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A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 0.0-999.0, Lupus Nephritis Have renal biopsy proven Lupus Nephritis (with the biopsy-based diagnosis date no earlier than January 1, 1995) Reside within designated counties of eastern North Carolina and South Carolina | 1 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-999.0, Rash Non-small-Cell Lung Cancer To be eligible for the study, subjects must fulfill all of the following Be male or female ≥18 years of age (inclusive) Have been prescribed Tarceva as a single agent to treat locally advanced or metastatic NSCLC, after failing at least 1 prior chemotherapy regimen Present with acute signs and symptoms of rash on the face that meet the following Are suspected to be related to Tarceva at least 3 inflammatory lesions, and Are less than CTCAE Grade 3 in severity Have an Eastern Co-operative Oncology Group (ECOG) performance status ≤2 and a life expectancy of at least 4 months Sign an approved informed consent form for the study Be willing to comply with the protocol Subjects meeting any of the following will be excluded from the study A skin examination reveals the presence of another skin disease and/or condition (excessive facial hair, excessive scarring, sunburn, or other disfigurement) located on the face that, in the study physician's opinion, would confound the evaluation of the rash A diagnosis of G6PD deficiency, defined as having a G6PD value below the lower limit of normal A diagnosis of anemia, defined as hemoglobin <9.5 g/dL Undergoing any current therapy for NSCLC other than Tarceva Prior treatment with Iressa, Erbitux, or any experimental HER1/EGFR inhibitor Treatment with topical antibiotics, topical steroids, and other topical treatments on the face within 14 days of Day 0 (start of study treatment) Treatment with any systemic antibiotics within 7 days of Day 0 (start of study treatment) Treatment with any systemic medication or therapy known to affect anti-inflammatory responses within 30 days prior to Day 0 (start of study treatment). These medications but are not limited to, oral corticosteroids, cyclosporine, and methotrexate. Short-term treatment with non-steroidal anti-inflammatory drugs (NSAIDs) before the study for non-rash related conditions is acceptable, provided that exposure is limited to ≤7 days per course. Chronic low-dose aspirin use is also acceptable Active participation in an experimental therapy study or received experimental therapy within 30 days of Day 0 (start of study treatment) | 0 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 20.0-999.0, SLE Rheumatoid Arthritis Healthy Subjects SLE, RA, healthy | 2 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-999.0, Atherosclerosis Thromboembolism Systemic Lupus Erythematosus Age > 18 years Fulfillment of at least 4 of the American College of Rheumatology (ACR) for SLE Presence of any two of the following risk factors SLE duration of >= 5 years Postmenopausal Age >= 40 years Diabetes mellitus Hypertension (140/90 mmHg) Serum low density lipoprotein (LDL) level >= 2.6 mmol/L or total cholesterol >= 5.5 mmol/L Obesity (body mass index >= 27 kg/m2) Patients with known allergy to aspirin, or any other non-steroidal anti-inflammatory drugs (NSAIDs), or statins Patient with a history of severe gastrointestinal intolerance to aspirin (e.g., gastrointestinal bleeding) or other NSAIDs Patients with history of arterial or venous thromboembolism Patients receiving aspirin or other anti-platelet agents Patients receiving long-term non-aspirin NSAIDs Patients receiving anticoagulation therapy (e.g., warfarin) Patients with history of intolerance or allergy to the statins Pregnant or lactating women | 2 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-65.0, Systemic Lupus Erythematosus Eligible women will be those having any two of the following Amenorrhea of 6 months or more Serum follicle-stimulating hormone level of 30 IU/L or more Menopausal symptoms Age 48 years or older Women older than 65 years Severe lupus activity at baseline (SLEDAI score, more than 30) Use of estrogens within 3 months of the screening visit Serum creatinine of 2.0 mg/dL or more Hypertriglyceridemia 500 mg/dL or more Metabolic bone diseases Liver disease Untreated hyperthyroidism Recent thrombosis Malignancy | 0 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-999.0, Systemic Lupus Erythematosus Age of 18 and above Diagnosis of Systemic Lupus Erythematosus (SLE) according to the American College of Rheumatology (ACR) Classification Criteria Treatment with HCQ for at least 6 months, without modification of HCQ dosage for 2 months Stable dosage of HCQ from one day to another (200 g x 2/day or 400 mg once a day or 200 mg once a day) No increase in the steroids dosage during the 3 previous weeks Steroids dosage lower or equal to 0. 5 mg/kg/day of prednisone equivalent No modifications of a possible immunosuppressor during the 2 previous months < or = 12 Signature of the consent of participation Known retinopathy, present or passed Severe cataract obstructing the ophthalmologic monitoring patients Past history of intolerance with HCQ (in particular gastro-intestinal, or retinal) during the possible former use of a higher dosage Use of nivaquine during the 3 previous months Treatment with biotherapy (for example Rituximab) during the 12 previous months Calculated clearance of creatinin lower than 60 ml/min Chronic alcoholism Liver failure Desire of pregnancy in the next 7 months | 1 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-999.0, Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE) as defined by meeting at least 4 of the 11 classification of the American College of Rheumatology for the classification of Systemic Lupus Erythematosus, either sequentially or coincident. The 4 need not be present at study entry Renal biopsy within 12 months prior to screening visit indicating active proliferative lupus glomerulonephritis (met ISN/RPS Class III or IV classification [2003], excluding Class III [C], IV-S [C] and IV-G [C], or the World Health Organization Class III or IV classification [1982], excluding Class IIIc, IVd). If the renal biopsy was performed >3 months but ≤12 months prior to screening visit, at least 1 of the following 3 serologies (performed locally) must have been abnormal prior to screening visit: complement (C3 or C4) level below normal range OR anti-dsDNA >upper limit of normal range A stable serum creatinine ≤3 mg/dL Subjects with a rise in serum creatinine of ≥1 mg/dL within 1 month prior to the screening visit Subjects with drug-induced SLE, as opposed to idiopathic SLE Subjects with severe, unstable and/or progressive Central nervous system (CNS) lupus Subjects with autoimmune disease other than SLE as their main diagnosis (e.g.; Rheumatoid arthritis (RA), Multiple Sclerosis [MS]) Subjects who have received treatment with cyclophosphamide within 3 months of randomization (Day 1) Subjects who have received treatment with rituximab < 6 months prior to the screening visit | 1 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-999.0, Systemic Lupus Erythematosus men and women with diagnosis of SLE years and above negative pregnancy test for female subjects of child-bearing age and must accept not to attempt to get pregnant during the period of the study Subject with active disease as defined by SLAM of at least 8 SLICC/ACR damage index of less or equal to 15 Subject must be on stable does of NSAIDs, prednisone, or antimalarial (chloroquine sulfate or hydroxychloroquine) at least 4 weeks preceding the study subjects can be under other medications as long as condition or treatment will not interfere with the experimental medications and assessments must understand either French or English and can give written informed consent previous history of hypersensitivity or intolerance to methotrexate or folic acid total SLAM of less than 8 or total SLICC/ACR score of more than 15 history of medical non-compliance or inability to comply with instructions subject who have received intra-articular or intramuscular corticosteroids in the four weeks prior to study entry clinically significant acute or chronic liver disease with the exception of autoimmune liver disease alcohol use in excess of 2 ounces of 100 proof liquor or its equivalent/week insulin requiring diabetes mellitus with morbid obesity renal impairment such that the serum creatinine is more than or equal to 175 umol/I (SI units) or 2.0 mg/dl interstitial lung disease as defined by an abnormal chest x-ray or decrease diffusion capacity (DLCO < 70% of predicted) without evidence of pulmonary hypertension WBC count ,3,000/ cubic mm. and/or platelet count ,80,000/ cubic mm | 1 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-999.0, Systemic Lupus Erythematosus Males or females, aged 18 years and over Patients meeting the diagnostic for SLE (Appendix 2), according to ACR guidelines (including screening for anti-dsDNA (antibody to native DNA in abnormal titer)) > 6 Patients treated with maintenance therapy including azathioprine Patients who are willing and able to participate in the study and from whom written informed consent has been obtained Creatinine clearance of < 20ml/min Patients with any clinically significant infection Patients with known hypersensitivity to myfortic ® or to drugs with similar chemical structures Patients with a history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin Patients with SLE active CNS manifestations or a past history of SLE CNS complications (e.g. psychosis, grand mal seizures) Patients who have received prior therapy with mycophenolic acids (MPAs) (e.g. MMF) Patients who have received an investigational drug within four weeks prior to study entry Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception | 1 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-999.0, Systemic Lupus Erythematosus Cutaneous Lupus Diagnosis of Systemic Lupus Erythematosus or Cutaneous Lupus Patient of a rheumatologist at Duke University Medical Center Inability to travel to Duke for follow-up visits Inability to speak English Not able to provide informed consent | 1 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-999.0, Lupus Nephritis age at least 18 years diagnosis of SLE by ACR diagnosis of proliferative lupus nephritis (ISN/RPS class III or IV) currently on prednisolone (5 to 20 mg/day) in partial or complete remission for at least 3 months currently pregnant in end-stage renal failure receiving corticosteroids for an indication other than lupus nephritis | 1 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 0.0-21.0, Lupus Age: Less than 21 years at baseline exam Diagnosis: patients must meet for one of five diagnostic categories based on classification according to three parameters; aPL positivity, APS and SLE criteria The five diagnostic categories are SLE with no aPL SLE with aPL, but without manifestations of APS SLE-like APS SLE with APS Primary APS | 2 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 7.0-22.0, Lupus Erythematosus, Systemic SlE subjects 4/11 of the American College of Rheumatology for SLE (23), age less than 22 years Neonatal SLE or drug-induced SLE Subjects who are pregnant, and subjects weighing over 300 pounds, as the densitometry techniques are not reliable above this weight Subjects receiving calcium or vitamin D supplementation will not be excluded but this information will be recorded and evaluated further in the dietary/nutritional assessment | 2 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-65.0, Lupus Erythematosus, Systemic age 18 to 65 years SLE as defined by the ACR classification Stable SLE (treatment not modified during the 2 months preceding the date W0) SLE treated by immunosuppressant only or systemic corticosteroids at a dose ≥ 5 mg/j or systemic corticosteroids at any dose associated with one or more immunosuppressive drugs SLE treated by hydroxychloroquine only months following females must have an effective method of contraception during the first 7 months of the study and with a negative serum or urinary pregnancy test females not wishing to have a child during the 7 months following W0 physical examination signed written and informed consent pregnant females or females wishing to have a child during the 7 months following W0 subjects infected with HIV and/or HBV( Ag HBs+) and or HVC medical history of allergy to any vaccine component receipt of any pneumococcal vaccine less than 5 years receipt of other vaccine within one month prior to enrolment (inclusion visit W0) receipt of immunoglobulin within three months prior to enrolment (inclusion visit W0) splenectomy hematopoietic disorders which give contra-indications to intramuscular and hypodermic route injections active malignancy , cirrhosis intercurrent illness within one month prior to enrolment (inclusion visit W0) | 1 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-999.0, Systemic Lupus Eythematosus (SLE) Fulfill the revised ACR for SLE with either evidence of active disease according to SLE Disease Activity Index (SLEDAI) Patients who are pregnant or nursing women, or those with life threatening disease | 2 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-999.0, Systemic Lupus Erythematosus Written Informed consent Age >18 yrs SLE meeting ACR {Tan, Cohen, et al. 1982 1482 /id} for at least 6 months.(SLE group) Stable disease activity as evidenced by no change in immunosuppressive therapy in the past 1 month If female of childbearing potential must use an effective method of birth control Renal disease (creatinine >1.5 mg/dL, dialysis, 2+ or more proteinuria) Previous or current history of peptic ulcer disease or gastrointestinal bleed Previous or current thromboembolic or ischemic cardiovascular event (stroke, myocardial infarction, angina) can do aspirin part of study Currently taking an anticoagulant or antiplatelet agent (besides aspirin) Thrombocytopenia (platelet count <135,000) Pregnancy Allergy to aspirin, NSAIDs NSAIDs in the previous week | 1 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 0.0-999.0, Spondylitis, Ankylosing Arthritis, Rheumatoid Psoriasis Arthritis, Psoriatic Participants with ankylosing spondylitis who did not show adequate response to general treatments and with increased serological indices related to severe axial symptoms and inflammation Participants with rheumatoid arthritis who show insufficient response to disease modifying antirheumatic drug (DMARD) including methotrexate Participants with serious, active and progressive disease not previously treated with methotrexate or other DMARD Participant with moderate to serious plaque psoriasis who are unresponsive, contra indicant or intolerable to the systemic therapy including cyclosporine, methotrexate or Psoralen Ultra-Violet A (PUVA) Participant with active, progressive, psoriatic arthritis who have shown insufficient response to DMARD treatment | 0 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-999.0, Systemic Lupus Erythematosus (SLE) For SLE Subjects SLE patients who exhibit ongoing disease activity by greater or equal to 4 SLE patients whose disease activity is controlled by administration of corticosteroids, most commonly, at least 10 mg/day of prednisone years of age or older Updated vaccinations prior to study entry Use of effective contraception for male patients before, during and up to 12 weeks after sirolimus therapy For Healthy Control Subjects years of age or older Must be matched with one of the SLE patients enrolled in the study by age, gender and ethnic origin Must not have any acute or chronic illness For SLE Subjects Patients who are pregnant Patients with allergy or intolerance to sirolimus Patients with life-threatening manifestations of SLE Patients with proteinuria exceeding 500 mg/24 h or urine protein/creatine ratio >0.5 Patients with total cholesterol > 300 mg/dl or triglyceride > 400 mg.dl will be excluded Patients with acute infection requiring antibiotics Patients on sirolimus who develop infections and require intravenous antibiotics and fail to show clinical improvement in 5 days Patients concurrently undergoing B cell-depleting therapy, cyclophosphamide, cyclosporine, and tacrolimus Patients who have received investigational biologic B-cell depleting products within one year of study initiation | 1 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-60.0, Systemic Lupus Erythematosus High LDL Cholesterol Level SLE patients that on prednisolone more than 30 mg/day Normal liver faction: AST and ALT < 80 mg/dl Normal muscle enzyme : CPK < 100 U/L LDL cholesterol level > 100 mg/dl Patients that was treated with pulse methylprednisolone or corticosteroid equivalent to prednisolone > 1mg/kg/day at screening Statin allergy On statin treatment before screening On cyclosporine, antifugal (azole group), antibiotics (macrolide group), rifampicin, warfarin, phenytoin Pregnancy Abnormal liver function: AST or ALT > 80 mg/dl Abnormal muscle enzyme : CPK > 300 U/L | 1 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 1.0-17.0, Purpura, Thrombocytopaenic, Idiopathic Subjects between 1 year and <18 years of age at Day 1 Written informed consent from subject's guardian and accompanying informed assent from subject (for children over 6 years old) Confirmed diagnosis of chronic ITP, according to the American Society of Hematology / British Committee for Standards in Haematology (ASH/BCSH) guidelines [George, 1996; BCSH, 2003]. In addition, a peripheral blood smear or bone marrow examination should support the diagnosis of ITP with no evidence of other causes of thrombocytopenia Subjects who are refractory or have relapsed after at least one prior ITP therapy or are not eligible, for a medical reason, for other treatments Day 1 (or within 48 hours prior) platelet count <30 Gi/L Previous therapy for ITP with immunoglobulins (IVIg and anti-D) must have been completed at least 2 weeks prior to Day 1 or have been clearly ineffective Subjects treated with concomitant ITP medication (e.g. corticosteroids or azathioprine) must be receiving a dose that has been stable for at least 4 weeks prior to Day 1 Previous treatment for ITP with splenectomy, rituximab and cyclophosphamide must have been completed at least 4 weeks prior to Day 1 or have clearly been ineffective Subjects must have prothrombin time (PT/INR) and activated partial thromboplastin time (aPTT) within 80 to 120% of the normal range Subjects must have a complete blood count (CBC) not suggestive of another hematological disorder Any clinically relevant abnormality, other than ITP, identified on the screening examination or any other medical condition or circumstance, which in the opinion of the investigator makes the subject unsuitable for participation in the study or suggests another primary diagnosis (e.g. thrombocytopenia is secondary to another disease) Concurrent or past malignant disease, including myeloproliferative disorder Subjects who are not suitable for continuation of their current therapy for at least 7 additional additional weeks Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding Day 1 History of platelet agglutination abnormality that prevents reliable measurement of platelet counts Diagnosis of secondary immune thrombocytopenia, including those with laboratory or clinical evidence of HIV infection, anti-phospholipid antibody syndrome, chronic hepatitis B infection, hepatitis C virus infection, or any evidence of active hepatitis at the time of subject screening Subject with Evans syndrome (autoimmune thrombocytopenia and autoimmune hemolysis) Subjects with known inherited thrombocytopenia (e.g. MYH-9 disorders) Subjects treated with drugs that affect platelet function (including but not limited to aspirin, clopidogrel and/or NSAIDs) or anti-coagulants for >3 consecutive days within 2 weeks of Day 1 Subjects who have previously received eltrombopag or any other thrombopoietin receptor agonist | 0 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 19.0-60.0, Posttraumatic Stress Disorders Outpatients between the 19-60 years of age with a diagnosis of PTSD Women must not be currently pregnant and must use a reliable method of contraception for the duration of the study Subjects must be on stable medication (4 weeks minimum) for their PTSD (symptomatic despite current treatment), must be able to provide written informed consent, must be able adequately understand and comply with the study's instructions and protocol Those not meeting the and those not able to give informed consent Women who are currently pregnant or nursing Those at immediate risk of harming self or others; those who have a clinically significant medical illness or other significant psychiatric illness currently abusing alcohol or drugs currently being treated with an investigational medication or medication that is contraindicated with cannabinoids have a known allergy to cannabis-based products | 0 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-80.0, Metabolic Syndrome Cardiovascular Risk Factors Systemic Lupus Erythematosus Persons aged 18 and above Persons fulfill the diagnostic of the 1997 American College of Rheumatology for systemic lupus erythematosus in the patient group a history myocardial infarction, angina or stroke | 2 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-999.0, Systemic Lupus Erythematosus Age > 18 years at the time of signing the informed consent form Fulfil at least 4 for SLE as defined by the American College of Rheumatology (ACR) Present with active SLE disease with at least one of the following symptoms i) Arthritis > 2 joints with pain and signs of inflammation (i.e. tenderness, swelling, or effusion) ii) Inflammatory-type skin rash iii) Oral ulcers Laboratory values as follows Hemoglobin ≥ 100 g/L Absolute neutrophil count ≥ 1.0 x 109/L Total bilirubin ≤ 1.5 x upper limit of normal (ULN) AST (SGOT) / ALT (SGPT) ≤ 2.5 x ULN Active severe SLE flare with central nervous system (CNS) manifestations, active renal lupus, systemic vasculitis, active pericarditis, active pleuritis, active peritonitis or other SLE manifestations requiring treatment not allowed by the study protocol Severe renal impairment (estimated or measured GFR <50%) Oral treatment with corticosteroids (>15 mg/day prednisolone or equivalent) or changes in corticosteroid dosing within 30 days prior to the first dose of study medication. This also includes intraarticular steroid injections or topical treatment for SLE symptoms. Inhaled or topical steroids may be given for reasons other than SLE disease activity (such as asthma, contact dermatitis) as clinically indicated Intravenous corticosteroids within 3 months prior to the first dose of study medication Intravenous cyclophosphamide within 6 months prior to the first dose of study medication Treatment with anti-rheumatic/immunosuppressive drugs within 3 months prior to first dose of study medication, other than the following medications at stable doses: methotrexate (≤25 mg/week), azathioprine (≤2.5 mg/kg/day), hydroxychloroquine and mycophenolate mofetil (≤3000 mg/day) B-cell depletion therapy (such as treatment with Rituximab) within 12 months prior to the first dose of study medication Potent inhibitors or inducers of CYP3A4 intravenously or orally within 14 days prior to first dose of study medication History of myocardial infarction or current uncontrolled angina, severe uncontrolled ventricular arrhythmias, symptomatic congestive heart failure, unstable angina pectoris, or electrocardiographic evidence of acute ischemia Marked baseline prolongation of QT/QTc interval (eg, repeated demonstration of a QTc interval >450 milliseconds | 1 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-65.0, Inflammation Systemic Lupus Erythematosus Diagnosis of systemic lupus erythematosus (SLE) Disease duration: 6 months or longer Stable, mild to moderately active systemic lupus erythematosus (SLE) Receiving stable maintenance therapy Significant Lupus Nephritis Active central nervous system (CNS) disease Significant arterial or venous thrombosis (blood clots) within 12 months prior to trial start Body weight of 260 lbs/120 kg or more History of alcohol or substance abuse History of cancer Infections Viral infections: HIV, Hepatitis B or C, Epstein-Barr Virus (EBV), Cytomegalovirus (CMV), Varicella-Zoster Virus (VZV), or Herpes Simplex Virus (HSV-1 or HSV-2) Tuberculosis Severe systemic bacterial, viral or fungal infections within the past 12 months prior to trial start | 1 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-999.0, SLE no administration of drugs that would potentially influence QT duration except hydroxychloroquine no history of ischemic heart disease, congestive heart failure, atrial fibrillation, bundle branch block or abnormal serum electrolytes normal resting ECG and a good-quality ECG recording to measure the QT interval moderate or severe valve disease atrial fibrillation and other ECG abnormalities systolic left ventricular dysfunction (ejection fraction <50% or left ventricular end diastolic dimension >5.5 mm unreliable identification of the end of the T wave in the ECG and known presence of cardiac disease including hypertension, diabetes or coronary artery disease | 1 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 10.0-45.0, Systemic Lupus Erythematosus Sister Diagnosed with SLE Proband must be a female and have documented SLE that meets ACR criteria. SLE must be diagnosed by and including age 40 Proband must have at least one biological sister ≥ 10 years of age and ≤ 45 who is available and willing to donate a blood sample and enroll in a longitudinal study. Both full and half siblings qualify If above are met for the proband, there are no exclusions Sister who does not have SLE Female with a full or half sister who has been documented SLE that meets ACR criteria Sister must be currently between ages ≥ 10 and ≤ 45 at the time of enrollment and not have a diagnosis of SLE Sister must be able to complete questionnaires and should be willing to donate a blood sample at baseline and follow-up Sister should communicate to the recruiter that she is willing to be followed for a period of at least two years by phone and/or internet If Sister meets there will be no exclusions | 1 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-60.0, Systemic Lupus Erythematosus Atherosclerosis Female SLE patients Age 18-60 years If premenopausal using a reliable method of contraception Clinically stable disease Taking hydroxychloroquine and up to 15mgs of prednisolone daily Smokers Pregnancy or breast feeding Use of other immunosuppressants (hydroxychloroquine and stable dose of prednisolone up to 15 mgs daily will be permitted) Use of any investigational drug within 1 month prior to screening Acute infections 2 weeks prior to Visit 1 History of ischaemic heart disease or end stage renal disease Current signs or symptoms of severe, progressive or uncontrolled hepatic, haematological, gastroenterological, endocrine, pulmonary, cardiac or neurological disease | 1 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-65.0, Systemic Lupus Erythematosus age 18-65 Diagnosis of SLE based on ACR presently enrolled in a yoga program osteoporosis (T score ≥ -2.5) avascular necrosis taking quinolone in the preceding 3 months taking ≥ 30 mg of prednisone daily history of joint replacement or organ transplant Persons with any pre-existing condition that would prevent attendance at the yoga classes | 2 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 10.0-999.0, Infections, Papillomavirus Subject must be female Subject must be aged 10 and over Subject with obvious fever Subject with obvious severe acute disease Subject with hypersensitivity to any component of Cervarix® Other than above, subject who is in inappropriate conditions for vaccination | 2 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 2.0-18.0, Juvenile Idiopathic Arthritis Diagnosis must have been before the patient's 16th birthday Disease duration of at least 6 months before study entry Must have 5 or more joints with active arthritis Must be taking a stable dose of methotrexate 10-30 mg/meter squared (patients with body surface area [BSA] 1.67 square meter or more must be taking a minimum of 15 mg/week of methotrexate) May take a stable dose of prednisone less than 10 mg/day 4 weeks prior to entry or may take a stable dose of (non-steroidal anti-inflammatory drugs) 2 weeks prior to entry Must have qualifying laboratory values at the first visit Have known allergies, hypersensitivity, or intolerance to golimumab or similar therapeutics Are pregnant or breast-feeding, or planning a pregnancy or fathering a child within 6 months after the last study agent administration Have initiated and/or immunosuppressive therapy within 4 weeks prior to study initiation | 0 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-999.0, Lupus Erythematosus Diagnosed with cutaneous lupus erythematosus and/or systemic lupus erythematosus by clinical, laboratory, and histopathological findings Ability to speak and read English or Spanish at a 6th grade reading level (a translator will be available with additional consent forms in Spanish) Ability to give written informed consent Less than 18 years of age, since the characteristics of the disease in these subjects could be very different Due to a medication, in which its discontinuation results in the resolution of cutaneous lupus, since the characteristics of the disease in these subjects could be very different Medical conditions who do not warrant a skin biopsy Unable to give written, informed consent or undergo a skin biopsy and/or venipuncture for any other reason | 2 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-45.0, Systemic Lupus Erythematosus All SLE (Systemic Lupus Erythematosus) pregnant women (aged 18 years) before 14 weeks of gestation, with autoimmune thyroid antibodies SLE (Systemic Lupus Erythematosus) patients already on levothyroxine. Those patients discovered to be hypothyroid who need levothyroxine as part of standard of care | 0 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 5.0-21.0, Systemic Lupus Erythematosus For SLE subjects: Subjects age 5-21 drawn from rheumatology clinic at Children's Hospital of Philadelphia diagnosed with SLE for at least 1 month. Also subjects with no known vertebral compression fracture of L2 For Control subjects: Subjects age 5-21. Controls will be a 50% male/female For SLE subjects: Subjects with SLE will be excluded if they have conditions or drug exposure unrelated to SLE and known to impact growth or bone health For Control subjects: Chronic disease or syndrome known to affect growth or bone health, prematurity (<37 weeks gestation), or use of any medication known to affect growth | 2 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 20.0-999.0, Systemic Lupus Erythematosus Subjects who gave consent to this study participation and signed into informed consent form Subjects who are at least 20 years of age at Screening visit Have a clinical diagnosis of Systemic Lupus Erythematosus (SLE) according to the American College of Rheumatology (ACR) classification with 4 or more of the 11 ACR present, serially or simultaneously during any interval or observation Be on either no SLE medication or a stable SLE treatment regimen of any medication (e.g., low-dose prednisone, NSAIDs; alone or in combination) for a period of at least 2 months prior to the Screening visit Males and females. A female subject is eligible to enter the study if at least one of the following conditions apply Not pregnant or nursing Of non-childbearing potential (ie, women who had a hysterectomy, are postmenopausal which is defined as 1 year without menses, have both ovaries surgically removed or have current documented tubal ligation); or Of childbearing potential (ie, women with functional ovaries and no documented impairment of oviductal or uterine function that would cause sterility). This category includes women with oligomenorrhoea [even severe], women who are perimenopausal or have just begun to menstruate. These women must have a negative serum pregnancy test at screening, and agree to 1 of the following Complete abstinence from penile-vaginal intercourse, when this is the female's preferred and usual lifestyle, from 2 weeks prior to administration of the 1st dose of investigational product until 8 weeks after the last dose of investigational product; or Consistent and correct use of 1 of the following acceptable methods of birth control for 1 month prior to the start of the investigational product and for 8 weeks after the last dose of investigational product Active lupus nephritis requiring hemodialysis, intravenous cyclophosphamide (Cytoxan),or high-dose prednisone (>60 mg/day) within 6 months prior to the Screening visit The subject has severe lupus kidney disease (defined by proteinuria > 6 g/day) within 6 months prior to the Screening visit Received IVIG or plasmapheresis within 6 months prior to Screening visit Active CNS lupus [including seizures, psychosis, organic brain syndrome, cerebrovascular accident (CVA), motor neuropathy, vasculitis] requiring medical intervention within 6 months prior to Screening visit The subject has hypogammaglobulinemia or IgA deficiency (IgA level < 10 mg/dL) History of renal transplant History or clinical evidence of active significant acute or chronic diseases (i.e., cardiovascular, pulmonary, untreated hypertension, anemia, gastrointestinal, hepatic, renal, neurological, cancer, or infectious diseases) which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk History of any other medical disease, laboratory abnormalities, or conditions which would make the subject (in the opinion of the Investigator) unsuitable for the study History of any infection requiring hospitalization or parenteral antibiotics within 4 weeks prior to Screening visit The subject has an abnormality on 12-lead ECG at screening which is clinically significant in the opinion of the investigator | 1 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 0.0-70.0, Systemic Scleroderma Patients with SSc as defined by the American College of Rheumatology with diffuse cutaneous disease (except Group 5) at risk of disease progression Patients must have failed a prior >= 4-month course of either MMF/Myfortic or cyclophosphamide before being eligible for the study (determined at >= 1 week before start of mobilization); "failure" is defined as evidence of disease progression or absence of improvement; the response prior to MMF of cyclophosphamide will be assessed by the participating site study rheumatologist Patients must meet in at least 1 of the following 6 groups GROUP 1 Patients must have 1) both a and b below; and 2) either c, or d a) Diffuse cutaneous scleroderma as defined by skin thickening proximal to the elbows and knees and/or involving the torso in addition to distal extremity involvement; a skin score will be obtained but not used to determine b) Duration of systemic sclerosis =< 7 years from the onset of first non-Raynaud's symptom; for those patients with disease activity between 5-7 years from the onset of first non-Raynaud's symptom, recent progression or activity of disease must be documented c) Presence of SSc-related pulmonary disease with forced vital capacity (FVC) < 80% or hemoglobin-adjusted diffusing capacity for carbon monoxide (DLCO) < 70% of predicted AND evidence of alveolitis by high-resolution chest computed tomography (CT) scan and/or by bronchoalveolar lavage (BAL) (if high resolution computed tomography [HRCT] fails to show ground glass, then BAL for diagnosis of alveolitis must be confirmed); alveolitis by BAL cell count will be defined based on a BAL cell differential count (> 3% neutrophils and/or > 2% eosinophils) from any lavaged lobe d) History of SSc-related renal disease that may not be active at the time of screening; stable serum creatinine must be documented for a minimum of 3 months post-renal crisis at the time of the baseline visit; history of scleroderma hypertensive renal crisis is included in this criterion and is defined as follows History of new-onset hypertension based on any of the following (measurements must be repeated and confirmed at least 2 hours apart within 3 days of first event-associated observation, with a change from baseline) Subjects with pulmonary, cardiac, hepatic, or renal impairment that would limit their ability to receive cytoreductive therapy and compromise their survival; this includes, but is not restricted to, subjects with any of the following Pulmonary dysfunction defined as Severe pulmonary dysfunction with (1) a hemoglobin corrected DLCO < 40% of predicted at the Baseline Screening visit, or (3) FVC < 45% of predicted Baseline Screening visit, or Partial pressure (pO2) < 70 mmHg or pCO2 >= 45 mmHg without supplemental oxygen, or O2 saturation < 92% at rest without supplemental oxygen as measured by forehead pulse oximeter Significant pulmonary artery hypertension (PAH) defined as Peak systolic pulmonary artery pressure > 50 mmHg by resting echocardiogram will require right heart catheterization; if pulmonary artery pressure (PAP) is not evaluable on echocardiogram due to lack of a Tricuspid regurgitant jet, then normal anatomy and function as evidenced by normal right atrium and ventricle size, shape and wall thickness and septum shape must be documented to rule-out PAH; otherwise, right heart catheterization is indicated; prior history of PAH but controlled with medications will not patients from the protocol; PAH is considered controlled with medications if peak systolic pulmonary artery pressure is < 45 mmHg or mean pulmonary artery pressure by right heart catheterization is < 30 mmHg at rest Mean pulmonary artery pressure by right heart catheterization exceeding 30 mmHg at rest; if mean PAP is elevated and pulmonary vascular resistance and transpulmonary gradient are normal then the patient is eligible for the protocol New York Heart Association (NYHA)/World Health Organization Class III or IV Cardiac: Uncontrolled clinically significant arrhythmias; clinical evidence of significant congestive heart failure (CHF) (NYHA Class III or IV); left ventricular ejection fraction (LVEF) < 50% by echocardiogram or prior insertion of a pacemaker or cardioverter-defibrillator | 1 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-999.0, Vitamin D Deficiency Systemic lupus erythematosus Age > 18 years Serum vitamin D levels [25(OH)D] < 30 ng/mL Low to moderate active disease without modification of associated treatments Pregnancy Serum 25(OH)D levels > 30 ng/mL Flare requiring modification of treatments | 2 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-999.0, Brain Metastases Small Cell Lung Cancer Brain metastases Age ≥ 18 years Signed informed consent Recursive Partitioning Analysis (RPA) class III patients Recursive Partitioning Analysis (RPA) class I-II patients and >3 brain metastases Patients with small cell lung cancer extended disease eligible for prophylactic Whole-Brain Radiotherapy (WBRT) Previous whole brain radiotherapy | 0 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-999.0, Systemic Lupus Erythematosus Male or female of ≥18 years of age Written informed consent Diagnosis of SLE satisfying at least 4 out of the 11 ACR during the course of their illness Disease duration of at least 6 months score ≥ 6 at screening Positive test results for antinuclear antibody (ANA) (HEp-2 ANA ≥1:80) and/or anti-double-stranded deoxyribonucleic acid (dsDNA) (≥30 IU/mL) at screening Negative serum pregnancy test and highly effective method of contraception for woman of childbearing potential Increase in dosing of corticosteroids within 2 weeks prior to screening Introduction of MMF within 3 months prior to TD1 or increase in dosing within 1 month before screening Change in dosing of immunosuppressants or corticosteroids during the screening period Serum IgG < 6g/L Estimated Glomerular Filtration Rate (GFR) <50 mL/min/1.73m² Urinary protein:creatinine ratio >2 mg/mg History of demyelinating disease Breastfeeding or pregnancy Legal or limited legal capacity Additional | 1 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-30.0, Schistosomiasis Bilharziasis Urinary Schistosomiasis All subjects had to meet the study within 21 days prior to treatment Caucasian volunteers No smoker biological parameters (haematological, biochemical, renal and hepatic) in normal range Health Insurance sign inform consent inflammatory or immunological pathology such as atopic diseases, evidence of inflammation or acute infection (including positive serology to viral hepatitis B and C or HIV) any immunological deficiency any clinically relevant alcohol or drug use (cannabis, opiates, cocaine, amphetamines, benzodiazepines, nicotine, barbiturates, meprobamate or antidepressant drugs according to urine drug and metabolites screen) current immunosuppressor treatment any other medication use within 2 weeks before the study any vaccination within the last 6 months no antibodies against Sh28GST protein | 0 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-90.0, Systemic Lupus Erythematosus Patients with systemic Lupus erythematosus Patients without systemic Lupus erythematosus | 2 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-999.0, Immune Thrombocytopenia Systemic Lupus Erythematosus Patients older than 18 years old Immune Thrombopenia according to the American Society of Hematology (ASH) guidelines 2011 Positive antinuclear antibodies > 1/160e on Hep2 cells Secondary ITP (eg HIV, HCV, HBV, lymphoproliferative disorders...) | 2 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-999.0, Cutaneous Lupus Erythematosus-Systemic Lupus Erythematosus Patients diagnosed as cutaneous lupus erythematosus (CLE) Patients receiving corticosteroid more than 15mg/day of the equivalent dose of prednisolone Patients whose CLASI activity scores were less than 4 point at the initiation of Screening (Visit 1) and Day1 (Visit 2) (evaluated by a dermatology specialist) Patients whose fluctuations of CLASI activity scores were ≥20% between Visit 1 and Visit 2 (evaluated by a dermatology specialist). The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial | 0 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-999.0, Systemic Lupus Erythematosus Have completed the BEL113750 Protocol in Northeast Asia through Week 48 Be able to receive the first dose of belimumab for BEL114333 four weeks (minimum of 2 weeks, maximum of 8 weeks) after the last dose in BEL113750 Have developed clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SLE (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases), or experienced an adverse event (AE) in the Phase 3 study that could, in the opinion of the principal investigator, put the subject at undue risk Have developed any other medical diseases (e.g., cardiopulmonary), laboratory abnormalities, or conditions (e.g., poor venous access) that in the opinion of the principal investigator, makes the subject unstable for the study | 0 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-999.0, Systemic Lupus Erythematosus Key Black race Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria Active SLE disease Autoantibody-positive On stable SLE treatment regimen which may corticosteroids (for example, prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants (for example, azathioprine, methotrexate, mycophenolate) Key Pregnant or nursing Have received treatment with any B cell targeted therapy (for example, rituximab or belimumab) at any time Have received treatment with an investigational biological agent in the past year Have received intravenous (IV) cyclophosphamide within the past 90 days Have severe active lupus kidney disease Have severe active central nervous system (CNS) lupus Have required management of acute or chronic infections within the past 60 days Have current drug or alcohol abuse or dependence Tested positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C Have a history of severe allergic reaction to contrast agents or biological medicines | 1 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 5.0-17.0, Systemic Lupus Erythematosus years to 17 years of age at enrollment Have a clinical diagnosis of SLE according to the American College of Rheumatology (ACR) classification criteria Have active SLE disease (SELENA score ≥ 6) Have positive anti-nuclear antibody (ANA) test results Are on a stable SLE treatment regimen at a fixed dose for a period of at least 30 days prior to Day 0 Females of childbearing age are willing to use appropriate contraception Subject age appropriate assent and parent or legal guardian informed consent to participate Pregnant or nursing Have received treatment with belimumab (BENLYSTA®) at any time. (BENLYSTA® is a registered trademark of the GSK group of companies.) Treatment with any B cell targeted therapy (for example, rituximab) or an investigational biological agent in the past year Have received anti-TNF therapy; Interleukin-1 receptor antagonist; IVIG; or plasmapheresis within 90 days of Day 0 Have received high dose prednisone or equivalent (>1.5mg/kg/day) within 60 days of baseline Have received intravenous (IV) cyclophosphamide within 60 days of Day 0 Have received any new immunosuppressive/immunomodulatory agent, anti-malarial agent within 60 days of baseline Have severe lupus kidney disease Have active central nervous system (CNS) lupus Have had a major organ transplant | 0 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-64.0, Inflammation Systemic Lupus Erythematosus Men and women (not pregnant and not nursing) Subjects with SLE meeting the American College of Rheumatology (ACR) with a disease duration of at least 6 months Subjects with clinically active SLE defined as a Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score of at least 6 and positive for antinuclear antibody (ANA) and/or Anti-double-stranded DNA antibody (anti-dsDNA) If taken, background medication must be stable Presence or history of active lupus nephritis (LN) within the last 4 months or active central nervous system (CNS) disease within the last 12 months Body mass index (BMI) below 18 kg/m^2 or above 38 kg/m^2 | 2 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 12.0-60.0, Systemic Lupus Erythematosus The American College of Rheumatology established eleven in 1982,which were revised in 1997 as a classificatory instrument to operationalise the definition of SLE in clinical trials Malar rash (rash on cheeks) Discoid rash (red, scaly patches on skin that cause scarring) Serositis: Pleurisy (inflammation of the membrane around the lungs) or pericarditis (inflammation of the membrane around the heart) Oral ulcers (includes oral or nasopharyngeal ulcers) Arthritis: nonerosive arthritis of two or more peripheral joints, with tenderness, swelling, or effusion Photosensitivity (exposure to ultraviolet light causes rash, or other symptoms of SLE flareups) Blood—hematologic disorder—hemolytic anemia (low red blood cell count) or leukopenia (white blood cell count<4000/µl), lymphopenia (<1500/µl) or thrombocytopenia (<100000/µl) in the absence of offending drug. Hypocomplementemia is also seen, due to either consumption of C3 and C4 by immune complex-induced inflammation or to congenitally complement deficiency, which may predispose to SLE Renal disorder: More than 0.5 g per day protein in urine or cellular casts seen in urine under a microscope Antinuclear antibody test positive Poor compliance With lupus mental damage complication, occurrence of epilepsy or unable to express subjective symptoms during the observation period Taking drugs that affect cytochrome P450 2B6, cytochrome P450 3A4 and cytochrome P450 2C19, except corticosteroids Abnormal liver function | 2 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-999.0, Systemic Lupus Erythematosus Key Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria Active SLE disease Autoantibody-positive On stable SLE treatment regimen which may corticosteroids (for example, prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants (for example, azathioprine, methotrexate, mycophenolate) Key Pregnant or nursing Have received treatment with any of the following: belimumab, either as a marketed product or as an investigational agent; any B cell targeted therapy (for example, rituximab) in the past year; or any biological agent (for example, adalimumab, etanercept, infliximab, or anakinra) in the past 90 days Have received a live vaccine within the past 30 days Have severe active lupus kidney disease Have severe active central nervous system (CNS) lupus Current or past positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C | 1 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-999.0, Systemic Lupus Erythematosus Key Clinical diagnosis of active SLE Autoantibody-positive Current SLE treatment includes and/or immunosuppressants (for example, azathioprine, methotrexate, cyclophosphamide, mycophenolate, and biologics) Key Have received treatment with an investigational agent within the past year Are currently enrolled in a placebo-controlled (belimumab) clinical trial or a continuation trial in which belimumab is used as an investigational agent Have a history of exposure, but are not currently receiving Current SLE treatment includes only an antimalarial (for example, hydroxychloroquine) or only steroids | 1 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-60.0, Antiphospholipid Syndrome Persistent(at least 12 weeks apart)aPL-positivity within 12 months prior to the screening defined as aCL IgG/M (>40U,medium-to-high titer,and/or greater than the 99th percentile)and/or aβ2GPI IgG/M(>40U, medium-to-high titer, and/or greater than the 99th percentile)and/or Positive LA test based on the International Society of Thrombosis & Haematosis Recommendations Selected History of thrombosis (arterial, venous, and/or biopsy proven microthrombosis History of Transient Ischemic Attack Confirmed by a Neurologist SLE Diagnosis based on the ACR Classification > 4/11 Other Systemic Autoimmune Diseases diagnosed based on ACR Classification Current Hydroxychloroquine or another antimalarial treatment (-3 months) Current warfarin treatment (-3 months) Current heparin therapy( -3 months) Current pregnancy History of Hydroxychloroquine eye toxicity History of Hydroxychloroquine allergy | 1 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-70.0, Lupus Erythematosus, Cutaneous Lupus Erythematosus, Systemic Lupus Erythematosus, Discoid have active DLE or active SCLE confirmed by histological analysis have a confirmed diagnosis of SLE with SLE Disease Activity Index (SLEDAI) of >6 and current or historical positive ANA or anti-dsDNA have an active skin lesion that can be biopsied if using hydroxychloroquine or chloroquine, must be on stable doses for at least 2 months prior to screening have an active skin disease other than CLE have any known malignancy within the previous 5 years (with the exception of a non-melanoma skin cancer that has been treated with no evidence of recurrence) have used a topical corticosteroid on active lesion have donated blood (volume >=500 mL) within 56 days prior to screening has been treated with drugs that are associated with CLE induction within 2 months prior to the screening have been treated with >10 mg/day prednisone therapy or equivalent in the last 4 weeks prior to screening | 2 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-60.0, Eyebrow Hypotrichosis Thin Eyebrow male or female aged 18-60 years hypotrichosis of eyebrows healthy informed consent obtained underlying diseases alopecia areata or trichotillomania thyroid diseases pregnancy or breast feeding previous eyebrow tattoo, trauma or accident history of eyebrow or hair medications in 6 months history of minoxidil or its ingredient allergy history of eyebrow surgery | 0 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-999.0, Cetuximab-induced Papulopustular (Acneiform) Rash Who Have Metastatic Colorectal Cancer or Head and Neck Squamous Cell Carcinoma Patients 18 years or older with underlying diagnosis of metastatic colorectal cancer or head and neck squamous cell carcinoma including newly diagnosed patient Patients must provide written informed consent to participate in the study Anticipated initiation of cetuximab treatment with or without additional chemotherapy Able to self-administer topical interventions or provide for another person to apply the topical interventions Females of childbearing potential who are pregnant or nursing Patients with allergy, hypersensitivity or other contraindication to dapsone, sulfa antibiotics, or excipients of the dapsone gel product Patients with pre-existing dermatologic condition affecting the face and chest that would impair assessment of papulopustular rash including dense and/or long facial hair (per investigator discretion) Patients currently using prescription and/or over-the-counter topical medications to the face and/or chest who are unwilling to discontinue use during the trial intervention period (day 0 ± 2 days through day 28 ± 2 days) Previous or concurrent radiation therapy to head, neck, and chest (i.e. application sites only) Previous therapy with cetuximab within 6 months of consent | 0 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-70.0, Systemic Lupus Erythematosus SLE Able and willing to give written informed consent and comply with requirements of the study Age 18 years, inclusive, at randomization Diagnosis of SLE, per ACR [32] m-SLEDAI score < 4 at screening visit (SLEDAI score without serologies) Physician Global Assessment (0-3) score of 1 or less at screening visit On a stable dose of MMF (1000-3000 mg/day) for at least 12 weeks prior to randomization Total duration of stable or decreasing MMF therapy must be at least two years for subjects initiating MMF for renal indications (with or without concurrent extra-renal manifestations), or one year for subjects initiating MMF for extra-renal indications A history of life-threatening neuropsychiatric SLE within 1 calendar year prior to randomization Any of the following laboratory abnormalities at the screening visit Proteinuria as defined by a spot protein/creatinine ratio > 1.0 mg/mg Serum creatinine > 2.0 mg/dL Transaminases > 2.5x the upper limit of normal (ULN) Hemoglobin < 9 g/dL, unless the subject has documented hemoglobinopathy White blood count (WBC) < 2000/mm3 (equivalent to < 2 x109/L) Neutrophils < 1000/mm3 (equivalent to < 1 x109/L) Platelet count < 75,000/mm3 (equivalent to < 75 x 109/L) Prednisone > 25 mg/day (or its equivalent) within 24 weeks prior to randomization for lupus activity | 1 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-75.0, Alopecia Areata Patients between 18 to 75 years of age Patients with a diagnosis of patch type alopecia areata Patients will have >30% and <95% total scalp hair loss at baseline as measured using the SALT score. Two patients with current episodes of alopecia totalis/universalis may be included in this study Duration of hair loss greater than 3 months No evidence of regrowth present at baseline Patients may be naïve to treatment or unresponsive to intralesional (IL) steroids or other treatments for alopecia areata Patients with a history of or active skin disease on the scalp such as psoriasis or seborrheic dermatitis Patients in whom the diagnosis of alopecia areata is in question Patients with active medical conditions or malignancies (except adequately treated basal or squamous cell carcinoma) that in the opinion of the investigator would increase the risks associated with study participation, including patients with a history of recurrent infections Women of childbearing potential who are unable or unwilling to use two forms of birth control for the study duration Women who are pregnant or nursing Patients known to be HIV or hepatitis B or C positive Patients with history or evidence of hematopoietic abnormality Patients with <200K platelet count at baseline Patients with history or evidence of renal or hepatic impairment Patients with history of immunosuppression or history of recurrent serious infections | 1 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 0.0-999.0, Systemic Lupus Erythematosus (SLE) Male or female subject, major or minor of any age with SLE (defined according to the ACR criteria) Onset pediatric (<18 years) OR Syndromic Lupus (associated with growth retardation, neurological deficit not related to lupus, frostbite, lymphoproliferation, the kidney malformations, heart, lung, brain calcifications) OR Lupus in context with familial consanguinity OR Familial cases (2 cases of SLE related first degree relative) OR related topic of the first degree to a lupus patient participant (if family lupus or related parents) A person or beneficiary entitled to a social security scheme or similar Informed consent signed by the person (or parent / holding parental authority for minors) none | 1 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 8.0-18.0, Systemic Lupus Erythematosus (SLE) Subjects who meet the following will be allowed to participate in the study Complete immunization history must be available at time of enrollment Patients will be aged 8-18 years at time of enrollment Patient will have stable disease activity (no changes in >2 points) during the 3 months preceding enrollment Patients can be enrolled as soon as the seasonal IIV is available and prior to the onset of influenza activity in the community. Generally this will be between September 2013-January2014. If feasible, enrollment will end in December 2013, which is usually before influenza circulates widely in the community Subjects who meet the following will not be allowed to participate in the study Females who are known to be pregnant or breastfeeding Moderate to high SLE disease activity at enrollment (SLEDAI >6) Oral temp ≥100F (≥37.8) within 72 hours prior to vaccination History of allergy to egg or egg products or history of allergic reaction to previous influenza vaccination or vaccine constituent History of Guillain-Barré syndrome after previous immunizations Unstable SLE disease activity during 3 months prior to enrollment (change in score >2) Requirement for high-dose IV Solumedrol and/or Cytoxan pulse therapy during 6 months prior to study Any condition that study site investigator deems would put patient at unacceptable risk of injury or render patient unable to meet requirements of the protocol Received pre-medication with analgesic or antipyretic agents in the 6 hours prior to first vaccination, or planned medication with analgesic or antipyretic in the week following first vaccination. This criterion should not preclude subjects receiving such medication if the need arises. However, pre-medication is to be discouraged | 0 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-70.0, Lupus Erythematosus, Cutaneous Lupus Erythematosus, Systemic Lupus Erythematosus, Discoid Healthy Have Discoid Lupus Erythematosus (DLE) or Subacute Cutaneous Lupus Erythematosus (SCLE) with or without a diagnosis of Systemic Lupus Erythematosus (SLE) Active DLE or active SCLE confirmed by histological analysis (for participants with DLE or SCLE without SLE) Confirmed diagnosis of SLE using American College of Rheumatology and has current or historical positive antinuclear antibodies (ANA) or anti double-stranded deoxyribonucleic acid (anti-dsDNA) (for participants with DLE or SCLE with SLE) An active skin lesion that can be biopsied (for participants with lupus erythematosus) Known or thought to have a diagnosis of drug-induced lupus An active skin disease that is not a manifestation of lupus erythematosus Has an acute cutaneous lupus erythematosus rash only If taking anti-malarial therapy has not been on a stable dose for at least 8 weeks before Day 1 Participants treated with greater than 10mg/day of prednisone therapy or equivalent in the last 4 weeks prior to Day 1 Positive serology for human immunodeficiency virus antibody, hepatitis B virus, or hepatitis C virus | 2 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-999.0, Systemic Lupus Erythematosus Fulfill at least 4 diagnostic for SLE defined by American College of Rheumatology Positive antinuclear antibodies (ANA) and/or anti-double stranded DNA (anti-dsDNA) Active SLE disease as defined by score ≥10 despite on-going stable corticosteroid therapy Subjects with stable nephritis may be enrolled years of age or older Severe active vasculitis, active central nervous system lupus, uncontrolled hypertension or poorly controlled diabetes Malignancy within past 5 years Known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C Liver disease Anemia, neutropenia, or thrombocytopenia Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections History of active tuberculosis or a history of tuberculosis infection Pregnant or nursing | 0 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-75.0, Lupus Erythematosus Graft-versus-host Disease Four or more American College of Rheumatology (ACR) for the classification of SLE or 4 or more of the SLICE Involvement of one or more of the following organ systems: renal, neurologic, hematologic, cardiac, pulmonary, gastrointestinal A lack of response to corticosteroids in moderate-to-high doses, and to either an equivalent degree of immunosuppression with azathioprine, methotrexate, cyclosporin, tacrolimus, belimumab, rituximab, mycophenolate mofetil, and/or appropriate other treatment Patients should be eligible for transplantation according to the BMT Policy Manual Age less than 18 years and over 75 years Any risk of pregnancy Patients who are preterminal or moribund | 1 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-999.0, Systemic Lupus Erythematosus Received a minimun of 6 months therapy with with belimumab 10 mg/kg in their current SLE belimumab continuation study Be 18 years of age at the Day 0 visit Non-prenant, non-lactating females willing to comply with specific birth control requirements as set forth in the protocol Able to provide written informed consent to participate Subjects who wish to enroll in the control group and the group taking a 6 month belimumab treatment holiday will need a score of 3 or less after the minimum of 6 months belimumab therapy, as well as having C3 and C4 complement levels at or above the lower limit of the central laboratory reference range, and are on a stable SLE treatment regimen during the 30 day screening period prior to Day 0 Subjects who wish to enroll in the long-term discontinuation group have voluntarily withdrawn from their continuation studies Subjects who have developed clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SLE, or experienced an adverse event (AE) in their belimumab continuation study that could, in the opinion of the principle investigator, put the subject at undue risk Subjects who have developed any other medical diseases, laboratory abnormalities, or conditions that, in the opinion of the principle investigator, makes the subject unsuitable for the study | 1 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-999.0, Cutaneous Lupus Any male or female 18 years or older of age with a diagnosis of cutaneous lupus by a dermatologist Capable of understanding and willing to provide a signed and dated written voluntary informed consent before any protocol specific procedures are performed Able to complete the study and comply with study instructions, including attending all study visits Individuals younger than 18 years of age Known allergy or sensitivity to study medication Inability to complete all study-related visits Introduction of any other prescription medication, topical or systemic, for cutaneous lupus while participating in the study | 0 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-999.0, Rash Due to Epidermal Growth Factor Receptor Inhibitors Age 18 years and older Subjects with any cancer receiving Cetuximab or Panitumumab on a weekly or every 2 weeks basis Scheduled to start Cetuximab or Panitumumab treatment Males or non-pregnant, non-lactating females who are postmenopausal, naturally or surgically sterile, or with a negative subunit hCG pregnancy test immediately prior to study entry Able to understand and provide signed informed consent Ability to reliably apply topical FDX104 and vehicle twice a day to the appropriate part of the face Willingness to minimize sun exposure for 5 weeks from randomization ECOG performance status 0-2 Prior allergic reaction or severe intolerance to Doxcycycline and/or other tetracyclines Prior allergic reaction or severe intolerance to soy or coconut oil Cutaneous metastases on the face or might spread to the face The presence of any active skin disease (e.g., eczema), tattoos or other problems at application site, (i.e., located on the face) that, in the investigator's opinion, could confound the evaluation of the rash or make topical application unacceptable Hair on the face (e.g beard) which would interfere with the application of the study drug or its evaluation ANC <1,500/mm3 (or<1.5x109/L), or Platelet count < 100,000/mm3 (or <100x109/L) Abnormal renal functions: Serum creatinine >1.6 mg/dL or 142umol/L (SI units) or calculated estimated creatinine clearance <40 ml/min1.73 m2 based on Cockcroft and Gault formula Abnormal hepatic functions: Serum Aspartate transaminase (AST) or alanine tansaminase (ALT) >5 institutional upper limit of normal (ULN). Or Total billirubin > 2 x institutional ULN or >5 x institutional ULN if documented liver metastasis Any clinically significant safety laboratory results that, in the opinion of the Investigator, would place the subject at undue risk if the subject were to participate in the study Any clinically significant finding on the physical examination that, in the opinion of the Investigator, would place the subject at undue risk if the subject were to participate in the study | 0 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-999.0, Lupus Nephritis Diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology (ACR) criteria Positive antinuclear antibody (ANA) or positive anti-ds DNA test results at visit -1 or any time within 14 days before visit -1 Active proliferative lupus nephritis, as defined by either of the following Kidney biopsy documentation within the last 3 months of ISN/RPS proliferative nephritis: Class III, Class IV, or Class V in combination with Class III or IV Active urinary sediment and kidney biopsy documentation within the last 12 months of ISN/RPS proliferative nephritis: Class III, Class IV, or Class V in combination with Class III or IV. Active urinary sediment is defined as any one of the following >5 RBC/hpf in the absence of menses and infection >5 WBC/hpf in the absence of infection; or Cellular casts limited to RBC or WBC casts UPCR >1 at study entry based on a 24-hour collection Ability to provide informed consent New onset lupus nephritis, defined as lupus nephritis for which the participant has not yet been treated with either mycophenolate mofetil or cyclophosphamide Neutropenia (absolute neutrophil count <1500/mm^3) Thrombocytopenia (platelets <50,000/mm^3) Moderately severe anemia (Hgb < mg/dL) Moderately severe hypogammaglobulinemia (IgG <450 mg/dL) or IgA <10mg/dL Positive QuantiFERON TB Gold test results Pulmonary fibrotic changes on chest radiograph consistent with prior healed tuberculosis Active bacterial, viral, fungal, or opportunistic infections Evidence of infection with human immunodeficiency virus (HIV), hepatitis B (as assessed by HBsAg and anti-HBc) or hepatitis C | 0 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-64.0, Lupus Erythematosus, Systemic age 18 years American College of Rheumatology (ACR) diagnosis of SLE (1997 revised see appendix 1) Severe SLE flare at screening (see also section 5.2.3.2.), defined as a situation in which 1 or more of the following are met Increase in (SLE Disease Activity Index) with 12 or more points New or worse SLE-related activity of major organs, i.e.: central nervous system (CNS-) SLE (includes NPSLE), vasculitis, nephritis, pericarditis and/or myocarditis, myositis, thrombocytopenia < 60, hemolytic anemia < 4.4mmol/L (=7.0g/dL) Refractory disease, defined as persisting or progressive disease activity (SLEDAI > 6 points) despite conventional immunosuppressive treatment and 1 or more of the following failure of the initial induction treatment at six months, for which a switch to another induction therapy regime has already been carried out intolerance or contraindication for cyclophosphamide and mycophenolate mofetil (MMF) exceeding a cumulative dose of 15 gram of cyclophosphamide a second relapse within two years after start of the initial induction therapy Active pregnancy, as proven by a positive urine beta-HCG (human chorionic gonadotropin) test or a positive serum beta-HCG Significant B-cell depletion (peripheral B-cell counts < 60x10E6) Significant hypogammaglobulinemia (IgG < 8.0 g/L) Immunization with a live vaccine 1 month before screening Active infection at time of screening, as follows Hospitalization for treatment of infection within previous 2 months of day 0 of the study Use of parenteral (intravenous of intramuscular) antibiotics ( including anti-bacterial, anti-viral, anti-fungal or anti-parasitic agents) within previous 2 months of day 0 of the study | 1 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-70.0, Thrombocytopenia Patients fulfilled the 1997 ACR modified or SLICC classification of SLE； New onset thrombocytopenia: platelet count <30X109/L(by both routine test and citric acid anti-coagulated blood count test) within 3 months Thrombocytopenia caused by other reasons, including drugs； Positive for active HAV(hepatitis A virus)/HBV(hepatitis B virus) infection Active HIV(human immunodeficiency virus) or HCV(hepatitis C virus) infection Active HP(Helicopter pylori) infection Severe liver and kidney dysfunction； Severe neuropsychiatric lupus； No response to high dose steroid and/or cyclophosphamide 1 month prior to study enrollment； Uncontrolled diabetes or hypertension before entry Active GI bleeding 3 months before entry Intolerant to HCQ in the past treatment history； | 0 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-999.0, Lupus Erythematosus man and women over 18 YO suffering from SLE (American College of Rheumatology criterias) without SLE flare for 3 months with a signed consent and social security affiliation (required in France) Viral infection within 15 days Other chronic inflammatory disease People with special protection (defined in articles : L1121 §5-8 et articles L3212-§1-3 of French healt care law) | 0 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-35.0, Systemic Lupus Erythematosus SLE patients Female patients aged 18-35 years Fulfilling the American College of Rheumatology (ACR) for the classification of SLE Having participated in the investigators' original HPV study in 2010 Able to give written informed consent Controls Women aged 18-35 years, matched those of SLE patients recruited No known chronic medical diseases Having participated in our HPV study in 2010 | 1 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 6.0-999.0, Systemic Lupus Erythematosus diagnosed with lupus by a qualified physician consents to have 23andMe (via a partner) contact the physician to obtain medical record information willing to submit a saliva sample for DNA testing and complete online surveys related to condition at least 6 years old (minors under 18 require parental consent to enroll) access to the internet resides in the United States | 2 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-75.0, Systemic Lupus Erythematosus Eligible male and female subjects, Age ≥ 18 and ≤ 75 years with Body mass index ≥ 18 and ≤ 35 kg/m2 at screening visit Diagnosed SLE (defined by ≥ 4 of the 11 American College of Rheumatology (ACR) classification for SLE) for at least 3 months before screening Moderate to severe SLE disease activity demonstrated by total score ≥ 6, including skin and joint involvement CLASI Activity score ≥ 5 or at least 5 of 66/68 joints with pain and signs of inflammation Positive anti-nuclear antibodies (ANA) test at screening No change in concomitant medication for SLE activity maintenance and symptom control regarding type of medication and dose level for at least 8 weeks prior to baseline (for steroids and NSAIDs/pain medication 2 weeks) Normal electrocardiogram (ECG) Active, severe neuropsychiatric SLE defined as any neuropsychiatric element scoring BILAG level A disease or lupus nephritis Diagnosed psoriasis Presence or history of malignancy within the previous 5 years Systemic antibiotic treatment within 2 weeks before baseline visit A positive diagnosis for viral hepatitis B or hepatitis C or Human immunodeficiency virus (HIV) or tested positive for tuberculosis as assessed or recent infection with Herpes Zoster or Herpes Simplex (Type 1 and Type 2), Epstein-Barr virus (EBV) or cytomegalovirus (CMV) infection or reactivation at screening Clinically significant hematologic abnormalities attributed to SLE: Haemoglobin < 8 g/dL; Platelets < 50 E9/L; Leucocytes < 2.0 E9/L Active or history of inflammatory bowel disease (including active or history of colitis) Received the following medications Rituximab within the last 48 weeks before screening Belimumab within the last 12 weeks before screening | 1 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-75.0, Systemic Lupus Erythematosus Patients with SLE according to the ACR revised criteria Quiescent disease without flare since at least one year (SELENA < or equal to 4, BILAG C, D or E, PGA 0) _ Treatment with 5 milligrams/day of prednisone since at least 1 year failure to sign the informed consent or unable to consent Patient participating to another clinical trial Pregnancy or plan to become pregnant | 0 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-60.0, Androgenetic Alopecia Men and women, age 18-60 with AGA Completed informed consent form Ludwig stage 1-2 for women Norwood Hamilton Stage 3 to 5 for men Pregnancy or breastfeeding Younger than 18 years Uses of minoxidil and/or 5-alpha reductase inhibitors (such as finasteride or dutasteride) within 3 months of enrolling in the study History of hair transplantation Use of any cosmetic product aimed at improving or correcting the signs of hair loss within 2 weeks prior to screening Facial cancer (squamous and basal cell carcinoma, melanoma) Hereditary or acquired hematologic/coagulation disorders such as: platelet dysfunction syndrome, critical thrombocytopenia, hypofibrinogenemia, impaired coagulation, drepanocytosis (sickle cell anemia) Hemodynamic instability Acute infection Auto-immune disease such as Hashimoto, rheumatoid arthritis, or lupus (exception: vitiligo and alopecia areata) | 0 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-65.0, Systemic Lupus Erythematosus Patients between 18 and 65 years old, male or female, of any race Historical presence of at least 4 of 11 of the ACR Classification 34 Evidence of a positive ANA (≥1:80 titer) or positive dsDNA antibody test within 6 months of screening Clinically active SLE determined by score ≥6 and the presence of one BILAG A or two BILAG Bs at screening, despite standard of care therapy If BILAG A or two BILAG Bs in the Renal organ system, must have completed at least 6 months of therapy with either mycophenolate mofetil or cyclophosphamide for the current episode of nephritis Able and willing to give written informed consent Active CNS lupus affecting mental status Active lupus nephritis requiring dialysis Laboratory exclusions: eGFR <30, WBC <2.0/mm3, hemoglobin <8 g/dL, platelet count <30,000/mm3, AST or ALT >4 times upper limit normal; Positive testing for HIV, hepatitis B or hepatitis C Pregnant or breast feeding; males or females not willing to use adequate contraception History of renal transplantation Herpes zoster within the past 90 days or any infection requiring hospitalization or intravenous antibiotics within the past 60 days Clinically significant EKG or chest x-ray changes Any other medical condition, related or unrelated to SLE, which in the opinion of the investigator would render the patient inappropriate or too unstable to complete study protocol Use of prednisone >0.5 mg/kg (or equivalent corticosteroid) within 1 month of Baseline visit Change or addition to immunosuppressant regimen within 3 months of Baseline visit (except corticosteroids); Use of other experimental therapeutic agents within 3 months of Baseline visit | 1 |
A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen. | eligible ages (years): 16.0-999.0, Appendicitis Criteria:patients with appendicitis, not receiving operation - nil | 1 |
A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen. | eligible ages (years): 18.0-999.0, Appendicitis Two or more symptoms of acute appendicitis for at least 24 hours or radiologic evidence of complicated appendicitis Able to take medicine orally after recovering from surgery If female, using birth control History of allergy to any study medication Life expectancy < 72 hours II (health) score > 25 Neutropenic (low white blood cell count) HIV positive with current or past CD4 count < 200/mm^3 Low platelet count (bleeds easily) Malnourished with low albumin Condition requiring use of major tranquilizers | 2 |
A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen. | eligible ages (years): 15.0-999.0, Appendicitis Gastroenteritis Patients with acute appendicitis Patients with acute gastroenteritis Patients older than 15 years of age Other acute abdominal diseases | 2 |
A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen. | eligible ages (years): 12.0-80.0, Perforated Appendicitis All patients admitted at the emergency station of our hospital expressing pain other than the right lower abdominal quadrant The results of a clinical examination favored the diagnosis of perforated acute appendicitis, and the result of abdominal computed tomography revealed signs of acute appendicitis and intra-abdominal fluid accumulation Patients were accepted to our study only if perforated appendicitis remained as the most likely diagnosis of their condition and if they were between 12 from 80 years old with informed consent Age less than 12 years older than 80 years perforated appendicitis was not revealed by pathologic investigation diverticulitis being diagnosed during surgery pelvic inflammatory disease or other gynecologic disease found during laparoscopic examination or diagnosed before operation the patient declining to enroll in this study | 0 |
A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen. | eligible ages (years): 8.0-18.0, Appendicitis Age 8-18 years, referred from emergency department for suspected appendicitis and receiving either CT scan or ultrasound of the abdomen for diagnosis Failure to pass MRI metal screening. Claustrophobia or need for sedation due to inability to hold still | 2 |
A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen. | eligible ages (years): 15.0-999.0, Appendicitis age over 15 years suspected acute appendicitis suitability for laparoscopy patients refusal to participate lack of a laparoscopic surgeon | 2 |
A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen. | eligible ages (years): 18.0-999.0, Appendicitis Adult patient with acute appendicitis Children | 0 |
A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen. | eligible ages (years): 18.0-60.0, Acute Appendicitis Age range from 18 to 60 years CT scan diagnosed uncomplicated acute appendicitis Age under 18 years or age over 60 years Pregnancy or breast-feeding Allergy to contrast media or iodine Renal insufficiency metformin medication (DM) Peritonitis (a perforated appendix) Lack of co-operation (unable to give consent) A severe other medical condition CT-scan: other diagnosis, fecal lithiasis in appendix, perforation, abscess, suspicion of a tumour | 0 |
A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen. | eligible ages (years): 18.0-999.0, Acute Appendicitis Patients will be at least 18 years of age Male or female (excluding pregnant females) Patients with ASA ≦ 3 Patients informed about the study, and will have read; understood and signed the patient informed consent. Patients will be willing and able to submit to postoperative follow-up evaluations Patients have previous history of abdominal surgery Patients with ASA > 3 Patients with any conditions that were not suspected preoperatively and are only discovered at the time of the operation Patients who are incompetent in giving consent | 0 |
A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen. | eligible ages (years): 8.0-14.0, Peritoneal Dessication Damage and Inflammation Peri-operative Hypothermia Healthy volunteers aged 8-14 years presenting to Starship Children's Hospital (Auckland, New Zealand) within the study period diagnosed clinically with acute appendicitis requiring diagnostic laparoscopy +/ appendicectomy Consent to participate in study not obtained, partial or total blindness, unable to speak and read sufficient English, presence of any abdominal prostheses, diagnosis of mental retardation, developmental delay, neuromuscular impairment, attention-deficit disorder, chronic pain, or psychiatric illness, immunosuppression, allergy to morphine, and history of previous abdominal surgery | 0 |
A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen. | eligible ages (years): 2.0-18.0, Appendicitis All children with a delayed diagnosis of perforated appendicitis. Delayed diagnosis will be defined as symptoms for 4 or more days. Duration of symptoms will be defined as the time pain started Confirmed diagnosis of perforated appendicitis. The diagnosis of perforated appendicitis will be based on diagnostic imaging (CT scan or ultrasound), showing an established appendiceal abscess or phlegmon Consent to participate Uncertainty about the diagnosis The need for laparotomy for another reason Free intraperitoneal air on imaging Perforated appendicitis with diffuse abdominal fluid on imaging associated with a clinical picture of severe sepsis Children with other medical condition that may affect the decision to operate e.g: children with inflammatory bowel disease | 0 |
A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen. | eligible ages (years): 14.0-999.0, Lower Abdominal Pain Right Iliac Fossa Pain Acute Appendicitis Age >14 years Lower / RIF Abdominal Pain Clinical Suspicion of Acute Appendicitis i.e Alvarado Score 5-6 (equivocal for acute appendicitis) Alvarado Score 7-8 (probably appendicitis) Alvarado Score 9-10 (highly likely appendicitis) Informed consent (patient or legal representative) Diffuse peritonitis Antibiotic (Penicillin) documented allergy Ongoing previously started antibiotic therapy Previous appendectomy Positive pregnancy test IBD history or suspicion of IBD recrudescence | 2 |
A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen. | eligible ages (years): 12.0-65.0, Gangrenous Appendicitis patients with diagnosis of acute appendicitis with intraoperative finding of a gangrenous appendix who accepted to enter the study patients under 12 or older 65 years old Patients with possible immunosuppression such as diabetes, cancer, kidney failure, liver failure Pregnancy Patients who have received antibiotic treatment within seven days before surgery Patients difficult to monitor or follow up | 1 |
A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen. | eligible ages (years): 3.0-18.0, Appendicitis Chief complaint of acute appendicitis Patients with symptoms greater than 7 days | 2 |
A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen. | eligible ages (years): 18.0-999.0, Appendicitis Abdominal Pain Abdominal Sepsis Age >18 years of age (subject to the current ethics approval protocol, may change) Clinical suspicion of appendicitis as the primary or differential diagnoses Patients able to provide informed consent Age <18 years of age (subject to the current ethics approval protocol, may change) Abdominal discomfort without tenderness or rebound or clinical suspicion of appendicitis Pregnancy Patients with impaired consciousness Patients not able to provide informed consent Patients that will receive an appendicectomy as part of another elective procedure | 0 |
A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen. | eligible ages (years): 1.0-14.0, Complicated Appendicitis Children age 1-14 years CA that was defined by one of the followings Demonstration by abdominal ultrasound (US) and/or computed tomography (CT) of appendix perforation and/or peri-appendicular abscess Demonstration by abdominal ultrasound (US) of free fluid, and signs of diffuse peritoneal irritation in the right lower quadrant of the abdomen 3 Documented allergy to any of the study medications, acute or renal insufficiency at admission, and severe septic shock at admission | 0 |
A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen. | eligible ages (years): 16.0-95.0, Appendicitis all patients undergoing appendectomy for suspected appendicitis preexisting liver disease | 1 |
A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen. | eligible ages (years): 15.0-80.0, Appendicitis Patients with appendicitis Any patient with immunosuppressive or immunodeppressive known pathological conditions Any patient with a pathological report describing a normal appendix | 2 |
A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen. | eligible ages (years): 18.0-999.0, Appendicitis Age above 18 years Patients undergoing diagnostic laparoscopy for acute appendicitis American Society of Anaesthesiology group 1-3 General Anaesthesia Inability to cooperate Inability to understand and talk danish Allergic to ropivacaine Drug and alcohol abuse Pregnancy or nursing | 0 |
A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen. | eligible ages (years): 15.0-44.0, Appendicitis Emergency department visit with suspected symptoms and signs of acute appendicitis Intravenous contrast-enhanced computed tomography examination requested due to suspicion of appendicitis Willing to provide telephone or cell phone numbers for follow-up Signed informed consent provided prior to study entry Prior cross-sectional imaging tests to evaluate the presenting symptoms and signs Prior history of surgical removal of the appendix | 1 |
A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen. | eligible ages (years): 6.0-90.0, Appendicitis Appendicitis (Perforated/ Non-perforated) Free fluid Age: 6 Immunosuppression (recent chemotherapy, chronic use of immunosuppressive medication) Age < 6 and > 90y | 2 |
A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen. | eligible ages (years): 18.0-85.0, Rectum Cancer Patients coming to FirstJilinU diagnosed rectum cancer by endoscopy and pathology The rectum cancer is the first malignant neoplasm the patient has got The cancer is solitary, and is 3cm to 20cm to the anus The surgical method is limited to Dixon Being in the acute phase of inflammation before operation and emergency surgery Patients receiving steroid medication or preoperative radiotherapy。 Discovering macrometastasis before or in the operation The rectum cancer that can't be radical resected | 0 |
A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen. | eligible ages (years): 18.0-75.0, Shoulder Pain English speaking patient Female Age 18-75 must undergo laparoscopic surgery willing to participate in the study Male patients Under 18 or older than 75 Laparoscopic procedures that get converted to laparotomy Intraoperative hemorrhage more than 500 cc Patients with active joint disease History of shoulder surgery Intraoperative laceration to the liver Malignancy Long term daily narcotic use Chronic right upper quadrant/ shoulder pain | 0 |
A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen. | eligible ages (years): 0.0-999.0, Appendicitis All patients, of all ages, undergoing appendicectomy (OPCS code H01) during the time period January 2001 December 2010 Patients undergoing appendicectomy for whom this is incidental to a more major abdominal procedure Patients non-resident in Scotland | 1 |
A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen. | eligible ages (years): 0.0-999.0, Appendicitis All patients, of all ages, undergoing appendicectomy (OPCS code H01) during the time period January 2001 December 2010 Patients undergoing appendicectomy for whom this is incidental to a more major abdominal procedure Patients non-resident in Scotland | 1 |
A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen. | eligible ages (years): 18.0-999.0, Appendicitis Patients operated for the clinical suspicion of acute appendicitis that will undergo a diagnostic laparoscopy Age ≥ 18 years Written informed consent Diagnostic laparoscopy and planned appendectomy for an appendectomy a froid Primarily chosen for an open appendectomy Not able to give informed consent (for example language barrier or legally incapable) Refused informed consent | 0 |
A 15-year-old girl presents to the ER with abdominal pain. The pain appeared gradually and was periumbilical at first, localizing to the right lower quadrant over hours. She has had no appetite since yesterday but denies diarrhea. She has had no sexual partners and her menses are regular. On examination, she has localized rebound tenderness over the right lower quadrant. On an abdominal ultrasound, a markedly edematous appendix is seen. | eligible ages (years): 2.0-12.0, Appendicitis All patients aged 2 years old who within the 10 year period of January 2001 December 2010 are entered on the SMR01 database as having a code for appendicectomy Episodes will be extracted with the following codes OPCS (Office of Population Censuses and Surveys), revision 4.5 H01 Emergency excision of appendix We will patients for whom incidental appendicectomy has occurred at the same time as another major abdominal surgical procedure We will patients who are non-resident in Scotland since we will be unable to derive depravity index and urban-rural classification, and may not have access to information on co-morbidities and mortality | 0 |
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