoplasms, Connective and Soft Tissue Bone Neoplasms Must have a diagnosis or presumed diagnosis of bone or soft tissue tumor as defined by the WHO classification of tumors of soft tissue and bone (4th ed.) Patient, or his/her designated power of attorney, must be able to understand and approve of the consent to participate Prisoners are excluded from participation in the 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): 18.0-999.0, Non Small Cell Lung Cancer For in the study subjects should fulfill the following 1. Provision of written informed consent to treatment and companion translational studies prior to any study specific procedures 2. Patients must be > 18 years of age. 3. Affiliation to an health insurance 4. Histological diagnosis of NSCLC 5. Advanced or metastatic disease (stage IIIB/IV) 6. Access to the original tumor biopsy or planning of a fresh tumor biopsy before start the platinium based chemotherapy 7. Chemonaive for NSCLC or patient having received adjuvant chemotherapy at least 2 years before trial enrolment or patient currently receiving his/her first platinum-based chemotherapy for advanced NSCLC (first line or second line only if the first line was an anti-PD-1 or anti-PD-L1 agent monotherapy) 8. No other cancer in the previous 3 years, except cervical cancer or cutaneous cancer 9. Absence of EGFR-sensitising mutation or ALK translocation 10. ECOG Performance Status of 0-1 11. Fit to receive 6 cycles or currently receiving of platinum-based induction chemotherapy 12. At the start of the platinium based induction chemotherapy measurable lesions by v1.1 i.e. at least one lesion, not previously irradiated, that can be accurately measured at baseline as ≥ 10mm in the longest diameter (except lymph nodes that must have short axis ≥ 15mm) with computed tomography (CT), magnetic resonance imaging (MRI) or clinical examination and which is suitable for accurate repeated measurements. 13 is only for patients registered before starting the platinum-based induction chemotherapy: 13. Patients must have normal organ and bone marrow function measured within 14 days prior to administration of the platinum based treatment Haemoglobin ≥ 10.0 g/dL Absolute neutrophil count (ANC) ≥ 1.5 x 109/L Platelet count ≥ 100 x 109/L Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be ≤ 5x ULN Creatinine clearance > 60mL/min as calculated by Cockroft-Gault formula for cisplatin administration; creatinine clearance >/= 51mL/min by Cockroft-Gault formula for carboplatin administration 14. Evidence of non-childbearing status for women of childbearing potential: negative serum pregnancy test within 14 days of study treatment. Postmenopausal is defined as Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments LH and FSH levels in the post-menopausal range for women under 50 Radiation-induced oophorectomy with last menses >1 year ago | 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, Endosseous Dental Implant Failure All patients in need for implant treatment 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): 18.0-999.0, Breast Neoplasms The patient has signed and dated the informed consent document and it has been obtained before conducting any procedure specifically for the study. 2. Availability of a tumor tissue sample, archival (primary tumour) or from the metastatic lesions (preferable) for the central ER, PgR and HER2 testing. 3. Histological/cytological confirmation of breast cancer with evidence of metastatic disease (loco-regional or distant), not amenable to resection or radiation therapy with curative intent. 4. Documented positive hormone receptor status (> or = 1% of tumour cells with oestrogen receptor [ER] and/or progesterone receptor [PgR] expression) based on central testing on the most recent tumour biopsy. 5. Documented HER2-negative tumour based on central testing on the most recent tumour biopsy. HER2-negative tumour is determined as immunohistochemistry score 0/1+ or negative by in situ hybridization (FISH/CISH/SISH) defined as a HER2/CEP17 ratio <2 or for single probe assessment a HER2 copy number <4. 6. Patients must have received at least 5 years of endocrine therapy in the adjuvant setting as treatment for early disease and remained disease free for more than 12 months following its completion or have "de novo" metastatic disease. Patients that have been scheduled 5 years with adjuvant endocrine therapy and stopped treatment, by patient's own decision, after completing at least 3 years of treatment, can be also be included as long as they have remained free of disease 3 years after discontinuing the endocrine therapy. 7. Patients must have at least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline and is suitable for repeated assessment by CT, MRI, plan x-ray or physical examination. Clinical lesions will only be considered measurable when they are superficial and ≥10mm diameter as assessed using callipers (e.g. skin nodules). Patients with bone-only disease must have a lytic or mixed (lytic + blastic) lesion, which has not been previously irradiated and can be accurately assessed by CT/MRI according to version 1.1. 8. Postmenopausal patient, defined as a woman fulfilling any one of the following (based on the NCCN definition of menopause [National Comprehensive Cancer Network 2008]) Prior bilateral oophorectomy Age > 60 years Age ≤ 60 years and with amenorrhea for 12 or more months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and follicle stimulating hormone and estradiol in the postmenopausal range. 9. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2. 10. At least 18 years of age. 11. Life expectancy ≥ 12 weeks. 12. Adequate organ and bone marrow function ANC ≥ 1,500/mm3 (1.5x109/L) Platelets ≥ 100,000/mm3 (100x109/L) Haemoglobin (Hgb) ≥ 9g/dL (90g/L) Serum creatinine ≤ 1.5xUpper Limit of Normal (ULN) or estimated creatinine clearance ≥ 60ml/min as calculated using the method standard for the institution Total serum bilirubin ≤ 1.5xULN (<3xULN if Gilbert´s disease) AST and/or ALT ≤ 3xULN (≤5xULN if liver metastases present) Prior systemic therapy for metastatic disease. Note: patients with a local recurrent disease treated with surgery (R0) and receiving a "second hormonal adjuvant therapy for five years" will be allowed, provided they have remained disease free for more than 12 months following its completion. 2. Have "de novo" locally advanced disease. 3. Current use of food or drugs known to be potent CYP3A4 inhibitors, drugs known to be potent CYP3A4 inducers, and drugs that are known to prolong the QT interval. 4. Presence of life-threatening metastatic visceral disease, defined as extensive hepatic involvement, or any degree of brain or leptomeningeal involvement (past or present), or symptomatic pulmonary lymphangitis spread, or any known bone marrow infiltration due to breast cancer. Patients with discrete pulmonary parenchymal metastases are eligible, provided their respiratory function is not significantly compromised as a result of disease. 5. Treatment with a non-approved or experimental drug within 4 weeks before randomization. 6. Prior treatment with any CDK4/6 inhibitor or fulvestrant. 7. Current or prior malignancy within previous 5 years (other than breast cancer or adequately treated basal cell or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix). 8. History of Bleeding diathesis (i.e., disseminated intravascular coagulation [DIC], clotting factor deficiency) or long-term (>6 months) anticoagulant therapy (other than antiplatelet therapy and low dose coumarin derivatives provided that the International Normalised Ratio (INR) is less than 1.6). Hypersensitivity to active or inactive excipients of fulvestrant, palbociclib/placebo or castor oil Any severe concomitant condition which makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the trial protocol, e.g. uncontrolled cardiac disease or uncontrolled diabetes mellitus. 9. QTc interval > 480msec, family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation or Torsade de Pointes. 10. Uncontrolled electrolyte disorders that can compound the effects of a QTc-prolonging drug (eg, hypocalcaemia, hypokalaemia, hypomagnesaemia). 11. Impairment of gastro-intestinal (GI) function or GI disease that may significantly alter the absorption of palbociclib, such as history of GI surgery which may result in intestinal blind loops and patients with clinically significant gastro-paresis, short bowel syndrome, unresolved nausea, vomiting, active inflammatory bowel disease or diarrhoea of CTCAE grade > 1. 12. Prior hematopoietic stem cell or bone marrow transplantation. 13. Known human immunodeficiency virus infection. 14. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study | 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): 0.0-70.0, Osteoarthritis Bilateral Total Knee Arthroplasty Age ≤ 70 years Undergoing bilateral, simultaneous, primary knee replacements neurological, vascular or cardiac problems that limit function unstable orthopedic conditions that limit functional performance previous history of inflammatory arthritis or other inflammatory systemic conditions previous history of deep vein thrombosis in either lower extremity lymphedema or other conditions that lead to lower extremity edema that may influence the outcomes 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): 21.0-999.0, HPV Vaccination Born in Mexico or born in the U.S. but self-describes as Mexican-American Spanish is her/his primary language Has a minimum of one child between the ages of 9 and 17 who has not received the HPV vaccine and who lives with the parent/guardian as per self report Self-identifies as the child's main caregiver Currently owns a cell phone, uses text messaging services and is willing to accept text messages for this study Will not be in the NYC area for the duration of the study period (6-9 months) Presence of a serious psychiatric or cognitive impairment likely to preclude meaningful informed consent and adherence to the protocol per the consenting professional's judgment | 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 Prostate Cancer mCRPC status mCRPC patients defined as; adenocarcinoma of the prostate with systemic metastatic disease despite castrate levels of testosterone (<50 ng/dL) due to orchiectomy or LHRH agonist. o Patients must have one or more of the following to be considered mCRPC Metastatic Disease Progression: >20% increase in the sum of diameters of measurable lesions from the time of maximal regression or appearance of one or more new lesions Bone Scan Progression: Appearance of one or more new lesions on bone scan attributable to prostate cancer PSA Progression: PSA ≥2 ng/ml that has risen serially on at least two occasions, each at least one week apart (PSA1 < PSA2 < PSA3) PSMA PET/CT scan progression: Appearance of one or more new lesions on PSMA PET/CT scan attributable to prostate cancer At enrolment, mCRPC patients must fit into one of the following 5 categories: 1. Treatment naïve for mCRPC (have not yet started approved therapies for CRPC ie: Abiraterone/Enzalutamide/Apalutamide / or Docetaxel, Cabazitaxel or other approved first line chemotherapy; less than 4 weeks on approved therapies is still considered to be treatment naïve) Or 2. Receiving Abi/Enza/Apa for mCRPC AND responding or stable (PSA values must be stable or declining after at least 4 weeks since starting Abi/Enza/Apa for mCRPC) Or 3. Patients with PSA progression while on Abi/Enza/Apa are eligible as long as they are asymptomatic AND there is no intent on starting chemotherapy within 6 months Or 4. Patients treated with Docetaxel, Cabazitaxel or other approved first line chemotherapy as first line for mCRPC who are asymptomatic without ANY evidence of progression Or 5. Patients may have progressed following first line Docetaxel, Cabazitaxel or other first line chemotherapy and are now receiving treatment with Abi/Enza/Apa. These patients must absolutely be responding or stable (PSA values must be stable or declining after starting Abi/Enza/Apa treatment) and have an estimated life expectancy of more than 1 year. mHSPC Status mHSPC patients must be classified as either high-risk or high-volume mHSPC. These groups are defined as adenocarcinoma of the prostate with systemic metastatic disease and patients also fit into one of the following 2 categories: 6. High-risk: defined as having at least 2 of three (i) Gleason score ≥8, (ii) presence of ≥3 lesions on bone scan, or (iii) presence of Protocol Version 5.0, 19 August 2019 4 measurable visceral lesions (PSMA PET imaging should not be used in the definition of high-risk disease) Or 7. High-volume: defined as having the presence of visceral metastases and/or ≥ four bone metastases with at least one outside of the vertebral column and pelvis (PSMA PET imaging should not be used in the definition of high-volume disease) Additional for all groups All patients will be required to be on ADT during the study period or have had a prior bilateral orchiectomy Men with small cell neuroendocrine tumours or features of small cell disease are not eligible | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-64.0, Edentulous Alveolar Ridge Patients with bilateral edentulous condition either partial or complete. 2. Patients maintaining adequate oral hygiene 3. Patients with dimensions of alveolar jaw bone in Occlusso-Gingival position >10mm and Bucco-Lingual position < 6mm Systemic diseases which are likely to compromise Implant surgery like Diabetes Mellitus Type I, II and Osteoporosis. 2. Patients with oral parafunctional habits like Bruxism. 3. Smokers who smoke more than 10 cigarettes a day. 4. Self-declared pregnancy or intention to become Pregnant. 5. The use of Regenerative procedures in conjunction with Implant placement.Eg Grafts ,Sinus Lift procedures | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 1.0-60.0, Bone Defect Bone Nonunion the patients with bone defect and bone nonunion caused by tumor or trauma the length of bone defect in long diaphysis is more than 4cm or more than half of the shaft diameter the size of bone defect is more than 5cmx5cm the patients are unable to use autologous bone graft or other treatments the patients request to use the treatment of tissue-engineered bone Supportive family with willingness to participate in completing questionnaires Patients with serious diseases such as hemorrhagic disorders, infection, tumor, contagion and so on Patients who are pregnant Patients with serious abnormal cardiopulmonary function Patients disagree to use the tissue-engineered bone Patients are older than 60 years Patients who are regarded to be unqualified by investigator | 0 |
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