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The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-999.0, Alzheimer's Disease Diagnosis of Alzheimer's disease Women must have had a partial or complete hysterectomy Mini Mental Status Evaluation score of 18-27 HAM-D score less than or equal to 18 Able to provide written informed consent On a stable dose of an acetylcholinesterase inhibitor for at least 12 weeks prior to screening visit Ambulatory, or ambulatory with walker or cane Sufficient hearing and vision to enable the patient to comply with the study procedures Caregiver available to participate in the assessment of the patient and monitor dosing Women with an intact uterus A clinically significant medical condition, including lab abnormality, which in the opinion of the investigator would place the patient at undue risk, or would impair the patient's ability to participate in the study. These but are not limited to: history of cerebral vascular accident (CVA), adrenal insufficiency, porphyrias, autoimmune disorders, type I diabetes, chronic obstructive pulmonary disease (COPD), hematologic or oncologic disorders in the previous 2 years, vitamin B12 or folate deficiency A clinically significant active gastrointestinal, renal, hepatic, endocrine, or cardiovascular system disease that is not well controlled by diet, pharmacological treatment, or other therapeutic intervention History of psychotic episodes or bipolar disorder, or additional diagnosis of delusions, delerium, or depression Evidence of other psychiatric or neurologic disorders (e.g., stroke, schizophrenia, or Parkinson disease) Hachinski ischemia score of 5 or more Known hypersensitivity to cholinesterase inhibitors Use of systemic or pulmonary inhaled corticosteroids within the 30 days prior to randomization, or require use of these medications during the study Use of memantine (Namenda) within the 30 days prior to randomization, or require use of this medication during the study Currently taking medications known to significantly induce or inhibit the metabolism of CYP 3A4, or have taken these medications 7 days prior to randomization (see list below under prohibited medications) | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-999.0, Prostatic Neoplasms Have histological evidence of adenocarcinoma of the prostate Have progressive castrate metastatic disease Castrate levels of testosterone (<50 ng/ml). Treatment to maintain castrate levels of testosterone must be continued Must have evidence of at least 3 bone metastases on bone scan Patients for whom initial hormone treatment (exclusive of neoadjuvant hormone therapy) was a combined androgen blockade approach, must show progression of disease following withdrawal of the anti-androgen prior to enrollment Patients undergoing prior bisphosphonate treatments are eligible Patients who have received one prior treatment with 153Sm lexidronam or 89Sr are eligible provided it is at least 12 weeks from treatment with 153Sm lexidronam or 24 weeks from treatment with 89Sr Life expectancy of at least 12 weeks (based on co-morbidity) KPS>60 Lab requirements Patients with small cell carcinoma Patients with predominant visceral metastases (>3 lung or liver lesions) or symptomatic lymphadenopathy (scrotal or pedal edema) Patients who have received more than one course of external beam radiation therapy directed at bone lesions Clinically significant cardiac disease (New York Heart Association Class III/IV) History of other malignancies (other than non-melanoma skin cancer), unless in complete remission or off therapy for that disease for at least five years Have or are participating in a research study protocol or clinical trial protocol within 30 days of the date of the baseline visit | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 18.0-70.0, Helicobacter Pylori Infection Non Ulcer Dyspepsia Duodenal Ulcer Gastric Ulcer Chronic Active Gastritis Gastritis Presence of active H. pylori infection Age >18 years Allergy to drug administered Liver or kidney failure Pregnancy Previous treatment for H. pylori infection | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 12.0-18.0, Contraception Bone Density Adolescent females who have had any menses in the 6 months prior to enrollment Must have a negative pregnancy test Concomitant medication use of bone modifying agents, glucocorticoids, heparin, and anticonvulsants Screening Spinal BMD with z score not greater than -2 of matched young normals | 1 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-75.0, Gastric Neoplasm Curative operation with D2 or greater lymph node dissection 2. Histologically proven gastric adenocarcinoma 3. Macroscopically serosa-positive (T3-4) 4. No metastases to level 3 lymph nodes station (N0-2) 5. 75 years or younger 6. Negative peritoneal lavage cytology 7. Adequate organ function WBC >=4000/mm3,Hb >=11.0g/dl,Plt >=100.000/mm3,AST/ALT, T.Bil, BUN, Creatinine <=2.5 x Normal Upper Limit,Creatinine clearance <=70 ml/min 8. Written informed consent Prior chemotherapy or radiotherapy 2. Synchronous or metachronous malignancy in other organs | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 8.0-999.0, Charcot-Marie-Tooth Disease Criteria:Patients with Genetically confirmed CMT 1a disease - | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 13.0-999.0, Epilepsy Patients over 13 years old (complete the elementary school course). 2. Patients had at least two seizures in the past and at least one seizure for the last 3 months before screening. 3. Patients had no antiepileptic drugs for the last 4 months. 4. Women of childbearing age who agree to contraception during participating this clinical trial Pregnancy 2. Patients who have progressive neurologic disease 3. Allergy to sulfonamides 4. Use of acetazolamide within a year 5. Hemolytic anemia 6. Patients who have abnormal liver function (GOT or GPT) values more than twice the normal values. 7. Patients who have abnormal renal function (BUN or Creatinine) values more than three times the normal values. 8. Patients who have history of drug or alcohol abuse. 9. Glucose-6-phosphate dehydrogenase deficiency. 10. Patients who were detected with renal stones on KUB (Kidney-Ureter-Bladder) test. 11. Patients who have progressive internal or surgical disease. 12. Patients who have progressive psychiatric disease. 13. Patients who have mental retardation (IQ 70 and less). 14. Patients taking Vit C | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 18.0-999.0, Rheumatoid Arthritis Participation in CZP trial C87014 or C87011 If female and of childbearing potential, she agrees to participate in this study by providing written informed consent, has been using adequate contraception since her last menses, will use adequate contraception during the study and for 12 weeks after the last dose of study drug (or longer if required by local regulations), is not lactating, and has had a negative urine pregnancy test on the day of receiving the first dose of study drug Must have provided written informed consent before undergoing any study procedures History (Hx) of chronic infection, serious or life-threatening infection (including Herpes Zoster) within 6 months prior, or any current symptom indicating infection Current or recent Hx of severe, progressive and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebral disease Any finding indicative of Tuberculosis at end of previous study Known HIV infection Persistently abnormal AST (Aspartate Aminotransferase) or ALT (Alanine Aminotransferase) results (> 2 times upper limit of normal) Hemoglobin (Hgb) levels < 9 g/dL or Hematocrit < 30 % Total White Blood Cell (WBC) count of < 3.0 x 100/L (< 3000/mm^3) Platelet count < 100 x 100 L (100,000/mm^3) Serum creatinine > 1.5 times upper limit of normal based on patient age and sex | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 18.0-999.0, Tuberculosis HIV Infections HIV-infected 2. Age >=18 years 3. Tuberculin skin test positive or negative 4. Laboratory Hemoglobin (Hgb) >6.5 gm/dl Neutrophil count >1,000 cells/mm3 Platelets >75,000/mm3 AST (SGOT) <122 U/L Creatinine <1.5 mg/dl Beta HCG = negative 5. Karnofsky performance status >=60 6. Signed informed consent History of TB in the last 3 years or current active TB 2. History of noncompliance to chronic therapies | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 15.0-30.0, Anorexia Nervosa Diagnosis anorexia nervosa according to DSM-IV (Diagnostic and Statistical Manual of Mental Disorders. Washington, DC) Refusal to gain weight to or over a minimal normal weight (BMI < 17,5 kg/m²) Fear of gaining weight despite underweight Contraindication for taking blood samples (haemoglobin < 8,5 g/dl) Medication which could influence the lipid metabolism (current and the last two months) Acute or chronic diseases, particularly malign diseases Diseases which could affect the safety of the patients or which could interfere with aims of the study Positive pregnancy test Excessive alcohol consumption (more than 30 g alcohol per day) or alcohol consumption within two days before sampling blood Disability to communicate with the investigator because of linguistic problems or because of a limited mental state for healthy subjects: Age matched with patients with anorexia nervosa (18 years to 30 years) Well status of health Female Negative pregnancy test No clinical relevant diagnosis, particularly no hyperlipoproteinemias (LDL < 160 mg/dl) BMI > 18,0 kg/m² and < 25 kg/m² for healthy subjects: Medication which could influence the lipid metabolism (current and two months ago inclusively) Acute or chronic diseases, particularly malign diseases Diseases which could affect the safety of the patients or which could interfere with aims of the study Positive pregnancy test Excessive alcohol consumption (more than 30 g alcohol per day) or alcohol consumption within two days before sampling blood Disability to communicate with the investigator because of linguistic problems or because of a limited mental state | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-75.0, Esophageal Neoplasms Carcinoma, Squamous Cell histologically proven squamous cell carcinoma of the thoracic esophagus 2. pathologic stages IIa, IIb, III except T4 3. an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 4. no previous history of chemotherapy nor radiotherapy 5. an essentially normal clinical laboratory profile (white blood cell count or WBC, >=4,000 /mm3; hemoglobin or Hb, >=10g/dl; platelet count or Plt, >=100,000 /mm3; total serum bilirubin<=1.2 mg/dl; aspartate aminotransaminase or AST and alanine aminotransaminase or ALT no higher than twice normal; creatinine or CRTN, <=1.2 mg/dl; creatinine clearance or CCr, >=60 ml/minute; and arterial oxygen tension or PaO2, >=65 torr 6. oral or written informed consent obtained before randomization severe heart diseases 2. uncontrollable hyper tension or diabetes mellitus 3. severe pulmonary dysfunction 4. HBs positive 5. active bacterial infection 6. synchronous or metachronous (within 5 years) malignancy 7. pregnant female 8. psychiatric medication | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 2.0-40.0, Focal Glomerulosclerosis Aged 2-42 years at onset of proteinuria 2. Aged ≤ 42 years at time of randomization (randomization date before 43rd birthday) 3. Estimated glomerular filtration rate (GFR) ≥ 40 ml/min/1.73 m2 at most recent measurement prior to randomization 1. For patients < age 18 years: Schwartz formula 2. For patients ≥ age 18 years: Cockroft-Gault formula 4. Up/c > 1.0 g/g creatinine on first morning void at time of randomization 5. Biopsy confirmed as primary FSGS (including all subtypes) by study pathologist. 6. Steroid resistance: During the last treatment course with high dose steroids prior to randomization, the patient must have demonstrated steroid resistance defined below and not have had a complete remission of proteinuria (Up/c < 0.2 or dipstick urine protein negative/trace) subsequently. The course of steroid treatment that defines resistance must be the same or equivalent to at least 4 weeks of every day dosing with a minimum cumulative dose of 56 mg/kg or 1680 mg of prednisone or its equivalent. 7. May be taking angiotensin-converting enzyme inhibitor (ACEI), angiotensin receptor blocking agent (ARB), vitamin E, or lipid lowering therapy 8. Willingness to comply with clinical trial protocol, medications, and follow-up visits, etc. 9. Screen failure in FSGS-CT based on prior treatment with excluded medication 10. Treatment failure in FSGS-CT based on failure to achieve remission after 26 weeks or 52 weeks of test therapy, i.e., cyclosporine or mycophenolate mofetil (MMF) + oral dexamethasone pulses Secondary FSGS 2. Treated with cyclophosphamide, chlorambucil, levamisole, methotrexate, nitrogen mustard, or other immunosuppressive medications in the 30 days prior to randomization 3. Lactation, pregnancy, or refusal of birth control in women of child bearing potential 4. Participation in another therapeutic trial concurrently or for 30 days prior to randomization 5. Active/serious infection (including, but not limited to hepatitis B or C, HIV) 6. Malignancy 7. Systemic lupus erythematosus (SLE) or multiple sclerosis 8. Hepatic disease defined as serum AST/ALT > 2.5X the upper limit of normal 9. Patients with blood pressure > 140/95 or > 95th percentile for age/height while receiving maximal doses of 3 or more antihypertensive agents. 10. Diabetes mellitus (DM) type I or II. 11. Hematocrit < 30% 12. Organ transplantation 13. Obesity (based on estimated dry weight at disease onset prior to steroid therapy) defined as: 1. Body mass index (BMI) > 97th percentile for age if aged 2-20 years 2. BMI > 40 kg/m2 if aged ≥ 21 years 14. Allergy to study medications 15. Inability to consent/assent | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-18.0, Liver Transplantation Subjects who meet all of the following are eligible for this study: 1. Male or female patients, not older than 18 years old. 2. Primary liver transplantation 3. Patient is capable of understanding the purpose and risks of the study and has been informed both orally and in writing and has given informed consent Subjects who meet one or more of the following are not eligible for this study: 1. Female patients who are pregnant or are breast feeding 2. Patients > 18 years old 3. Combined liver-kidney transplantation 4. Recipient of second liver graft 5. Patients are allergic, hyper-sensitive or intolerant to HCO-60 or structurally related compounds, macrolide antibiotics or tacrolimus. 6. Patients with known HIV-anamnesis 7. Patient requires ongoing dosing with a systemic immunosuppressive drug at study entry for another indication than the prophylaxis of liver graft rejection 8. Patient has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, or active peptic ulcer. 9. Patient is participating or has participated in another clinical study and/or is taking or has been taking an investigational drug in the past 28 days. 10. Other reasons which depend on the assessment of the physician (no MMF will be given to patients with severe persistent hypersplenism (WBC < 3.500/ml, platelets < 50.000/ml) | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-75.0, Melanoma Melanoma stage III (regional lymph node recurrence). Will be selected the patients with only one invaded lymph node confirmed by anatomopathological exam after lymph nodes excision Absence of visceral metastases verified by physical examination, chest radiography, liver echography and brain-chest-liver CT-Scan Age < 75 years, both genders ECOG 0-2, Karnofsky > 80% Negative pregnancy test performed at the screening visit for fertile women The potentially fertile women must use an oral contraception or an intra-uterine device (IUD) until three months following the last injection of the study treatment The patients must have fully recovered from surgery HIV 1/2: The patients must be negative for antibodies HIV 1 and HIV 2 and for Ag P24 or DGV HIV HBV: The patients must be negative for the antigen, but can be positive for the antibodies but with a negative DNA PCR HCV: The patients must be negative for the antibodies Patient with more than one invaded lymph node confirmed by anatomopathological exam Presence of melanoma metastases discovered by clinical or radiological examination at the screening visit Patients must not have received any Chemotherapy, immunotherapy or radiotherapy within the preceding 4 weeks (6 weeks since prior nitrosurea and mitomycin C therapies) Presence of cardiac affections (congestive cardiac insufficiency, coronaropathy, not controlled HTA) Any serious active medical illnesses, for example: Active systemic infections requiring of antibiotics, coagulation disorders or any other condition which requires concomitant medications not allowed during this study Presence of the second active cancer other than surgically cured non-melanoma skin cancer or cervical carcinoma in-situ Any affection requiring a systemic corticotherapy or a treatment by Interferon A Any active auto-immune disease including the insulin-dependent diabetes or a immunodeficiency. The vitiligo is not an Thyroid dysfunction not responsive to therapy Positive Serology for HIV, HVB, HVC or HTLV1/2 | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-999.0, Oral Cavity Squamous Cell Carcinoma Clinically free of disease after having undergone surgery for histologically confirmed primary keratinizing SCC of the oral cavity. buccal mucosa upper lip (140.3) lower lip (140.4) cheek (145.0) retromolar area (145.6) bucco-alveolar sulci upper and lower (145.1) oral tongue dorsum (141.1) lateral border (141.2) inferior surface (141.3) With any one of the risk factors of recurrence listed below: Nodal extracapsular spread of disease (ECS) Number of positive node > 2 Perineural involvement Lymphovascular emboli/permeation in resected surgical specimen Histologically positive surgical margin Karnofsky performance status of <50 Concurrent or previous second primary cancer (excluding non-melanoma skin cancer) Gross residual disease following surgery Distant metastasis before or at the time of adjuvant treatment Serum creatinine > 1.4 mg/dl, WBC <3500/mm3, platelet <100,000/mm3 - | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 15.0-50.0, Multiple Sclerosis Ages 15-50 Three months within the acute onset of neurological symptoms suggestive of multiple sclerosis Diagnosis of clinically probable MS (CPMS) C3: 1 attack with at least 1 clinical manifestation in addition to positive brain MRI as defined in the protocol, signifying paraclinical evidence (Poser 1983) Positive Brain MRI: at least 4 focal lesions involving the white matter of 3 lesions if one is periventricular > 3mm diameter, each Negative pregnancy test and use of effective contraceptives for female patients who are sexually active Signed written informed consent Blood tests suggestive of other autoimmune diseases Known allergic reaction to MRI contrast media A clear regression of the neurological symptoms after the first attack that excludes a primary progressive course Corticosteroid treatment in the previous 4 weeks Previous treatment with immunosuppressive medications such as cyclophosphamide, azathioprine, methotrexate, mitoxantrone, or cyclosporine Previous treatment with interferon beta 1a or 1b copolymer-1 IVIg, plasmapheresis | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 20.0-70.0, Orbital Trauma Orbital Fractures age: 20 years facial trauma with orbital fractures No other coexistent conditions eg. diabetes, heart disease, etc | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-999.0, Pregnancy Primiparae No medical indication for specialistic care The pregnant woman will be able to give birth at home or at a hospital The woman and her partner will be fluent in the Dutch language | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 18.0-85.0, Breast Neoplasms Lung Neoplasms Ovarian Neoplasms Sarcoma, Soft Tissue Patients with pathological diagnoses of breast, lung, and ovarian adenocarcinomas and soft tissue sarcoma Patients with de novo malignancies and no previous chemotherapy Patients with advanced refractory malignancies who received no more than 2 standard chemotherapy treatment protocols Patients of any age group Patients must have tumor which is accessible and agree to undergo biopsies, or drainage of effusions Patients for whom chemotherapy is a treatment option Patients with symptomatic/uncontrolled parenchymal brain metastasis and non-accessible tumors Patients with meningeal metastasis Patients for whom chemotherapy is not clinically indicated Pregnancy. During the course of the study, all patients of childbearing potential should be instructed to contact the treating physician if they suspect they might have conceived a child; for females, a missing or late menstrual period should be reported to the treating physician. If pregnancy is confirmed by a pregnancy test, the patient must not receive study medication and must not be enrolled into the study or, if already enrolled, must be withdrawn from the study. If a male patient is suspected of having fathered a child while on the study drugs, the pregnant female partner must be notified and counseled regarding the risk to the fetus. Pregnancy during the course of this study will be reported to the Principal Investigator as a serious adverse event. Women of childbearing potential are defined to any female who has experienced menarche and has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not post-menopausal (defined as amenorrhea for more than 12 consecutive months); this also includes females using oral, implanted, or injectable contraceptive hormones, mechanical devices, or barrier methods to prevent pregnancy | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 2.0-999.0, Kidney Disease Glomerular Disease Idiopathic Nephrotic Syndrome Focal Segmental Glomerulosclerosis Collapsing Glomerulopathy Children with newly diagnosed clinical idiopathic nephrotic syndrome between the ages of 2-18 years. 2. Children with previously diagnosed clinical idiopathic nephrotic syndrome between the age of 2-18 years at the time of diagnosis who sustain a relapse of nephrotic syndrome while off steroid therapy. A relapse is defined as a urine protein level of 2+ (100mg/dl) or greater on a first morning urine sample for 3 consecutive days. While a quantitative urine protein/creatinine ratio is more precise, this semi-quantitative definition accords with pediatric practice. Relapses will be treated according to standard clinical practice. 3. Children and adults who participate in NIH trials of remittive therapy for MCD/FSGS/CG (e.g. Podocyte dexamethasone or Retinoids for podocyte disease) will be eligible. 4. Also, we will study up to 10 healthy adult volunteers IN ANY OF THE 1. Age less than 2 years. The rationale for excluding children under the age of 2 yr is that nephrotic syndrome is unusual in this age group and may have etiologies other than MCD and FSGS 2. Uncontrolled hypertension (a systolic or diastolic which is greater than 95% population mean for child s age and sex, while receiving therapy), azotemia (serum creatinine greater than 1.5mg/dL), gross hematuria at the time of presentation (clinical markers of primary or secondary GN). 3. Hypocomplementemia, positive ANA, anti-DS DNA, ASO, anti-DNase B, MPO, PR-3, Hepatitis B and C and HIV serologies. 2. In children or adults: 1. Clinical contra-indications to steroid therapy. 2. The presence of medical conditions that might interfere with the interpretation of results, such as cancer, diabetes, or a long history of hypertension. 3. Healthy adult volunteers: 1. age greater than 18 yrs; no history of hypertension, diabetes, or other chronic illness that might complicate interpretation of the results; not taking prescription medication. CKD STUDY: 1. Renal biopsy diagnosis of glomerular disease or interstitial nephritis or clinical diagnosis of diabetic nephropathy. 2. Mild or moderate renal insufficiency, defined as eGFR less than 60 ml/min/1.73m(2) but greater than 30 ml/min/1.73m(2) The presence of medical conditions that might interfere with the interpretation of results, such as cancer. STUDY: 1. Adults greater than 18 years old. Few children have diabetic nephropathy and the frequent blood draws would be problematic for children. 2. Type 1 or Type 2 diabetes. Later studies will be expanded to other glomerular diseases. 3. Urinary albumin/creatinine ratio greater than 30 mg/g. The rationale is to patients with macroproteinuria and patients with microalbuminuria. 4. Estimated GFR greater than 30 mL/min/1.73m(2). The rationale is to patients with severe CKD Allergy to ACE inhibitor or ARB 2. Current or planned pregnancy; urine HCG performed at start of study and on the day of iothalamate infusion. 3. Serum potassium greater than 5.0 mEq/L off angiotensin antagonist therapy 4. The presence of medical conditions which would make interpretation of results difficult such as cancer. 5. History of iodine allergy or severe asthma (history of emergency department visit or hospitalization). SEX IN 1. Age 18-30; Young adults are less likely to have undetected chronic renal disease. 2. BMI 18-27.5 kg/m(2); Obesity may alter renal function. 3. BP consistently less than 130/80; Pre-hypertension or hypertension may affect the kidney Any chronic illness that might interfere with interpretation of the study; certain illnesses that do not require therapy may be consistent with including mild asthma or psychiatric illness. 2. Cancer other than non-melanoma skin cancer in the past 5 years. 3. Need for any chronic or intermittent medication other than acetaminophen. 4. Women: amenorrhea, irregular menses, menstrual cycles less than 26 days or greater than 32 days, or use of contraceptive hormones (unwilling or unable to switch to non-hormonal means of contraception); Irregular cycle may be non-ovulatory and associated with abnormal sex hormone profiles, which will complicate data interpretation. 5. Use of nicotine or illicit drugs. 6. Febrile illness or urinary tract infection: postpone admission one week or more. SALT AND BLOOD IN 1. Men Age 18-35 2. BMI 18-25 kg/m(2) 3. BP consistently less than 130/80 Any chronic illness that might interfere with interpretation of the study; certain illnesses that do not require therapy may be consistent with including mild asthma or psychiatric illness 2. Cancer other than non-melanoma skin cancer in the past 5 years 3. Need for any chronic or intermittent medication other than acetaminophen 4. Use of nicotine or illicit drug 5. Febrile illness or urinary tract infection: postpone admission one week or more | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 23.0-999.0, Opioid Dependence Minimum age 23 years Opiate dependency for at least 5 years Current main diagnosis of opiate dependency according to the ICD-10 Current daily and predominantly intravenous heroin consumption or continuing heroin consumption in maintenance treatment Symptoms of physical illness indicating a poor state of health according to the OTI health scale; at least 13 current symptoms must be found OR Current mental symptoms or disturbances, i.e. a standardised GSI value of the SCL-90-R (Franke 1995) of at least 60 points No participation in an addiction treatment programme (a.a. maintenance, inpatient or outpatient treatment) at least within the last 6 months, but documented previous experience with drug therapies OR Negative course of maintenance treatment according to the guidelines of the German Medi¬cal Council (Bundesärztekam¬mer 1997) due to (a) continuous additional consumption of heroin (50% of the urine samples positive within the last 6 months) or cocaine (harmful use of cocaine/crack according to ICD-10) in a documented maintenance period of at least 6 months with a current maintenance dose of at least 60 mg d l methadone (or 30 mg levo¬methadone) daily Residence or registration in the city (or city state) or region that conducts the heroin treat¬ment for at least 12 months Voluntary participation and ability to comply with the treatment conditions (willingness to change treatment location; compliance; treatment control/documentation; evalua¬tion) Written consent to comply with the treatment conditions Persons who are currently in prison or awaiting trial or who can be expected to be taken into custody within the next 3 months Persons who had voluntary phases of abstinence of at least 2 months during the last 12 months Known epilepsy or generalised convulsions during the last 12 months Hypersensitivity to test substances and additives Regular intake of MAO inhibitors Serious bronchial asthma, COPD, Cor pulmonale Serious cardiac arrhythmia Prostatic hypertrophy (with urinary retention) Urethral stricture Life threatening liver disorders (exogenous hepatic coma) | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 15.0-70.0, Autoimmune Thyroiditis Hashimotos Thyroiditis Clinically approved AIT patients who do not use any medication other than LT4 to keep TSH in the lower half of normal range Any kind of drug use other than LT4 or any kind of known pathology which may effect GIS absorption | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-18.0, Stage I Lymphoepithelioma of the Nasopharynx Stage I Squamous Cell Carcinoma of the Nasopharynx Stage II Lymphoepithelioma of the Nasopharynx Stage II Squamous Cell Carcinoma of the Nasopharynx Stage III Lymphoepithelioma of the Nasopharynx Stage III Squamous Cell Carcinoma of the Nasopharynx Stage IV Lymphoepithelioma of the Nasopharynx Stage IV Squamous Cell Carcinoma of the Nasopharynx Histological diagnosis of nasopharyngeal carcinoma WHO type II or III Stage I-IV disease Newly diagnosed disease Performance status Patients ≤ 16 years of age: Lansky 60-100% Patients > 16 years of age: Karnofsky 60-100% Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min Creatinine based on age/gender as follows No greater than 0.4 mg/dL (for patients 1 month to < 6 months of age) No greater than 0.5 mg/dL (for patients 6 months to < 1 year of age) | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | 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 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 18.0-999.0, Myasthenia Gravis Acquired generalized MG diagnosed by one of the Principal Investigators based on Examination by site PI showing myasthenic weakness that is not limited to the ocular or peri-ocular muscles Elevated acetylcholine receptor antibodies Positive edrophonium chloride test or abnormal neuromuscular transmission demonstrated by single fiber EMG or repetitive nerve stimulation. 2. Aged at least 18. 3. Able to give informed consent. 4. Taking a constant dose of Mestinon for at least 2 weeks. 5. Symptom severity that would, in the judgment of the site investigator, justify initiation of immunosuppressive treatment. 6. Able and willing to comply with study requirements Thymoma now or in the past. 2. Plasma exchange or IVIG treatment within 90 days of randomization. 3. Treatment with azathioprine, cyclosporine, mycophenolate mofetil, or other immunosuppressive medication since onset of MG. Treatment with prednisone or other corticosteroids within the previous 90 days. • Exception: patients may have taken doses of these immunosuppressant medications that are judged by the Principal Investigator to have been clinically insignificant, i.e. unlikely to produce improvement in MG. 4. Women of childbearing potential who are pregnant, breast-feeding or not practicing effective contraception. 5. Renal failure, active thyroid or hepatocellular disease, chronic infection, poorly controlled cardiac disease, or any other illness, including psychiatric disease, that would, in the opinion of the treating physician, make it unsafe for the patient to participate or would interfere with the interpretation of study results. 6. Weakness affecting only ocular or peri-ocular muscles (Myasthenia Gravis Foundation of America Class I). 7. Severe weakness predominantly affecting oropharyngeal, respiratory muscles or both (MGFA Class IVB). 8. Crisis or impending crisis (defined as FVC <10ml/Kg or bulbar weakness severe enough to compromise airway protection.) 9. Hemoglobin <10mg/dl; WBC <3,500. 10. History of non-compliance with treatment and office visits. 11. Thymectomy within 12 months before randomization. 12. Concurrent medical condition that would pose an unacceptable risk from immunosuppression, including a positive skin test for tuberculosis (PPD), unless the patient has previously received appropriate treatment | 1 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-6.0, Hyperbilirubinemia Erythroblastosis, Fetal All newborns with a gestational age equal or higher than 32 weeks, with a Rh (D) positive blood type, children of sensitized Rh (D) negative mothers, regardless if they were submitted or not to an intra-uterus transfusion Newborns in serious condition, hydropic, hemodynamically instable or with indication for exchange transfusion at birth. The indications for exchange transfusion at birth are: presence of bilirubin in the umbilical cord higher or equal to 4mg%; hydrops, cardiac insufficiency secondary to severe anemia | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-70.0, Lymphoma Histologically proven extranodal NK/T-cell lymphoma, nasal type according to the WHO classification (must be pathology-proven EBV DNA positive as well as cytoplasmic CD3 +, while CD56+ is not an essential diagnostic criteria. ). Newly diagnosed patients. 2. Any of lymphomatous involvement exist in nasal cavity and/or paranasal sinuses, orbit, Waldeyer's ring, and oral cavity performance status with ECOG scale 0-2. 3. Stage I or contiguous stage II, measurable or evaluable lymphoma by clinical imaging No previous chemotherapy and/or radiotherapy. 4. ANC ≧ 2,000/mm3, Platelet ≧ 100,000/mm3 of peripheral blood. 5. Age <70. 6. Total bilirubin < 2.5 mg/dl, Serum creatinine ≦1.5 mg/dl, Blood urea nitrogen (BUN) ≦ 25 mg/dl Pregnancy or lactation period 2.Severe intercurrent illness, eg. Infection, heart failure 3.Myocardial infarction within recent 12 months 4.Known hypersensitivity to any component drug of the treatment regimen - | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 15.0-60.0, Preeclampsia Pregnancy Induced Hypertension Gestational Hypertension Chronic Hypertension Superimposed Preeclampsia Any patient with preeclampsia (BP > 140 systolic and/or > 90 mmHg diastolic with 1+ or more proteinuria [or a 24 hour specimen with > 300 mg/day]), chronic hypertension (or superimposed preeclampsia), or gestational hypertension deemed to be at risk for eclamptic convulsions and who would routinely be treated in the participating institution with some form of anti-seizure prophylaxis during labor and delivery Any patient for whom informed consent cannot be obtained Any patient who has received an antihypertensive medication within 6 hours prior to enrollment will not be eligible but those who have received antihypertensive medications other than beta-blockers or magnesium sulfate may still be enrolled as long as they have not been given a dose within the 6 hours prior to enrollment. If a patient has received MgSO4 or a short acting beta-blocker or calcium channel blocker more than 12 hours prior to enrollment or if they have received a long acting beta-blocker more than 24 hours before enrollment she may still be considered eligible. This stipulation will allow increased recruitment of patients especially those with chronic hypertension and those transferred from outlying institutions. We expect these patients to be a minority of the enrollment A history of bronchial asthma, emphysema, heart block, angina, cardiomyopathy or myocardial infarction Any history or signs of congestive cardiac failure, or arrhythmia with a ventricular rate of less than 60 bpm Patients with severe mental or physical disorders which, in the opinion of the investigators, might affect responsiveness to therapy or any other aspect of the study Patients who are allergic to drugs with a chemical structure similar to labetalol or magnesium sulfate Patients given magnesium sulfate, labetalol or short acting beta blockers or calcium channel blockers less than 12 hours prior to enrollment in the study Evidence of fetal distress or fetal anomalies Inability to secure intravenous access Patient's primary physician declines to enroll patient in study | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 18.0-65.0, Myasthenia Gravis Male and female MG patients age greater than 18 and less than 65 years Onset of generalized MG within the last 5 years Positive serum anti-acetylcholine receptor binding antibodies (muscle acetylcholine receptors, AchRAb =/> 1.00 nmol/L. AchRAb levels of 0.50-0.99 nmol/L will be acceptable if there is another confirmatory test for MG, including single-fiber electromyography (EMG), repetitive nerve stimulation, or unequivocal edrophonium testing.) MGFA class II-IV at entry, using the MG Foundation of America (MGFA) classification, while receiving optimal anti-cholinesterase treatment with or without oral prednisone Ocular MG without generalized weakness (MGFA Class I) or minimal weakness that would not require the use of corticosteroids Myasthenic weakness requiring intubation (MGFA Class IV) in the prior month Immunosuppressive therapy other than corticosteroids in the preceding year Medically unfit for thymectomy Chest CT evidence of thymoma Pregnancy or lactation; contraindications to the use of corticosteroids, unless postmenopausal or surgically sterile. Women considering becoming pregnant during the period of the study are to be excluded A serious concurrent medical, neurological or psychiatric condition that would interfere with thymectomy or subsequent clinical assessments Current alternate day dose of prednisone > than 1.5 mg/kg or 100 mg or the equivalent daily doses (> 0.75 mg/kg or 50 mg) Participation in another experimental clinical trial History of alcohol or drug abuse within the 2 years prior to randomization | 1 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 18.0-65.0, Classical Hodgkin Lymphoma Nodular Sclerosis Mixed Cellularity Lymphocyte Depletion Lymphocyte Rich stage I-IIA/B with adverse prognostic or III-IV disease Age 18 and Over Performance status ECOG 0-3 Hematopoietic WBC at least 4000/mm3(unless documented bone marrow involvement) Hepatic bilirubin no greater then 5 mg/dL RENAL:Creatinine no greater than 2.0mg/dL not pregnant or nursing Fertile patients must use effective contraception HIV negative No other malignancy within the past 5 years | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 18.0-999.0, Myasthenia Gravis age > or equal to 18 years old with a confirmed diagnosis of myasthenia gravis and worsening weakness age <18; severe myasthenia gravis requiring intensive care admission; change in immunosuppresive medication in previous 3 months; patients with severe bulbar weakness at risk for aspiration and respiratory failure; patients with other serious underlying medical conditions (renal failure, congestive heart failure); unwilling to provide informed consent | 1 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 5.0-70.0, Kidney Transplant Kidney Transplant Recipient Graft Function/Survival de Novo HLA Antibodies Development Stage 1 for All Participants Willing to provide informed consent Previously diagnosed end stage renal disease (ESRD) Received kidney transplant within 3 and 36 months of study entry Willing to comply with the study protocol Willing to use acceptable forms of contraception during the study and for 12 months following rituximab/placebo therapy Willing to refrain from breastfeeding during the study and for 12 months following rituximab therapy Stage 1 for Pediatric Participants (<\=18 Years of Age) Parent or guardian willing to provide informed consent Have received all childhood vaccinations prior to study entry Stage 2 for Pilot Treatment Study Three to 39 months post-transplant for All Participants Recipient of a kidney from a donor older than 70 years of age Multi-organ transplant History of organ transplantation other than current kidney transplantation Previous treatment with rituximab History of severe allergic reactions to monoclonal antibodies History of allergic reaction to iodine glomerular filtration rate (GFR) assay Lack of intravenous (IV) access Sensitized to greater than 5% Panel Reactive Antibody (PRA) within 12 weeks prior to transplant History of recurrent bacterial or other significant infections | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 16.0-64.0, Myasthenia Gravis Clinically diagnosed as myasthenia gravis Those whose MG symptoms are well-controlled by the treatment with prednisone Steroid non-refractory Myasthenia Gravis: ≧20mg and ≦40mg / alternate day of steroid dose required to maintain Those who have thymoma or the history of thymoma (Masaoka stage III or IV) Patients who received steroid pulse therapy, plasma exchange therapy, globulin therapy or radiation therapy within 12 weeks prior to the initiation of test drug Patients who started the immunosuppressant therapy or increased the dose of immunosuppressant within 12 weeks prior to the initiation of test drug Patients who had undergone thymectomy within 24 weeks prior to the initiation of test drug Pancreatitis or diabetes Serum creatinine≦1.5mg/dL | 1 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 16.0-64.0, Myasthenia Gravis Clinically diagnosed as myasthenia gravis Those whose MG symptoms are not controlled by the treatment with prednisone Those who had undergone thymectomy | 2 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 18.0-999.0, Hypercholesterolemia Patients are eligible for study entry based on the following 1. Males or females greater than or equal to 18 years of age 2. Females must not be pregnant or lactating. Females of childbearing potential and males must use a reliable means of contraception. 3. LDL-C level greater than the NCEP goals, as determined by patients' risk category according to NCEP ATP III 4. Risk category for coronary heart disease and coronary heart disease equivalent with LDL goal of < 100 mg/dL 5. Baseline lipid LDL-C = 100 to160 mg/dL and triglyceride level = 100 to 500 mg/dL 6. Normal thyroid function tests (total T3, total T4, and thyroid-stimulating hormone [TSH]) 7. Hemoglobin A1C < 8.5% on a stable oral hypoglycemic or insulin regimen 8. On stable lipid modification pharmacotherapy (including a statin) for at least 2 weeks prior to study entry. Patients must be on at least half of the maximal doses of statins (as assessed by the Investigator), or be intolerant to statins such that the doses are not achievable. 9. Able to give informed consent Pre-Randomization Patients will not be eligible for the study based on the following 1. History of thyroid disorders of any form within 24 weeks prior to study entry 2. Active liver disease and/or liver transaminases greater than 1.5 X upper limit of normal 3. Active myocarditis, hypertrophic cardiomyopathy, uncorrected primary valvular disease, restrictive cardiomyopathy, uncorrected congenital heart disease, or constrictive pericarditis 4. Myocardial infarction, unstable ischemic heart disease, stroke, or coronary revascularization procedure within 24 weeks prior to study entry 5. Moderate or severe symptomatic congestive heart failure (New York Heart Association class III and IV) 6. Drug or alcohol dependence, or other conditions which may affect study compliance 7. Renal insufficiency (serum creatinine > 2 mg/dL) 8. Subjects taking other hormonal therapies (other than oral contraceptive agents and postmenopausal hormone replacement therapy) e.g., glucocorticoids, androgens, or growth hormones 9. Use of thyroid supplements (levothyroxine, liothyronine, etc.) or any preparation containing thyromimetic agents within 24 weeks prior to study entry 10. History of coagulopathy or use of anticoagulants such as warfarin 11. Unstable endocrine/metabolic syndrome that may affect lipid metabolism 12. History of atrial or ventricular arrhythmia 13. Diagnosis of other non-cardiac underlying medical conditions expected to impact mortality within 24 weeks after randomization | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-999.0, Pregnancy Have been exposed to within 8 weeks prior to conception or at any time during pregnancy Provide sufficient information to determine that the pregnancy is prospectively registered (i.e., the outcome of pregnancy must be unknown prospectively) Provide verbal consent to participate in the Registry, and Verbally provide the contact information for herself, her healthcare provider (HCP), and the infant's HCP (if applicable) None | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-49.0, Adult Malignant Mesenchymoma Adult Rhabdomyosarcoma Childhood Alveolar Rhabdomyosarcoma Childhood Botryoid-Type Embryonal Rhabdomyosarcoma Childhood Embryonal Rhabdomyosarcoma Childhood Malignant Mesenchymoma Non-Metastatic Childhood Soft Tissue Sarcoma Stage I Adult Soft Tissue Sarcoma Stage II Adult Soft Tissue Sarcoma Stage III Adult Soft Tissue Sarcoma Untreated Childhood Rhabdomyosarcoma Patients with newly diagnosed embryonal RMS, botryoid or spindle cell variants of embryonal RMS, ectomesenchymoma, or alveolar RMS are eligible for this study Enrollment on COG-D9902 to confirm local histologic diagnosis with central pathology review is required for all patients Patients may be enrolled on ARST0531 and start protocol treatment prior to receipt of central pathology review results Patient must have Intermediate-risk RMS defined as Embryonal, botryoid, or spindle cell RMS, or ectomesenchymoma: stage 2 or 3 and group III OR Alveolar RMS: stage 1-3 and group I-III Staging ipsilateral retroperitoneal lymph node dissection (SIRLND) is required for all patients >= 10 years of age with paratesticular tumors and for patients < 10 years with clinically or radiographically involved lymph nodes (except when extensive lymph node involvement, defined as two or more lymph nodes > 2 cm in dimension, is identified by imaging studies) Regional lymph node sampling or sentinel lymph node procedure is required for histologic evaluation in patients with extremity tumors Clinically or radiographically enlarged nodes should be sampled for histologic evaluation Detection of metastasis by optional FDG PET (not required for study enrollment); FDG PET may detect abnormalities suggestive of metastasis not identified by bone scan, computed tomography (CT), or bone marrow aspiration/biopsy; the prognostic significance of FDG PET-detected abnormalities is not clear; FDG PET-detected abnormalities MUST be confirmed to be metastases by an additional imaging modality (such as magnetic resonance imaging [MRI] or CT) OR pathologic confirmation; unless FDG PET abnormalities are confirmed by another imaging modality or biopsy, FDG PET abnormalities will NOT be considered evidence of metastasis | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 5.0-75.0, Hepatitis B Diagnosis of acute hepatitis B Bilirubin > 5 mg/dl at presentation Patients with co-infection, a history of hepatotoxic drug intake or alcohol use >20g/day, or any evidence of chronic liver disease in the past, at presentation or during follow-up | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 3.0-21.0, Anaplastic Medulloblastoma Medulloblastoma Newly diagnosed, previously untreated: (1) M0 medulloblastoma with > 1.5 cm^2 residual; (2) M+ medulloblastoma; patients with diffusely anaplastic medulloblastoma are eligible regardless of M-stage or residual tumor As of amendment # 2, enrollment of patients with supratentorial PNET has been discontinued All patients with M4 disease are not eligible A pre-operative magnetic resonance imaging (MRI) scan of the brain with and without contrast is required; NOTE: computed tomography (CT) scans are NOT sufficient for study Post-operative head MRI scan with and without contrast (preferably within 72 hours post-surgery); for patients who undergo stereotactic biopsy only, either a pre or post-operative MRI is sufficient; for patients with M2 and M3 disease, a post-op MRI is strongly encouraged, but not mandatory Spinal MRI imaging with and without gadolinium is required within 10 days of surgery if done pre-operatively or within 28 days of surgery if done post-operatively; for posterior fossa tumors, pre-operative MRI scans are preferred Lumbar cerebrospinal fluid (CSF) cytology examination must be obtained pre-operatively or within 31 days following surgery; the optimal time for obtaining CSF is prior to surgery or 1-3 weeks following surgery; ventricular CSF (either pre or post-op) may be used only if a post-operative spinal tap is contraindicated; if a spinal tap is contraindicated and there is no ventricular CSF available, then CSF cytology can be waived for patients with supratentorial tumors or if there is documentation of spinal subarachnoid metastases (M3); patients who are categorized as M1 must have either an intra-operative positive CSF (via lumbar puncture at the end of the procedure) or a positive lumbar CSF obtained > 7 days post-operatively Patients must have a Karnofsky performance level of >= 30 for patients > 16 years of age or a Lansky performance scale of >= 30 for patients =< 16 years of age and life expectancy > 8 weeks No previous chemotherapy or radiation therapy | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 50.0-75.0, Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative Chronic Myelomonocytic Leukemia de Novo Myelodysplastic Syndrome Essential Thrombocythemia Myeloproliferative Neoplasm Paroxysmal Nocturnal Hemoglobinuria Polycythemia Vera Polycythemia Vera, Post-Polycythemic Myelofibrosis Phase Primary Myelofibrosis Refractory Anemia Refractory Anemia With Excess Blasts Refractory Anemia With Ring Sideroblasts Refractory Cytopenia With Multilineage Dysplasia Refractory Cytopenia With Multilineage Dysplasia and Ring Sideroblasts Patients aged >= 50 and < 75 years (yrs) with CMML, or previously untreated MDS or MPD Patients aged < 50 yrs at high risk for regimen related toxicity using standard high dose regimens; factors considered high risk pre-existing conditions such as a chronic disease affecting kidneys, liver, lungs, or heart or previous failed HCT An human leukocyte antigen (HLA)-identical related or an HLA-matched unrelated donor (Fred Hutchinson Cancer Research Center [FHCRC] matching allowed will be Grade 1.0 to 2.1) is available Recovery from the effects of previous chemotherapy, with a minimum of 21 days from initiation of last therapy; hydroxyurea or anagrelide may be used to manage elevated cell counts in patients up to the time they begin therapy under this protocol Patients < 12 yrs of age must be discussed on a case by case basis with the primary investigator (PI) of the protocol prior to registration A signed informed consent form or minor assent form MDS: MDS classifiable by the World Health Organization (WHO) system as RA, RARS, refractory cytopenia with multilineage dysplasia (RCMD), RCMD and ringed sideroblasts (RCMD-RS) or RAEB MDS: No previous myelosuppressive therapy; for the purpose of this protocol myelosuppressive chemotherapy will be defined as chemotherapy given with the intent of inducing a complete remission (e.g., standard 7+3, high dose intermittent ARA-C [HIDAC], or Mylotarg) MDS: Patients must have < 10% marrow blasts; fewer than 10% marrow blasts must be documented by marrow examination within 3 weeks of initiation of conditioning CMML: Patients with CMML1 who have not received myelosuppressive therapy must have < 10% marrow blasts; fewer than 10% marrow blasts must be documented by marrow examination within 3 weeks of initiation of conditioning; OR patients with CMML who have progressed beyond CMML1 and have received myelosuppressive chemotherapy must have < 5% marrow blasts; fewer than 5% marrow blasts must be documented by marrow examination within 3 weeks of initiation of conditioning Organ dysfunction as defined by the following Symptomatic coronary artery disease or cardiac ejection fraction < 35% (or, if unable to obtain ejection fraction, shortening fraction of < 26%); if shortening fraction is < 26% a cardiology consult is required with the principal investigator (PI) having final approval of eligibility; ejection fraction is required if age > 50 years or there is a history of anthracycline exposure or history of cardiac disease Diffusing capacity of the lung for carbon monoxide (DLCO) < 35%, TLC < 35%, forced expiratory volume (FEV)1 < 35% and/or receiving supplementary continuous oxygen; the FHCRC PI of the study must approve of enrollment of all patients with pulmonary nodules Liver function abnormalities: Patient with clinical or laboratory evidence of liver disease will be evaluated for the cause of liver disease, its clinical severity in terms of liver function, bridging fibrosis, and the degree of portal hypertension; the patient will be excluded if he/she is found to have fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction evinced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin > 3mg/dL, or symptomatic biliary disease Bone marrow documenting blast count >= 10% or >= 5% in CMML patients who have progressed beyond CMML1 and received myelosuppressive chemotherapy Patients with active non-hematologic malignancies (except non-melanoma skin cancers); this does not apply to patients with non-hematologic malignancies that do not require therapy Patients with a history of non-hematologic malignancies (except non-melanoma skin cancers) currently in a complete remission, who are less than 5 years from the time of complete remission, and have a > 20% risk of disease recurrence Presence of >= 5% circulating leukemic blasts (in the peripheral blood) detected by standard pathology Active central nervous system (CNS) involvement of disease Karnofsky performance score < 70% or Lansky-Play Performance score < 70 for pediatric patients | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 65.0-999.0, Newly Diagnosed Multiple Myeloma Must understand and voluntarily sign an informed consent form 2. Age greater than or equal to 65 years at the time of signing the informed consent 3. Newly diagnosed with symptomatic multiple myeloma as defined by the 3 below: MM diagnostic (all of next 3 required) 1. Monoclonal plasma cells in the bone marrow greater than or equal to 10% and/or presence of a biopsy-proven plasmacytoma 2. Monoclonal protein present in the serum and/or urine 3. Myeloma-related organ dysfunction (at least one of the following) [C] Calcium elevation in the blood (serum calcium >10.5mg/dl or upper limit of normal) [R] Renal insufficiency (serum creatinine >2mg/dl) [A] Anemia (hemoglobin <10g/dl or 2g < normal) [B] Lytic bone lesions or osteoporosis AND have measurable disease as defined by the following; IgG multiple myeloma: Serum monoclonal paraprotein (M-protein) level greater than or equal to 1.0 g/dL or urine M-protein level greater than or equal to 200 mg/24 hours IgA multiple myeloma: Serum M-protein level greater than or equal to 0.5 g/dL or urine M-protein level greater than or equal to 200 mg/24 hours IgD multiple myeloma: Serum M-protein level greater than or equal to 0.05 g/dL or urine M-protein level greater than or equal to 200 mg/24 hours Light chain multiple myeloma: Serum M-protein level greater than or equal to 1.0 g/dL or urine M-protein level greater than or equal to 200 mg/24 hours IgM multiple myeloma (IgM M-protein plus lytic bone disease documented by skeletal survey plain films): Serum M-protein level greater than or equal to 1.0g/dL or urine M-protein level greater than or equal to 200mg/24hours 4. Karnofsky performance status greater than or equal to 60%. 5. Able to adhere to the study visit schedule and other protocol requirements. 6. Women of Childbearing potential (WCBP) must: a. Have a negative medically supervised pregnancy test prior to the start of study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the subject practices and continues sexual abstinence. b Either commit to continued abstinence from heterosexual intercourse (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including dose interruptions), and for 28 days after discontinuation of study therapy. 7. Males Subjects must: 1. Agree to use a condom during sexual contact with a WCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and after the cessation of study therapy. 2. Agree to not donate semen during study drug therapy and for a period after end of study drug therapy. 8. All subjects must 1. Have an understanding that the study drug could have potential teratogenic risk. 2. Agree to abstain from donating blood while taking study drug therapy and following discontinuation of study drug therapy. 3. Agree not to share study medication with another person. 4. All patients must be counseled about pregnancy precautions and risks of fetal exposure. Female Subjects: Females of childbearing potential (FCBP) with regular cycles must agree to have pregnancy tests weekly for the first 28 days of study participation and then every 28 days while on study, at study discontinuation, and at day 28 following discontinuation from the study. If menstrual cycles are irregular, the pregnancy testing must occur weekly for the first 28 days and then every 14 days while on study, at study discontinuation, and at days 14 and 28 following discontinuation from the study. In addition to the required pregnancy testing, the Investigator must confirm with FCBP that she is continuing to use two reliable methods of birth control at each visit. Counseling about pregnancy precautions and the potential risks of fetal exposure must be conducted at a minimum of every 28 days. During counseling, subjects must be reminded to not share study drug and to not donate blood. Pregnancy testing and counseling must be performed if a subject misses her period or if her pregnancy test or her menstrual bleeding is abnormal. Study drug treatment must be discontinued during this evaluation. Females must agree to abstain from breastfeeding during study participation and for at least 28 days after the discontinuation from the study. Male Subjects: Counseling about the requirement for latex condom use during sexual contact with females of childbearing potential and the potential risks of fetal exposure must be conducted at a minimum of every 28 days. During counseling, subjects must be reminded to not share study drug and to not donate blood, sperm, or semen. If pregnancy or a positive pregnancy test does occur in a study subject or the partner of a study subject during study participation, study drug must be immediately discontinued Previous treatment with antimyeloma therapy (does not radiotherapy, bisphosphonates, or a single short course of steroid [i.e., less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 28 days [4 weeks] of randomization]). 2. Any serious medical condition, including the presence of laboratory abnormalities, which places the subject at an unacceptable risk if he or she participates in this study or confounds experimental the ability to interpret data from the study. 3. Pregnant or lactating females. 4. Radiotherapy within 14 days (2 weeks) of randomization. 5. Plasmapheresis within 28 days (4 weeks) of randomization. 6. Any of the following laboratory abnormalities: Absolute neutrophil count (ANC) < 1,500 cells/mL (1.5*10^9/L) Platelet count < 75,000 cells/uL (75*10^9/L) for subjects in whom < 50% of bone marrow nucleated cells are plasma cells; but platelet count <30,000/uL for subjects in whom >= 50% of bone marrow nucleated cells are plasma cells Haemoglobin < 8.0 g/dL (80 g/L) Serum creatinine > 2.5 mg/dL (221 µmol/L) Serum aspartate aminotransferase (SGOT/AST) or alanine aminotransferase (SGPT/ALT) > 3.0 times upper limit of normal (ULN) 7. Prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for greater than or equal to 3 years. Exceptions the following: Basal cell carcinoma of the skin Squamous cell carcinoma of the skin Carcinoma in situ of the cervix Carcinoma in situ of the breast Incidental histologic finding of prostate cancer (TNM Classification of Malignant Tumours (TNM) stage of T1a or T1b) 8. Neuropathy of >= grade 2 severity. 9. Known human immunodeficiency virus (HIV) positivity or active infectious hepatitis, type A, B or C | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 15.0-65.0, Myasthenia Gravis (Patients must fulfill all of the following) 1. Established diagnosis of myasthenia gravis defined as clinical evidence of muscle weakness and fatigue ability and supported, an abnormal EMG-NCV repetitive nerve stimulation (or single-fiber EMG) or Lambert-Eaton Myasthenic Syndrome without evidence of malignancy. 2. Ages 15-65 years. 3. Positive antibody preferred (anti-AchR, MuSK, voltage gated calcium channel, anti-striational). 4. Failure of thymectomy (except for Lambert-Eaton Myasthenic Syndrome). 5. Failure anticholinesterase therapy, corticosteroids, and at least two of the following: azathioprine, cyclosporin, CellCept, cyclophosphamide, plasma exchange, or IVIG. Failure is defined as at least 6 months of the above drug therapy and an Osserman score of IIB, III, or IV and not clinically improving. And at least one of the following: 1. History of myasthenia crises (requiring mechanical ventilation) despite thymectomy and immunosuppressive therapy. 2. Hospitalized or on ventilator support for myasthenia gravis within the last 18 months despite thymectomy and immunosuppressive therapy. 3. Inability to maintain nutrition due to muscle weakness. 4. A Karnofsky performance status of 70% or less (may or may not be able to care for self, but unable to carry on normal activity or unable to do active work) Significant end organ damage such as: 1. LVEF <40% or deterioration of LVEF during exercise test on MUGA or echocardiogram. 2. Untreated life-threatening arrhythmia, active ischemic heart disease or heart failure. 3. DLCO < 40% of predicted value. 4. Serum creatinine > 2.5 mg/dl. 5. Liver cirrhosis, transaminases >3x of normal limits, or bilirubin >2.0 unless due to Gilberts disease. 2. HIV positive. 3. Uncontrolled diabetes mellitus, or any other illness that in the opinion of the investigators would jeopardize the ability of the patient to tolerate aggressive treatment. 4. Prior history of malignancy except localized basal cell or squamous skin cancer. Other malignancies for which the patient is judged to be cured by local surgical therapy, such as (but not limited to) head and neck cancer, or stage I or II breast cancer, will be considered on an individual basis. 5. Positive pregnancy test, inability or unable to pursue effective means of birth control, failure to willingly accept or comprehend irreversible sterility as a side effect of therapy. 6. Psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible. 7. Inability to give informed consent 8. Congenital myasthenia gravis 9. Neonatal myasthenia gravis 10. Osserman grade 1 or 2 11. Pure red cell aplasia 12. Any patient on insulin | 2 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 18.0-70.0, Hepatocellular Carcinoma Histologically proven hepatocellular carcinoma. 2. HCC underwent curative resection within 6 weeks before registration. 3. Grossly, the resection margin should be > 1 cm. 4. Tumors, either single, < 5 cm in size or no more than 3 for size < 3 cm. 5. Patients must have a performance status of ECOG score < 2. 6. Patients must have adequate liver reservation and adequate hemogram Pugh-Child's Score < 7 The serum total bilirubin level are < 2 mg/dl The prothrombin times are < 3 sec above normal control The platelet are > 7.5 x 104 / mm3 The WBC are > 3,000 / mm3. 7. Patient must have serum creatinine < 1.5 mg/dl 8. Cardiac function with NYHA classification < Grade II 9. HBsAg (+) . 10. Signed informed consent Patients who have non-curative resection are not eligible. 2. Resected HCCs with histologically positive margins are not eligible. 3. HCCs with radiological evidence of portal vein thrombus are not eligible. 4. Patients with other systemic diseases which required concurrent usage of glucoticosteroid or immunosuppressant agent(s) are not eligible. 5. Patients with advanced second primary malignancy are not eligible. 6. Patients with pregnancy or breast-feeding are not eligible. 7. Patients with severe cardiopulmonary diseases are not eligible. 8. Patients with clinically significant psychiatric disorder are not eligible. 9. Patients who had antineoplastic chemotherapeutic or immuno-therapeutic drugs or corticosteroids within 6 weeks of commencing the protocol are not eligible. 10. Patients who had prior lamividine and/or adefovir dipivoxil therapy are not eligible. 11. Anti-HCV positive patients are not eligible | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 18.0-999.0, Bladder Cancer (All questions must be answered YES) Has the patient given written informed consent? Is the patient at least 18 years old? Does the patient have transitional cell carcinoma of the bladder with clinically apparent stage Ta, grade G1-G2? If the patient is a female of childbearing potential, is she using an acceptable/effective method of contraception? If the patient is a female of childbearing potential, has she had a negative serum pregnancy test within the past 14 days? Is the patient willing and able to abide by the protocol? (All questions must be answered NO) Does the patient have more than 4 bladder tumors? Does any single bladder tumor exceed 3.5 cm in diameter? Does the patient have a single, primary (no previous diagnosis of TCC) bladder tumor <0.5 cm? Has the patient ever received Apaziquone? Does the patient have, or has the patient ever had, any bladder tumor known to be other than stage Ta or grade G1 or G2 (low grade [WHO/ISUP classification])? Does the patient have, or has the patient ever had any bladder tumor with histology other than transitional cell carcinoma? Does the patient have, or has the patient ever had, carcinoma in situ (CIS)? Does the patient have an active urinary tract infection? Does the patient have a bleeding disorder or a screening platelet count < 100 x 10^9/L? | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 18.0-65.0, HIV Infections Cardiovascular Disease for Group 1 (HIV-infected group) 1. Age greater than or equal to 18 and less than or equal to 65 years of age 2. HIV positive, on the same combination ARV regimen for > than 6 months, including but not limited to either 2 NRTIs and an NNRTI or PI, or a triple NRTI regimen 3. CD4 >350 cells/mm3 for Group 2 (HIV Negative, Healthy Control, age and BMI matched to HIV subjects) 1. No history of HIV infection (negative HIV test) 2. Age greater than or equal to 18 and less than or equal to 65 years of age for Group 1 (HIV-infected group) 1. Hgb < 10.0 g/dL, creatinine > 1.5 mg/dL, SGPT > 2.5x ULN 2. Use of glucocorticoid, testosterone, growth hormone or other anabolic agents within the past 6 months 3. New antiretroviral regimen within 6 months of study initiation 4. Active substance abuse 5. Medications known to affect glucose or body composition 6. Positive pregnancy test or recently pregnant within the past year or lactating 7. Presence of active cancers 8. Acute viral, bacterial or other infections (excluding HIV) 9. Weight loss in the past 3 months of greater than 10 pounds for Group 2 (HIV Negative, Healthy Control, age and BMI matched to HIV subjects) 1. Hgb < 10.0 g/dL, creatinine > 1.5 mg/dL, SGPT > 2.5x ULN 2. Use of glucocorticoid, testosterone, growth hormone or other anabolic agents within the past 6 months. 3. Active substance abuse 4. Medications known to affect glucose or body composition 5. Positive pregnancy test or recently pregnant within the past year or lactating 6. Acute viral, bacterial or other infections 7. Weight loss in the past 3 months of greater than 10 pounds | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-75.0, Acute Promyelocytic Leukemia Age <= 75 years ECOG = 3 Morphological diagnosis of M3 or M3v. Those cases without typical morphology but with PML-RARa rearrangement may also be included Genetic diagnosis: t(15;17), PML-RARa rearrangement, monoclonal anti-PML positive. Obviously, the result of these tests may become available after having initiated the treatment based on a tentative morphological diagnosis. The presence of secondary cytogenetic changes associated with t(15;17) is not a reason for nor do they require a different therapeutic approach Age > 75 years (the treatment with this protocol can be considered on an individual basis but these patients will be analysed separately) Absence of PML-RARa rearrangement Prior antileukemic chemotherapy Presence of an associated neoplasm Presence of a severe psychiatric disease HIV seropositivity Contraindication for intensive chemotherapy, especially to anthracyclines Serum creatinine = 2.5 mg/dL Bilirubin, alkaline phosphatase, or SGOT > 3 times the upper normal limit Positive pregnancy test | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-999.0, Muscular Atrophy, Spinal Individuals or family members of individuals who have been diagnosed with SMA | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-999.0, Hgb C Hemoglobinopathy All patients diagnosed as homozygous for Hgb C disease or double heterozygous in combination to other abnormal hemoglobin, and all the carriers detected in the hematology laboratory during the screening for abnormal hemoglobins in northern Israel | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 18.0-45.0, Hepatitis C Healthy, hepatitis C virus (HCV) negative 45 year old healthy adults. Insufficient data are available in adults to judge risk in children In good general health as determined by medical history, physical examination and the following screening labs Complete Blood Count (CBC): Total WBC (White Blood Cell): 3.5-14 thousand/microliter (MCL); Hemoglobin (Hgb): Men: 12.2-18 g/dl and Women: 10.5-17 g/dl Creatinine: Men: less than or equal to 1.4 mg/dl; Women: less than or equal to 1.2 mg/dl Glucose: 50 mg/dl to less than or equal to 109 mg/dl Alanine Aminotransferase (ALT): Men 2-60 units/litre (U/I): Women: 3-40 U/I Aspartate Aminotransferase (AST): Men: 2-50 U/I, Women 2-35 U/I Total bilirubin: Men: less than or equal to 1.5 mg/dl: Women: less than or equal to 1.3 mg/dl Urinalysis: negative or trace protein, negative glucose, less than or equal to 3 Red Blood Cells (RBC)/High Power Field (HPF) and less than or equal to 5WBC/HPF (in nonmenstruating females) Diabetes Cancer other than squamous cell skin cancer which has been excised History of myocardial infarction or arrhythmia requiring hospitalization Syncope requiring hospitalization Unconsciousness other than a simple concussion Seizures other than febrile seizures as a child <5 years of age Current liver disease (not including Gilbert's disease) Autoimmune disease (does not thyroid disease or vitiligo) Splenectomy Uncontrolled hypertension [blood pressure (BP) >150/90; anti-hypertensive medications are acceptable) | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 16.0-999.0, Generalized Myasthenia Gravis Patients diagnosed as generalized myasthenia gravis Patients who are not controlled by current therapy and need plasmapheresis therapy Patients who have the high-dose steroid therapy for over a month in past years, and also who take steroid or immunosuppressant on the day of consent Patients who had not any dose increase or new dosing of steroid or immunosuppressant within 4 weeks prior to enrollment Patients who received steroid pulse therapy, globulin therapy or plasmapheresis therapy within 12 weeks prior to enrollment Patients who had undergone thymectomy within 24 weeks prior to enrollment Patients with 3 points item in bulbar symptom of MG-ADL scale Patients with severe hepatic disorder, severe renal disorder or severe heat disorder Patients who have received treatment of malignant tumors Patients who have the anamnesis of shock or hypersensitivity to this drug Patients who have been diagnosed as hereditary fructose intolerance Patients who have the anamnesis of cerebral infarction or symptom of these diseases Patients who have been diagnosed as IgA deficiency in their past history Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant | 2 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 18.0-999.0, Breast Cancer Histologically or cytologically confirmed adenocarcinoma of the breast with measurable locally recurrent, locally advanced (that is not amenable to resection with curative intent), or metastatic disease Patients must consent to have a biopsy performed to obtain fresh tissue or be able to identify a FFPE tissue block in which tissue samples can be obtained to complete the testing for this study Planned chemotherapy regimen of paclitaxel and Avastin for the treatment of metastatic breast cancer Females age > 18 years Written informed consent and HIPAA authorization for release of personal health information Patients must not have had chemotherapy for locally recurrent or metastatic breast cancer Hormonal therapy for locally recurrent or metastatic disease must have been discontinued at least 2 weeks prior to study entry Patients must not have had adjuvant or neoadjuvant taxane therapy within 12 months prior to study entry Breast cancer overexpressing HER-2 (gene amplification by FISH or 3+ overexpression by immunohistochemistry) are not eligible unless they have received prior therapy with Herceptin Patients must not have had a major surgical procedure within 4 weeks prior to study entry. (Placement of vascular access device, and breast biopsy, will not be considered major surgery.) Patients must not have had a minor surgical procedure, placement of an access device, or fine needle aspiration within 7 days of starting protocol therapy Patients must not have had radiation within 2 weeks prior to study entry Previously radiated area(s) must not be the only site of disease for study entry Patients must not have a history of bleeding diathesis or have used anticoagulant therapy within 10 days of study entry. (Low dose anticoagulant therapy to maintain patency of a vascular access device is allowed.) Patients with a history of deep vein thrombosis or pulmonary embolism are not eligible | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 12.0-75.0, Myasthenic Syndromes, Congenital Male or female patients , with congenital myasthenia, belonging to a previously reported kindred diagnosed with COLQ deficiency History of allergy to Ephedrine or any inactive component Significant abnormalities in screening Cardiovascular parameters (blood pressure, pulse) Surgery within 6 weeks of screening Concurrent use of any other medication except steroids Pregnancy Thyrotoxicosis Co-morbid conditions or other neurological disorders that would confound assessment of clinical parameters Participation in another clinical trial within 30 days of study start Patients who are non-cooperative or parents/ legal guardians who are unwilling to sign consent form | 1 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 12.0-18.0, Depression Signed informed consent Adolescents aged 12 to 18 years Patients meeting the for mild to moderate depression according to the DSM-IV scale Physical and laboratory examination at baseline compatible with study ECG at baseline compatible with study Score of at least 40 on the Children's Depression Rating Scale Revised (CDRS-R) at baseline Patients with psychosis, bi-polar disease, schizophrenia or significant developmental disorder Patients with epilepsy Patients with a history of alcohol or substance abuse in the past year Initiation of psychotherapy or behavioral therapy in the 2 months prior to screening or during the study Patients who have previously failed to respond to SSRI's or SRNI's Patients who have been treated with antidepressants within 2 weeks of screening (4 weeks if fluoxetine) Patients with a contraindication to taking either Remotiv or fluoxetine or taking medication contraindicated when taking Remotiv or fluoxetine | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-30.0, Ewing Sarcoma of Bone Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Diagnosis of extracranial Ewing sarcoma or peripheral primitive neuroectodermal tumor of bone or soft tissue Newly diagnosed disease Disease confirmed by biopsy only with no attempt at complete or partial resection Unplanned excision allowed provided adequate imaging was obtained prior to surgery and incompletely resected disease is controlled by local therapy No esthesioneuroblastoma Localized disease, including any of the following sites Chest wall tumors with ipsilateral pleural effusions, ipsilateral positive pleural fluid cytology, or ipsilateral pleural based secondary tumor nodules No contralateral pleural effusions or pleural nodules Regional lymph nodes that are clinically suspicious or confirmed by biopsy No distant lymph node metastases | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 18.0-80.0, Refractory Myasthenia Gravis for patient selection will be based upon the recent recommendations for clinical research standards by the Task Force of the Medical Scientific Advisory Board of the Myasthenia Gravis Foundation of America (Jaretzki et al, 2000). Patients will be included in the trial based upon fulfilling all the given below, except that they will be required to fulfill criterion 3 OR 4: 1. Patients must have a diagnosis of "Definite" MG (Seybold, 1999) as based on clinical, electrophysiological and serological (Appendix 1) 2. Patients must have disease predominantly affecting bulbar or respiratory muscles of moderate or severe degree (Osserman grades 2B, 3 without crisis, or 4 without crisis) (Osserman and Genkins, 1971 and Appendix 2) as listed in Appendix 3, and a Quantitative MG score of <25 (Appendix 7) 3. Patients must have disease refractory to treatment for at least 12 months with prednisone at a dose of 15mg/day and/or immunosuppressive drugs (azathioprine or cyclophosphamide at a dose of 100mg/day or cyclosporine at a dose to produce trough levels of >50), with or without thymectomy and plasmapheresis/IVIG alone or in combination with above drugs at intervals of no more than once every 3 weeks, OR 4. Patients must have experienced intolerance or unacceptable side-effects following treatment with corticosteroids, immunosuppressive drugs (azathioprine, cyclophosphamide or cyclosporine), plasmapheresis or IVIG 5. Patients must be between 18 years and 80 years old 6. Patients must have adequate organ function / laboratory parameters as measured by the following (values should be obtained within 2 weeks prior to enrollment) Documented CD20 + cells Absolute neutrophil count: >2000/mm3 Platelets: >100,000/mm3 Hemoglobin: >10 gm/dL Adequate renal function as indicated by normal BUN and creatinine levels Adequate liver function, as indicated by AST and ALT <2x Upper Limit of normal Normal serum electrolytes 7. Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for one year after completion of treatment 8. Written informed consent Patients will be excluded from the trial based on the following 1. Myasthenic crisis with a forced vital capacity (FVC) of <30% predicted, irrespective of need for respiratory support, or severe bulbar involvement (Appendix 3) 2. Patients requiring maintenance plasmapheresis or IVIG infusions at intervals of less than once every three weeks 3. Patients requiring respiratory support with invasive or non-invasive ventilation 4. Severe, uncontrolled or untreated concomitant cardiac (New York Heart Classification III or IV disease), hepatic, pulmonary, renal, hematologic or psychiatric disease 5. Toxicity grade 2 or more prior to treatment with rituximab in patients who failed prior treatments 6. Patients unwilling to attend for follow-up visits according to the study design 7. Patients will be excluded based on the following History of HIV disease Active Hepatitis B infection Pregnancy (a serum pregnancy test will be performed for all women of childbearing potential immediately before treatment) Active infection 8. Pregnant or breastfeeding women may not participate due to the lack of information on effects of rituximab on the fetus and developing child 9. Concomitant malignancies or previous malignancies within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. 10. No prior monoclonal antibody therapy. 11. History of significant psychiatric disease that will interfere with the consenting procedure, research visits, treatment protocol or evaluation of patients in the study | 1 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 13.0-17.0, Pediatric Obesity Insulin Resistance Hyperinsulinemia Attending weight management clinic at Yale New Haven Hospital Good general health, taking no other medication on a chronic basis Age 13 to 17 yrs in puberty (girls: breast Tanner stage II to IV, and boys: testes size > 6 ml) The presence of insulin resistance, defined by fasting insulin levels greater than 30 µU/ml, and HOMA insulin resistance index > 6 Normal glucose tolerance based on a 2-hr plasma glucose (<140 mg/dl) after the OGTT All female subjects must have a negative urine pregnancy test during the study visits and must use an effective method of contraception if they are sexually active. Without their parent(s) present, all potential female subjects will be asked about their sexual activity and the specific form of contraception they are using Baseline creatinine > 1.0 mg/dl Hepatic disease with elevated liver function test (ALT or AST) ≥ 2 X the upper limits of normal Pregnancy Presence of other endocrinopathies; except treated hypothyroidism on stable replacement doses of thyroid hormone Presence of cardiac, pulmonary or other significant chronic illness Adolescents with psychiatric disorder, claustrophobia or with substance abuse Recent use (within six months) of anorexic agents Presence of anemia (hematocrit < 35) Mixed ethnic background (defined as two parents of different ethnicity) Adolescents with metal implants (i.e. cardiac pace maker, metal prostheses, bullet remnants) | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-999.0, Muscular Dystrophies Persons with muscular dystrophies None | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 18.0-80.0, Myasthenia Gravis, Generalized adult patients 18 to 80 years of age diagnosis of myasthenia gravis history of myasthenia weakness involving more than ocular (ie eye) or peri-ocular muscle duration of myasthenia gravis symptoms (including ocular symptoms) <=10 years prednisone dose >=20 mg/day (or equivalent alternate-day dose) for >=4 weeks female patients who are pregnant, breastfeeding, or lactating regularly scheduled plasma exchange (PE) or intravenous immunoglobulin (IVIG) treatment, or PE or IVIG treatment within 2 weeks prior to randomization any prior clinically significant use of CellCept or other immunosuppressive therapy (except corticosteroids), or within 8 weeks prior to randomization | 1 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 18.0-999.0, Invasive Thymoma and Thymic Carcinoma Recurrent Thymoma and Thymic Carcinoma Stage III Thymoma Stage IVA Thymoma Stage IVB Thymoma Histologically confirmed invasive thymoma or thymic carcinoma, meeting the following Relapsed or refractory disease Metastatic, unresectable disease Locally invasive disease allowed provided it is not resectable and has been previously treated Progressive disease Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques or >= 10 mm by spiral CT scan Must have received >= 1 prior chemotherapy regimen No active brain metastases Patients with previously treated brain metastases (surgical resection or radiotherapy) are eligible provided they have documented stable brain disease for >= 1 month after completion of therapy and are asymptomatic ECOG performance status 0-2 | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-69.0, Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Diagnosis of advanced hematologic malignancy or other disease not curable by conventional chemotherapy, including any of the following Acute myeloid leukemia in complete remission (CR)* (as defined by hematologic recovery, < 5% blasts in the bone marrow by morphology, and a cellularity of > 15%), meeting one of the following In first complete remission (CR1) AND has high-risk disease as evidenced by any of the following Preceding myelodysplastic syndromes (MDS) High-risk cytogenetics (e.g., monosomy 5 or 7, or as defined by referring institution treatment protocol) Required > 2 courses of therapy to obtain CR Erythroblastic or megakaryocytic leukemia In second CR (CR2) or beyond Acute lymphoblastic leukemia in CR* (as defined by hematologic recovery, < 5% blasts in the bone marrow by morphology, and a cellularity of > 15%), meeting one of the following In CR1 AND has high-risk disease as evidenced by any of the following | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 18.0-80.0, Myasthenia Gravis Generalized MG MGFA Clinical Classification Class II, III or IVa QMG total score ≥12 Minimum score of two (2) in four (4) or more test items in the QMG Able to give informed consent Have failed at least two immunosuppressants after one year of treatment A positive serologic test for binding anti-acetylcholine receptor Abs at Screening and one of the following a) history of abnormal neuromuscular transmission test demonstrated by single-fiber electromyography or repetitive nerve stimulation, or b) history of positive anticholinesterase test, eg, edrophonium chloride test, or c) patient has demonstrated improvement in MG signs on acetylcholinesterase inhibitors as assessed by treating physician History of thymoma or other neoplasms of the thymus History of thymectomy within 12 months prior to screening Pregnancy or lactation Current or chronic use of plasmapheresis/plasma exchange IVIG treatment within 8 weeks prior to screening Use of etanercept within 2 months prior to screening Use of rituximab (RITUXAN®) within 6 months prior to screening MGFA Class I, IVb, and V Crisis or impending crisis | 1 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 16.0-84.0, Aphakia Patients with aphakia due to complicated cataract surgery, weakness in lens support (capsula, zonulae) Marfans´s syndrome Aphakia due to preexisting corneal, retinal o uveal disease, low endothelial cell count | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 18.0-80.0, Myositis Myasthenia Gravis For myositis III. Idiopathic myositis 1. Myositis as defined by the 119th ENMC: 1. Proximal myopathy with weakness 2. Subacute or insidious onset over 18 years 3. Myogenic syndrome on EMG (optional) 4. Muscle fibre necrosis and regeneration and/or inflammatory cell infiltrate on muscular biopsy 2. Specific AAbs : anti-synthetases (anti-JO1, anti-PL7, or anti-PL12), or anti-SRP. IV. Refractory to the conventional treatments Resistance to conventional treatments is defined as an inadequate response to, or intolerable side effects with conventional treatments, such as corticosteroids, azathioprine, methotrexate, cyclophosphamide, cyclosporine, IgIV and/or plasma exchange. At least one or more of these drugs or therapeutical approaches (used alone or as a combination) must have been unsuccessfully tested before inclusion. Inadequate response is defined as the lack of improvement and/or the degradation of evaluation parameters (defined bellow) despite these conventional therapies, that led to a modification or a reintroduction of treatment For myasthenia III. Generalised MG Generalised seropositive MG as defined by the Texas Clinical Classification System: 1. Extraocular muscle weakness quantified with MG muscle score (MMS), whose inter and inter observer reproducibility has been demonstrated [44]. 2. Specific AAbs : anti-AchR IV. Refractory to the conventional treatments Resistance to conventional treatments is defined as an inadequate response to, or intolerable side effects with conventional treatments, such as corticosteroids, azathioprine, methotrexate, cyclophosphamide, cyclosporine, IgIV and/or plasma exchange. At least one or more of these drugs or therapeutical approaches (used alone or as a combination) must have been unsuccessfully tested before inclusion. Inadequate response is defined as the lack of improvement and/or the degradation of evaluation parameters (defined bellow) despite these conventional therapies, that led to a modification or a reintroduction of treatment Other muscular diseases, such as: 1. body myositis 2. Macrophagic myofasciitis 3. Inherited myopathies Secondary IM to one other connective tissue disorders 1. Systemic scleroderma (ARA and/or "LEROY AND criteria) 2. Sjögren's syndrome (European criteria) 3. Systemic lupus erythematosus (ACR criteria) 4. Rheumatoid arthritis (ACR criteria) 5. Mixed connective tissue disease (ACR criteria) Other myasthenic syndrome, such as: 1. Non generalised, ocular MG 2. Lambert Eaton syndrome 3. MG associated with malignant thymoma 4. Inherited myasthenic syndrome Cancer (or cancer-associated myositis) Age < 18 years Pregnancy HIV seropositivity Evolutive infection (B, C hepatitis, tuberculosis) Lack of approved consent | 1 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 18.0-45.0, Healthy Were in the age range of 18-45 years Were neither overweight nor underweight for his height as per the Life Insurance Corporation of India height/weight chart for non-medical cases Had voluntarily given written informed consent to participate in this study Were of normal health as determined by medical history and physical examination of the subjects performed within 21 days prior to the commencement of the study Hypersensitivity or allergy to Cyclobenzaprine hydrochloride or related group of drugs Use of MAO Inhibitors in the past 2 weeks / history of Hyperthyroidism History of hypotension, dizziness, syncope or those who had previously experienced a hypotensive response to other medications History of arrhythmia, heart block or congestive heart failure History of urinary disorders especially urinary retention History of seizures, tinnitus, tremors, visual disorders, psychosomatic illness, recurrent palpitations, Jaundice Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection Presence of values which were significantly different from normal reference ranges and/or judged clinically significant for haemoglobin, total white blood cells count, differential WBC count or platelet count Positive for urinary screen testing of drugs of abuse (opiates or cannabinoids) | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-65.0, Osteoporosis, Postmenopausal Postmenopausal, ambulatory females, "postmenopausal" defined as the absence of menses for at least 12 continuous months) In general good health as determined by medical history, physical examination, and laboratory tests LS spine BMD T-score between -1.0 and -2.4, inclusive At least one analyzable BMD site at both the hip (left or right) and LS spine (at least 3 measurable lumbar spine vertebrae, without fracture or sufficient degenerative disease) Currently receiving no medications for the treatment or prevention of osteoporosis Had been on continuous HRT for at least 1 year prior to enrollment. The HRT must have ended within 18 months prior to the baseline visit, and the subject must have been off HRT medication for at least 3 months at the time of baseline visit Subjects rendered menopausal by surgical procedures between the ages of 55 and 65 years A history of cancer within 10 years prior to entry into the study, except for relatively "benign" and cured skin cancers such as basal and squamous cell carcinoma A history of hyperparathyroidism, hyperthyroidism, osteomalacia, or other metabolic bone disease within one year prior to enrollment Any condition or disease that may interfere with the evaluation of at least 3 lumbar vertebrae (not necessarily contiguous), determined in a screening radiograph by a radiologist at the central facility (e.g., confluent aortic calcifications, severe osteoarthritis, spinal fusion, lumbar spine fractures) Evidence of clinically significant organic or psychiatric disease on history or physical examination, which in the opinion of the investigator would prevent the patient from completing the study Markedly abnormal pretreatment laboratory finds that, in the opinion of the investigator, would prevent the patient from completing the study A history of using any of the following medications prior to starting study Any bisphosphonate therapy Selective estrogen receptor modulators (SERMs) Parathyroid hormone Fluorides | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 16.0-50.0, Bacterial Vaginosis Women will be included whether their complaint is symptoms of BV and have a positive whiff test/vaginal swab or if they have a positive whiff test/vaginal swab and are then asked if they have any symptoms of BV present. The following must be met for enrolment in the study: 1. ages 16-50 and premenopausal; 2. capable of giving written informed consent; 3. English speaking; 4. negative pregnancy test on enrolment day; 5. agree to follow study protocol; 6. documented BV infection by positive vaginal swab +/ positive whiff test/pH > 4.5; 7. agree to no intercourse for the 10 days of treatment (or to use non-lubricated condoms if unavoidable); 8. agree not to douche or use any intravaginal products during treatment (including tampons, medications, devices); 9. abstain from alcohol during the 10 days of treatment (from 24 hours before through 72 hours after taking study medication); 10. agree to no new medications or antibiotics during treatment; 11. no current sexually transmitted infection as determined by history, physical exam and negative swabs for chlamydia, gonorrhea, candidiasis, trichomonas; 12. patient is reliable for follow up The following women would be excluded from study participation: 1. less than 16 or post-menopausal; 2. negative vaginal swab regardless of whiff test/pH > 4.5; 3. menstruating at diagnosis; 4. symptoms so severe as to make allocation to placebo unacceptable to the patient; 5. currently pregnant or at high risk for pregnancy; 6. current sexually transmitted infection (HIV, hepatitis, chlamydia, gonorrhea, trichomonas, HPV or HSV); 7. current yeast infection as determined by history, physical and swabs; 8. history of PID; 9. allergy to latex or metronidazole; 10. presently lactating; 11. any open wound, excoriation, vaginal irritation and including bartholin's cyst/abscess as determined by physical exam; 12. presence of another vulvar, vaginal or medical condition, including cervical neoplasia treatment, that might confound treatment response; 13. using lithium, anti-coagulants or disulfiram drugs; 14. any antifungal or antibiotic use 14 days prior to enrolment 15. PAP smear done within one week of enrollment | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 18.0-999.0, Myasthenia Gravis Patients must have MGFA MG grades 2, 3, or 4 generalized myasthenia gravis, according to the MGFA classification system Elevated acetylcholine receptor antibody (AChR-Ab) titer Patient's signs and symptoms should not be better explained by another disease process Prednisone dose of at least 10 mg/day (or the equivalent in alternate days) and the subject must be on a stable dose of prednisone for 30 days prior to the screening visit A history of chronic degenerative, psychiatric, or neurologic disorder other than MG that can produce weakness or fatigue Other major chronic or debilitating illnesses within six months prior to study entry Female patients who are premenopausal and are: (a) pregnant on the basis of a serum pregnancy test, (b) breast-feeding, or (c) not using an effective method of double barrier (1 hormonal plus 1 barrier method or 2 simultaneous barrier methods) birth control (birth control pills, male condom, female condom, intrauterine device, Norplant, tubal ligation, or other sterilization procedures) Altered levels of consciousness, dementia, or abnormal mental status Evidence of thymoma on chest CT or MRI. Such a finding could require immediate thymectomy and would preclude entry into the study Thymectomy in the previous three months Patients who have been medicated with azathioprine, cyclosporine, cyclophosphamide, mycophenolate mofetil, IVIg, or other immunosuppressive drugs within the last 60 days Chest X-ray with evidence of tumor, infection, or interstitial lung disease Clinical history of chronic or recurrent infections Daily use of non-steroidal anti-inflammatory drugs (NSAIDs) | 1 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 12.0-18.0, Juvenile Idiopathic Arthritis Systemic Lupus Erythematosus Juvenile Dermatomyositis Females Clinical diagnosis of JIA, SLE or JDM And who are in the following age groups years (these girls are vaccinated via the National Vaccination Program from September 2009) 18 years (these girls are vaccinated during a national vaccination campaign from March-May 2009) Current co-medication: all co-medication prescribed may be continued And in the control group: healthy girls aged 13-17 years (these girls are vaccinated during a national vaccination campaign from March-May 2009) No HPV vaccination Refusal to allow venous puncture Proven or suspected cervical carcinoma | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 10.0-90.0, Stroke acute or subacute phase of stroke chronic phase of stroke | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 16.0-999.0, Peptic Ulcer Hemorrhage Bleeding peptic ulcer: Among patients suspected to have upper GI bleeding based on hematemesis or melena, those with peptic ulcers(Forrest I, IIa and IIb) in whom active bleeding, non-bleeding visible vessels and fresh blood clots are observed on upper GI endoscopy performed within 24 hours after the hospitalization patients who achieved primary hemostasis with endoscopic hemostasis procedure via upper GI endoscopy Patients who refuse endoscopic procedure Patients with complications from gastric ulcer that require operative treatment prior to upper GI endoscopic treatment(e.g., gastric outlet obstruction, peptic ulcer perforation) Pregnancy Patients with serious concurrent diseases such as malignant tumors or end-stage diseases History of previous gastrectomy or vagotomy Known hypersensitivity to proton pump inhibitors Elderly patients Epilepsy | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-999.0, Limbal Stem Cell Deficiency Patients suffering from LSCD IIa and IIb. Those suffering from IIc may be included once inflammation has subsided and cornea can be staged as IIb Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial Women of child-bearing potential should use adequate contraception prior to study entry and for the duration of study participation Subjects who are pregnant or lactating Subjects who have sensitivity to drugs that provide local anesthesia Subjects suffering from active infection of the external eye Medical conditions that prohibit the use of systemic immunosuppression (in cases of allogenic transplantation) | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 3.0-75.0, Accelerated Phase Chronic Myelogenous Leukemia Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome Adult Acute Lymphoblastic Leukemia in Remission Adult Acute Myeloid Leukemia in Remission Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Del(5q) Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) Adult Nasal Type Extranodal NK/T-cell Lymphoma Anaplastic Large Cell Lymphoma Angioimmunoblastic T-cell Lymphoma Aplastic Anemia Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative Childhood Acute Lymphoblastic Leukemia in Remission Childhood Acute Myeloid Leukemia in Remission Childhood Chronic Myelogenous Leukemia Childhood Diffuse Large Cell Lymphoma Childhood Immunoblastic Large Cell Lymphoma Childhood Myelodysplastic Syndromes Childhood Nasal Type Extranodal NK/T-cell Lymphoma Chronic Eosinophilic Leukemia Chronic Myelomonocytic Leukemia Chronic Neutrophilic Leukemia Chronic Phase Chronic Myelogenous Leukemia de Novo Myelodysplastic Syndromes Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Fanconi Anemia Juvenile Myelomonocytic Leukemia Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable Nodal Marginal Zone B-cell Lymphoma Noncontiguous Stage II Adult Burkitt Lymphoma Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma Noncontiguous Stage II Adult Lymphoblastic Lymphoma Noncontiguous Stage II Grade 1 Follicular Lymphoma Noncontiguous Stage II Grade 2 Follicular Lymphoma Noncontiguous Stage II Grade 3 Follicular Lymphoma Noncontiguous Stage II Mantle Cell Lymphoma Noncontiguous Stage II Marginal Zone Lymphoma Noncontiguous Stage II Small Lymphocytic Lymphoma Paroxysmal Nocturnal Hemoglobinuria Previously Treated Myelodysplastic Syndromes Primary Myelofibrosis Recurrent Adult Acute Lymphoblastic Leukemia Recurrent Adult Acute Myeloid Leukemia Recurrent Adult Burkitt Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Adult Diffuse Mixed Cell Lymphoma Recurrent Adult Diffuse Small Cleaved Cell Lymphoma Recurrent Adult Grade III Lymphomatoid Granulomatosis Recurrent Adult Hodgkin Lymphoma Recurrent Adult Immunoblastic Large Cell Lymphoma Recurrent Adult Lymphoblastic Lymphoma Recurrent Adult T-cell Leukemia/Lymphoma Recurrent Childhood Acute Lymphoblastic Leukemia Recurrent Childhood Acute Myeloid Leukemia Recurrent Childhood Anaplastic Large Cell Lymphoma Recurrent Childhood Grade III Lymphomatoid Granulomatosis Recurrent Childhood Large Cell Lymphoma Recurrent Childhood Lymphoblastic Lymphoma Recurrent Childhood Small Noncleaved Cell Lymphoma Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Recurrent Marginal Zone Lymphoma Recurrent Mycosis Fungoides/Sezary Syndrome Recurrent Small Lymphocytic Lymphoma Recurrent/Refractory Childhood Hodgkin Lymphoma Refractory Chronic Lymphocytic Leukemia Refractory Multiple Myeloma Relapsing Chronic Myelogenous Leukemia Secondary Acute Myeloid Leukemia Secondary Myelodysplastic Syndromes Splenic Marginal Zone Lymphoma Stage III Adult Diffuse Small Cleaved Cell Lymphoma Stage III Adult Immunoblastic Large Cell Lymphoma Stage III Adult Lymphoblastic Lymphoma Stage III Grade 1 Follicular Lymphoma Stage III Grade 2 Follicular Lymphoma Stage III Grade 3 Follicular Lymphoma Stage III Mantle Cell Lymphoma Stage III Marginal Zone Lymphoma Stage III Small Lymphocytic Lymphoma Stage IV Adult Burkitt Lymphoma Stage IV Adult Diffuse Small Cleaved Cell Lymphoma Stage IV Adult Immunoblastic Large Cell Lymphoma Stage IV Adult Lymphoblastic Lymphoma Stage IV Grade 1 Follicular Lymphoma Stage IV Grade 2 Follicular Lymphoma Stage IV Grade 3 Follicular Lymphoma Stage IV Mantle Cell Lymphoma Stage IV Marginal Zone Lymphoma Stage IV Small Lymphocytic Lymphoma Waldenström Macroglobulinemia Diagnosis of a histology documented hematologic malignancy or marrow disorder Bone marrow failure disorders and other non-malignant hematologic or immunologic disorders Acquired bone marrow failure disorders aplastic anemia, paroxysmal nocturnal hemoglobinuria (PNH) Primary allogeneic hematopoietic stem cell transplantation (HSCT) is appropriate for selected patients with severe aplastic anemia; however, patients with aplastic anemia must have failed at least one cycle of standard immunosuppressive therapy with calcineurin inhibitor plus anti-thymocyte globulin (ATG) if a fully-matched donor is not available Patients with PNH must have a history of thrombosis related to PNH Hereditary bone marrow failure disorders Fanconi anemia or related chromosomal breakage syndrome dyskeratosis congenita, Diamond-Blackfan anemia, Shwachman-Diamond syndrome, Kostmann syndrome, congenital amegakaryocytic thrombocytopenia Fanconi anemia or related chromosomal breakage syndrome: positive chromosome breakage analysis using diepoxybutane (DEB) or mitomycin C if applicable Dyskeratosis: diagnosis is supported by using either telomerase reverse transcriptase (TERC) gene mutation in autosomal dominant Dyskeratosis Congenita or Xlinked DKC1 gene mutation Other non-malignant hematologic or immunologic disorders that require transplantation Quantitative or qualitative congenital platelet disorders (including but not limited to congenital amegakaryocytopenia, absent-radii syndrome, Glanzmann's thrombasthenia) Uncontrolled central nervous system (CNS) disease (for hematologic malignancies) Karnofsky (adult) or Lansky (for =< 16 years) performance status =< 50% Diffusing capacity of the lung for carbon monoxide (DLCO) less than 40% predicted, corrected for hemoglobin (Hb) and/or alveolar ventilation Cardiac: left ventricular ejection fraction less than 40% Bilirubin >= 3 x upper limit of normal Liver alkaline phosphatase >= 3 x upper limit of normal Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvate transaminase (SGPT) >= 3 x upper limit of normal Child's class B and C liver failure Calculated creatinine clearance < 40 cc/min by the modified Cockcroft-Gault formula for adults or the Schwartz formula for pediatrics Patients who have received maximally allowed doses (given in 2 Gy fractions, or equivalent) of previous radiation therapy to various organs as follows | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-999.0, Stress Healthy first-time mothers with singleton baby delivered at term with no complications Mothers with chronic health problems Pregnancy complications, OR Infants with congenital problems or conditions requiring admission to the intensive care nursery | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 9.0-18.0, Cervical Cancer Genital Warts A healthy, medically well female between the ages of 9 years. (Must be between 9 years and younger than 19 years of age) at time of enrollment 2. Must be receiving either a 3rd dose of HPV vaccine (All Groups) or a 2nd dose of HPV vaccine (Group 2 only) For Group 1 The second dose of HPV vaccine must not have been administered and it must be within the specified dosing interval for the second dose of HPV vaccine (> 90 days since the first dose of HPV vaccine) OR 2) The second dose of HPV vaccine must have been administered > 90 days after the first dose of HPV vaccine and it must be within the specified dosing interval for the third dose of HPV vaccine (> 60 days < 180 days since the second dose of HPV) For Group 2 The second dose of HPV vaccine must have been administered > 30 days and < 90 days after the first dose of HPV vaccine and it must be within the specified dosing interval for the third dose (> 180 days since the second dose of HPV) For Group 3 The second dose of HPV vaccine must have been administered > 30 days and < 90 days after the first dose of HPV vaccine and it must be within the specified dosing interval for the third dose (> 60 days < 180 days since the second dose of HPV) Unable to comply with the study protocol 2. Receipt of three or more doses of HPV vaccine or receipt of doses of HPV vaccine outside the pre-specified time windows 3. Receipt of blood and or blood products (including immunoglobulin) in the past 3 months or anticipated receipt during the study period 4. Receipt of a live virus vaccine (varicella virus containing vaccine, any measles, mumps, or rubella virus containing vaccine such as MMR, or yellow fever vaccine but not including live attenuated influenza virus vaccine) within 4 weeks of receipt of the 3rd dose of HPV vaccine or anticipated receipt of a live virus vaccine within 4 weeks after the 3rd dose of HPV vaccine 5. History of any physical, mental, or developmental disorder that study personnel believe may hinder a participant's ability to comply with the study requirements 6. History of malignancy or confirmed or suspected immunodeficient condition such as HIV infection 7. Receipt of or history of receipt of any medications or treatments that affect the immune system, such as immune globulin, interferon, immunomodulators, cytotoxic drugs or other drugs known to be frequently associated with significant major organ toxicity since six months prior to the first HPV vaccine dose. Receipt of long-term (greater than or equal to 2 weeks) potentially immunosuppressive corticosteroid use within six months prior to HPV vaccine dose 1 and enrollment or anticipated receipt during the study period. Specifically, potentially immunosuppressive corticosteroids are any parenteral corticosteroid, high dose (>800 mcg/day) beclomethasone dipropionate or equivalent medication. Nasal and topical steroids are allowed. 8. Current or former participation in HPV vaccine related research. 9. Receipt of an investigational or alternate HPV vaccine | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 1.0-21.0, Unspecified Childhood Solid Tumor, Protocol Specific Patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of serum or cerebrospinal fluid (CSF) alpha-fetoprotein or beta-human chorionic gonadotropin (HCG); slides or tissue blocks from either initial diagnosis or relapse must be available for central review Patients must have either measurable or evaluable disease Patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age; note: neurologic deficits in patients with central nervous system (CNS) tumors must have been clinically stable for a minimum of 1 week prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study Myelosuppressive chemotherapy: must not have received within 3 weeks of enrollment onto this study (6 weeks if prior nitrosourea) Hematopoietic growth factors: at least 7 days since the completion of therapy with a growth factor that supports platelet or white cell number or function Biologic (anti-neoplastic agent): at least 7 days since the completion of therapy with a biologic agent; at least 6 weeks must have elapsed since prior therapy that includes a monoclonal antibody; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair Radiation therapy (XRT): >= 2 wks for local palliative XRT (small port); >= 3 months must have elapsed if prior total-body irradiation (TBI), craniospinal XRT or if >= 50% radiation of pelvis; >= 6 wks must have elapsed if other substantial bone marrow (BM) radiation Stem cell transplant or rescue: no evidence of active graft vs. host disease and >= 2 months must have elapsed since transplant Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 110 U/L; for the purpose of this study, the ULN for SGPT is 45 U/L Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of the study and for 3 months after the last dose of IMC-A12 Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for the 7 days prior to enrollment are not eligible Patients who are currently receiving another investigational drug are not eligible Patients who are currently receiving other anticancer agents are not eligible Patients receiving insulin or growth hormone therapy are not eligible Patients must not be receiving enzyme-inducing anticonvulsants Patients must not be receiving any of the following potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers or inhibitors: erythromycin, clarithromycin, ketoconazole, azithromycin, itraconazole, grapefruit juice or St. John's wort Patients receiving warfarin for the purpose of systemic anticoagulation are not eligible; use of low-dose warfarin for maintaining patency of central venous catheters is allowed Patients who have an uncontrolled infection are not eligible | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 60.0-90.0, Alzheimer's Disease Ambulatory male or female patient, aged 60-90 years old included at screening, and living at home Patient having a clinical diagnosis of probable AD according to National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria Mild to moderate AD with a MMSE total score ≥ 12 and ≤ 24 at screening Written informed consent obtained from the patient or, if appropriate, from legal representative according to local laws and regulations. The caregiver will also have to sign a specific informed consent form regarding his/her participation in the study Patient treated for AD treatment with one AChEI (donepezil, galantamine, or rivastigmine), according to the recommended posology mentioned in the summary of product characteristics, for at least 3 months and with a stable dose for at least 2 months prior to screening. The dose should be kept unchanged throughout the study duration Patient with a cerebral CT-scan or cerebral MRI compatible with AD diagnosis, with no brain lesions that may be related to another diagnosis and that could be responsible for the current patient's condition (ex, but not limited to, non-AD dementia, brain injury, brain tumour, stroke, normal pressure hydrocephalus,…). A cerebral CT-scan or cerebral MRI has to be performed and results have to be available prior patient's randomization if the results of the brain imagery performed to settle the AD diagnosis are not available in the patient's file. Brain imaging has also to be performed if considered necessary by the investigator, such as in case of emerging neurological symptoms or in case of worsening of existing neurological symptoms Neurological exam without any particularities or without any specific focal signs likely to be related to other conditions than AD No contra-indication to AChEI treatment and absence of significant adverse events considered to be related to AChEI treatment at screening and randomisation Patient and patient's caregiver able to comply with study procedures, notably regarding the drug intake at the end of the meal which has to be supervised by the caregiver or another competent person Diagnosis of vascular dementia according to NINDS-AIREN or other non-AD dementia, or CNS pathology (including but not limited to brain injury, brain tumour, stroke, normal pressure hydrocephalus, Parkinson's disease, epilepsy,multiple sclerosis,…) that may be responsible for dementia Clinically significant pathology and/or uncontrolled condition, including but not limited to cancer, infectious (like AIDS), gastro-intestinal, hepatic, renal, respiratory, endocrine(like diabetes mellitus, thyroiditis) pathology History or current clinically significant psychiatric pathology (including but not limited to psychotic disorders, bipolar disorder, personality disorders) that may interfere with study assessments Current major depressive disorder, either treated or not, associated with clinically significant symptoms Low blood level of vitamin B12, TSH levels out of normal range at screening Current forbidden medication intake or intake within 2 weeks prior to screening Recent history (within the past year prior to inclusion) or current cardiovascular pathology and/or symptoms considered as clinically significant, including but not limited to angina pectoris, uncontrolled arrhythmia, significant ECG abnormalities. Lifetime history of heart failure, myocardial infarction, severe and/or uncontrolled angina pectoris,and/or ventricular arrhythmia disqualifies the patient History or presence of clinically conditions that may interfere with product metabolism or with study assessments Systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 90 mmHg at screening and/or randomisation QTc interval (Bazett's correction) ≥ 430 msec for male and ≥ 450 msec for female at screening | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 1.0-21.0, Leukemia Diagnosis of B-cell precursor acute lymphoblastic leukemia (ALL) High-risk disease Participation in clinical trial COG-P9906 required (pilot project) In complete remission Consented to future studies using banked tissue specimens Participation in clinical trial and COG-AALL03B1 and linked therapeutic studies COG-AALL0232 and COG AALL0331(expansion project) Experienced a bone marrow relapse within 36 months of initial diagnosis Consented to future studies using banked tissue specimens Have matched ALL blast and germline specimens | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-999.0, Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer Pathologically confirmed adenocarcinoma of 1 of the following types Ovarian Primary peritoneal Fallopian tube Must meet 1 of the following De novo malignancy with no prior chemotherapy Advanced refractory malignancy with ≤ 2 standard chemotherapy treatment protocols Tumor must be accessible for biopsy or drainage of effusions Chemotherapy is considered a treatment option No symptomatic or uncontrolled parenchymal brain metastases | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-45.0, Healthy Each woman enrolled in the trial must meet the following Competent to provide informed consent to participate in the trial and has done so At least the minimum age is 18 to 45 years old Had sex 1 to 4 days in past month and expects to continue at that frequency for the next 6.5 months At low risk for sexually transmitted infection (STI), operationally meaning that neither she nor her partner to her knowledge has had any of the following More than one sexual partner currently or any expectation of having more than one sexual partner in the next 6.5 months Diagnosis of human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C Treatment for a STI within the past 6 months, excluding recurrent genital herpes or condyloma Sharing of illicit injection drug equipment ever in the past Willing to use the study regimen as her only contraceptive method for the next 6.5 months (except that she may also use condoms if needed for protection from STIs) To be eligible for enrollment, a woman must not meet any of the following Pregnant as verified by a pregnancy test at enrollment Has an indication of current subfecundity, specifically Her last pregnancy ended within the last 8 weeks, or she has had fewer than two menstrual periods since resolution of last pregnancy She has not had normal monthly menses for the past 2 months She is currently breastfeeding She has used any hormonal contraceptive other than emergency contraceptive pills since the onset of her last menstrual period Has received an injection of a long term injectable contraceptive in the last 9 months Currently has an intrauterine device Has had a sterilization procedure or ectopic pregnancy | 1 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 18.0-999.0, Metastatic Cancer Metastatic cancer that expresses Her-2 at greater than or equal to 2+ and assessed by immunohistochemistry (IHC) in the clinical laboratory improvement amendment (CLIA) approved test in the Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI), National Institutes of Health (NIH). 2. Patients must have previously received systemic standard care (or effective salvage chemotherapy regimens) for metastatic disease, if known to be effective for that disease, and have been either non-responders (progressive disease) or have recurred. Subjects with estrogen receptor-positive or progesterone receptor-positive breast cancer must have progressed on or not be a candidate for anti-estrogens or aromatase inhibitors and all breast cancer patients must have progressed on or not be a candidate for an anthracycline-containing regimen and a taxane-containing regimen. 3. Patients with breast cancer must have previously received trastuzumab. Patients will not continue to receive trastuzumab during the trial period. 4. Greater than or equal to 18 years of age. 5. Willing to sign a durable power of attorney 6. Able to understand and sign the Informed Consent Document 7. Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0 or 1. 8. Life expectancy of greater than three months. 9. Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for up to four months after receiving the preparative regimen. 10. Serology: 1. Seronegative for human immunodeficiency virus (HIV) antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune-competence and thus be less responsive to the experimental treatment and more susceptible to its toxicities.) 2. Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by reverse transcriptase polymerase chain reaction (RT-PCR) and be hepatitis C virus ribonucleic acid (HCV RNA) negative. 3. Women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the preparative chemotherapy on the fetus. 11. Hematology: 1. Absolute neutrophil count greater than 1000/mm^3 without the support of filgrastim. 2. White blood cell (WBC) (> 3000/mm^3). 3. Platelet count greater than 100,000/mm^3. 4. Hemoglobin greater than 8.0 g/dl. 12. Chemistry: 1. Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less or equal to 2.5 times the upper limit of normal. 2. Serum creatinine less than or equal to 1.6 mg/dl. 3. Total bilirubin less than or equal to 1.5 mg/dl, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl. 13. Left ventricular ejection fraction (LVEF) greater than or equal to 50%. 14. More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, and patients' toxicities must have recovered to a grade 1 or less (except for toxicities such as alopecia or vitiligo). 15. Patients who have previously received anti-cytotoxic T-lymphocyte antigen 4 (CTLA4) antibody therapy must have a normal colonoscopy with normal colonic biopsies Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. 2. Active systemic infections; coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system; myocardial infarction; cardiac arrhythmias; obstructive or restrictive pulmonary disease. 3. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease). 4. Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities). 5. Concurrent Systemic steroid therapy 6. History of severe immediate hypersensitivity reaction to any of the agents used in this study. 7. History of coronary revascularization or ischemic symptoms 8. Documented forced expiratory volume in 1 second (FEV1) less than or equal to 60% predicted tested in patients with: 1. A prolonged history of cigarette smoking (20 pack/year of smoking within the past 2 years). 2. Symptoms of respiratory dysfunction | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 18.0-70.0, Primary Mediastinal B-cell Lymphoma Diffuse, Large B-cell Lymphoma Diffuse Large B-Cell Lymphoma Transformed From Follicular Lymphoma Mantle Cell Patient must have a cluster of differentiation 19 (CD19)-expressing B-cell lymphoma. Patients with diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, and diffuse large B-cell lymphoma transformed from follicular lymphoma must have measurable disease after at least two prior chemotherapy regimens one of which must have contained doxorubicin and rituximab. 2. Confirmation of diagnosis of B-cell malignancy and positivity for CD19 confirmed by the Laboratory of Pathology of the National Cancer Institute (NCI). The choice of whether to use flow cytometry or immunohistochemistry will be determined by what is the most easily available tissue sample in each patient. Immunohistochemistry will be used for lymph node biopsies, flow cytometry will be used for peripheral blood, fine needle aspirates and bone marrow samples. 3. Patients must have indications for treatment for their B-cell malignancy at the time of enrollment on this trial. 4. Greater than or equal to 18 years of age and less than or equal to age 70. 5. Willing to sign a durable power of attorney. 6. Able to understand and sign the Informed Consent Document. 7. Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0 or 1. 8. Life expectancy of greater than three months. 9. Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for four months after treatment. 10. Women of child bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the treatment on the fetus. 11. Serology Seronegative for human immunodeficiency virus (HIV) antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune -competence and thus be less responsive to the experimental treatment and more susceptible to its toxicities.) Seronegative for hepatitis B antigen and hepatitis C antibody unless antigen negative. If hepatitis C antibody test is positive. Then patients must be tested for the presence of antigen by reverse transcription-polymerase chain reaction (RT-PCR) and be hepatitis C virus ribonucleic acid (HCV RNA) negative. 12. Hematology Absolute neutrophil count greater than or equal to 1000/mm^3 without the support of filgrastim Platelet count greater than or equal to 50,000/mm^3 Hemoglobin greater than 8.0 g/dl Lymphocyte count less than or equal to 4,000/ mm^3 13. Chemistry Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less or equal to 5 times the upper limit of normal Serum creatinine less than or equal to 1.6 mg/dl Total bilirubin less than or equal to 1.5 mg/dl, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl 14. More than three weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, and patient toxicities must have recovered to a grade 1 or less (except for toxicities such as alopecia or vitiligo). 15. Normal cardiac ejection fraction and no evidence of pericardial effusion as determined by an echocardiogram Patients that require urgent therapy due to tumor mass effects such as bowel obstruction or blood vessel compression. 2. Patients that have active hemolytic anemia. 3. Patients with active brain metastases, or with a history of any central nervous system (CNS) metastases or cerebrospinal fluid malignant cells. Note: patients who are asymptomatic but are found to have malignant cells in the cerebrospinal fluid (CSF) on lumbar puncture prior to treatment will be considered eligible. 4. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant. 5. Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease. 6. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease). 7. Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities). 8. Concurrent systemic steroid therapy. 9. History of severe immediate hypersensitivity reaction to any of the agents used in this study. 10. History of allogeneic stem cell transplantation 11. Patients with cardiac atrial or cardiac ventricular lymphoma involvement. Screening Evaluation: Within 4 weeks prior to starting the chemotherapy regimen: 1. Complete history and physical examination, including, weight and vital signs, noting in detail the exact size and location of any lesions that exist. (Note: patient history may be obtained within 8 weeks.) 2. Chest x-ray 3. Electrocardiography (EKG) 4. Baseline computed tomography (CT) of the chest, abdomen and pelvis, positron emission tomography (PET) scan, and brain magnetic resonance imaging (MRI) to evaluate the status of disease. Additional scans and x-rays may be performed if clinically indicated based on patient signs and symptoms. 5. HIV antibody titer and Hepatitis B surface antigen (HbsAG) determination, and anti HCV, (Note: May be performed within 3 months of the chemotherapy start date). 6. Anti cytomegalovirus (CMV) antibody titer, herpes simplex virus (HSV) serology, and Epstein-Barr virus (EBV) panel (Note: patients who are known to be positive for any of the above do not need to be retested; may be performed within 3 months of chemotherapy start date) 7. Patients with a left ventricular ejection fraction (LVEF) of less than or equal to 55% will not proceed to treatment (Note: may be performed within 8 weeks of treatment). 8. Cluster of differentiation 19 (CD19) staining of malignant cells by immunohistochemistry or flow cytometry (testing is permitted to be conducted at any time prior to this point). 9. All patients must have a T cells, B cells, and natural killer cells (TBNK) for Peripheral blood cluster of differentiation 3 (CD3) count and CD19#. 10. Patients with a history of leptomeningeal disease, or signs/symptoms suggestive of leptomeningeal involvement, or with symptoms of central nervous system malignancy such as new onset severe headaches, neck stiffness, or any focal neurologic findings on physical exam will have lumbar puncture for examination of cerebral spinal fluid. 11. Patients may undergo lumbar puncture (LP) for flow cytometry of the CSF in order to assess the presence of CD19 positive lymphocytes for potential correlation with neurologic toxicity. Patients who have no neurologic symptoms at the time of LP will be eligible for enrollment regardless of the results of the flow cytometry. Within 14 days prior to starting the chemotherapy regimen: 12. Chem 20: (Sodium (Na), Potassium (K), Chloride (Cl), Total carbon dioxide (CO2) (bicarbonate), Creatinine, Glucose, Urea nitrogen (BUN), Albumin, Calcium total, Magnesium total (Mg), Inorganic Phosphorus, Alkaline Phosphatase, ALT/glutamic pyruvic transaminase (GPT), AST/glutamic oxaloacetic (GOT), Total Bilirubin, Direct Bilirubin, lactate hydrogenase (LD), Total Protein, Total creatine kinase (CK), Uric Acid) 13. Thyroid panel 14. Complete blood count (CBC) with differential and platelet count 15. Prothrombin time (PT)/partial thromboplastin time (PTT) 16. Urinalysis and culture, if indicated Within 7 days prior to starting the chemotherapy regimen: 17. Beta-human chorionic gonadotropin (βHCG) pregnancy test (serum or urine) on all women of child-bearing potential 18. ECOG performance status of 0 or 1 | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 16.0-999.0, Cleft Lip and Palate Maxillary Hypoplasia Cleft lip and palate patients who required maxillary advancement ranging from 4-10 mm syndromic cases, skeletal maturity not yet reached | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 9.0-26.0, Cervical Cancers Vulvar Cancer Vaginal Cancer Genital Lesions PAP Test Abnormalities HPV Infections Boys and Girls Age 9 to 15 Participant has not had sexual intercourse prior to the study and does not plan to become sexually active during the study period Day 1 to Month 7 Women Age 16 to 26 Participant has never had Pap testing or has had only normal results Participant has had 0 to 4 sexual partners at the time of enrollment Boys and Girls Age 9 to 15 History of allergic reaction that required medical intervention Currently enrolled in any other clinical study Participant is pregnant Participant is immunocompromised or has taken immunosuppressants in the last year Participant has received a marketed HPV vaccine or participated in an HPV vaccine clinical trial Participant has a history of positive test for HPV Women Age 16 to 26 History of allergic reaction that required medical intervention Currently enrolled in any other clinical study Participant is pregnant | 1 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 14.0-21.0, Exercise-related Amenorrhea Females 14-21 years old Note: Our pilot data are reassuring in that young women 18-25 years old with hypothalamic amenorrhea are not adversely affected with estrogen use. In fact, in our prospective study, beneficial effects were observed both in young women 18-25 years old using oral estrogen, and in 14-18 year old adolescent girls using transdermal estrogen. We therefore feel that including girls in the 14-21 year age range will not be hazardous to their bone health. In fact, given the lack of data in this age group, it is important to study younger women and teenagers rather than extrapolate data from studies in adults to this younger population. Hormone dynamics differ in teenagers compared with adults, and bone mass accrual is even more dependent on estrogen and IGF-1 in younger than older women who have already achieved peak bone mass Bone age (BA) >15 years Note: 99% of adult height is achieved at a BA of 15 years, thus estrogen replacement will not result in stunting of height potential after this age. Although we could have chosen to girls with a BA >14 in this study, we are limiting this to girls with a BA of >15 years. This is because 2% of growth potential persists at a BA of 14 years, versus only 1% at a BA of 15 years (~0.6" of potential height (130)). Thus, to avoid potential stunting of growth potential with estrogen replacement, we have chosen to girls with BA of > 15 years BMI between 10th-90th percentiles for age Amenorrhea (for AA): absence of menses for > three months (74) within a period of oligomenorrhea (cycle length > six weeks) for >six months, or absence of menarche at >16 years Eumenorrhea (EA and controls): > nine menses (cycle length 21-35 days) in preceding year Non-athlete healthy controls will be eligible if weight bearing exercise activity is less than two hours a week and if they are not participating in organized team sports Endurance athletes Note: severity of low BMD and menstrual dysfunction differ by kind of exercise and activity. For example, runners have a higher prevalence of menstrual irregularity than swimmers and cyclists (131). By limiting enrollment to endurance athletes, we will eliminate variability from the type of activity. Endurance training is defined as > 4 h of aerobic weight-bearing training of the legs or specific endurance training weekly, or > 20 miles of running weekly for a period of > 6 months in the last year Other conditions that may affect bone metabolism | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-999.0, Cleft Lip Patients with unilateral cleft lip and palate deformities and alveolar defects Patients without alveolar cleft Patients with syndromes that did not require periosteoplastic procedures as well as patients with systemic illnesses that may affect the result of the study (for instance diabetes) | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 20.0-70.0, Myasthenia Gravis Male or female age between 20-70 (including 20 and 70 years old) Osserman II and III Myasthenia Gravis Positive serum anti-acetylcholine receptor antibodies Poor control of disease with daily dose of prednisone ≥ 30 mg or 0.5 mg/kg at 3 months before enrollment Without immunosuppressive therapy other than steroid Ocular MG or minimal clinical syndrome that would not require the therapy of steroids Negative serum anti-acetylcholine receptor antibodies Use immunosuppressants other than steroids in the preceding year Previous use other investigational medication within 3 months or current participate other clinical study Poor renal function: serum creatinine > 3.0 mg/dl or estimated creatinine clearance < 30 ml/min Females who are pregnancy or breast-feeding Recent history, within 5 years, of malignancy Unwilling or unable to participate the necessary continuous visits and examinations | 1 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 10.0-999.0, Anaplasmosis Tick-borne Disease Ehrlichia patient with at least one of following symptoms : fever or muscular pain or articular pain or respiratory signs or neurological signs or meningitis or erythema occurring during the three weeks after a tick bite- patient with fever with at least one of following : thrombocytopenia, leucopenia, hepatitis, without any other cause that can explain these abnormalities patient with tick-borne encephalitis, or primary stage Lyme borreliosis children less that 10 years pregnancy patients with an other diagnosis that can explain clinical symptoms or biological abnormalities antibiotherapy with cyclins during the days before | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 18.0-55.0, Musculoskeletal Pain Signed and dated informed consent prior to participation Subjects in good health as determined by the Investigator Age 18-55 Willing to abstain from any physical therapy, hard physical work, exercise or sauna during the study observation period (Screening to Final Visit) For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are also allowed for participation Participation in another clinical study within the last 30 days and during the study Subjects who are inmates of psychiatric wards, prisons, or other state institutions Investigator or any other team member involved directly or indirectly in the conduct of the clinical study Pregnancy or lactation Alcohol or drug abuse Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma Skin lesions, dermatological diseases or tattoo in the treatment areas Known hypersensitivity or allergy (including photoallergy) to NSAID´s including celecoxib, sulfonamides and ingredients used in pharmaceutical products and cosmetics including galactose Varicosis, thrombophlebitis and other vascular disorders of the lower extremities Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-skeletal system of the lower limbs | 1 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 18.0-999.0, HIV Infection Liver Failure Evidence of Liver Transplantation Age ≥ 18 Documented HIV-1 infection, hepatitis B or C co-infection is allowed Plasma viral load at screening visit below 50 copies per mL for at least 6 months Patient with severe liver failure (Meld Score ≥ 15 and/or refractory ascites and/or haemorrhage of digestive tract and/or hepatic encephalopathy) for taking part into period 1 Patient eligible for the liver transplant waiting list or immediate post transplantation for taking part into period 2 Abstinence from alcohol intake for at least 6 months (WHO norm) Withdrawal from intravenous drug use for at least 6 months (methadone substitution is permitted) No ongoing class C opportunistic infection (1993 CDC classification) Patient whose clinical and immunovirological condition allows triple therapy with raltegravir + 2 NRTI or raltegravir + NRTI + enfuvirtide Patient whose HIV population, according to cumulative genotypes carried out on viral RNA together with treatment history (if available and interpreted as per the ANRS-AC11 algorithm version no.19) does not present a profile of mutations associated with resistance to raltegravir and is sensitive to at least two fully active* agents selected among nucleoside/nucleotide reverse transcriptase analogs NRTI (abacavir, lamivudine, emtricitabine, tenofovir) or enfuvirtide *An ARV agent is considered to be fully active if the cumulative genotypes do not show any mutation associated with resistance or any mutation associated with "possible resistance" More than two virological failures during antiretroviral treatment Currently receiving treatment with an agent in development (apart from an authorization for temporary use) Plasma viral load at screening visit ≥ 50 copies per mL during at least the last 6 months Pregnant women, or women liable to become pregnant, breast-feeding women, no contraception, or refusal to use contraception All conditions (including but not limited to alcohol intake and drug use) liable to compromise, in the investigator's opinion, the safety of treatment and/or the patient's compliance with the protocol Patient not having any effective options for NRTI +/ enfuvirtide (defined in the criteria) Ongoing treatment with interferon-alpha or ribavirin for hepatitis C Concomitant medication including one or more agents liable to induce UGT1A1 and reduce raltegravir concentrations anti-infective agents: rifampicin/rifampin | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.5-999.0, HIV Infection Rheumatic Disease Cancer Transplant Pediatrics medically recommended influenza A(H1N1) immunization signed informed consent failure or refusal to provide sufficient blood for antibody determination | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 18.0-59.0, First Episode Psychosis Aged 18-59 years and meet DSM-IV diagnostic for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version Meeting DSM-IV for another axis I diagnosis, including substance abuse or dependence Needing another nonantipsychotic psychotropic medication at enrollment Having a serious or unstable medical illness Pregnant or lactating women or women without adequate contraception will be also excluded | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 14.0-999.0, Preeclampsia Hypertension Women with preeclampsia who receive care at the University of Michigan Hospitals No current use of PAP therapy Willing and able to provide informed consent Current PAP therapy Any medical reason why PAP therapy may not be suitable (e.g., in patients with recent head trauma) Cognitively impaired and unable to understand informed consent | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 18.0-999.0, Metastatic Melanoma ENTRY Locally advanced or metastatic melanoma Measurable Histologically or cytologically confirmed Surgically incurable HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes PRIOR/CONCURRENT If prior Proleukin treatment, must have had clinical benefit No prior systemic cytotoxic chemotherapy for melanoma No concurrent radiotherapy, chemotherapy, or other immunotherapy More than 4 weeks since prior major radiotherapy | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 3.0-10.0, Exotropia Age 3 to < 11 years Intermittent exotropia (manifest deviation) meeting all of the following Intermittent exotropia at distance OR constant exotropia at distance and either intermittent exotropia or exophoria at near Largest exodeviation at either distance, near OR remote distance between 15 and 50 prism diopters (PD) (inclusive) by prism and alternate cover test (PACT) Exodeviation at least 15 PD at distance and near by PACT Basic type or pseudo divergence excess type Stereoacuity of 400 arcsec or better at near by Preschool Randot stereotest (better of 2 measures) Visual acuity in the worse eye at least 0.3 logMAR (20/40 on ATS HOTV or 70 letters on E-ETDRS) No interocular difference of visual acuity more than 0.2 logMAR (2 lines on ATS HOTV or 10 letters on E-ETDRS testing) Absence of high AC/A ratio (exclude > 6:1) Coexisting vertical deviation, oblique muscle dysfunction, dissociated vertical deviation (DVD), or A or V pattern, any of which the investigator plans to address with vertical transposition of horizontal rectus muscles, oblique surgery, or vertical rectus muscle surgery, i.e., only small vertical deviations, oblique muscle dysfunction, DVD, and A or V patterns not requiring surgery are allowed Limitation of ocular rotations due to restrictive or paretic strabismus Craniofacial malformations affecting the orbits Interocular visual acuity difference of more than 0.2 logMAR (2 lines on ATS HOTV for patients 3 to < 7 years old or 10 letters on E-ETDRS for patients ≥ 7 years old) and/or investigator plans to initiate amblyopia treatment at this time High AC/A ratio (exclude > 6:1 by gradient method) Prior strabismus surgery or botulinum toxin injection Ocular disorders that would reduce visual acuity (except refractive error) Prior intraocular or refractive surgery Significant neurological impairment such as cerebral palsy. Patients with mild speech and/or learning disabilities are eligible Investigator planning to change refractive correction at this time (if the patient is otherwise eligible, the investigator should consider prescribing refractive correction and bringing the patient back at a later time for enrollment) | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-999.0, Acute Myeloblastic Leukemia For intensive chemotherapy: 1. Patients with the novo AML or secondary to MDS or previous treatment, regardless of age. 2. Signed written informed consent. 3. ECOG ≤ 2. If ECOG is greater than 2 due to AML, the patient can be included in the study. 4. LVEF > 40 % measured by means of echocardiography. 5. If background of respiratory disease (not related to the AML), risk factors or clinical for COPD, the values of functional tests, including DLCO, should be greater than 50% of the expected. 6. Bilirubin, alkaline phosphatase and ALT < of 3 fold the upper normal value, providing that it is not due to the disease that motivates the treatment (AML). 7. Serum creatinine < 2,5 mg/dL providing that it is not due to the disease that motivates the treatment (AML). 8. In fertile aged women, negative pregnancy test and use of contraception methods are required. Any patient who does not meet the and for treatment with intensive chemotherapy can be evaluated individually when considering that could still obtain benefit from this treatment considering that could still obtain benefit from this treatment. for GO administration in patient candidates for intensive chemotherapy Same for intensive chemotherapy, including the following specifications: 1. CD33 positive (more than 5 % of the leukemic population) 2. for treatment with GO in cases of serious hepatic disease not due to AML. 3. In patients who are going to receive GO in two cycles, the second one will be only administrated if the toxicity due to the first cycle is recovered. 4. Though the GO administered dose is much lower than usual, it is recommended a period of two months between GO administration and hematopoietic stem cell transplantation (HSCT). for the modification of high dose ARA-C The dose of Ara-C in cycles containing HiDAC should be reduced in the following cases: 1. The hematopoietic recovery in the previous cycle has been longer than 28 days. 2. Presence in the previous cycles of a confluent maculopapular rash or drug-induced shedding. 3. More than 4 episodes of watery diarrhea per day. 4. Increase of 4 fold the previous normal value of aminotransferases or alkaline phosphatase in any of the cycles. 5. Total bilirubin greater than 3 mg/dL in any of the cycles. 6. Treatment with HiDAC will be definitively suspended (even that included in the BEA conditioning) when previous toxicity severe cerebellar ataxia, confusion or another sign of central nervous toxicity that has not another clear explanation Patients with blastic crisis of a chronic myeloid leukemia or other myeloproliferative syndromes evolving to acute leukemia. 2. Patients with AML in relapse. 3. Acute promyelocytic leukemia (M3 or M3v). 4. Absence of signed written informed consent. 5. ECOG ≥ 3 that it is not due to the disease that motivates the treatment (AML). 6. LVEF < 40 % determined by echocardiography study. 7. Values of respiratory functional tests, including DLCO, lower than 50% of the expected. 8. Bilirubin, alkaline phosphatase or GOT > 3 fold the upper normal value, providing that it is not due to the disease that motivates the treatment (AML). 9. Serum creatinine > of 2.5 mg/dL providing that it is not due to the disease that motivates the treatment (AML). 10. Positive pregnancy test or not use of effective contraception in fertile aged women. 11. Previous treatment with antileukemic chemotherapy, except hydroxyurea. 12. Presence of an active neoplasia different from the AML. 13. Presence of a serious psychiatric disease. 14. Positive HIV test. 15. Any other condition which limits or dissuades from the treatment with intensive chemotherapy, especially with anthracyclines | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 10.0-18.0, Autism A formal diagnosis of Autism or Pervasive Developmental Disorder not otherwise specified (PDD-NOS), given by a child neurologist Age: 10-18 years A signed parental consent form Evidence for one of the following conditions an underlying infectious disease chromosomal abnormality metabolic disorder specific brain related disorder (such as tuberous sclerosis) history of fetal cytomegalovirus infection birth asphyxia a history of major head injury a chronic use of non-steroidal anti-inflammatory drugs, (NSAID) known brain damage | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 18.0-999.0, Myasthenia Gravis Thymoma Patients with compelling indications for thymectomy due to thymoma (with or without myasthenia gravis), Or Patients with elective indication for thymectomy due to thymoma without myasthenia gravis Patients with indication for a heart or thyroid surgery, in which for op-technical reasons, a (partial) resection of the thymus is performed Signed informed consent form Age > 17 Years Other immunological diseases such as rheumatoid arthritis, multiple sclerosis | 1 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 0.0-999.0, Foetal Growth Problem Small for Gestational Age Participation in the trial Patients with SGA (small for gestational age) short stature that are still growing Known or suspected allergy to study product(s) or related products Diabetes Mellitus Patients with malignant tumor(s) Pregnant or likely to get pregnant | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 15.0-45.0, Polycystic Ovary Syndrome PCOM by ultrasound Diagnosis Anovulation, Oligo menses Hyperandrogenism Women who had been diagnosed with other etiology that should be excluded in PCOS diagnosis, such as hyperprolactinemia, hypogonadotropic hypogonadism, premature ovarian failure, congenital adrenal hyperplastic, androgen-secreting tumor, Cushing's syndrome, disorders of uterus (such as Asherman's syndrome, Mullerian agenesis), chromosomal anomalies (such as Turner syndrome) Women who did not have sufficient clinical or biochemical records Girls who had menarche at <3 years of age and women who were >40 years of age | 0 |
The patient is a 16-year-old girl recently diagnosed with myasthenia gravis, class IIa. She complains of diplopia and weakness affecting in her upper extremities. She had a positive anti-AChR antibody test, and her single fiber electromyography (SFEMG) was positive. She is on acetylcholinesterase inhibitor treatment combined with immunosuppressants. But she still has some symptoms. She does not smoke or use illicit drugs. She is not sexually active, and her menses are regular. Her physical exam and lab studies are not remarkable for any other abnormalities. BP: 110/75 Hgb: 11 g/dl WBC: 8000 /mm3 Plt: 300000 /ml Creatinine: 0.5 mg/dl BUN: 10 mg/dl Beta hcg: negative for pregnancy | eligible ages (years): 18.0-80.0, Cognitive Dysfunction Over18 years old ASA I-III Fluency in Hebrew, Russian, or Arabic Absence of serious hearing or vision impairment History of head trauma, neurological diseases, alcoholism, drug abuse, consumption of psychotropic drugs or antidepressants Heart failure (NYHA > 3) Liver failure Respiratory problems (asthma, etc.) | 0 |
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