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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, Recurrent Mantle Cell Lymphoma Patients must have histologically or cytologically confirmed mantle cell lymphoma as defined by the World Health Organization; all patients must have either t(11;14) by karyotype or fluorescent in-situ hybridization (FISH) or positive immunohistochemistry for cyclin D1 Subjects must have measurable disease defined as at least one tumor lesion of at least 1.5 cm or a peripheral blood cluster of differentiation (CD)5+, CD19+ lymphocyte count of at least 5,000 cells/uL Subjects must have received at least one prior treatment regimen Subjects that have received a prior Bruton's agammaglobulinemia tyrosine kinase (BTK) inhibitor or cyclin-dependent kinases 4 and 6 (CDK4/6) inhibition are ineligible Subjects that have undergone prior allogeneic stem cell transplantation will only be eligible if the transplant occurred at least 1 year prior to study entry, the patient is no longer taking any immunosuppressive therapy, and there are no significant ongoing transplant-related adverse effects Subjects must not have received chemotherapy =< 21 days prior to first administration of study treatment, monoclonal antibody =< 6 weeks prior to first administration of study treatment, and/or radiotherapy or other investigational agents =< 4 weeks prior to first administration study treatment unless the subjects' tumor has progressed on the previous therapy and the investigator believes that the patient should not postpone further therapy and, all treatment-related toxicities have resolved to Common Terminology for Adverse Events (CTCAE) version (v) 5 =< grade 1; subjects may be receiving equivalent to prednisone at a maximum dose of 20 mg/day orally Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%) Patients must have normal organ and marrow function, independent of transfusion or growth factor support within 14 days before enrollment; patients should not receive growth factors or transfusions for at least 7 days prior to the first dose of study drug, with the exception of pegylated GCSF (pegfilgrastim) and darbepoetin, which require at least 14 days prior to screening and enrollment Absolute neutrophil count (ANC) >= 750 cells/uL (within 14 days before enrollment) Platelets >= 50,000 cells/uL (within 14 days before enrollment) Subjects with known or suspected central nervous system (CNS) involvement are not eligible Subjects with serologic status reflecting active viral hepatitis B or C infection are not eligible; subjects that are positive for hepatitis B core antibody positive hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR-positive patients will be excluded.) Subjects with uncontrolled human immunodeficiency virus (HIV) are not eligible; controlled HIV is defined as a CD4 count > institutional lower limit of normal and no current co-infection; uncontrolled HIV is all other HIV infection; note that patients with controlled infection should be allowed to participate only if they are not receiving prohibited cytochrome P450 (CYP) interactive medications Subjects unable to swallow capsules or with disease significantly affecting gastrointestinal function and/or inhibiting small intestine absorption, such as malabsorption syndrome, resection of the stomach or small bowel, partial or complete bowel obstruction, or symptomatic inflammatory bowel disease are not eligible Subjects with uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements are not eligible; recent infections requiring systemic treatment need to have completed therapy > 14 days before the first dose of the study drugs Subjects with uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura (ITP) resulting in declining platelet or hemoglobin levels within the 4 weeks prior to first dose of study drug are not eligible Patients with transfusion-dependent thrombocytopenia are not eligible Subjects with acute coronary syndrome within 6 months prior to enrollment or has New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities are not eligible; prior to study entry, any electrocardiogram (ECG) abnormality at screening has to be documented by the investigator as not medically relevant Subjects with a history of stroke or intracranial hemorrhage within 6 months prior to enrollment are not eligible Subjects with a history of malignancy are not eligible with the exception of the following | 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 Ureter Carcinoma Metastatic Urethral Carcinoma Stage III Bladder Urothelial Carcinoma AJCC v6 and v7 Stage III Ureter Cancer AJCC v7 Stage III Urethral Cancer AJCC v7 Stage IV Bladder Urothelial Carcinoma AJCC v7 Stage IV Ureter Cancer AJCC v7 Stage IV Urethral Cancer AJCC v7 Ureter Urothelial Carcinoma Urethral Urothelial Carcinoma Patients must have locally advanced or metastatic predominantly urothelial carcinoma of the bladder, ureter, or urethra that is not amenable to curative surgical treatment Patients must have histologically confirmed predominantly urothelial carcinoma of the bladder, ureter, or urethra Patients must have measurable disease per Response Evaluation in Solid Tumors (RECIST) defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam Patients must be ineligible for treatment with cisplatin, based on one of Calculated creatinine clearance (CrCl) >= 30 and < 60 mL/min (Cockcroft-Gault) CTCAE grade (Gr) >= 2 hearing loss CTCAE Gr >= 2 neuropathy Patients must not have received prior systemic therapy for their advanced cancer; prior intravesical therapy completed 4 weeks prior to enrollment and adjuvant/neoadjuvant chemotherapy completed more than 6 months prior to diagnosis of advanced disease are permitted Zubrod performance status =< 2 (Karnofsky >= 60%) Life expectancy of greater than 3 months Patients with a small cell component in their histology are excluded Patients who have had chemotherapy for the treatment of the advanced or unresectable urothelial cancer of the bladder are not eligible; patients who were previously treated for local disease must not have received radiotherapy or chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study and must have recovered from adverse events due to agents administered more than 4 weeks earlier; patients who have received neoadjuvant or adjuvant chemotherapy must have completed treatment at least 6 months prior to diagnosis of metastatic disease Patients who are receiving any other investigational agents Patients with known brain metastases should be excluded from this clinical trial History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine and eribulin Uncontrolled intercurrent illness including, but not limited to, a second cancer diagnosis within the past 5 years, or a cancer undergoing any treatment, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with eribulin and gemcitabine Human immunodeficiency virus (HIV)-positive patients with inadequate cluster of differentiation (CD)4 counts or those who are on combination antiretroviral therapy with strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) effects are ineligible for this trial Patients with baseline corrected QT (QTc) prolongation greater than grade 1 are excluded from this study; patients with grade 1 QTc elevation are eligible but must be monitored with electrocardiogram (ECG) (EKG) exams, for the first 3 cycles of treatment; eribulin time to maximum concentration (Cmax) after infusion is about 10 minutes, and half life is 40 minutes; ECG (EKG) should be performed between 10 to 40 minutes after eribulin administration (on day 1 and day 8 of treatment); continued ECG (EKG) monitoring beyond cycle 3 can be done at the discretion of the treating physician Patients with congenital long QT syndrome are excluded from this 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, Metastatic Pancreatic Adenocarcinoma Stage III Pancreatic Cancer AJCC v6 and v7 Stage IV Pancreatic Cancer AJCC v6 and v7 Unresectable Pancreatic Carcinoma PHASE I STUDY - ARM A (DOSE LEVEL 1) AND ARM B (DOSE LEVEL 2) Patients must have histologically or cytologically confirmed metastatic or unresectable locally advanced adenocarcinoma of the pancreas with no prior systemic therapy for metastatic or locally advanced disease Previous neo-adjuvant or adjuvant treatment is allowed provided that it was given >= 6 months prior to registration Patients must NOT be receiving any other investigational agents concurrently and must not have received any other investigational agents =< 4 weeks prior to registration Patients must not have a pre-existing > grade 1 motor or sensory neuropathy Patients must NOT have history of allergic reactions attributed to compounds of similar chemical or biologic composition to nab-paclitaxel, gemcitabine or AZD1775 Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Patients must have a life expectancy of >= 12 weeks Patients may have had prior radiotherapy for metastatic disease as long as it was > 4 weeks prior to registration and the patient has recovered from adverse events associated with the 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, Advanced Solid Tumors Relapsed/Refractory Lymphoma Male or female participants 18 years of age or older. 2. Histologically or cytologically confirmed metastatic and/or advanced solid tumors or lymphomas for which standard curative or life-prolonging treatment does not exist or is no longer effective or tolerable. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 4. Female participants who Are post-menopausal for at least 1 year before the screening visit, OR Are surgically sterile, OR If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 30 days after the last dose of study drug, or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant (periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception). 5. Male participants, even if surgically sterilized (ie, status postvasectomy), who Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant (periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception). 6. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care. 7. Suitable venous access for the study-required blood sampling, including pharmacokinetics. 8. Ability to swallow tablets. 9. Participants with biliary obstruction for which a stent had been placed are eligible provided that the stent has been in place for more than 14 days before the first dose of alisertib and liver function has stabilized. 10. Recovered from the reversible effects of prior antineoplastic therapy (ie, ≤ Grade 1 toxicity or baseline). 11. Clinical laboratory values as specified below Absolute neutrophil count (ANC) ≥ 1500/μL and platelet count ≥ 75,000/μL Participants with normal hepatic function: Total bilirubin and alanine aminotransferase (ALT) must be ≤ upper limit of the normal range (ULN) Participants with moderate hepatic impairment: total bilirubin must be > 1.5 to 3 x ULN with any ALT level Participants with severe hepatic impairment: total bilirubin must be > 3 x ULN with any ALT level Participants of North/East Asian ethnicity (ie, Japanese, Chinese, Korean) will be excluded. 2. Recurrent nausea and/or vomiting within 14 days before the first dose of alisertib or known gastrointestinal (GI) abnormality or GI procedure that could interfere with or modify the oral absorption or tolerance of alisertib. Examples but are not limited to, disease-related bowel obstruction, pancreatic insufficiency, use of pancreatic enzymes, a gastric condition (such as severe reflux or active peptic ulcer disease) that requires chronic and uninterrupted use of proton pump inhibitors, partial gastrectomy, history of small intestine surgery, and celiac disease. 3. Participants requiring treatment with clinically significant enzyme inducers, such as the enzyme-inducing anti-epileptic drugs phenytoin, carbamazepine, phenobarbital, oxcarbazepine, primidone, rifampin, rifabutin, rifapentine, or St. John's wort within 14 days before the first dose of alisertib or requiring the use of these medications during the study. 4. A medical condition requiring use of pancreatic enzymes; daily, chronic, or regular use of proton pump inhibitors (PPIs); or histamine 2 (H2) receptor antagonists. Participants who intermittently use these medications, must meet the following No use of PPIs within 5 days before the first dose of alisertib No use of H2 antagonist or pancreatic enzymes within 24 hours before the first dose of alisertib. 5. Inadequate bone marrow or other organ function (excluding hepatic impairment per criteria). 6. Female participants who are lactating and breastfeeding or have a positive serum pregnancy test during the Screening period or a positive urine pregnancy test on Day 1 before first dose of alisertib. 7. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol. 8. Treatment with any anticancer therapy or any investigational products within 3 weeks before the first dose of study drug. 9. Exposure to nitrosoureas or mitomycin C within 42 days before the first dose of study drug. 10. Radiotherapy within 14 days before the first dose of study drug. 11. Prior treatment with radiation therapy involving ≥ 25% of the hematopoietically active bone marrow within 42 days before the first dose of study drug. 12. Major surgery within 14 days before the first dose of study drug. 13. Serious infection within 14 days before the first dose of study drug. Participant must have recovered from infection before first dose. 14. Life-threatening illness unrelated to cancer. 15. Symptomatic brain metastasis. Participants with brain metastases Must have stable neurologic status following local therapy (surgery or radiation) for at least 2 weeks after completion of the definitive therapy AND Must be without neurologic dysfunction that would confound the evaluation of neurologic or other adverse events (AEs). 16. Clinically significant coagulopathy or bleeding disorder. 17. Severe central nervous system, pulmonary, or renal disease not related to the participant's cancer. 18. Known human immunodeficiency virus (HIV) positive. 19. Known history of hepatitis C infection or suspected currently active hepatitis C infection, or known or suspected history of hepatitis B infection. Participants with known or suspected history of hepatitis B infection were to be screened and excluded when any of the following conditions were met Received hematopoietic stem cell transplantation (either allogeneic or autologous), or Received any rituximab-containing treatment regimen in the last 12 months before entering the study, or Tested positive for the presence of at least 1 of the following 3 markers in blood (evaluated at Screening): hepatitis B surface antigen (HBsAg), antibodies against hepatitis B core antigen (anti-HBc), or hepatitis B virus deoxyribonucleic acid (HBV DNA). 20. Any of the following cardiovascular conditions Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure, angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities Corrected QT interval (QTc) > 500 milliseconds in a 12-lead electrocardiogram (ECG) during screening. 21. History of uncontrolled sleep apnea syndrome or other condition that could result in excessive daytime sleepiness, such as severe chronic obstructive pulmonary disease. 22. Use of moderate or strong cytochrome P450 (CYP) 3A inhibitors or CYP3A inducers within 2 weeks before the first dose of study drug | 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, Arrhythmias in Pregnancy Pregnant or postpartum women presenting to Groote Schuur Hospital with cardiovascular disease -Individuals with structural heart disease | 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 Age 18-65 years 2. Diagnosis of severe asthma 3. Confirmed therapy adherence via serum Prednisolone and cortisol levels Mild and moderate asthma 2. Community acquired pneumonia 3. Acute porphyria 4. Pregnant and breast feeding women 5. Patients hypersensitive to ethylenediamine or allergic to the theophyllines, caffeine and/or theorbromine. 6. Patient with known hypersensitivity to components and in systemic fungal infection 7. Patients that are being administered live attenuated vaccines | 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): 0.0-42.0, Infertility Age of women <43 years 2. Normal uterine cavity on saline sonogram 3. Endometrial thickness >=8mm on the day of hCG Planned not to have fresh embryo transfer 2. Cycle cancelled prior to hCG administration 3. Natural cycle IVF 4. Presence of hydrosalpinges on scanning which are not surgically treated 5. Presence of endometrial polyps on scanning 6. Undergoing preimplantation genetic diagnosis | 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, Other Complication of Kidney Transplant Renal Transplant Rejection Male and female patients aged over 18 years with no immunological risk (PRA <25% and no DSA) who are receiving their first cadaveric or living kidney transplant. 2. Patients who, three months after the transplantation, are receiving tacrolimus in combination with mycophenolic acid (MPA) or mycophenolate mofetil (MMF) plus steroids, with stable plasma levels of tacrolimus. 3. No clinical or histological immunological dysfunction before randomization 4. No de novo anti-HLA DSA at the time of randomization. 5. Patients who wish to and are able to give written informed consent to participate in the study. 6. For women, agreeing to use efficient contraception during the study Patients who receive a multiorgan transplant. 2. Retransplants. 3. Presence of DSA before the transplant or at the time of randomization. 4. Cold ischemia time >30 hours 5. Patients with serum creatinine >2 mg/dL or proteinuria >1g/day at the time of randomization 6. Prior episode of severe rejection (II-B-III in the Banff/13 classification) prior to randomization. 7. Presence of subclinical rejection on the protocol biopsy prior to randomization 8. Patients with BK-polyomavirus nephropathy at the time of randomization. 9. Patients with recurrent or de novo glomerulonephritis. 10. Patients who are being treated with immunosuppressive drugs other than those in the randomized clinical trial in question. 11. Patients who are positive for the human immunodeficiency virus (HIV) or those who have a severe systemic infection that, in the investigator's judgment, will require continued treatment. 12. Patients with any present or prior (during the previous 5 years) malignant disease, except basal or squamous cell carcinoma that has been excised | 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, Opioid Dependence Age 18-60. 2. Meets DSM-IV for current opiate dependence disorder of at least six months duration, supported by urine toxicology OR COWS score > or =6 OR Naloxone Challenge. 3. Voluntarily seeking treatment for opioid dependence. 4. In otherwise good health based on complete medical history and physical examination. 5. Able to give written informed consent. 6. Failed outpatient induction onto XR-NTX in Protocol #6374 Methadone maintenance treatment or regular use of illicit methadone (> 30 mg per week). 2. Maintenance on, or regular use of, buprenorphine or other long-acting opioid agonists. 3.) Pregnancy, lactation, or failure in a sexually active woman to use adequate contraceptive methods. 4) Active medical illness which might make participation hazardous, such as untreated hypertension, acute hepatitis with AST or ALT > 3 times normal, AIDS, unstable diabetes. 5) Active psychiatric disorder which might interfere with participation or make participation hazardous, including DSM-5 Schizophrenia or any psychotic disorder, severe Major Depressive Disorder, or suicide risk or 1 or more suicide attempts within the past year. 6) Physiologically dependent on alcohol or sedative-hypnotics with impending withdrawal. Other substance use diagnoses are not exclusionary. 7) History of allergic or adverse reaction to buprenorphine, naltrexone, naloxone, clonidine, or clonazepam. 8) Chronic organic mental disorder (e.g. AIDS dementia). 9) History of accidental drug overdose in the last 3 years as defined as an episode of opioid-induced unconsciousness or incapacitation, whether or not medical treatment was sought or received. 10) Painful medical condition that requires ongoing opioid analgesia or anticipated surgery necessitating opioid medications | 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): 5.0-999.0, Food Allergy Signed informed consent For single shot study: history of a hazelnut, walnut, celeriac allergy due to an unequivocal accidental exposure with typical acute allergic reaction within the preceding 2 years and positive allergen-specific skin prick test/specific Immunoglobulin E or recent positive oral food challenge with hazel, walnut or celeriac within previous 2 years in children <16 years, but no time limit specified for adults For matrix comparison study: history of peanut or hazelnut allergy For walnut/PPI study: history of walnut allergy. The minimum age for this study is 18 years Severe disease (heart, liver, kidney), acute febrile infection Intake of Ketotifen (past 2 weeks), corticosteroids (past 2 weeks), histamine-1-receptor blocker (past 3 days apart first generation past 7 days) Anaphylactic reaction (past 4 weeks) Uncontrolled bronchial asthma, forced expiratory volume < 70% predicted Pregnancy Acute infection or allergy Uncontrolled atopic dermatitis Chronic urticaria Mastocytosis Uncontrolled hypertension | 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, Acromegaly Neuroendocrine Tumors Acromegaly Male or female patients ≥18 years of age Acromegaly currently treated with Sandostatin LAR NET Male or female patients ≥18 years of age Functional, well-differentiated (Grade 1 or Grade 2) NET with symptoms of carcinoid syndrome (number of bowel movements and/or flushing) Currently treated with Sandostatin LAR for symptom control Acromegaly Inadequate bone marrow function Abnormal coagulation or chronic treatment with warfarin or coumarin derivates Impaired liver, cardiac and/or renal function Known gallbladder, bile duct disease or pancreatitis Diabetes with poorly controlled blood glucose levels despite adequate therapy Hypothyroidisms not adequately treated NET Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, pancreatic islet cell carcinoma, insulinoma, glucagonoma, gastrinoma, goblet cell carcinoid, typical and atypical lung carcinoids, large cell neuroendocrine carcinoma and small cell carcinoma Carcinoid syndrome refractory to treatment with conventional doses of somatostatin analogues (SSAs) Inadequate bone marrow function | 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, Rosacea The subject is a male or female, who is at least 18 years of age or older at Screening visit. 2. The subject has a clinical diagnosis of mild to moderate erythemato-telangiectatic rosacea or mild to moderate papulo-pustular rosacea according to the National Rosacea Society grading (Wilkin et al., 2004) 3. The subject had at least five flushing episodes during the last week before Screening and Baseline visits The subject has particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin), or other concomitant facial dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus or actinic telangiectasia; 2. The subject has current treatment with monoamine oxidase inhibitors, barbiturates, opiates, sedatives, systemic anesthetics, or alpha-agonists; 3. The subject has less than 3 months stable dose treatment with tricyclic anti-depressants, cardiac glycosides, beta blockers or other antihypertensive agents | 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, Macular Disease Patients who visit Department of Ophthalmology, Kagawa University Hospital with macular diseases, such as AMD, PCV, RAP, RVO, DME, ERM, MH, VMTS Patients who are agreed with the participation of this study 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): 18.0-80.0, Crohn Disease Subject has provided informed consent. 2. Male or female subjects, 18 to 80 years of age, inclusive. 3. Prior diagnosis of CD confirmed by endoscopy or imaging for > 3 months prior to enrollment with active disease, defined as a Crohn's Disease Activity Index (CDAI) score >220 to <450 and at least one of either: fecal calprotectin >250 ug/g feces, or CRP >8 mg/L. 4. Patients will have evidence of ileocolonic, colonic, or ileal disease that is visualized either endoscopically or on MRI within the prior 6 months. 5. Patients must carry at least one G allele at rs2062305. 6. Patients will be eligible for the study if they are receiving any of the following mesalamine for >8 weeks with the dose remaining stable for 4 weeks prior to screening a maximum of 20 mg of prednisone per day (or steroid equivalent), with the dose remaining stable for 2 weeks prior to screening. Steroids must be held stable for the first 4 weeks of the study and then must be tapered by 5 mg per week, to be discontinued entirely by week 8 mercaptopurine, methotrexate or azathioprine for ≥3 months, with the dose remaining stable for 8 weeks prior to screening Monoclonal antibody or experimental agent use within 12 weeks before screening. 2. Use of non-approved drugs for CD. 3. Anticipated need for surgery within 12 weeks 4. Active sepsis, or use of antibiotics within two weeks prior to screening for the treatment of infection. 5. Pregnant, lactating or planning to become pregnant during the study 6. Inability to reliably use birth control for men and women during the course of therapy. 7. Known allergy to Denosumab or ingredients in formulation 8. Treatment of cancer within the last 5 years (except for non-melanoma skin cancers). 9. Recent jaw infection, invasive dental procedures (tooth extraction, dental implants or surgery), anti-angiogenic medications, or hypocalcemia within 1 month prior to screening. 10. Patients will also be excluded if they meet any of the following Proctocolectomy or total colectomy; stoma; a history of allergy to murine proteins; or treatment with parenteral corticosteroids or corticotropin within four weeks before screening. Serum Hg < 80 g/L, liver enzymes ≥ 2-fold elevated, or other serum biochemistry considered unsafe, or requiring treatment, in the opinion of the investigator | 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, Atrial Fibrillation ≥ 18 years of age Patients of African, European, and Hispanic descent History of typical or early-onset symptomatic (≥2 episodes/month) paroxysmal/persistent AF ECG that was recorded within 1 month of randomization showing AF Eligible for both Flecainide(Class I) and Sotalol (Class III) AAD Able to give informed consent Permanent AF or isolated atrial flutter Cardiac or thoracic surgery within the previous 6 months Previous use of amiodarone other than short-term use (e.g. for an acute arrhythmia in hospital) Medical condition that is likely to be fatal in less than one year A history of prior AF ablation Have already been tried on 2 or more AADs in the past for AF Creatinine clearance <40 ml/min Left ventricular ejection fraction < 50% Contra-indication to a Class I AAD e.g., structural heart disease, or history of MI Contra-indication to a Class III AAD, e.g., congenital or acquired long QT syndrome with QTc>480 ms in females and >460 ms in males at baseline | 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): 18.0-35.0, Sleep Pregnancy Stillbirth Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Very Low Birth Weight Fetal Growth Retardation Fetal Hypoxia ≥18 years old low-risk singleton pregnancy entering the last trimester of pregnancy (in range 26-30 weeks of gestation) residing in the Greater Accra Metropolitan Area or area served by the Korle Bu Teaching Hospital fluent in either English, Twi, or Ga BMI ≥ 35 at booking (first antenatal appointment for current pregnancy) pregnancy complicated by obstetric complications (hypertension [pre-eclampsia, gestational hypertension, chronic hypertension], diabetes [gestational or not], or intra-uterine growth restriction [<10th %ile for growth]) sleep complicated by medical conditions (known to get <4 hours of sleep per night due to insomnia, or musculoskeletal disorder that prevents sleeping on a certain side [e.g., arthritic shoulder]) multiple pregnancy known fetal abnormality maternal age >35 | 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, Aggressive Systemic Mastocytosis (ASM) SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) Mast Cell Leukemia (MCL) Smoldering Systemic Mastocytosis (SSM) Indolent Systemic Mastocytosis (ISM) ISM Subgroup Fully Recruited Documented diagnosis of one of the following conditions based upon World Health Organization (WHO) diagnostic aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated clonal hematologic non-mast cell lineage disease (SM-AHNMD), mast cell leukemia (MCL), smoldering systemic mastocytosis (SSM), indolent systemic mastocytosis (ISM) Diagnosis confirmed by bone marrow biopsy Fluency in English Willingness and ability to participate in a one-hour interview A condition or situation that would interfere with participation in an interview (e.g., cognitive impairment or disorder, alcohol or drug abuse) Known human immunodeficiency virus or acquired immunodeficiency syndrome-related illness Any other prior malignancy except for the following: Adequately treated basal cell or squamous cell skin cancer; In situ cervical cancer; Adequately treated Stage I or II cancer from which the subject is currently in complete remission, or other cancer from which the subject has been disease-free for 2 years | 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, Aggressive Systemic Mastocytosis Mast Cell Leukemia Systemic Mastocytosis Diagnosis of systemic mastocytosis per 2008 World Health Organization (WHO) criteria. Those with advanced systemic mastocytosis (ASM); mast cell leukemia (MCL); or systemic mastocytosis-associated hematological clonal non-mast cell lineage disease (SM-AHNMD) required to have at least 1 organ damage finding Serum aspartate transaminase (AST) or alanine transaminase (ALT) ≤ 3.0 x upper limit of normal (ULN); if considered related to ASM/MCL ≤ 5 x ULN Estimated creatinine clearance ≥ 30 mL/min (Cockcroft-Gault) Total bilirubin ≤ 1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin); if considered related to ASM/MCL ≤ 3 x ULN Female subjects must be of non-reproductive potential, or if of childbearing potential must have a negative serum pregnancy test upon study entry Must agree to use highly effective methods of birth control Written informed consent Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3 Life expectancy > 12 weeks Received any investigational agent, chemotherapy, interferon-alpha, or 2-chlorodeoxyadenosine (2-CdA, cladribine) within 30 days prior to day 1; or monoclonal antibody ≤ 6 weeks prior to first administration of study treatment (patients with an AHNMD with progressive leukocytosis who require control of their counts are permitted to receive hydroxyurea) Diagnosis of AHNMD requiring immediate cytoreductive therapy or targeted drugs (eg, acute myeloid leukemia [AML]) History of other malignancies, except Malignancy treated with curative intent and with no known active disease present for ≥ 3 years before the first dose of study drug, and at low risk for recurrence Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease Adequately treated carcinoma in situ without evidence of disease Concurrent systemic immunosuppressant therapy (eg, cyclosporine A, tacrolimus, etc., or chronic administration [> 14 days] of > 10 mg/day of prednisone) within 28 days of the first dose of study drug Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug Systemic treatment for infection completed ≤ 14 days before the first dose of study drug Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to Common Terminology for Adverse Event (CTCAE, version 4), grade 0 or 1, or to the levels dictated in the inclusion/ | 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, Recurrent Lung Squamous Cell Carcinoma Stage IV Lung Squamous Cell Carcinoma AJCC v7 Patients must have histologically or cytologically confirmed stage IV or recurrent squamous cell lung cancer or KRAS mutant lung cancer that harbors any of the NFE2L2 mutations or KEAP1 mutations; any KEAP1 mutation will be eligible Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) with conventional techniques or as >= 10 mm (>= 1 cm) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam Patients must have completed at least 1 prior line of systemic therapy; patients who have declined first line therapy or for whom first-line therapy would be clinically inappropriate, will be considered eligible for the trial Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%) Life expectancy of greater than 3 months Leukocytes >= 3,000/mcL Absolute neutrophil count >= 1,500/mcL Platelets >= 100,000/mcL Total bilirubin within normal institutional limits Fasting serum glucose =< 130 mg/dL or hemoglobin A1C (HBA1C) < 7.0% Patients who have had chemotherapy or radiotherapy within 2 weeks prior to the planned start of study treatment or those who have not recovered to baseline or less than grade 2 from adverse events from prior treatments Patients who are receiving any other investigational agents Patients with untreated central nervous system (CNS) metastases; patients with treated CNS metastases who are off steroids are eligible History of allergic reactions attributed to compounds of similar chemical or biologic composition to MLN0128 (TAK-228) Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; no ischemic myocardial or cerebrovascular event, class III or IV heart failure, placement of pacemaker, or pulmonary embolism within six months of receiving first dose of MLN0128 (TAK-228) Baseline prolongation of the rate-corrected QT interval (QTc) > 480 milliseconds, or history of congenital long QT syndrome, or torsades de pointes Pregnant women are excluded from this study because MLN0128 (TAK-228) is an mTOR agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with MLN0128 (TAK-228), breastfeeding should be discontinued if the mother is treated with MLN0128 (TAK-228) Patients previously treated with an mammalian TOR (mTOR) or PI3K inhibitor Concomitant administration of any proton pump inhibitor (PPI) is not permitted during the study; patients receiving PPI therapy before enrollment must stop using the PPI for 7 days before their first dose of study drugs Uncontrolled diabetes mellitus (fasting plasma glucose > 130 mg/dL despite optimal medical management of hyperglycemia) | 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 Suspicion of systemic mastocytosis, for whom bone marrow sampling (bone marrow biopsy and/or bone marrow aspiration) is carried out as part of normal workup of the disease in the center of reference and centers of competence in mastocytosis Patient whose written informed consent has been obtained Patients with a contra-indication to marrow sampling (anticoagulant and/or anti-clotting treatments Thrombocytopenia < 50 000/mm2) for whom it is impossible to formally conclude the final type of mast cell disease: SM, CM, mast cell activation syndrome | 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, Lymphoma, Mantle-Cell Histologically confirmed MCL Patients who have previously received treatment with ibrutinib (modified by amendment 1), including Completion of at least 1 cycle of treatment with ibrutinib and confirmed evidence of disease progression or refractoriness to treatment or Discontinuation of ibrutinib treatment at an earlier time due to toxicity Measurable disease according to the Lugano Classification At least 28 days or 5 half-lives, whichever is shorter, from the completion of anti-cancer treatment (including, but not limited to, immunotherapy, chemotherapy, targeted therapy and biologic therapy) to the start of study treatment, excluding ibrutinib where the window may be less and at minimum 3 days (modified by amendment 1) Availability of fresh tumor tissue at screening Male or female patients ≥ 18 years old ECOG (Eastern Cooperative Oncology Group) performance status of ≤ 2 Left ventricular ejection fraction (LVEF) by echocardiogram or multiple gated acquisition (MUGA) scan ≥ the lower limit of normal (LLN) for the Institution Any of the following as the only site(s) of disease: palpable lymph nodes not visible on imaging studies, skin lesions, or bone marrow involvement only Current central nervous system (CNS) involvement by lymphoma New York Heart Association (NYHA) class III or IV heart disease Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months). Myocardial infarction less than 6 months before start of study treatment Uncontrolled arterial hypertension despite optimal medical management (per investigator's assessment) (modified by amendment 1) Type I or II diabetes mellitus with HbA1c > 8.5% at screening (modified by amendment 1) Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before start of study treatment. However, if a patient has recovered to ECOG performance status of ≤ 2 he/she may be enrolled provided that other are met Ongoing or active infection of Common Terminology for Adverse Events (CTCAE) Grade ≥ 3 Known history of human immunodeficiency virus (HIV) infection Acute or chronic hepatitis B (HBV) or hepatitis C (HCV) infection requiring concomitant treatment prohibited by this protocol (i.e.immunosuppressive therapy) | 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 Meet the American College of Rheumatology for the diagnosis of SLE，1997 Under standard treatment (≥ 2 months) at the time of Background treatment failed to control flares or to permit prednisone tapering With at least one of the following manifestations: thrombocytopenia, disease-associated rash, mouth ulcer, non-infectious type of fever, active vasculitis, renal disorder(proteinuria>0.5g/day), neuropsychiatric SLE Positive for at least one of the following laboratory tests: ANA>1:160, anti-dsDNA, immunoglobulin>20g/L, decreased C3 or C4, leukopenia<3×10^9/L, thrombocytopenia<100×10^9/L SLE disease activity index(SLEDAI) ≥ 8 Negative HIV test Negative for hepatitis B and C virus Negative urine pregnancy test Written informed consent form Sever chronic liver, kidney, lung or heart dysfunction; (heart failure (≥ grade III NYHA), hepatic insufficiency (transaminases> 3N) ) Serious infection such as bacteremia, sepsis Cancer or history of cancer cured for less than five years (except in situ carcinoma of the cervix or Basocellular carcinoma) High-dose steroid pulse therapy (>1.5mg/kg) or IV bolus of corticosteroids in the last 2 months History of administration of rituximab or other biologics Purified protein derivative (tuberculin) >10mm Mental disorder or any other chronic illness or drug-abuse that could interfere with the ability to comply with the protocol or to give information Inability to comply with IL-2 treatment 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): 18.0-75.0, Mastocytosis Systemic Mastocytosis Indolent Systemic Mastocytosis Diagnosis of indolent systemic mastocytosis (ISM) according to the WHO and the consensus proposal (2001) Experiencing at least one predefined qualifying symptom in at least two organ systems within 3 months of Screening despite the use of H1 and/or H2 antihistamines and other anti-mediator therapy Experiencing symptoms with a severity score of at least 4 for at least 7 out of 14 days during the Run-in period with at least one predefined qualifying symptom each from at least two organ systems, despite the use of H1 and/or H2 antihistamines and/or other anti-mediator therapy Willing and able to use an eDiary device daily for the duration of the study Completed at least 5 eDiary reports during each of two consecutive weeks of the Run-in period Willing and able to provide written informed consent prior to any study procedures Advanced systemic mastocytosis (i.e., aggressive systemic mastocytosis [ASM], mast cell leukemia [MCL], or systemic mastocytosis with an associated clonal hematologic non-mast cell lineage disease [SM-AHNMD] ) Current or recent history of clinically significant cardiovascular, hematological, renal, neurologic, hepatic, endocrine, psychiatric, malignant, or other illnesses that could put the patient at risk or compromise the quality of the study data as determined by the Investigator Use of oral cromolyn sodium within 6 weeks of Screening History of systemic corticosteroid, immunosuppressive, or anti-IgE monoclonal antibody therapy (e.g., omalizumab) within 6 months of Screening History of anaphylaxis requiring systemic treatment (i.e., corticosteroid or epinephrine) within 12 months of Screening Upper or lower respiratory tract infection within 4 weeks of Screening History of malignancy within the last 5 years, except basal cell carcinoma or cervix carcinoma in situ Major surgery within 6 months of Screening Current or recent history (within 12 months) of excessive use or abuse of alcohol Current or recent history (within 12 months) of abusing legal drugs or use of illegal drugs or substances | 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): 18.0-99.0, Drug-Related Side Effects and Adverse Reactions Adverse Drug Events Veterans age 18 years or older Having a VA primary care provider (PCP) at any VA facility in VISN-1 Planned discharge home (as opposed to another facility) Computer and internet access Anticipated to be discharged with at least 5 medications Having a VA PCP will be defined as having seen the provider within the past two years Planned discharge home will be ascertained from the Veteran's nurse; approximately 75% of VA Boston discharges are to home The nurse will also provide number of anticipated discharge medications Cognitive impairment (as determined by the Callahan screener) | 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, Lung Cancer Lung Metastases Histologically/cytologically proven primary thoracic or breast malignancy, lymphoma or lung metastases (which are not required to be biopsy-proven) treated with definitive intent at MSK Prior treatment with thoracic radiotherapy completed >4 weeks and ≤ 9 months prior to enrollment Radiographic evidence of radiation pneumonitis on a CT scan of the chest with or without contrast Newly diagnosed clinical grade 2 or higher radiation pneumonitis according to CTCAE version 4.0 Age≥18 years KPS > 70% Reduction of any acute toxicity from radiation treatment to grade 1 Written informed consent signed prior to entry into the study Current oral steroid use > 4 weeks prior to registration Ongoing treatment with radiotherapy to thorax, cytotoxic or biological therapies for this malignancy, except the following therapies which are permitted: Pembrolizumab, Nivolumab, Afatinib and all hormonal therapies Mean esophageal radiation dose >45 Gy Diagnosis of diffuse radiation pneumonitis Untreated or symptomatic brain metastases or leptomeningeal disease Liver metastases Other active malignancies requiring oncologic treatment (Note: non-melanoma skin cancer, superficial bladder cancer etc. are eligible) Radiographic evidence of cavitary or necrotic tumor and local invasion of major blood vessels Active chronic Hepatitis C and/or B infection Gastrointestinal disorders that would interfere with drug absorption | 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, Crohn's Disease A CDAI score greater than 150 at baseline was required for .(1) steroid-dependent: unable to reduce steroids below the equivalent of prednisone 10 mg/day (or budesonide below 3 mg/day) within 3 months of starting steroids, or who have a relapse within 3 months of stopping steroids.(2) thiopurines-non-responsive: active disease or clinical relapse despite administration of azathioprine (1.5-2 mg per kg per day) or 6-mercaptopurine (0.75-1.5 mg per kg per day) for 4 months. (3) thiopurines intolerant: intolerance to or adverse events of thiopurines. The were (1) isolated L4 CD; (2) disease including symptomatic stenosis of intestine or abdominal abscess requiring immediate surgery; (3) Current or past history of malignancy or organ transplantation; (4) Serious infections within 3 months; (5) Previous history of neuropathy or symptoms of neuropathy or abnormal electromyography prior to thalidomide; (6) infliximab treatment in the previous 8 weeks; (7) progressive or uncontrolled renal, hepatic, hematological, pulmonary and cardiac disease and（8）ongoing 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, Tobacco Smoking Pregnancy the woman presents for her first prenatal visit before 14-week gestation she is a smoker years or older (legal age for consent and for consuming tobacco in Romania) married or in a stable relationship phone service in the home or mobile phone willing to have the partner contacted for participation, upon brief explanation of the study partner declines participation upon phone recruitment attempt | 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, Depression Subjects have signed a current version of the Informed Consent and HIPAA documents prior to initiation of study procedures Able to comprehend English Diagnosis of Diagnostic and Statistical Manual of Mental Disorders (DSM)-V major depression and currently off antidepressant medication, unless otherwise approved by the PI or PI's designee Depression as the primary axis I disorder Negative pregnancy test for women of childbearing potential Not breast feeding At least two CRP tests conducted to establish reliability Evidence of untreated or poorly controlled endocrine, cardiovascular, pulmonary, hematological, renal, or neurological disease History of central nervous system (CNS) trauma or active seizure disorder requiring medication unless otherwise approved by principal investigator, or PI's designee Current or history of migraines, glaucoma, melanoma, or bleeding disorder of any kind Autoimmune or inflammatory disorder of any kind Embedded metallic objects, prosthetics made of paramagnetic metals, aneurysmal clips and/or a history of claustrophobia Chronic infection (e.g. hepatitis B or C or Human Immunodeficiency Virus infection) Chronic use of agents known to affect the immune system including glucocorticoid therapy within the past 6 months, methotrexate within the past 1 year, chemotherapy of any kind (past or present), immunotherapy of any kind (past or present), aspirin or non-steroidal anti-inflammatory drugs (NSAIDs; within the past 2 weeks), statins (within the past 1 month), vaccinations (within the past 2 weeks), topical steroids (within the past 2 weeks), and antibiotics (within the past two weeks) unless otherwise approved by principal investigator or PI's designee Suicide attempt within six months of screening, or active suicidal intent or plan, or score >2 on Hamilton Depression Rating Scale (HDRS), or Quick Inventory of Depressive Symptomatology Self-Report (QIDS) or Patient Health Questionnaire (PHQ-9) Suicide Item, unless otherwise approved by the PI or PI's designee A positive pregnancy test Organ transplants | 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): 19.0-999.0, Chronic GVHD After HCT for Cancer or Immune Disease (Main) Newly diagnosed chronic GVHD as defined by the National Institutes of Health (NIH) Consensus with no more than 24 weeks of treatment with systemic steroids. AND 2. Chronic GVHD must be refractory or dependent to standard therapy, defined as (one of the following) Progression on prednisone 7 mg/kg/week for 2 weeks, or Stable disease on ≥ 3.5 mg/kg/week of prednisone for 4-8 weeks, or Inability to taper prednisone below 3.5 mg/kg/week (Main) Persistent, recurrent or late-onset acute GVHD, without signs of chronic GVHD. OR 2. Overlap GVHD syndrome with uncontrolled features of previously diagnosed acute GVHD. OR 3. Treatment with more than two systemic non-steroidal immunosuppressants within 4 weeks prior to enrollment. OR 4. Time from allogeneic transplantation > 2 years. OR 5. Lymphocyte count < 0.2 x 109/L on two last consecutive CBCs before | 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): 18.0-37.0, Unexplained Infertility Infertility Primary or secondary infertility ≥12 months Diagnosis of unexplained infertility ≤36 months Anti-Mullerian hormone ≥0.4 ng/mL and/or follicle-stimulating hormone ≤13 IU/L in early follicular phase regular cycle of 25-35 days positive ovulation tests, and/or luteal phase serum progesterone ≥25mmol/L in a natural cycle normal semen analysis normal uterine cavity patent tubes Negative genitourinary test for gonorrhoea and chlamydia ≤12 months Body mass index ≥35 kg/m2 Ongoing 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): 18.0-55.0, Multiple Sclerosis, Relapsing-Remitting Diagnosis of RMS in accordance with the revised McDonald Received at least one previous immunization against TT or tetanus and diphtheria (DT/Td) or tetanus, diphtheria, and acellular pertussis (DTaP/Tdap) Expanded Disability Status Scale (EDSS) at Screening from 0 to 5.5 points, inclusive For sexually active female participants of reproductive potential, use of reliable means of contraception Contraindications for or intolerance to oral or IV corticosteroids, including IV methylprednisolone, according to the country label Known presence of other neurologic disorders Treatment with any investigational agent within 24 weeks of screening or 5 half-lives of the investigational drug, whichever is longer, or treatment with any experimental procedure for multiple sclerosis | 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, Pregnancy Pregnant women at ≥37 weeks gestation by reliable dating as determined by the American College of Obstetricians and Gynecologists (i.e. gestational age supported by one of the following: ultrasound prior to 20 weeks of gestation, fetal heart tones auscultated by Doppler for 30+ weeks, or documented serum or urine pregnancy test 36+ weeks ago) 2. Scheduled induction of labor with indication and timing supported by the Family Birth Center induction of labor guideline entitled "Induction of labor: Indications and Timing" 3. Singleton gestation 4. Cephalic presentation 5. Amniotic fluid index greater than or equal to 5 centimeters 6. Formal prenatal ultrasound documenting the absence of placenta previa 7. Bishop score <6 and cervical dilation <3cm 8. The woman is able to give appropriate consent and has undergone an informed consent process. 9. Maternal age ≥ 18 years old at the time of consent New diagnosis requiring immediate hospitalization for monitoring (such as new onset hypertensive disease of pregnancy) 2. Vaginal bleeding 3. Active labor 4. Premature rupture of membranes as determined by positive ferning and as supported by pooling of fluid in the vaginal vault. 5. Uterine tachysystole (>5 contractions in 10 minutes) 6. Nonreassuring fetal heart tracing before or after Foley placement 7. Chorioamnionitis or maternal fever 8. Intrauterine fetal demise 9. Contraindication to vaginal delivery, relative or absolute (i.e. transfundal uterine surgery) 10. Abnormal placentation including a low lying placenta 11. Prior cesarean delivery 12. Intrauterine growth restriction (growth <10th percentile by formal ultrasound) 13. Known fetal anomaly 14. Human immunodeficiency virus, Hepatitis C, or active herpes infection 15. Maternal cardiopulmonary disease requiring cardiac monitoring during labor 16. Pregestational diabetes 17. Rh isoimmunization 18. Non-English speaking 19. Distance from the hospital over 60 minutes by car, unreliable communication via telephone, or unreliable transportation | 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, Malignant Digestive System Neoplasm Nausea and Vomiting Patients who have a diagnosis of GI malignancy and who are scheduled to receive their initial treatment with an oxaliplatin-containing regimen in combination with 5-fluorouracil; these combinations such as fluorouracil, oxaliplatin, and leucovorin calcium (FOLFOX), + bevacizumab, + cetuximab Standard antiemetic therapy with initial treatment must the dolasetron and dexamethasone; the minimum adequate doses either Dolasetron (Anzemet) 100mg PO/IV or 1.8mg/kg IV AND Dexamethasone (Decadron) 10mg PO/IV Patient must agree, as part of the informed consent, to keep a journal of the episodes of nausea, vomiting, retching, and amount of rescue medications used on days 1 to 5 (day 1 = day of treatment) Signed informed consent Allergy or intolerance to dolasetron and dexamethasone Use of another antiemetic agent (5HT3 antagonists, phenothiazines, butyrophenones, cannabinoids, metoclopramide, or corticosteroids) within 72 hours of day 1 of the study An episode of vomiting or retching within 24 hours before the start of the initial treatment with oxaliplatin-containing regimen Severe concurrent illness other than neoplasia Gastrointestinal obstruction or an active peptic ulcer Radiation therapy to the abdomen or pelvis within 1 week before or after day 1 of the study Absolute neutrophil count of less than 1.5 x 10^9/L (unless physician approves to proceed with chemotherapy) or Platelets less than 100 x 109/L (unless physician approves to proceed with chemotherapy) Total bilirubin > 2 x upper limits of normal Patients who are pregnant or breast feeding | 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, Aggressive Systemic Mastocytosis Systemic Mastocytosis-associated Hematologic Non-mast Cell Disease Mast Cell Leukemia Relapsed or Refractory Myeloid Malignancies For Part 1:Patients must have one of the following diagnoses based on World Heath Organization (WHO) diagnostic Aggressive systemic mastocytosis (ASM) Systemic mastocytosis with an associated hematologic neoplasm (SM-AHN) and at least 1 C-finding attributable to systemic mastocytosis (SM). The AHN must be myeloid, with the following exceptions that are excluded: Acute myeloid leukemia (AML), Myelodysplastic syndrome (MDS) that is very high or high-risk as defined by the International prognostic scoring system for myelodysplastic syndromes (IPSS-R) and Philadelphia chromosome positive malignancies Mast cell leukemia (MCL) Histologically or cytologically confirmed myeloid malignancy that is relapsed or refractory to standard treatments. AML, MDS that is very high or high-risk as defined by the IPSS-R, and Philadelphia chromosome positive malignancies are excluded Upon discussion with the sponsor, other relapsed or refractory, potentially avapritinib-responsive hematologic neoplasms (e.g., evidence of aberrant KIT or platelet derived growth factor receptor (PDGFR) signaling) may be considered for enrollment. For Part 2, patients must have one of the following diagnoses, based on WHO diagnostic QT interval corrected using Fridericia's formula (QTcF) >480 milliseconds Platelet count <50,000/μL (within 4 weeks of the first dose of study drug) or receiving platelet transfusion(s) Absolute neutrophil count <500/μL Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >3 x the upper limit of normal (ULN); >5 × ULN if associated with clinically suspected liver infiltration by mastocytosis or another disease for which the patient enrolled into the study Total bilirubin >1.5 × ULN; >3 × ULN if associated with liver infiltration by the disease being treated or in the presence of Gilbert's Disease (In the case of Gilbert's disease, a direct bilirubin > 2.0 ULN would be an exclusion.) Estimated (Cockroft-Gault formula) or measured creatinine clearance <40 mL/min Brain malignancy or metastases to the brain History of a seizure disorder or requirement for anti-seizure medication Known risk of intracranial bleeding, such as a brain aneurysm or history of subdural or subarachnoid bleeding Eosinophilia and known positivity for the FIP1L1-PGDFRA fusion, unless the patient has demonstrated relapse or progressive disease on prior imatinib therapy | 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): 0.0-999.0, Mastocytosis Any patient with a diagnosis of mastocytosis, including systemic mastocytosis and cutaneous mastocytosis and any subtypes of these diseases, who is willing and able to provide written online informed consent None | 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): 18.0-65.0, Actinic Keratosis Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events; 2. Fitzpatrick skin types I-IV (due to lack of safety data for the investigational product in darker skin types); 3. Complete a Medical Screening form as well as a Medical Personal History form Have any visible skin disease at the application site which, in the opinion of the investigative personnel, will interfere with the evaluation of the test site reaction; 2. Are not willing to refrain from using topical/systemic analgesics for 72 hours prior to and during the study (daily use of 81 mg aspirin is acceptable and occasional use of acetaminophen will be permitted); 3. Are using systemic/topical corticosteroids for 3 weeks prior to and during the study, or systemic/topical antihistamines for 72 hours prior to and during the study; 4. Are using medication which, in the opinion of the investigative personnel, will interfere with the study results, including anti-inflammatory medications; 5. Are unwilling or unable to refrain from the use of sunscreens, cosmetics, creams, ointments, lotions, or similar products on the back during the study; 6. Have psoriasis and/or active atopic dermatitis/eczema; 7. Have damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site | 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, Myocardial Infarction Patients which, after telemedical triage, are admitted to a cardiac department in suspicions of myocardial infarction A peripheral venous catheter has been inserted prehospitally and blood has drawn from it, before flushing it Age below 18 years Patients in which an informed concent can not be obtained (psychiatric disease, dementia, under influence of drugs etc.) Suspected STEMI and referral to Primary percutaneous coronary intervention (PPCI), referral to a highly specialized cardiac department for another cardiac reason (e.g ventricular tachycardia, ventricular fibrillation, 3° Atrio-ventricular block.) Known central Diabetes insipidus Other diagnosis as obvious reason for symptoms at time of admittance (e.g. a new diagnosis of supraventricular tachycardia, pulmonary embolism, aortic dissection) AND no suspicions of ACS | 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): 3.0-17.0, Dermatitis, Atopic Patients between the ages of 3-17 experiencing a symmetric, bilateral flare of atopic dermatitis 2. The flares must reach a certain threshold for based on the investigator's global assessment scale Systemic infection or bacterial skin infections 2. Eczema herpeticum 3. Evidence of suppression of the Hypothalamic-Pituitary-Adrenal axis 4. Non-English or Non-Spanish speaking | 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): 3.0-999.0, Lymphoma Lymphoma, Non-Hodgkin Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Prior to Cell Procurement Informed consent explained to, understood by and signed by the subject or legal guardian for pediatric subjects; subject and/or legal guradian given a copy of informed consent form for procurement Ages 3 to 17 years of age for pediatric subjects (weight must be ≥10kg), and for adults ages ≥18 years of age Diagnosis of recurrent HL or NHL in subjects who have failed >2 prior treatment regimens. Subjects relapsed after autologous or allogeneic stem cell transplant are eligible for this study. CD30+ disease (result can be pending at the time of cell procurement, but must be confirmed prior to treatment with cells). NOTE: CD30+ disease requires documented CD30 expression by immunohistochemistry based on the institutional hematopathology standard. Karnofsky or Lansky score of >60% (Karnofsky for ≥16 years old and Lansky for <16 years old) Evidence of adequate organ function as defined by Hemoglobin ≥ 8.0 g/dL (transfusion independent for 2 weeks prior to enrollment) Total bilirubin ≤ 1.5 × ULN, unless attributed to Gilbert's Syndrome AST ≤ 3 × ULN Serum creatinine ≤ 1.5 × ULN For subjects <18 years old use the following table for serum creatinine requirements: Maximum Serum Creatinine (mg/dL) Age (years) Male Female 3 to <6 ≤0.8 ≤0.8 6 to <10 ≤1.0 ≤1.0 10 to <13 ≤1.2 ≤1.2 13 to <16 ≤1.5 ≤1.4 ≥16 and <18 ≤1.7 ≤1.4 Negative serum pregnancy test in females within 72 hours prior to procurement or documentation that the subject is post-menopausal or premenarchal. Women of childbearing potential (WOCBP) should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study, and for 6 months after the study is concluded. WOCBP are those who have not been surgically sterilized or have not been free from menses for >1 year. • Postmenopausal status must be confirmed with documentation of absence of menses for >1 year Prior to Cell Procurement Pregnant or lactating Tumor in a location where enlargement could cause airway obstruction Active infection with HIV, HTLV, HCV (can be pending at the time of cell procurement; only those samples confirming lack of active infection will be used to generate transduced cells) defined as not being well controlled on therapy. Subjects are required to have negative HIV antibody or negative HIV viral load, negative HTLV1 and 2 antibody, negative HCV antibody or viral load. Hepatitis B: Subjects who are positive for Hepatitis B Surface Antigen (can be pending at the time of cell procurement; only those samples confirming lack of active infection will be used to generate transduced cells) are excluded". Subjects who are Hepatitis B Surface Antigen negative but hepatitis B core antibody positive must have their hepatitis B viral load checked. These subjects will be excluded if their viral load is positive at baseline. Subjects who are core antibody positive and viral load negative at baseline will be considered eligible. Prior to Lymphodepletion Informed consent explained to, understood by and signed by the subject or legal guardian for pediatric subjects; subject and/or legal guradian given a copy of informed consent form. CD30+ disease (result can be pending at the time of cell procurement, but must be confirmed prior to lymphodepletion); Note: CD30+ disease requires documented CD30 expression by immunohistochemistry based on the institutional hematopathology standard. Prior to administration of lymphodepletion Absolute neutrophil count (ANC) is > 1.0 × 109/L Platelet count > 75 × 109/L For Grade 4 neutropenia, Grade ≥3 febrile neutropenia, or Grade 4 thrombocytopenia, hold bendamustine until toxicity resolve to Grade ≤2 For WOCBP negative serum pregnancy test within 72 hours prior to lymphodepletion. Imaging results from within 7 days (30 days in subjects with cutaneous T cell lymphoma) prior to lymphodepletion. Subjects who have received bridging chemotherapy must have imaging performed at least 3 weeks after most recent therapy (imaging does not need to be repeated if it is within 7 days prior to lymphodepletion). Karnofsky or Lansky score of >60% (Karnofsky for pediatric subjects ≥16 years old and Lansky for <16 years old). Available autologous transduced activated T cells that meet the Certificate of Analysis (CofA) acceptance criteria. Women of childbearing potential (WOCBP) should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study, and for 6 months after the study is concluded. WOCBP are those who have not been surgically sterilized or have not been free from menses for > 1 year Prior to Lymphodepletion Received any investigational agents or received any tumor vaccines within the previous six weeks prior to cell infusion. Received anti-CD30 antibody-based therapy within the previous 4 weeks prior to cell infusion. Received chemotherapy within the previous 3 weeks prior to lymphodepletion. Subject has rapidly progressive disease, per treating oncologist's discretion. Subject is not a good candidate for CAR T cell therapy, per treating oncologist's discretion. Pregnant or lactating. Tumor in a location where enlargement could cause airway obstruction. Current use of systemic corticosteroids at doses equivalent of ≥10mg prednisone daily or its equivalent; those receiving <10mg daily may be enrolled at discretion of investigator. Inhaled steroids are allowed. For pediatric subjects, physiologic replacement hydrocortisone at doses 6-12 mg/m2/day is allowed. Equivalently dosed alternative steroids are allowed at discretion of investigator, though not to exceed 10mg prednisone per day. Inhaled steroids are allowed. Subjects on strong inhibitors of CYP1A2 (e.g., fluvoxamine, ciprofloxacin) as these may increase plasma concentrations of bendamustine, and decrease plasma concentrations of its metabolites. See http://medicine.iupui.edu/clinpharm/ddis/ for an updated list of strong inhibitors of CYP1A2 Active infection with HIV, HTLV, HCV (can be pending at the time of cell procurement; only those samples confirming lack of active infection will be used to generate transduced cells) defined as not being well controlled on therapy. Subjects are required to have negative HIV antibody or negative HIV viral load, negative HTLV1 and 2 antibody, negative HCV antibody or viral load. Hepatitis B: Subjects who are positive for Hepatitis B Surface Antigen are excluded. Subjects who are Hepatitis B Surface Antigen negative but hepatitis B core Antibody positive must have their hepatitis B viral load checked. These subjects will be excluded if their viral load is positive at baseline. Subjects who are core antibody positive and viral load negative at baseline will be considered eligible if the subject has initiated an anti-HBV prophylaxis regimen prior to lymphodepletion. Prior to Infusion of Cells Evidence of adequate organ function as defined by Total bilirubin ≤1.5 × ULN, unless attributed to Gilbert's Syndrome AST ≤3 × ULN Serum creatinine ≤1.5 × ULN Pulse oximetry of >90% on room air For subjects <18 years old use following table for serum creatinine requirements: Maximum Serum Creatinine (mg/dL) Age (years) Male Female 3 to <6 ≤0.8 ≤0.8 6 to <10 ≤1.0 ≤1.0 10 to <13 ≤1.2 ≤1.2 13 to <16 ≤1.5 ≤1.4 ≥16 and <18 ≤1.7 ≤1.4 Karnofsky or Lansky score of >60% (Karnofsky for ≥16 years old and Lansky for <16 years old) Available autologous transduced activated T cells that meet the Certificate of Analysis (CofA) acceptance criteria. Women of childbearing potential (WOCBP) should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study, and for 6 months after the study is concluded. WOCBP are those who have not been surgically sterilized or have not been free from menses for > 1 year | 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, Acute Non-complicated Postural Neck Pain will ages of 18-64 who present with non-complicated postural neck pain, indications for cervical manipulation, including pain, decreased range of motion, and hypertonicity will discogenic pain or radicular symptoms, pregnancy, contraindications to manipulation, and previous neck surgery | 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, Steroid-refractory aGvHD Subsequent to Allogeneic Hematopoietic Cell Transplantation Patient must be ≥18years of age, males or females; 2. Patient must have been recipients of a single allogeneic HCT; bone marrow, peripheral blood and/or umbilical cord blood recipients are allowed 3. Patients must have aGvHD without feature of classic chronic GvHD or overlap GvHD; 4. Patients must have received no prior treatment for aGvHD other than steroids; 5. Patients must have biopsy proven grade II to IV aGvHD progressing after at least 3 days, non-improving grade III to IV aGvHD persistent after at least 7 days, or non-improving grade II aGvHD persistent after at least 14 days of methylprednisolone 2mg/kg/day or equivalent; Patients with initial response but have flare of aGvHD within 14 days with methylprednisolone > 0.5 mg/kg/day or equivalent are also eligible; 6. Patient must have an ANC of > 500/mm3 and no evidence of HCT graft failure or multi-organ failure; 7. Patient must have Karnofsky Performance Status (KPS) ≥50%; 8. Patient must give informed consent and sign an approved consent form prior to any study procedures; 9. Females of childbearing potential must have a negative pregnancy test result prior to enrollment. Males and females of childbearing potential must agree to use a highly effective method of birth control during the study Uncontrolled infections not responsive to antimicrobial therapy or requiring intensive critical care or vasopressors; 2. Evidence of end-organ infection due to CMV; 3. HIV infection or a known HIV-related malignancy (NOTE: patients positive for hepatitis B or hepatitis C are not excluded, and may be evaluated on a case by case basis). 4. Tuberculosis, history of tuberculosis or a known positive Quantiferon test for tuberculosis 5. Donor lymphocyte infusion for residual or relapsed disease or mixed chimerism. DLI as part of the planned HCT protocol are allowed 6. Relapsed disease after transplant or progressive malignant disease, including post-transplant lymphoproliferative disease; any secondary malignancy diagnosed since HCT 7. Renal failure requiring hemodialysis 8. Need ICU care, with life expectancy of less than 28 days, with ongoing or unresolved veno-occlusive disease, with unstable hemodynamics, with evidence of current or previous clinically significant disease, medical condition or finding of the medical examination (including vital signs and ECG), that in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data 9. History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients 10. Pregnant or nursing | 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, Type 2 Diabetes Mellitus Hypertension Active patient at McMaster Family Health Team Aged 18+ Diagnosis of Diabetes Diagnosis of Hypertension Regular access to a computer And at least ONE of Uncontrolled HbA1C measures (in the past 6 months, or most recent) Uncontrolled recent blood pressure (in the past 3 months, or most recent) 90 or higher (either number higher) Newly diagnosed with diabetes (diagnosed within 6 months) End-stage organ damage/other complications of diabetes [e.g. renal dysfunction, diabetic neuropathy] identified as deceased explicitly stated they do not want to be part of a research project reside in long-term care are receiving end-of-life care directly related to anyone from the McMaster University Department of Family Medicine not a participant in another project | 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): 0.25-23.0, Urticaria Pigmentosa Cutaneous Mastocytosis Affected subject: Subjects will be eligible to participate in the study if all of the following conditions exist: 1. Clinical diagnosis of urticaria pigmentosa/cutaneous mastocytosis with representative skin lesions 2. Age <23 years 3. Capable of giving consent if 18 or older for Parent: 1. Over 16 years of age 2. Biologic parent to affected subject 3. Capable of providing consent for Sibling: 1. Biologic sibling to affected subject 2. Capable of giving consent if 18 or older - Absence of skin findings representative of classic urticaria pigmentosa 2. Patients with primarily systemic mastocytosis 3. Unable or unwilling to participate in study procedures for Parent/Sibling: 1. Unable or unwilling to participate in study procedures | 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, Urothelial Carcinoma Urothelial Cancer Lung Neoplasms Small Cell Lung Cancer Prostate Cancer Phase I Patients must have advanced solid tumor that is resistant or refractory to standard therapy A minimum of 2 weeks will be required from any prior therapy, including chemotherapy, immunotherapy and/or radiation. In addition, recovery to Grade less than or equal to 1 from all reversible toxicities related to prior therapy is required at study entry Patients do not need to have measurable disease to enroll on phase I Age greater than or equal 18 years ECOG performance status less than or equal to 2 Patients with treated brain metastases (surgery, whole or stereotactic brain radiation) are allowed provided the lesions have been stable for at least 2 weeks and the patient is off steroids or is on a stable dose of steroids. Patients with brain metastases should not require use of enzyme-inducing antiepileptic drugs (e.g., carbamazepine, phenytoin, or phenobarbital) within 14 days before first dose and during study. Use of newer antiepileptics that do not produce enzyme induction drug-drug interactions (DDIs) is allowed Patients must have normal organ and marrow function as defined below leukocytes greater than or equal to 3,000/mcL absolute neutrophil count >1,500/mcL without growth factor support | 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 (SLE) Repository Corticotropin Injection Able to provide informed consent Diagnosis of SLE according to the American College of Rheumatology revised (fulfilled ≥ 4 criteria) Hematologic BILAG scores due to hemolytic anemia or thrombocytopenia of BILAG A (including hemolytic anemia with hemoglobin < 8.0 g/dL or platelet count < 25 x 109 l) or BILAG B (including hemolytic anemia with hemoglobin 8.0 9 g/dDL or platelet count 25 x 109 l) based on screening laboratory assessment Currently taking prednisone ≥ 7.5 mg or equivalent for hematologic SLE for at least 2 weeks prior to screening Use of antimalarials and NSAIDs (stable regimen within the 4 weeks prior to screening), as well as methotrexate, azathioprine, and mycophenolate mofetil (stable regimen within the 4 weeks prior to screening) are permitted but not required. If used, the regimen must remain stable through the study. An increase or addition of SLE medication at any time during the study is not permitted Ability to comply with study procedures, which SC injections of study medication, adhering to concomitant medication restrictions, and attending scheduled office visits Patients with a recent history (< 2 week prior to screening) of starting prednisone or equivalent Patients with active nephritis, defined as serum creatinine > 2.5 mg/dL or protein/creatinine ratio (PCR) > 1.5 g/g, or patients that required hemodialysis within 3 months prior to screening Active central nervous system (CNS) lupus (including seizures, psychosis, organic brain syndrome, cerebrovascular accident, cerebritis, or CNS vasculitis), requiring therapeutic intervention within 3 months prior to screening Type 1 or type 2 diabetes mellitus (history of gestational diabetes is not an exclusion), or patients currently taking hypoglycemic medication Patients with a history of concomitant medication use as follows: a. Receipt of the following within 1 month prior to screening: i. Any steroid injection (IM, intraarticular, or IV) b. Receipt of any of the following within 3 months prior to screening: i. Cyclosporine ii. Any non-biologic investigational drug c. Receipt of the following within 4 months prior to screening: i. IVIg ii. Plasmapheresis d. Receipt of cyclophosphamide within 6 months prior to screening e. Receipt of the following within 12 months prior to screening: i. B cell targeted therapy (rituximab or other anti-CD20 agent, anti-CD22 [epratuzumab], anti-CD52 [alentuzumab], or belimumab) ii. Abatacept iii. Any biologic investigational agent Contraindication per Acthar Prescribing Information: scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, or adrenal cortical hyperfunction. 1. For the purposes of this study, osteoporosis is defined as evidence of vertebral or long bone fracture, or lumbar spine T-score > 2.0 standard deviations below the mean of the reference population. 2. For the purposes of this study, history of peptic ulcer is defined as ≤ 6 months prior to screening. 3. For the purposes of this study, congestive heart failure is defined as New York Heart Association Functional Class III-IV. 4. For the purposes of this study, uncontrolled hypertension is defined as a mean systolic blood pressure ≥ 140 mm Hg and/or diastolic blood pressure ≥ 90 mm Hg on ≥ 3 seated readings taken at least 5 minutes apart during the screening period Reproductive status: 1. Women who are pregnant, 2. Women who are breastfeeding, 3. Women of childbearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period, as evaluated by the Investigator (women of non-childbearing potential are those that have a history of hysterectomy, bilateral oophorectomy, or are postmenopausal with no history of menstrual flow for ≥ 12 months prior to screening) Immune System: Known immunocompromised status (not related to SLE or therapies for SLE), including individuals who have undergone organ transplantation or who are known to be positive for the human immunodeficiency virus Patients with acute or chronic hepatitis C, or active hepatitis B infection, positive interferon gamma release assay (IGRA) or signs or symptoms concerning for active tuberculosis (TB); or use of antibiotics (antibacterial, antiviral, antifungal, or antiparasitic agent) within 4 weeks of randomization for treatment of an active infection Presence of any other clinically significant disease or disorder which, in the opinion of the Investigator (by its nature or by being inadequately controlled), might put the patient at risk due to participation in the study, or may influence the results of the study or the patient's ability to complete 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): 18.0-50.0, Vitiligo To be eligible for participation, subjects must meet all of the following Must have a clinical exam consistent with and diagnosis of non-segmental vitiligo Must be normally pigmented No clinical presentation of vitiligo Outside of the specified age range No clinical diagnosis of vitiligo Use of systemic therapies, including but not limited to methotrexate, etretinate, or cyclosporine, calcineurin inhibitors and/ or vitamin D analogs within 4 weeks of enrollment Use of topical steroids or topical immunodilators at biopsy site within 4 weeks of enrollment History of keloids or hypertrophic scars Patients with pacemakers or defibrillators or heart valves Patients on Plavix, Warfarin or similar anticoagulation medicine Pregnant females Lactating women Allergies or sensitivity to lidocaine or epinephrine | 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, Indolent Systemic Mastocytosis Provided written informed consent 2. Male or female aged ≥18 and ≤65 years at the time of signing the informed consent form 3. Confirmed diagnosis of ISM based on World Health Organization (WHO) (Appendix 1) 4. Presence of at least 1 of the following SM related symptoms: 1. Flushing (at least 1 episode per week) 2. Pruritus (minimum MAS2 score of 4) (Appendix 2) 3. Diarrhea (minimum MAS2 score of 4) (Appendix 2) 4. Anaphylaxis (at least 1 episode [grade 2 or higher] within the last 12 months) 5. Serum total tryptase exceeded 15 ng/mL* at 2 or more measurements obtained 1 or more months apart within the last 2 years (*Note: this varies from the minor criterion of "persistently exceeds 20 ng/mL" in the WHO for diagnosis of ISM) 6. Willing and able to comply with the study procedures and visit schedule, including follow-up visits 7. Able to communicate effectively with the study site personnel 8. Negative Screening urine drug tests (alcohol, amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, cotinine, methadone, methaqualone, opiates, phencyclidine) 9. Negative Screening ova and parasite test 10. Determined by the Investigator to be in good health as documented by the medical history, physical examination (PE), vital sign assessments, 12 lead ECG, clinical laboratory assessments, and by general observations 11. Women of child bearing potential, must be using highly effective methods of birth control (failure rate <1% per year when used consistently and correctly) at least 4 weeks prior to Screening until Day 85. Women should be informed of the potential risks associated with becoming pregnant while enrolled. Accepted forms of contraception are implants, injectables, combined oral contraceptives, and some intrauterine devices (IUDs). In addition, a barrier method must always be used concomitantly to the highly effective method. Double-barrier is not considered a highly effective method. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) is not an acceptable means of contraception. Female patients are considered to not be of child-bearing potential when they are post-menopausal for at least 2 years with follicle-stimulating hormone (FSH) levels >40 mIU/mL, are surgically sterilized, or have undergone hysterectomy. 12. Male patients with female partners of childbearing potential must agree to use a condom without spermicide during sexual activity with female partners of childbearing potential. Female sexual partners of male patients must be willing to avoid pregnancy according to the above described methods Known hypersensitivity to any constituent of the study drug 2. Presence of an associated hematologic non-mast-cell lineage disorder or MC leukemia 3. Any disease or condition (medical or surgical) which, in the opinion of the Investigator, might compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, skeletal, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of AK002, or would place the patient at increased risk 4. The presence of abnormal laboratory values considered to be clinically significant by the Investigator 5. Participation in a concurrent interventional study with the last intervention occurring within 30 days prior to administration of study drug (90 days or 5 half-lives, whichever is longer, for biologic products) 6. Treatment with chemotherapy or radiotherapy in the preceding 6 months 7. Treatment for a clinically significant helminthic parasitic infection within 6 months of screening 8. Use during the 7 days before Screening (or 5 half-lives, whichever is longer) or expected to require the use of angiotensin converting enzyme (ACE) inhibitors or beta blockers 9. Use during the 30 days before Screening (or 5 half lives, whichever is longer) or expected to require the use of omalizumab, immunosuppressive drugs, or systemic corticosteroids with a daily dose >10 mg prednisone or equivalent 10. Vaccination with live attenuated vaccines within 30 days prior to initiation of treatment in the study, during the treatment period, or vaccination expected within 5 half-lives (4 months) of the study drug administration 11. Donation or loss of >500 mL of blood within 56 days prior to administration of study drug or donation of plasma within 7 days prior to administration of study drug 12. Has not refrained from excessive caffeine consumption (>3 cups of coffee per day or equivalent) for 48 hours prior to study drug administration and agreed to this do so throughout the inpatient period 13. Positive hepatitis serology results, except for vaccinated patients or patients with past but resolved hepatitis, at Screening 14. Positive HIV serology results at Screening 15. Any other reason that in the opinion of the Investigator or the Medical Monitor makes the patient unsuitable for enrollment 16. Patient is vulnerable (e.g., patient kept in detention) | 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): 65.0-999.0, Chronic Disease Patient admitted to the Internal Medicine or Geriatrics department Admitted to hospital because of an exacerbation of any previous chronic condition Terminal ill patients at admission Patients with lower forecast life than 1 year Patient admitted to the hospital only because an acute problem In patient home care | 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, Functional Pancreatic Neuroendocrine Tumor Malignant Somatostatinoma Merkel Cell Carcinoma Metastatic Adrenal Gland Pheochromocytoma Metastatic Carcinoid Tumor Multiple Endocrine Neoplasia Type 1 Multiple Endocrine Neoplasia Type 2A Multiple Endocrine Neoplasia Type 2B Neuroendocrine Neoplasm Non-Functional Pancreatic Neuroendocrine Tumor Pancreatic Glucagonoma Pancreatic Insulinoma Recurrent Adrenal Cortex Carcinoma Recurrent Adrenal Gland Pheochromocytoma Recurrent Merkel Cell Carcinoma Somatostatin-Producing Neuroendocrine Tumor Stage III Adrenal Cortex Carcinoma Stage III Thyroid Gland Medullary Carcinoma Stage IIIA Merkel Cell Carcinoma Stage IIIB Merkel Cell Carcinoma Stage IV Adrenal Cortex Carcinoma Stage IV Merkel Cell Carcinoma Stage IVA Thyroid Gland Medullary Carcinoma Stage IVB Thyroid Gland Medullary Carcinoma Stage IVC Thyroid Gland Medullary Carcinoma Thymic Carcinoid Tumor VIP-Producing Neuroendocrine Tumor Well Differentiated Adrenal Cortex Carcinoma Zollinger Ellison Syndrome Pathologically confirmed metastatic unresectable well differentiated (low grade and intermediate grade) neuroendocrine tumors (Ki-67 < 20% and mitotic rate < 2 per 10 high power field) that demonstrate progressive disease (by serial computed tomography [CT] or magnetic resonance imaging [MRI] scans) in past 12 months including Carcinoid tumors originating anywhere in the body including the gastrointestinal (GI) tract or bronchial tree or thymus Pancreatic neuroendocrine tumors (including functional and non-functional islet cell, insulinomas and glucagonomas) Pheochromocytomas Gastrinomas (Zollinger-Ellison syndrome) Multiple endocrine neoplasia (MEN type I/II) Adrenal carcinomas with NET markers by immunohistochemistry (IHC) or serum Somatostatinoma VIPoma (vasoactive intestinal peptide) Merkel cell tumors Prior chemotherapy with combination of capecitabine (or 5-flourouracil [5-FU]) "and" temozolomide (or dacarbazine [DTIC]) will be excluded; patients can have had prior therapies up to 3 prior chemotherapy regimens such as streptozocin, anthracyclines, irinotecan, etoposide, or a platinum agent including single agent capecitabine (or 5FU) or temozolomide (or DTIC) History of severe hypersensitivity reaction to capecitabine, 5-FU, temozolomide or DTIC will be excluded (i.e. anaphylaxis or anaphylactoid reactions) Patients who have active or uncontrolled infection or serious medical or psychiatric illness preventing informed consent or on intensive treatment Patients with brain metastases are excluded Patients with uncontrolled seizures or any neurological conditions resulting in increased risk for seizures are not eligible for study entry Patients with documented central nervous system (CNS) ischemia and/or infarction, whether symptomatic or discovered incidentally without clinical symptoms, will be excluded from study participation Patients with a history of the arterial or venous thromboembolism within =< 12 months of study entry are not eligible Human immunodeficiency virus (HIV)-positive patients on antiretroviral therapy are excluded from the study Patients with another active malignancy within the past five years except for carcinoma in situ of cervix or in situ carcinoma of the bladder or non-melanomatous carcinoma of the skin Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities | 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): 12.0-999.0, Hypereosinophilic Syndrome Capable of giving signed informed consent/assent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol Twelve years of age or older, at the time of signing the informed consent/assent Subjects who have been diagnosed with HES for at least 6 months at randomization A history of two or more HES flares within the past 12 months prior to screening. Historical HES flares are defined as documented HES-related worsening of clinical symptoms or blood eosinophil counts requiring an escalation in therapy. At least one HES flare within the past 12 months must not be related to a decrease in HES therapy during the 4 weeks prior to the flare Subjects must have blood eosinophil count >=1000 cells/µL present in the sample collected during screening (within 4 weeks prior to randomization) Subjects must be on a stable dose of HES therapy for the 4 weeks prior to randomization. HES therapy includes but is not limited to oral corticosteroid, immunosuppressive, and cytotoxic therapy Male or female. A female subject is eligible to participate if she is not pregnant, not lactating, and either non-reproductive potential or reproductive potential and agree to use a highly effective method to avoid pregnancy from 30 days prior to the first dose of study medication and until 4 months after the last dose of study treatment Life-threatening HES or life-threatening HES co-morbidities: Imminently life-threatening HES disease severity such that the likelihood of death is high unless the course of the disease is interrupted within 12 weeks prior to randomization Subjects who have known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, hematological, respiratory or any other system abnormalities that are not associated with HES and are uncontrolled with standard treatment Eosinophilia of unknown clinical significance Twelve-lead electrocardiogram (ECG) finding: QT interval corrected for heart rate (QTc) > 450 msec or QTc > 480 msec in subjects with bundle branch block or an abnormal ECG finding from the 12-lead ECG conducted at Visit 1 if considered to be clinically significant and would impact the subject's participation during the study based on the evaluation of the Investigator Subjects with documented history of any clinically significant cardiac damage prior to screening that, in the opinion of the investigator, would impact the subject's participation during the study Liver abnormality/disease Alanine transaminase (ALT) >2.5x upper limit of normal (ULN) or ALT>5xULN if documented HES with liver manifestations, or bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent), or current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment). Stable chronic liver disease should generally be defined by the absence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice, or cirrhosis. NOTE: Chronic stable hepatitis B and C (e.g., presence of hepatitis B surface antigen (HBsAg) or positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment) are acceptable if subject otherwise meets entry criteria Clinical diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA) Subjects with a history of or current lymphoma, or subjects with current malignancy or previous history of cancer in remission for less than 12 months prior to randomization. Subjects that had localized carcinoma (i.e., basal or squamous cell) of the skin which was resected for cure will not be excluded FIP1 like 1-platelet derived growth factor receptor (FIP1L1-PDGFR) Status: Subjects who test positive for the FIP1L1-PDGFR fusion tyrosine kinase gene translocation | 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): 18.0-99.0, Neoplasm Metastasis Sarcoma Neoplasms, Germ Cell and Embryonal Melanoma Patients with bilateral pulmonary metastases from sarcomas, melanomas, germ cell tumors, or epithelial malignancies metastatic to the lungs, mediastinum, or pleura who can be rendered no clinical evidence of active disease (NED) or minimal residual disease (MRD) by standard of care metastasectomy where NED refers to diagnostic tests failing to detect presence of disease and MRD refers to low-volume, subclinical disease which is not amenable to standard of care biopsy for histologic confirmation and poses no immediate threat to patient health and would not otherwise warrant standard of care treatment but surveillance instead Patients must have a minimum of two metastases per hemithorax Patients with active disease outside the thorax may be eligible for study once the extrathoracic disease is definitively treated by local modalities such as radiation, surgery, or radiofrequency ablation Patients must have adequate pulmonary reserve evidenced by predicted post-operative FEV1 and DLCO equal to or greater than 40% predicted; pCO2 less than 50 mm Hg and pO2 greater than 60 mm Hg on room air ABG; and be on no immunosuppressive medications except inhaled corticosteroids Patients must have received first line standard systemic therapy for their metastases (if applicable) Patients with intracranial metastases, which have been treated by surgery or radiation therapy, may be eligible for study provided there is no evidence of active disease and no requirement for anticonvulsant therapy or steroids following treatment Patients must have an ECOG performance status of 0-2 Patients must have recovered from non-hematologic toxicities associated with treatment of malignancy to less than or equal to grade 1 Patients must be 18 years of age or older due to the unknown effects of systemic DNA hypomethylation and immunologic responses to germ cell-restricted gene products during childhood and adolescent development Patients must have evidence of adequate bone marrow reserve, hepatic and renal function as evidenced by the following laboratory parameters Patients with uncontrollable progression of extra-thoracic disease will be excluded from study Patients requiring corticosteroids (other than inhaled) will be excluded Patients receiving warfarin anticoagulation, who cannot be transferred to other agents such as enoxaparin or dabigatran, and for whom anticoagulants cannot be held for up to 24 hours will be excluded Patients with uncontrolled hypertension (>160/95), unstable coronary disease evidenced by uncontrolled arrhythmias, unstable angina, decompensated CHF (>NYHA Class II), or myocardial infarction within 6 months of study will be excluded Patients with other cardiac diseases may be excluded at the discretion of the PI following consultation with Cardiology consultants Pregnant and/or lactating women will be excluded due to the unknown, potentially harmful effects of immune response to CT-X antigens and stem cell proteins that may be expressed in placenta, fetus, and neonates Patients with active infections, including HIV, will be excluded, due to unknown effects DAC/THU on systemic immunity For patients enrolled on celecoxib cohort: history of ulcer disease or gastrointestinal bleeding, hypersensitivity or asthma to celecoxib, sulfa drugs, aspirin or other NSAID | 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, Systemic Lupus Erythematosus SLE diagnosis fulfilled the Systemic Lupus International Collaborating Clinic revision of the American College of Rheumatology Classification for SLE Disease stabilized ≥ 1 year ≤ 3 Anti-double strand DNA negative by IF measurement and ≤ 200IU/ml by ELISA method Complement 3 (C3) ≥ 0.5*lower limit of the normal range, and fluctuation of the C3 is less than 10% within the last year hour urine protein ≤ 0.5g Prednisone (or equivalent) ≤ 7.5mg/d for more than 6 months No use of immunosuppressants including CsA, MMF, CTX, FK506, LEF, MTX in recent 6 months. But hydroxychloroquine (HCQ) is permitted and should be in use Never use biologic agents including Rituximab, Belimumab, Epratuzumab and so on No severe organ involvement in recent 2 years including lupus encephalosis, diffused alveolar hemorrhage, thrombotic thrombocytopenia purpura, rapid progressive glomerulonephritis, severe thrombocytopenia, severe hemolytic anemia, myocardial involvement, myeleterosis or severe peripheral neuropathy Active SLE In pregnancy or breastfeeding, plan for pregnancy Plan or has been on a surgery in recent 6 months Current infection History of malignancy Severe organ dysfunction or other complications Unable to follow up Inappropriate to be enrolled Psoriasis, porphyria, arrhythmia or eye diseases that contradict with HCQ usage | 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, Gout >/= to 18 yrs of age with Current physician diagnosed gout current hyperuricemia (serum urate level >6.8 mg/dl) self-report of at least two gout flares in the previous 6 months current smartphone user utilizing a FitBit compatible smart Phone (with the ability to download RheumPRO from Apple/Google Play store) | 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, Systemic Auto-immune Diseases Quality of Life For all patients Patients aged 18 to 75 years Patients able to understand written and spoken French Patients who have been given oral and written information about the research For patients with SLE SLE defined by American College of Rheumatology (ACR) 1997 For patients with systemic sclerosis SSc according to the Leroy or American Rheumatism Association (ARA) For patients with IM IM according to the Trojanov Refusal to take part in the study Cognitive/psychological status incompatible with interviews | 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, Hepatitis B, Chronic Hepatitis D, Chronic Signed written informed consent Any patients not enrolled in the REP 301 protocol or not successfully completing all treatment and follow-up visits in the REP 301 protocol 2. A history of alcohol abuse within the last year 3. The use of illicit drugs within the past two years. 4. Inability to provide informed consent. 5. Inability or unwillingness to provide blood samples | 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): 1.0-31.0, B Acute Lymphoblastic Leukemia Central Nervous System Leukemia Ph-Like Acute Lymphoblastic Leukemia Testicular Leukemia Patients must be enrolled on APEC14B1 and consented to Screening on the Part A consent form prior to enrollment on AALL1131 White Blood Cell Count (WBC) Age 1-9.99 years: WBC >= 50 000/uL Age 10-30.99 years: Any WBC Age 1-30.99 years: Any WBC with Testicular leukemia CNS leukemia (CNS3) Steroid pretreatment Patients must have newly diagnosed B lymphoblastic leukemia (2008 World Health Organization [WHO] classification) (also termed B-precursor acute lymphoblastic leukemia); patients with Down syndrome are also eligible Organ function requirements for patients with Ph-like ALL and a predicted TKI-sensitive mutation: patients identified as Ph-like with a TKI-sensitive kinase mutation must have assessment of organ function performed within 3 days of study entry onto the dasatinib arm of AALL1131 With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or any cancer diagnosed prior to the initiation of protocol therapy on AALL1131; patients cannot have secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy; patients receiving prior steroid therapy may be eligible for AALL1131 Patients with BCR-ABL1 fusion are not eligible for post-induction therapy on this study but may be eligible to enroll in a successor Children's Oncology Group (COG) Philadelphia positive (Ph+) ALL trial by day 15 Induction DS HR B-ALL patients with Induction failure or BCR-ABL1 Female patients who are pregnant are ineligible since fetal toxicities and teratogenic effects have been noted for several of the study drugs Lactating females are not eligible unless they have agreed not to breastfeed their infant Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation | 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, Pancreatic Neuroendocrine Tumor G1 Pancreatic Neuroendocrine Tumor G2 Refractory Pancreatic Neuroendocrine Carcinoma Patients must have unresectable or metastatic, histologically confirmed low or intermediate grade (Klimstra Criteria) pancreatic neuroendocrine tumor (PNET) with radiological evidence of disease progression since last treatment Refractory disease to treatment with an mTOR inhibitor Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, are ineligible Disease that is currently not amenable to surgery, radiation, or combined modality therapy with curative intent Patients must not have poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid and small cell carcinoma Patients must have measurable disease Documented radiological evidence for disease progression (measurable or nonmeasurable) =< 12 months prior to enrollment NOTE: If patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation; at least one measurable lesion as per Response Evaluation in Solid Tumors (RECIST) Prior or concurrent therapy with SSA is permitted; a stable dose at least 2 months prior to study start and must continue on the stable dose while receiving study treatment; SSA is not considered as systemic treatment Recovered from adverse events to grade 1 or less toxicity according to Common Terminology for Adverse Events version 4.0 (CTCAE 4.0) due to agents administered previously | 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, Eating Disorders Primary diagnosis: eating disorder according to DSM IV (Diagnostic and statistical manual of mental disorders fourth edition) based on diagnostic interview Illness duration of ED >10 Participated in at least three failed specialized eating disorder treatments Written informed consent Having the mental capacity to make provide informed consent to research participation Somatically stable Somatically unstable | 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): 0.0-65.0, Chronic Graft-versus-host Disease Written informed consent Male not pregnant female patients <65 years old Diagnosis of cGVHD steroid refractory (no response after Prednisone ≥1mg/kg ) or steroid-dependent cGVHD (had an initial response followed by a cGVHD flare upon steroid taper) Patient intolerant to steroid therapy Patients with stable disease, not well controlled by the current treatment Pregnancy HIV positive Severe liver or renal impairment: serum creatinine >2.5 mg/dl; serum bilirubin>2.5 mg/dl (without evidence of hepatic cGVHD) Uncontrolled malignancies including the persistence of the underlying malignancy before the Allogeneic Transplantation and the relapse of hematopoietic malignancy Any other investigational agents administered within last four weeks Cardiac insufficiency (>grade II, New York Heart Association classification) Inability to comply with medical therapy or follow-up | 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, Systemic Lupus Erythematosus Meet the American College of Rheumatology for the diagnosis of SLE Under standard treatment (≥ 2 months) at the time of Background treatment failed to control flares or to permit prednisone tapering With at least one of the following manifestations: thrombocytopenia, disease-associated rash, mouth ulcer, non-infectious type of fever, active vasculitis, renal disorder(proteinuria>0.5g/day), neuropsychiatric SLE Positive for at least one of the following laboratory tests: ANA>1:160, anti-dsDNA, immunoglobulin>20g/L, decreased C3 or C4, leukopenia<3×10^9/L, thrombocytopenia<100×10^9/L SLE disease activity index(SLEDAI) ≥ 8 Negative HIV test Negative for hepatitis B and C virus Written informed consent form Sever chronic liver, kidney, lung or heart dysfunction; (heart failure (≥ grade III NYHA), hepatic insufficiency (transaminases> 3N) ) Serious infection such as bacteremia, sepsis Cancer or history of cancer cured for less than five years (except in situ carcinoma of the cervix or Basocellular carcinoma) High-dose steroid pulse therapy (>1.5mg/kg) or IV bolus of corticosteroids in the last 2 months History of administration of rituximab or other biologics Purified protein derivative (tuberculin) >10mm Mental disorder or any other chronic illness or drug-abuse that could interfere with the ability to comply with the protocol or to give information Inability to comply with IL-2 treatment 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): 18.0-999.0, Acute Urticaria Male or female patients with a diagnosis of acute urticaria who need treatment with antihistamine to alleviate their symptoms; 2. 18 years of age or older; 3. Be willing and able to give informed consent; 4. Patients with a Patient rated Pruritus Severity Score ≥ 1 Receipt of an investigational drug or device, within the past 30 days; 2. Patients in whom an antihistamine may be contraindicated (e.g. narrow angle glaucoma, symptomatic prostatic hypertrophy); 3. Patients who, in the opinion of the investigator, may not tolerate an IV injection of diphenhydramine 50 mg, or cetirizine 10 mg; 4. Receipt of any antihistamine (H1 antagonist) within the past 2 hours regardless of the route of administration, e.g. diphenhydramine, cetirizine, loratadine, fexofenadine, levocetirizine, desloratadine; 5. Receipt of an H2 antagonist within the past 2 hours; 6. Receipt of doxepin within the past 2 hours; doxepin is an antidepressant, but it also has antihistamine properties; 7. Receipt of steroids by the oral, IV, IM, or inhalational routes route within the past 4 hours to manage an acute allergic reaction; 8. Receipt of epinephrine (EpiPen or any other brand) within the past 20 minutes; 9. Anaphylaxis prior to the acute anaphylactic symptoms having been treated. 10. Has known allergy to hydroxyzine, cetirizine or levocetirizine, or diphenhydramine; 11. Pregnancy or breastfeeding; 12. Patients who have an acute allergic reaction to medication they are taking (e.g. antibiotics, NSAIDs, etc.) and who cannot stop the medication; 13. Patients who, based on their medical history or in the opinion of the investigator, have chronic urticaria, hereditary angioedema, urticaria refractory to antihistamines, or dermatological disease that interferes with evaluation of a therapeutic response; 14. Any condition that in the view of the investigator makes the subject unsuitable for enrollment in this study; 15. History of HIV or other known immunodeficiency; 16. Major medical or psychiatric illness, other than acute urticaria, at the time of presentation; 17. Inability to provide informed consent. 18. Patients on concomitant p-glycoprotein inhibitors | 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, Lupus Nephritis Active lupus nephritis Fulfill ACR classification (2009) for SLE Proteinuria ≥1g/24h at screening Nephritis of class III, IV, V, III+IV or IV+V, confirmed by renal pathology within 90 days prior to screening Body weight ≥40kg SLE-2K score ≥8 Agreement of contraception Informed consent obtained Active severe SLE-driven renal disease or unstable renal disease at screening Active severe or unstable neuropsychiatric SLE Clinically significant active infection including ongoing and chronic infections History of receiving cyclophosphamide, azathioprine, tacrolimus , mycophenolate moetil or rituximab treatment with 90 days prior to screening History of human immunodeficiency virus (HIV) Confirmed Positive tests for hepatitis B or positive test for hepatitis C Active tuberculosis Live or attenuated vaccine within 4 weeks prior to screening Subjects with significant hematologic abnormalities Abnormal liver function test at screening (ALT, AST or total bilirubin over 2 fold of upper normal level | 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, Infection Systemic Age ≥ 18 years Signed informed consent Assumed or proven infection Patient admitted to the unit participating in the study Patients with severe immunosuppression, such as severe neutropenia (<500 neut/mm3), transplantation of solid organs or cells hematopoietic, HIV infection with CD4+ < 200/mm3 Patients with multiple trauma, burns or surgery grid size in the last 5 days (Except surgery for focus control) Use of antibiotics supposedly or proven to be effective against the infectious process in for more than 48 hours Patients undergoing palliative care Patients with death expectancy for the next 24 hours Patients with bacteremia caused by Staphylococcus aureus or Candida spp Patients with infections that are known to require prolonged antibiotic therapy | 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): 3.0-15.0, Nephrotic Syndrome Steroid-Dependent Interleukin 2 Children between 3 and 15 years of age (included) with a steroid responsive idiopathic nephrotic syndrome Idiopathic nephrotic syndrome progressing for less than 1 year Steroid dependent idiopathic nephrotic syndrome (at least 1 relapse when steroids are tapered off or within 3 months after their withdrawal, and reliance on steroids > 15 mg/m² every other day) Steroid dose at between 15 and 60 mg/m²every other day Patient with a stable dose of steroids within the 8 days before and after the first injection of IL2 Patient in remission for more than 15 days Patient affiliated to a French health insurance Signed consent of parental authority Hypersensitivity to IL2 or to one of its excipients Significant history or presence of cardiopathy Signs of evolving infection requiring an antibiotic treatment Respiratory distress, respiratory infection or chronic respiratory failure Serious dysfunction of one of the vital organs Leukocytes < 4000/mm3 ; platelets < 100 000/mm3; hematocrit <30% Anomaly of serum bilirubin and creatinin levels History of organ allograft Other pre-existing autoimmune disease Male and female pubescent teenagers under the age of 15 | 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, Smoking Oxygen Deficiencies Sixty patients undergoing lobectomy using one lung ventilation by double lumen tube, ASA physical status 2 and 3 Recent chest infection, morbid obesity, renal, hepatic and ischemic hearts disease, asthma | 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, Diabetes Mellitus The patient is a pregnant female 18 years of age or older 2. The patient has been diagnosed with gestational diabetes or is a patient with known diabetes and a confirmed viable pregnancy 3. The pregnancy has a singleton pregnancy 4. The patient has access to a cellular phone with a text messaging plan The patient does not have a cellular phone 2. The patient becomes hospitalized for a pregnancy complication for the remainder of pregnancy 3. The fetus has a chromosomal or non-chromosomal malformation | 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, Myelomonocytic, Chronic ≥18 years of age at the time of signing the informed consent form CMML-1 with indication for treatment according to NMDSG guidelines* Life expectancy of more than three months and ability to undergo routine outpatient evaluations for efficacy, safety, and compliance The patient must be informed of the investigational nature of the study and written informed consent obtained and signed including, but not limited to increasing WBC, transfusion dependence, B-symptoms, splenomegaly Acute myeloid leukemia CMML-2 according to WHO criteria Systemic mastocytosis Previous or intended allogeneic stem cell transplantation Concomitant or intended cytostatic or cytoreductive therapy other than hydroxyurea (HU) * ECOG performance status ≥3 Platelet count (TPK) <30x109/L NYHA class III or IV cardiac disease, hypotension or severe hypertension, vasomotor instability, serious or uncontrolled cardiac dysrhythmias (including ventricular arrhythmias) at any time, acute myocardial infarction within the past 12 months, angina pectoris or symptomatic arteriosclerotic blood vessel disease Other active malignancies except in situ carcinoma of the cervix, localized squamous or basal cell carcinoma of the skin Serious concurrent or recent non-malignant medical conditions which, in the opinion of the Investigator, makes the patient unsuitable for participation in this 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, Pelvic Organ Prolapse Urinary Incontinence,Stress Surgery Female patients Over 18 years old Speak English and are capable of giving informed consent and are able to complete the English patient questionnaire Are willing to return to the office for all necessary visits associated with the study Had outpatient gynecology pelvic floor surgery for prolapse or stress urinary incontinence Failed the voiding trial in the recovery room Discharged to home on POD#0 Pre-operative urinary retention as defined as PVR > 200ml Prior incontinence surgery Passed the voiding trial in the recovery room Require prolonged catheterization due to urethral/bladder abnormality (ie vesicovaginal fistula, urethral diverticulum) or intra-op urethral or bladder injury or for intensive post-operative monitoring Patients who take any post-operative antibiotics, other than prophylaxis during catheterization, for reasons other than a UTI as diagnosed and prescribed as part of the study Patients who take any supplements to prevent UTIs, including but not limited to D-Mannose, Hiprex, or Ellura Receive any post-operative vaginal estrogen during the study period Have any neurological conditions that may affect bladder function (ie. Multiple sclerosis, spinal cord injuries, etc.) Patients with pre-operative narcotic medication use due to chronic pain Patients who take any over-active bladder medication within one week of their surgery | 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): 18.0-99.0, Systemic Lupus Erythematosus Arthritis Adults aged at least 18 years old Active musculoskeletal SLE defined by inflammatory musculoskeletal pain with either clinical synovitis, ultrasound tenosynovitis or positive power Doppler in at least 1 joint No contraindication to the use of IV methylprednisolone, biosimilar rituximab, or any other required medications such as antipyretics and antihistamines Willing to use appropriate contraception if at risk of pregnancy Disease activity that is refractory to hydroxychoroquine, or patients unable to take hydroxychoroquine due to contra-indication or prior toxicity • Severe "critical" SLE flare defined as: (i) BILAG 2004 A flare in CNS system; (ii) BILAG 2004 A flare in the renal system; or (iii) any other SLE manifestation requiring more immunosuppression than allowed within the protocol in the physician's opinion Pregnancy Breast Feeding Receipt of daily oral glucocorticoids greater than 10mg prednisolone or equivalent at screening or within the previous 5 days, or change in glucocorticoid dose in the previous 5 days Receipt of intramuscular or intravenous glucocorticoids within the past 4 weeks Receipt of intravenous immunoglobulin, plasma exchange or cyclophosphamide within the last 3 months Rituximab within the past 18 months or other biologic therapies within the past 6 months Active infections, including but not limited to the human immunodeficiency virus, hepatitis B (including prior infection as judged by positive Hepatitis B core antibody) or hepatitis C Serum IgG below the lower limit of the local laboratory range Receipt of a live attenuated vaccine within 3 months prior to study 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): 18.0-80.0, Colitis, Ulcerative Colitis Ulcerative Exacerbation Willingness to comply with all trial procedures and being available for the duration of the trial Clinically and histologically verified ulcerative colitis eligible for treatment with thiopurines due to steroid dependence (failure to taper steroid or starting a second course of systemic steroids within 1 year) or patients with the need for rescue therapy with anti-TumorNecrosisFactorα (anti-TNFα) A sigmoidoscopy or colonoscopy showing active inflammation during the present disease flare Negative stool test for pathogen bacteria incl. Clostridium difficile Informed consent Normal TPMT genotype (homozygous wild-type) Oral 5-Asa dose stable for 2 weeks Kidney disease with a GlomerularFiltration Rate (GFR) < 50 ml/min Persistent alanine aminotransferase U/L (ALT) twice above upper limit of the normal range Participation in other interventional clinical trials Pregnancy or breastfeeding Previous thiopurin treatment Previous or current treatment with other biologics than anti-TNFα Not being able to comply with the study, assessed by investigator | 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, Transplant Dysfunction Magnesium Disorder Kidney transplant recipients who used only proton pump inhibitors and did not use histamine H2 receptor antagonists (Only PPI) Kidney transplant recipients who used histamine H2 receptor antagonists and did not use proton pump inhibitors (Only H2RA) Kidney transplant recipients who used both proton pump inhibitors and histamine H2 receptor antagonists (PPI and H2RA) Kidney transplant recipients who used neither proton pump inhibitors nor histamine H2 receptor antagonists (No Acid Suppressive Treatment) Patients who are unwilling or unable to 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): 18.0-75.0, Urticaria Aged 18-75 years, inclusive Diagnosis of chronic spontaneous urticaria (CSU) refractory to H1 antihistamines at the time of randomization Willing and able to complete an Urticaria Participant Daily eDiary for the duration of the study No evidence of active or latent or inadequately treated infection with tuberculosis (TB) Partcipants with a history of Bacille Calmette-Guérin (BCG) vaccination should be screened using the QuantiFERON-TB-Gold (QFT) test Only for participants currently receiving proton-pump inhibitors (PPIs) or H2 receptor antagonists (H2RAs): Treatment must be at a stable dose during the 2-week screening period prior to randomization and with a plan to remain at a stable dose for the duration of the study For women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 4 weeks after the last dose of study drug. Women must refrain from donating eggs during this same period Treatment with omalizumab or other monoclonal antibody therapies used to treat CSU within 4 months prior to screening or primary nonresponse to omalizumab Use of a non-biologic investigational drug or participation in an investigational study with a non-biologic drug within 30 days prior to study drug administration on Day 1 (or within 5 half-lives of the investigational product, whichever is greater) Use of a biologic investigational therapy or participation in an investigational study involving biologic therapy within 90 days or 5 half-lives, whichever is greater, prior to study drug administration on Day 1 Previous treatment with GDC-0853 or other Bruton's tyrosine kinase (BTK) inhibitors Participants whose urticaria is solely due to physical urticaria Other diseases with symptoms of urticaria or angioedema, including urticarial vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary or acquired angioedema, lymphoma, or leukemia Atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, or other skin disease associated with itch such as psoriasis Routine doses of the following medications within 30 days prior to screening: systemic or cutaneous (topical) corticosteroids (prescription or over the counter), hydroxychloroquine, methotrexate, cyclosporine, or cyclophosphamide Prior utilization of intravenous (IV) steroids for treatment of laryngeal angioedema Intravenous immunoglobulin G (IV IG) or plasmapheresis within 30 days prior to screening | 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, Urinary Retention Voiding Disorders Females at least 18 years of age Understand and voluntarily sign an informed consent form English-speaking (able to read and understand English) Undergoing total laparoscopic hysterectomy for benign indication Undergoing concomitant procedures in addition to hysterectomy which may cause urinary dysfunction Undergoing robotic-assisted laparoscopy or laparotomy Known history of pre-operative urinary incontinence or retention History of prior bladder or prolapse surgery Neurologic or spinal cord injury affecting bladder function Pregnant women Evidence of gynecologic malignancy Currently taking anticholinergic medications | 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, Facial Papulopustular Rosacea Moderate-to-severe rosacea (as per the IGA score) on the proposed facial treatment area consisting of: 1. At least 15 and not more than 75 facial papules and pustules, excluding lesions involving the eyes and scalp; 2. No more than 2 nodules on the face. 2. Presence of or history of erythema and/or flushing on the face Presence of any skin condition and/or Excessive facial hair, on the face that would interfere with the diagnosis or assessment of rosacea. 2. Moderate or severe rhinophyma, dense telangiectasia (score 3, severe), or plaque-like facial edema. 3. History of hypersensitivity or allergy to minocycline, any other tetracycline, or of any other component of the formulation. 4. Active ocular rosacea (eg, conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics | 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): 21.0-99.0, Relapse and / or Refractory Myeloma Multiple myeloma, diagnosed according to standard with relapsing and refractory disease at study entry 2. Patients must have evaluable multiple myeloma with at least one of the following (within 21 days of starting treatment) 1. Serum M-protein ≥ 0.5g/dL, or 2. In subjects without detectable serum M-protein, Urine M-protein ≥ 200mg/24 hour, or serum free light chai (sFLC) > 100mg/L (involved light chain) and an abnormal kappa/Lambda ratio 3. Must receive at least 1 line of prior treatment. (Induction therapy followed by stem cell transplantation and consolidation/maintenance therapy will be considered as one line of treatment) 4. Must have relapsed disease and/or be refractory to prior treatment except for thalidomide or lenalidomide. Refractoriness is defined as disease progression on treatment or progression within 6 months after the last dose of a given therapy. Relapse is defined according to the of IMWG 5. Males and females ≥ 18 years of age or > country's legal age for adult consent 6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 7. Patients must meet the following clinical laboratory with 21 days of starting treatment: 1. Absolute neutrophil count (ANC) ≥ 1,000/mm3 and platelet ≥ 50,000/mm3 (≥ 30,000/mm3 if myeloma involvement in the bone marrow is >50%) 2. Total bilirubin ≤ 1.5 x the upper limit of the normal range (ULN). Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN. 3. Calculated creatinine clearance ≥ 30mL/min. 8. Written informed consent in accordance with federal, local and institutional guidelines Female patients who are lactating or pregnant 2. Multiple Myeloma of IgM subtype 3. Glucocorticoid therapy (prednisolone > 30mg/day or equivalent) within 14 days prior to informed consent obtained 4. POEMS syndrome 5. Plasma cell leukemia or circulating plasma cells ≥ 2 x 109/L 6. Waldenstrom's Macroglobulinaemia 7. Existing peripheral neuropathy of grade 2 or higher or presence of neuropathic pain 8. Patients with known amyloidosis 9. Chemotherapy with approved or investigation anticancer therapeutics within 21 days prior to starting Dara-TD treatment 10. Focal radiation therapy within 7 days prior to start of Dara-TD. Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to start of pomalidomide 11. Immunotherapy (excluding steroids) 21 days prior to start of Dara-TD 12. Major surgery (excluding kyphoplasty) within 28 days prior to start of Dara-TD 13. Active congestive heart failure (New York Heart Association [NYHA] Class III or IV), symptomatic ischaemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within 4 months prior to informed consent obtained 14. Known HIV seropositive, hepatitis C infection, and/or hepatitis B (except for patients with hepatitis B surface antigen or core antibody receiving and responding to antiviral therapy directed at hepatitis B: these patients are allowed) 15. Patients with known cirrhosis 16. Patients with creatinine clearance <30m/min 17. Second malignancy within the past 3 years except: 1. Adequately treated basal cell or squamous cell skin cancer 2. Carcinoma in situ of the cervix 3. Breast carcinoma in situ with full surgical resection 18. Patients with myelodysplastic syndrome 19. Patients with steroid or thalidomide hypersensitivity 20. Patients previously treated with daratumumab or other anti-CD38 antibodies. 21. Ongoing graft-versus-host disease 22. Patients with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to starting Dara-TD treatment 23. Disease refractory to thalidomide or lenalidomide 24. Contraindication to any of the required concomitant drugs or supportive treatments 25. Any clinically significant medical disease or psychiatric condition that, in the investigator's opinion, may interfere with protocol adherence or a patient's ability to give 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): 18.0-45.0, Urinary Tract Infections (UTI's) pre-menopausal women present with an acute, uncomplicated, culture confirmed UTI, defined as dysuria, urgency and/or frequency at least one previous medically diagnosed UTI in past 12 months using a reliable method of birth control ie: history of tubal ligation, male partner with vasectomy, steroidal contraception, Nuva-Ring, IUD, use of non spermicidal condoms or abstinence can provide written consent can understand and read English history of urogenital infection within the past 30 days, including: UTI, medically diagnosed vaginitis current symptoms suggestive of pyelonephritis (fever>100.4, flank pain of costovertebral angle tenderness, nausea and vomiting history of functional or anatomic urologic abnormalities, urologic surgery of chronic urinary catheterization history of pyelonephritis within the past 6 months diagnosis of N. gonorrhoeae, C. trachomatis or T. vaginalis on two or more occasions during previous six months known HIV infection of seropositivity investigational drug use within 30 days of enrollment visit or current participation in another clinical trial diabetes, other significant medical problem or intercurrent acute illness that in the Nurse Practitioner's and/or Principal Investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objective. At the randomization visit, has any of the following findings on pelvic or other physical examination unable to visualize cervix clinically significant abnormalities, such as inflammation, erosion and/or petechiae (bleeding under the skin) of external genitalia, vaginal or cervix on visual examination | 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, Inflammatory Disorder Autoimmune Informed Consent as documented by signature (Appendix Informed Consent Form) Age ≥ 18 years Daily glucocorticoid dose ≥ 7.5 mg prednisone-equivalent at the time of Therapy over ≥ 28 days, ≥ 7.5 mg average daily dose, with a cumulative glucocorticoid dose ≥ 420 mg prednisone-equivalent prior to Tapering not or no longer mandatory to treat underlying disease Primary adrenal failure Treatment with systemic depot glucocorticoids (e.g. intramuscular, epidural) Incapability to administer glucocorticoid cover treatment in situations of stress Inability or unwillingness to provide informed consent Women who are pregnant or breast feeding Intention to become pregnant during the course of the study Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases Known or suspected non-compliance Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant Participation in another study with investigational drug within the 30 days preceding and during the present 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): 7.0-999.0, Drug Hypersensitivity Penicillin Allergy Antibiotic Allergy All patients seven years of age or older who have a low-risk, non-life-threatening history of adverse reaction to an antibiotic Patients under the age of seven Pregnant patients Patients with a history of a drug reaction that is high-risk and life-threatening including life-threatening angioedema, bronchospasm, or anaphylactic shock or a history of severe non-IgE-mediated reactions including serum sickness, Stevens-Johnson syndrome, toxic epidermal necrolysis, interstitial nephritis, hepatitis, hemolytic anemia, DRESS, skin and/or oral blisters, hypersensitivity vasculitis, pneumonitis, or pulmonary fibrosis Patients who have taken antihistamines within 3 days of the drug challenge | 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, Colitis, Ulcerative Age>18 years Voluntary to participate to the study Flare-up of ulcerative colitis with Mayo score >6 Ability to receive steroid or anti-TNF therapy Agree the rectosigmoidoscopy and the therapies Age <18 years Pregnancy Disagree the rectosigmoidoscopy or the therapies Participation to the evaluation of a new therapy Colectomy (partial or total) Contraindication of steroid or anti-TNF therapy Anticoagulant 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): 6.0-999.0, Lupus Erythematosus, Systemic Patient aged ≥ 6 years Patient who met the American College of Rheumatology (ACR) or the Systemic Lupus International Collaborating Clinics Classification (SLICC) for systemic lupus erythematosus Patients needs (re)initiation of oral prednisone regimen at least at 0.5 mg/Kg/d(or >30mg/d for patients >60 kg) in combination with mycophenolate mofetyl or mycofenolic acid or cyclophosphamide at usual dose including : i) patient who receives bolus of methylprednisolone the week before and/or the week after for treating the lupus flare ii) patient who was previously treated by a low-prednisone dose (≤ 7.5 mg/d in patients ≥ 60 kg and ≤ 0.1 mg/kd/d in patient < 60 kg). iii) patient who was previously treated by prednisone ≥ 0,5 mg/kg/d (or >30mg/d for patients >60 kg) but stopped since at least one month before Patient with stable doses of other immunosuppressive or biological drugs before (at least 15 days for Imurel, Methotrexate, Tacrolimus ; at least 6 months for Rituximab, Belimumab) and during the 3 months of patient participation in the study Signed informed consent form by the patient (if aged ≥ 18 years), or by the parents / legal guardian and patient's agreement (if aged < 18 years) Patient affiliated to the health insurance system Patient presents contraindications to corticosteroids Patient presents contraindications to MMF, mycofenolic acid or cyclophosphamide for patient receiving immunosupressor Patient cannot be treated by oral way Patient whose physician has planned to stop prednisone in less than 3 months Patient (or parents for minor) are unable to give a written informed consent for physical or psychical reasons Patient disagrees with 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, Diffuse Large B Cell Lymphoma Diagnosed as diffuse large B-cell Lymphoma with positive CD20 results; 2. Age between 18 to 75 years old; 3. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2; 4. No history of malignant tumors, having no tumor other than DLBCL at the time of enrollment; 5. Life expectancy no less than 6 months 6. The patient or his/her attorney would be able to provide written consent for necessary examinations or procedures; 7. IPI mark>1 History of autologous stem cell transplantation; 2. History of other malignant tumors, except skin basal cell carcinoma and in situ cervical cancer; 3. With uncontrolled cardiovascular/ cerebrovascular disease, coagulation disorders, connective tissue disease, severe infectious diseases; 4. Lymphoma originated in the central nervous system; 5. Left ventricular ejection fraction ≦50％ 6. Abnormal lab results in enrollment: 1. Neutrophil count: <1.5*109/L； 2. Platelet count <75*109/L； 3. AST or ALT >2 times the upper limit of normal level，AKP and total bilirubin >1.5 times the upper limit of normal level; 4. serum creatinine >1.5 times the upper limit of normal level; 7. Other uncontrolled medical conditions which the investigators think might influence the results of the trial; 8. Patients with mental illnesses or other diseases that might not comply with the trial plan; 9. Women during pregnancy or lactation; 10. HIV positive patients; 11. HbsAg (+) patients with HBV DNA(+), can be enrolled only when his/her HBV DNA turns negative; patients with HBsAg(-) HBcAb(+) can be enrolled only when his/her HBV DNA turns negative | 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, Infection Heart Failure COPD Asthma Gout Flare Chronic Kidney Diseases Hypertensive Urgency Atrial Fibrillation Rapid Anticoagulants; Increased Resides within either a 5-mile or 20 minute driving radius of emergency department Has capacity to consent to study OR can assent to study and has proxy who can consent >= 18 years-old Can identify a potential caregiver who agrees to stay with patient for first 24 hours of admission. Caregiver must be competent to call care team if a problem is evident to her/him. After 24 hours, this caregiver should be available for as-needed spot checks on the patient. This criterion may be waived for highly competent patients at the patient and clinician's discretion Primary or possible diagnosis of cellulitis, heart failure, complicated urinary tract infection, pneumonia, COPD/asthma, other infection, chronic kidney disease, malignant pain, diabetes and its complications, gout flare, hypertensive urgency, previously diagnosed atrial fibrillation with rapid ventricular response, anticoagulation needs, or a patient who desires only medical management that requires inpatient admission, as determined by the emergency room team Undomiciled No working heat (October-April), no working air conditioning if forecast > 80°F (June-September), or no running water On methadone requiring daily pickup of medication In police custody Resides in facility that provides on-site medical care (e.g., skilled nursing facility) Domestic violence screen positive Acute delirium, as determined by the Confusion Assessment Method Cannot establish peripheral access in emergency department (or access requires ultrasound guidance) Secondary condition: end-stage renal disease, acute myocardial infarction, acute cerebral vascular accident, acute hemorrhage Primary diagnosis requires multiple or routine administrations of intravenous narcotics for pain control | 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, Gastroesophageal Reflux > 18 years old Male or female PPI on home medication reconciliation GERD that is symptom controlled (per questionnaire), OR Gastritis that is symptom controlled (per questionnaire), OR An unclear indication for PPI use but free of GERD/gastritis/ulcer symptoms (includes patients on GI prophylaxis from the hospital and continued medication) Desire or willingness to be off of PPI chronically On PPI chronically (> 2 months or 8 weeks, can be intermittent use) Initial PPI dose cannot exceed more than the equivalent of Omeprazole 40mg PO BID Comprehend English well (per provider's discretion; to understand questionnaires, instructions, etc.) On PPI for fewer than 2 months Co-morbid diagnosis of Peptic Ulcer Disease, H.pylori infection, Barrett's esophagus, malignancy, Inflammatory Bowel Disease Diagnosis of moderate to severe renal impairment (defined as CrCl <50 mL/min; reasoning due to caution of H2RB on renal failure) Diagnosis of prolonged QT interval with renal impairment (reasoning due to H2RB with concomitant renal failure may increase QT interval if not renally dosed) True allergy to Proton Pump Inhibitor and / or H2 Receptor Blocker Patients with frequent cardiac angina symptoms (decreasing the dose of PPI may cause rebound GERD and the patient may think they are having a heart attack) Pregnant women, fetuses, neonates or fetal material Females of reproductive potential at time of research that are not on a form on birth control (OCPs, tubal ligation, etc) or lactating Adults with decisional impairment Prisoners | 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, Chemotherapy-induced Nausea and Vomiting No prior chemotherapy Confirmed malignancy, scheduled to receive carboplatin monotherapy, or carboplatin in combination with agents of minimal, low, or moderate emetic potential Laboratory parameters adequate for chemotherapy Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 3 or 4 Presence of nausea and vomiting or use of major antiemetic agents during the 24 hours before chemotherapy administration Patients receiving radiotherapy within 5 days prior to the carboplatin Pregnancy or lactation Known allergy to any of the 3 antiemetics | 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, Osteoarthritis, Knee Patients of co-investigator physicians Age 18+ years Diagnosis of symptomatic knee osteoarthritis Scheduled for a hyaluronic acid injection into the knee Provider is available to administer teaching method Patients who are already enrolled in the study Non-English speaking | 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, Stroke have had a stroke (ischemic or hemorrhagic) resulting in physical impairment; 2. have enough preserved cognitive ability to learn VRT 3. are receiving inpatient or outpatient stroke rehabilitation services; 4. are able to stand independently for at least 2 minutes 5. have a study partner who could attend 2 training sessions with the participant and was able to be in the home with the participant while doing VRT; 6. can read, speak and understand English; 7. live within 50 km of Élisabeth Bruyère Hospital; 8. are able and willing to attend 4 appointments at Élisabeth Bruyère Hospital (2 for assessment; 2 for training); 9. will not be travelling away from home for more than 2 days a week for the duration of the study; 10. have enough space in their home to do VRT safely have an unstable medical condition, seizures or vertigo, 2. are unable to perform mild to moderate exercise safely | 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, Adult-Onset Still Disease Critically Ill AOSD (history of newly diagnosed) ICU admission between January 2001 and June 2017 adults under protection admission in step-down unit | 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, Vaginal Laxity Urinary Incontinence Sexual Dysfunction Healthy female adult subjects presenting, clinically, with VL, and has expressed interest in treatment will be considered eligible for the study. Enrollment of subject will depend on meeting the following Voluntarily signed informed consent form Ages ≥ 18 Completed urine pregnancy examination with negative result if premenopausal Self-reported perceptions of vaginal laxity defined as "very loose," "moderately loose," or slightly loose" on the Vaginal Laxity Questionnaire Up to Baden-Walker Grade 2 or Stage 2 Pelvic Organ Prolapse (≤ 1 cm past hymen) Papanicolaou smear cytology within 36 months prior to treatment showing no dysplasia Subject willing to take valacyclovir at 100 mg PO q12h x 3 for history recurrent episode of HSV or 1000mg PO q daily x 5 days Baden-Walker System Severe pelvic prolapse (≥ Stage 3); Pelvic organ prolapse up to 1 cm beyond the hymenal ring Active STD (e.g. genital herpes, condylomata) Body mass index ≥ 35 Previous reconstructive vaginal surgery, vaginal lasers, or vaginal injections of fat or fillers within 6 months Current urinary tract infection Actively participating in, or planning on participating in, pelvic floor muscle strengthening exercises Presence of pacemaker, AICD, or other electrical health maintenance device Immunosuppression (pathological or medication induced, such as steroids, methotrexate) inflammatory drugs on a chronic basis (e.g., ibuprofen, aspirin and steroids) that can affect collagen or healing. Subject may qualify if willingly fulfills a 30-day washout period of such drugs prior to treatment.They were using anti-inflammatory drugs on a chronic basis (e.g., ibuprofen, aspirin and steroids) that can affect collagen or healing. Subject may qualify if willingly fulfills a 30 days washout period of such drugs prior to treatment. Those with clinically significant anxiety or depression that may prohibit completion of treatments and/or suffering a medical problem that might interfere with wound healing. • All subjects on oral contraceptives prior to enrollment are encouraged to take these throughout 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, Osteoarthritis, Knee Osteoarthritis, Hip Key (additional may apply at screening): 1. A clinical diagnosis of osteoarthritis (OA) of the knee or hip based on the American College of Rheumatology with radiologic evidence of OA (K-L score ≥2 for the index joint) at the screening visit. 2. Willing to discontinue current pain medications and to adhere to study requirements for rescue treatments (acetaminophen/paracetamol to be taken as needed with a maximum daily dose of 2500 mg [countries where 500 mg strength tablets/capsules are available] or 2600 mg [countries where 325 mg strength tablets/capsules are available]) 3. A history of at least 12 weeks of inadequate pain relief or intolerance to analgesics used for pain due to OA of the knee or hip 4. Currently using a stable dose of NSAID 5. Willing to discontinue glucosamine sulfate and chondroitin sulfate treatments during the 24 weeks of treatment Key (additional may apply at screening): 1. Non-compliance with the numeric rating scale (NRS) recording during the pre-randomization period 2. History or presence at the screening visit of non-OA inflammatory joint disease, Paget's disease of the spine, pelvis or femur, neuropathic disorders, multiple sclerosis, fibromyalgia, tumors or infections of the spinal cord, or renal osteodystrophy 3. History or presence on imaging of arthropathy, hip or knee dislocation, extensive subchondral cysts, evidence of severe structural damage, bone collapse, or primary metastatic tumor with the exception of chondromas or pathologic fractures 4. Trauma to the index joint within 3 months prior to the screening visit 5. Signs or symptoms of carpal tunnel syndrome within 6 months of screening 6. Patient is not a candidate for magnetic resonance imaging (MRI) 7. Is scheduled for a JR surgery to be performed during the study period or who would be unwilling or unable to undergo JR surgery if needed 8. History or presence at the screening visit of autonomic or diabetic neuropathy, or other peripheral neuropathy, including reflex sympathetic dystrophy 9. Evidence of autonomic neuropathy as defined in the schedule of assessments (SoAs) 10. History or diagnosis of chronic autonomic failure syndrome including pure autonomic failure, multiple system atrophy 11. Use of systemic corticosteroids within 30 days prior to the screening visit. Intra-articular corticosteroids in the index joint within 12 weeks prior to the screening visit, or to any other joint within 30 days prior to the screening visit 12. Exposure to an anti-NGF antibody prior to the screening visit or known sensitivity or intolerance to anti-NGF antibodies 13. Women of childbearing potential who are unwilling to practice highly effective contraception prior to the start of the first treatment, during the study, and for at least 20 weeks after the last dose | 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, Dysphasia Patients undergoing a primary 1 to 2-level MIS TLIF Diagnosis: myelopathy, radiculopathy, myeloradiculopathy, stenosis, herniated nucleus pulposus, degenerative disc disease, spondylosis, osteophytic complexes, and foraminal stenosis Patients able to provide informed consent Allergies or other contraindications to medicines in the protocol including: (a) Existing history of gastrointestinal bleeding Current Smokers Lumbar spine trauma Bilateral cages Lack of 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): 0.5-16.0, Food Allergy Food Allergy in Infants Food Allergy in Children Food Allergen Sensitisation Milk Allergy Egg Allergy Nut Allergy Children ≥6 months and <16 years old; 2. Suspected IgE-mediated food allergy defined by History of an immediate-type allergic reaction to a specific food or No history of consumption of the specific food or IgE sensitisation documented by skin prick test (≥1 mm) or serum specific IgE (≥0.10 KU/L); 3. Avoidance of the specific food for at least 2 days prior to blood collection for BAT and specific IgE and prior to the challenge; 4. Informed consent obtained from parent or guardian and assent obtained from the child Clinically significant chronic illness other than atopic diseases; 2. Previous history of severe life-threatening reaction to the suspected food with documented decrease in oxygen saturation (<90%), hypotension (≥20% reduction in systolic blood pressure) and/or admission to intensive care; 3. Unwillingness to comply with study procedures, namely to undergo a diagnostic food challenge; 4. Contra-indication for diagnostic food challenge, namely Uncontrolled atopic diseases (e.g. eczema, asthma, rhinitis) Chronic medical conditions that pose significant risk in the event of anaphylaxis or treatment of anaphylaxis (e.g. cardiac disease, severe lung disease, pregnancy, mastocytosis) Inability to discontinue medications that might interfere with assessment or safety (e.g. antihistamines, β-agonists, β-blockers, NSAIDs, ACE inhibitor, antacids) Recent (within 7-14 days) treatment with systemic steroids or prolonged high-dose systemic steroids or immunosuppressants; 5. Undergoing treatment with omalizumab, food allergen immunotherapy or other systemic immunomodulatory treatment; 6. Inability to stop anti-histamines prior to SPT | 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 Subjects must be >=18 years of age at the time of signing the informed consent Subjects who have clinical diagnosis of SLE based on 4 or more of the 11 American College of Rheumatology (ACR) criteria Subjects who have a screening score >=6 (This refers to the total score. Serological activity, i.e., anti-double stranded deoxyribonucleic acid [dsDNA]) positivity and/or hypocomplementemia is not required to be present in assessment, but are scored if present) Subjects who have unequivocally positive autoantibody test results defined as an anti-nuclear (ANA) titer >=1:80 and/or a positive anti-dsDNA (>=30 International Units per milliliter [IU/mL]) serum antibody test from 2 independent time points as follows: Positive test results from 2 independent time points within the study screening period. Screening results must be based on the study's central laboratory results. Or, one positive historical test result and 1 positive test result during the screening period Subjects who are on a stable SLE treatment regimen consisting of any of these medications (alone or in combination) for a period of at least 30 days prior to Day 1 (i.e. day of first dose of study treatment) with the exception that switching one agent for another of the same class for tolerability or availability reasons, which will be allowed within 30 days of Day 1: Corticosteroids (prednisone or prednisone equivalent); For those subjects on alternating daily doses of steroids, use the average of 2 daily doses to calculate the average daily steroid dose; Any immunosuppressant or immunomodulatory agents including methotrexate, azathioprine, leflunomide, mycophenolate (including mycophenolate mofetil, mycophenolate mofetil hydrochloride, and mycophenolate sodium), calcineurin inhibitors (example [e.g.] tacrolimus, cyclosporine), sirolimus, oral cyclophosphamide, 6-mercaptopurine, mizoribine, or thalidomide; Anti-malarials (e.g., hydroxychloroquine, chloroquine, quinacrine); Non steroidal anti-inflammatory drugs (NSAIDs) Male and/or female. A female subject is eligible to participate if she is not pregnant not breastfeeding, and at least one of the these conditions applies: Not a woman of childbearing potential (WOCBP) or A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 16 weeks after the last dose of belimumab, or at least 12 months after the last dose of rituximab or rituximab-placebo Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol Symptomatic herpes zoster within 3 months prior to screening Evidence of active or latent tuberculosis (TB). Documentation may medical history and examination, chest X-rays (posterior, anterior, and lateral), and TB testing: either a positive tuberculin skin test (TST; defined as a skin induration ≥5 mm at 48 to 72 hours, regardless of Baccillus Calmette-Guerin (BCG) or other vaccination history) or a positive (not indeterminate) QuantiFERON-TB Gold Plus test Significant allergies to humanized monoclonal antibodies History of hypersensitivity to belimumab and/or rituximab or known to have titers of human anti-mouse antibody or history of hypersensitivity reactions when treated with other diagnostic or therapeutic monoclonal antibodies Lymphoma, leukemia, or any malignancy within the past 5 years (yrs) except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 yrs Alanine transferase (ALT) greater than 2 times upper limit of normal (ULN) Bilirubin greater than 1.5 times ULN (isolated bilirubin greater than 1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin less than 35%) Immunoglobulin A (IgA) deficiency (IgA level less than 10 milligram per decilitre [mg/dL]) Immunoglobulin G (IgG) less than 250 mg/dL. For Germany only, IgG less than 400mg/dL Neutrophils less than 1.5 times 10^9 | 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, Pain, Postoperative Patients undergoing hysterectomy Coronary Artery Disease Peptic Ulcer Disease Chronic Renal Disease Liver disease Alcohol Abuse Daily narcotic usage Narcotic use 24 hours prior to surgery Crohn's Disease History of myocardial infarction History of stroke | 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, Analgesia Patients of either sex undergoing elective tota knee replacement surgery Patients are capable to provide an informed consent Age 18-65 years Patients with Asthma, copd or any other respiratory disease Persistent nausea , vomiting at the time of randomization Treated with MAO inhibitors, Tricyclic antidepressants, SSRIs and SNRIs Patients with ASA grading 3 or more Drug abuse history, opioid tolerance or dependence, known history of opiod allergies Renal or liver disease Major psychiatric disorder Pregnancy and lactation Emergency surgery Bone tumor, epilepsy or patients with migraine | 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, Autism Spectrum Disorder People who are awaiting an ASD assessment at the host site People who have never visited the site before People who do not receive a diagnosis of ASD following the study will not be included in the inferential statistical analysis. However, they will still be participants in the study and their data will be reported descriptively | 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, Osteoporosis Systemic Mastocytosis Male or female >/= 18 years of age at time of informed consent Willingness and ability to sign informed consent, comply with scheduled visits, treatment plan, laboratory tests and other study procedures Patient with Indolent systemic or cutaneous mastocytosis according to WHO (Appendix 4) with any specific treatment including corticosteroid, chemotherapy and immunomodulating drugs Patient with osteoporosis defined as bone mineral density T score ≤ -2.5 at the lumbar spine, OR osteopenia defined as BMD T-score >-2,5 and ≤ -1 at the lumbar spine and low energy fracture (defined as fractures that are associated with decreased bone mineral density. Are excluded fractures of skull, face, mandible, metacarpals, fingers, or toes, pathologic fracture, and fracture that are associated with severe trauma). (in case of osteoarthritis at the lumbar spine, the T score at left femoral neck or total left hip can be used to define osteoporosis or osteopenia) Patient with aggressive mastocytosis or/and Associated Hematologic Non-Mastocytosis Disease (AHNMD) Patient with conditions that influence bone metabolism (primitive hyperparathyroidism, hyperaldosteronism, hypercorticism, etc …) Patient treated with intravenous bisphosphonate within 1 year prior to enrolment or with any other antiosteoporotic treatment within 3 months before enrolment. (per os bisphosphonate, strontium ranelate) Calcium and vitamin supplementation will be accepted Patient previously treated with denosumab Patient with hypocalcemia and/or hypo25-hydroxyvitamin D level non substituted prior enrolment Woman without contraceptive treatment if of childbearing age Pregnant or breastfeeding woman Patient with contraindication to denosumab Patient with medical, psychiatric or other conditions that may interfere with patient safety Patient with dental problem that need any dental surgery within 6 months after enrolment | 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): 20.0-80.0, Compare the Response Rate of Atypical GERD After PPI Therapy atypical GERD symptoms (cough, globus, or NCCP) 2. with or without typical GERD symptoms (heartburn or acid regurgitation) 3. A total Reflux Symptom Index (RSI) score ≥13 Patients who currently took pro-kinetic agents, baclofen, antacid, sucralfate, histamin-2 receptor antagonists, PPI, antitussive, non-steroid anti-inflammatory drugs, anxiolytics, or anti-depressants during screening and during study period 2. Patients who have severe cardiac, pulmonary, hepatic, or renal diseases 3. Patients who have uncured underlying malignancy 4. Patients with laryngeal or pharyngeal disorders 5. Patients with a history of gastrointestinal (GI) surgery, symptoms of GI tract obstruction 6. Patients with a contraindication for PPI use | 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, Cardiotoxicity HER2/Neu Positive Metastatic Malignant Neoplasm in the Brain Recurrent Breast Carcinoma Stage IV Breast Cancer AJCC v6 and v7 STEP 1 Patients must have metastatic breast cancer and be initiating within 7 days of step 1 registration or continuing trastuzumab?based HER-2 targeted therapy without concurrent anthracyclines in first or second line setting; patients may have brain metastasis; there is no limit for number of doses of HER-2 targeted therapy prior to registration; examples of eligible HER-2 targeted therapy Trastuzumab Trastuzumab + chemotherapy or hormonal therapy Trastuzumab + other HER-2 targeted agent with or without chemotherapy (such as pertuzumab) Ado-trastuzumab (Kadcyla) NOTE: Patients on lapatinib without trastuzumab are not eligible; planned treatment with concurrent HER-2 targeted therapy and anthracyclines is not permitted Patients must be at increased risk for cardiotoxicity defined by at least one of the following Previous anthracycline exposure, OR or more of the following risk factors for heart disease | 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): 18.0-44.0, Plasma Volume Micronutrients Menstrual Cycle Female to 44 years of age General good health (does not have a known, ongoing health condition/medical issue that requires regular monitoring by a doctor or regular visits to the hospital) BMI 18.5-24.9 kg/m2 Regular menstrual cycle (26-35 days) Non-smoker Non-pregnant If pregnant before, ≥12 months since last pregnancy Known allergy to shellfish or iodine Blood pressure on the day of measurements is low or high (systolic blood pressure (SBP) <90 or ≥130 mmHg and/or diastolic blood pressure (DBP) <60 or ≥80 mmHg) Currently has low or high blood pressure (SBP <90 or ≥130 mmHg and/or DBP <60 or ≥80 mmHg), self-reported Current hypertension or previous hypertensive disorder in pregnancy (gestational hypertension or preeclampsia) Taking regular medication(s) (physician's prescribed medications for a health condition) Currently trying to conceive Currently breastfeeding Currently using hormonal birth control or used within last 3 months Used depot medroxyprogesterone acetate (DMPA) in the past 12 months Diagnosis of polycystic ovary syndrome | 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, System; Lupus Erythematosus ≥ 18 years of age who can consent for themselves Location U.S Proficient in English (speaking, reading, and writing) Own or have reliable access to a smartphone (iPhone or Android) Provision of medical record Diagnosis of Lupus SLE as indicated in medical record Symptomatic lupus as indicated by a score of at least 6 on one or more of BPI-SF questions 3, 5, or 6 and/or a score of at least 3 on one or more of the first four questions on the FACIT Current prescription for one or more of the following medications: 20mg/day of oral prednisone (or other oral corticosteroid equivalent dose); methotrexate and/or other immunosuppressive therapy of any dosage such as cyclophosphamide (Cytoxan®), methotrexate (Rheumatrex™), or azathioprine (muran®), adalimumab (Humira Pen, Humira Pen Crohn's-UC-HS Start, Humira Pediatric Crohn's Start, Humira, and Humira Pen Psoriasis-Uveitis), Plaquenil, Cellcept; monoclonal antibodies (mAbs) such as Benlysta® (belimuab, formerly called LymphoStat-B™); rituximab (Rituxan, MabThera and others) Able and willing to consent to study protocol Pregnant and/or planning to get pregnant before end of 16-week intervention In prison during any part of the 16-month study period Resident of a nursing home, wards of the state, or Institutionalized during any part of the 16-month study period Persons with decisional incapacity/cognitive impairment Participating in another clinical trial, interventional or observational research during the study period Plan or intention to receive/start during the 16-week (112 day) intervention period either: 1. a standing dose of oral steroid agents at a 20mg dose of prednisone (or other oral corticosteroid equivalent dose); 2. pulses or tapers of steroids for flares for more than a total of 30 days within the observation period 3. any pulse/taper dose of steroids during the last 4 weeks of the intervention period; 4. immunosuppressive agents, or biologic response modifiers Diagnosed with cancer | 0 |
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