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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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 dated Aggressive systemic mastocytosis Other dermatological diseases at treated skin site Known hypersensitivity to study drugs or their components Mental disorders Drug or alcohol dependency Any other chronic or acute illness requiring systemic treatment which might have any influence on the outcome of the study in the 4 weeks before start of treatment and during the study (investigator's decision) Immunodeficiency including HIV Pregnancy or lactation Participation in another clinical trial within the last 30 days Malignant skin lesions | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 to first IVIg Agrees to two acceptable forms of contraception* if randomized to cyclophosphamide group IUD (except progesterone T), Combination oral contraceptives, transdermal patch, vaginal ring, hormonal injectables or implantables, male latex condom, diaphragm, cervical cap, or vaginal sponge (contains spermicide) Normal organ function confirmed by CBC, UA, LFTs and Ig levels within defined Responds yes to at least one of the below Persistence of clinical manifestations of disease despite steroid treatment Flare in disease activity after an attempt at steroid tapering Use of IVIg within past 3 weeks or the use of a cytotoxic drug within the past 2 weeks Participating in another clinical trial at the time of screening and enrollment Medical condition that precludes use of IVIg or cyclophosphamide (i.e. pregnancy breastfeeding, underlying chronic infection, concurrent opportunistic infection, sepsis or volume depletion Renal insufficiency ( GFR <90, proteinuria (>1+, x 2), creatinine >1.8 or increased WBC or RBCs which cannot be explained by cystitis.) Known hypersensitivity to study drugs, IVIg or cyclophosphamide | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 * upper limit of normal; and albumin >/= 2.8 g/dL) Provide written informed consent Female patients of childbearing potential must have a negative pregnancy test within 14 days prior to first dose of study drug, and must agree to use an effective means of contraception following the pregnancy test, throughout the study and for at least three weeks after their last treatment on protocol History of hypersensitivity to diphtheria toxin Active cardiovascular disease as defined by New York Heart Association (NYHA) Class III-IV categorization Serious intercurrent medical illnesses or active infections requiring parenteral antibiotics that would interfere with the ability of the patient to carry out the treatment program Concurrent malignancy (other than resected basal or squamous cell skin cancers or in-situ cervical cancer). Unless, patient has SM-associated clonal hematologic disease that does not require therapy, as judged by treating physician and approved by principal investigator Female patients who are pregnant or breastfeeding No chemotherapy, radiotherapy, immunotherapy, hormonal anticancer therapy, or experimental medications (including approved drugs tested in an investigational setting) may be administered while a patient is a participant in this protocol | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 currently experiencing menopausal hot flashes Patient consumes more than 2 alcoholic beverages per day Patient has poorly controlled Type 1 or Type 2 diabetes mellitus Patient engages in vigorous exercise or an aggressive diet regimen | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 for hot flashes You are currently using Niacin/or Niacin containing products with a daily dose over 50 mg/day You are sensitive to niacin You have a history gout You drink more than 2 glasses of alcohol per day and you are not willing to stop You don't have access to a telephone | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 have a history of cancer, gout, peptic ulcers, diabetes, liver, heart disease or high blood pressure or you are HIV positive You consume more than 14 alcoholic drinks per week or more than 2 drinks per day | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 score > 10 Refractoriness to high dose intravenous steroid therapy (≥ 0.8 mg/kg/d of methylprednisolone or equivalent) given for at least 5 days Adequate contraception for male or female subjects of childbearing potential, which will be continued throughout the study and at least 3 months after study termination Pregnant or breast-feeding woman Previous treatment with cyclosporine or infliximab Azathioprine or 6-mercaptopurine treatment initiated more than 4 weeks before inclusion Indication for immediate surgery History of colorectal dysplasia Diagnosis of Crohn's disease Positive stool tests for amoebiasis and/or positive bacteriological culture for Salmonella, Shigella, Yersinia and Campylobacter and/or presence of Clostridium difficile B toxin in the stools Renal failure (creatininemia > upper limit of normal laboratory value) Uncontrolled high blood pressure HIV, HBV viral infection (except the presence of positive anti-HBs antibodies) with serology not older than 3 months | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 labeling and refrain from picking at the device, applying topical medications to the wound, and swimming or soaking in a tub until the sutures are removed patient agrees to return for follow-up evaluation patient (or guardian) signs the informed consent patient is reasonably expected to survive the study significant multiple trauma (merely multiple wounds are allowed) peripheral vascular disease insulin dependent diabetes mellitus known to have a blood clotting disorder receiving antibiotic therapy for preexisting condition or infection known to be HIV-positive or otherwise immunocompromised known personal or family history of keloid formation or hypertrophy currently taking systemic steroids known allergy to cyanoacrylate, formaldehyde, tapes or adhesives participating in another current clinical study | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 flare > 20 mm larger than diluent control, and summation wheal > 6 mm larger than diluent control at the screening Visit 1 Asthma that required treatment with medication other than an inhaled, short-acting beta agonist Signs and symptoms of currently active allergic disease (SAR, perennial allergic rhinitis, episodic allergic rhinitis) Upper respiratory tract infection, sinusitis, asthma or flu-like symptoms within 2 weeks prior to Visit 1 Dermatographism or other skin conditions that might interfere with the interpretation of the skin test results Treatment with escalating doses of immunotherapy, oral immunotherapy, or short course (rush) immunotherapy Any excessive amounts of alcohol (no more than two drinks/day on average) Any excessive use of caffeine (more than six cups of coffee per day or equivalent) Any history of chronic alcohol or mood-altering drug abuse Any use of tobacco/nicotine products within 90 days of visit 1 Any disease state or surgery known to affect the gastrointestinal absorption of drugs | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 - usually requiring previous sinus surgery procedure(s). sinusitis will have been confirmed by imaging studies presently and/or in the past. history of adverse reaction to aspirin and/or aspirin-like drugs (e.g., ibuprofen, naproxen, etc.) compatible with AERD. • Candidate for Xolair [Omalizumab] Moderate-severe persistent asthma IgE = 30-700 IU/ml IgE mediated (allergic) potential to inhalant allergen(s) by cutaneous or in vitro testing Women of childbearing potential not using appropriate contraception method(s) Women currently breastfeeding Women who desire to become pregnant during the time of participation in this study Men who desire to get someone pregnant during participation in this study Known sensitivity to Xolair [Omalizumab] IgE level < 30 IU/ml, or > 700 IU/ml No evidence of atopy by immediate hypersensitivity skin testing Use of any other investigational agent in the last 30 days Age < 18 years Current tobacco habituation | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 one year, with a maximum interval between 2 infliximab infusions of 3 months Patient with continuous remission without steroids for at least 6 months, except IV steroids for infusion reaction prophylaxis CDAI<150 Contraception all over the study Patient having experienced an severe acute infusion reaction to infliximab, defined by an anaphylactoïd reaction (drop in blood pressure, bronchospasm, dyspnea) requiring the arrest of the infliximab infusion Patient having experienced a severe delayed infusion reaction to infliximab, defined by fever, arthralgia, myalgia, requiring a steroid treatment Patient with dominant perianal disease and absence of active intestinal disease at the time of infliximab induction Patient with active perianal disease at the time of inclusion Patient with stoma Patient with debilitating extra-intestinal manifestation at the time of inclusion Non cooperating subjects Pregnant or lactating women | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 hepatic (liver) disease, allergy to ketorolac, amino amide local anesthetic, or contraindications to spinal anesthesia Patients on dialysis for kidney failure or patients that are jaundice or have a diagnosis of liver failure Patients routinely taking narcotic pain medications for pain other than their primary hip pain Patients that are taking Lyrica (pregabalin) or Gabapentin (neurontin) for the treatment of seizures | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 menstrual cycles (21-35 days) or amenorrheic for at least 3 months due to use of a long acting progestin or continuous use of oral contraceptives Subject is willing to insert pre-filled vaginal applicators Subject is willing to be asked questions about personal medical health and sexual history Normal Pap smear collected at the screening visit. If a subject's Visit 0 Pap smear result is any of the following, the person is ineligible for participation: ASC-US (atypical squamous cells of undetermined significance), AGC (atypical glandular cells), ASC-H (atypical squamous cells, cannot r/o high grade lesion), LSIL (low grade squamous intraepithelial lesions), HSIL (high grade squamous intraepithelial lesions), adenocarcinoma in situ, adenocarcinoma, squamous cell carcinoma in situ, squamous cell carcinoma or inadequate sample Vaginal and cervical anatomy that in the opinion of the Investigator lends itself easily to colposcopy Capable of reading and writing English and providing informed consent Previous sexual experience including vaginal intercourse Previous gynecological examinations Urogenital infection at screening or within the 21 days prior to screening. This includes urinary tract infection, Trichomonas vaginalis, Neisseria gonorrhoeae, Chlamydia trachomatis or Treponema pallidum. Subjects may be re-screened at least 21 days after the respective antibiotic or antifungal therapies have been completed History of recurrent genital herpes Diagnosis of N. gonorrhoeae, C. trachomatis, T. pallidum or T. vaginalis on two or more occasions during the six months prior to screening Pregnancy or within 2 months of last pregnancy (all subjects will have a urine pregnancy test prior to enrollment) Lactation Vaginal or systemic antibiotic or antifungal therapy within 21 days of the Screening visit or within 30 days of Enrollment visit Investigational drug use within 30 days or 10 half-lives of the drug, whichever is longer, of enrollment visit. Planned investigational drug use while participating in this study Menopause IUD insertion or removal within the last 3 months Pelvic surgery within the last 3 months | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 unwilling to perform PFTS or to return for follow-up evaluations Underlying lung disease such as emphysema, untreated active tuberculosis, Uncontrolled diabetes (fasting glucose > 250 mg/dL Uncontrolled hypertension (160/95 mmHg) Pregnancy | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 higher than 95 mmHg Use of other medications (statins, NSAI ect..) Known allergy to tomato, carotenoids, or vitamin E Diabetes Mellitus Obesity BMI>32 Significant dyslipidemia | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 Known Cerebral Vascular Lesion (i.e. Aneurysm, Arteriovenous malformation) Ischemic CVA within the last 3 months Suspected Aortic Dissection Active Bleeding Known Bleeding/Clotting Disorder Closed Head Trauma within the past 3 months Major Surgery (Abdominal/Thoracic) within the last 3 weeks Active GI Bleeding Currently taking Warfarin | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 patients enrolled in the sub-study were enrolled if SBP at the time of enrollment was ≤160 mmHg Required antihypertensive therapy to achieve systolic blood pressure ≤160 mmHg Written informed consent obtained Decision for early surgical evacuation prior to 30 minutes of clevidipine Receipt of an oral antihypertensive within 2 hours prior to initiation of clevidipine Treatment with a continuous infusion of an IV antihypertension agent prior to initiation of clevidipine. Bolus treatment with urapidil (Germany only), labetalol or hydralazine was permitted. ICP-monitored patients enrolled in the sub-study could be enrolled with a continuous infusion of an IV antihypertensive agent prior to the initiation of clevidipine Intracerebral hematoma considered to be related to trauma by the neurologist or neurosurgeon Aneurysmal sub-arachnoid hemorrhage Glasgow coma score of <5 and fixed dilated pupils Expectation that the patient would not tolerate or require intravenous antihypertensive therapy for a minimum of 30 minutes Known or suspected aortic dissection Acute myocardial infarction on presentation Positive pregnancy test or known 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 Treatment with more than 20 mg of prednisone per day Evidence of unstable clinically significant disease (e.g., cardiovascular, cerebrovascular, respiratory, or renal disease, or any other unstable serious disorder) other than SLE History of cancer (other than resected cutaneous basal and squamous cell carcinoma or in situ cervical cancer) with less than 5 years' documentation of a disease-free state | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 Polymerase chain reaction or HIV culture performed at any age; 2) Age >18 months, licensed ELISA with confirmatory Western Blot Patients with history of atraumatic fractures, known renal or liver disease, known malabsorption syndrome, or inflammatory bowel disease. Use of corticosteroids, exculding inhaled steroids (current or within past 6 months) Current use of anticonvulsant drug Daily cigarette smoking Daily consumption of alcohol containing beverages Current use of tenofovir | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 nonpregnant and nonlactating, and utilizing an acceptable method of contraception Has a body mass index between 18 and 34 inclusive (weight/height2) Based on sleep history, the subject reports subjective sleep latency greater than or equal to 45 minutes and reports wake time after persistent sleep onset of greater than or equal to 45 minutes The subject has an average wake time after persistent sleep onset of at least 60 minutes as determined by polysomnography during Screening (Day -7 PM through Day -5 AM). Wake time after persistent sleep onset must be greater than or equal to 30 minutes each night of polysomnography Screening In addition to meeting the for wake time after persistent sleep onset, must have an average latency to persistent sleep of at least 20 minutes as determined by polysomnography during Screening (Day -7 PM through Day -5 AM). Latency to persistent sleep must be greater than or equal to 15 minutes each night of polysomnography Screening Based on sleep history, the subject's habitual bedtime is between 9:00 PM and 1:00 AM Is willing to have a fixed bedtime and agrees to go to bed within +/-30 minutes of the habitual bedtime during the entire study Is willing to remain in bed for at least 8 hours each night during the entire study Based on sleep history, the subject either has not been using pharmacological assistance to sleep or uses pharmacological assistance no more than 4 times per week during the 3 months prior to Initial Screening. Subjects must agree to discontinue the use of all pharmacological sleep aids beginning 1 week prior to polysomnography Screening and throughout the entire duration of the study Has a known hypersensitivity to doxepin or related compounds (tricyclic antidepressants), or ramelteon or related compounds, including melatonin, and 5-hydroxytryptophan Has participated in any other investigational study and/or taken any investigational drug within 30 days prior to the first dose of single-blind study medication Has sleep schedule changes required by employment (eg, shift worker) within 3 months prior to the first dose of single-blind study medication Has flown across greater than 3 time zones within 7 days prior to Initial Screening, or will travel across 2 or more time zones during the course of the study Has participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to the first dose of single-blind study medication Is required to take or intends to continue taking any disallowed medication or any prescription medication or over-the counter medication that is known to affect the sleep/wake function or otherwise interfere with evaluation of the study medication, including Anxiolytics central nervous system active drugs (including herbal) Hypnotics Narcotic analgesics Antidepressants Beta blockers Anticonvulsants St. John's Wort | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 drug within 4 weeks preceding this study or planning to participate in another study at any time during the period of this study Any significant medical or psychiatric condition that could affect the interpretation of the PK data, or which otherwise would contraindicate participation in a clinical trial Any GI disease, abnormality or gastric surgery that may interfere with gastric emptying, motility and drug absorption Subject who has donated a unit of blood or plasma within 3 months prior to the Screening Visit | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 organs No nonsymptomatic mastocytosis Life expectancy > 3 months Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception for 1 month prior to, during, and until first menstrual cycle after completion of study treatment | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 field or disc progression for a minimum of 6 months included the following any form of steroid medication use within the last 6 weeks previous intra-ocular or refractive surgery no light perception vision. Patients with or without rhinitis (allergic/ non-allergic/ mixed), with rhinitis defined as allergies and/ or nasal congestion present for greater than one year, were eligible | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 = to 50 mm on the 0-100 mm VAS Contraindicated for, intolerant or unresponsive to NSAIDs, colchicine or both Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis Presence of severe renal function impairment Contraindication to intramuscular injection Known presence or suspicion of active or recurrent bacterial, fungal or viral infection at the time of enrollment Evidence of active pulmonary disease Live vaccinations within 3 months prior to the start of the study Use of forbidden therapy Other protocol-defined inclusion/ applied | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 of mast cells in a multifocal or diffuse pattern in skin and/or bone marrow biopsy 3. Patient with documented treatment failure of his/her handicap(s) with at least one of the following therapy used at optimized dose: Anti H1, Anti H2, Proton pump inhibitor, Osteoclast inhibitor, Cromoglycate Sodium, Antileukotriene 4. Handicapped status defined as at least two of the following handicaps, including at least one among pruritus, flushes, depression and fatigue: pruritus score ≥ 9, number of flushes per week ≥ 8, Hamilton rating scale for depression (HAMD-17) score ≥ 19, number of stools per day ≥ 4, number of mictions per day ≥ 8, Fatigue Impact Scale total score (asthenia) ≥ 75 5. Patients with OPA ≥ 2 (moderate to intolerable general handicap) 6. ECOG ≤ 2 7. Patient with adequate organ function Patient with one of the following mastocytosis: Cutaneous Mastocytosis, Not documented Smouldering Systemic Mastocytosis or Indolent Systemic Mastocytosis, Systemic Mastocytosis with an Associated clonal Hematologic Non Mast cell lineage Disease (SM-AHNMD), Mast cell leukemia (MCL), Aggressive systemic mastocytosis (ASM) 2. Previous treatment with any Tyrosine Kinase Inhibitor 3. Patient with recent cardiac history of: Acute coronary syndrome, Acute heart failure, Significant ventricular arrhythmia; patient with cardiac failure class III or IV; Syncope without known aetiology within 3 months, uncontrolled severe hypertension. 4. Patient with any condition that the physician judges could be detrimental to subjects participating in this study; including any clinically important deviations from normal clinical laboratory values or concurrent medical events Previous treatment 5. Change in the symptomatic treatment of mastocytosis or administration of any new treatment of mastocytosis within 4 weeks prior to baseline 6. Treatment with any investigational agent within 4 weeks prior to baseline | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 defined by a history of symptoms at least once a week but less than daily (step 2) (5) Current asthma treatment includes short-acting inhaled β-agonist alone as needed Patient fulfils all the following signs and symptoms of asthma History of symptoms including, but not limited to dyspnea, wheezing, chest tightness, cough, or sputum production for at least 12 months A forced expiratory volume in one second (FEV1) of at least 80% of the predicted value (pre-bronchodilator) while withholding β-agonist for at least six hours Patient has a diagnosis of asthma as defined by 1) an increase in FEV1 or PEF of ≥12% (absolute value), 20 to 30 minutes after inhaled β-agonist administration, OR 2) a positive methacholine PC20 (provocative concentration causing a 20% fall in FEV1) of 8 mg/ml or lower which was performed within the previous 12 months, OR 3) a fall in FEV1 of at least 15% after an exercise challenge which was performed within the previous 12 months. β-agonist reversibility and the methacholine and exercise challenge tests may be satisfied within the previous 12 months if there is adequate source documentation Patients demonstrate symptoms requiring β-agonist use on ≥2 and ≤6 days of the week for the previous two weeks Patient is able to chew a tablet Patient is judged to be in good, stable physical and mental health (except for his/her asthma) based on the medical history, physical examination, and routine laboratory data, and appears able to successfully complete this trial none | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 fever controlled by medication) in the absence of documented fever One or more respiratory symptoms of influenza-like illness which may the following Sore throat Runny or stuffy nose Cough One or more constitutional symptoms of influenza-like illness which may the following Myalgia (aches and pains) Headache Fatigue; 3. Subjects (or parent/guardian) willing and able to provide informed consent. Written subject informed consent for this study protocol must be obtained prior to study enrollment. Each subject (or parent or guardian) must personally sign and date the Subject Informed Consent Form prior to his/her participation in this clinical study Subjects not presenting with at least three symptoms of influenza-like illness as outlined above. 2. Subjects who have received influenza antiviral medication or an investigational influenza drug treatment within the previous 30 days of study enrollment. 3. Subjects (children and adults) for whom the obtaining of swab samples, nasal wash or aspirate samples is contraindicated or not possible. 4. Subjects with a medical condition that prevents swab samples or nasal washes or aspirate samples from being obtained. 5. Active duty military personnel (participating military study sites only). 6. Subjects (or parent/guardian) unwilling or unable to provide 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 GVHD or no response to at least 7 days of steroid treatment In addition to steroids the patient has received either cyclosporin Written informed consent MSC donor must be HIV, HTLV, hepatitis BS antigen, HCV and HBC, Treponema Pallidum antibody negative. MSC donors can be mismatched related donor, third party matched or mismatched donor Patients with poor performance, not expected to survive 3 weeks Donor Chimerism below 90% Active uncontrolled CMV, EBV or fungal infection | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 fever controlled by medication) in the absence of documented fever One or more respiratory symptoms of influenza-like illness which may the following Sore throat Runny or stuffy nose Cough One or more constitutional symptoms of influenza-like illness which may the following Myalgia (aches and pains) Headache Fatigue 3. Subjects (or parent/guardian) willing and able to provide informed consent; 4. Subjects must be enrolled in Arm 3 of the FLU-05 clinical study. Written subject informed consent for this study protocol must be obtained prior to study enrollment. Each subject (or parent or guardian) must personally sign and date the Subject Informed Consent Form prior to his/her participation in this clinical study Subjects not presenting with at least three symptoms of influenza-like illness as outlined above. 2. Subjects who have received influenza antiviral medication or an investigational influenza drug treatment within the previous 30 days of study enrollment. 3. Subjects (children and adults) for whom the obtaining of aspirate samples is contraindicated or not possible. 4. Subjects with a medical condition that prevents nasal washes or aspirate samples from being obtained. 5. Active duty military personnel (participating military study sites only). 6. Subjects (or parent/guardian) unwilling or unable to provide 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 of an activating point mutation in the phosphotransferase domain of c-Kit such as D816V c-Kit mutation in at least one of the two infiltrated organs: bone marrow and/or skin and/or other tissue. 4. Handicap defined as at least one of the following handicaps a number of flush per day ≥ 1 a pruritus score ≥ 9 a number of stools per day ≥ 4 a Pollakyuria (on a per day basis) ≥ 8 a QLQ-C30 score ≥ 83 a Hamilton rating scale for depression ≥ 12 Performance status > 2 (ECOG). 2. Inadequate organ function, except if the abnormalities are due to involvement by mast cells | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 negative FISH) Measurable or evaluable disease No symptomatic or progressive CNS (central nervous system) metastases | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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-G000-301 or -303 Esophageal motility disorders (achalasia, scleroderma, or esophageal spasm). 2. Barrett's esophagus or esophageal stricture. 3. Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine receptor antagonists (H2RA), antacids, sucralfate, misoprostol, prokinetics or drugs with significant anticholinergic effects throughout the study. 4. Subjects who require chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs), oral steroids (>= 20 mg/day prednisone or equivalent), or aspirin (->; 325 mg/day). 5. Significant hepatic, renal, respiratory, endocrine, hematologic, neurologic, psychiatric, or cardiovascular system abnormalities that would be likely to interfere with the conduct of the study, the interpretation of study results, or the health of the subject during the study. 6. Any condition that would make the subject, in the opinion of the investigator or sponsor, unsuitable for the study | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 E3810-G000-302 or -303. KEY Esophageal motility disorders (achalasia, scleroderma, or esophageal spasm). 2. Barrett's esophagus or esophageal stricture. 3. Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine receptor antagonists (H2RA), antacids, sucralfate, misoprostol, prokinetics or drugs with significant anticholinergic effects throughout the study. 4. Subjects who require chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs), oral steroids (>= 20 mg/day prednisone or equivalent), or aspirin (->; 325 mg/day). 5. Significant hepatic, renal, respiratory, endocrine, hematologic, neurologic, psychiatric, or cardiovascular system abnormalities that would be likely to interfere with the conduct of the study, the interpretation of study results, or the health of the subject during the study. 6. Any condition that would make the subject, in the opinion of the Investigator or Sponsor, unsuitable for the study | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 the following laboratory parameters (unless due to disease status as determined by the treating physician) Hepatitis A, B and C status will be tested prior to therapy, but results will not patients from participation (if positive, patients will be told they are at higher risk of adverse effects from allogeneic transplantation) Bilirubin less than 6 times the upper limit of normal Liver transaminases (AST, ALT) and alkaline phosphatase less than 10 times the upper limit of normal (unless due to active myositis) Patients with a creatinine greater than 2.5 times the upper limit of normal are eligible, but will be told that they are at greater risk for kidney damage that could possibly result in temporary or even permanent dialysis Patients of childbearing potential must agree to use some form of adequate birth control during the periods they receive chemotherapy and any post-chemotherapy medications related to the transplant. Females of child bearing potential must have a negative serum B-HCG within 1 week of starting therapy Patients between the ages of 18 and 69, inclusive are eligible for this trial Pregnant or lactating women Active uncontrolled infection Patients who are serologically true-positive for HIV Patients with other major medical or psychiatric illnesses, which the treating physician feels, could seriously compromise tolerance to this protocol Uncontrolled hypertension (BP > 100 diastolic despite treatment with maximum doses of at least 3 simultaneous or concurrent antihypertensives over a 2-month period) Uncontrolled malignant arrythmias or clinical evidence of congestive heart failure (New York Class IV) 6/6 HLA-Matched Related PBSC Donor Inclusion/ Adult donors must be capable of providing informed consent; Potential donors under the age of 18 must have a 'single patient exemption' approved by the IRB and the donor and a guardian must provide assent Donor must be 6/6 HLA matched, and related to the patient Donor must not have any medical condition which would make apheresis and G-CSF administration more than a minimal risk, and should have the following: 1. Adequate cardiac function by history and physical examination. Those with a history of cardiac problems should undergo a stress evaluation or be evaluated by a cardiologist and deemed eligible to donate. 2. bilirubin and hepatic transaminases < or equal to 2.5 x ULN, 3. adequate hematologic parameters including a hematocrit > 35% for males and 33% for females, white blood cell count of > or equal to 3,000, and platelets > or equal to 80,000. 4. Donors with a known allergy to E. coli-derived products are ineligible for mobilization with G-CSF Females of childbearing potential should have a negative serum beta-HCG test within 1 week of beginning G-CSF | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 at least 1 on the 0-3 scale for the swelling and the tenderness assessments of the gouty index joint 5. Current presentation of acute gout flare in 3 joints or less Treatment with any non-steroidal anti-inflammatory drug (NSAIDs) or opiates within 48 hours prior to baseline assessments. Treatment with long-acting NSAIDs within 1 month prior to baseline visit. Treatment with naproxen, meloxicam, nabumetone, celecoxib and indomethacin SR within 5 days prior to baseline visit. 2. Treatment with oral analgesics within 6 hours before baseline assessments. Treatment with topical analgesics within 12 hours before baseline assessments 3. History of NSAID intolerance 4. Participants with history of chronic, gouty arthritis | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 communicate suitably with the investigator and study coordinator 4. Patients must have tolerated the drug at therapeutic doses, but have shown a true lack of improvement in symptoms 5. Must have shown clinically significant superiority in improvement in ADHD symptoms on amphetamine relative to MPH Must not have a true allergy to methylphenidate or amphetamines 2. Must not have a history of serious adverse reactions to methylphenidate | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 the patient's healthcare practitioner. 3. Provide copies of pertinent medical history and laboratory studies. 4. Have a health care provider outside of NIH. 5. Be willing to give informed consent. 6. Be willing to donate blood for sample storage to be used for future research. Non-affected relatives/guardian must: 1. Be at least 2 years of age and no older than 90 years of age. 2. Have a relative who is enrolled on this protocol and is known to have documented history of a physical urticaria. 3. Not have a history of physical urticaria. 4. Be willing to give informed consent. 5. Be willing to donate blood for sample storage to be used for future research. Normal volunteers must: 1. Be 18-65 years of age. 2. Be non-atopic (not have a history of allergic rhinitis, asthma, atopic dermatitis) per subject s medical history. 3. Have the ability to give informed consent. 4. Be willing to donate blood for sample storage to be used for future research. 5. Not have a history of physical urticaria The following apply to all subjects: 1. Presence of conditions which, in the judgment of the investigator or the referring physician, may put the subject at undue risk, such as acute infection, severe thrombocytopenia (minimum platelet count of 30,000), or significant cardiovascular disease 2. Any condition that in the view of the principal investigator (PI) would make the subject unsuitable for enrollment in this study 3. History of HIV or other known immunodeficiency 4. History or evidence of chronic Hepatitis B and/or C infection 5. 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 anaphylaxis and other diseases in the differential diagnoses have been considered. Anaphylaxis episodes (mild-severe) at least 6 times within the past 1 year period, documented according to medical records physician report, or patient report and 1 episode within the last 4 months, and with at least 1 of the following: 1. Elevated serum tryptase above baseline within 2 hours of the event. 2. Emergency room visit with documented anaphylaxis without an etiology established by the acute onset of an illness (minutes to several hours) with involvement of the skin, mucosal tissue, or both (e.g., generalized hives, pruritus or flushing, swollen lips-tongue-uvula) [Grade 1]* and at least 1 of the following: 1. Respiratory compromise or gastrointestinal involvement (e.g., dyspnea, wheeze-bronchospasm, stridor, reduced peak expiratory flow, hypoxemia, nausea, vomiting, or abdominal pain [Grade 2]*). 2. Reduced blood pressure or associated symptoms of end-organ dysfunction (e.g., hypotonia [collapse], syncope, or incontinence [Grade 3]*). 3. Hospitalization for anaphylaxis: hospital records with documented anaphylaxis without known cause established by the acute onset of an illness (minutes to several hours) with involvement of the skin, mucosal tissue, or both (e.g., generalized hives, pruritus or flushing, swollen lips-tongue-uvula) [Grade 1]*) and at least one of the following: 1. Respiratory compromise or gastrointestinal involvement (e.g., dyspnea, wheeze-bronchospasm, stridor, reduced peak expiratory flow, hypoxemia, nausea, vomiting, or abdominal pain [Grade 2]*). 2. Reduced blood pressure or associated symptoms of end-organ dysfunction (e.g., hypotonia [collapse], syncope, or incontinence [Grade 3]*). 4. Letter of referral, with copies of pertinent medical history and laboratory tests, from prospective study participant s local physician. 5. Ability to give informed consent. 6. Women of childbearing potential must have a negative beta-HCG serum or urine pregnancy test prior to each injection, and must agree to practice abstinence or effective contraception from initiation of the protocol and for 3 months following the last infusion of the study agent (effective contraception methods abstinence; surgical sterilization of either partner, barrier methods such as diaphragm, condom, cap, or sponge; or hormonal contraception) Severity grading of anaphylaxis A volunteer who satisfies any of the following will be ineligible to participate in this study. 1. Presence of conditions which, in the judgment of the investigator or the referring physician, may put the subject at undue risk for study participation or travel (such as an acute infection, severe thrombocytopenia, coronary artery disease, uncontrolled hypertension, congestive heart failure, chronic beta blocker therapy such as atenolol or metoprolol, or myeloproliferative disease). 2. History of malignancy 3. Known cause for anaphylaxis or flushing 4. Diagnosis of mastocytosis 5. Inability to provide informed consent 6. Inability or refusal to undergo a bone marrow biopsy and aspirate 7. HIV positive or other known immunodeficiency 8. Active or chronic hepatitis 9. Use of any other investigational agent within 30 days of the study 10. Current use of chronic-oral corticosteroids or other immunosuppressant medications 11. Pregnant or nursing women 12. Positive pregnancy test 13. IgE levels and subject s weight that cause dosing to be above dosing guidelines | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 the following Prior radiotherapy completed > 6 months from re-irradiation Prior radiotherapy in the region of the study cancer that would result in overlap of radiation therapy fields Majority of the recurrent tumor volume (> 50%) received prior radiotherapy dose of 30-75 Gy No distant metastatic disease ECOG performance status 0-2 Life expectancy ≥ 3 months | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 with medical co-morbidities, massive effusions, or tumor burden such that an optimal resection is unlikely) who undergo a core biopsy that is positive for malignancy. 2. Patients who have undergone tumor reduction must have either stage III suboptimal (> 2 cm residual) disease or stage IV disease. 3. Patients may have had no prior chemotherapeutic regimen. 4. Zubrod performance status of 0, 1, or 2. 5. Patients must have recovered from effects of recent surgery. They should be free of significant infection. 6. Patients must have adequate: Bone marrow function: WBC >/= than 3,000/microlitre, platelets > 100,000/microlitre, absolute neutrophil (ANC) count >/= than 1.5/microlitre. Renal function: Creatinine </= 1.5 mg%. Hepatic function: Bilirubin </= 1.5 mg/dl, SGOT and alkaline phosphatase </= 3 X institutional normal. 7. Patients must have adequate: Neurologic function: Pre-existing peripheral neurologic toxicity is allowed but limited to parasthesia and decreased vibratory sense without motor weakness. Intermittent constipation managed with laxatives is allowed, without evidence of bowel obstruction. Psychiatric function: Functions independently without evidence of delirium, confusion, suicidal ideation, or untreated depression. 8. Patients who have signed an approved informed consent Patients with borderline or grade 1 (low grade) tumors. 2. Patients who have received any prior cytotoxic chemotherapy or radiotherapy. 3. Patients with septicemia, severe infection, acute hepatitis, or gastrointestinal bleeding at the time of protocol entry. 4. Patients with unstable angina or those who have had a myocardial infarction within the past six months. Patients with evidence of abnormal cardiac conduction (e.g., bundle branch block, heart block, etc.) are eligible if their disease has been stable for the past six months. 5. Patients whose circumstances do not permit completion of the study or the required follow-up. 6. Patients with a history of another malignancy within 5 years. Patients who have had a prior malignancy but remain continuously free of recurrent or persistent disease for more than 5 years may be entered in the study after consultation with the study chair. 7. Patients with significant pre-existing cardiac disease (NYHA class III-IV) will be excluded | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 asthmatics as defined by an FEV1 ≤ 60% or PEF variability > 30% or with continual daytime or nocturnal symptoms Nasal Polyposis grade 2/3, deviated nasal septum ≥ 50% The use of oral corticosteroids within the last 3 months Recent respiratory tract infection (2 months) Significant concomitant respiratory disease Any other significant medical condition or investigation which may jeopardise the safety of the participant or the conduct of the protocol Any significant abnormal laboratory result as deemed by the investigators Pregnancy, planned pregnancy or lactation Known or suspected contra-indication to any of the IMP's Concomitant use of medicines (prescribed, over the counter or herbal) that may interfere with the trial | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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-indications or known intolerance to the study medications. 2. History of congestive heart failure, carcinoid, rosacea, renal failure (GFR<60 ml/min/m2). 3. Active liver disease. 4. Active diabetes (defined as any history of type 1 diabetes, or history of type 2 diabetes plus one or more of the following: fasting glucose>= 126mg/dL at screening or use of anti-diabetic medications within 12 months, or glucose>200mg/dL 2 hours after a 75 g oral glucose challenge within 12 months. 5. History of major surgery within the past 6 weeks, or anticipated major surgery during the course of the study, or any history of organ transplant. 6. History of drug abuse within the past 3 years, or regular alcohol use of greater than 14 drinks per week. 7. Women who are pregnant, plan to conceive or lactate. 8. Peri-menopausal women or women currently experiencing flushing. 9. Currently taking vasoactive medications, anti-hypertensives, anti-histamines, Selective Serotonin Re-uptake Inhibitors (SSRIs), oral steroids, leukotriene inhibitors, supplemental quercetin and > 50mg niacin | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 progression while receiving the last fludarabine-containing regimen, or disease progression in responders (i.e., achieved a PR or CR) within 6 mos of the last cycle of the last fludarabine-containing regimen received (e.g., fludarabine monotherapy, FR, or FC) or in responders (i.e., achieved a PR or CR ) within 24 mos of the last cycle of FCR Intolerant to fludarabine is defined as discontinuation of therapy within 2 cycles due to side effects/toxicity from the last fludarabine-containing regimen ECOG score of <=1 Adequate coagulation, renal, & hepatic function at Screening as follows Serum creatinine <= 2.0 mg/dL or calculated creatinine clearance >= 50 mL/min AST & ALT <= 3.0 x ULN Bilirubin <= 1.5 x ULN Gilbert's Syndrome may have a Bilirubin > 1.5 x ULN; aPTT, PT, not to exceed 1.2 x ULN Adequate bone marrow (BM) independent of any growth factor support (with the exception of subjects with BM heavily infiltrated with underlying disease [80% or more] who may use growth factor support to achieve adequate BM) at Screening as follows History/clinically suspicious for cancer-related CNS disease Undergone allogeneic stem cell transplant Undergone autologous stem cell transplant w/i 6 mos prior to 1st dose History/predisposing condition of bleeding or currently exhibits signs of bleeding Recent history of non-chemotherapy induced thrombocytopenic associated bleeding w/i 6 mos prior to 1st dose Active peptic ulcer disease or other hemorrhagic esophagitis/gastritis Active immune thrombocytopenic purpura or history of being refractory to platelet transfusions w/i 1 yr prior to 1st dose Currently receiving/requires anticoagulation therapy or any drugs or herbal supplements that affect platelet function, with the exception of low-dose anticoagulation medications used to maintain the patency of a central IV catheter Significant history of cardiovascular disease, renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic disease Positive for HIV, Hepatitis B, or Hepatitis C | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 equal to or less than 2 5. Adequate liver function as shown by serum bilirubin equal to or less than 1.5 * upper limit of normal (ULN), and serum alanine aminotransferase (ALT) equal to or less than 3 * ULN. 6. Signed informed consent Patients with low blood cell counts (Grade 3 or 4), unless it is known that the low blood cell count is due to systemic mastocytosis. 2. Treatment with any conventional (specifically, interferon or cladribine) or investigational medicine for SM within the preceding 4 weeks 3. Chronic treatment with systemic steroids (unless limited to 10 mg prednisone equivalent per day or less) or another immunosuppressive agent 4. Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin. Patient may have SM-associated clonal hematologic disease that does not require therapy, as judged by the treating physician and approved by the principal investigator). 5. Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study as judged by the Principal Investigator (i.e., severely impaired lung function, uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, unstable angina, or congestive heart failure New York Heart Association Class III or IV, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within six months, chronic liver or renal disease, active upper GI tract ulceration) 6. A known history of human immunodeficiency virus (HIV) seropositivity 7. Women who are pregnant or breast feeding,or women/men able to conceive and unwilling to practice an effective method of birth control. Women of childbearing potential must have a negative urine or serum pregnancy test within 48 hours prior to administration of obatoclax. Women of childbearing potential is defined as women who have not undergone a hysterectomy or bilateral oophorectomy, has not been naturally postmenopausal for at least 24 consecutive months. 8. Patients with a known hypersensitivity to obatoclax mesylate or to its excipients (PEG 300 and Tween 20) 9. Patients unwilling to or unable to comply with the protocol | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | eligible ages (years): 18.0-999.0, Metastatic Cancer Metastatic cancer that expresses Her-2 at greater than or equal to 2+ and assessed by immunohistochemistry (IHC) in the clinical laboratory improvement amendment (CLIA) approved test in the Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI), National Institutes of Health (NIH). 2. Patients must have previously received systemic standard care (or effective salvage chemotherapy regimens) for metastatic disease, if known to be effective for that disease, and have been either non-responders (progressive disease) or have recurred. Subjects with estrogen receptor-positive or progesterone receptor-positive breast cancer must have progressed on or not be a candidate for anti-estrogens or aromatase inhibitors and all breast cancer patients must have progressed on or not be a candidate for an anthracycline-containing regimen and a taxane-containing regimen. 3. Patients with breast cancer must have previously received trastuzumab. Patients will not continue to receive trastuzumab during the trial period. 4. Greater than or equal to 18 years of age. 5. Willing to sign a durable power of attorney 6. Able to understand and sign the Informed Consent Document 7. Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0 or 1. 8. Life expectancy of greater than three months. 9. Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for up to four months after receiving the preparative regimen. 10. Serology: 1. Seronegative for human immunodeficiency virus (HIV) antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune-competence and thus be less responsive to the experimental treatment and more susceptible to its toxicities.) 2. Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by reverse transcriptase polymerase chain reaction (RT-PCR) and be hepatitis C virus ribonucleic acid (HCV RNA) negative. 3. Women of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects of the preparative chemotherapy on the fetus. 11. Hematology: 1. Absolute neutrophil count greater than 1000/mm^3 without the support of filgrastim. 2. White blood cell (WBC) (> 3000/mm^3). 3. Platelet count greater than 100,000/mm^3. 4. Hemoglobin greater than 8.0 g/dl. 12. Chemistry: 1. Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less or equal to 2.5 times the upper limit of normal. 2. Serum creatinine less than or equal to 1.6 mg/dl. 3. Total bilirubin less than or equal to 1.5 mg/dl, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl. 13. Left ventricular ejection fraction (LVEF) greater than or equal to 50%. 14. More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, and patients' toxicities must have recovered to a grade 1 or less (except for toxicities such as alopecia or vitiligo). 15. Patients who have previously received anti-cytotoxic T-lymphocyte antigen 4 (CTLA4) antibody therapy must have a normal colonoscopy with normal colonic biopsies Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. 2. Active systemic infections; coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system; myocardial infarction; cardiac arrhythmias; obstructive or restrictive pulmonary disease. 3. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease). 4. Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities). 5. Concurrent Systemic steroid therapy 6. History of severe immediate hypersensitivity reaction to any of the agents used in this study. 7. History of coronary revascularization or ischemic symptoms 8. Documented forced expiratory volume in 1 second (FEV1) less than or equal to 60% predicted tested in patients with: 1. A prolonged history of cigarette smoking (20 pack/year of smoking within the past 2 years). 2. Symptoms of respiratory dysfunction | 0 |
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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 severe injury, including fracture or nerve injury Use of oral NSAIDs or opioids within 12-24 hours of injury Presence or history of peptic ulcers or GI bleeding A history of intolerance to NSAIDs, acetaminophen, adhesives Positive pregnancy test Positive drug screen | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 disease Stable CNS disease allowed provided that it's adequately treated and not under active treatment Hormone receptor status not specified Menopausal status not specified ECOG performance status 0-1 ANC > 1,000/mm^3 | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 8 weeks prior to the screening period or naïve patients who had not received VDRA or cinacalcet within 8 weeks of screening. 3. Patient was on maintenance HD (hemodialysis) 3 times weekly (TIW) for at least 3 months prior to screening and was expected to remain on HD for the duration of the study. 4. For entry into the Pre-Treatment Washout Period (for patients who were not naïve to VDRAs and cinacalcet), the patient had to have screening laboratory values of iPTH level 130 to 700 pg/mL Serum Total Alkaline Phosphatase level >= 40 U/L Calcium level <= 10.0 mg/dL (2.49 mmol/L) Calcium-phosphorus product (CaxP) <= 75 mg2/dL2 (US) and <= 70 mg2/dL2 (non-US) Patient had a history of parathyroidectomy. 2. Patient had a current malignancy (with the exception of basal or squamous cell carcinoma of the skin), or clinically significant liver disease, in the opinion of the investigator. 3. Use of known inhibitors (i.e., ketoconazole) or inducers (i.e., carbamazepine) of cytochrome P450 (including grapefruit and/or grapefruit juice) 3A (CYP3A) or drugs metabolized by cytochrome P450 2D6 (CYP2D6) (e.g., flecainide, vinblastine, thioridazine, and most tricyclic antidepressants) within 2 weeks prior to study drug administration. Commonly used beta blockers such as metoprolol and carvedilol are allowed but are metabolized by CYP2D6; thus, an adjustment to a lower dose may have been required. 4. Patient was known to be human immunodeficiency (HIV) positive | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 must be available at baseline or ≤ 6 months prior to study entry Subjects may have not prior treatment with chemotherapeutic regimen including imatinib or have either failed a prior chemotherapeutic regimen including imatinib or other agent At least two weeks must have elapsed from the last dose of chemotherapy, hormonal therapy, immunotherapy, biological therapy or investigational product and radiation therapy, and subjects must have recovered to baseline or Grade ≤ 1 (NCI CTCAE, version 3.0) from the toxicities resulting from any of those recent therapies prior to the first dose of dasatinib ECOG performance status of 0, 1 or 2 Subject must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and requirements of the study Adequate liver and renal functions defined as Total bilirubin ≤ 2 x upper limit of normal (ULN) or ≤ 4 ULN if the sole cause of liver elevation is due to SM WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to at least 4 weeks after the last dose of investigational product Women who are pregnant or breastfeeding Indolent SM (presence of B-findings without severe mediator-related symptoms) Pericarditis, clinically significant pleural effusion or ascites within 12 months prior to study entry not attributable to SM Pulmonary infiltrates within 4 weeks prior to study entry or abnormal chest X-ray at baseline not attributable to SM Any surgical procedure, excluding central venous catheter placement or other minor procedures (e.g. skin biopsy) within 14 days prior to initiation of dasatinib therapy Presence of active bacterial, fungal or viral infections at study entry Clinically significant cardiac disease (NYHA Class III or IV) including preexisting arrhythmia, (such as ventricular tachycardia, ventricular fibrillation, or "Torsade de Pointes"), myocardial infarction, uncontrolled angina within 6 months, congestive heart failure, or cardiomyopathy Abnormal QTcF interval prolonged ( ≥ 450 msec) after electrolytes have been corrected on baseline ECG Malabsorption syndrome not attributable to SM or uncontrolled (e.g. not corrected by antimediator therapy) gastrointestinal toxicities (nausea, diarrhea, vomiting) NCI CTCAE Grade = 2 | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 chronic disease as determined by brief history Safety or circumstantial reasons why volunteer cannot comply with the protocol | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | eligible ages (years): 18.0-55.0, Musculoskeletal Pain Signed and dated informed consent prior to participation Subjects in good health as determined by the Investigator Age 18-55 Willing to abstain from any physical therapy, hard physical work, exercise or sauna during the study observation period (Screening to Final Visit) For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are also allowed for participation Participation in another clinical study within the last 30 days and during the study Subjects who are inmates of psychiatric wards, prisons, or other state institutions Investigator or any other team member involved directly or indirectly in the conduct of the clinical study Pregnancy or lactation Alcohol or drug abuse Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma Skin lesions, dermatological diseases or tattoo in the treatment areas Known hypersensitivity or allergy (including photoallergy) to NSAID´s including celecoxib, sulfonamides and ingredients used in pharmaceutical products and cosmetics including galactose Varicosis, thrombophlebitis and other vascular disorders of the lower extremities Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-skeletal system of the lower limbs | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | eligible ages (years): 18.0-999.0, HIV Infection Liver Failure Evidence of Liver Transplantation Age ≥ 18 Documented HIV-1 infection, hepatitis B or C co-infection is allowed Plasma viral load at screening visit below 50 copies per mL for at least 6 months Patient with severe liver failure (Meld Score ≥ 15 and/or refractory ascites and/or haemorrhage of digestive tract and/or hepatic encephalopathy) for taking part into period 1 Patient eligible for the liver transplant waiting list or immediate post transplantation for taking part into period 2 Abstinence from alcohol intake for at least 6 months (WHO norm) Withdrawal from intravenous drug use for at least 6 months (methadone substitution is permitted) No ongoing class C opportunistic infection (1993 CDC classification) Patient whose clinical and immunovirological condition allows triple therapy with raltegravir + 2 NRTI or raltegravir + NRTI + enfuvirtide Patient whose HIV population, according to cumulative genotypes carried out on viral RNA together with treatment history (if available and interpreted as per the ANRS-AC11 algorithm version no.19) does not present a profile of mutations associated with resistance to raltegravir and is sensitive to at least two fully active* agents selected among nucleoside/nucleotide reverse transcriptase analogs NRTI (abacavir, lamivudine, emtricitabine, tenofovir) or enfuvirtide *An ARV agent is considered to be fully active if the cumulative genotypes do not show any mutation associated with resistance or any mutation associated with "possible resistance" More than two virological failures during antiretroviral treatment Currently receiving treatment with an agent in development (apart from an authorization for temporary use) Plasma viral load at screening visit ≥ 50 copies per mL during at least the last 6 months Pregnant women, or women liable to become pregnant, breast-feeding women, no contraception, or refusal to use contraception All conditions (including but not limited to alcohol intake and drug use) liable to compromise, in the investigator's opinion, the safety of treatment and/or the patient's compliance with the protocol Patient not having any effective options for NRTI +/ enfuvirtide (defined in the criteria) Ongoing treatment with interferon-alpha or ribavirin for hepatitis C Concomitant medication including one or more agents liable to induce UGT1A1 and reduce raltegravir concentrations anti-infective agents: rifampicin/rifampin | 0 |
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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | eligible ages (years): 18.0-59.0, First Episode Psychosis Aged 18-59 years and meet DSM-IV diagnostic for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version Meeting DSM-IV for another axis I diagnosis, including substance abuse or dependence Needing another nonantipsychotic psychotropic medication at enrollment Having a serious or unstable medical illness Pregnant or lactating women or women without adequate contraception will be also excluded | 0 |
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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 (VAS) History of ≥ 3 gout flares within the 12 months prior to study entry Contraindication, intolerance, or lack of efficacy for non-steroidal anti-inflammatory drugs (NSAIDs) and/or colchicine Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis Presence of severe renal function impairment Use of specified pain relief medications or biologics ( corticosteroids, narcotics, paracetamol/acetominophen, ibuprofen, colchicine, IL-blocker, and tumor necrosis factor inhibitor) within specified periods prior to study entry Live vaccinations within 3 months prior to randomization Requirement for administration of antibiotics against latent tuberculosis (TB) Refractory heart failure (Stage D) Unstable cardiac arrhythmias or unstable symptomatic coronary ischemia Any active or recurrent bacterial, fungal, or viral infection Extension Study 1: Completion of the Core study. A patient was defined as completing the core study if they completed the study up to and including visit 7 Continuation in this extension study was considered inappropriate by the treating physician. Extension Study 2: Completed of the first extension study CACZ885H2356E1. A patient was defined as completing the first extension study if they completed the study up to and including Visit 10). -Continuation in this extension study was considered inappropriate by the treating physician Other protocol-defined applied to the core and extension studies | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | eligible ages (years): 18.0-999.0, Metastatic Melanoma ENTRY Locally advanced or metastatic melanoma Measurable Histologically or cytologically confirmed Surgically incurable HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes PRIOR/CONCURRENT If prior Proleukin treatment, must have had clinical benefit No prior systemic cytotoxic chemotherapy for melanoma No concurrent radiotherapy, chemotherapy, or other immunotherapy More than 4 weeks since prior major radiotherapy | 0 |
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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 measurable lesion ≥ 2 cm by conventional techniques or ≥ 1 cm by spiral CT scan Must have failed ≥ 1 cisplatin-based conventional chemotherapy regimen for metastatic disease (neoadjuvant/adjuvant therapy excluded) No history or clinical evidence of CNS metastases or leptomeningeal carcinomatosis, except for individuals who were previously treated for CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for the past 6 months ECOG performance status 0-1 Life expectancy ≥ 12 weeks Hemoglobin ≥ 9.0 g/dL Absolute neutrophil count ≥ 1,000/μL | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 a smoking cessation program, or use other smoking cessation medications in the next 2 months Provide a Carbon Monoxide reading of ≤10 ppm at Medical screening History of substance abuse and/or currently receiving treatment for substance abuse (e.g., alcohol, opioids, cocaine, marijuana, or stimulants) Current alcohol consumption that exceeds 25 standard drinks/week Providing a breath alcohol concentration (BAC) reading of > 0.01 at any session Women who are pregnant, planning a pregnancy, or lactating; all female subjects shall undergo a urine pregnancy test at each session Women of child-bearing age must agree in writing to use an approved method of contraception History or current diagnosis of psychosis, major current depression or bipolar disorder, ADHD, schizophrenia, or any Axis 1 disorder as identified by the MINI Serious or unstable disease within the past 6 months (e.g., cancer [except melanoma], heart disease, HIV) History of epilepsy or a seizure disorder | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 approved product label for Patient confirmed pregnancy or active breastfeeding Any other condition that, in the opinion of the Investigator, may compromise the safety or compliance of the patient or would preclude the patient from successful completion of the study | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 solid tumors curatively treated with no evidence of disease for > 3 years Albumin < 3.2 Patients on concurrent chronic steroids, other than those allowed for routine antiemetics, or inhaled steroids Patients receiving phenobarbital, phenytoin, orlistat and cholestyramine Hypercalcemia (Calcium >10.5 mg/dl) Calcium x Phosphorus > 70 mg2/dL2 | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 Condition Patients presenting to the Behavioral Medicine Service are generally individuals with an acute or chronic medical condition or medically related concern with or without an associated DSM-IV psychiatric disorder, as well as adult patients who require assistance with changing health or health-risk behaviors. Patients presenting to the OCD program typically have obsessive compulsive disorder, body dysmorphic disorder, Tourette syndrome, compulsive skin picking, or trichotillomania. Patients presenting to the general CBT program typically have panic disorder, social phobia, generalized anxiety disorder, depression, specific phobia, post traumatic stress disorder, attention deficit hyperactivity disorder, or an eating disorder. Patients at any of the programs have an identifiable behavior or behavioral pattern/ mood problem that they would like to change Age 18 or older Ability to provide informed consent and comply with the study procedures Ability to complete self-report questionnaires (either written hardcopy or computer-based version) with adequate accommodation, if necessary Patients with a PCP at MGH, receiving specialty care at MGH, or employees of MGH Exhibit active suicidality (suicidal ideation with intent or plan) to the point that more intensive treatment (i.e. acute hospitalization) is required Active untreated and unstable bipolar disorder (i.e. stable bipolar disorder under care of a psychiatrist is allowed) Psychosis Mental retardation Any condition that, after the baseline evaluation, is determined to preclude treatment with cognitive behavioral therapy Received more than 4 sessions of CBT for the target disorder within the past 3 years | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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, and infectious diseases. These conditions but are not limited to Diabetes Heart failure Pulmonary disease Rheumatoid arthritis Systemic lupus erythematosus Sarcoidosis Sj(SqrRoot)(Delta)grens syndrome Dermatomyositis Psoriasis | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 the ED physician (e.g., past asthma history, recorded response to β-agonists in the ED, and increased asthma symptoms). In the event of a new diagnosis, the patient is still eligible for the study if the treating physician feels that the history is compatible with a diagnosis of asthma; 4. Patients must have evidence of airflow obstruction on presentation at the ED, defined as an FEV1 or PEF <80% of predicted; 5. Patients must not have a history of more than 20 pack-years of smoking; 6. All patients should have a PCP (FP, nurse practitioner or internist) with whom to follow-up or attempts will be made to find one for them These ensure the of suspected COPD patients and patients who require different treatments: 1. Patients with asthma who are primarily cared for by a Respirologist/Pulmonologist; 2. Patients not seen by an emergency physician in the ED (e.g., direct referrals); 3. Physician diagnosis of acute COPD (e.g., failure of FEV1 or PEF to respond to ED treatment and a FEV1/FVC ratio ≤ 70%); 4. Radiologically confirmed pneumonia during the 10 days preceding trial entry; 5. Patients with an active history of bronchiectasis, cystic fibrosis, or lung cancer; 6. Clinically confirmed congestive heart failure at ED presentation; 7. Patients not able/unwilling to perform spirometry assessment; 8. Inability to provide informed consent or comply with the study protocol due to cognitive impairment, language barrier, or no contact details; 9. Patient has previously participated in the study; 10. Patients who in the opinion of the investigator are unsuitable for enrolment | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 (VAS) History of ≥ 3 gout flares within the 12 months prior to study entry Contraindication, or intolerance, or lack of efficacy for non-steroidal anti-inflammatory drugs (NSAID) and/or colchicine Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis Presence of severe renal function impairment Use of specified pain relief medications or biologics (corticosteroids, narcotics, paracetamol/acetominophen, ibuprofen, colchicine, IL-blocker, and tumor necrosis factor inhibitor within specified periods prior to study entry Live vaccinations within 3 months prior to randomization Requirement for administration of antibiotics against latent tuberculosis (TB) Refractory heart failure (Stage D) Unstable cardiac arrhythmias or unstable symptomatic coronary ischemia Any active or recurrent bacterial, fungal, or viral infection Extension Study 1 Completion of the Core study. A patient was defined as completing the core study if they completed the study up to and including visit 7 Continuation in this extension study was considered inappropriate by the treating physician. Extension Study 2 | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 hydrochloride IV over 30 minutes on days 1, 8, and 15 of a 28-day course at a dose of 1,000 to 1,200 mg/m² for a total of four courses Pegylated liposomal doxorubicin hydrochloride IV over 1 hour on days 1 and 15 of a 28-day course at a dose of 20 mg/m² for a total of four courses NOTE: *These recommended regimens can be altered according to local institutional policies. In case of drug intolerance, the study regimen can be switched from one regimen to the other. NOTE: **Local low-dose/energy-ionizing radiation therapy allowed as part of the debulking process to treat lesions that do not respond after 3 courses of debulking chemotherapy Sézary cell burden must be decreased by at least 50% after debulking in patients with Sézary syndrome Disease not appropriate for skin-directed therapy per local institution standards No disease progression between registration and randomization No CNS involvement WHO performance status 0-2 | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 intolerance or hypersensibility to any of the active components Active infection Unmeasurable levels of TMPT Pregnancy Presence of a severe flare that requires other immunosuppressive treatment for its control Any Psychiatric or social condition that did not ensure the patient´s follow-up and patient´s collaboration Previous treatment with EC-MPS or Azathioprine in the last 2 months Previous treatment with biological therapy in the last 3 months for anti-TNF therapy or in the last year for anti-CD20 therapy ALT or GPT >120 UI/mL non-lupus related in the last 30 days | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 resistant to both a taxane and an anthracycline-containing chemotherapy regimen, or resistant to taxanes and for whom further anthracycline therapy is not indicated Patients with controlled brain metastases must have finished receiving radiation therapy and if on corticosteroids, be on a stable or tapering dose of ≤ 10 mg/day of prednisone or equivalent for at least 28 days prior to study entry Measurable disease Female 18 years of age or older Performance status less than or equal to 2 Life expectancy of more than 3 months Blood, liver and kidney laboratory test results that meet protocol requirements Patients must have a negative serum pregnancy test within 14 days before enrollment and agree to use medically acceptable and effective birth control from enrollment until at least 30 days after the last dose of pralatrexate. Patients who are postmenopausal for at least 1 year (more than 12 months since last menses) or are surgically sterilized do not require this test Patients with only bone metastasis Patients with a single metastatic site without histological proof that the lesion is metastatic breast cancer Patients with inflammatory breast cancer Treatment with systemic chemotherapy, hormone therapy, radiation therapy, or other investigational therapy within 3 weeks (6 weeks for nitrosoureas, mitomycin C) prior to enrollment, except for the following Bisphosphonates, if ongoing Prior treatment with methotrexate Prior treatment with anti-angiogenics within 6 months prior to enrollment Have received more than 2 prior chemotherapy regimens (more than 3 if one of the treatments was neoadjuvant or adjuvant chemotherapy) Have previously received pralatrexate Have received more than the allowed maximum total dose of anthracycline | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 living with his/her family of origin immediately preceding the inpatient stay and would return to live with his/her family after discharge; and The patient and at least one family member were willing to participate Patient on conservatorship or legal guardian status | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 elapsed time Significant signs and symptoms of currently active allergic disease (SAR, perennial allergic rhinitis, episodic allergic rhinitis) Upper respiratory tract infection, sinusitis, asthma or flu-like symptoms within 2 weeks prior to visit 1 Subjects who have dermatographism or other skin conditions which might interfere with the interpretation of the skin test results Subjects who are receiving escalating doses of immunotherapy, oral immunotherapy or short course (rush) immunotherapy Known hypersensitivity to the investigational product or to drugs with similar chemical properties Pregnancy and/or breast feeding Use of antihistamines, steroids, or other drugs which may affect the skin-response Use of any medications or agents that are not specified above that may confound the interpretation of the results | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 vitamin D replacement or supplementation History of having been treated with antimycobacterial therapy for < 6 months or with < 4 first-line anti-tuberculous drugs Extra pulmonary TB Immune suppressed; with HIV infection, hepatic, renal failure, malignancy, diabetes mellitus Sarcoidosis, hyperparathyroidism Already on or requiring corticosteroids, immunosuppressive agents, thiazide diuretics Breast feeding or pregnant Symptomatic cardiac disease Seriously ill or moribund patients with advanced respiratory impairment (cor pulmonale, hypercapnia, respiratory acidosis, congestive cardiac failure) Allergy/sensitivity to study drugs or their formulations | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 trial. 4. Willingness to refrain from the use of self-administered supplements during the trial Serum 25(OH)D levels ≤ 20 nmol/L or ≥ 65 nmol/L. 2. BMD total hip below 5 standard deviation (using III adult young white men and women as the point of reference) or history of osteoporotic fracture. 3. Moderate to severe fracture in one or more vertebrae by Instant Vertebral Assessment on DXA. 4. Treatment with HRT, SERMS, calcitonin, PTH, androgens, bisphosphonates, phosphate or anabolic steroids during 6 months prior to entry. 5. Use of systemic corticosteroids (oral or IV) within the last year at an average dose of greater than 5 mg per day of oral prednisone or equivalent for a period of three months or more prior to screening. 6. Hypercalcemia (serum calcium > 10.6 mg (dl) or history of primary hyperparathyroidism. 7. History of chronic liver disease, chronic renal insufficiency, Parkinson's, metabolic bone disease, hematologic tumors, rheumatologic disease requiring steroids, malabsorption or new diagnosis or active treat-ment of cancer 12 months prior to inclusion. 8. Use of medications that influence bone metabolism (e.g. anticonvulsants). 9. Significant deviation from normal in either: history, physical examination or laboratory tests as evaluated by the Principle Investigator. Participants with a history of hypercalciuria, nephrolithiasis and active sarcoidosis will also be excluded. 10. Participation in another investigational trial 30 days prior to screening. 11. Spinal disease that affects interpretation of bone densitometry like scoliosis with a Cobb angle greater than 15o, history of surgery at lumbosacral spine. 12. Bilateral hip replacement. 13. Currently smoking more than 10 cigarettes daily. 14. Body width on DXA > 25 cm. 15. Patients who are deemed unsafe to perform muscular function testing as evaluated by the investigator. --------- Study participants should live close to the study site, as this study requires multiple visits over a four year period | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 Must report race /ethnicity as African American or Hispanic or live in a low-SES block group (a census block group with a median income of < $65,000) Must speak English or Spanish Hearing impaired patients who cannot use the telephone | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 patients assigned to PC PCPs from clinics/departments other than General Internal Medicine or Family Medicine will be excluded from the analysis | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 Myeloblastic Leukemia Without Maturation (M1) Adult Acute Myeloid Leukemia in Remission Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Del(5q) Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With T(15;17)(q22;q12) Adult Acute Myeloid Leukemia With T(16;16)(p13;q22) Adult Acute Myeloid Leukemia With T(8;21)(q22;q22) Adult Acute Myelomonocytic Leukemia (M4) Adult Acute Promyelocytic Leukemia (M3) Adult Erythroleukemia (M6a) Adult Nasal Type Extranodal NK/T-cell Lymphoma Adult Pure Erythroid Leukemia (M6b) Anaplastic Large Cell Lymphoma Angioimmunoblastic T-cell Lymphoma Burkitt Lymphoma Childhood Acute Erythroleukemia (M6) Childhood Acute Lymphoblastic Leukemia in Remission Childhood Acute Megakaryocytic Leukemia (M7) Childhood Acute Monoblastic Leukemia (M5a) Childhood Acute Monocytic Leukemia (M5b) Childhood Acute Myeloblastic Leukemia With Maturation (M2) Childhood Acute Myeloblastic Leukemia Without Maturation (M1) Childhood Acute Myeloid Leukemia in Remission Childhood Acute Myelomonocytic Leukemia (M4) Childhood Acute Promyelocytic Leukemia (M3) Childhood Chronic Myelogenous Leukemia Childhood Myelodysplastic Syndromes Chronic Phase Chronic Myelogenous Leukemia Cutaneous B-cell Non-Hodgkin Lymphoma De Novo Myelodysplastic Syndromes Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Hepatosplenic T-cell Lymphoma Intraocular Lymphoma Nodal Marginal Zone B-cell Lymphoma Peripheral T-Cell Lymphoma Post-transplant Lymphoproliferative Disorder Previously Treated Myelodysplastic Syndromes Recurrent Adult Acute Lymphoblastic Leukemia Recurrent Adult Acute Myeloid Leukemia Recurrent Adult Burkitt Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Adult Diffuse Mixed Cell Lymphoma Recurrent Adult Diffuse Small Cleaved Cell Lymphoma Recurrent Adult Grade III Lymphomatoid Granulomatosis Recurrent Adult Hodgkin Lymphoma Recurrent Adult Immunoblastic Large Cell Lymphoma Recurrent Adult Lymphoblastic Lymphoma Recurrent Adult Non-Hodgkin Lymphoma Recurrent Adult T-cell Leukemia/Lymphoma Recurrent Childhood Acute Lymphoblastic Leukemia Recurrent Childhood Acute Myeloid Leukemia Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Recurrent Marginal Zone Lymphoma Recurrent Mycosis Fungoides/Sezary Syndrome Recurrent Small Lymphocytic Lymphoma Refractory Multiple Myeloma Relapsing Chronic Myelogenous Leukemia Secondary Myelodysplastic Syndromes Small Intestine Lymphoma Splenic Marginal Zone Lymphoma Testicular Lymphoma Waldenstrom Macroglobulinemia Acute non-lymphocytic leukemia (FAB types M1-M7) in first, or second remission, or early first or second bone or marrow relapse (>31% marrow blasts and no circulating peripheral blasts) All patients with acute promyelocytic leukemia in first complete remission who have received retinoic acid and chemotherapy are not eligible Acute lymphocytic leukemia in first or second remission, or early first or second bone marrow relapse (31% marrow blasts and no circulating peripheral blasts) Pediatric ALL patients in first complete remission are not eligible Chronic myelogenous leukemia in first or second chronic phase, or accelerated phase Myelodysplastic syndrome =< 50 years Lymphoma patients age =< 50 years (non Hodgkins or Hodgkins) in first or second relapse, or refractory disease, who are ineligible for autologous bone marrow transplantation because of tumor in the bone marrow Multiple myeloma patients age =< 50 who have relapsed or are refractory to at least 2 chemo-radiation or chemotherapy regimens Patients who have failed a previous allogeneic bone marrow transplant Patients with inborn errors of metabolism | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 MRI scan Provision of signed, written and dated informed consent History of any clinically significant disease or disorder History or presence of gastrointestinal, hepatic or renal disease Prolonged QTcF >450 ms or shortened QTcF <340 ms or family history of long QT syndrome History of severe allergy or hypersensitivity or ongoing allergy or hypersensitivity Healthy volunteer suffers from claustrophobia | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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. Oxygen by hood <27% with majority* of saturations ≥ 90% in prior 24 hours A2. Oxygen by hood 27-30% with majority* of saturations ≥ 96% in prior 24 hours B. Infants receiving oxygen by nasal cannula at restΔ B1. Oxygen by nasal cannula <27% oxygen and majority* of saturations ≥90% in prior 24 hours B2. Oxygen by nasal cannula 27-30% oxygen and majority* saturations ≥96% on prior 24 hours C. Infants receiving room air by nasal cannula at ANY liter per minute (lpm) flow Need for mechanical ventilation or continuous positive airway pressure (CPAP) Oxygen by hood >30% Oxygen by nasal cannula >30% effective oxygen | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 visit 8 (week 24) the Cephalon sponsored clinical study with CEP 33457 (study C33457/2047) and, in the investigator's opinion, would benefit from continued participation in a clinical study Women must be surgically sterile, 2 years postmenopausal, or, if of childbearing potential, using a medically accepted method of contraception, and must agree to continued use of this method for the duration of the study and for 30 days after discontinuation of study drug treatment The patient has New York Heart Association (NYHA) Class III or IV congestive heart failure The patient has an estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73 m2 (via Modification of Diet in Renal Disease [MDRD] equation) The patient has an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value greater than 2 times the upper limit of normal (ULN) or a total bilirubin level greater than 1.5 times ULN The patient has a planned immunization with a live or live attenuated vaccine within 3 months prior to administration of the first dose of study drug and for 3 months after administration of the last dose of study drug The patient has any clinically significant abnormalities on ECG that are not related to SLE, as determined by the investigator. Patients with stable ECG changes without evidence of active cardiovascular disease may participate at the discretion of the investigator and medical monitor The patient has an ongoing active systemic infection requiring treatment or a history of severe infection, such as hepatitis or pneumonia, in the 3 months prior to administration of the first dose of study drug. Less severe infections in the 3 months prior to administration of the first dose of study drug are permitted at the discretion of the investigator and medical monitor The patient has any concomitant medical condition unrelated to SLE that may interfere with his or her safety or with evaluation of the study drug, as determined by the investigator The patient has a history of a positive test result for hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab) The patient has a known positive history of antibodies to human immunodeficiency virus (HIV) or HIV disease The patient has a history of alcohol or substance dependence or abuse (with the exception of nicotine), according to the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association, Fourth Edition, Text Revision (DSM-IV-TR), within 3 months of the screening visit for study C33457/2047, or has current substance abuse | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 least 3 anaphylactic shocks or syncops requiring either use of adrenaline or medical assistance Cutaneous Mastocytosis (CM) 2. Skin biopsy-documented mastocytosis and evaluable disease based upon Histological typical infiltrates of mast cells in a multifocal or diffuse pattern in skin biopsy Clinical typical skin lesions (maculopapular, urticaria pigmentosa, mastocytoma) 3. Missing data (c-kit molecular analysis not done) or documented presence of an activating point mutation in the phosphotransferase domain of c-kit such as D816V c-kit mutation in at least one infiltrated organ (bone marrow or skin) 4. Refractory to at least one of the symptomatic treatments such as Anti H1 Anti H2 Patients with one of the following mastocytosis Systemic Mastocytosis with an Associated clonal Hematologic Non Mast cell lineage Disease (SM-AHNMD) Mast cell leukemia (MCL) Aggressive systemic mastocytosis (ASM) 2. Patient with a major surgery within 2 weeks prior to study entry 3. No vulnerable population will be included in this study Life expectancy < 6 months Patient is < 5 years free of malignancy, except treated basal cell skin cancer or cervical carcinoma in situ Patient with grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study) Patient has a severe and/or uncontrolled medical disease Patient has a known diagnosis of human immunodeficiency virus (HIV) infection | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 of HCC plus Alpha Fetoprotein (AFP) > 400ng/ml will be considered diagnostic of HCC Measurable Disease: Patients must have measurable disease. Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥20 mm with conventional techniques (PET, CT, MRI, x-ray) or as ≥10 mm with spiral CT scan. All tumor measurements must be recorded in millimeters (or decimal fractions of centimeters). A positive bone scan, osteoblastic metastases, and pleural or peritoneal effusions are not considered measurable. Patients with only these lesions are not eligible for entry to the study Prior Therapy: Patients may or may not have received prior systemic therapy in the metastatic setting. No prior treatment with an mTOR inhibitor or with doxorubicin is permitted. Participants must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study. No chemotherapy or radiotherapy may be given within 4 weeks prior to the start of protocol treatment Age: Patients must be ≥18 years old. Because no dosing or toxicity data are currently available on the use of temsirolimus in combination with pegylated liposomal doxorubicin in patients <18 years of age, children are excluded from this study Performance Status: ECOG 0-2 at study entry Life Expectancy: Patients must have a life expectancy of greater than 12 weeks. Required Laboratory Values absolute neutrophil count ≥1,500/mm3 platelets ≥100,000/mm3 hemoglobin ≥9.0 g/dL total bilirubin ≤1.5 x ULN | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 predispose to pediatric CD, Limbergen, JV. Annu. Rev. Genom. Human Genet. 2009; 10:89-116) that has failed therapy with prednisone, 5 ASA products and has failed an anti-TNF therapy. Failure is defined as a CDAI (appendix A) 250-400 or a Craig Severity Score that is > 17 (appendix C). B)Relapse after an autologous HSCT with a CDAI (appendix A) 250-400 or a Craig Severity Score that is > 17 (appendix C) HIV positive. 2. History of coronary artery disease, or congestive heart failure. 3. Uncontrolled diabetes mellitus or any other illness that in the opinion of the investigators would jeopardize the ability of the patient to tolerate aggressive chemotherapy. 4. Prior history of malignancy except localized basal cell or squamous skin cancer. Other malignancies for which the patient is judged to be cured by local surgical therapy, such as head and neck cancer, or stage I breast cancer will be considered on an individual basis 5. Positive pregnancy test, lactation, inability or unwillingness to pursue effective means of birth control, failure to accept or comprehend irreversible sterility as a side effect of therapy. 6. Psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible. 7. FEV 1/FVC < 50% of predicted, DLCO < 50% of predicted. 8. Resting LVEF < 50%. 9. Bilirubin > 2.0 mg/dl, transferase (AST) > 2x upper limit of normal, unless the abnormalities are secondary to Crohn's disease. 10. Serum creatinine > 2.0 mg/dl. 11. Platelet count less than 100,000/ul, ANC less than 1500/ul. 12. Patients presenting with intestinal perforation or toxic megacolon, or a suppurative problem that will require urgent surgery. In addition, the patient may not have any active infection. The presence of intestinal stomas does not the patient from study. 13. Pre-study peripheral blood counts must a platelet count greater than 100,000/ul and an absolute neutrophil count greater than 1500/ul. 14. Creatinine clearance more than 20% below lower limit of normal for age and sex. 15. Short gut syndrome. Donor 1. Donor must be an HLA 6 out of 6 matched sibling of HLA matched sibling donor 1. Physiologic age > 50 years old or <18 years old 2. HIV positive 3. Active ischemic heart disease or heart failure 4. Acute or chronic active hepatitis 5. Uncontrolled diabetes mellitus or any other illness that in the opinion of the investigators would jeopardize the ability of the donor to tolerate stem cell collection 6. Prior history of malignancy except localized basal cell or squamous skin cancer. Other malignancies for which the patient is judged to be cured by local surgical therapy, such as (but not limited to) head and neck cancer, or stage I or II breast cancer will be considered on an individual basis. 7. Positive pregnancy test 8. Psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible 9. Major hematological abnormalities such as platelet count less than 100,000/ul, ANC less than 1000/ul 10. Donor has history of Crohn's or ulcerative colitis | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 (total bilirubin ≥ 2.0 mg/dl, AST or ALT > 3 x upper limit of normal) Impaired renal function (≥ 2.0 mg/dL) Grade III-IV cytopenias not related to mastocytosis Severe cardiopathy (grade III/IV of NYHA, or left ventricular ejection fraction < 50%) Pregnancy or breastfeeding Female patients who do not use contraceptive methods | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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/L). 3. Patients who have a history of > or = 3 febrile acute HIDS flares in a 6-month period when not receiving prophylaxis treatment (e.g. anakinra daily treatment) with a duration of each flare lasting > or = 4 days and limiting the normal daily activities Pregnant or nursing (lactating) women. 2. History of being immunocompromised, including a positive HIV at screening (ELISA and Western blot) test result. 3. Positive Hepatitis B or Hepatitis C. 4. Live vaccinations within 3 months prior to the start of the trial 5. Positive tuberculosis screening test. Other protocol-defined inclusion/ | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 or partial remission) after a course of 8 weeks of 1.0 mg/kg/d prednisone or equal dose of steroid therapy 2. Steroid dependent: recurrence of nephrotic proteinuria during tapering of prednisone at a dose > 10 mg/day or within the first 2 weeks after withdrawal of prednisone 3. Frequently recurrence: initial remission with steroid induction therapy, but relapsed 2 or more in 6 months or 3 or more within 12 months 4. Failure to respond (either complete or partial remission) even after CTX, MMF or CsA therapy combined with steroid eGFR ≥ 60 ml/min/1.73 m2 Provision of written informed consent by subject or guardian Systemic disease eGFR < 60ml/min/1.73m2 Diagnosed DM Malignant tumors (except fully cured basal cell carcinoma) Familial nephritic syndrome History of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease) within 3 month prior to enter this study Any Active systemic infection or history of serious infection within one month of entry or known infection with HIV, hepatitis B, or hepatitis C Known hypersensitivity or contraindication to tacrolimus, corticosteroids Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening Pregnancy, nursing or use of a non-reliable method of contraception | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 the following:Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), or Alanine Aminotransferase ALT) and/or Bilirubin > 2 mg/dl in the absence of biliary obstruction 5. Able to provide informed written consent Hypertriglyceridemia (triglycerides [TG] > 400) 2. Allergy to fish or egg protein 3. Currently on therapeutic doses of Coumadin, heparin, or low molecular eight heparin 4. Hemodynamically unstable 5. Bilirubin > 5 mg/dL 6. Documented liver metastases 7. Unstable diabetes with known diabetic ketoacidosis within 7 days of screening 8. Recent cardiac infarction (within 6 months) and taking plavix 9. Severe hemorrhagic disorders 10. Current anticoagulation therapy for deep venous thromboembolism or pulmonary embolism 11. Active sepsis 12. Undefined coma status 13. In patients with abnormal kidney function, renal insufficiency with calculated creatinine clearance < 30 mL/min 14. Pregnancy or lactation | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 years Patients with serious infections Patients with active tuberculosis or undergoing anti-TB therapy Patients currently treated with systemic immunosuppressive agents Female patients who are pregnant or breast feeding;Contraception must be performed by a save reliable and accept method such as oral or implanted contraceptives, intravaginal or male preservatives or permanent methods such as tubal ligation Patients with known positivity for human immunodeficiency virus (HIV). HIV screening will be performed by an HIV 1/2 Antibody-detection test. Note: Specific immunotherapy for insect sting allergy is no | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 operationally feasible (in practice, this excluded a handful very small, isolated clusters that would have presented extraordinary logistical challenges) Is home to women who primarily deliver at one of our four staffed birth facilities (in practice this excluded one village on the edge of the study area, in which women travel to another district for deliveries). A woman will be eligible to participate in the study if she Is in the first or second trimester of pregnancy (gestational age ≤ 24 weeks gestation; this is to ensure that the intervention is actually delivered prior to 27 weeks) Is carrying a live singleton fetus (twins will be excluded) Is the primary cook in her household or compound; and Is a non-smoker | 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 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | 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 specimens for further study (Patients would be excluded if they have only limited amount of clinical specimens, which should all be sent for clinical analysis.) 3. Consent is obtained from the patient Patients will be excluded if they couldn't sign the consent. Otherwise, no specific were considered | 0 |
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