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Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-999.0, Cutaneous Mastocytosis Chronic stable symptomatic maculopapulous cutaneous mastocytosis or systemic mastocytosis with involvement of the skin and with positive Darier's Sign comparable skin lesional areas Otherwise healthy according to physical examination Informed consent signed and...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-85.0, Pemphigus Vulgaris Lesions consistent with pemphigus foliaceus or vulgaris Diagnosis confirmed by histology and IIF ≥ 40 within past month On ≥20mg/day of prednisone per day for two weeks or ≥ 80mg/day for one week Women of childbearing potential negative HCG obtained two weeks prior ...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-999.0, Hematologic Disease request of a standard size totally implanted venous port patent superior vena cava normal clotting tests (PT>40% and platelet count >40000/mm3) unable to provide written informed consent
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 0.0-999.0, Leukemia Systemic Mastocytosis Patients with SM, including mast cell leukemia (MCL) ECOG Performance Status (PS) 0-3 Adequate renal function (indicated by serum creatinine </= 2.5 mg/dL); adequate hepatic function (indicated by ALT </= 3 * upper limit of normal; total bilirubin </= 3 ...
2
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 16.0-68.0, Lung Transplantation Primary Graft Dysfunction Candidates for lung transplantation Differential diagnosis of PGD Pulmonary Edema Stenosis or thrombosis of pulmonary artery/vein anastomosis
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-70.0, Flushing Patient is male or female between 18 and 70 years of age Females of reproductive potential must agree to take acceptable contraceptive precautions for the duration of the study Patient has a history of hypersensitivity to niacin or niacin-containing products Patient is curre...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-70.0, Flushing Patients must be male or female between 18 to 70 years Qualified women must be sterile (through surgery) and/or post-menopausal, and/or agree to use birth control You are a woman who is having hot flashes, receiving Hormone Replacement Therapy (HRT), and/or other therapies f...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-70.0, Flushing Men and women, 18 to 70 years of age for whom treatment with Niacin would be appropriate but who are not taking > 50mg at screening Must be willing to complete electronic diary Subject is having menopausal hot flashes and/or receiving hormone replacement therapy (HRT) You ha...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-999.0, Ulcerative Colitis Steroid Refractory Age > 18 years Diagnosis of UC according to Lennard-Jones (Appendix 1) Endoscopically demonstrated colorectal lesions localized above the anal margin and extending at least up to 15cm proximally Severe acute flare of UC with a Lichtiger Index sco...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 1.0-999.0, Lacerations at least 1 year of age in good general health in the opinion of the Investigator have at least one traumatic wound meeting the for closure as defined in current Dermabond product labeling patient must be willing to follow instructions for wound care listed in device labeli...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 12.0-55.0, Allergy Healthy male or non-pregnant, non-lactating female subjects; 12-55 years of age; within 15% of normal body weight for their height or had a body mass index (BMI) less than 29.9 kg/m2; positive histamine skin prick tests (or a duplicate histamine skin prick test) of summation f...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-999.0, Aspirin Sensitivity Age > 18 years Fulfill diagnostic for AERD (described below), and be a candidate for aspirin desensitization chronic asthma frequently moderate-severe or severe patients will have history compatible with variable airflow obstruction. chronic rhinosinusitis - usual...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 14.0-82.0, Bell´s Palsy Patients with Bell´s palsy evaluated within the first 72 hours Peptic ulcer Tuberculosis Moderate or severe diabetes Moderate or severe hypertension Glaucoma Manifest cardiac disease Psychosis Renal or hepatic dysfunction, and Pregnancy
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-999.0, Crohn Disease Crohn's disease Age > 18 years Patient written informed consent Patient having been treated with infliximab for confirmed Crohn's disease with active intestinal lesions Patient treated with infliximab for at least 1 year, associated with an immunosuppressor for at least...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-50.0, Acute Migraine Headache Acute migraine headache Pregnant Hypertension Chest pain < 18 Allergy to any of the meds
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-999.0, Hip Arthroplasty American Society of Anesthesiologists (ASA) physical status I, II, III > Age 18 Primary unilateral total hip arthroplasty under spinal anesthesia Known allergy to study medication Weight > 300 pounds Obstructive sleep apnea Patients with severe renal (kidney) or hep...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-75.0, Type 2 Diabetes Participated in DIO-502 Did not participate in DIO-502
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-64.0, Asthma Patients with previously diagnosed asthma on inhaled corticosteroids, systemic steroids and/or long acting beta agonist (for a period of 6 mo to 5 years) Age 18-64 Male or female Children under age 18 Adults 65 or older Patients with COPD
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-40.0, Bacterial Vaginosis Untreated BV (asymptomatic or symptomatic) as diagnosed during the screening visit using Amsel AND confirmed in the laboratory using the Nugent scoring system (Nugent Score ≥ 7) Otherwise healthy pre-menopausal women 18-40 years of age at date of screening Regular ...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-999.0, Pneumocystis Carinii Pneumonia HIV Infection Hospital admission for suspected PCP Confirmatory test for PCP (bronchoscopy with bronchoalveolar lavage), pO2>70 mmHg or pO2<70 mmHg while breathing room air years or older Contraindications to corticosteroid therapy Unable and or unwill...
1
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 35.0-60.0, Hypertension Aged 35-60 No antihypertensive treatment in the past or present SBP< 145 or 85<DBP<95 Informed consent signed Unwilling to participate in the study Treated essential secondary or complicated hypertension SBP lower than 135 or higher than 145 mmHg DBP lower than 85 or hig...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-999.0, Anaphylaxis years and older English speaking Meets one of the above definitions of anaphylaxis Signs/symptoms onset <12 hours will get epinephrine or will not get epinephrine because of contraindication to epinephrine administration History of Intracranial Hemorrhage at anytime Know...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-999.0, Hypertension Hemorrhage CT evidence of intracerebral hemorrhage (diagnosis and treatment within 12 hours of symptom onset) Age 18 years or older Baseline systolic blood pressure (immediately prior to initiation of clevidipine) >160 mmHg measured using an arterial line. ICP-monitored ...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-70.0, Lupus Erythematosus, Systemic Diagnosis of SLE (by greater than or equal to 4 American College of Rheumatology [ACR] Revised Criteria) greater than 6 months before study day 1 History of a positive antinuclear antibody (ANA) titer greater than or equal to 1:160 or equivalent Treatmen...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 6.0-16.0, HIV Infection Bone Mass Subject, parent, or legal guardian able and willing to provide informed consent/assent. Subject able and willing to comply with requirements of study HIV-infected subjects must have diagnosis confirmed with one or more of the following tests: 1) HIV DNA Polymera...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
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 potentia...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-80.0, Sleep Initiation and Maintenance Disorders Based on sleep history, the subject has had primary insomnia as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition Revised (DSM-IV-TR™) for at least 3 months Female patients of childbearing potential must be non...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-55.0, Healthy Volunteer Body Mass Index (BMI) of greater than or equal to 19 to less than or equal to 30 kg/m2 and weight of greater than or equal to 50 to less than or equal to 100 kg Clinically normal physical exams and laboratory measurements Subject has received another investigational...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-75.0, Non Neoplastic Condition Precancerous Condition Diagnosis of systemic mastocytosis Aggressive or borderline (smoldering) disease (in first line or more) Relapsed or progressive disease Measurable or evaluable disease Presence of c-Kit D816V mutation in the skin, spine, or infiltrated ...
1
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-85.0, Intraocular Pressure included the following age 18 to 85 years inclusive OHT or mild to moderate POAG with cup-disc ratio of less than 0.8 vertically and mean deviation of less than -12.00 dB on Humphrey perimetry well controlled disease defined by IOP being at target and no visual fi...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-80.0, Acute Gout History of at least 1 gout flare prior to the Screening Visit Meeting the American College of Rheumatology (ACR) 1977 preliminary for the classification of acute arthritis of primary gout Presence of acute gout flare for no longer than 5 days Baseline pain intensity > or = ...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-75.0, Indolent Systemic Mastocytosis Patient with one of the following documented mastocytosis as per WHO classification: Smouldering Systemic Mastocytosis, Severe Indolent Mastocytosis 2. Patient with documented mastocytosis and evaluable disease based upon histological typical infiltrates...
1
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 15.0-70.0, Asthma Patient is male or female, at least 15 years of age and no more than 70 years Patient has mild persistent asthma (step 2) of the Guidelines for the Diagnosis and Management of Asthma issued by the National Heart, Lung, and Blood Institute of the National Institutes of Health as...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 0.0-999.0, Influenza Male or female subjects of any age; 2. Subjects presenting to the investigative site within 4 days of symptom onset, with Fever ≥ 38.0°C (100.4°F) if taken orally, or ≥ 38.5°C (101.2°F) if taken rectally; or a self-reported history of fever or feeling feverish (includes feve...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 0.083-68.0, Graft-versus-host-disease Newly diagnosed acute grade II-IV GVHD or chronic GVHD with an acute pattern matching grade II-IV after allogeneic stem cell transplantation Patients must have received 2 mg/kg/day of prednisolon for at least 3 consecutive days and experience progression of ...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 0.0-999.0, Influenza Male or female subjects of any age; 2. Subjects presenting to the investigative site within 4 days of symptom onset, with Fever ≥ 38.0°C (100.4°F) if taken orally, or ≥ 38.5°C (101.2°F) if taken rectally; or a self-reported history of fever or feeling feverish (includes feve...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-999.0, Mastocytosis Patients with documented Indolent systemic mastocytosis with handicap (ISMwh) having at least 2 infiltrated* organs (skin and /or bone-marrow and/or internal organ). 2. Bone-marrow, or skin or internal biopsy-documented mastocytosis and evaluable disease. 3. The absence ...
1
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-999.0, Breast Cancer Histologically confirmed breast cancer meeting 1 of the following Unresectable stage IIIB or IIIC disease Stage IV disease Must be negative for all of the following Estrogen receptor (< 10%) Progesterone receptor (<10%) HER-2 (negative FISH, IHC 0 , or IHC +2 with negat...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-75.0, Gastroesophageal Reflux Disease (GERD) Prior completion of Study E3810-G000-301 or -303. Subjects will need to have healed erosive esophagitis (absence of esophageal mucosal breaks or erosions) confirmed by EGD and sustained resolution of heartburn at Visit 4 or 5 of Study E3810-G000-...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-75.0, Gastroesophageal Reflux Disease (GERD) KEY 1. Prior completion of Study E3810-G000-302 or -303. Subjects will need to have healed erosive esophagitis (absence of esophageal mucosal breaks or erosions) confirmed by EGD and sustained resolution of heartburn at Visit 4 or 5 of Study E381...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-69.0, Systemic Lupus Erythematosus Systemic Sclerosis Patient Performance status must be CALGB PS 0, 1, or 2 (or Karnofsky 40-100%) Patients must have a 6/6 HLA-matched related donor who is evaluated and deemed able to provide PBSCs and/or marrow by the transplant team Patients must meet th...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-70.0, Acute Gout Flare Male or female 18 years of age 2. Previously met the preliminary of ARA for the classification of the acute arthritis of primary gout 3. Presenting with an acute attack (flare) of gout within 48 hours of pain onset and pain of at least moderate severity 4. Must have a...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 6.0-999.0, Attention-Deficit/Hyperactivity Disorder Patients will be male or female outpatients who are at least 6 years of age (there is no upper age limit) 2. Patients must meet DSM-IV for ADHD 3. Patients and parents/guardians must have a degree of understanding sufficient to be able to commu...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 2.0-90.0, Hypersensitivity, Immediate Autoinflammatory Syndromes Physical Urticaria Familial Cold Autoinflammatory Syndromes Affected subjects/guardian must: 1. Be at least 2 years of age and no older than 90 years of age. 2. Have a history of a physical urticaria, which has been evaluated by th...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-70.0, Anaphylaxis Hypotension Bronchospasm Angioedema Volunteers must satisfy all of the following to be eligible for this study. Subject must be at least 18 years of age and no older than 70 years of age. Diagnosis of idiopathic anaphylaxis, a diagnosis of assigned after other causes of an...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-120.0, Head and Neck Cancer Histologically confirmed squamous cell carcinoma of the oral cavity, paranasal sinuses, nasopharynx, larynx, hypopharynx, or oropharynx Medically or surgically inoperable disease or patient refuses surgery Recurrent disease Previously irradiated disease meeting t...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 0.0-999.0, Ovarian Cancer Peritoneal Cavity Cancer Patients with newly diagnosed histologically confirmed advanced stage (III & IV) epithelial ovarian cancer, fallopian tube or peritoneal cancer. --OR- Patients with a suspected malignancy who are unsuitable candidates for surgery (i.e., those wi...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-65.0, Asthma Allergic Rhinitis Mild to moderate atopic asthmatics with FEV1 ≥ 60% on ≤ 1000 ug BDP and concomitant persistent allergic rhinitis (SPT +ve and PC20 < 4 mg/ml) Male or female aged 18-65 years Informed Consent Ability to comply with the requirements of the protocol Severe asthm...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 21.0-75.0, Flushing Men and women from the age of 21 to 75, inclusive subjects, 8 men, 8 women. 2. Ability to understand and agree to informed consent. 3. Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures Contra-indica...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-999.0, B-cell Chronic Lymphocytic Leukemia >= 18 yrs of age, have B-cell CLL, failed at least 1 prior fludarabine-containing regimen Refractory to 1 fludarabine-containing regimen is defined as failure to achieve at least PR to the last fludarabine-containing regimen received, or disease pr...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-999.0, Leukemia Systemic Mastocytosis Patients with Systemic Mastocytosis (SM); including mast cell leukemia. 2. Age equal to or greater than 18 years 3. Minimum of two weeks since any major surgery or completion of radiation 4. Eastern Cooperative Oncology Group (ECOG) performance status e...
1
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-999.0, Metastatic Cancer Metastatic cancer that expresses Her-2 at greater than or equal to 2+ and assessed by immunohistochemistry (IHC) in the clinical laboratory improvement amendment (CLIA) approved test in the Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer I...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-75.0, Acute Pain Soft Tissue Injury Male and female subjects 18-75 years of age Sustained recent, painful unilateral mild to moderate soft tissue injury (between the mid-bicep to wrist or mid-thigh to ankle) Meet baseline pain criterion Open wound or infection at site of injury Evidence of...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-60.0, B-Cell Lymphoma Age 18 to 60 y.o Aggressive Large B-Cell Lymphoma (CD20+) Ann Arbor stage III, IV IH or high adjusted IPI signed inform consent Age < 18 ou > 60 y.o other type of lymphoma serology VIH + other neoplasms apart from basal cell carcinoma or situ carcinoma
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-120.0, Breast Cancer Histologically confirmed adenocarcinoma of the breast Does not overexpress HER-2/neu, defined as FISH negative or 0, 1+, or 2+ by IHC Stage IV disease Must not be eligible for therapy of known curative potential for metastatic breast cancer Measurable or evaluable disea...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-999.0, Chronic Kidney Disease Secondary Hyperparathyroidism Hemodialysis Male or female patients >= 18 years old. 2. Patient was diagnosed with Stage 5 chronic kidney disease (CKD) and had been receiving intravenous (IV) or oral vitamin D receptor activators (VDRAs) or cinacalcet during the...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-999.0, Systemic Mastocytosis Signed Written Informed Consent Subjects with confirmed diagnosis of SM according to the WHO and the following must be met All SM clinical variations, smoldering SM should have ≥ 2 B-findings and severe mediator related symptoms KIT mutation status on BM cells m...
1
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 14.0-70.0, Systemic Lupus Erythematosus SLE Groups (Group A and B): 1. ACR for SLE. 2. At least two organ systems moderately active to a minimum of BILAG B or score of 6. Control group (Group C): 1. Age, ethnicity and gender matched (2:1) with an SLE study participant. 2. Free of active or major...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-55.0, Musculoskeletal Pain Signed and dated informed consent prior to participation Subjects in good health as determined by the Investigator Age 18-55 Willing to abstain from any physical therapy, hard physical work, exercise or sauna during the study observation period (Screening to Final...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-999.0, HIV Infection Liver Failure Evidence of Liver Transplantation Age ≥ 18 Documented HIV-1 infection, hepatitis B or C co-infection is allowed Plasma viral load at screening visit below 50 copies per mL for at least 6 months Patient with severe liver failure (Meld Score ≥ 15 and/or refr...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 0.5-999.0, HIV Infection Rheumatic Disease Cancer Transplant Pediatrics medically recommended influenza A(H1N1) immunization signed informed consent failure or refusal to provide sufficient blood for antibody determination
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-59.0, First Episode Psychosis Aged 18-59 years and meet DSM-IV diagnostic for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version Meeting DSM-IV for...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-85.0, Acute Gout Core Study Meeting the American College of Rheumatology (ACR) 1977 preliminary for the classification of acute arthritis of primary gout Onset of current acute gout flare within 5 days prior to study entry Baseline pain intensity ≥ 50 mm on the 0-100 mm visual analog scale ...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-999.0, Metastatic Melanoma ENTRY Locally advanced or metastatic melanoma Measurable Histologically or cytologically confirmed Surgically incurable HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes PRIOR/CONCURRENT If prior Proleukin treatment, must have had clinical be...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-999.0, Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer Histologically confirmed diagnosis of transitional cell tumors of the bladder or the urothelium Metastatic disease Relapsed or refractory disease Measurable disease, defined as ≥ 1 unidimensionally...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-70.0, Autogenous Bone Grafts Patients on opioids Neuropathic disease Chronic conditions
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-50.0, Nicotine Dependence Non-treatment seeking smokers of European ancestry Between 18 and 50 years old Smoking at least 10 cigarettes per day for at least the past 6 months Able to provide informed consent Fluent, English-speaking Weight ≤ 300 lbs Current enrollment or plans to enroll in...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 16.0-999.0, Hereditary Angioedema (HAE) Patients indicated per the approved product label for Patient or guardian is able to understand and sign the informed consent form Patient is willing and able to undergo a skin test procedure at screening (baseline) Patient contraindicated per the approve...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-999.0, Colorectal Cancer Patients with Stage IV (metastatic) colorectal cancer Baseline 25-hydroxy vitamin D level < 30 ng/ml Age ≥18 years of age Current or previous malignancy except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other so...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-999.0, Obsessive Compulsive Disorder Body Dysmorphic Disorder Tourette Syndrome Trichotillomania Panic Disorder Social Phobia Generalized Anxiety Disorder Depression Post-Traumatic Stress Disorder Attention Deficit Hyperactivity Disorder Eating Disorder Specific Phobia General Medical Condi...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-40.0, Wounds and Injuries Wound Healing Ulcer Healthy male volunteers age 18 to 40 All volunteers must sign informed consent indicating their understanding that specimens and demographic information will be collected solely for research purposes Subjects with known inflammatory, chronic, a...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 17.0-55.0, Acute Asthma Age 17-55 years old; 2. Patients treated and discharged from one of the four study sites with acute asthma (not simply for a prescription refill) during the study period; 3. Patients must have had a previous physician-diagnosis of asthma and an exacerbation diagnosed by t...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-85.0, Acute Gout Core Study Meeting the American College of Rheumatology (ACR) 1977 preliminary for the classification of acute arthritis of primary gout Onset of current acute gout flare within 5 days prior to study entry Baseline pain intensity ≥ 50 mm on the 0-100 mm visual analog scale ...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-120.0, Lymphoma Diagnoses of advanced T-cell cutaneous lymphoma or mycosis fungoides/Sézary syndrome Stage IIB-IV disease Achieved complete or partial response after undergoing prior debulking therapy with 1 of the following recommended* regimens with or without radiotherapy** Gemcitabine h...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-65.0, Systemic Lupus Erythematosus Age>18 years Fulfill at least 4 of the 11 for the ACR classification Any extra-renal flare with an and/or one BILAG A or 2 B Oral corticosteroids>10 mg/day and HCQ > 400 mg/day for at least 30 days prior to Presence of active renal disease Previous intole...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-999.0, Breast Cancer Breast Tumors Neoplasms, Breast Cancer of the Breast Human Mammary Carcinoma HER-2 negative advanced or metastatic breast cancer Disease has become worse after at least 1 prior chemotherapy regimen for advanced or metastatic disease Advanced or metastatic disease resist...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-50.0, Schizophrenia DSM-IV diagnosis of schizophrenia or schizoaffective disorder Between 18 and 50 years of age Of Mexican origin and speaks Spanish fluently Was without antipsychotic medication without medical authorization for one continuous week in the month prior to hospitalization Was...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-65.0, Histamine Responsive Allergy Patients Healthy male and female subjects, 18 to 65 years of age Patients must demonstrate a positive reaction to a Histamine skin-prick test. Manifested by a histamine-induced wheal of >3mm in diameter over the normal saline control after 15 minutes of el...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 15.0-999.0, Tuberculosis, Pulmonary Adults (≥16 years on 1st March 2009) Males and Nonpregnant females Active Pulmonary Tuberculosis diagnosed by Sputum Smear positivity for Acid fast bacilli (AFB) Diagnosis within one week of into study Not already on antituberculous treatment Not receiving vit...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 60.0-999.0, Determine Effect of Vitamin D on Bone Health in Elderly African American Women Ambulatory women older than 60 years of age. Self declared as African Americans. 2. 20 nmol/L < serum 25(OH)D level < 65 nmol/L. 3. Willingness to take study drug and participate for four years in the tria...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-999.0, Smoking Smoking Cessation Must be 18 years of age or older Must be a current smoker Must receive primary care at one of the participating clinics Must have had a PCP visit within the last month at a participating clinic Must have a working phone number listed in Partner's database Mu...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-999.0, Obesity Geisinger General Internal and Family Medicine PCPs (include physician, physical assistants and CRNP) PCP must be active between May 2008 May 2009 Average patient age between 30-60 (no individual patients will be identified using personal identification) Minimum of 100 patien...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 0.0-999.0, Accelerated Phase Chronic Myelogenous Leukemia Adult Acute Lymphoblastic Leukemia in Remission Adult Acute Megakaryoblastic Leukemia (M7) Adult Acute Monoblastic Leukemia (M5a) Adult Acute Monocytic Leukemia (M5b) Adult Acute Myeloblastic Leukemia With Maturation (M2) Adult Acute Myel...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 20.0-45.0, Brain Distribution of [11C]AZ12807110 and AZD5213 Healthy male and/or female volunteers between 20 to 45 years with suitable veins for cannulation or repeated venipuncture (pilot panel) Female must be of non-child bearing potential (pilot panel) BMI between 18 to 30 30 kg/m2 Normal MR...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-999.0, Nephrotic Syndrome Idiopathic nephrotic syndrome Flare of idiopathic syndrome without treatment from one year Confirming by Renal Biopsy Secondary nephrotic syndrome Pregnancy Focal Segmental Glomerular sclerosis lesion in the Biopsy Neutropenia < 2000/mm3 Hb<9gr/dl
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 0.692-0.712, Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature Bronchopulmonary Dysplasia (BPD) Infant with birthweight 401-1500 grams Alive at 36+1 week corrected age On supplemental oxygen as follows A. Infants receiving oxygen by hood at rest A1. Oxy...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-70.0, Systemic Lupus Erythematosus The patient has an established diagnosis of systemic lupus erythematosus (SLE) as defined by ACR Classification Revised Criteria. The diagnosis is fulfilled provided that at least 4 are met The patient previously participated in and completed at least visi...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-999.0, Mastocytosis Patients with one of the following documented mastocytosis Smouldering systemic mastocytosis Indolent systemic mastocytosis with organomegaly Indolent Systemic Mastocytosis having 2 infiltrated organs (skin and bone-marrow) Any mastocytosis with in the last 6 months at l...
2
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
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 conse...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-999.0, Liver Neoplasms Histologic Diagnosis: Patients must have a histologically or cytologically proven hepatocellular cancer (HCC) that is not amenable to treatment via resection or liver transplantation. In the absence of a tissue diagnosis, nodules on CT with a characteristic appearance...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-45.0, Crohn's Disease Patient 1. Age >18 years and less than age 45 years at time of pretransplant evaluation and, 2. Ability to give informed consent. And either A or B A)An established clinical diagnosis of severe CD with disease onset before 16 years old (at least 71 genetic loci predisp...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-999.0, Systemic Mastocytosis Age older than 18 years Diagnosis of systemic mastocytosis in the absence of c-kit mutation ECOG ≤ 3 Signed informed consent Previous therapy with a tyrosin kinase inhibitor Positive antibodies against HIV or active viral hepatitis Impaired liver function (tota...
2
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 2.0-999.0, Mevalonate Kinase Deficiency Patients with a diagnosis of HIDS proven by DNA analysis and/or enzymatic studies. 2. At time of start of drug treatment: active HIDS as evidenced by a physician global assessment of HIDS flare severity ≥ 2 and CRP values >10 mg/L (normal CRP < or = 10 mg/...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 14.0-60.0, Nephrotic Syndrome Subjects of either sex, 14-60 years of age Diagnosis of Nephrotic syndrome with hypoalbuminemia (< 3.0g/dl) and heavy proteinuria (> 3.5g/24hr) and secondary Nephrotic syndrome Refractory Nephrotic Syndrome 1. Steroid resistant: failure to respond (either complete o...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-80.0, Cancer Hepatic Injury Male or Female; ages 18 to 80 years old 2. Receiving treatment at Cancer Treatment Centers of America 3. Receiving PN (either in the infusion center or at home) 4. Have existing hepatic dysfunction defined as Elevation of > 3x the normal level of one or more of t...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 21.0-999.0, Anaphylaxis Anaphylaxis in association with exercise on at least two occasions During anaphylactic reaction, the subject must have experienced one or more of the following: flushing, hypotension, lack of urticaria Pregnancy
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-70.0, Mastocytosis Histological proven mastocytosis (cutaneous or systemic) Diagnosis made by one marrow unction and/or skin biopsy or other histological work up Age: 18-70 years Age <18 years Known hypersensitivity to omalizumab or any of its components History of cancer in previous 5 yea...
1
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 21.0-999.0, Systemic Mastocytosis Systemic Mastocytosis Current treatment with Imatinib mesylate, cladribine or interferon alpha
2
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 0.0-999.0, Very Low Birth Weight Baby Pneumonia A cluster was eligible to participate if it Is located in Kintampo North or South Districts (this is the core study area for KHRC) Is primarily rural (in practice, this excludes Kintampo, which is a small city of approximately 40,000 people) Is ope...
0
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 ...
eligible ages (years): 18.0-999.0, Non-small Cell Lung Cancer (NSCLC) Patients will be enrolled if they fulfill all of the following 1. With indication for the following interventions: Thoracentesis Fine-needle aspiration and biopsy of primary tumor or metastases Bronchoalveolar lavage 2. With enough residual specimen...
0