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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): 0.0-999.0, Swelling Lips & Face All with oral and/or maxillofacial swelling Any other swellings that were caused by trauma and/or fracture, extended below the neck or patient reluctant to undergo US were excluded from the study | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Advanced Breast Cancer Obtention and signing of the molecular preselection consent regarding the mutational BRCA status confirmation prior to provision of the informed consent. 2. Provision of informed consent prior to any study specific procedures. 3. Male or female ≥18 years of age at the time of signing the Informed Consent Form (ICF). 4. Histologically and/or cytologically confirmed breast cancer with evidence of advanced disease (locoregionally recurrent or metastatic) not amenable to resection or radiation therapy with curative intent. 5. Patients with histologically and/or cytologically locally confirmed diagnosis of Human Epidermal Growth Factor Receptor 2 (HER2)-positive breast cancer according to the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) May 2018 criteria. 6. Patients with documented germinal mutation in Breast Cancer (BRCA)1 or BRCA2 genes that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function). Patients with germinal BRCA1/2 mutations that are considered to be non-detrimental (e.g., "Variants of uncertain clinical significance" or "Variant of unknown significance" or "Variant, favor polymorphism" or "benign polymorphism," etc.) will not be eligible for the study. Patients with known germinal BRCA status prior to enrollment are considered eligible to participate. 7. of resistance to trastuzumab defined as Relapse on (neo) adjuvant treatment or within 6 months from completion, or Progression on a trastuzumab regimen for advanced disease. No limitations on the number of prior trastuzumab regimens. 8. At least one prior systemic regimen for advanced disease including a pertuzumab or T-DM1 based regimen. No limitations on the number of prior systemic regimens. 9. Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 1. 10. Life expectancy greater or equal to 16 weeks. 11. Patients must have evaluable or measurable disease by Computed Tomography (CT) scan or Magnetic resonance imaging (MRI), according to Response Evaluation in Solid Tumors (RECIST) 1.1 criteria. 12. Patients must have normal organ and bone marrow function within 35 days prior to administration of study treatment as defined below Hematological: White blood cell (WBC) count >3.0 x 109/L, absolute neutrophil count (ANC) ≥1.5 x 109/L, platelet count ≥100.0 x109/L, and hemoglobin ≥ 10 g/dL Hepatic: bilirubin ≤ 1.5 times the upper limit of normal (x ULN) (≤2.0 in patients with known Gilberts syndrome) or direct bilirubin ≤ 1 x ULN; alkaline phosphatase (ALP), Aspartate aminotransferase (AST) / Serum Glutamic Oxaloacetic Transaminase (SGOT), and Alanine aminotransferase (ALT) / Serum Glutamic Pyruvate Transaminase (SGPT) ≤ 2.5 x institutional ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN Renal: Serum creatinine ≤ 1.5 x ULN or based on a 24-hour urine test or estimated creatinine clearance ≥ 51 mL/min using the Cockcroft-Gault equation: Estimated creatinine clearance = (140-age [years]) x weight (kg) (x F)a serum creatinine (mg/dL) x 72a where F=0.85 for females and F=1 for males. 13. Patients have been informed about the nature of study, including the exploratory studies and has agreed to participate and signed the ICF prior to participation in any study-related activities. 14. Males, postmenopausal and premenopausal women. Premenopausal women of childbearing potential (not undergoing to tubal ligation or hysterectomy) must have a negative blood or urine pregnancy test within 28 days prior to the start of study treatment and confirmed on Day 1 prior to commencing treatment Postmenopausal status is defined as either Prior bilateral oophorectomy; Or Age > 60 years; Or Age < 60 years and amenorrhoeic for 12 months in the absence of chemotherapy, tamoxifen, toremifene or ovarian suppression, and Follicle-stimulating hormone (FSH) and estradiol in postmenopausal range; Or Age < 60 years and taking tamoxifen or toremifene and FSH and plasma estradiol level in postmenopausal ranges; Or Radiation-induced castration with >1-year interval since last menses. Premenopausal status is defined as all those women who do not meet any of above criteria. Note: Documented hysterectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure, otherwise the patient must be willing to use 2 highly effective forms of contraception in combination male condom plus an acceptable hormonal or non-hormonal method) throughout the study. Information must be captured appropriately within the site's source documents. Correct forms of contraception for males and females are detailed in Appendix 5: Acceptable birth control methods. 15. Patients is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations. 16. Snap frozen or formalin fixed paraffin-embedded (FFPE) tumor sample is mandatory for exploratory central testing. 17. Patients must fulfil the relative field on the informed consent for donating blood samples and serial biopsies at baseline and on disease progression for the exploratory biomarker studies Patients that have previously received any poly(ADP-ribose) polymerase (PARP) inhibitor (PARPi) for any reason, including olaparib. 2. Involvement in the planning and/or conduct of the study (applies to both Sponsor's staff and/or staff at the study site). 3. Patients simultaneously enrolled in any interventional clinical trial. 4. Patients who have received any systemic chemotherapy during the last 3 weeks prior initiating protocol therapy. 5. Patients who have had radiation therapy encompassing >20% of the bone marrow within 3 weeks prior to start of treatment, excepting for palliative radiation therapy to a small field >1-week prior to Day 1 of study. 6. Resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation >500 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome. 7. Concomitant use of known strong Cytochrome P450 (CYP)3A inhibitors (e.g., itraconazole, telithromycin, clarithromycin, boosted protease inhibitors, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks. 8. Concomitant use of known strong (e.g. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (e.g. bosentan, efavirenz, modafinil). The required washout period prior to starting study treatment is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents. 9. Persistent toxicities (Common Terminology for Adverse Events (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia. 10. Patients with Myelodysplastic syndrome (MDS) / Acute myeloid leukemia (AML) or with features suggestive of MDS/AML. 11. Patients having diagnosis, detection, or treatment of another type of cancer during the last 5 years prior to initiating protocol therapy (except adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, definitively treated ductal carcinoma in situ, stage 1, grade 1 endometrial carcinoma), or other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ≤5 years). 12. Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery. 13. Patients considered a high medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples but are not limited to, uncontrolled ventricular arrhythmia, recent (within 6 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution CT scan or any psychiatric disorder that prohibits obtaining informed consent. 14. Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication. 15. Immunocompromised patients (e.g., patients who are known to be serologically positive for human immunodeficiency virus and those with undetectable viral load). 16. Patients with a known hypersensitivity to olaparib or trastuzumab or any of the excipients of the products. 17. Clinically significant cardiovascular disease (stroke, unstable angina pectoris, or documented myocardial infarction) within 6 months prior to study entry; history of documented congestive heart failure (New York Heart Association II-III-IV); symptomatic pericarditis; documented cardiomyopathy; ventricular arrhythmias with the exception of benign premature ventricular contractions; conduction abnormality requiring a pacemaker; other arrhythmias not controlled with medication]. 18. Left ventricular ejection fraction below 55% as determined by multiple-gated acquisition (MUGA) scan or echocardiography (ECHO). 19. Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg) despite adequate antihypertensive treatment. 20. Patients currently receiving anti-coagulant therapy (low molecular weight heparin and warfarin with careful monitoring of patients are permitted), or another immunosuppressive agent (standard premedication for chemotherapy and local applications are allowed). 21. Patients with pulmonary disease requiring continuous oxygen therapy. 22. Previous history of bleeding diathesis. 23. Patients with known active hepatitis (i.e. Hepatitis B or C). 24. Patients with moderate or severe hepatic impairment. 25. Chronic daily treatment with corticosteroids with a dose of ≥ 10 mg/day methylprednisolone equivalent (excluding inhaled steroids), except for prophylaxis use. 26. Previous allogenic bone marrow transplant or double umbilical cord blood transplantation. 27. Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment and in a dose < 10 mg/day methylprednisolone equivalent. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days. Female patients who are pregnant or breastfeeding, or adults of reproductive potential who are not using effective birth control methods. Patients unwilling to or unable to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and 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): 18.0-999.0, Choroidal Melanoma Indeterminate Lesions of Eye Have been clinically diagnosed with primary CM or IL at the time of entry to a previous Aura Biosciences sponsored clinical trial Have received AU-011 or assigned to an observation cohort in a previous Aura sponsored clinical trial 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): 0.0-999.0, Detection of PCM1-JAK2 Fusion Gene by FISH in the Two Types of t-MDS/AML and Relationship Between PCM1-JAK2 Fusion Gene and Cumulative Dose, Dose Intensity • Myelodysplastic syndromes: the diagnosis of MDS must be confirmed by a bone marrow aspirate and/or biopsy : blast count must be < 20%; patients with any International Prognostic Score (IPSS) are eligible; patients with low or intermediate (INT)-1 IPSS must have a platelet count < 50x10⁹/L and/or absolute neutrophil count (ANC) < 50x10⁹/L Acute myeloid leukemia with multilineage dysplasia: the diagnosis of AML-TLD must be confirmed by a bone marrow aspirate and/or biopsy NOTE: there must be evidence of >= 20% blasts on the review of the bone marrow aspirate and/or biopsy; AML-TLD will be interpreted to patients formerly diagnosed by French-American-British (FAB) as refractory anemia with excess blasts in transformation (RAEB-t), as well as patients with no history of antecedent hematologic disorder who have AML which meets for AML-TLD by World Health Organization (WHO) criteria; patients with AML-TLD must have a white blood cell (WBC) =< 30x10⁹/L documented within 4 weeks prior to study entry (two sets of counts that are 2 weeks apart will be taken); patients whose WBC has doubled within this period of time and is greater than 20x10⁹/L at the time of screening will not be eligible Patients have started therapy (cytotoxic agents and ionizing radiotherapy) at least 2 years ago other therapy related neoplasms other than myelodplastic syndrome or acute myeloid leukemia | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, Pressure-related Osteitis Patient ≥ 18 years Spinal cord injured patients with pressure-related osteitis treated with flap coverage and short antibiotic treatment Patient < 18 years Patient under under guardianship Patient with concomitant infections Patient having declare his opposition to study participation | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 60.0-85.0, Male Osteoporosis DXA BMD T-score < or = -2.0 at either lumbar spine (LS), femoral neck (FN) or total hip (TH) sites; or DXA BMD T-score < or = -1.5 with at least one additional important clinical risk factor for osteoporotic fracture [e.g., fragility fracture after age 50 years; parental history of hip fracture; history of hypogonadism, prior glucocorticoid therapy (>3 months prior), current smoking, prevalent vertebral fracture(s), or prior hyperthyroidism on stable treatment] At least 2 LS vertebral levels with reliable BMD values (i.e., at least 2 without compression or hardware) Metabolic bone disease other than osteoporosis (e.g., Paget's disease, hyperparathyroidism) Any osteoporosis drug therapy within 12 months; any prior course of TPTD for > or = 3 months; any history of IV bisphosphonate therapy; oral bisphosphonate therapy exceeding 3 months in past 2 years; oral bisphosphonate treatment exceeding 2 years ever; or use of denosumab (within the past 3 years or > 3 or = injections ever) Oral glucocorticoid use (> or = 5 mg prednisone) taken within 3 months prior to enrollment Hypercalcemia (albumin-corrected serum [Ca] >10.2 mg/dL), hypocalcemia (albumin-corrected serum [Ca] <8.8 mg/dL), elevated intact PTH level, or hypercalciuria (urinary Ca >300 mg/24 hours) at screening OH vitamin D levels <20 ng/ml or >80 ng/ml at screening Estimated glomerular filtration rate < 30 ml/min (chronic kidney disease (CKD) stage 4 or 5) Cancer within past 5 years except for non-melanomatous skin cancers History of skeletal radiation, prior history of osteosarcoma or bone metastases Substance abuse (>3 drinks/day), liver disease or impaired liver function (abnormal liver function tests defined as greater than 3 times the upper limit of normal), known cirrhosis, malabsorption Poorly controlled diabetes (A1c >9.0%) or current thiazolidinedione therapy | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 25.0-40.0, Traumatic Brain Injury Neurobehavioral Manifestation Sleep Disorder Fatigue Are 25 to 40 years of age Are active duty service members or veterans May be NIH employees/staff who are either active duty service members or veterans; except for those who are employed by NINR or subordinates, relatives, and/or co-workers of NINR employees/staff Have sustained at least 1 TBI, >= 6 months and <= 5 years since their most recent TBI, which includes any self-reported loss of consciousness (LOC) established by the OSU during the pre-screening phone call Are able to provide their own consent Are able to understand the protocol, as shown by scoring a 6 out of 6 on a consent quiz Currently receiving treatment for a medical illness or recent injury that precludes protocol participation, may interfere with study participation, and/or should be treated/stabilized prior to study participation for safety reasons (e.g., cancer, recent fracture(s) requiring therapy and/or pain medication, severe infection). Individuals with stable medical conditions such as hypertension that are controlled by medication will be included Current physical health status will be assessed by self-report, history and physical exam by a credentialed physician or nurse practitioner, and standard laboratory tests Current unstable endocrine disorder (e.g., uncontrolled diabetes). Unstable endocrine disorders require treatment to ensure health and safety of the patient before participation is possible. Individuals with stable endocrine disorders (e.g., controlled diabetes) may participate in the protocol but they will be excluded from the hydrocortisone stimulation test. This will be assessed by self-report during the history and physical exam and by standard laboratory tests Have a major medical illness that is associated with fatigue (e.g., chronic fatigue [diagnosed prior to their TBI or less than 6 months following TBI], multiple sclerosis, or cancer). This will ensure that symptoms of fatigue are as a result of TBI and not another co-morbid illness. This will be assessed by self-report Currently consuming any of the following sleep modifying medications: benzodiazepines; benzodiazepine receptor agonists; opiates; or sedatives. These medications will directly affect the results of the PSG and actigraphy analysis, as such participants currently taking these medications will be excluded. This will be assessed by self-report Currently using the sleep modifying medications melatonin and/or Benadryl greater than 2 times per week and/or unable or unwilling refrain from using them during protocol participation. These medications will directly affect the results of the PSG and actigraphy analysis, as such participants who are unwilling/unable to refrain from using these medications will be excluded. This will be assessed by self-report Current psychiatric condition for which immediate treatment is required to prevent harm to self or others such as active suicidality or active manic phase in someone who has bi-polar disorder. This is to ensure patient safety and care. This will be assessed by self-report and as part of the history and physical exam Are pregnant. Pregnancy is associated with increased fatigue and sleep disturbances, as such this condition will affect the outcomes of this analysis.his will be assessed by self-report. This will also be assessed on visit 2 by a urine pregnancy test. Individuals who are nursing are eligible but will not participate in the hydrocortisone stimulation test Received a diagnosis of severe obstructive sleep apnea (OSA) and/or current reliance on continuous positive airway pressure (CPAP) therapy to aid sleep. Severe OSA and CPAP use will directly affect the result s of this study, as such these participants will be excluded. This will be assessed by self-report. **Participant may be able to participate in the protocol but will not be able to have an MRI if they have any of the following Metal in the body such as pacemakers, stimulators, pumps, aneurysm clips, metallic prostheses, artificial heart valves, cochlear implants or shrapnel fragments, or if they are a welder or metal worker | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 50.0-80.0, Overweight or Obesity male and female subjects age: 50 years post or peri-menopausal Smokers and non-smokers BMI 25 to 40 kg/m2 Dietary Inflammatory Index, DII: 0 to +10 Fruit and vegetable intake <4 servings/d Adherence to a 6-week "wash-out" period Age <50 and >79.9 years Dietary Inflammatory Index, DII 1 to -10 Subjects with any kind of food allergy or histamine intolerance Aversion to stop the intake of nutritional supplements and food, that could interfere with the study outcome Food supplements, functional foods and dietetic products with anti-inflammatory or redox-biological relevance like omega-3 fatty acids, plant/herbal extracts/concentrates, vitamin and mineral supplements Fruit and vegetable intake >3 servings per day Hypertension, starting with grade 2 according to the classification of the European Society of Hypertension: systolic blood pressure > 160 mmHg, diastolic blood pressure >100 mmHg Medication: any anti-inflammatory medication and medication with relevant antioxidant properties, blood pressure lowering medication, psychotropic drugs, immunosuppressives, cytostatics, anticoagulants, contraceptives, diuretics, pain medication | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Prostate Cancer Male Age≥ 18 years old Non-metastatic prostate cancer with histologically confirmed Gleason sum ≥8 Eligible for radical prostatectomy with a delay of 6 to 9 weeks Intraprostatic maximum standardized uptake value (SUVmax) ≥4 at 18-FDG-PET/CT exam Not be castrated or under androgen deprivation therapy Not have received prior neo adjuvant hormonotherapy Provided archival formalin-fixed, paraffin embedded tumor biopsy of the prostate tumor lesion not previously irradiated Performance status of Eastern Cooperative Oncology Group 0 to 1 Adequate organ function Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4 (Cytotoxic T-lymphocyte-Associated Protein 4), OX-40, CD137) Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to allocation Has received prior radiotherapy to the prostate or other organs within 2 weeks of start of study treatment Has received a live vaccine within 30 days prior to the first dose of study drug Is participating or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug Other primary cancer within 3 years Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, Hypophosphatasia Bone Diseases, Metabolic Bone for Hypophosphatasia (HPP) genetically verified hypophosphatasia age >18 years written informed consent complete serological and radiological examinations für Controls healthy men and women without any history of musculoskeletal diseases written informed consent Alkaline phosphatase (AP) in reference range complete serological and radiological examinations for both Groups inflammatory diseases other genetic disorders affecting bone such as osteogenesis imperfecta, Ehlers-Danlos-syndrome and fibrous dysplasia diabetes mellitus type 1 and 2 COPD chronic kidney and liver dysfunction systemic glucocorticoid use and glucocorticoid induced osteoporosis eating disorders HIV-infections and any malignancy including plasmacytosis and lymphoma | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 16.0-90.0, Gaucher Disease Type 1 To be enrolled in this study the subject must meet the following 1. Subject is greater than 16 years old but not older than 90 years 2. Signed Informed Consent/Assent 3. Subject is able and willing to sign informed consent or assent 4. If the subject has GD1, the must have a confirmed diagnosis of Gaucher disease by GCase enzyme activity DNA analysis demonstrating pathogenic variants in the GBA gene a) Have evidence of hepatitis B, hepatitis C infection or any other chronic infectious disease b) Be 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): 18.0-999.0, Advanced Hepatobiliary and Malignant Tumors Patients are ≥ 18 years old; 2) Pathological diagnosis confirmed advanced hepatocellular carcinoma, intrahepatic cholangiocellular carcinoma, extrahepatic cholangiocellular carcinoma, gallbladder carcinoma and pancreatic cancer by histopathological examination; 3) Having at least one measurable lesion according to the 1.1 tumor evaluation criteria; 4) Estimated survival time > 3 months; 5) There are no other concurrent anti-cancer treatments (including local radiotherapy and molecular targeted therapy, etc.) or previous treatment history; 6) ECOG PS score ≤ 2 points; 7) Cardiac color Doppler examination indicates a left ventricular ejection fraction (LVEF) ≥ 50%; 8) Having no obvious signs of hematological disease, ANC≥1.5×109/L, platelet count≥100×109/L, Hb≥90g/L, WBC≥3.0×109/L, and no bleeding tendency before enrollment; 9) Liver function test: total bilirubin (TBIL) is ≤ 1.5 times the upper limit of normal value, alanine aminotransferase (ALT), aspartate aminotransferase (AST) are ≤ 2.5 times the upper limit of normal value; renal function test: serum creatinine (Cr) ≤ 1.5mg/dl, or calculated creatinine clearance ≥50ml/min; 10) Patients can understand and sign the informed consent form Pregnant or lactating female patients (women of childbearing age must be confirmed to have negative pregnancy test results within 7 days prior to the first dose, if they are positive, ultrasound examination is required to be performed to pregnancy); women of childbearing age refuse to receive contraception. 2) Having other malignant tumors, except cured basal cell carcinoma of the skin or squamous cell carcinoma of the skin or in situ carcinoma in any other regions; 3) Having abnormal bone marrow hyperplasia and other hematopoietic disorders; 4) Having active infections, HIV infection, and viral hepatitis that require systemic treatment; 5) Child-Pugh score > 7 points; 6) Being combined with medium-large ascites or hepatic encephalopathy; 7) Subjects with ≥1 peripheral neuropathy according to the National Cancer Institute Common Toxicity Response Standard (NCI-CTC) version 5.0; 8)Patients with severe cardiovascular diseases such as cerebrovascular accidents occurring within 6 months, myocardial infarction, hypertension that cannot be controlled after drug intervention, unstable angina pectoris, heart failure (NYHA 2-4), and arrhythmia requiring drugs intervention; 9) Being allergic to the drug or drug ingredients used in this test or having hypersensitivity history; 10) Having received any other drug treatment or participated in another interventional clinical trial within 30 days of the screening period; 11) Having dementia, mental state changes or any mental illness that may interfere with understanding or making informed consent or completing a questionnaire; 12) Being considered to be unsuitable for enrollment by investigators | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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 Patient with diagnosed alveolar osteitis Minimal age limit 18 years Patient capable to fully understand and comply with the requirements of the study Patient younger than 18 years Pregnant or lactant woman Patient diagnosed with cancer Patient with a history of radiotherapy in the head and neck area Patient undergone bisphosphonate treatment within the last two years Patient who had been given antibiotics less than two weeks prior the AO onset Patient with hypersensitivity or allergy to any substances contained in the tested drug Patient who smokes more than 10 cigarettes per day | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, Knee Osteoarthritis Arthroplasty Complications Swelling; Leg knee osteoarthritis post-operation of total knee arthroplasty single leg knee arthroplasty vital signs unstable uncontrolled blood pressure diabetes mellitus neoplasm neurological disorder fibromyalgia cardiac pacemaker musculoskeletal involvement other than TKA | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-40.0, Impacted Third Molar Tooth Older than 18 of age Asymptomatic bilateral mesioangular impacted mandibular third molar (Pell and Gregory class II, position B) Fully covered with mucosa and bone Alcohol abuse Smoking Pregnancy No allergy Presence of acute severe periodontitis | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, Anesthesia Pain, Acute All patients over 18 yrs old Cognitive decline, mental illness, drug addicts and non-Swedish speakers. Skin damage to fingers that make application more difficult. - | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 40.0-90.0, Patients With Osteoarthritis Undergoing CAS-TKA primary and unilateral computer-assisted total knee arthroplasty (1) patients who underwent bilateral TKAs, unicompartmental TKA or revision TKA (2) patients who had to remove previous implants or history of high-tibial or distal femoral corrective osteotomy (3) patients who were unable to response to the questionnaires | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Bone Resorption Dental Diseases Patient aged ≥ 18 years old 2. Patient able to read, understand and give written consent to participate in the study 3. Patient affiliated with a social security system or beneficiary of such a system 4. Partially edentulous patient with 1 to 2 intercalary missing teeth or a terminal gap with distal vertical and lateral support bone volume 5. Presence of a bone deficit requiring horizontal and / or vertical bone augmentation (stage 4 or 5 of the Benic and Hammerle classification) treated by GBR for delayed placement of up to 4 dental implants 6. Possibility of acquisition by CBCT for the required protocol visits General contraindication to bone graft and implant surgery 2. Pregnant woman or planned pregnancy during the study period or breast-feeding woman; 3. Patient who has had a bone augmentation by GBR during the previous 12 months, in the area targeted for filling with the allogeneic material 4. Patient who received less than 3 months ago a CBCT acquisition at the operative site 5. Patient simultaneously requiring more than one GBR augmentation in the same quadrant 6. Patient with signs of local infection at the targeted graft site 7. Systemic, metabolic or autoimmune disease that may adversely affect healing of soft and bone tissue (eg, unbalanced type 1 or type 2 diabetes) 8. Use of treatments (chemotherapy or radiotherapy) or drugs (bisphosphonates, chronic steroids) known to potentially interfere with tissue healing 9. Patient presenting a dental plaque objectified by an oral examination (Loe ≥ 2 on more than 50% of the dental surfaces) 10. Patient smoker of more than 10 cigarettes a day 11. Any other condition that, in the investigator's opinion, would be detrimental to the safety of the patient or fail to meet the requirements of the protocol | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-65.0, Alveolar Osteitis Impacted Tooth Patients Age ≥ 18 years of age Willing and able to provide informed consent Ability to cooperate with the requirements of the study protocol Healthy patients without medical diseases or a history of bleeding problems Patients with the need of extraction of third molars The third molars had to be symmetrical, partially-erupted and in the Class I, Level B according to Pell & Gregory classification and in the vertical angulations according to Winter's classification Patients who have pre-existing abscess or cellulitis, acute pericoronitis, or pre-existing conditions such as an odontogenic cyst or tumour associated with their third molars Patients who were pregnant and breastfeeding Patients with drug usage such as bisphosphonate, steroids and antidepressants Patients who had a smoking habit | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 70.0-999.0, Patients of Advanced Age (≥ 70 Years) With a Clinical Diagnosis of Chronic Dry Mouth ≥ 70 years of age Clinical diagnosis of chronic dry mouth defined as a Numeric Rating Scale (NRS) score ≥ 5 (scale 0 with 0 = no dry mouth and 10= worst possible dry mouth) on severity of xerostomia for more than 3 months Existence of cognitive impairment and/or diagnosis of dementia appraised by treating physician Inability to fill out the questionnaires due to other reasons Prior radiation therapy of the head-and-neck region Known m. Sjögren disease Contra-indications for parasympathicomimetics (uncontrolled asthma, acute heart failure, active peptic ulceration, known hypersensitivity to pilocarpine, and when miosis is undesirable, e.g., in acute iritis and in narrow-angle (angle closure) glaucoma | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 10.0-16.0, Scoliosis Idiopathic Scoliosis; Adolescence Patients with scoliosis diagnosed and followed up by the attending physician 16 age group Patients who voluntarily agreed to participate in the study Living in Antalya/TURKEY Mental retardation, congenital scoliosis or spinal deformity, spinal surgery, neuromuscular disease, rheumatologic disease, tumor, cardiovascular or pulmonary disease, vertigo attack or balance problem, neurological disease İndividual who does not sign the consent form | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, Achilles Tendinopathy Men and non-pregnant women aged 18-60 years Patients suffering from a gradually evolving painful condition in the Achilles tendon located at the midportion for at least 12 weeks (Diagnosis based on clinical examination showing a painful thickening of the Achilles tendon located at a level of 2 to 6cm above the tendon insertion, and confirmed by ultrasonography: local thickening of the tendon, irregular tendon structure with hypoechoic areas and irregular fiber orientation) VISA-A score less than 65 at baseline Be informed of the nature of the study and provide written informed consent Clinical suspicion of insertional disorders (pain at the site of the insertion of the Achilles tendon on the calcaneum) Concomitant or previous participation in a clinical investigation within the last 3 months (wash out) prior to study Clinical suspicion of an Achilles tendon rupture Suspicion of internal disorders: spondylarthropathy, gout, hyperlipidemia, Rheumatoid Arthritis and sarcoidosis Severe foot deformity Condition that prevents the patients from executing an active exercise program Pregnant or lactating females History of treatment with corticosteroids, estrogens, long term quinolone antibiotics, and cholesterol drugs Persons with electronic implants (e.g. pacemaker, cochlear implants, drug pump, deep brain stimulator, etc.) Patients with organ transplants | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, Hypophosphatasia HPP (CASES) Clinical diagnosis of HPP (with or without previous genetic test confirmation) Evidence of burden of disease (HPP) including abnormal gait, muscle weakness, pain, recurring fractures, slow healing fractures and/or bone deformities Age ≥ 18 years Able and willing to participate in the study Able to give written informed consent (CONTROLS) Healthy men and women with normal bone mineral density (defined as a DXA bone mineral density T score at the lumbar spine or total hip greater than -1) Age ≥ 18 years Able and willing to participate in the study HPP (CASES) Individuals with BMI<18, or BMI>30 kg/m2 Other conditions known to affect serum ALP and PLP Coeliac disease, B12 deficiency, untreated hypothyroidism, Wilson's disease Taking nutritional supplements containing vitamin B6 within past two weeks History of, or current: Severe ischaemic heart disease, rheumatoid arthritis, ankylosing spondylitis, cancer (concurrent) History of, or current neurological diseases affecting the neuromuscular system including Parkinson's disease, CVA, muscular dystrophy, myasthenia, cerebral trauma, peripheral neuropathy Treatment for more than 3 months in a year or under treatment with oral corticosteroids History of any long term immobilization (duration greater than three months) Conditions or surgery which prevent the acquisition or analysis of musculoskeletal images | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 13.0-60.0, Psoriasis minimum age 13 years maximum age 60 years both males and females affected with mild, moderate and severe psoriasis hypertension cardiovascular disorders pregnancy lactation renal failure liver failure hypersensitivity to drug | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, X-linked Hypophosphatemia Hereditary Hypophosphatemia Understand oral and written Danish Able to consent For XLH only: 1. genetically verified XLH by detection of a disease-causing mutation in PHEX or a positive family history of X-linked hypophosphatemia. 2. biochemically verified hereditary hypophosphatemia: serum PO4 below normal range and low TmPO4/GFR, and/or elevated serum FGF23 and a history of childhood rickets or spontaneous endodontic abscesses to acquired hypophosphatemia, e.g., tumor-induced osteomalacia P-25OHD < 25 mmol/L* Severe co-morbidities, which in the opinion of the investigator may have major impact on study outcomes. This may but is not limited to o poorly controlled hyperthyroidism o Paget disease o type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus o severe and chronic cardiac, liver, or renal disease o Cushing syndrome o Rheumatoid arthritis o Active pancreatitis o Malnutrition o Recent prolonged immobility* o Active malignancy (including myeloma) Treatment with o Burosumab Beta-blockers Oral steroids For controls only disturbances in the calcium or phosphate homeostasis participants with low 25OHD levels or recent immobility may be re-screened for participations 6 months after this has been corrected | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, Dental Implant Failed Periodontally healthy remaining dentition or presenting with mild gingivitis with adequate oral hygiene Presence of a partially edentulous alveolar ridge that is planned to be restored with no more than 2 implants To have 1 or 2 implants restored with a crown or fixed bridge Presence of a non-infected site Presence of enough bone and soft tissue for the implant to be placed without additional bone augmentation in a 1-stage approach (with healing abutment) Implants 6 mm long or longer Subjects able and willing to provide written informed consent and comply with study procedures Subjects taking regular analgesics or antidepressants Smoking 10 cigarettes/cigars or more per day Marijuana smokers Use of vaping devices or e-cigarettes Drug abuse Completely edentulous individuals Pregnant and nursing women Allergies to macrolides, and/or non-steroidal anti-inflammatory analgesics Active peptic ulcers or susceptibility to peptic ulcers Any systemic or local immunodeficiency | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 0.0-22.0, Acute Myeloid Leukemia All patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to enrollment and treatment on AAML1831. Submission of diagnostic specimens must be done according to the Manual of Procedures). Risk stratification will not be possible without the submission of viable samples. Given there are multiple required samples, bone marrow acquisition techniques such as frequent repositioning or performing bilateral bone marrow testing should be considered to avoid insufficient material for required studies. Consider a repeat marrow prior to starting treatment if there is insufficient diagnostic material for the required studies Patients must be less than 22 years of age at the time of study enrollment Patient must be newly diagnosed with de novo AML according to the 2016 World Health Organization (WHO) classification with or without extramedullary disease Patient must have 1 of the following >= 20% bone marrow blasts (obtained within 14 days prior to enrollment) In cases where extensive fibrosis may result in a dry tap, blast count can be obtained from touch imprints or estimated from an adequate bone marrow core biopsy < 20% bone marrow blasts with one or more of the genetic abnormalities (sample obtained within 14 days prior to enrollment) A complete blood count (CBC) documenting the presence of at least 1,000/uL (i.e., a white blood cell [WBC] count >= 10,000/uL with >= 10% blasts or a WBC count of >= 5,000/uL with >= 20% blasts) circulating leukemic cells (blasts) if a bone marrow aspirate or biopsy cannot be performed (performed within 7 days prior to enrollment) ARM C: Patient must be >= 2 years of age at the time of Late Callback ARM C: Patient must have FLT3/ITD allelic ratio > 0.1 as reported by Molecular Oncology Patients with myeloid neoplasms with germline predisposition are not eligible Fanconi anemia Shwachman Diamond syndrome Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21 Any other known bone marrow failure syndrome Any concurrent malignancy Juvenile myelomonocytic leukemia (JMML) Philadelphia chromosome positive AML Mixed phenotype acute leukemia Acute promyelocytic leukemia | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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 Male aged 18 years and older. 2. Patients were diagnosed with high risk localized prostate cancer (cT3/4 and/or Gleason score ≥8 and/or prostate biopsy or PSA ≥ 20 ng/dl) or loco-regional prostate cancer (pelvic lymphadenopathy of ≥2 cm on axial imaging). 3. High PSMA expression was confirmed. PET PSMA with tracer uptake greater than normal liver (maximal standardized uptake value ≥1.5 of liver). In addition, no PET FDG positive sites without high PSMA expression. 4. Patients should have an Eastern Cooperative Oncology Group (ECOG) performance status score5 of 1 or lower and life expectancy of > 10 years Clinically significant impaired bone marrow defined by platelet count lower than 150×103/µl, white blood cells count lower than 4×103/µl, hemoglobin concentration lower than 12mg/dl. 2. Impaired liver function defined by albumin concentration lower than 3.5 gr/dl. 3. Impaired kidney function defined by glomerular filtration rate (GFR) lower than 40 mL/min. 4. Recent radiotherapy (within two months) 5. Concomitant usage of nephrotoxic drugs 6. Evidence of distant metastatic disease (distal lymphadenopathy, visceral or bone 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): 50.0-80.0, Osteoarthritis, Hip Age 50-80 Continuous worsening of hip pain with an onset of minimum 3 months Hip Pain intensity >40mm on a visual analogue scale (VAS) ranging from 0 (no pain) to 100mm (maximal pain) during weight bearing for the last 7 days HHS < 65 (Harris Hip Score) Hip OA fulfilling the ACR (American College of Rheumatology) [33] Hip MRI scan showing large (>1 cm diameter) Bone Marrow lesions (BMLs) Willing and able to consent and comply with the study protocol eGFR (estimated glomerular filtration rate) < 35 ml/min or hypocalcemia Exposure to any treatment affecting bone other than Ca+D ( bisphosphonates, Denosumab teriparatide or continuous treatment of prednisolone) Diseases affecting bone and joints (i.e inflammatory joint diseases, osteonecrosis with segmental collapse and deformation, primary bone cancer or known skeletal metastases) Severe vitamin D deficiency (S-25(OH)D < 25 nmol/l) has to be supplemented with Ca+D before zoledronic acid infusion Ipsilateral knee prosthesis Contralateral hip prosthesis Women of child bearing potential (WOCBP). Female participants must be in a postmenopausal state or permanent sterile Hypersensitivity or previous allergic reaction to ZA or other bisphosphonates Hypersensitivity or previous allergic reaction to Calcigran Forte (a calcium and vitamine D supplement) or Prednisolone | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 20.0-50.0, Pulpitis - Irreversible Participants free from any systemic disease Deep caries in a permanent lower molar with mature roots Probing pocket depth and mobility within normal limits No signs of pulpal necrosis including sinus tract or swelling Vital bleeding pulp tissue should be present in all canals after complete pulpotomy The tooth is restorable Clinical diagnosis of symptomatic irreversible pulpitis based on subjective and objective examinations Subjective examination: Patients complaining of intermittent or spontaneous pain or pain exacerbated by dramatic temperature changes especially to cold stimuli and lasting for a few seconds to several hours Objective examination Clinical examination: Teeth that will experience immediate, excruciatingly painful sensation as soon as the cold stimulus is placed on and which may last for a while even after the removal of the stimulus Negative response to cold testing No pulp exposure after caries excavation Bleeding could not be controlled in 10 minutes after 2.5% NaOCl Absence of bleeding from any of the canals Teeth with radiographic signs of internal resorption Pulpal calcifications Participants with stainless-steel wires and brackets | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, Burning Mouth Syndrome Burning mouth sensation without oral lesions that could be involved with painful symptoms Symtoms of burning sensation more than 3 months Patients who are under antineoplastic treatment or with a history of malignant neoplasms of the head and neck Active treatment with benzodiazepines or systemic antidepressants Pregnant women Patients unable to follow the indications for administration of oral topical medications Unstimulated saliva production ≤ 0,1 mililiters/minute Sistemic diseases that can produce burning sensation | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, Locally Advanced Solid Tumor Metastatic Cancer Solid Tumor HER2-positive Gastric Cancer HER2-positive Metastatic Breast Cancer Signed informed consent Subjects must be ≥ 18 years of age Subject with advanced or metastatic solid tumors that is not amenable to surgical resection and is not eligible or has refused other approved therapeutic options that have demonstrated clinical benefit Histologically confirmed HER2 expression Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 Measurable or non-measurable evaluable disease according to 1.1 Adequate hematologic and end-organ function at baseline Oxygen saturation via pulse oxygenation ≥ 90% at rest on room air Untreated central nervous system (CNS) metastases Multiple primary malignancies Clinically significant cardiovascular disease such as New York Heart Association (NYHA) cardiac disease (class III or greater) Pregnant or lactating female Serious, uncontrolled medical disorder that, in the opinion of the Investigator, would impair the ability of the subject to receive study treatment History of autoimmune or immune mediated symptomatic disease Any anti-cancer chemotherapy or targeted small molecule therapy, or experimental therapy/device within 4 weeks or 5 half-lives of the drug prior to planned start of 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): 18.0-100.0, Prostate Cancer For those received hormonal therapy will be recruited for study (active arm) Study subject 1. Male patients 18 years or older 2. Adenocarcinoma of the prostate either histologically or cytologically confirmed 3. Decided to be put on ADT -bilateral orchidectomy or LHRH agonist or LHRH antagonist, with or without additional antiandrogen 4. After ADT performed, serum testosterone level should reach castrated level, i.e. < 50 ng/dL after 6 weeks of treatment 5. Able to consent for the participate in the study For those do not plan to receive hormonal therapy (based on the clinical assessment by the investigators) will be recruited as control arm Control subject: 1. Male patients 18 years or older 2. Adenocarcinoma of the prostate either histologically or cytologically confirmed 3. Able to consent for the participate in the study Patient did not able to provide consent or comply with the follow-up arrangement 2. Patient with life expectancy of less than 2 years based on clinical judgement | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, Neck Pain Neck Pain, Posterior Age 18 to 90 years Tenderness to palpation over affected areas (using average 4 kg force for 70 kg person) Average pain score >/= 4 over the week prior to enrollment On stable doses of analgesics for 2 weeks prior to enrollment Chronic mechanical neck pain > 3 months in duration Boundaries are upper trapezius, mastoid processes, shoulders Radicular pain as determined by clinical presentation Opioid dose in oral morphine equivalents/day > 30 Moderate or severe hepatic disease (will obtain blood work and individuals with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the normal range Previous neck surgery Known structural defect presumed to be the primary pain generator (e.g. severe degenerative disc or facet joint disease) Serious medical (e.g. unstable angina) or psychiatric (e.g. poorly controlled depression, active substance abuse) that could interfere with treatment or pain response Secondary gain Pregnancy or breastfeeding painDETECT score > 18 Known allergy to lidocaine | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 25.0-999.0, Alveolar Bone Resorption Wound Heal All of the following must be fulfilled for Patient must have willingness to read and sign a copy of the Informed Consent Form Males and females, ≥25 years old Patient in need of a single permanent tooth extraction with clinical and/or radiographic evidence of unrestorable maxillary premolars, canines, or incisors with at least one adjacent tooth present, and with periodontal attachment preserved at least for 2/3rd of the root nor associated with acute periapical pathology Post-extraction alveolar bone defect with ≤50 % buccal bone loss. This will be confirmed at Visit 2 after extraction. In case of >50% buccal bone loss, the participant will be withdrawn Patient in good general health as documented by self-assessment Full mouth bleeding and plaque scores (FMBS <10% and FMPS <20%) recorded within the previous 8 weeks Uncontrolled or untreated periodontal disease History of local (head and neck) radiation therapy Presence of oral lesions in the area of the extraction (such as ulceration, malignancy) Severe bruxing or clenching habits Acute endodontic lesion in the test tooth or in the neighbouring areas to the extraction procedure (sites with presence of an asymptomatic chronic lesion are eligible) Medical history that includes uncontrolled diabetes or hepatic or renal disease, or other serious medical conditions that can impact on bone metabolism (e.g. rheumatoid arthritis, osteoporosis) or transmittable diseases (e.g. AIDS) History of alcohol or drug abuse Smokers Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study results) Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into 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): 18.0-999.0, Enterococcal Bacteremia Hospitalized patient ≥1 positive blood culture with Enterococcus spp. (VRE or VSE) during hospitalization bacterial isolate(s) is/are available for further characterization Repeat blood culture(s) within 7 days from the first positive culture Cultures obtained from patients not admitted to the hospital Isolate(s) not available for further 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): 20.0-45.0, Dental Implant Patients age between 20-45 years with no gender predilection Patients with non-restorable maxillary posterior tooth which need to be extracted (premolar -molar region) Patients with good oral hygiene Bony defects more than 2 mm during implant placement treated by bone substitute Patients fully capable to comply with the study protocol Patients with any systemic disease affecting bone quality as uncontrolled diabetes Heavy smokers (more than 20 cigarettes per day) Sites with acute oral infection Pregnant and lactating patients Untreated periodontal disease Previous chemotherapy or irradiation of the head and neck Inadequate interocclusal space | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 17.0-57.0, Temporomandibular Joint Dysfunction For Group 1 (group with TMJD) Patients diagnosed with TMJD Able to understand and speak Turkish and cooperate Aged 17 years or older and 65 years or younger Patients have articular sounds in the form of clicks or crepitation from the TMJ during mouth opening or chewing Sensitivity and pain in the TMJ at palpation Not receiving TMJ treatment in the past six months Presence of TMJD symptoms for at least three months For Group 2 (group without TMJD) Able to understand and speak Turkish and cooperate Aged 17 years or aged 17 years or older and 65 years or younger For Group 1 (group with TMJD) Absence of at least one of the TMJD symptoms Presence of a history of tumor, cervical discopathy, orthopedic and rheumatic pathologies, head, neck and/or jaw surgery and pregnancy For Group 2 (group without TMJD) Presence of at least one of the symptoms of TMJD Presence of a history of tumor, cervical discopathy, orthopedic and rheumatic pathologies, head, neck and/or jaw surgery and 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): 18.0-70.0, Vespid Venom Allergy Legally competent male and female subjects who are currently treated or who have been treated with vespid venom immunotherapy Age ≥18 and ≤70 years Written consent of the participant after being informed Pregnancy Autoimmune disease Uncontrolled cardiovascular disease Uncontrolled asthma | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, Alveolar Osteitis no known medical history of abnormal platelet counts patients with symmetric teeth qualified for extraction patients treated previously for existing dry socket patients allergic to acetylsalicylic acid systemic diseases pregnancy lactation drugs known to affect the number or function of platelets abnormal platelet counts | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, Alveolar Osteitis Patients who have one or more of the following in addition to severe pain, which occur within and around the socket 1-3 days after extraction and do not decrease with pain killers With a partially or completely disintegrated blood clot in the socket With exposed bone that gives a dark gray appearance With bad odor Who does not want to be volunteer for the study Smokers During pregnancy or lactation Has a chronic systemic disorder that will affect recovery Has hematological disorder Cooperation cannot be established Previously received radiotherapy or chemotherapy Patients using oral contraceptives | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 20.0-40.0, Cervicogenic Headache Headache frequency of at least 1 per week for a minimum of 3 months Secondary Headache (cervical spine dysfunction) International Classification of headache Disorder: 1. Pain localized in the neck and occiput, which can spread to other areas in the head, such as forehead, orbital region, temples, vertex, or ears, usually unilateral. 2. Pain is precipitated or aggravated by specific neck movements or sustained postures. 3. At least one of the following: 1. Resistance to or limitation of passive neck movements 2. Changes in neck muscle contour, texture, tone, or response to active and passive stretching and contraction 3. Abnormal tenderness of neck musculature Other types of headache Trigger points of upper cervical muscles Congenital conditions of cervical spine Cervical Disc herniation Fracture Cervical Artery disease Red flags of Thrust Joint Manipulation | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, Infant Cerebral Palsy Neonatal For the parents: Parents of children under 24 months of age at high risk of cerebral palsy who have given their oral consent. Children at high risk of cerebral palsy are defined as Premature children ≤ 31 WG + 6 days or birth weight less than 1000g Children who have had a stroke or stage 2 or 3 hypoxia-ischemia according to the Sarnat classification. The selection of parents may be retrospective with less than 24 months since hospital discharge. 2. For the health professionals: Physiotherapists, psychomotricians, psychologists and doctors involved in the care of children at high risk of cerebral palsy A person who is physically or cognitively unable to participate in a one-on-one interview or who does not have a sufficient command of the French language Parents aged <18 years Parents in protective custody Parents of children with major orthopedic or traumatic disorders unrelated to the high risk of cerebral palsy Parents of a child with a genetic 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, Plasma Cell Myeloma Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 Neutrophil values > 1,000/uL Diagnosis of multiple myeloma: on maintenance or continued treatment Show no signs of comorbidities, myeloma symptoms, or treatment side effects that would put them in danger when participating in the study according to the physician's discretion Able to understand and comply with study instructions, including willing to purchase and consume study beverage daily if in intervention arm or, avoid regular consumption of fermented dairy foods (kefir, yogurt, lassi, etc.) if in the control arm Understand the investigational nature of the study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Allergies to milk Lactose intolerance Current habitual (> 3 times per week) consumption of yogurt, kefir, lassi, over-the-counter probiotic dietary supplements Chronic inflammatory bowel disease Autologous stem cell transplantation or chimeric antigen receptor (CAR)-T cell therapy within the last 6 months Prior allogeneic stem cell transplantation Major comorbidities that would cause danger to the patient when participating in the study Pregnant or nursing female participants Unwilling or unable to follow protocol requirements Any condition which in the investigator's opinion deems the participant an unsuitable candidate to take part in study 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): 18.0-100.0, Neuroendocrine Tumors Metastatic, or unresectable, histologically confirmed well-differentiated grade 1 and 2 neuroendocrine tumor with a positive gallium 68 Dotatate scan within 6 months prior to study enrollment Baseline CT scan or MRI with measurable progressive disease based on Failure of at least one prior systemic cancer treatment for this diagnosis Recovered from AEs of previously administered therapeutic agents to Grade 2 or less toxicity according to CTCAE version 5.0 ECOG performance status ≤2 normal organ and marrow function Prior exposure to Lutetium Lu 177 Dotatate History of allergic reactions attributed to compounds of similar chemical or biologic composition to Telotristat or Lutetium Lu 177 Dotatate Presence of unstable angina or myocardial infarction NYHA Class III or IV heart failure uncontrolled angina history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities Pregnant or lactating women Women of childbearing potential or male patients of reproductive potential Any other significant medical or psychiatric condition, currently uncontrolled by treatment, which may interfere with completion of the study | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 1.0-30.0, Down Syndrome Recurrent B Acute Lymphoblastic Leukemia Patients must be >= 1 and < 31 years at time of enrollment Patients must have first relapse of CD19+ B-ALL (relapse blasts must express CD19) in one of the following categories Isolated bone marrow relapse Isolated central nervous system (CNS) (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse Combined bone marrow with extramedullary relapse in the CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testes Patients with Down syndrome (DS) are eligible in the following categories Isolated bone marrow relapse Combined bone marrow with CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study Patients with B-lymphoblastic lymphoma (B-LLy) Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia Patients with Philadelphia chromosome positive (Ph+) B-ALL Patients with mixed phenotype acute leukemia (MPAL) Patients with known Charcot-Marie-Tooth disease Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype Patients with active, uncontrolled infection defined as Positive bacterial blood culture within 48 hours of study enrollment Receiving IV or PO antibiotics for an infection with continued signs or symptoms. Note: Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection as long as cultures have been negative for at least 48 hours and signs or symptoms of active infection have resolved. For patients with clostridium (C.) difficile diarrhea, at least 72 hours of antibacterial therapy must have elapsed and stools must have normalized to baseline Fever above 38.2 degrees Celsius (C) within 48 hours of study enrollment with clinical signs of infection. Fever without clinical signs of infection that is attributed to tumor burden is allowed as long as blood cultures are negative for > 48 hours | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 5.0-8.0, Dental Pulp Cavity Primary molars with at least one of the following signs and symptoms were eligible and were included in the study badly decayed with signs of irreversible pulpitis necrosis and chronic infection such as: pain or tenderness to percussion and palpation, abscess, fistula-opening, gingival swelling, grade II and greater pathological tooth mobility, evidence of periapical/bifurcation radiolucency, All the teeth included, had physiological root resorption of less than one third of the root Teeth showing radiographic evidence of excessive internal or external root resorption perforated pulpal floor excessive bone loss in furcation area involving the underlying tooth germ non restorable teeth were excluded from the study | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Osteonecrosis of the Jaw, Bisphosphonate Induced Osteonecrosis of the Jaw, Bisphosphonate Related Diagnosis of stage I or stage II medication related osteonecrosis of the jaws (MRONJ) according to the 2014 AAOMS position paper Coexistence of any medical or social condition that prevents proper adherence to treatment or follow-ups (dependent patients without adequate socio-familiar support, drug addiction, severe psychiatric illness, terminal disease with life expectancy less than 3 months) Coexistence of Brown's Tumor, Paget's Disease or other bone diseases with the exception of Osteoporosis or bone 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): 18.0-999.0, Coxarthrosis; Primary Coxarthrosis; Secondary Patient with primary or secondary hip arthritis, at stage II to III of the radiological classification of Tönnis and for whom total hip replacement is indicated by surgeon Signed consent Patient beneficiary of a social security plan Patient Under 18 Patient Under protective measure (guardianship, curatorship) or unable to consent Patient requiring revision THR Patient with geographic mobility plan before the end of the follow-up Symptomatic contralateral hip Symptomatic dorsolumbar rachis Pelvis or spine surgery planed during the follow-up Pregnant or nursing woman | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, Stress Fracture of Tibia or Fibula Soldiers actively enlisted in the U.S. Army attached to basic training unit at Fort Jackson Soldiers diagnosed with a tibial diaphyseal BSI requiring convalescent leave Skeletally mature Willing to self-administer study medication Desire to continue their military commitment History of any form of cancer Currently pregnant Paget's disease of bone Unexplained elevations of alkaline phosphatase (elevations in alkaline phosphatase may signal undiagnosed Paget's disease of bone) Pediatric and young adult patients with open epiphyses Prior external beam or implant radiation therapy involving the skeleton Recent (within the last 6 months) urolithiasis (kidney stones) Elevated serum calcium, alkaline phosphatase or uric acid Orthostatic hypotension | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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 Disease Patients aged > 18 years resident in Campania Region Patients diagnosed with metastatic disease candidates for radiotherapy Metastatic patients candidates for radiotherapy re-treatment Oligometastatic patients candidates for radiotherapy; Patients who have given their consent Patients aged < 18 years Patients who are unable to express consent to sensitive data and radiant treatment | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 4.0-7.0, Reversible Pulpitis Aged 4 to 7 years , in good general health and mentally free The parents provided written informed consent Cariously exposed primary molars with reversible pulpitis Teeth should be vital Restorable teeth Hemostasis achieved after complete pulpotomy With systemic disease Physical or mental disability Unable to attend follow-up visits Refusal of participation Previously accessed teeth History of spontaneous or prolonged pain Swelling, tenderness to percussion or palpation, or pathological mobility Pre-operative radiographic pathology such as resorption(internal or external),per-radicular or furcation radiolucency Haemorrhage control is unachievable after pulpotomy | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, Low Back Pain Acute Pain patients aged>18 years old initiation of acute low back pain in the 10 days prior to study entry and functionally impairing low back pain, which we defined as a score of > 5 on the Roland-Morris Disability Questionnaire (RMDQ) aged>65 years old history of trauma radicular pain, which we defined as pain radiating below the gluteal folds history of vertebral tumor or metastasis patients who were pregnant or lactating unavailable for follow-up with allergy or contraindication to the investigational medications chronic analgesic use autoimmune diseases or inflammatory rheumatic disorders cardiopulmonary restrictions | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 4.0-7.0, Pulp Disease, Dental Medically free children who will be able and cooperative in all steps of the study. 2 Asymptomatic primary molars with a deep carious lesion. 3 Vital pulp due to dental caries with no clinical sign of pulpal degeneration (spontaneous pain, fistula, mobility) prior to treatment. 3 Preliminary radiographs indicating absence of pathologic internal or external root resorption, or any evidence of inter-radicular bone destruction. 4 Absence of pre-operative pain or they will only have a short-term pain. 5 No tenderness to percussion. 6-Age ranging 4-6 years Excessive bleeding during pulp amputation. 2 Non vital teeth. 3 -History of spontaneous or prolonged pain. 4 Swelling, tenderness, to percussion or palpation, or pathologic mobility. 5 pre-operative radiographic pathology such as resorption (internal, external); periradicular or furcation radiolucency, or a widened periodontal ligament space. 6 Parent or guardians who refuse participating in the study | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 20.0-60.0, Bone Marrow Stimulating Modified Suture Bridge Arthroscopy confirmed small to medium rotator cuff injury The data of preoperative functional examination were complete Unilateral rotator cuff injury Clinical follow-up can be completed Anterior superior rotator cuff injury with simple subscapular injury or combined subscapular injury Previous shoulder surgery (incision or arthroscopy) Combined with diseases of other parts of the same limb Combined with Bankart injury, acromioclavicular joint disease, greater tuberosity fracture, glenoid fracture and so on Bilateral onset Unable or unwilling to receive clinical 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): 18.0-999.0, X-linked Hypophosphatemia Male or female, aged ≥ 18 years, inclusive Diagnosis of X-linked Hypophosphatemia supported by classic clinical features of adult XLH (e.g. short statue or bowed legs, clinical symptoms as judged by the investigator) and at least one of the following at Screening visit documented PHEX mutation in either the patient, or in a directly related family member with appropriate X-linked inheritance Increased serum levels of c-term FGF23 or iFGF23 Biochemical findings consistent with XLH at Screening visit following overnight fasting Serum phosphorus level or TmP/GFR below lab specific lower limit of normal (LLN) Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min (using the Chronic Kidney Disease Epidemiology Collaboration equitation) or eGFR of 30 up to 60 mL/min at Screening visit with confirmation that the renal insufficiency is not due to nephrocalcinosis Subjects who provide written informed consent after the nature of the study has been explained, and prior to any research-related procedures Hypocalcemia or hypercalcemia, defined as serum calcium levels outside the age-adjusted normal limits and deemed as clinically significant in the opinion of the investigator Vitamin D deficiency (25OH D3 < 20ng/ml); if Vitamin D is low at screening, substitution is allowed and recompensation has to be confirmed before treatment start by normalized levels of Vitamin D (25OH D3 ≥ 20ng/ml) Serum intact parathyroid hormone (iPTH) >2.5-fold the upper limit of normal (ULN) Severe renal insufficiency with a Glomerular filtration rate (eGFR) <30 at screening Treatment with oral phosphate and / or active vitamin D analogues in addition to Burosumab treatment. (In order to ensure appropriate patient care and preclude any harm due to deficient supply, required supplementation with oral phosphate salts and/or active vitamin D analogues at screening can be continued during the run-in phase but has to be stopped before Baseline and Initiation of treatment with Burosumab.) Treatment with bisphosphates or Denosumab within the last 6 months Treatment with Teriparatide within the last 3 months Intake of calcimimetics within 30 days before screening Patients with known hypersensitivity to Burosumab and the active substances of any of the excipients of Burosumab Presence of a concurrent disease or condition that would interfere with study participation or affect safety in the opinion of the investigator | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, Head and Neck Cancer Covid19 Patient Care patient diagnosed with cancer of the upper aero digestive tract patient benefiting from a medical consultation patient benefiting from a multidisciplinary consultation meeting for treatment decision between 01/03/2020 and 28/02/2021 patient diagnosed with cancer other than upper aero digestive tract cancer patient whose treatment decision was made before 01/03/2020 (date considered as the beginning of the epidemic at the CHU Amiens-Picardie) | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, The Fixation Mainly Plays a Firm Role in the Tracheal Intubation and Reduces the Occurrence of Complications Patients with SICU intubation had been intubated for <8h at the time of entry (the interval of oral care was 8h) Patients with brain diseases or septic shock caused by abdominal infection There was no pulmonary infection before endotracheal intubation Facial skin integrity Good oral cavity: no odor, no residue, no oral diseases, oral mucosa integrity Informed consent is given by the family members and the informed consent is signed No adhesive tape allergy Oral injury caused by suction Endotracheal intubation time < 48 h In the experiment is not willing to carry on the experiment, quit voluntarily | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 20.0-60.0, Implant Stability Patients who have at least one missing tooth Patient with hyperlipidemia (LDL < 160 mg/dl ) Patients with sufficient interarch space Patients aged from 20 to 60 years old Good oral hygiene.(Wiesner et al. 2010) Accepts 6 months follow-up period (cooperative patients) Patient provides an informed consent Patients with signs of acute infection related to the area of interest Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits (Lobbezoo et al. 2006) Current and former smokers (Lambert et al, 2000) Pregnant women Psychological problems - | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-50.0, Necrotic Pulp Patient's age between 18-50 years. 2. Male and female. 3. Systemically healthy patients (ASA I or II). 4. Mature mandibular molar teeth with: Necrotic pulps, normal periapical radiographic appearance and no intra-canal calcifications or internal resorptive lesions Medically compromised patients having substantive functional limitations (ASA III or IV). 2. Patients having two or more adjacent teeth requiring endodontic treatment. 3. Patients who received antibiotic therapy within the last three months before treatment. 4. Patients administered analgesics in the last 24 hours before treatment. 5. Teeth with Vital pulps Immature apices Acute periapical abscess, swellings and facial cellulitis Periodontally hopeless (mobility grade II or III) Previous root canal treatment Non-restorable coronal portion. 6. TMJ problems, bruxism or traumatic occlusion. 7. Inability to perceive the given instructions | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 16.0-999.0, Venomous Snakebites Local Anesthesia Painless Injection Regional Anesthesia Dermatologic Surgery Cutaneous Pain Musculoskeletal Pain All volunteer subjects will be healthy, mature in behavior and temperament, without mental impairment and at least 16 years of age A volunteer TLE research subject must be a non-medical-professional layperson and must have signed an IRB-approved informed consent form prior to participation All subjects must weigh at least 40kg = 88lb Anyone who has a significant fear of needles or fear of injections A history of lidocaine allergy A significant history of epinephrine hypersensitivity History of an adverse reaction to percutaneous injections, such as fainting and lightheadedness (vasovagal reactions, near syncope) Significant needle phobia or anxiety Vasovagal reaction associated with any medical procedures or the sight of blood Uncontrolled or labile hypertension Hyperthyroidism, thyroid medications Recent phenylephrine (Actifed®) or pseudoephedrine use Any significant cardiac arrhythmia including controlled atrial fibrillation tachycardia, mitral valve prolapse | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-75.0, Idiopathic Retroperitoneal Fibrosis age 18-75 diagnosed as IRPF. The diagnosis of idiopathic retroperitoneal fibrosis is based on the following aspects :(1) the swelling of retroperitoneal tissue , which seems neoplastic; (2) A large number of lymphocytes proliferated and infiltrated in the affected tissues and organs, and tissues showed inflammation, fibrosis and sclerosis, in which IgG4-positive cells accounted for less than 50% of plasma cells; (3) Increased inflammatory markers, such as ESR and CRP; (4) Good response to glucocorticoid therapy malignancy retroperitoneal fibrosis secondary to other diseases or drugs or abdominal surgeries | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 6.0-12.0, Cost Effectiveness • Healthy children with no physical or mental disorders. Children with newly fully erupted permanent molars (PMs) Teeth will be excluded from the study if they had any of the following Dental caries in dentine History of pain or swelling. Parents refused their children participate in the trial | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 20.0-70.0, Cervicogenic Headache • Both Genders Age between 20 to 75 Years Neck pain referring the unilateral pain to the sub-occipital region and head Headache intensifying upon manual pressure to upper cervical joints and muscles With the cranio-cervical Flexion rotation exam, neck pain and ipsilateral headache and restriction of C1 and C2 rotation • Tension headache (Headache on both sides) If the patient not tolerate the cranio-cervical Flexion rotation test Patients presents with autonomic symptoms like visual disturbance, vertigo, dizziness If the physiotherapeutic modalities used for head pain in the last 6 months Headache other than cervical origins Clinically diagnosed as case of cervical radiculopathy or myelopathy Extreme cervical discomfort due to disk herniation, stenosis of the spinal canal and cervical arthritis Each other disorder that may be contraindicated in the upper cervical area of myofascial release | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, Facial Pain Temporomandibular Disorder Temporomandibular Joint Disorders Temporomandibular; Functional Disturbance Orofacial pain in the joint or muscles, degree NRS≥3 Clicking phenomenon during TMJ opening or closing movement Deviation movement during opening of the lower jaw Legal competence and presence of the signed declaration of consent Drug abuse Depression Polyarthritis | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 50.0-85.0, Total Knee Arthroplasty Scheduled to undergo a primary, unilateral total knee arthroplasty secondary to end-stage osteoarthritis Discharge to location other than home after surgery History of heart failure, lymphatic insufficiency, hepatic disease, pre-existing pitting edema, varicose vein ligation or any other condition associated with lower extremity swelling Unstable orthopedic conditions (besides OA/TKA) that limit function Other neurological, vascular, or cardiac problems that limit function or cause chronic lower extremity swelling No caregiver or inability to touch toes which can affect the ability to don/doff the compression garment Current smoker or history of substance abuse Surgical complication necessitating an altered course of rehabilitation Uncontrolled diabetes (hemoglobin A1c level >8.0) Body mass index >40 kg/m2 | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, Sleep Hygiene Reside in Harrison County of West Virginia Ability to read and understand English Ability to provide informed consent Inability to read and understand English Inability or unwillingness to provide informed consent Presence of sleep apnea Depression Severe insomnia Using prescription sleeping medication or narcotics Acute illness including stroke, heart attack, heart failure or pneumonia with or without COVID-19 infection requiring hospital admission within the last 8 weeks | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, Alveolar Osteitis (1) > 18 years; (2) untreated AO after extraction of a permanent tooth (excluding wisdom teeth); and (3) diagnosis of AO based on the of Blum (Blum 2002) (1) patients with chronic diseases and/or taking any medication, influencing hard and soft tissue healing; (2) pregnancy; (3) history of hypersensitivity or allergy to HY; (4) inability to attend follow-up appointments; (5) intake of preoperative antibiotics | 0 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 0.083-999.0, Movement Disorder Any volunteer of any age from birth to old age who is deemed medically fit to participate and is willing to provide their informed consent will be included in the study | 0 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 18.0-999.0, Parkinson's Disease Individuals age 18 or over from families in which an autosomal dominant form of Parkinson's disease is apparently being inherited. The diagnosis must be supported by accepted clinical tremor, bradykinesia, and responsiveness to L-DOPA. Unaffected family members will also be enrolled. Subjects must give consent. Parkinson's disease may be associated with dementia. Decisionally-impaired individuals will be enrolled | 1 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 18.0-999.0, Parkinson's Disease Individuals over the age of 18 from families in which there are three or more individuals affected with Parkinson's disease (within three generations) and the proband was the only affected person available or willing to participate in the study The diagnosis must be supported by accepted clinical tremor, bradykinesia, and responsiveness to L-DOPA. PD may be associated with dementia. The study will lose power if individuals with mental impairment and PD are excluded. For this reason, decisionally-impaired individuals will be enrolled No one under 18 will be enrolled because, with the exception of the rare autosomal recessive PD due to parkin mutations, PD does not affect minors. Study design does not involve testing fetuses | 1 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 0.0-999.0, Cerebellar Disease Dementia Healthy Parkinson's Disease Right handed normal volunteers (18-65 years old). Patients with Parkinson's disease off medication. Patients with cerebellar deficits. Patients with frontal lobe lesions. Patients with frontal lobe dementia Subjects with personal or family history of seizures or other neurological disorders. Pregnant women. Volunteers or patients with severe coronary artery disease. Metal in the cranium except mouth. Intracardiac lines. Increased intracranial pressure as evaluated by clinical means. Cardiac pacemakers. Intake of neuroleptics | 2 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 0.0-999.0, Tremor A total of 20 subjects will be enrolled in the study. 10 normal subjects will be enrolled in the study. All will have an 8-12 Hz component of physiologic tremor as determined by neurophysiologic studies. Patients will have a prominent 8-12 Hz spike on accelerometry recordings that is associated with an EMG spike at the same frequency. 5 patients with essential palatal tremor and 5 patients with symptomatic palatal tremor will be included. All participants must be a minimum of 21 years of age The presence of any medical condition, such as liver disease, history or family history of alcoholism, that can reasonably be expected to subject the patient to unwarranted risk or compromise the value of the data. Any patient with pathologic tremor, such as parkinsonian rest tremor, essential tremor, or tremor secondary to medications or structural brain lesions. Any clinically significant laboratory abnormalities. Lack of effective contraception. Patients who are pregnant. Inability to understand the nature of the study or its procedures. Persons under the age of 21, who are not of legal age to consume alcohol in Maryland. Patients taking any psychoactive medications including certain cough or cold medicine preparations. No one will be excluded or discriminated against based on the grounds of race, creed, gender, color, or national origin. Every attempt will be made to women and minorities in the study population | 1 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 0.0-999.0, Parkinson Disease All patients will have parkinsonism of undetermined etiology. Males and females between the ages of 18 and 85 are eligible for the study. No presence or history of any medical condition that can reasonably be expected to subject the patient to unwarranted risks, specifically those who have the following: a history of convulsive, hepatic, or renal disorders; currently receiving treatment for myocardial infarction, arrhythmia or cardiac failure; and pregnant women or anyone not practicing an effective means of birth control | 2 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 0.0-999.0, Movement Disorders Parkinson Disease All patients will carry a diagnosis of idiopathic Parkinson's Disease based on the presence of a characteristic clinical history and neurologic findings. Most will have relatively advanced disease with associated motor response complications. Males and females between the ages of 18-75. No presence or history of any medical condition that can reasonably be expected to subject the patient to unwarranted risk. No patients with baseline QTc prolongation (greater than 440 msec). No pregnant women nor those not practicing effective means of birth control | 2 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 0.0-999.0, Parkinson Disease All patients will carry a diagnosis of Parkinson's Disease based on the presence of a characteristic clinical history and neurological findings. Symptom severity will range from Hoehn & Yahr stage II-IV. Males and females between the ages 30-76 are eligible for the study. Initial emphasis will be on patients who are taking few or no other medications than levodopa for their Parkinson's disease. No presence or history of any medical condition that can reasonably be expected to subject the patient to unwarranted risk. No patients with a history of significant cardiac (myocardial infarction within 12 months prior to study, dysrhythmia; QTc intervals greater than 440 msec). No patients who are convulsive, hepatic, or with renal disorders (exceeding the upper limit of normal values for LFT's and creatinine respectively). No patients with evidence of other serious medical illness, a history of alcohol or drug abuse, those who have participated in an investigational trial within 28 days prior to study, and pregnant or nursing women or anyone not practicing effective means of birth control | 1 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 35.0-75.0, Parkinson Disease ENTRY --Disease Characteristics- Advanced Parkinson's disease Hoehn-Yahr stage IV or worse during "off" periods Hoehn-Yahr stage III or better during "on" periods Predictable motor fluctuations with at least 20% of waking day in the "off" stage No atypical parkinsonism or secondary parkinsonism --Prior/Concurrent Therapy- Biologic therapy: Not specified Chemotherapy: Stable doses of levodopa/carbidopa or any other antiparkinson therapy for 2 months prior to study Surgery: No previous intracranial/neurosurgical procedures --Patient Characteristics- Renal: Creatinine clearance at least 70 mL/min or creatinine no greater than 1.8 mg/dL Protein no greater than 300 mg/dL Other: Not pregnant or nursing Adequate contraception required of fertile patients Prior history of good response to levodopa No sensitivity to cyclosporine Not HIV positive (e.g., HIV I or II) No human T-cell leukemia/lymphoma virus (HTLV-1) No tremors interfering with stereotactic surgery No clinically significant medical, neoplastic or infectious disease No clinically significant laboratory abnormality No dementia that precludes signing informed consent or score of less than 24 on Mini-Mental status examination | 1 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 0.0-999.0, Dyskinesias Parkinson Disease Males and females between the ages of 30 and 75 are eligible for the study. All will carry the diagnosis of idiopathic Parkinson's disease based on the presence of a characteristic clinical history and neurological findings. All will have relatively advanced disease (Hoehn and Yahr Stages II to IV) with levodopa-associated motor response complications, including wearing-off fluctuations and peak-dose dyskinesias. No presence or history of any medical condition that can reasonably be expected to subject the patient to unwarranted risk. No clinically significant laboratory abnormalities including liver enzyme elevations more than three times the upper limit of normal, or neutropenia (WBC less than 4000). No parkinson's disease patients exhibiting diphasic or end-of-dose dyskinesias or disabling dystonia. Since LY300164 is an inhibitor of CP4503A4, patients receiving certain drugs metabolized by that pathway will not be included. No patients who are unable to be treated with levodopa/carbidopa alone or a single, relatively short-acting dopamine agonist. No patients who require additional treatment with amantadine or other concomitant medications. No pregnant women or those not practicing effective means of birth control since the influence of any investigational compound on the unborn child and reproductive organs is unknown | 1 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 30.0-999.0, Parkinson's Disease The subjects must have the three cardinal features of PD: slowness of movement, resting tremor and rigidity. The signs of PD must be greater on one side Disorders that mimic PD Other serious medical problems | 2 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 30.0-999.0, Parkinson's Disease Early, mild PD, not requiring medications Age 30 or older Duration from time of diagnosis of PD: less than 2 years Hoehn & Yahr Stage 1 or 2 Exposure to levodopa or dopamine agonist of 14 days or less | 1 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 0.0-999.0, Parkinson Disease Healthy Patients: Patients with established, dopa-responsive PD, Hoehn and Yahr stage I-III, age 21 and older will be included. Patients will be recruited from the NINDS HMCS and ETB clinical programs and from the community. Healthy Controls: Healthy controls 21 and older will be recruited through the NIH Clinical Research Volunteer Program and from the community Exclusionary will be: any significant medical or psychiatric illness (other than PD), pregnancy, history of epilepsy, concurrent use of tricyclic antidepressants, neuroleptic agents, or any other licit or illicit drugs that could lower the seizure threshold or significantly affect cortical excitability. Persons with surgically or traumatically implanted foreign bodies in the head (other than dental appliances of fillings) that may pose a physical hazard during magnetic stimulation will also be excluded. Patients: Patients with persistent "resting" tremor that precludes testing at rest may be excluded as well as any patient to whom the screening physician makes a judgment that withdrawal of medications poses a significant risk due to immobility or risk of falling. Patients on long-acting dopamine agonists will also be excluded. Patients in Hoehn and Yahr stage IV will also be excluded, since they are least likely to tolerate medication withdrawal and are also unlikely to be able to maintain muscle relaxation for TMS testing. No significant medical or psychiatric illness (other than PD), pregnancy, history of epilepsy, concurrent use of tricyclic antidepressants, neuroleptic agents, or any other licit or illicit drugs that could lower the seizure threshold or significantly affect cortical excitability. Must not have surgically or traumatically implanted foreign bodies in the head (other than dental appliances or fillings) that may pose a physical hazard during magnetic stimulation. Ages 21 and older will be recruited through the NIH Clinical Research Volunteer Program (CRVP) and from the community. All individuals will be processed through the CRVP before participating. Recruitment will be focused on optimizing age, sex, educational, and racial matching with patient group. Patients' spouses will be invited to participate. No significant medical or psychiatric illness (other than PD), pregnancy, history of epilepsy, concurrent use of tricyclic antidepressants, neuroleptic agents, or any other licit or illicit drugs that could lower the seizure threshold or significantly affect cortical excitability. Must not have surgically or traumatically implanted foreign bodies in the head (other than dental appliances or fillings) that may pose a physical hazard during magnetic stimulation | 1 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 40.0-85.0, Parkinson Disease Ambulatory patients with Parkinson's Disease, defined as a clinical state in which at least two of these four cardinal features are present slowness of movement, 2) tremor at rest, 3) muscular rigidity, 4) gait disturbance or posture imbalance Ambulatory patients with Parkinson's Disease not exercising regularly more than 2x per week. Willing to be randomly assigned to 1 of the 3 exercise modalities: Tai Chi, Qi Gong and Aerobic exercise. NOTE THAT IN THE STUDY BI-WEEKLY IN A 16-WEEK PLUS AT EMORY. IS TO LOCAL | 2 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 21.0-999.0, Parkinson Disease We will only PD patients with a stable clinical response to L-DOPA and DAergic agents. We will only recruit patients with early or mild-to-moderate PD (score on Hoehn & Yahr scale 148 less than 3). To obtain a homogeneous group, the PD cohort will comprise only non-demented, non-depressed, with parkinsonian symptoms and signs primarily akineto-rigid. If resting tremor is present, only patients with mild or moderate tremor (UPDRS tremor ratings 1 or 2 in the right upper limb) will be included in the study. Our group of healthy volunteers will the following age range: 21-30 years, 31-40 years, 41-50 years, 51-60 years, 61-70 years, and 70 years and over. Research subjects may be male or female and they must be right-handed. Pregnant women will not participate in the study. Research subjects will be asked to refrain from caffeine and nicotine for at least 12 hours and to abstain from alcohol at least 24 hours before the fMRI Subjects belonging to one of the following groups will be excluded from the study: Subjects with a familial history of PD. Patients with a marked resting tremor (score at the UPDRS scale above 3 in the right upper limb). Patients with a score at Hoehn & Yahr scale equal or above 3. Patients with progressive neurological disorders other than PD. Subjects with cognitive impairment (i.e., score on Mattis scale below 123/144). Subjects with significant mood disturbances (i.e., score on BDI scale above 10). Subjects with abnormal MRI findings at visual inspection (prominent normal variants such as mega cisterna or cavum septum pellucidum, signs of severe cortical or subcortical atrophy, brain tumors, vascular diseases, trauma or AVMs). Subjects with a history of significant medical disorders, or requiring chronic treatment with other drugs that cannot be stopped. Subjects with prior exposure to neuroleptic agents or drug use. Subjects with significant past and present history of hypertension, cardiovascular disease and diabetes mellitus. Subjects with severe orthopedic or rheumatologic pathology of the right upper limb. Subjects with past or present neuropsychiatric illness, head trauma with loss of consciousness, epilepsy, cerebro-vascular disease, past and present history of alcohol or substance abuse, including cigarettes, medical conditions that may alter cerebral functioning Subjects with cancer. Subjects who have pacemakers, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including heart valves and cochlear implants) or shrapnel fragments. Subjects incapable of giving an informed consent. Subjects with a positive pregnancy test. Subjects with pre-existing eyes condition. Subjects who are unable to tolerate being off of antiparkinsonian medications for 12 hours. Children will be excluded from the study because PD is infrequent before age 30 | 1 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 18.0-999.0, Parkinson's Disease Movement Disorders Subjects will be recruited from members of the Agricultural Health Study cohort | 1 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 30.0-75.0, Parkinson's Disease Clinical diagnosis of Idiopathic Parkinson's Disease based on the presence of at least 2 of the cardinal motor signs (akinesia/bradykinesia, rigidity, tremor, and gait/balance disorder) and a clear response to levodopa therapy Hoeh & Yahr staging III or worse "off " medication periods Intractable, disabling motor fluctuations, dyskinesias, or freezing episodes Unsatisfactory clinical response to maximal medical management or previous surgical treatment Stable on Parkinson's medications for at least 30 days with total L-dopa equivalence varying no more than +/ twenty percent during the 30 day period Absence of cognitive, or psychiatric or other co-morbidities that might interfere with the patient's ability to understand and sign the informed consent form Clinically significant medical history that increases pre / post operative complications (Cardiac or pulmonary disease, uncontrolled hypertension, diabetes…) Secondary or atypical parkinsonism as suggested by: i. History of stroke, encephalitis, exposure to toxins or neuroleptics. ii. Neurologic signs of upper motor neuron or cerebella involvement, supranuclear gaze palsy, or significant autonomic dysfunction. iii. MRI scan with evidence of significant brain atrophy, lacunar infracts, or iron deposits in the putamen | 1 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 1.0-999.0, Retinoschisis Eligible participants must satisfy one of the below Male diagnosed with X-Linked Juvenile Retinoschisis (proband). A proband will be defined as the first X-Linked Juvenile Retinoschisis diagnosed male in a given family who contacts the NIH for participation in the study; or Female who is a suspected carrier (i.e., mother of proband); or Other relative of proband including affected and unaffected males and females. The participant (or the participant s legal guardian) understands and signs this protocol s informed consent document and minor participants between the ages of 7 and 17 must provide assent Affected males will be ineligible for participation if The participant has a significant media opacity or other obstruction precluding a complete fundus examination including retinal photography The participant is unwilling or unable to contribute a blood sample for genotyping if there is not existing genetic analysis data from a documented family member. Both affected and unaffected individuals will be ineligible for participation if The participant is younger than two years (seen at the NIH) or younger than nine months (participating offsite through medical record review and blood submission) The participant is unable to cooperate with study procedures without anesthesia | 0 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 18.0-999.0, Parkinson Disease Individuals over the age of 18 from families in which an inherited form of parkinson's disease is apparent will be enrolled. These patients are already enrolled in the Genetic linkage analysis protocol 97-HG-0173. The diagnosis of Parkinson's disease must be supported by accepted clinical including: tremor, bradykinesia, rigidity and responsiveness to L-DOPA. Unaffected family members found to be at risk, will also be enrolled. The normal control group will be comprised of anonymous platelet donors from the NIH Department of Transfusion Medicine and of individuals over the age of 18 with no known neurological disorder and normal neurological examination matched by age and sex that may be actively recruited. Individuals with Lewy Body disease (LBD) that meet current for diagnosis (hallucinations, diurnal variation, and dementia associated with extrapyramidal symptoms within a one year period) will also be included in the study Because some medications can alter mitochondrial function, patients on MAO inhibitors, antidiabetic sulfonylureas and benzodiazepines will be excluded from the study. No person under the age of 18 will be enrolled in this study. This is due to the fact that, except for very rare occasions, Parkinson's disease affects only adults | 1 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 0.0-999.0, Dyskinesias Parkinson Disease Patients who meet all of the following will be able to participate in the study: 1. Patient is between the ages of 30 and 80, inclusive; 2. Patient has been diagnosed with idiopathic Parkinson's disease based on the presence of a characteristic clinical history and neurological findings; 3. Patient has relatively advanced disease with levodopa-associated motor response complications, including peak-dose dyskinesias and wearing-off fluctuations ; 4. Patient is willing to adhere to protocol requirements as evidenced by written, informed consent Patients meeting any of the following will not be enrolled or immediately withdrawn from the study, as appropriate: 1. Patient has a history of any medical condition that can reasonably be expected to subject them to unwaranted risk; 2. Patient has clinically significant laboratory abnormalities including impaired renal function (CL(cr) equals 30-50 ml/min.); 3. Patient is uable to br treated with levodopa/carbidopa alone or with a single, relatively short-acting dopamine agonist, such as pramipexole or ropinirole; 4. Patient is taking a prohibited concomitant medication; 5. Patient has not been using or was not continuing to use an adequate contraceptive method for the last 30 days, or is not at least one year post-menopausal (if female); 6. Patient is pregnant or breastfeeding; 7. Patient is implanted with bilateral deep brain stimulators; 8. Patient has prior pallidotomy or other ablative surgeries for treatment of PD; 9. Patient has cognitive impairment (MMSE less than 25); 10. Patient has participated in a clinical study with an investigational drug within the last 30 days; 11. Patient has a condition (such as active drug or alcohol abuse) that, in the opinion of the investigators, would interfere with compliance or safety; 12. Patient is unwilling to sign an informed consent or to comply with protocol requirements; 13. Patient has a history of psychiatric illness | 1 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 30.0-999.0, Parkinson Disease Depression To be eligible you must be years old or older diagnosed with Parkinson's disease experiencing symptoms of depression such as sadness, decreased energy, or problems sleeping | 1 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 30.0-999.0, Parkinson's Disease Dyskinesia The subject is an out-patient The subject presents with a diagnosis of idiopathic Parkinson's disease Prior therapy with all registered Parkinsonian medication is allowed (For female subjects) The subject is pregnant or lactating The subject is participating in another clinical study or has done so within the past 30 days The subject has received neurosurgical intervention related to PD The subject has relevant renal impairment The subject has relevant hepatic impairment The subject is suffering from any dementia or psychiatric illness The subject has a history of allergic asthma | 2 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 18.0-65.0, Dyspepsia Patients must have completed the 8 week double-blind study ITOFD04-01 Female patients must not be pregnant (must have a negative serum pregnancy test) Patients with any newly occurring medical condition which was an criterion at ITOFD04-01 study entry | 0 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 18.0-65.0, Dyspepsia Patients must have completed the 8 week double-blind study ITOFD04-03 Female patients must not be pregnant (must have a negative serum pregnancy test) Patients with any newly occurring medical condition which was an criterion at ITOFD04-03 study entry | 0 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 22.0-999.0, Parkinson's Disease Parkinsonian Syndrome As a participant with PD or PS Age >21 Clinical diagnosis of PD or PS (at least two of the three cardinal symptoms: resting tremor, rigidity, bradykinesia) and a clinical response to dopaminergic therapy For Healthy Control Age >21 As a participant with PD or PS Any other concomitant neurologic condition likely to interfere with handwriting, use of the computer, or other motor tasks tested in this study (e.g. stroke, demyelinating disease, visual loss) For Healthy Control Any indication of parkinsonism on examination Any other concomitant neurologic condition likely to interfere with handwriting, use of the computer, or other motor tasks (e.g. stroke, demyelinating disease, visual loss) | 2 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 14.0-999.0, Syncope, Vasovagal, Neurally-Mediated Syncope as a cause of loss of consciousness according to European Society of Cardiology > 2 lifetime syncopal spells preceding enrollment > or = to -2 points on the Syncope Symptom Score for Structurally Normal Hearts Age > 18 years with informed consent, or age > 14 years with consent and informed parental consent Other causes of syncope, such as ventricular tachycardia, complete heart block, postural (orthostatic) hypotension or hypersensitive carotid sinus syndrome An inability to give informed consent Important valvular, coronary, myocardial or conduction abnormality or significant arrhythmia Hypertrophic cardiomyopathy A known intolerance to fludrocortisone Another clinical need for fludrocortisone that cannot be met with other drugs A permanent pacemaker A seizure disorder A major chronic non cardiovascular disease Hypertension (blood pressure ≥ 130/85 on 2 occasions) or heart failure | 0 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 22.0-999.0, Parkinson Disease Prior participation in the study titled Dopamine Transporter Imaging Assessment of Parkinson's Disease Progression (DAMD17-99-1-9472) [123I] B-CIT and Spect in Vivo Imaging Assessment of Dopamine Transporter Density in Subjects With Early Parkinson's Disease Participating in Earlier Vs. Later Levodopa in Parkinson's Disease (ELLDOPA)] Inability to sign informed consent and participate in all study procedures Mini mental status exam < 25 Pregnancy | 1 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 40.0-999.0, Parkinson's Disease Stable Parkinson's disease idiopathic PD with Hoehn and Yahr state II or III | 2 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 1.0-90.0, Parkinson's Disease Epilepsy Patients presenting with Parkinson's disease, with a family history or not Minors presenting clinical signs of the disease Controls (without signs of the disease), matched by sex and age with the patients Relatives for the familial cases Patients presenting with an epilepsy episode (myoclonic epilepsy of the newborn, with febrile seizures, of the frontal lobe) Lack of signed informed consent | 1 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 30.0-999.0, Parkinson's Disease Clinical diagnosis of idiopathic Parkinson's disease exhibiting at least 2 or 3 symptoms Motor functions must be regarded as non-disabling by the patient History, signs or symptoms suggesting the diagnosis of atypical or secondary parkinsonism History of dyskinesia Previous or current use of entacapone or tolcapone Unstable Parkinson's disease patients requiring/receiving regimens of levodopa Subjects taking levodopa/DDCI controlled release or extended release formulations | 2 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 18.0-999.0, Head and Neck Cancer Patients must have documented advanced, locally recurrent, or metastatic head and neck carcinoma, which is untreatable by surgical resection or radiation therapy Prior chemotherapy for advanced/metastatic disease is allowed (1 regimen only) Patients must be taxane-naïve (no prior docetaxel or paclitaxel) Patients who have received chemoradiation as a primary therapy for advanced head and neck cancer are eligible Patients must have measurable or evaluable disease. Pre-study imaging for disease assessment must be done within 28 days of registration Patients with brain metastases are eligible if they have been stable for at least six weeks post-radiation therapy Aged 18 years or older Performance status of 0-2 by Zubrod criteria Life expectancy of at least 12 weeks Hematologic: absolute neutrophil count (ANC) equal to or > 1,500/mm3; hemoglobin equal to or > 8.0 g/dl; platelets equal to or > 100,000/mm3 Patients with congestive heart failure, second or third degree heart block or recent myocardial infarction within 12 months from registration are not eligible Peripheral neuropathy equal to or greater than grade 2 Patients with a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80 Use of standard chemotherapy or investigational agents for treatment of head and neck cancer within 28 days of 1st dose of study drug Any medical or psychiatric illness which, in the opinion of the principal investigator, would compromise the patient's ability to tolerate this treatment regimen Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil Pregnant or lactating women, women of childbearing potential with either a positive pregnancy test (PPT) at baseline, or sexually active females not using a reliable contraceptive method while on study and for at least six months after chemotherapy. (Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.) Sexually active patients not using a reliable contraceptive method while on study and for at least six months after chemotherapy Patients with malabsorption syndromes will be excluded. Administration of capecitabine through feeding tubes is permitted Serious concurrent infections | 0 |
The patient is a 55-year-old man who was recently diagnosed with Parkinson's disease. He is complaining of slowness of movement and tremors. His disease is ranked as mild, Hoehn-Yahr Stage I. His past medical history is significant for hypertension and hypercholesterolemia. He lives with his wife. They have three children. He used to be active with gardening before his diagnosis. He complains of shaking and slow movement. He had difficulty entering through a door, as he was frozen and needed guidance to step in. His handwriting is getting smaller. He is offered Levodopa and Trihexyphenidyl. He is an alert and cooperative man who does not have any signs of dementia. He does not smoke or use any illicit drugs. | eligible ages (years): 42.0-80.0, Parkinson Disease Main Male or female patient with idiopathic Parkinson Disease (PD) diagnosed for at least 2 years Patient aged 40 years or over at time of diagnosis of PD and not older than 80 years at screening visit Modified Hoehn and Yahr stage of II to III at "on" time Treatment with Levodopa at an optimised dose, 4 to 8 times per day, this dose being stable for at least 4 weeks prior to screening visit Motor fluctuations, with 2.0 to 6.0 cumulative hours of "off" time every day during waking hours, documented from patient's diary completed for 2 consecutive days before baseline visit. Main Neuropsychiatric exclusions: Non-idiopathic PD, dementia (Mini Mental State Exam <26), history of psychosis, history or current Axis I or Axis II mental disorder according to DSM-IV, etc Other medical exclusions, like ECG abnormalities, hypotension and/or symptomatic orthostatic hypotension, some abnormal laboratory parameters (e.g. severe renal impairment), etc Pharmacological exclusions, e.g. selegiline within 8 weeks prior to screening visit, regular use of anti-depressant drugs, any medication with central dopaminergic antagonist activity, etc | 1 |
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