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The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-999.0, Coronary Heart Disease the presence of an established diagnosis in patients with coronary artery disease unstable angina pectoris (NS). When making a diagnosis, the recommendations of ESH / ESC (2015) and RCO / WHO (2014) were used stable exertional angina (SSN) I-III FC. When making the diagnosis, the IHD classification was used, adopted at the IV Congress of Cardiologists of the Republic of Uzbekistan (2000), as well as in accordance with the recommendations of ESH / ESC (2019) and RCO / WHO (2017) The patient's refusal to participate in the study Pregnancy and lactation Severe and unstable condition of the patient, making it difficult to conduct a questionnaire (for ethical reasons) Acute violation of cerebral circulation History of acute or chronic psychosis The presence of concomitant acute diseases or chronic diseases in the acute stage. Throughout the study, all patients were assigned the right to voluntarily withdraw from the study at their own request, notifying the researcher in writing or orally | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.083, Rhesus Isoimmunization term or preterm infants born to Rh negative mother Infants with Rh negative factor major congenital malformation fetal hydrops short umbilical cord less than 25cm nuchal cord multiple gestation unstable maternal hemodynamic condition placenta abruption placenta previa uterine rupture | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.083, Lung Ultrasound • Gestational age < 28 weeks Birth weight <1000 grams Newborns diagnosed only with RDS clinically and by chest X-Ray findings • Gestational age ≤ 28 weeks Birth weight ≤ 1000 grams Newborns with congenital anomalies | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.077, Antibiotic Side Effect Late preterm and term babies Babies who are fed only breast milk and / or formula with breast milk Babies who have to be given formula support in the early period because they cannot receive breast milk or are not sufficient in the neonatal period, therefore probiotic support is started and continues Babies whose antibiotic treatment is started in the neonatal period Babies whose parents consent to participate in the study Hypoxic ischemic encephalopathy Babies with urinary tract infections Babies with a history of premature rupture of membranes Chromosomal abnormality Those with major congenital anomaly, gastrointestinal system anomaly Presence of any known immunodeficiency | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-45.0, Parkinson Disease Subjects who are willing and are able to provide a written informed consent to participate in the study. 2. Without Plann for pregnancy or pregnant within 3 months after enrollment throughout the trial. 3. Subjects aged between 18 and 45 (both inclusive) years old. 4. Healthy volunteers has a body weight ≥50 kg (for male) or ≥ 45kg (for female) and body mass index ≥18 and ≤28 kg/m2 at screening. 5. Subjects, who are healthy, as having no clinically significant abnormalities in vital signs, physical examination, clinical laboratory test results, Chest X-ray and 12-lead electrocardiogram (ECG) Subjects with a positive serology for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies and/or TP antibodies at screening. 2. Patients with the following diseases of clinical significance, including but not limited to those with gastrointestinal, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental, or cardiovascular and cerebrovascular diseases. 3. nown allergic reactions or hypersensitivity to any excipient of the drug formulation(s)， anaphylaxis physique. 4. Use of any prescription or non-prescription medications within 14 days prior to initial dosing，Use of any drugs that inhibit or induce liver metabolism within 28 days before the first dose, or use of any of the following drugs within 28 days before the first dose: monoamine oxidase inhibitors, opioids, serotonergic drugs, sympathetic nerves Drugs, breast cancer resistance protein substrates, dopaminergic antagonists, etc. 5. Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing. 6. Positive results from urine drug screen test. 7. History of alcoholism or drink regularly within 3 months prior to the study (defined as Alcohol consumption of > 21 units/week), or positive results from alcohol breath test. 8. Regular smoking of more than 10 cigarettes per day within 3 months before administration of study drug, or inability to refrain from smoking during the course of the study. 9. Donate blood or lose blood 400 mL or more within 1 month prior to initial dosing. 10. Subjects who plan to receive or have had organ transplants. 11. Females who are lactating/breastfeeding, or positive result from pregnancy test for women of child-bearing potential. 12. Subjects who participated in another clinical trial within 3 months prior to initial dosing. 13. Any other condition with in the opinion of the investigator would render the patient unsuitable for in the study | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-999.0, Dystocia dystocic labor with a need of oxytocin >=34w of gestation Nondystocic labors Women who don't understand Swedish or English Premature deliveries (<34w) | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 20.0-45.0, Healthy age 20-45 years natural delivery, singleton pregnancy healthy term infants（at 37-42 weeks of pregnancy） don't smoke and drink self-evaluation as physical health breastfeeding at least until three months of age Apgar score > 8 sign informed consent suffering from mastitis gestational diabetes, hypertension and other metabolic diseases AIDS, tuberculosis and other acute or chronic infectious diseases severe heart and kidney diseases mental system diseases cancer and other malignant consumptive disease take drugs that affect nutrient metabolism infants with congenital and genetic diseases with lactation contraindications don't agree to sign informed consent | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-45.0, Insomnia Subjects who are willing and are able to provide a written informed consent to participate in the study. 2. Without Plan for pregnancy or pregnant within 3 months after enrollment throughout the trial. 3. Subjects aged between 18 and 45 (both inclusive) years old. 4. Healthy volunteers have a body weight ≥50 kg (for male) or ≥ 45kg (for female) and body mass index ≥18 and ≤28 kg/m2 at screening. 5. Subjects, who are healthy, as having no clinically significant abnormalities in vital signs, physical examination, clinical laboratory test results, Chest X-ray and 12-lead electrocardiogram (ECG) Subjects with a heart rate ≥100 beats per minute or ≤ 60 beats per minute at screening or baseline. 2. Subjects with a positive serology for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies and/or TP antibodies at screening. 3. Subjects with history of digestive system,urinary system, liver,central nervous system, blood system, endocrine system,respiratory system,immune system,cardiovascular system,and/or malignant tumor or others medical conditions (such as history of mental illness, etc.) that are not suitable for clinical trial participation;Subjects with history of stroke, epilepsy, bipolar disorder/mania, high intraocular pressure, or acute angular-closure glaucoma. 4. Subjects with history of sleep-related illness. 5. Subjects with history of severe involuntary hypoglycemia 6. Known allergic reactions or hypersensitivity to any excipient of the drug formulation(s) ,or anaphylaxis physique. 7. Use of any prescription or non-prescription medications within 14 days prior to initial dosing,or Use of any medications known to inhibit or induce cytochrome P enzyme drug metabolism within 28 days prior to initial dosing. 8. Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing. 9. Positive results from urine drug screen test. 10. History of alcoholism or drink regularly within 3 months prior to the study(defined as Alcohol consumption of > 21 units/week), or positive results from alcohol breath test. 11. Regular smoking of more than 10 cigarettes per day within 3 months before administration of study drug. 12. Donate blood or lose blood 400 mL or more within 1 month prior to initial dosing. 13. Subjects who plan to receive or have had organ transplants. 14. Females who are lactating/breastfeeding, or positive result from pregnancy test for women of child-bearing potential. 15 Subjects who participated in another clinical trial within 3 months prior to initial dosing. 16.Any other condition with in the opinion of the investigator would render the patient unsuitable for in the study | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-1.0, Plagiocephaly, Nonsynostotic Plagiocephaly, Positional Congenital Muscular Torticollis Sign of positional plagiocephaly Infants below 12 moths age No neurological disorders No infectious diseases No respiratory diseases No other treatments | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 40.0-79.0, Chronic Pain Hypertension Diuretics Drug Reactions SCS Male or Female, age 40-79 2. Chronic low back pain 3. Permanent spinal cord stimulator implant for chronic pain 4. Stage 1 hypertension (BP 130-139/80-89 mmHg) with ASCVD risk ≥10% 5. Stage 2 hypertension (BP ≥ 140/90 mmHg) 6. Willing to visit research lab (Fairway CTSU) 7. Willing to undergo a blood draw 8. Able to provide written informed consent Any history of abnormal responses (allergy) to thiazide-type drugs 2. Currently taking any antihypertensive medication 3. Stage 1 hypertension (BP 130-139/80-89 mmHg) with ASCVD risk <10% 4. BP ≥160/100 (these patients should be promptly treated with 2 medications) 5. Secondary hypertension (e.g., aldosteronism, renal artery stenosis) 6. Symptomatic hypotension (weakness or syncope upon standing) 7. Renal failure 8. Diabetes requiring insulin or glucose-lowering drugs 9. History of neurological disease (e.g., dementias, Parkinson's) 10. History of stroke 11. Current diagnosis of cancer 12. Women who are pregnant or planning to become pregnant 13. Any active infection 14. Subject is unwilling or unable to comply with the protocol 15. If currently taking a NSAID, willing to stop for at least 3 days prior to beginning study and throughout study | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 4.0-999.0, Pmm2-CDG CDG1A Molecularly and/or enzymatically-confirmed PMM2-CDG Age ≥4 years old, and Affected with ataxia evidenced by mini International Cooperative Ataxia Rating Scale (Mini-ICARS) score >0 at baseline Hepatic impairment defined as AST/ALT >5x ULN in the last 12 months Renal impairment defined as serum creatinine: > 0.5 mg/dL (<6 years); > 0.7 mg/dL (7-10 years); > 1.24 mg/dL (> 11 years) Hypersensitivity to acetazolamide Hypersensitivity to any of the components of the placebo History of treatment with experimental drug within 28 days of Visit 1 Currently taking Mecamylamine, Sodium Phosphates, Salicylates, Mefloquine, Methenamine and other Carbonic Anhydrase Inhibitors | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 20.0-34.0, Child Development Child Obesity Child Behavior Nutritional and Metabolic Diseases Asthma in Children Cardiovascular Risk Factor Bone Loss Not pregnant, resident in Southampton UK GP requested no contact | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.038, Jaundice, Neonatal Well neonates 0 weeks gestation or greater, over 24 hours old Inpatients at Princess Royal Maternity (PRM), NHS Greater Glasgow and Clyde Unwell neonates Less than 35+0 weeks' gestation Less than 24 hours old Mother unable or too distressed to give informed consent | 1 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-75.0, Hepatic Encephalopathy The 1. cirrhosis due to HCV infection 2. age 18 to 75 years, 3. experiencing at least one episode of OHE, 4. MELD score ≤ 25 Patients with neurological or communication problems, 2. hepatocellular carcinoma 3. diabetes mellitus 4. active infection 5. serum creatinine > 2 mg/dl, Hg < 8 g/dL, serum Na < 125 mmol/L or serum K < 2.5 mmol/L . 6. Patients with previous intake of rifaximin as prophylaxis or any antibiotic within the last month | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-3.0, Urinary Tract Infections in Children Subject is 3 years of age or younger Subject is non-toilet trained, as communicated by subject's parent/guardian Subject is presenting to the emergency department with symptoms for UTI, as described by AAP guidelines (Newborns with UTI may present with jaundice, sepsis, failure to thrive, vomiting, or fever. In infants and young children, typical signs and symptoms fever, strong-smelling urine, hematuria, abdominal or flank pain, and new-onset urinary incontinence) or as determined by PI Subject's parent/guardian is able to provide informed consent Any subject with known underlying abnormalities to the genitourinary tract (e.g. prenatal hydronephrosis) Any subject who has had prior genitourinary tract or abdominal surgery Any subject who is toilet trained (i.e. able to provide a clean catch urine sample) Any subject with an active rash or skin lesion in the suprapubic area Any subject with a known allergy to LDPE, Elvax, or Crodamide plastics | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 0.0-0.077, Neonatal Sepsis Full term neonates of both genders from birth to the 28th day of life diagnosed with sepsis by history, clinical findings, laboratory findings, and blood culture. The clinical findings included the presence of three or more of the following (1) temperature instability (hypothermia, hyperthermia) (2) respiratory alterations (grunting, intercostal retractions, apnea, tachypnea, cyanosis) (3) cardiovascular alterations (bradycardia, tachycardia, poor perfusion, hypotension) (4) neurologic alterations (hypotonia, lethargy, seizures) (5) gastrointestinal alterations (feeding intolerance, abdominal distension). CRP values >10 mg/L were considered to be positive Preterm neonates Neonates with CNS malformations, metabolic disorders, chromosomal abnormalities, intrauterine growth restriction, or birth asphyxia were excluded from the study | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-50.0, Cachexia Healthy male and female volunteers, 18 to 50 years of age, inclusive. 2. A body mass index (BMI) between 18 and 30 kg/m2 and weight between 60 and 90 kg. 3. Healthy as indicated by a comprehensive clinical assessment (detailed medical history and complete physical examination). Supine blood pressure (BP), heart rate (HR), electrocardiogram (ECG) intervals and routine laboratory tests within the normal range of the study center (see Appendix 4) or considered not clinically significant by the Investigator. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin must be < 1.5 times the upper limit of the normal range (ULN). Total bilirubin, if above 1.5 x ULN, is only acceptable with a history of Gilbert's Syndrome. 4. Non-smoker or ex-smoker for longer than 6 months. 5. Sexually active pre-menopausal female subjects and female partners of male subjects must use adequate contraceptive measures, while on study and for at least 100 days after the IMP administration. Sexually active male subjects must use adequate contraceptive measures, while on study and for at least 160 days after the last dose of IMP. All fertile male and female subjects and their partners must agree to use a highly effective method of contraception. Effective birth control includes hormonal contraception (oral, intravaginal, transdermal, injectable or implantable), intrauterine device (IUD) plus one barrier method; or 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm). Vasectomy (at least 3 months before IMP administration) and vasectomized partner (provided that the partner is the sole sexual partner of the trial participant and that the absence of sperm in the ejaculate has been confirmed) are acceptable methods of contraception, as well as post-menopausal female for at least 1 year (confirmed with serum follicle stimulating hormone [FSH] > 25.8 IU/L at screening), or surgically sterilized female subjects. Abstinence is not an acceptable contraception method. Female subjects who are of non-childbearing potential due to a surgical procedure or medical condition must provide documentation, and vasectomized male subjects must bring in the surgical report of the procedure. 6. Able to sign and understand an ICF and able to comply with study restrictions prior to selection Presence or history of any disorder that may prevent the successful completion of the study. 2. Clinically significant abnormalities in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis), such as White blood cell count < 3.0x109/L Neutrophils < 1.5x109/L or clinically abnormal according to the subject's ethnic group (must be > 1.0x109/L for subjects of African descent) Hemoglobin < 10 g/dL Platelet count < 125x109/L or > 450x109/L ALT > 1.5 ULN AST > 1.5 ULN Total bilirubin > 1.5 ULN (except in the presence of Gilbert's syndrome) Creatinine > 1.2 ULN Sodium < 132 mmol/L or > 147 mmol/L | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-79.0, Chronic Kidney Disease Age Participant must be 18 to 79 years of age (inclusive) at the time of signing the informed consent. Weight Body mass index (BMI) within the range 18 to 35 kg/m^2 (inclusive). Sex and Contraceptive/Barrier Requirements Male and female white participants. Main for participants with hepatic impairment Participants with hepatic impairment (Child Pugh A or B) Participants with stable liver disease in the last 2 months. Main for control group of participants Healthy male and female white participants Mean age and body weight in the control group and in the two groups with hepatic impairment (Child Pugh A and B) should not vary by more than ±10 years and ±10 kg Gender-matched Main for all participants Medical and surgical history Participants with a medical disorder, condition, or history of such that would impair the participant's ability to participate or complete this study in the opinion of the investigator or the sponsor. Medication, drug use and special behavioral patterns Suspicion of drug or alcohol abuse. Other Participation in another clinical trial within 3 months (for previous multi-dose study) or 1 month (for previous single dose study) before dosing periods from other studies or simultaneous participation in other clinical studies. coronavirus disease 2019 (COVID-19) specific History of COVID-19 Contact with severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) positive or COVID-19 patient within the last 4 weeks prior to admission to the clinical unit Positive SARS-CoV-2 viral polymerase chain reaction (PCR) test Main for participants with hepatic impairment Medical and surgical history | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 17.0-40.0, Previous Cesarean Section Scar Pregnant women without any medical disorders Gestational age: 36-40 weeks Pregnant woman with singleton pregnancy Clinically adequate pelvis Normal ultrasonographic findings (gestational age, fetal structures and placental site) Cephalic vertex presentation Patients not inlabour Previous repair of ruptured uterus Women with history of long-term treatment for infertility Multiple pregnancies Previous operations in uterus rather than cesarean section Polyhydramnios and Fetal macrosomia Women with bad obstetric history (previous IUFD or difficult delivery) Disturbance of fetal heart rate (determined with the CTG) | 0 |
The patient is a 3-day-old female infant with jaundice that started one day ago. She was born at 34w of gestation and kept in an incubator due to her gestational age. Vital signs were reported as: axillary temperature: 36.3°C, heart rate: 154 beats/min, respiratory rate: 37 breaths/min, and blood pressure: 65/33 mm Hg. Her weight is 2.1 kg, length is 45 cm, and head circumference 32 cm. She presents with yellow sclera and icteric body. Her liver and spleen are normal to palpation. Laboratory results are as follows: Serum total bilirubin: 21.02 mg/dL Direct bilirubin of 2.04 mg/dL AST: 37 U/L ALT: 20 U/L GGT: 745 U/L Alkaline phosphatase: 531 U/L Creatinine: 0.3 mg/dL Urea: 29 mg/dL Na: 147 mEq/L K: 4.5 mEq/L CRP: 3 mg/L Complete blood cell count within the normal range. She is diagnosed with neonatal jaundice that may require phototherapy. | eligible ages (years): 18.0-999.0, Gestational Diabetes - Age ≥ 18yrs, and at least one of the following NICE risk factors for glucose intolerance: body mass index ≥ 30kg/m2 a family history of diabetes (first-degree relative) previous macrosomic baby (>4.5kg) minority ethnic family origin with a high prevalence of diabetes pre-existing type 1 or type 2 diabetes mellitus, a previous history of GDM, booking HbA1c ≥ 48mmol/mol (6.5%), anaemia diagnosed on booking full blood count, booking diagnosis of a multiple pregnancy, use of corticosteroids or metformin within 12 weeks of booking | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 16.0-54.0, Osteoporosis ENTRY --Disease Characteristics-- Low bone mass (T score less than -2.0) with no secondary cause on routine exam Premenopausal OR Perimenopausal --Prior/Concurrent Therapy-- Chemotherapy: No prior or concurrent chemotherapeutic agents Endocrine therapy: No prior or concurrent glucocorticoids or suppressive doses of thyroid hormone Other: No prior or concurrent anticonvulsants --Patient Characteristics-- Hematopoietic: No multiple myeloma Other: No hyperparathyroidism No thyrotoxicosis No anorexia nervosa No Paget's disease of bone No rheumatoid arthritis No Cushing's syndrome No malabsorption syndrome No type I diabetes mellitus | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, Healthy Inflammation Male or female volunteers referred for extraction of third molars willing to undergo two surgical appointments for the extraction of unilateral third molars. Between the ages of 16 to 35 years (based upon eruption patterns and age-related complications associated with surgical extraction of third molars). In good general health ASA status 1 or 2 (healthy subjects based upon for safe outpatient conscious sedation). Willing to undergo observation period for four hours postoperatively. Willing to return at 48 hours for measurement of pain, swelling, and tissue biopsy. Willing to return for a total of four visits beyond the screening visit Pregnant or lactating females. Current mental disorder or substance abuse. Allergy to aspirin or NSAIDs. Chronic use of medications confounding assessment of the inflammatory response or analgesia (antihistamines, NSAIDs, steroids, antidepressants). Presence of chronic debilitating disease (such as diabetes, rheumatoid arthritis, liver disease, etc). Presence of symptomatic tooth suggesting infection or inflammation. Unusual surgical difficulty encountered during the surgical procedure | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, Adenocarcinoma of the Prostate Hormone-resistant Prostate Cancer Recurrent Prostate Cancer Stage IV Prostate Cancer Patients must have histologically documented adenocarcinoma of the prostate with progressive systemic (metastatic) disease despite castrate levels of testosterone due to orchiectomy or LHRH agonist (which must be continued); castrate levels of testosterone must be maintained At the time of enrollment, patients must have evidence of metastatic disease, either Measurable disease (with any PSA) OR Non-measurable disease with PSA >= 5 ng/ml; patients with PSA >= 5 ng/ml only are not eligible OF Any lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques: 1) physical exam for clinically palpable lymph nodes and superficial skin lesions, 2) chest X-ray for clearly defined lung lesions surrounded by aerated lung OR those lesions measured as >= 10 mm with a spiral CT scan or MRI Measurable lesions (up to a maximum of 10 in number) representative of all organs involved to be identified as target lesions; the sum of the longest diameters (LD) for all target lesions will be calculated and reported as baseline sum LD If measurable disease is confined to a solitary lesion then its neoplastic nature will need to be confirmed by histology Ultrasound may not be used to measure tumor lesions that are not easily accessible clinically OF NON-MEASURABLE Non-target lesions all other lesions, including small lesions with longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan and truly non-measurable lesions, which Bone lesions | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 0.0-999.0, Usher Syndrome Retinitis Pigmentosa Congenital Hearing Impairment Any Ashkenazi Jewish individual with combined hearing and visual loss that is or may be any type of Usher syndrome, or a family member of said individual Any individual who is not an Ashkenazi Jew or does not have combined hearing and visual loss or whose disease has been previously determined not to be Usher syndrome | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Small Lymphocytic Lymphoma Histologically documented non-Hodgkin's lymphoma; core biopsies are acceptable if they contain adequate tissue for primary diagnosis and immunophenotyping; bone marrow biopsies as the sole means of diagnosis are not acceptable for follicular lymphomas; patients with NHL must have one of the following World Health Organization (WHO) histologic subtypes Follicular, grade 1 Follicular, grade 2 Follicular, grade 3 B-cell small lymphocytic lymphoma Note: Patients diagnosed more than one year prior to entry on protocol must have a repeat lymph node biopsy; in the event of rapid tumor growth, rising LDH, or the onset of B symptoms in a period of time less than one year a rebiopsy is also required; patients are ineligible for this study if a separate lymph node biopsy shows a lymphoma with a higher grade; failure to submit pathology slides within 60 days of patient registration will result in patient being declared ineligible No known lymphomatous involvement of the CNS including either parenchymal or leptomeningeal involvement (lumbar puncture prior to study is not required in the absence of neurologic symptoms) or any seizure disorders or prior brain injury which could precipitate seizures Measurable disease must be present either on physical examination or imaging studies; evaluable disease alone is not acceptable; any tumor mass reproducibly measurable in two perpendicular diameters and > 1x1 cm by physical examination, X-ray, computerized tomography (CT), or magnetic resonance imaging (MRI) is acceptable; whenever CT is specified, it should be understood that MRI may be substituted as long as the measurements for tumor response are made on two successive studies employing the same procedure; the following lesions are not considered measurable Barium studies Ascites or pleural effusion | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 5.0-999.0, Osteoporosis Chronic inflammatory disease or transplant recipient, currently on steroid therapy at supraphysiologic dose (greater than hydrocortisone equivalent of 15 mg/m2/day) for more than 6 months Bone age less then 14 years in females, 16 years in males, to correspond to < 90% of peak BMD And Presence of glucocorticoid induced bone disease defined by Presence of at least one atraumatic fracture (defined as fracture that occurs during activities of daily living, without a fall), or a vertebral fracture, OR AP lumbar spine BMD (determined by DEXA) of more than 2 or more SD below the mean lumbar BMD for a healthy child of similar stature (height age). OR A low trauma fracture (suspicious fracture defined as a fracture the occurs with a fall from standing height or below, and not during a high velocity activity) and AP spine BMD 1.5 or more SD below the mean for height age, OR Recent loss of BMD of greater then 3% over a 6 month or greater interval at any one of the following sites, lumbar spine, total hip or whole body (excluding head). OR Recent increase in BMD of less then 3% over a 12 month period at all of the three sites listed above | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, Glioblatoma Gliosarcoma Anaplastic Astrocytoma Oligodendroglioma Anaplastic Oligoastrocytoma Adult patients (greater than or equal to 18 yrs of age) with tumors of the CNS or a history of a CNS tumor who are being evaluated for protocols within the National Cancer Institute. All patients or their previously designated LAR (Legally Authorized Representative) (if the patient is deemed by the treating physician to be impaired or questionably impaired in such a way that the ability of the patient to give informed consent is questionable) must sign an informed consent indicating that they are aware of the investigational nature of this study and the risks of the procedures that will be performed to assess for primary research protocols 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): 2.0-80.0, Mastocytosis Monoclonal Bone Marrow Tryptase Two to 80 years of age. Histologic evidence of increased mast cell number by bone marrow and/or skin biopsy or documentation of mastocytosis in the skin supported with a photograph of diagnostic skin lesion Must be under the care of a primary care physician to be enrolled. Ability to provide informed consent Anemia with hemoglobin less than 8 g/dL, hematocrit less than 24. Any condition that in the opinion of the investigator contraindicates participation in this study. Two to 80 years of age. A biological relative without the diagnosis of mastocytosis by skin examination or histologic evidence in a skin or bone marrow biopsy Subject has a primary medical care provider outside the NIH Ability to provide informed consent Any condition that in the opinion of the investigator contraindicates participation in this study | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Hodgkin Disease Lymphoma, Large-Cell Sarcoma, Kaposi Lymphoma, T-Cell, Cutaneous Lymphoma, B-Cell Histologically confirmed CD30+ hematologic malignancy. Immunohistochemistry or flow cytometry may be performed on either original diagnostic biopsy material or biopsy of relapsed disease. Patients must have at least one of the following Patients with HD must have failed systemic chemotherapy either as initial therapy for advanced stage disease or as salvage therapy after initial radiotherapy (XRT) for early stage disease and be ineligible for, or refuse treatment by stem cell transplantation Patients with other CD30+ malignancies must be beyond 1st remission or refractory to front line chemotherapy Patients with refractory or chemo-resistant multiple myeloma (MM), as defined by a failure to respond (<50% reduction in M-protein level), or disease progression less than 2 months after receiving at least two conventional chemotherapy regimens Patients with MM in the Plateau Phase of their disease may be included in the study. Plateau phase will be defined as persistent (more than 6 weeks) M-protein in the serum or urine despite a significant initial reduction (>50%) in response to previous therapy. These patients should have received at least two of the conventional chemotherapy regimens listed above prior to enrollment in this study Patients with relapsed MM as defined by disease progression more than 2 months after initial therapy and subsequent failure to respond (<50% reduction or progression in M-protein levels) to ONE of the above listed regimens or other salvage regimens (high dose cyclophosphamide, topotecan). Patients must have at least one of the following Bidimensional or unidimensional measurable disease on physical examination or radiologic evaluation Circulating tumor cells in peripheral blood Evidence of bone marrow disease to any degree in patients with HD >10% tumor cells in bone marrow in patients with other CD30+ malignancies A diagnosis of Cutaneous T-Cell Lymphoma (CTCL) or non-secretory MM Symptomatic cardiac disease including ventricular dysfunction, coronary artery disease or arrhythmias More than one primary malignancy with the exception of non-melanoma skin cancer or cervical carcinoma in situ (CIN) on a biopsy or squamous intraepithelial lesion (SIL) on PAP smear Active viral, bacterial, or systemic fungal infection including known HIV positivity Symptomatic brain metastases requiring treatment Concurrent therapy with other anti-neoplastic agents, corticosteroids, or experimental agents Any serious underlying medical condition which would impair the ability of the patient to receive or tolerate the planned treatment including prior allergic reactions to recombinant human or murine proteins Receipt of any therapeutic mAbs within 6 months unless a recent serum testing reveals no antibody titer and no evidence of anti-chimeric or anti-murine antibody in the peripheral circulation Female patients who are pregnant or breastfeeding Dementia or altered mental status that would prohibit the understanding and rendering of informed consent | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 30.0-999.0, Paget's Disease of Bone years or older Serum alkaline phosphatase (SAP) 2 times upper limit normal (ULN) Confirmed diagnosis of Paget's disease of the bone (by x-ray, magnetic resonance imaging, computerized tomography, radioisotope imaging, etc.) days washout calcitonin day washout bisphosphonate Allergic reaction to bisphosphonates History of upper gastrointestinal disorders History of iritis, uveitis Calculated creatinine clearance < 30 ml/min at baseline Evidence of vitamin D deficiency Other protocol-defined inclusion/ applied | 2 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Anal Cancer Histologically confirmed high-grade anal squamous intraepithelial lesions (HSIL) with residual HSIL of the anal canal or margin by high-resolution anoscopy Declined routine surgery or not a candidate for surgical excision of HSIL Documented evidence of HIV infection by one of the following methods Serologic (ELISA or western blot) Culture Quantitative polymerase chain reaction or bDNA assays HIV RNA no greater than 500 copies/mL CD4 at least 200 x 10^6/L Must have received stable highly active antiviral therapy (HAART) for at least 4 weeks before study HAART defined as 3 or more agents, including a protease inhibitor or nonnucleoside reverse transcriptase inhibitor that is approved or available through expanded access combination antiviral 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): 13.0-999.0, HIV Infections AIDS-Related Opportunistic Infections Note: Participants who enrolled in this study prior to Version 3.0 will be offered and allowed to switch to FTC/TDF if they wish. However, participants under the age of 18 cannot receive FTC/TDF through this study. for Step 1 HIV-1 infected Currently being treated for OI (including Pneumocystis carinii pneumonia [PCP]; cryptococcal meningitis; disseminated histoplasmosis; disseminated Mycobacterium avium complex [MAC]; cytomegalovirus [CMV] retinitis; CMV encephalitis; toxoplasmic encephalitis; other atypical non-tuberculous, non-MAC mycobacterial infections; or other serious, invasive BIs). Participants who have tuberculosis (TB) alone are ineligible for this study. Participants with bacterial pneumonia or serious BI must have a CD4 count less than 200 cells/mm3 within 30 days prior to study entry. Participants with other serious OIs, including other AIDS-defining and -related OIs for which appropriate therapy other than ART exists are eligible, pending investigator approval. Participants' current OI treatment must have been started within 14 days prior to study entry, but may have been discontinued prior to study entry Able to take oral medications Parent or guardian willing to provide informed consent, if applicable Willing to use acceptable methods of contraception for Step 1 Any ART within 8 weeks prior to study entry or more days of any ARV within 6 months prior to entry History of more than one virologic, immunologic, or clinical treatment failure while on a HAART regimen, or a history of more than one regimen change for unknown reasons Systemic cancer chemotherapy within 30 days prior to study entry Immunomodulators within 30 days prior to study entry, including growth factors, immune globulin, interleukins, and interferons (unless for hepatitis C virus or Kaposi's sarcoma) Investigational ARV agents at study entry Systemic investigational agents (except ARV drugs) within 30 days prior to study entry will be allowed at the study official's discretion Anticipated use of certain medications Kidney failure requiring dialysis | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, Adoption Genetic Counseling English-speaking adoptees, over 18 years of age, who were placed in unrelated adoptive families Adult adoptee that participated in piloting | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, Hepatitis Age at entry at least 18 years. 2. Serum alanine (ALT) or aspartate (AST) aminotransferase activities that are above the upper limits of normal. 3. Evidence of steatohepatitis on liver biopsy done within the previous 12 months with a NASH activity score of at least 4 (of a total possible score of 16) including a score of at least 1 each for steatosis, hepatocellular injury and parenchymal inflammation. Histological of steatohepatitis (1) macrovesicular steatosis, (2) acinar zone 3 hepatocellular injury (ballooning degeneration), (3) parenchymal and (4) portal inflammation. Additionally helpful, but not required, features the presence of (5) Mallory's hyaline and (6) pericellular and/or sinusoidal fibrosis that predominantly involves zone 3. 4. Written informed consent Evidence of another form of liver disease. 1. Hepatitis B as defined as presence of hepatitis B surface antigen (HBsAg). 2. Hepatitis C as defined by presence of hepatitis C virus (HCV) RNA in serum. 3. Autoimmune hepatitis as defined by anti-nuclear antibody (ANA) of 1:160 or greater and liver histology consistent with autoimmune hepatitis or previous response to immunosuppressive therapy. 4. Autoimmune cholestatic liver disorders as defined by elevation of alkaline phosphatase and anti-mitochondrial antibody of greater than 1:80 or liver histology consistent with primary biliary cirrhosis or elevation of alkaline phosphatase and liver histology consistent with sclerosing cholangitis. 5. Wilson disease as defined by ceruloplasmin below the limits of normal and liver histology consistent with Wilson disease. 6. Alpha-1-antitrypsin deficiency as defined by alpha-1-antitrypsin level less than normal and liver histology consistent with alpha-1-antitrypsin deficiency. 7. Hemochromatosis as defined by presence of 3+ or 4+ stainable iron on liver biopsy and homozygosity for C282Y or compound heterozygosity for C282Y/H63D. 8. Drug-induced liver disease as defined on the basis of typical exposure and history. 9. Bile duct obstruction as shown by imaging studies. 2. History of excess alcohol ingestion, averaging more than 30 gm/day (3 drinks per day) in the previous 10 years, or history of alcohol intake averaging greater than 10 gm/day (1drink per day: 7 drinks per week) in the previous one year. 3. Contraindications to liver biopsy: platelet counts less than 75,000/mm(3) or prothrombin time greater than 16 seconds. 4. Decompensated liver disease, Child-Pugh score greater than or equal to 7 points. 5. History of gastrointestinal bypass surgery or ingestion of drugs known to produce hepatic steatosis including corticosteroids, high-dose estrogens, methotrexate, tetracycline or amiodarone in the previous 6 months. 6. Presence of diabetes mellitus as defined by: fasting plasma glucose of greater than or equal to 126 mg/dl on two separate occasion, or diabetic symptoms with a random plasma glucose of greater than or equal to 200 mg/dl (34). 7. Use of anti-diabetic drugs, including insulin, biguanides, sulfonylureas, or thiazolidinediones in the previous 6 months. 8. Significant systemic or major illnesses other than liver disease, including congestive heart failure, coronary artery disease, cerebrovascular disease, pulmonary disease with hypoxia, renal failure, organ transplantation, serious psychiatric disease, malignancy that, in the opinion of the investigator would preclude treatment with metformin and adequate follow up. 9. Positive test for anti-HIV. 10. Active substance abuse, such as alcohol, inhaled or injection drugs within the previous one year. 11. Pregnancy or inability to practice adequate contraception in women of childbearing potential. 12. Evidence of hepatocellular carcinoma: alpha-fetoprotein levels greater than 200 ng/ml and/or liver mass on imaging study that is suggestive of liver cancer. 13. Any other condition, which, in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study. 14. History of hypersensitivity reactions to metformin. 15. Serum creatinine greater than 1.5 mg/dl in men and greater than 1.4 mg/dl in women | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 45.0-75.0, Osteoporosis A diagnosis of osteoporosis or low bone mass (T score < or = to -1) Female, 45 to 75 years old (inclusive) Postmenopausal (cessation of menses or oophorectomy) by at least 3 years Bone mineral density: (BMD) at spine or hip >1 standard deviation below mean for young normals of same sex (T score < or = to -1) Adequate liver function as indicated by a total bilirubin, AST, and ALT being within institutional normal limits Serum creatinine within institutional normal limits Signed, written informed consent Able to comply with study procedures and follow-up examinations Ionized calcium and 25-hydroxyvitamin D3 must be within institutional normal limits PTH must be within institutional normal limits Known hypersensitivity to study drug or related compounds (e.g., bisphosphonates) Use of any drugs for treatment of osteoporosis in the previous 6 months (e.g., bisphosphonates, hormone-replacement therapy [HRT]) Any chronic or continued use of drugs that are known to affect bone metabolism (e.g., diuretics, glucocorticoids, oral contraceptives) Gallstone diagnosed within the past 5 years or a history of multiple gallstones Previous significant gastrointestinal surgery (except appendectomy) or gastrointestinal disease Abnormal thyroid function (by thyroid-stimulating hormone [TSH] assay, normal range 0.5-5.0 U/L) Secondary osteoporosis (e.g., steroid-induced) and/or any other disorder affecting calcium or mineral metabolism Use of investigational agents within previous 30 days Patients with existing heart problems (e.g., congestive heart failure, unstable angina, conduction delay) Patients taking calcium channel blockers, beta blockers, digitalis, or antihypertensive agents | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 0.0-999.0, Healthy Tooth Extraction Male or female volunteers referred for third molar extraction willing to undergo 2 or 3 visits: 1 screening visit; 1 surgical appointment; and possible 1 follow-up research-related appointment Between the ages of 16 to 35 years (based upon eruption patterns and age-related complications associated with surgical extraction of third molars) In general good health American Society of Anesthesiologists (ASA) status I or II (healthy subjects based upon for safe administration of out-patient conscious sedation) Willing to undergo observation period for three hours postoperatively Ability to complete a 100 mm visual analog scale and a category scale every 20 minutes for the first 3 postoperative hours Willing to have a microdialysis probe placed beneath the surgical flap during the first 3 hours post-surgery Willing to have a preoperative biopsy on the day of surgery, and a postoperative biopsy either within 3 hours or at 24 hours following surgery Willing to return, if needed, 24 hours post-operation for the postoperative biopsy Must have two lower partial bony impacted wisdom teeth fully covered by intact soft tissue (rating equals 3) or fully bony impacted (rating equals 4) wisdom teeth (mandibular third molars) As assessed at the screening visit, the sum of the mandibular third molar surgical difficulty ratings must be between 6 to 8 in order to evaluate subjects experiencing similar pain levels Patients who are allergic to aspirin, NSAIDs, sulfites, or amide anesthetics Patients who have had asthma, or hives Patients who are pregnant or nursing Patients with history of peptic ulcers and/or GI bleeding Chronic use of medications confounding the assessment of the inflammatory response or analgesia, for example, NSAIDs, COX-2 inhibitors, antihistamines, steroids, antidepressants Patients who have significant psychiatric history Patients who have a clinical signs suggestive of infection, inflammation, or pre-existing pain at either extraction site Patients with severe kidney disease Patients who are taking any of the following drugs: ACE inhibitor; potassium sparing diuretics; aspirin on a near daily basis; coumadin or other blood thinners Patients who are taking drugs known to inhibit P450 2C9 and drugs metabolized by P450 2D6 Patients who have G6PD deficiency and those taking St. John's Wort Unusual surgical difficulty (determined from panoramic radiograph or during the actual surgery) | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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 Cancer Prostate Cancer Histologic Documentation: Histologic documentation of prostate adenocarcinoma. Patients with small cell, neuroendocrine, or transitional cell carcinomas are not eligible. 2. Staging: At least one bone metastasis by radiographic imaging (bone scan, magnetic resonance imaging, computed tomography, or plain radiographs). Indeterminate lesions should be confirmed by a second imaging method. Imaging to document bone metastases is to be completed either within 12 weeks before registration or within 12 weeks before initiating androgen deprivation therapy for bone metastases. 3. Hormone Therapy While on this study, patients must receive androgen deprivation therapy (ADT) for treatment of prostate cancer. Androgen deprivation therapy may have begun prior to enrollment on this study; however patients must have initiated ADT ≤ 6 months prior to enrollment Androgen deprivation therapy is defined as bilateral orchiectomy or gonadotropin- releasing hormone (GnRH) agonist with or without an antiandrogen Patients treated with intermittent androgen deprivation therapy are not eligible except for patients concurrently enrolled in SWOG-9346/INT-0162/CALGB 9594, Phase III Study of Intermittent Androgen Deprivation in Patients with Stage D2 Prostate Cancer. 4. Prior Treatment Hormone therapy at any point prior to 6 months before enrollment is prohibited. This includes any of the following treatments orchiectomy GnRH agonist (e. g., leuprolide, goserelin, triptorelin) estrogen therapy antiandrogen (e. g., bicalutamide, flutamide, nilutamide), or any other therapy known to lower testosterone level or inhibit testosterone effect | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 21.0-999.0, Chest Pain Myocardial Ischemia Heart Disease Coronary Arterial Disease (CAD) Angina Subjects with functional class (CCS) III or IV angina Subjects who have attempted "best" medical therapy without control of symptoms All subjects must have a recent coronary angiogram (within the last 3 months) Clinical signs and symptoms of clinically significant ischemia on nuclear perfusion imaging Subjects must be able to complete a minimum of 1 minute but no more than 6 minutes of the Standard Bruce Protocol Subject experiences angina during the baseline exercise tolerance test Subjects must either be no longer capable of reproduction or taking acceptable measures to prevent reproduction during the study Normal renal function Normal liver function Normal blood count. Angiographic Inclusions Predominant congestive heart failure symptoms Patients who have been hospitalized with a primary diagnosis of CHF in the prior 6 months Patients who have had diuretics added to their medical regimen or an increase in diuretic dosage for signs or symptoms of CHF in the past 6 months Patients with a left ventricular ejection fraction of less than 25% as determined by transthoracic echocardiography Patients with physical findings consistent with ongoing uncontrolled CHF Myocardial infarction within 30 days of treatment Successful coronary revascularization procedures within 3 months of study enrollment Documented stroke or transient ischemic attack (TIA) within 60 days of study enrollment History of severe aortic stenosis or insufficiency; severe mitral stenosis; or severe mitral insufficiency Severe co-morbidity associated with a reduction in life expectancy of less than 1 year | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 0.0-999.0, HIV Infections Cohort 1 patients about to start tenofovir DF HIV-infected children between the ages of 4 years and less than 21 years Clinical decision has been made to start the patient on tenofovir DF-containing antiretroviral regimen BSA greater than or equal to 0.85 m2 Sexually active patients must be willing to use a medically acceptable form of birth control, which includes abstinence, while they are being treated on this study Not pregnant or breast feeding OH-Vitamin D level greater than 20 ng/ml (supplementation allowed) Less than or equal to grade 1 serum calcium or ionized calcium (supplementation allowed) AST and ALT less than or equal to 7.5 times the upper limit of normal | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, Sarcoma Suspected low-grade intracompartmental chondrosarcoma, as defined by the following Resorption of prior calcifications (indicated by a change in radiographic appearance over time) AND/OR meets at least 2, but no more than 4, of the following Permeative appearance of medullary bone, defined as presence of tumor around 3 sides of a trabecula of normal bone Endosteal scalloping, defined as > 50% of adjacent cortical thickness Cortical thickening beyond the thickness of adjacent normal bone Bone expansion, defined as a circumferential increase in diameter of the bone beyond the adjacent normal bone Positive (i.e., increased uptake or "hot") bone scan No cortical disruption and/or soft tissue mass by radiography and CT scan (3 mm cuts are optimal) or MRI No presumptive axial (spinal) involvement No multifocal disease by bone scan Age | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-70.0, HIV Infections Osteopenia Osteoporosis HIV-infected On stable antiretroviral regimen for at least 3 months Able to walk Lumbar spine or total hip BMD T-score at least 1.5 SD and no more than 3.5 SD below the mean BMD No prevalent fractures at entry OR 1 prevalent vertebral fracture that has been asymptomatic during the last 2 years prior to study entry HIV viral load of less than 5000 copies/ml within the 2 months prior to study entry CD4 count of more than 100 cells/mm3 within the 2 months prior to study entry Willing to use acceptable forms of contraception during the study period and for 6 months after study completion. Participants who are female and postmenopausal will be required to take hormone replacement therapy during this study Prior treatment with bisphosphonates or fluoride Use of supraphysiologic systemic estrogen/androgen therapy or corticosteroid therapy within the 3 months prior to study entry. Participants who have taken hormone replacement therapy are not excluded Significant liver or kidney disease Hemoglobin less than 8 g/dL Serum calcium less than 8 mg/dL Laboratory evidence of low levels of estrogens or androgens Laboratory evidence of overactive parathyroid glands History of thyroid, parathyroid, or other endocrinologic disorder known to affect bone Current use of any therapy known to affect bone Current or history of cancer or chemotherapy | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 30.0-999.0, Paget's Disease of Bone years or older SAP 2 times ULN Confirmed diagnosis of Paget's disease of the bone (by x-ray, magnetic resonance imaging, computerized tomography, radioisotope imaging, etc.) days washout calcitonin day washout bisphosphonate Allergic reaction to bisphosphonates History of upper GI disorders History of iritis, uveitis Calculated creatinine clearance < 30 ml/min at baseline Evidence of vitamin D deficiency Other protocol-defined inclusion/ | 2 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Osteopenia Renal Osteodystrophy Dialysis dependent for a minimum of 3 months Age greater than 18 years Low or normal bone turnover as defined by a mean intact PTH ≤400 pg/ml from a minimum of two values 6 months apart Informed consent Mean serum aluminum levels > 20 mcg/L during 1 year prior to consent Documented dementia Comorbidity such that survival for >3 years is unlikely Use of steroids within 3 months of consent Use of bisphosphonates in previous 2 years Use of sex hormones (testosterone or estrogen) within 3 months of consent Mean calcium < 9.0 mg/dL during the two months prior to consent Peritoneal dialysis patients Body weight < 45 kg | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Adenocarcinoma of the Prostate Hormone-resistant Prostate Cancer Recurrent Prostate Cancer Stage IV Prostate Cancer Patients must have histologically documented adenocarcinoma of the prostate with progressive systemic (clinically metastatic disease documented on bone, CT or MRI scan) disease despite castrate levels of testosterone due to orchiectomy or LHRH agonist; castrate levels of testosterone must be maintained All eligible patients must have a Gleason sum based on biopsy or TURP at the time of registration At the time of enrollment, patients must have evidence of progressive metastatic disease, either Measurable disease with any level of serum PSA OR Non-measurable disease with PSA ≥ 5 ng/ml; patients with PSA ≥ 5 ng/ml only and no other radiographic evidence of metastatic prostate cancer are not eligible Definition of Measurable Disease/Target Lesions Any lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques: 1) physical exam for clinically palpable lymph nodes and superficial skin lesions, 2) chest X-ray for clearly defined lung lesions surrounded by aerated lung OR those lesions measured as ≥ 10 mm with a spiral CT or MRI scan Measurable lesions (up to a maximum of 10 in number) representative of all organs involved to be identified as target lesions; the sum of the longest diameters (LD) for all target lesions will be calculated and reported as baseline sum LD If measurable disease is confined to a solitary lesion and is not consistent with prostate cancer, then its neoplastic nature must be confirmed by histology Ultrasound may not be used to measure tumor lesions that are not easily accessible clinically | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, Psoriasis + years of age Psoriasis vulgaris involving greater than 5% total body surface area No disease states or physical conditions which would impair evaluation of the test sites Willing and able to take test medications as directed in the protocol, make evaluation visits and follow protocol restrictions Failed systemic therapy for psoriasis (e.g., PUVA, retinoids, systemic steroids, methotrexate, etc.) Signed, written, witnessed informed consent form You must live within a reasonable driving distance of Ann Arbor, Michigan, and/or be able to attend all of the scheduled appointments during the study Use of any topical psoriasis treatment within weeks prior to the start of the study Use of any systemic medication within 4 weeks prior to the start of the study Involvement in an investigational study within the previous 4 weeks Inability to give informed consent History of drug dependency or alcoholism Severe infection within 4 weeks prior to study entry or the presence of chronic infection Significant psychiatric disorder Screening laboratory values which exceed the following limits Hematology WBC <3,500 cells/mm3, Hb <10.5g/dl, platelets <100,000 cells/mm3 | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 60.0-75.0, Healthy Volunteers Healthy men age 60 to 75 History of significant cardiac, renal, pulmonary, hepatic, benign prostatic hyperplasia, or malignant disease, current alcohol or illicit drug abuse, or major psychiatric disorders Current diagnoses of disorders known to affect bone metabolism including hyperthyroidism, hyperparathyroidism, osteomalacia, or Paget's disease Current use of medications known to affect bone metabolism including estrogens, androgens, anti-estrogens, bisphosphonates, calcitonin, fluoride, oral or inhaled glucocorticoids, suppressive doses of thyroxine, lithium, pharmacological doses of vitamin D (greater than 2000 IU/day), or anti-convulsants Cognitive or intellectual impairment that precludes complete understanding of the study protocol History of deep vein thrombosis, pulmonary embolism, or clotting disorders Serum 25-hydroxyvitamin D < 15 ng/mL Serum parathyroid hormone (PTH) < 10 or > 65 pg/mL Serum thyroid stimulating hormone (TSH) < 0.5 or > 5.0 U/L Serum calcium > 10.6 mg/dL Serum creatinine > 2 mg/dL | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 13.0-999.0, Alveolar Osteitis Dry Socket Infection Demographics: While all ages are eligible for study enrollment, as a practical matter, most patients having M3s removed are usually > 13-14 years of age Gender: Males and females will be offered to participate in this study Race: All races and ethnicities are eligible for study enrollment Clinical status: at least one impacted mandibular third molar ( M3 ) must be scheduled for extraction Anesthesia: Patient request that the procedure be executed using intravenous sedation or general anesthesia. Intravenous sedation will be accomplished with use of an IV placed in the antecubital fossa of each patient Health status: Healthy patients or patients with mild systemic disease, i.e. ASA status < 3, are eligible for study enrollment Pre-existing infection: Infection is characterised as having an area with frank purulence and/or cellulitis characterized by erythema, induration and inability to open the mouth wide enough to provide access to the airway Pre-existing Systemic Illness: as evidenced by severe dry mouth, patients who have undergone radiotherapy for oral cancer, patients that are immunocompromised, patients that require antibiotic prophylaxis for endocarditis, as well as, patients who are taking antimicrobials for other systemic diseases, i.e., uncontrolled diabetes., ASA status > 2 Allergic Reactions to Medications: Patients who are allergic to Penicillin and Clindamycin will be excluded from the study Anesthesia: Patient request that the operation be performed with local anesthesia without intravenous sedation or general anesthesia Pregnancy: Pregnancy is a relative contraindication for study enrollment. If after consultation with the obstetrician, there is no contraindication to removing the impacted teeth with sedation or contraindication to receiving the test medications (penicillin or clindamycin) and the patient wants to pursue treatment, she would be considered eligible for study enrollment | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 0.0-999.0, Pain male patients referred for extraction of third molars willing to undergo surgical extraction of all indicated third molars a minimum of one partial-bony impacted third molar, with a total difficulty score total of not less than 8 between the ages of 16 to 35 years (based upon eruption patterns and age-related complications associated with surgical extraction of third molars) in good general health ASA status 1 or 2 (healthy subjects based upon for safe outpatient conscious sedation) willing to undergo observation period for six hours postoperatively females current mental disorder or substance abuse allergy to aspirin, NSAIDs, or sulfonamide history of peptic ulcers and GI bleeding concurrent use of agents which may potentiate the sedative effect of study drugs, alcohol, opioids, benzodiazapines chronic use of medications confounding assessment of the inflammatory response or analgesia, antihistamines, NSAIDs, steroids, antidepressants presence of chronic debilitating disease (such as diabetes, rheumatoid arthritis, liver disease, etc.) presence of symptomatic tooth suggesting infection or inflammation excessive surgical difficulty encountered during the surgical procedure, resulting in a difficulty score of 5 for any tooth patients with acute narrow angle glaucoma, and open angle glaucoma who are not receiving therapy | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Multiple Myeloma History of histologically documented MM with relapsed or progressive disease after at least one line of prior therapy Patient has measurable disease in which to capture response, defined as one or more of the following Serum M-protein level > 1.0 gm/dl (10.0 g/L) measured by serum protein electrophoresis or immunoglobulin electrophoresis; or Urinary M-protein excretion > 1000 mg/24 hours; or Bone marrow plasmacytosis of > 30% by bone marrow aspirate and/or biopsy; or Serum free light chains (by the Freelite test) > 2 X the upper limit of normal, in the absence of renal failure Evidence of active disease by radiographic techniques Performance status (PS) of <= 2 as per Southwest Oncology Group scale, unless PS of 3-4 based solely on bone pain Patients must have a platelet count >= 50,000/mm3, and an absolute neutrophil count of at least 1,000/μl Patients must have adequate renal function defined as creatinine clearance > 30ml/min Chemotherapy or radiotherapy received within the previous 4 weeks Has received previous bortezomib therapy Significant neurotoxicity, defined as grade > 2 neurotoxicity per National Cancer Institute Common Toxicity Criteria Platelet count < 50,000/mm3, or ANC < 1,000/μl Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes syndrome Patient has hypersensitivity to bortezomib, boron, or mannitol Clinically significant hepatic dysfunction as noted by bilirubin or AST >3 times the upper normal limit or clinically significant concurrent hepatitis New York Hospital Association Class III or Class IV heart failure Myocardial infarction within the last 6 months Non-secretory multiple myeloma, unless the patient has measurable lesions on computed tomography, magnetic resonance imaging and/or positron emission tomography | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, Bone Diseases Patients with a benign bone lesion requiring surgical curettage Patients with infection, bone marrow disorders, or other contraindications to use of supplemental bone marrow aspiration as well as those who prefer autologous or allogeneic graft material alone (without synthetic filler) would be excluded | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, 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 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 15.0-999.0, Thyroid Diseases All patients with benign thyroid disease Unable to complete questionnaire: must be able to read and write Danish | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, Post-Menopausal Osteoporosis Post-Menopausal Osteopenia Postmenopausal: One year since the natural cessation of menses, or Hysterectomy with either postmenopausal status confirmed by FSH lab values, or age 55 and above AND 2. Osteopenic: T-score at baseline has to be between (and including) -1.0 and -2.0 in the lumbar spine (L1-L4), total hip or femoral neck, and the lowest reading of the above three measurements must be between -1.0 and -2.0 Women ever having had a fragility fracture after age 40; 2. Women currently on anticoagulants, previously on anticoagulants in the past 3 months, or expected to be on anticoagulants in the near future; 3. Women on hormone replacement therapy, raloxifene, bisphosphonates or calcitonin during the past 3 months; 4. Women who have ever been on a bisphosphonate for more than 6 months; 5. Women previously diagnosed with Paget's disease, hyperparathyroidism, hyperthyroidism or other metabolic bone diseases; 6. Women with decompensated diseases of the liver, kidney, pancreas, lung, or heart; 7. Women with a history of active cancer in the past 5 years; 8. Women taking mega-doses of vitamin A (more than 10,000 iu per day) or E (more than 400 iu per day); 9. Women involved in other clinical trials; 10. Any women who, in the opinion of the principal investigator, is at poor medical or psychiatric risk for the study | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 12.0-80.0, Bone Cancer Patients twelve years or older who are scheduled for massive fresh-frozen human structural bone allograft implantation at participating centers will be given the opportunity to participate in the study. All patients must have a reconstruction of the involved long bone with either an intercalary graft, an osteoarticular graft, or an allograft/endoprosthesis composite graft. The junction or union site studied will be the cortical-cortical, host allograft junction site, not the cancellous interfaces Patients who do not require major weight bearing cortical allograft bone grafts will be excluded. Also, women who are or could potentially become pregnant will be excluded from the study | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 50.0-75.0, Osteoporosis Post-menopausal women aged 50-75 years at Visit 1 (at least 5 years post cessation of menses, or FSH>20 IU/L, serum estradiol <110 pmol/L) Vertebral bone mineral density at least 2.5 S.D. below the mean of young normals. Patients must have at least 2 measurable contiguous vertebral bodies in the lumbar region, L1-L4 Ability to self administer injections Ability and willingness to give informed consent Evidence of 5 or more vertebral fractures Evidence of 2 or more vertebral fractures in the region L1-L4 Presence of significant cardiac disease as determined by history, physical examination and laboratory screens e.g. cardiac dysrhythmias Presence of significant hepatic, renal, pulmonary, gastrointestinal, hematological, endocrine, immunologic, neurological or psychiatric disease as determined by history, physical examination and laboratory screens. Specifically excluded are diseases known to contribute to osteoporosis: hyperparathyroidism, hyperthyroidism, glucocorticoid excess, hyper or hypocalcemia, Paget's disease, osteogenesis imperfecta, osteomalacia and severe scoliosis Evidence of lumbar fusions, osteophytes or excessive degenerative disease which precludes reasonable DXA measurement History or presence of cancer within the previous 5 years except for superficial basal cell and squamous cell carcinomas of the skin Treatment with any of the following therapies Any form of Estrogen within previous 6 months Prior use of Etidronate for more that 2 treatment cycles (2weeks/cycle) and/or any use within prior 6 months Any other bisphosphonate | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-70.0, Cervicogenic Headache Headache strictly unilateral without side-shift Traits indicating involvement of neck structures, fulfilling at least 2 of the following: I. Reduced neck range of motion II. Typical headache can be elicited by palpation or pressure on muscles of the occiput or in the neck. III. Typical headache can be precipitated by certain neck movements or by adopting a certain position of the head. IV. There is a radiation of pain to the ipsilateral shoulder or arm Positive effect of blockades. (In this study only a blockade of the greater occipital nerve will be applied) The condition has lasted for more than 1 year The headache should be present more than 15 days a month, and the frequency should be based on a headache diary filled in the last month before inclusion Cervical spinal stenosis, cervical disc herniation, or other neck pathology that should be treated surgically Malignant disorder Rheumatic disorder or other disorders which induces analgesic use other clinically relevant disease (liver, kidney, endocrinological, metabolical, systemic, psychiatric) Frequent other headache type that cannot be distinguished from cervicogenic headache Pending or ongoing litigation for head or neck trauma | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-75.0, Pain chronic shoulder pain and disability 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): 55.0-85.0, Osteoporosis Ambulatory postmenopausal women with established osteoporosis, based on the disease diagnostic 2. Presence of more than 1 clinical and/or radiological vertebral fractures OR more than 1 non-vertebral fracture 3. Presence of hip fracture with hip replacement surgical procedure (both uncemented or cemented total hip arthroplastics or endoprosthesis) in the 3-6 months before screening phase 4. Age range 55-85 years 5. Normal or clinically insignificant abnormal laboratory values (as determined by the investigator) including serum calcium, PTH(1 84), and 25 hydroxyvitamin D concentrations, and alkaline phosphatase activity History of diseases which affect bone metabolism, other than primary postmenopausal osteoporosis, such as Paget's disease, renal osteodystrophy, osteomalacia, any secondary causes of osteoporosis (included glucocorticoid-induced osteoporosis), hypoparathyroidism, hyperparathyroidism, hyperthyroidism 2. Actual cancer disease or history of malignant neoplasms in the 5 years prior to Visit 2, with the exception of superficial basal cell or squamous cell carcinomas of the skin that have been definitively treated. Subjects with carcinoma in situ of the uterine cervix treated definitively more than 1 year prior to entry into the study may be enrolled. 3. Increased baseline risk of osteosarcoma: Paget's disease of the bone or unexplained elevations of alkaline phosphatase; Prior radiation therapy involving the skeleton 4. Significantly impaired renal function 5. Significantly impaired hepatic function | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, Painful Joint Prostheses Patients selected for entry into this study will be men or women of any ethnic background who are scheduled to undergo clinical and diagnostic evaluation by a member of the Department of Orthopedic Surgery at the Hospital of the University of Pennsylvania Health System or by the collaborating physicians at the Rothman Institute or the VA Philadelphia Medical Center. Study I: FDG-PET imaging in painful partial or total joint prostheses Each patient who is a candidate will be evaluated by one of the collaborators mentioned above for a painful partial or total joint prosthesis. The patient will undergo an appropriate routine evaluation including history, physical examination, radiographic, scintigraphic, and necessary laboratory evaluation. An initial diagnosis must be made for each patient. The diagnosis of loosening will be established based on clinical examination and/or radiographic evaluation demonstrating clear evidence of this complication. Other etiologies for the joint pain, except for infection and aseptic loosening, need to be excluded. Surgical intervention (prosthesis revision) may or may not be planned for the patient who is a candidate for this study. Study II: FDG-PET imaging following uncomplicated partial or total joint arthroplasty All patients fulfilling the below will be considered potential candidates for this study. Each patient must have a diagnosis of degenerative joint disease caused by osteoarthritis (no previous hip surgery) and have undergone primary partial or total joint arthroplasty by a member of the Department of Orthopedic Surgery at the Hospital of the University of Pennsylvania or referring hospitals. Other causes of degenerative joint disease will be excluded by physical, radiographic and laboratory evaluation as clinically indicated. Osteoarthritis is the most common cause of degenerative joint disease, and in order to avoid any confounding factors in experimental results that may be caused by other types of disorders, only this group of patients will be studied. A patient will be eliminated from this group at anytime if the post-operative course is complicated by any process that is thought to influence the outcome. Variations from an uncomplicated postoperative course will be determined by the operating surgeon and clinical signs or other evidence to suggest infection, early loosening, or any other process directly involving the prosthesis Patients with other etiologies for pain, other than for infection and aseptic loosening, will be excluded from enrollment into 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): 13.0-999.0, Mild to Moderate Uncomplicated Skin and Skin Structure Infections Ambulatory male or female subjects > 13 years old A female subject must be non-lactating and at no risk for pregnancy Diagnosis of USSSI with 2 or more of the following local signs and symptoms Pain/tenderness Swelling Erythema Localized warmth Purulent drainage/discharge Induration Regional lymph node swelling or tenderness Medical history of hypersensitivity or allergic reaction to penicillin and/or cephalosporin (including cefdinir and cephalexin) antibiotics according to the judgment of the Investigator Subject with a complicated skin and skin structure infection as judged by the investigator A chronic or underlying skin condition at the site of infection (e.g., a secondary infected atopic dermatitis or eczema) or infections involving prosthetic materials (e.g., catheter tunnel infections, orthopedic hardware) A wound secondary to burn injury or acne vulgaris Any infection site that requires intraoperative surgical debridement excision of infected lesions or body parts Infections that can be treated by surgical incision alone according to the judgment of the Investigator Any other infection that necessitates the use of additional concomitant oral or parenteral antibiotic therapy Known significant renal or hepatic impairment indicated by | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 45.0-90.0, Postmenopausal Osteoporosis Ambulatory, postmenopausal women aged 45 to 90 years inclusive at the time of entry into the trial, whose last menstrual period or bilateral oophorectomy occurred at least 5 years prior to entry into the trial. Women below the age of 55 years in whom a bilateral oophorectomy cannot clearly be documented must have their postmenopausal status confirmed by a serum FSH level greater or equal to 30 IU/L and serum estradiol level lower or equal to 20 pg/ml or lower or equal to 73 pmol/L. 2. Free of severe or chronically disabling conditions other than osteoporosis. 3. Able to use a pen-type injection delivery system satisfactorily in the opinion of the investigator and willing to be trained on and use the pen-injector on a daily basis. 4. Without language barrier, cooperative, expected to return for all follow-up procedures, and have given informed consent after being informed of the risks, medications, and procedures to be used in the study. 5. Posterior-anterior lumbar spine (L-1 through L-4) BMD and/or femoral neck BMD and/or total hip BMD measurement at least 2.5 standard deviations (SD) below the average bone mass for young women (T-score below or equal to -2.5 standard deviations). The lumbar spine and hip BMD assessment and the determination of the patient's for entry into the screening phase will be made by the individual investigator. Any lumbar vertebra that cannot be analyzed due to artifacts, severe crush fracture, osteophytes, or other abnormalities, should be excluded from the analysis. A minimum of two lumbar vertebrae in the L-1 through L-4 region must be evaluable by DXA if this is the only anatomical site where the BMD cut-off level less than -2.5 SD is demonstrated. A DXA assessment performed within three months prior to Visit 1 may be acceptable for patient's eligibility. 6. Normal or clinically insignificant abnormal laboratory values (as defined by the investigator) including serum calcium, PTH(1 84), alkaline phosphatase History of unresolved skeletal diseases that affect bone metabolism other than postmenopausal osteoporosis including Paget's disease, renal osteodystrophy, osteomalacia, any secondary causes of osteoporosis, hyperparathyroidism (uncorrected), and intestinal malabsorption. 8. In the opinion of the investigator, have any medical or anatomical condition that potentially could put the patient at additional risk of an adverse event due to the biopsy procedure (for example, coagulation abnormality, anticoagulant medication, extreme obesity, etc). 9. Have undergone two previous iliac bone biopsies (one in each iliac crest). Patients with one previous iliac bone biopsy are eligible provided that the new sample is obtained from the contralateral iliac crest. 10. History of malignant neoplasms in the 5 years prior to Visit 1, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. Patients with carcinoma in situ of the uterine cervix treated definitively more than 1 year prior to entry into the study may be randomized. 11. Increased baseline risk of osteosarcoma; this includes subjects with Paget's disease of the bone, previous primary skeletal malignancy, or skeletal exposure to therapeutic irradiation, i.e. prior external beam or implant radiation therapy. As an elevation of serum skeletal alkaline phosphatase activity may indicate the presence of Paget's disease, an unexplained elevation of this enzyme activity will also be exclusionary. 12. Abnormal thyroid function not corrected by therapy. Normal thyroid function may be documented by a normal TSH during the screening phase or a combination of clinical and biochemical parameters which, in the judgment of the investigator and the Lilly Clinical Research Physician, sufficiently establishes the presence of normal thyroid function. 13. Active liver disease or clinical jaundice. 14. Significantly impaired renal function as defined by either of the following Serum creatinine that, in the opinion of the investigator, indicates significant renal impairment Measured or calculated endogenous creatinine clearance less than 30 mL/min using the following Cockcroft Gault formula for creatinine clearance (ClCr) for women: ClCr (mL/minute) = [[(140-age) x weight (kg)]x0.85] / [72 x serum Cr (mg/dL)] 15. Current or past treatment with any bisphosphonate, parathyroid hormone or its analogs, androgens or other anabolic steroids or therapeutic doses of fluorides at any time prior to Visit 2. Past treatment (more than 12 months before Visit 2) with a selective estrogen receptor modulator (SERM), nasal or injectable calcitonin, oral, transdermal, or injectable estrogens, progestins, estrogen analogs, estrogen agonists, estrogen antagonists or tibolone is allowed. Previous or current use of fluoridated water or topical dental fluoride treatments are permitted. 16. Treatment with Vitamin D greater than 50,000 IU/week, or with any dose of calcitriol or Vitamin D analogs or agonists in the 6 months prior to Visit 2. 17. Treatment with systemic corticosteroids in the last month prior to Visit 2 or for more than 14 days in the 1 year prior to Visit 2. Ophthalmic, otic, topical, orally inhaled, nasally inhaled, or intra-articular corticosteroid therapy may be used without these restrictions. However, orally inhaled or nasally inhaled corticosteroids in doses greater than 840 micrograms/day beclomethasone dipropionate or equivalent for more than 14 days in the last year prior to randomization will be disqualifying | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 21.0-999.0, Hot Flashes men > or =21 with prostate CA and hypogonadism for at least 3 months on growth promoting agents on appetite stimulating agents on Prednisone and others | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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 Men >18 years of age. No upper age limit 2. Written informed consent approved by institutional review board should be explained to and signed by patient 3. Documentation of histologically confirmed adenocarcinoma of the prostate. Gleason score of any sum is allowed on this study. 4. Metastatic disease as evidenced by visceral involvement, bone disease, or PSA elevation. 5. Patients should meet the of androgen independent prostate cancer (AIPC). Patients would fulfill these if they continue to progress despite complete androgen blockade (surgical or medical castration with anti-androgen) and despite an anti-androgen withdrawal trial. Failing anti-androgen withdrawal is defined as no decline by 25% or more 3-weeks after stopping anti-androgens. Progression on hormonal therapy is defined as ANY of the following PSA: 2 consecutive rising PSA values, at least 14-days apart, each being > 5 ng/ml For patients with visceral measurable disease, progression is defined as an increase by 50% or more in the size of measurable areas, or any development of new lesions For patients with bone-only disease, progression is defined as the appearance of 2 or more new areas of abnormal uptake on a bone scan, when compared to prior imaging studies. Changes in the uptake of already existing lesions will NOT be used to define progressive disease For patients with bone AND visceral disease, fulfilling any of the in 5.2 or 5.3 is sufficient to define progression. 6. Castration levels of testosterone (< 50 ng/dl) achieved via medical or surgical castration. Patients should continue on LHRH agonists throughout if this is the method used to achieve castration. 7. Life expectancy of at least 6 months 8. Adequate hematologic, renal, and liver function as evidenced by the following WBC > 2000 ANC > 1000 Platelet count > 100,000 HgB > 9.0 g/dl, Creatinine < 2 Total bilirubin < 2x upper limit of normal presence of brain metastases 2. Known HIV+ status 3. ECOG performance status of 2 or higher 4. Use of investigational agents within 4 weeks of starting 5. Patients with prior exposure to more than one chemotherapy program Patients who have received one chemotherapy schedule can be enrolled on study and receive GM-CSF (the maintenance arm) if their last chemotherapy was taxotere, given within the past 12 weeks, and they have demonstrated NO evidence of progression radiographically and biochemically. Prior exposure to steroids is NOT an 6. Patients with other active malignancies (excluding non-melanoma skin cancers)are excluded. Prior malignancies are not as long as last treatment for such malignancies was over 5 years prior to enrollment. 7. Treatment with investigational products are NOT an if therapy was last received over 4 weeks prior to enrollment. 8. Any medical intervention or other condition which, in the opinion of the principle investigator, could compromise adherence with study requirements | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 20.0-80.0, Lesions of the Liver Patients with a tumorous lesion in the liver observed in diagnostic imaging such as ultrasonography, etc., conducted between 1 and 35 days before administration of the investigational agent, who are scheduled to undergo a dynamic CT examination. 2. Patients between 20 and 80 years old at the time informed consent is obtained. 3. Patients weighing >= 55.6 and < 105.0 kg at the time consent is obtained and when the investigational agent is administered Issues affecting the safety evaluation of the investigational agent: 1. Patients who will have undergone or are scheduled to undergo an examination using another contrast agent from 7 days before administration of the investigational agent up to the time follow-up examinations are performed on day 8 after administration. 2. Patients for whom there is a strong possibility that a follow-up period, which extends up until examinations are performed on day 8 after administration, would not be possible, (i.e., when it will not be possible to evaluate delayed adverse drug reactions). 3. Patients who have undergone or are scheduled to undergo surgical treatment or a therapy such as percutaneous ethanol injection therapy, percutaneous microwave coagulation therapy, radiofrequency ablation, or transcatheter arterial embolization, etc., from the time diagnostic imaging such as abdominal ultrasonography is performed up until follow-up examinations are conducted on day 8 after administration. 4. Patients who are unable to discontinue taking analgesics during the period from the morning when the investigational agent is administered until CT examinations are completed. 5. Patients who cannot stop taking biguanide antidiabetic drugs, such as metformin hydrochloride and buformin hydrochloride, for three days after study agent administration (including administration day). 6. Patients who are currently participating in another clinical study. 7. Patients who participated in another clinical study within the 6 months prior to providing informed consent to participate in this study. General concerns relating to the safety of the subject: 1. Patients in the acute stage of illness with unstable symptoms, or patients in a life-threatening condition (when it is expected that emergency treatment may be required between the time of registration and the conclusion of the follow-up period, or when the patient is not expected to survive for 3 months following administration of the investigational agent, etc.) 2. Patients with a history of hypersensitivity to iodine or iodinated contrast agents. 3. Patients with serious thyroid disease (goiter, hyperthyroidism, etc.) 4. Patients with serious cardiopathy (New York Heart Association [NYHA] functional class IV heart failure, shock, cyanosis, peripheral circulatory insufficiency, ventricular tachycardia, ventricular fibrillation, or complete atrioventricular block) 5. Patients with serious hepatopathy [symptoms of liver failure (fulminant hepatitis) such as a disturbance of consciousness corresponding to grade 3 in the for Grading Adverse Drug Reactions of Medicinal Products.] 6. Patients with moderate serious nephropathy (acute kidney failure, chronic kidney failure, hydronephrosis, nephrotic syndrome, or uremia with serum creatinine levels of 2.0 mg/dL or more, corresponding to grade 2 or above in the for Grading Adverse Drug Reactions of Medicinal Products.) 7. Patients with bronchial asthma 8. Patients with acute pancreatitis 9. Patients with macroglobulinemia 10. Patients with multiple myeloma 11. Patients with tetany 12. Patients with pheochromocytoma or who are suspected of having pheochromocytoma 13. Pregnant and potentially pregnant women, and nursing mothers 14. Patients with a history of medicine hypersensitivity 15. Patients with serious myasthenia gravis 16. Patients judged by an investigator for any other reason to be ineligible for participation as a subject in this study | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Breast Cancer Women > 18 years of age with histologically or cytologically confirmed stage I, II or III breast cancer. 2. If adjuvant chemotherapy is recommended, it must be completed before study start. 3. Bone marrow aspirate positive by IC/FC assay a. Definition of positive: > 4 MM/ml b. Timing of bone marrow aspiration to determine study i. If patient is to receive either no adjuvant therapy or hormonal therapy alone, the aspiration may be performed at diagnosis as part of the large MM study at University of California, San Francisco, or following diagnosis if the patient received initial surgery elsewhere. This is also true for patients who have surgery following neoadjuvant therapy for breast cancer. ii. If the patient is to receive adjuvant chemotherapy, the aspiration will be performed at least three weeks after chemotherapy has been completed. 4. Adequate renal function as defined by: a. Creatinine must be < upper limit of normal 5. Normal liver function tests including total bilirubin, alkaline phosphatase, and aspartate aminotransferase (AST) / serum glutamic-oxaloacetic transaminase (SGOT) 6. Ability to understand and sign informed consent. 7. Concomitant hormonal therapy is allowed 8. Concomitant radiation therapy is allowed 9. Patients who have had surgery following neoadjuvant chemotherapy or hormonal therapy are eligible to participate in this trial History of allergy to bisphosphonates. Acute phase reactions occur in up to 24% of patients and disappear with subsequent dosing. An acute phase reaction does not qualify as an allergic reaction. 2. History of renal insufficiency. Renal insufficiency is defined by a serum creatinine greater than the upper limit of normal or a creatinine clearance < 50 mL/min due to any underlying cause. 3. Karnofsky Performance status < 90%. 4. Any significant medical condition that might interfere with treatment. 5. Women participating in this study are not allowed to receive other bisphosphonate therapy during the study period, either oral or intravenous. 6. Patients who are pregnant | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 0.0-999.0, Paget's Disease of Bone Patients with a monostotic form of PDB (as attested by plain X-rays and 99mTc MDP bone scintigraphy) Bone pain linked to Paget's disease itself Bisphosphonate therapy within the year prior to the study | 2 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 40.0-70.0, Breast Cancer Osteoporosis Diagnosis of ductal carcinoma in situ within the past 6 months Locally excised with tumor-free margins at least 1 mm Currently enrolled in protocol CRUK-IBIS-II-DCIS AND randomized to receive either anastrozole or placebo No T-score < -4.0 and/or > 2 low trauma vertebral fractures by dual-energy x-ray absorptiometry (DXA) Hormone receptor status: Estrogen or progesterone receptor positive tumor Female patient Postmenopausal No prior bilateral hip fracture or bilateral hip prostheses No concurrent metabolic bone disease, including any of the following Paget's disease | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Osteoporosis Prostate Cancer Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of the prostate within 12 months of registration Any one of the following clinical stages T3 disease, any N stage, M0 with any Gleason score and any prostate-specific antigen (PSA); < T3 stage, any N stage, M0 with Gleason's score ≥ 8 and any PSA; < T3 stage, any N stage, M0 with Gleason's score 7 and PSA ≥ 15 nanograms/ml; < T3 stage, any N stage, M0 with Gleason score < 7 and PSA ≥ 20 nanograms/ml A negative bone scan for metastatic disease It is mandatory that the treating physician determine the planned duration of LHRH therapy prior to the site registering the patient (minimum 1 year of therapy); If patient is receiving pre-treatment LHRH therapy, it must have begun ≤ 6 months prior to registration. If pelvic radiation therapy (RT) has started, it must have begun ≤ 8 weeks prior to registration Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup to be done within 16 weeks prior to registration History/physical examination Dental evaluation, including history of dental surgery (e.g., extraction or implant) Bone scan T and L spine films Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; e.g., carcinoma in situ of the breast or oral cavity are permissible Patients with baseline T scores of ≤ -2.5 are excluded Patients with baseline calculated creatinine clearance < 30 mL/min (estimated by Cockcroft-Gault formula below) are excluded. creatinine clearance male = [(140 age) x (wt in kg)] / [(serum creatinine) x (72)] Prior bisphosphonate therapy Prior pelvic radiation (other than for current prostate cancer) or prior systemic radiotherapeutic agents, such as strontium or samarium Patients receiving systemic chemotherapy, steroids, growth hormones, or calcitonin Patients with a history of Paget's disease or with uncontrolled thyroid or parathyroid dysfunction or with other diseases that influence bone metabolism Known hypersensitivity to zoledronic acid or other bisphosphonates Active dental problems at study entry, including infection of the teeth or jawbone; dental or fixture trauma; or a current or prior diagnosis of osteonecrosis of the jaw, exposed bone in the mouth, or slow healing after dental procedures | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Prostate Cancer Breast Cancer Bone Metastasis Prostate cancer with at least one cancer-related bone lesion with or without hormonal treatment Breast cancer with at least one cancer-related bone lesion Negative pregnancy test at screening in case of child-bearing potential and Performance status ECOG 0-2 Normal liver and kidney function Prior surgery, chemotherapy and radiotherapy is allowed. At least 4 weeks must have elapsed since the completion of surgery, chemotherapy and radiotherapy to breast or bone Prior treatment with bisphosphonates within 6 months before study start, and during treatment with zoledronic acid. Known hypersensitivity to zoledronic acid or other bisphosphonates. Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L) or ≥12.0mg/dl (3.00 mmol/L) Current/active dental problems including infection of the teeth or jawbone dental or fixture trauma current or previous osteonecrosis of the jaw exposed bone in the mouth slow healing after dental procedures recent (within 6 weeks) or planned dental or jaw surgery (extraction, implants) Patients with clinically symptomatic brain metastases. Severe physical or psychological concomitant diseases expected to impair compliance with the provisions of the study protocol or impair the assessment of drug of patient safety Clinically significant ascites, NYHA III or IV, cardiac failure, clinically relevant pathologic findings in ECG | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, Immunosuppression ALL patients will be adult liver transplant recipients, males or females, 18-80 years of age Patients currently receiving tacrolimus or cyclosporine with or without corticosteroids as part of their immunosuppressive regimen Patients must be receiving CellCept and must have attributable G.I. symptoms (nausea, vomiting, diarrhea, abdominal discomfort/pain, dyspepsia) Patients must be more than 30 days post-transplant to be eligible Females of childbearing potential must have a negative serum pregnancy test prior to the period Multi-organ transplant patients HIV positive patients Living-related liver transplant recipients Pregnant patients Patients with a history of extra-hepatic malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin Patients with thrombocytopenia (<50,000/mm3), with an absolute neutrophil count of <1,000/mm3 and/or leukocytopenia (<2,000/mm3), and/or hemoglobin <7.0 g/dL prior to enrollment Patients with a G.I. clinical problem at the time of enrollment (e.g. CMV infection or disease, C. difficile colitis, active peptic ulcer disease, gastroenteritis, inflammatory bowel disease) Presence of clinically significant infection requiring continued therapy or uncontrolled diabetes mellitus Evidence of drug and/or alcohol abuse Decisionally impaired subjects who are not medically or mentally capable of providing consent themselves | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, Thoracotomy Pain undergoing major elective thoracotomy through a classic incision, including segmentectomy, lobectomy, or wedge resection, 2) for women, a negative mammogram within the past year; 3) for women using oral contraceptives or hormone replacement therapy, the agreement to hold steady dosing of these medications for the duration of the study; and 4) ability to comprehend the consent information and to complete all study assessments age less than 18 years, 2) current alcohol or substance abuse/dependence; 3) delirium, dementia, or cognitive impairment (MMSE < 24; (23)); 4) use of analgesics (other than aspirin or non-steroidal anti-inflammatories) for a condition other than the reason for surgery; 5) milk or soy allergy; 6) lactose intolerance; 7) pre-operative chest pain; 8) women with a history of breast cancer; or 9) [use of an antibiotic within 3 months prior to surgery | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, Sarcoma Malignant Gastrointestinal Stromal Tumor 1.1 Patients must have a histologically confirmed diagnosis of (1) locally advanced unresectable or metastatic soft tissue sarcoma; or (2) unresectable/metastatic GIST previously treated with imatinib mesylate and is documented to have drug resistance to imatinib mesylate treatment defined by tumor progression. 5.1.2 Age greater than or equal to 18 years and younger than or equal to 70 years old. 5.1.3 Measurable disease: defined as lesions that can be measured in at least one dimension by physical examination or medical imaging techniques. Ascites, pleural effusions, and bone marrow disease will not considered measurable disease. 5.1.4 Patients must have an ECOG performance status of less than or equal to 2. 5.1.5 Patients must have recovered (defined as toxicity less than grade 2) from toxic effects of all prior therapy before entering onto study. 5.1.6 A treatment of drug free interval of at least 4 weeks since the last dose of chemotherapy or imatinib mesylate therapy is required. 5.1.7 More than 4 weeks since prior radiotherapy is required. 5.1.8 Adequate bone marrow function with an ANC greater than or equal to 1,500/ml, platelet count greater than or equal to 100,000/ ml (transfusion independent) and hemoglobin greater than or equal to 8.0 g/dl (transfusions permitted). 5.1.9 Patients must have adequate renal function with serum creatinine less than or equal to 1.5 mg/dl. 5.1.10 Patients must have adequate liver function, defined as bilirubin within 1.5 times the upper limit of normal, and liver transaminases within 2.5 times the upper limit of normal. 5.1.11 All patients must sign a document of informed consent indicating their awareness of the investigational nature and the risks of the study 2.1 Patients who have prior treatment with gemcitabine or taxane. 5.2.2 Pregnant or breast feeding females. 5.2.3 Active or uncontrolled infection. 5.2.4 Patients with brain or leptomeningeal 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, Breast Cancer With Bone Metastasis Confirmed diagnosis of Breast Cancer with at least one breast cancer-related bone lesion No treatment with bisphosphonates within 6 months prior to into the study Good health status (ECOG Performance status 0-2) Patients who do not have at least one breast cancer-related bone lesion that is detectable on conventional radiographs of bone (plain film) at screening Abnormal renal function History of diseases with influence on bone metabolism such as Paget's disease and primary hyperparathyroidism Pregnancy and lactation Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures, recent (within 6 weeks) or planned dental or jaw surgery (e.g..extraction, implants) | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, Cancer Metastasis Pain The patient must be 18 years of age or older The patient must have histologically proven malignancy in the primary site (breast, prostate, or lung) The patient must have a radiographic evidence of bone metastasis, and this must have been performed within 8 weeks prior to enrollment in the study. Acceptable studies plain radiographs, radionuclide bone scans, computed tomography scans, magnetic resonance imaging, and PET-CT scans The patient must have an intact anterior wall of spinal canal The patient must have significant pain (score 6 or above,)which appears to be related to the radiographically documented metastatic vertebra(e) in concern, as measured by the "Visual Analog Scale" The patient must be surgically and medically accepted for vertebroplasty/kyphoplasty operation Karnofsky Performance status >40 Expected life expectancy of 6 months or greater, as estimated by the physician in charge The patient must sign a study specific informed consent prior to enrollment Epidural soft tissue component Patients with vertebral metastases and with clinical or radiographic evidence of spinal cord or cauda equina impingement (effacement) or compression Inability to undergo anesthesia Hematologic primary malignancies Patients received systemic radiotherapy (89SR or 153SM)within 30 days prior to enrollmen | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 0.0-0.096, Vitamin D Deficiency Healthy singleton term born infants of appropriate size for gestational age (AGA) according to the Centers for Disease Control growth charts based on weight at birth between the 5th and 95th percentiles for sex; and born to healthy breastfeeding women. This allows us to assess growth and bone mineral accretion without bias of intrauterine growth restriction Infants of mothers with history of gestational diabetes or hypertension in pregnancy; chronic alcohol use; malabsorption syndromes due to malabsorption of vitamin D (celiac disease, Crohn's etc.); and multiple births Should any be identified after recruitment, the infant will be excluded from the main analyzes, but followed in a separate arm as intent-to-treat | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, Migraine for migraine subjects Age: 18 years, inclusive Gender: male or female Diagnosis: Episodic migraine with or without aura, as defined by the International Headache Society (IHS), for at least 6 months prior to enrollment An average of ≥1 migraine attack per month over the 6-month period prior to enrollment An average of <15 headache (of any type) days per month for the 6 months prior to enrollment Normal audiogram. (A hearing threshold of 20 dB or less at the frequency range of 200-8000Hz.). for control subjects Age: 18 years, inclusive for migraine subjects Any other headache diagnosis (e.g. cluster headache, hemicrania continua, post traumatic headache, etc.) except for episodic tension type headache (ETTH) with an average of no more than 10 ETTH headache days per month for the 6 months prior to enrollment (note: average <15 total HA days is specified in inclusion) Use of any headache preventive drug (determined by investigator) in the 90 days prior to screening Treatment with botulinum toxin (for any indication) within the 90 day period prior to enrollment Treatment with occipital nerve block or block, or block of any other nerve in the head or neck area, within the 30 day period prior to enrollment Any dermatological disease that may affect skin sensation Any neurological disease that may affect sensory functions (e.g stroke, multiple sclerosis, peripheral neuropathy) Cognitive disturbance that may affect the subject's ability to understand the study procedure Significant psychiatric disturbance that may impair the subject from co-operating with the study procedures Use of acute pain medications on a daily or frequent pattern (for any indication) as defined by the IHS | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Pain Intractable Pain Chronic Pain Have chronic and intractable neuropathic pain of the trunk and/or limbs of moderate to severe intensity and have failed treatment with an intraspinal infusion pump or other SCS device. Determination of failure of treatment will be based on subject feedback. Subjects with an active intraspinal infusion pump but with inadequate pain control will be allowed to participate Be 18 years of age or older Be an appropriate candidate for the surgical procedures required for this study Be willing and able to comply with all study related procedures and visits Be capable of reading and understanding patient information materials and giving written informed consent Have failed immediate past treatment with an intraspinal infusion pump or other SCS device because of technical reasons associated with the device such as unresolved lead migration, battery depletion, etc Have any evidence of neurologic instability requiring surgery Have any significant medical condition that in the opinion of the investigator may interfere with the conduct of the study or may adversely affect the subject's safety during the study Have any other active implantable device with the exception of a intraspinal infusion pump for pain medications Are pregnant or lactating or planning to become pregnant in the next year Have participated in any investigational drug or device trial in the last 4 weeks or plan to participate in any other investigational drug or device trial while on this study | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Prostate Cancer Patients with histologically confirmed diagnosis of prostate cancer who have not yet developed bone metastases Prostate cancer patients with a rise in PSA under hormone therapy. PSA Patients who have undergone prostatectomy: any rise in PSA or Patients without prostatectomy: 2 consecutive rises in PSA levels relative to a previous reference value, separated by one month. The first measurement must occur one month after the reference value and must be above the reference value. The second confirmatory measurement taken one month after the first measurement must be greater than the first measurement Previous chemotherapy or radiotherapy must have been performed ≥ 8 weeks prior to study entry Eastern Cooperative Oncology Group (ECOG) score of 0, 1 or 2 (patients that spend less than 50% of time in bed during the day) Adequate liver function serum total bilirubin concentration less than 1.5 x upper limit of normal value Age: ≥ 18 years Patient has given written informed consent prior to any study-specific procedures. Patients with psychiatric or addictive disorders which prevent them from giving their informed consent must not enter the study Prior treatment with a bisphosphonate Abnormal renal function as evidenced by a calculated creatinine clearance < 30 ml/minute Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L) or ≥ 12.0 mg/dl (3.00 mmol/L) Patients with clinically symptomatic brain metastases History of diseases with influence on bone metabolism such as Paget's disease and primary hyperparathyroidism Severe physical or psychological concomitant diseases that might impair compliance with the provisions of the study protocol or that might impair the assessment of drug or patient safety, e.g. clinically significant ascites, cardiac failure, NYHA III or IV, clinically relevant pathologic findings in ECG Known hypersensitivity to zoledronic acid or other bisphosphonates Use of other investigational drugs 30 days prior to the date of randomization Known history or present abuse of alcohol or drugs Subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-65.0, Systemic Lupus Erythematosus Eligible women will be those having any two of the following 1. Amenorrhea of 6 months or more. 2. Serum follicle-stimulating hormone level of 30 IU/L or more. 3. Menopausal symptoms. 4. Age 48 years or older Women older than 65 years. 2. Severe lupus activity at baseline (SLEDAI score, more than 30). 3. Use of estrogens within 3 months of the screening visit. 4. Serum creatinine of 2.0 mg/dL or more. 5. Hypertriglyceridemia 500 mg/dL or more. 6. Metabolic bone diseases. 7. Liver disease. 8. Untreated hyperthyroidism. 9. Recent thrombosis. 10. Malignancy. 11. Endometrial hyperplasia. 12. Undiagnosed uterine bleeding or cervical dysplasia | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-120.0, Metastatic Cancer Prostate Cancer Diagnosis of prostate cancer, meeting 1 of the following Metastatic hormone-sensitive disease prior to initiation of first-line androgen-deprivation therapy and meets the following Histologic confirmation of original diagnosis Hormone-sensitive is defined as progressive disease in the absence of androgen-deprivation therapy Presence of ≥ 3 convincing bone metastases, as defined by bone scintigraphy, CT scan (MRI if indicated), or plain x-ray Metastatic hormone-refractory disease prior to initiation of a first-line chemotherapy regimen that includes docetaxel and meets the following Histologic confirmation of original diagnosis Hormone-refractory is defined as development or advancement of metastatic disease with castrate testosterone levels (total testosterone < 20 ng/dL) Presence of ≥ 3 convincing bone metastases, as defined by bone scintigraphy, CT scan (MRI if indicated), or plain x-ray Must have castrate testosterone levels (< 20 ng/dL) from orchiectomy or undergoing maintenance with a luteinizing hormone-releasing hormone agonist | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, Rosacea Diagnosis of facial rosacea made or confirmed by one of the investigators Severity of signs of rosacea "greater than mild" at the time of enrollment Treatment for rosacea during the 3 months prior to enrollment Use of zinc dietary supplement > 25 mg per day during the 3 months prior to enrollment ( Most patients taking multivitamins with Zinc, often 15 mg per day, will not be excluded, whereas most patients taking additional Zinc supplements, often 25-50 mg per day or more will be excluded.) Diagnosis of rosacea fulminancy Pregnant or breast feeding | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-70.0, Hypoparathyroidism DiGeorge Syndrome Age at screening: 1. Premenopausal women: aged 18 to 45 years, 2. Postmenopausal women: aged greater than or equal to 53 years to 70 years and 5 years since last menses. For women without a uterus, subjects must have a clinical history of menopause for at least 5 years and an FSH greater than 30 U/L. 3. Men: aged 18 to 70 years, 2. Physician-diagnosed hypoparathyroidism of at least 1-year duration, confirmed by medical record review. The investigators will confirm the diagnosis during the screening visit at which time the subject must have an intact PTH < 30 pg/mL Moderate to severe hepatic disease defined as hepatic transaminases (ALT and AST) > 2 times the upper limit of normal 2. Severe renal insufficiency defined as a calculated GFR < 25 mL/min/1.73 m(2), using the CKD-EPI equation(15). 3. Allergy or intolerance to tetracycline antibiotics 4. Pregnant or lactating or planning to become pregnant during the course of the study. (Women who are able to get pregnant must agree to use an effective form of birth control while in this study.). 5. Perimenopausal defined by no menses for 6 months to 5 years and an FSH > 20 U/L at the screening and/or baseline visits.. 6. Chronic diseases that might affect mineral metabolism such as diabetes, celiac disease, Crohn s disease, Cushing s syndrome, or adrenal insufficiency 7. Concurrent treatment with doses of thyroid hormone intended to suppress thyroid stimulating hormone below the assay s detection limit or persistent thyroid cancer 8. History of a skeletal disease unrelated to hypoparathyroidism, such as osteoporosis or low bone density (defined as a DXA Z-Score < -2 in all subjects or T-score < -2 in subjects greater than or equal to 20 year old), osteosarcoma, Paget s disease, alkaline phosphatase > 1.5 times the upper limit of normal, or metastatic bone disease 9. History of retinoblastoma or Li-Fraumeni syndrome 10. History of treatment with bisphosphonates, calcitonin, tamoxifen, selective-estrogen receptor modulators, or directed skeletal irradiation 11. Use of oral or intravenous corticosteroids or estrogen replacement therapy for more than 3 weeks within the last 6 months 12. Use of depot medroxyprogesterone for contraception within the past 12 months 13. Chronic inadequate biochemical control with conventional therapy and/or calcium infusion dependent 14. Seizure disorder requiring antiepileptic medications 15. Treatment with PTH for more than 2 weeks continuously at any time, prior to study entry 16. Any cognitive impairment that limits the subject s ability to comply, independently or through the assistance of a legally authorized representative, with protocol procedures. 17. Open epiphyses as determined by an X-ray of the hand and wrist in subjects < 21 years of age | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Osteoporosis Osteitis Deformans Parathyroid Diseases Clinical diagnosis of a metabolic bone disorder 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): 4.0-75.0, Chordoma All English-speaking persons diagnosed with chordoma at age 18 years or less either at MGH or elsewhere, and treated by DRO, MGH between 1988 and the end of the study period (n =100). Ages will range from 5 months years. There is no age limit fo the self-administered questionnaire or the telephone interview because a parent can complete it on behalf of any case who is less than 18 years, but collection of buccal cells will be limited to cases older than or equal to age 6 years | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-75.0, Cervical Dystonia 75 year old male and female patients with idiopathic cervical dystonia - Secondary causes of dystonia; history of substance abuse, psychosis, ischemic heart disease, symptomatic postural hypotension, liver disease (LFTs > 2 times normal), renal disease Women who are pregnant or plan on becoming pregnant during the course of the trial Use of botulinum toxin as a treatment for cervical dystonia in the preceding 4 months Use of other GABA mediated drugs including: gabapentin, phenobarbital, benzodiazepines, or baclofen Use of other cannabinoids in the preceding month Refusal to refrain from use of other cannabinoid compounds during the course of the trial Refusal to refrain from operating heavy machinery or driving during the course of 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): 50.0-999.0, Hip Fracture Fragility hip fracture patient Previous Vitamin D supplementation is okay Patients with pathological fracture secondary to malignancy or intrinsic bone disease (eg. Paget's disease) Cancer in the past 10 years likely to metastasize to bone Renal insufficiency (creatinine <30 mls/min) Hypercalcemia (primary hyperparathyroidism; granulomatous diseases; drug-induced such as lithium, thiazides), hypocalcemia, hypercalciuria, fracture or stroke within the last 3 months Hormone replacement therapy, calcitonin, fluoride, or bisphosphonates during the previous 24 months Pre-existing bone abnormality Renal stones in past 10 years | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-75.0, Nasolabial Fold Wrinkles Subjects must sign a statement of IC and HIPAA authorization. In addition subjects must provide a separate release for use of their photographs in publications; any subject has a right to refuse the photo release without jeopardizing their ability to participate in the study Subjects must be 18-75 yrs of age, of any race or sex Female subjects must be post-menopausal for at least 1 yr or have had a hysterectomy; or have a had a tubal ligation; or if of child-bearing potential, must agree to use an approved method of birth control throughout the study (i.e, oral/systemic contraceptives, IUD, or spermicide in combination with barrier method of contraception) Subjects seeking augmentation therapy for bilateral correction of nasolabial folds. Subjects must have a score of greater than or equal to 2 and less than or equal to 4 on the photo-numeric wrinkle assessment scale (assessed by a blinded evaluator) of both the left and right nasolabial fold at Visit 1 Subjects with a personal history of allergic/anaphylactic reactions including hypersensitivity to local anesthetics (e.g.,lidocaine, etc.), bovine collagen, latex, silicone, carmellose, or mannitol Subjects with a known history of keloids or bleeding disorders Subjects with an active inflammatory process in the area to be treated (skin eruptions such as cysts, pimples, rashes, cancerous/pre-cancerous lesions, or any other active skin disease) Subjects with active hepatitis within the past year Subjects who are pregnant (confirmation by pregnancy testing),or plan to become pregnant within the study timeframe, or who are nursing Subjects who plan to undergo major facial surgery (e.g., rhinoplasty with or without implant, facelift, congenital defect repair, etc. during the course of the study Subjects with clinically important disease as judged by the investigator within 3 months of the study (e.g., significant lab abnormalities, myocardial infarct, stroke, cancer, connective tissue diseases, etc.) including subjects with medical conditions that might require the use of immunosuppressive medications during the trial (e.g., severe asthma, rheumatoid arthritis, etc.) Subjects who have used exclusionary medications/treatments | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, Nasolabial Fold Wrinkles Subjects must sign a statement of IC and HIPAA authorization. In addition subjects must provide a separate release for use of their photographs in publications; any subject has a right to refuse the photo release without jeopardizing their ability to participate in the study Subjects must be 18-75 yrs of age, of any race or sex Female subjects must be post-menopausal for at least 1 yr or have had a hysterectomy; or have a had a tubal ligation; or if of child-bearing potential, must agree to use an approved method of birth control throughout the study (i.e, oral/systemic contraceptives, IUD, or spermicide in combination with barrier method of contraception) Subjects seeking augmentation therapy for bilateral correction of nasolabial folds. Subjects must have a score of greater than or equal to 2 and less than or equal to 4 on the photo-numeric wrinkle assessment scale (assessed by a blinded evaluator) of both the left and right nasolabial fold at Visit 1 Subjects with a personal history of allergic/anaphylactic reactions including hypersensitivity to local anesthetics (e.g.,lidocaine, etc.), bovine collagen, latex, silicone, carmellose, or mannitol Subjects with a known history of keloids or bleeding disorders Subjects with an active inflammatory process in the area to be treated (skin eruptions such as cysts, pimples, rashes, cancerous/pre-cancerous lesions, or any other active skin disease) Subjects with active hepatitis within the past year Subjects who are pregnant (confirmation by pregnancy testing),or plan to become pregnant within the study timeframe, or who are nursing Subjects who plan to undergo major facial surgery (e.g., rhinoplasty with or without implant, facelift, congenital defect repair, etc. during the course of the study Subjects with clinically important disease as judged by the investigator within 3 months of the study (e.g., significant lab abnormalities, myocardial infarct, stroke, cancer, connective tissue diseases, etc.) including subjects with medical conditions that might require the use of immunosuppressive medications during the trial (e.g., severe asthma, rheumatoid arthritis, etc.) Subjects who have used exclusionary medications/treatments. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-120.0, Gastric Cancer Histologically or cytologically confirmed gastric adenocarcinoma meeting the following Stage IV disease OR stage III disease that was re-staged as metastatic disease at time of surgery Unresectable disease Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan No CNS metastases ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100% Absolute neutrophil count ≥ 1,500/mm^3 Hemoglobin ≥ 8.0 g/dL Platelet count ≥ 100,000/mm^3 Bilirubin normal | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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 A. Histopathological documentation of prostate cancer confirmed in the Laboratory of Pathology at the National Institutes of Health (NIH) Clinical Center, National Institutes of Health (NIH), the National Naval Medical Center, or Walter Reed Army Medical Center; or participating Institute's Department of Pathology prior to starting this study. If no pathologic specimen is available, patients may enroll with a pathologist's report showing a histologic diagnosis of prostate cancer and a clinical course consistent with the disease. B. Must have metastatic castration resistant prostate cancer (CRPC) with at least 2 bone lesions consistent with prostate cancer metastasis and progressive disease (2 rising PSA values separated by at least one week, new or enlarging lesions consistent with prostate cancer, or clinical progression) on docetaxel for metastatic prostate cancer or inability to tolerate docetaxel. C. Life expectancy greater than or equal to 6 months. D. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. E. No systemic steroid or steroid eye drop use within 2 weeks prior to initiation of experimental therapy. F. Hematological parameters (within 16 days of starting therapy) Granulocyte count greater than or equal to 1,500/mm^3 Platelet (PLT) count greater than or equal to 100,000/mm^3 Hemoglobin (Hgb) greater than or equal to 10 Gm/dL (Transfusion may be given to accomplish this) G. Biochemical parameters (within 16 days of starting therapy) -Hepatic function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 2.5 times upper limit of normal; bilirubin less than 1.5 mg/dL OR in patients with Gilbert's syndrome, a total bilirubin less than or equal to 3.0 mg/dL. H. No other active malignancies within the past 12 months (with the exception of nonmelanoma skin cancers or carcinoma in situ of the bladder and treated with curative intent) or life-threatening illnesses. I. Willing to travel to the National Institutes of Health (NIH) or participating Institute for follow-up visits. J. 18 years of age or greater. K. Able to understand and sign informed consent. L. Agree to use adequate contraception prior to study entry and for at least 4 months following the last vaccine injection. M. Patients must remain on medical castration therapy with testosterone-suppressing therapy (e.g., gonadotropin releasing hormone (GnRH) agonist), unless they have had surgical castration. N. Patients must have recovered from acute toxicities related to prior therapy or surgery. For chemotherapy, typically this is 3 to 4 weeks. O. Patients who are incontinent of urine should be willing to undergo bladder catheterization to minimize the risk of radioactive contamination of clothing, bed linen, and the patient's environment. P. Concurrent treatment with bisphosphonates is allowed. If bisphosphonates have been given within 2 weeks prior to planned (153)Sm-EDTMP, then a 99Tc whole-body scintigraphy (bone scan) will be performed to confirm uptake into lesions. Bisphosphonates will not be given within 48 hours after (153)Sm-EDTMP administration. Q. Serum creatinine less than or equal to 1.5 times upper limit of normal OR creatinine clearance on a 24-h urine collection of greater than or equal to 60 mL/min A. Patients should have no evidence, as listed below, of being immunocompromised Human immunodeficiency virus (HIV) positivity due to the potential for decreased tolerance and risk for severe side effects Hepatitis B or C positivity Concurrent use of topical steroids (including steroid eye drops) or systemic steroids. This is to avoid immunosuppression which may lead to potential complications with vaccinia (priming vaccination). Nasal or inhaled steroid use is permitted. B. Patients should have no autoimmune diseases that have required treatment, such as Addison's disease, Hashimoto's thyroiditis, systemic lupus erythematosus, Sjogren's syndrome, scleroderma, myasthenia gravis, Goodpasture's syndrome, or active Grave's disease. Patients with a history of autoimmunity that has not required systemic immunosuppressive therapy or does not threaten vital organ function, including central nervous system (CNS), heart, lungs, kidneys, skin, and gastrointestinal tract (GI) tract, will be allowed. C. History of allergy or untoward reaction to prior vaccination with vaccinia virus or to any component of the vaccinia vaccine regimen. Note: prior vaccination with vaccinia is not required. D. Do not administer the recombinant vaccinia vaccine if the recipient or, for at least 3 weeks after vaccination, their close household contacts (close household contacts are those who share housing or have close physical contact), are persons with active or a history of eczema or other eczematoid skin disorders; those with other acute, chronic or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds) until condition resolves; pregnant or nursing women; children 3 years of age and under; and immunodeficient or immunosuppressed persons (by disease or therapy), including HIV infection. E. Serious intercurrent medical illness (e.g., one that requires treatment) which would interfere with the ability of the patient to carry out the treatment program, including, but not limited to, inflammatory bowel disease, Crohn's disease, ulcerative colitis, or active diverticulitis. F. Patients with a history of cardiomyopathy or symptomatic congestive heart failure (unless stable on treatment), symptomatic arrhythmia not controlled by medication. Unstable atherosclerotic heart disease (e.g. unstable angina) who require active intervention and history of myocardial infarction or embolic stroke within the past 6 months. G. Patients with cardiac disease who have fatigue, palpitation, dyspnea or angina with ordinary physical activity (New York Heart Association class 2 or greater) are not eligible. H. Patients with a history of congestive heart failure or who have objective evidence of congestive heart failure by physical exam or imaging are not eligible, unless the underlying cause has been treated and patient has documented normal ejection fraction. I. Patients with pulmonary disease who have fatigue or dyspnea with ordinary physical activity are not eligible. J. Concurrent chemotherapy. K. No brain metastasis or history of seizures, encephalitis, or multiple sclerosis. L. Serious hypersensitivity reaction to egg products. M. Prior splenectomy. N. Contraindicated in patients who have known hypersensitivity to EDTMP or similar phosphonate compounds. O. Patients with symptomatic soft tissue disease or parenchymal disease will be excluded. P. Radiation therapy to bone within 4 weeks of study entry. Q. Patients previously treated with (153)Sm-EDTMP will be excluded. R. Patients requiring urgent local radiotherapy or orthopedic stabilization | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, Chondrocalcinosis Patients diagnosed as having calcium pyrophosphate dihydrate deposition disease Patients mimicking a rheumatoid arthritis disease, with positive rheumatoid factor or with psoriasis | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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 Breast Cancer Females with pathologically confirmed adenocarcinoma of the breast No prior chemotherapy for metastatic breast cancer At least 12 months between completion of adjuvant chemotherapy and the diagnosis of metastatic disease Stage IV disease Measurable disease (must be equal or greater to 2.0 cm using conventional Computed Tomography (CT) or equal or greater to 1.0 cm using spiral CT except for pulmonary lesions that are well documented on conventional CT scan which must be equal or greater than 1.0 cm) At least 4 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiation portal or there must be radiologic or clinical exam proof of progressive disease within the radiation portal At least 4 weeks since major surgery, with full recovery Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Age equal or greater to 18 Patients has the following blood counts at Baseline Concurrent immunotherapy or hormonal therapy (other than Herceptin) for breast cancer Parenchymal brain metastases, unless documented to be clinically and radiographically stable for at least 6 months after treatment Serious intercurrent medical or psychiatric illness, including serious active infection History of class II-IV congestive heart failure History of other malignancy within the last 5 years which could affect the diagnoses or assessment of breast cancer, with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix Patients who have received an investigational drug within the previous 3 weeks Patient is currently enrolled in a different clinical study in which investigational procedures are performed or investigational therapies are administered. Also a patient may not enroll in such clinical trials while participating in this study Pregnant or nursing women Patients with prior hypersensitivity to Taxol or Taxotere | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, Severe Septic Shock Written informed consent Proven or suspected Gram-negative bacterial infection Two out of four Systemic Inflammatory Response Syndrome (SIRS) existing for less than 24 h Acute onset of end-organ dysfunction in the preceding 12 h Prior therapy with alkaline phosphatase Known allergy for cow milk Probable death within 24 h Chronic renal failure requiring hemodialysis or peritoneal dialysis Acute pancreatitis with no established source of infection HIV seropositive Pregnant or lactating Confirmed Gram-positive or fungal sepsis Treatment with immunosuppressants including high doses of glucocorticosteroids | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 50.0-999.0, Osteoporosis Postmenopausal women at or above the age of 50, diagnosed with primary osteoporosis may be enrolled in the trial if the following inclusion/ apply. All must be answered "yes" for a subject to be enrolled in the trial. 1. Has the subject given informed consent according to local requirements before any trial related activities? (A trial related activity is any procedure that would not have been performed during the routine management of the subject). 2. Is the subject female and at or above the age of 50? 3. Has the subject been postmenopausal for more than 5 years in the judgement of the investigator? 4. Does the subject have primary osteoporosis and a T-score equal to or lower than -2.5 SD; T-scores must be assessed by DXA at the lumbar spine L1-L4, with a minimum of two assessable vertebrae, or at the total hip (right hip, if there is a right hip prosthesis, left hip can be used. If both hips are replaced the subject can be included with a lumbar scan only). 5. Is the subject currently taking calcium and vitamin D3 or is she willing to start such supplemental treatment and continue throughout the trial period, unless she develops hypercalcaemia? 6. Has the subject been taking supplemental calcium (1,000 mg) and vitamin D3 (800 IU) daily for at least 14 days (after screening) before blood sampling for evaluation? [*] 7. Is the subject able to self-inject PTH(1-84), or get the injections by a helper? [*] Note that no. 6 can not be evaluated at the time for screening, must be evaluated at randomisation, visit 2. See also and note [**] All must be answered "no" for a subject to be enrolled in the trial. Has the subject: 1. been treated with SERMS (selective oestrogen receptor modulators) or calcitonin within the last 1 month? 2. ever been treated with any bisphosphonate in intravenous form (i.v.)? 3. been treated with any bisphosphonates (alendronate, risedronate, or other bisphosphonates) for more than 3 years in total, or within the last 6 months? 4. been treated with fluoride for more than 3 months within the last 10 years? 5. ever been treated with strontium ranelate? 6. ever been treated with teriparatide or PTH(1-84)? 7. received or is the subject currently receiving chronic glucocorticosteroid treatment? Defined as more or equal to: 5.0 mg prednisolon or equivalent daily for 3 months during the last year or 2.5 mg prednisolon or equivalent daily for 6 months during the last year. Local and inhalation steroids are permitted. 8. been treated for cancer (other than basocellular skin cancer) within the last 5 years? 9. ever received radiation therapy to the skeleton? 10. ever had malignant disease affecting the skeleton? or does the subject: 11. currently receive antiepileptic medication? 12. take any other medication (other than calcium and vitamin D3) that is known to affect bone metabolism? according to the investigator's opinion. 13. have any known clinically significant diseases affecting calcium metabolism? 14. have any known history of metabolic bone diseases other than primary osteoporosis including hyperparathyroidism, Paget's disease, osteogenesis imperfecta, or osteomalacia)? 15. have any known history of hypersensitivity to parathyroid hormone or strontium or any of the excipients in the products? 16. have a serum vitamin D3, (serum 25(OH)D) level <20 ng/ml after at least 14 days of calcium and vitamin D3 supplementation? [**] 17. have a serum PTH of > 65 pg/ml and also a total serum calcium value >2.49 mmol/l? [**] 18. have hypercalcaemia (total serum calcium value >2.55 mmol/l), measured after at least 14 days of calcium and vitamin D3 supplementation? [**] 19. have elevated serum alkaline phosphatase? Defined as > 3X ULN [**] 20. have impaired kidney function with creatinine clearance < 30 ml/min (indirect measurement by serum creatinine)? [**] 21. have severe impaired liver function ? [**] 22. have phenylketonuria? or is the subject: 23. at risk of having venous thromboembolism including pulmonary embolism? according to the investigator's opinion. 24. scheduled for vertebroplasty? 25. currently participating in a clinical trial with an investigational medical product, or has done so within the last 90 days, or plan to do so within the next 32 weeks? Previous and current participation in non-interventional trials is allowed. [**] no. 16 to 21 can not be evaluated before the result of the blood sampling (planned within the screening period and after at least 14 days of supplemental calcium/vitamin D3 intake) is available | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, Paget's Disease of Bone Male or female, ages 18 to 90 years with a diagnosis of Paget's bone disease Patient cannot stand or sit upright for at least 30 minutes Patient has difficulty swallowing or problems with digestive system | 2 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-75.0, Alveolar Bone Loss Periodontal Bone Loss Patients requiring extraction of teeth with advanced intrabony periodontal defects at single rooted teeth without root concavities/furrows located in the maxilla and mandible (maxillary/mandibular premolars, maxillary incisors; presurgery probing depth ≥ 6 mm, intrasurgery defect depth ≥ 4 mm) or located the mesial or distal aspect of mandibular molar teeth without adjacent teeth (excluding defects also involving the furcation area) Teeth to be treated must be scheduled for extraction in a treatment plan established by clinicians unrelated to the study Male and female patients, aged 18 years Patients must be non-smokers Female patients must be infertile (either sterilized or postmenopausal). If a patient's menopausal status at screening is uncertain, levels of follicle stimulating hormone (FSH) should be determined. Patients with an FSH level > 25 IU/l and absence of menstrual bleeding > 6 months will satisfy the definition of postmenopausal status Patient must provide written informed consent Women of childbearing potential, pregnant or lactating women Participation in another clinical study within 30 days prior to study start Previous participation in this study Legal incompetence or restricted legal competence Alcoholism, drug dependency, smoking Acute or chronic infection at the application site Known infection with HIV, HBV, or HCV Severe allergic rhinitis which requires permanent medication Known intolerance of or hypersensitivity to ß-TCP or rhGDF?5 Presence of local or systemic malignant disease or history of local or systemic malignant disease in the past 5 years | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 18.0-999.0, Elbow Fracture Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: 1. Joint destruction and/or subluxation visible on x-ray 2. Resistance to conservative treatment Primary replacement after fracture of the radial head Symptomatic sequelae after radial head resection Revision following failed radial head arthroplasty Patient selection factors to be considered: 1. Need to obtain pain relief and improve function 2. Ability and willingness of the patient to follow instructions, including control of weight and activity levels 3. A good nutritional state of the patient 4. The patient must have reached full skeletal maturity Patients who have infection, sepsis, and osteomyelitis Patients who are uncooperative or have neurologic disorders who is capable or unwilling to follow directions Patients with distant foci of infections which may spread to the implant site Patients with rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram Patients who are pregnant Patients who are under 18 years of age Patients who have had fractures of the humerus Patients who have had revisions where other devices and treatments have failed | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 years old. The diagnosis of Paget's Disease of Bone is confirmed and Bisphosphonate will be started as first-line therapy. | eligible ages (years): 40.0-65.0, Osteoporosis Healthy postmenopausal women 40 to 65 years of age, inclusive, meeting at least one of the following: Postmenopausal defined by the STRAW of 12 months of spontaneous amenorrhea with serum FSH levels = 40 mIU/mL; History of bilateral oophorectomy (with or without hysterectomy) and at least 6 weeks post-surgical with serum FSH levels = 40 mIU/mL Body weight > 50 kg and BMI within the range 19 kg/m2 Capable of giving written informed consent Any clinically relevant biological or physical abnormality found or reported at screening which, in the opinion of the investigator, is clinically significant and would preclude safe participation in this study. These abnormalities may be identified on the screening history and physical or laboratory examination and 12-lead electrocardiogram (ECG) A subject may not participate in the study if any of the following laboratory results are above the upper limit of the normal range at screening: liver function tests (ALT, AST, GGT, alkaline phosphatase, total bilirubin), plasma amylase, glucose, alkaline phosphatase, or CPK A subject may not participate in the study if any of the following laboratory results are outside the normal range at screening: serum levels of albumin-adjusted calcium, total calcium, PTH, and urinary calcium A subject with vitamin D deficiency as defined by serum 25-hydroxy vitamin D < 20 ng/mL (equivalent to 50 nmol/L) at screening may not participate in the study. A QTc interval > 450 msec at screening Positive urine drug screen Positive for HIV, hepatitis B virus or hepatitis C virus assays Urinary cotinine levels indicative of smoking History of smoking or use of nicotine containing products within one year of screening History of regular alcohol consumption History of drug abuse within 6 months 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): 55.0-85.0, Osteoporosis, Post-Menopausal Ambulatory, postmenopausal women aged 55-85 years (at least 3 years have elapsed after menopausal) are included at the time of entry into the trial. They have to be free of severe or chronically disabling conditions other than osteoporosis The patient should have a documented (X-ray) prevalent osteoporotic vertebral fracture or non-vertebral fragility fracture (excluding major trauma). Vertebral deformities will be evaluated on lateral views of the thoracic and lumbar spine. T-12 will be visible on both views so that all vertebrae from T-4 to L-4 can be identified. The radiographs will be performed according to a standardized protocol L-1 through L-4 vertebrae must be without artifacts, multiple vertebral fractures; therefore at least 3 vertebrae should be without fractures, osteophytes, or other abnormalities that would interfere with the analysis of the posterior-anterior lumbar spine BMD measurement. The reading of the BMD, T-score should be in the range of 0 and 0 at least for one of the 2 sites measured (spine or hip). The initial lumbar spine and femoral neck BMD assessment and the determination of the patient's for entry into the screening phase will be made by the central quality assurance for BMD. The central quality assurance center will determine the patient's for enrollment into the treatment phase. If the L-1 vertebra cannot be analyzed due to artifacts, vertebral fracture, osteophytes, or other abnormalities, that vertebra should be excluded from the analysis Women without language barriers, cooperative and expected to return for all follow-up procedures and who have given informed consent before entering the study and after being informed of the risks, medications, and procedures to be used in the study Normal or clinically insignificant abnormal laboratory values including serum calcium, PTH (1-84) levels and alkaline phosphatase History of sprue, inflammatory bowel disease, or malabsorption syndrome in the 1 year prior to Visit 2 History of nephrolithiasis or urolithiasis in the 2 years prior to Visit 2. Patients with any history of nephro or urolithiasis must have an appropriate radiology study within 6 months prior to Visit 2. This radiology study, such as an intravenous pyelogram or a supine radiograph of the kidney-ureter-bladder, must document the absence of active disease History of other malignant neoplasms in the 5 years prior to screening, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. Patients with carcinoma in situ of the uterine cervix treated definitively more than 1 year prior to entry into the study may enter the study Patients who have an increased baseline risk of osteosarcoma: Paget's disease of the bone or unexplained elevations of alkaline phosphatase; patients who have received radiation therapy involving the skeleton History of diseases which affect bone metabolism other than postmenopausal osteoporosis such as Paget's disease, renal osteodystrophy, osteomalacia, any secondary causes of osteoporosis, hypoparathyroidism, hyperparathyroidism, or hyperthyroidism | 0 |
The patient is a 53-year-old man complaining of frequent headaches, generalized bone pain and difficulty chewing that started 6 years ago and is getting worse. Examination shows bilateral swellings around the molars. The swellings have increased since his last examination. Several extraoral lesions of the head and face are detected. The swellings are non-tender and attached to the underlying bone. Further evaluation shows increased uptake of radioactive substance as well as an increase in urinary pyridinoline. The serum alkaline phosphatase is 300 IU/L (the normal range is 44- 147 IU/L). The patient's sister had the same problems. She was diagnosed with Paget's disease of bone when she was 52 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, Liver Cirrhosis, Biliary Male or female age 18 to 70 years Stable dose of ursodeoxycholic acid (URSO, UDCA) for at least 6 months prior to screening Female patients must be postmenopausal, surgically sterile, or prepared to use 2 methods of contraception with all sexual partners during the study and for 14 days after the end of dosing Male patients must be prepared to use 2 methods of contraception with all sexual partners during the study and for 14 days after the end of the dosing Proven or likely PBC, as demonstrated by the patient presenting with at least 2 of the following 3 diagnostic factors: 1. History of increased AP levels for at least 6 months prior to Day 0 2. Positive AMA titer (>1:40 titer on immunofluorescence or M2 positive by ELISA) or PBC-specific antinuclear antibodies (antinuclear dot and nuclear rim positive) 3. Liver biopsy consistent with PBC Screening AP value between 1.5 and 10 × ULN Administration of the following drugs at any time during the 3 months prior to screening for the study: colchicine, methotrexate, azathioprine, or systemic corticosteroids Screening conjugated (direct) bilirubin >2 × ULN Screening ALT or AST >5 × ULN Screening serum creatinine >1.5 mg/dL (133 mol/L) History or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy, or poorly controlled ascites) History or presence of other concomitant liver diseases including hepatitis due to hepatitis B or C virus (HCV, HBV) infection, primary sclerosing cholangitis (PSC), alcoholic liver disease, definite autoimmune liver disease or biopsy proven nonalcoholic steatohepatitis (NASH) Pregnancy | 0 |
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