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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, Connective Tissue Diseases Systemic Sclerosis Systemic Lupus Erythematosus Patientw with either (1) systemic lupus erythematosus, (2) systemic sclerosis, or (3) other connective tissue diseases at risk of pulmonary hypertension Voluntarily agrees to participate by providing written informed consent Age ≥ 18 at enrolment Refuse to participate 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): 18.0-70.0, Rhinoplasty Non-steroidal Ant Inflammatory Drugs Opioid Use Patients 18-70 years old undergoing septorhinoplasty or rhinoplasty for either obstructive or aesthetic reasons. All approaches to rhinoplasty and surgical techniques utilized will be included. This will patients that undergo additional procedures during the rhinoplasty including osteotomies, turbinate reduction, septoplasty, nasal valve repair and ear cartilage graft Patients who undergo a rhinoplasty requiring a rib cartilage graft for the procedure as this is known to cause significant pleuritic chest pain Patients receiving functional endoscopic sinus surgery concurrently with the rhinoplasty will be excluded Patients with known history of gastrointestinal bleeds, peptic ulcer disease or who have other comorbidities that prevent them from taking NSAIDs Patients with a history of radiation, active head and neck malignancy or other pain disorders such as various rheumatologic diseases will be excluded to decrease confounding factors in the control of pain | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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 Unexplained infertility (UI) body mass index (BMI) ≥35 kg/m2 Follicle Stimulating Hormone >10 International Unit /Litter in early follicular phase diagnosed cause of infertility, menstrual cycle irregularity ovarian cysts sever cervical stenosis former IUI ongoing pregnancy and renal or hepatic diseases were all the | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | eligible ages (years): 18.0-999.0, Smoking Cessation Smoking, Cigarette Nicotine Dependence Key 1. Age 18 years or above 2. Daily smoker using 10 or more cigarettes per day 3. Willing to be smoke-free for 7 days 4. Is able to provide written informed consent (in English) to participate in the study and able to understand the procedures and study requirements. 5. Is willing to voluntarily sign and date an informed consent form that is approved by an institutional review board before the conduct of any study procedure. Key Current use of a smoking cessation medication (e.g. nicotine replacement, Varenicline, bupropion) 2. Current use of tobacco product other than cigarettes (e.g. e-cigarettes, smokeless tobacco) 3. Not pregnant or breastfeeding 4. Contraindication to the use of bupropion. 5. Additional may apply | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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, Stage IV Cancer Age of 18 and over, male or female; 2. Patients with histologically confirmed advanced (stage IV) gastric cancer, NSCLC, breast cancer or ovarian cancer, who choose monotherapy of oral vascular targeting drug (apatinib) due to intolerability or inappropriateness of other therapies; 3. Presence of measurable lesions (≥10mm on spiral CT scan) subject to 1.1; 4. Blood pressured controlled at 150/100 mHg following drug administration; 5. An ECOG PS score of between 0 and 1; 6. Findings of hematology and laboratory tests at the baseline that meet the following Hemoglobin ≥80g/L; Absolute neutrophil count (ANC) ≥1.5×10^9/L; Platelets ≥90×10^9/L; ALT/AST ≤ 2.5×ULN; or ALT/AST ≤ 5×ULN for patients with hepatic metastases; Serum total bilirubin ≤1.5×ULN; Serum urea nitrogen and creatinine ≤ 1.5×ULN; Serum albumin ≥30g/L; Coagulation function (INR≤1.5, APTT≤1.5 ULN); 7. A life expectancy of at least 3 months; 8. Subjects who volunteer to participate in this study and have signed the Informed Consent Form (ICF), with good compliance with treatment and follow-up Confirmed allergy to apatinin and or its excipients; 2. Hypertension (high blood pressure) that can not be controlled by drugs; 3. A history of active hemorragge, ulcer, intestinal perforation, intestinal obstruction, or major surgery no older than 30 days; 4. NYHA III-IV heart function, or severe hepatic or renal insufficiency (Grade 4); 5. Presence of multiple factors that affect oral medications, such as difficulty swallowing, nausea, vomiting, chronic diarrhea and intestinal obstruction; 6. Pregnant or lactating women, or women of child-bearing potential who have planned a pregnancy, or male and female patients who do not agree to practice adequate contraception during this study; 7. Patients who have a history of psychotropics abuse and can not quit, or who have mental disorders; 8. Participation in other drug clinical trial within the last 4 weeks; 9. Prior therapy with VEGFR inhibitors such as sorafenib and sunitinib; 10. Presence of comorbidities that seriously affect the patient's safety or ability to complete the study, in the investigator's judgment; 11. Patients who can not tolerate apatinib treatment as judged by the investigator depending on the their medical history; 12. Patients that are considered ineligible for this study by 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): 18.0-50.0, Immune Thrombocytopenia Meet the diagnostic for immune thrombocytopenia. 2. 18-50 years of age; gestational age over 32 weeks; 3. No response to the treatment of glucocorticoids and / or intravenous immunoglobulin (a stable dose of glucocorticoid could be accepted); 4. Platelet transfusion was not effective. 5. Platlet count of the patients <30* 10^9/L and had the risk of bleeding or bleeding. 6. No obvious abnormalities in liver and kidney function had (1.5 times higher than normal limit of the serum urea nitrogen, creatinine, serum transaminase and bilirubin ); 7. No severe cardiac and pulmonary dysfunction; 8. No history of mental illness; 9. Voluntarily signed written informed consent A history of serious allergies to biologics; 2. The history of thrombosis; 3. Thromboembolic or hemorrhagic disease; 4. Patients who are deemed unsuitable for the study by 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, Colitis, Ulcerative Hospitalized patients with known or newly diagnosed moderate to severe ulcerative colitis (as defined by the Mayo score ≥6) Consented within the first 48 hours of initiating IV steroids Risk score of >3 points (pts) Mean stool frequency/24 hrs (<4 = 0 pts, 4-6 = 1 pt, 7-9 = 2 pts, >9 = 4 pts) Colonic Dilation = 4pts Hypoalbuminemia (< 3mg/dL) = 1 pts Mayo endoscopic sub-score >2 (moderate to severe) Age >18 and able to make their own medical decisions Complication requiring urgent surgical intervention (in the opinion of the investigators) Clinically significant cardiac, renal, neurological, endocrine, respiratory or hepatic impairment in the opinion of the investigator, including but not limited to Pulmonary (COPD with CO2 retention; Previous/current imaging showing hyperinflation/air trapping/bullous disease/blebs (opinion of investigators), Current pneumothorax or previous spontaneous pneumothorax, Bronchogenic cyst(s)) Cardiac (Uncontrolled HTN (systolic >160 or diastolic >100), Unstable angina or myocardial infarction within the previous 3 months, Ejection fraction < 35%, Current or previous amiodarone use, ICD in place, Pacemaker in place not approved for chamber use) Hematological/Oncological (Current chemotherapeutic drug use, and past history of bleomycin use,Hereditary Spherocytosis, Sickle cell anemia) Gastrointestinal and Infectious Disease (Known or suspected Crohn's disease, Previous infection with mycobacterium, fungus, HIV, Hepatitis B or C, Severe gastrointestinal or systemic infection (opinion of investigator), Current capsule endoscopy or previously non-retrieved capsule Endocrinology (Uncontrolled hyperthyroidism) Neurological and Psychological (Vagal or other nerve stimulators, Uncontrolled seizure disorder, Medications or medical conditions that lower seizure threshold (opinion of the investigator), Drug or alcohol abuse/dependence,Current treatment for alcohol cessation with disulfiram, Current or recent (within past week) use of baclofen) Head and Neck (Previous middle ear damage, surgery or infection(s) which may increase the risk for needing ear tubes (opinion of the investigator),Current or previous retinal detachment or optic neuritis, Retinal or vitreous surgery within the past 3 months) Implanted devices not on the approved list for use with HBOT | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | eligible ages (years): 18.0-999.0, Chronic Spontaneous Urticaria Male and female patients 18 years or older Clinical and/or histopathological diagnosis of conventional CSU Unresponsive to oral antihistamine therapy Good general health as confirmed by medical history Patients who are willing and capable of cooperating to the extent and degree required by the protocol; and Patients who read and sign an approved informed consent for this study Vulnerable study population Pregnant or nursing women Women planning a pregnancy within the study period Current or previous Xolair use Biopsy proven neutrophilic rich urticaria Known history of adverse reaction to Nucala Severe asthma requiring high-dose inhaled or systemic corticosteroids | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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, Bell's Palsy Facial Nerve Paresis English as primary language Acute unilateral facial palsy without skin lesions which developed within a 72-hour period and is present for 21 days or less Moderate to severe facial palsy [House-Brackmann grade IV or greater] Another cause of facial nerve paralysis that is not idiopathic Otologic disease including otitis media, temporal bone fracture, a previous history of facial nerve palsy in either side, history of otologic surgery, and suspected Ramsay Hunt syndrome Systemic disease including history of tuberculosis, history of head and neck cancer, other neurological disorders, recent use of ototoxic medications, liver or renal dysfunction, and other illnesses that would contraindicate the use of high-dose steroid therapy 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, 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): 18.0-75.0, Dermatomyositis, Adult Type Must understand the risks and the benefits/purpose of the study and provide signed and dated informed consent Must be 18 years at time of signing the informed consent form Willing to participate in all required evaluations and procedures in the study including the ability to swallow pills without difficulty Patients must have a diagnosis of DM based upon the characteristic cutaneous findings proposed by Sontheimer[6] and/or a skin biopsy consistent with DM Patients must be candidate for systemic therapy for their DM skin disease defined by inadequate response to aggressive sun protection along with the use of potent topical corticosteroids and/or immunomodulators Patients with a diagnosis of dermatomyositis on steroid-sparing agent and/or systemic steroids (maximum dose of prednisone 1mg/Kg) and still having cutaneous disease activity of at least 5 on the CDASI scale If on immunosuppressive treatments and/or steroids, patients must be on stable doses for at least 4 weeks (28 days) Patients must undergo age appropriate cancer screening Females of childbearing potential (FCBP) must have a negative pregnancy test at screening (day 0 of the study and every month throughout the study). While on investigational product and for at least 28 days after taking the last dose of investigational product Increasing or changing dose of topical therapy within 14 days of study day 0 (including but not limited to topical corticosteroids, tacrolimus, pimecrolimus) Increasing or changing systemic steroids dosing within 28 days of study day 0 Increasing or changing dosing for concurrent therapy agents within 28 days or 5 half-lives of the biologic agent, whichever is longer, before study day 0: methotrexate, azathioprine, mycophenolate mofetil, hydroxychloroquine, dapsone, leflunomide, cyclosporine, biologic agents (anti-TNFs), IVIG, rituximab History of any clinically significant (as determined by the investigators) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major uncontrolled disease Any condition, including the presence of laboratory abnormalities, which places the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study Pregnant or breastfeeding Untreated Latent Mycobacterium tuberculosis infection or active tuberculosis infection as indicated by a positive Purified Protein Derivative (PPD) skin test or T-spot Any condition, including the presence of laboratory abnormalities that places the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study Patients with acute dermatomyositis onset and rapid progression of muscle disease or significant systemic involvement including pulmonary diseases associated with DM Prior major surgery or major life-threatening medical illness within 2 weeks | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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, Ventricular Tachycardia 80 years old, both males and females Single or dual chamber ICD or BiVentricular ICD in situ Ischemic or non-ischemic cardiomyopathy Receive a single shock from their ICD for monomorphic ventricular tachycardia ICD shock for polymorphic VT/VF or inappropriate shock Previous ventricular tachycardia ablation within 1 year NYHA Class IV heart failure or current inotrope therapy Ventricular tachycardia storm Listed for heart transplant or LVAD Pregnant as determined by urine pregnancy test prior to NIPS | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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 Crohn Disease Inflammatory Bowel Diseases Has confirmed diagnosis of CD or UC for at least 2 years prior to enrollment in the study. 2. Has a moderate to severe IBD flare at the time of enrollment or in participant anamnesis within 2 years before enrollment treated with steroids or/ and immunosuppressive agents or/ and biologic therapy. IBD flare(s) must be confirmed in the source documentation. 3. Current treatment with steroids or/ and immunosuppressive agents or/ and 5-aminosalicylate (ASA) or/ and biologic therapy Current or previous (within the last two years) indeterminate or not classified colitis. 2. Changing of IBD type in anamnesis (that is, from UC to CD, etc) within the last two years. 3. Current, previous (within the last two years) or planned (for the next one year) participation in interventional clinical trial. 4. Presenting of mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. 5. Has received previous treatment with biologic therapy/immunosuppressive agents for conditions other than IBD ever in their lifetime | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | eligible ages (years): 18.0-70.0, Traumatic Brain Injury Fatigue Cognitive Impairment mTBI 1. Male or female with a diagnosis of mild TBI. 2. At least 6-month post-injury. 3. Ages 18 to 70 years. 4. Lives in same household as paired control that meets inclusion/ 5. Participant is willing and able to give informed consent for participation in the study. mTBI Unable to walk unassisted. 2. Significant heart, liver, kidney, blood or respiratory disease. 3. History of chest pain or coronary heart disease. 4. Uncontrolled Diabetes mellitus. 5. Any history of a recently (12 months) diagnosed cancer other than a skin cancer (excluding melanoma). 6. Recent (within 6 months) treatment with anabolic steroids or corticosteroids. 7. Current alcohol or drug abuse. 8. Premorbid history of psychiatric disorder. 9. Premorbid history of head trauma. 10. Pregnancy or become pregnant during the trial. 11. Coumadin because of the risk of bleeding with daily injections of rhGH. 12. Subjects who are deficient in cortisol or thyroid at screening will be excluded until hormone abnormalities have been corrected. 13. Subjects with chronic pain who are being managed with narcotics will be excluded as the effects of central nervous system depressants may interfere with study test results. 14. Subjects with a history of inflammatory bowel disease, Celiac disease or active diverticular disease. 15. Subjects with a history of oral or IV antibiotics within the past 3 months. Household Control 1. Ages 18 to 70 years. 2. Lives in same household as paired mTBI subject that meets inclusion/exclusion criteria. 3. Participant is willing and able to give informed consent for participation in the study. Household Control Significant heart, liver, kidney, blood or respiratory disease. 2. Uncontrolled Diabetes mellitus. 3. Any history of a recently (12 months) diagnosed cancer other than a skin cancer (excluding melanoma). 4. Recent (within 6 months) treatment with anabolic steroids or corticosteroids. 5. Current alcohol or drug abuse. 6. Premorbid history of psychiatric disorder. 7. Premorbid history of head trauma. 8. Pregnancy or become pregnant during the trial. 9. Subjects who are deficient in thyroid at screening will be excluded until thyroid hormone is replaced. 10. Subjects with a history of inflammatory bowel disease, Celiac disease or active diverticular disease. 11. Subjects with a history of oral or IV antibiotics within the past 3 months | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | eligible ages (years): 18.0-999.0, Advanced Systemic Mastocytosis Aggressive Systemic Mastocytosis Systemic Mastocytosis With an Associated Hematologic Neoplasm Mast Cell Leukemia Key 1. Patient must have a diagnosis of aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematologic neoplasm (SM-AHN) or mast cell leukemia (MCL) based on World Health Organization diagnostic criteria. Before enrollment, the Study Steering Committee must confirm the diagnosis of AdvSM (based on Central Pathology Laboratory assessment of bone marrow). 2. Patient must have a serum tryptase ≥ 20 ng/mL. 3. Patient must have Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 3. Key Patient has received prior treatment with avapritinib. 2. Patient has received any cytoreductive therapy (including midostaurin and other TKIs, hydroxyurea, azacitidine) or an investigational agent less than 14 days, and for cladribine, interferon alpha, pegylated interferon and any antibody therapy (eg, brentuximab vedotin) less than 28 days before obtaining screening BM biopsy for this study. 3. Patient has eosinophilia and known positivity for the FIP1L1 fusion, unless the patient has demonstrated relapse or PD on prior imatinib therapy. Patients with eosinophilia (> 1.5 × 10^9/L), who do not have a detectable KIT D816 mutation, must be tested for a fusion mutation by fluorescence in situ hybridization (FISH) or polymerase chain reaction (PCR). 4. Patient has history of another primary malignancy that has been diagnosed or required therapy within 3 years before the first dose of study drug. The following are exempt from the 3-year limit: completely resected basal cell and squamous cell skin cancer, curatively treated localized prostate cancer, and completely resected carcinoma in situ of any site. 5. Patient has a QT interval corrected using Fridericia's formula (QTcF) > 480 msec. 6. Patient has a known risk or recent history (12 months before the first dose of study drug) of intracranial bleeding (eg, brain aneurysm, concomitant vitamin K antagonist use). 7. Platelet count < 50,000/μL (within 4 weeks of the first dose of study drug) or receiving platelet transfusion(s). 8. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 x the upper limit of normal (ULN); no restriction if due to suspected liver infiltration by mast cells. 9. Bilirubin >1.5 × ULN; no restriction if due to suspected liver infiltration by mast cells or Gilbert's disease. (In the case of Gilbert's disease, a direct bilirubin >2 × ULN would be an exclusion.) 10. Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2 or creatinine > 1.5 × ULN. 11. Patient has a primary brain malignancy or metastases to the brain. 12. Patient has a history of a seizure disorder (eg, epilepsy) or requirement for antiseizure medication | 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, Protamine Adverse Reaction ASA physical status 1-3 Schedule for open heart surgery History of allergy to the study drugs or protamine History of previous cardiac surgery or received protamine History of diabetes with insulin 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): 18.0-999.0, Triple -Negative Breast Cancer Estrogen Receptor Negative HER2/Neu Negative Anatomic Stage IV Breast Cancer AJCC Progesterone Receptor Negative Have pathologically confirmed diagnosis of unresectable or metastatic TNBC with no curative treatment options Have been informed of other treatment options Patient has lesion that can be biopsied and is willing to undergo the procedure as part of the protocol Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 1 Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately Ability to swallow and retain oral medication Have measurable disease per 1.1 present Any line of therapy allowed, radiologically confirmed progression on prior therapy No cancer-directed therapy for at least 3 weeks prior to study treatment (bone-directed therapies are allowed) Platelets >= 100,000/uL Patients currently treated with systemic immunosuppressive agents, including steroids (> than equivalent of 10 mg daily of prednisone), are ineligible until 3 weeks after removal from immunosuppressive treatment (inhaled steroids are allowed) Patients with active autoimmune disease or history of transplantation Pregnant or nursing female participants Unwilling or unable to follow protocol requirements Patients with known serious mood disorders (Major depression diagnosis is an exclusion. Other stable mood disorders on stable therapy for > 6 months or not requiring therapy may be allowed after consultation with PI Cardiac risk factors including Patients experiencing cardiac event(s) (acute coronary syndrome, myocardial infarction, or ischemia) within 3 months of signing consent Patients with a New York Heart Association classification of III or IV History of upper gastrointestinal ulceration, upper gastrointestinal bleeding, or upper gastrointestinal perforation within the past 3 years Prior allergic reaction or hypersensitivity to nonsteroidal antiinflammatory drugs (NSAIDs) or any drugs administered on protocol | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | eligible ages (years): 50.0-999.0, Polymyalgia Rheumatica Diagnosis of polymyalgia rheumatica (PMR) according to European League Against Rheumatism/American College of Rheumatology classification criteria Patients must be on prednisone of at least 7.5 mg/day (or equivalent) and not exceeding 20 mg/day at screening and during the screening period Patient is willing and able to take prednisone of 15 mg/day at randomization Patients must have a history of being treated for at least 8 weeks with prednisone (≥10 mg/day or equivalent) Patient must have had at least one episode of unequivocal PMR flare while attempting to taper prednisone at a dose that is ≥7.5 mg/day (or equivalent) within the past 12 Weeks prior to screening Unequivocal symptoms of PMR flare shoulder and/or hip girdle pain associated with inflammatory stiffness Patients must have erythrocyte sedimentation rate ≥30 mm/hr and/or C-reactive protein ≥10 mg/L associated with PMR disease activity within 12 weeks prior to screening Diagnosis of giant cell arteritis (e.g., persistent or recurrent localized headache, temporal artery or scalp tenderness, jaw claudication, extremity claudication, blurry or loss of vision, symptoms of stroke) Diagnosis of active fibromyalgia Concurrent rheumatoid arthritis or other inflammatory arthritis or other connective tissue diseases, such as but not limited to systemic lupus erythematosus, systemic sclerosis, vasculitis, myositis, mixed connective tissue disease, and ankylosing spondylitis Concurrent diagnosis of rhabdomyolysis or neuropathic muscular diseases Inadequately treated hypothyroidism Organ transplant recipient Therapeutic failure including inadequate response or intolerance, or contraindication, to biological IL-6 antagonist Any prior (within the defined period below) or concurrent use of immunosuppressive therapies but not limited to any of the following Janus kinase inhibitor within 4 weeks of baseline Alkylating agents including cyclophosphamide within 6 months of 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): 18.0-99.0, Chronic Lymphocytic Leukemia Age ≥ 18 years of age Diagnosed with CLL To be considered CLL, the subject must have an absolute lymphocytosis in the blood of at least 5,000 lymphocytes per microliter, or bone marrow lymphocytosis greater than or equal to 30% of all nucleated cells Histologic and immunophenotypic analysis should demonstrate small to moderate size lymphocytes with flow cytometry demonstrating a certain population of lymphocytes No prior therapy for their disease. Topical or inhaled corticosteroids are permitted for other medical conditions, ie asthma or dermatologic reasons Eastern Oncology Cooperative Group (ECOG) performance score of ≤ 2 Subjects with autoimmune hemolytic anemia or autoimmune thrombocytopenia will be eligible for treatment on this protocol regardless of disease stage upon discussion with the principal investigator An absolute neutrophil count > 1.0 109/L; hemoglobin > 8 g/dL; or a platelet count > 50 x 109/L (unless due to bone marrow failure) Adequate hepatic function activated partial thromboplastin time (aPTT) and prothrombin time (PT) not to exceed 1.5x the upper limit of reference ranges Subjects who have been previously treated for CLL or small lymphocytic lymphoma (SLL), except with corticosteroids for symptom relief Treatment with any of the following within 7 days prior to the first dose of study drug Steroid therapy for anti-neoplastic intent moderate or strong cytochrome P450 3A (CYP3A) inhibitors moderate or strong CYP3A inducers Subject has known allergy to both xanthine oxidase inhibitors and/or rasburicase Subject has a significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that in the opinion of the investigator would adversely affect his/her participating in this study Subject has evidence of other clinically significant uncontrolled condition(s) including, but not limited to: 1. Uncontrolled and/or active systemic infection (viral, bacterial or fungal) 2. Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative-, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate Subject is known to be positive for HIV. (HIV testing is not required.) New York Heart Association (NYHA) class II-IV heart failure or arrhythmia requiring treatment | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | eligible ages (years): 18.0-999.0, Pneumocystis Immunocompromised patient with (i) clinical and/or radiological suspicion of PCP, and (ii) bronchial fibroscopy with contributive BAL No immediate life-threatening conditions (estimated life expectancy >12h) No PCP treatment or PCP treatment < 48h Patient hospitalized in the Grenoble Alpes University Hospital with medical insurance Informed and written consent of the patient or its related Pregnancy, breastfeeding period of another clinical trial Deprivation of liberty | 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, Gaucher Disease Male or female participants with a confirmed diagnosis of Gaucher disease Participants who are either naïve to treatment or participants that have been treated with another therapeutic agent for Gaucher disease Participants who start VPRIV treatment or transition from VPRIV clinical studies during the enrollment period | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | eligible ages (years): 18.0-999.0, Cutaneous Mastocytosis Indolent Systemic Mastocytosis Adult, native French patient with cutaneous or indolent systemic mastocytosis and follow-up at Toulouse Patient having given his agreement of non-opposition Minor patient Patient with other forms of mast cell pathology except cutaneous and / or indolent systemic mastocytosis Patient with no mast cell pathology French non-native patient Patient in detention or under guardianship Patient not affiliated with Social Security | 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, Lymphoma DLBCL Lymphoma subtype --No comorbid disease Pregnancy Peptic ulcer Severe cardiac disease Osteoporosis | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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, Physician's Role Administration, Oral Inpatient Over 18 Able to tolerate oral medications Currently taking one of our eight medications under research intravenously Children (<18) Unable to tolerate an oral medication (or NPO) Severe disease severity (Ex. vasopressor dependent, seizures, etc...) | 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, HIV Disease Chronic Pain Attending physician or advance practice provider in one of the Institute of Advanced Medicine (IAM) clinics Designated PCP for at least 5 patients to whom he/she prescribes opioids Willing and able to adhere to study procedures including randomization, and refraining from discussion of study procedures with other clinical staff or patients Unwillingness to undergo randomization Plans to leave IAM within the study period | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | eligible ages (years): 18.0-999.0, Small Cell Lung Cancer Patients with an active autoimmune disease requiring systemic treatment within the past 3 months, or a syndrome that requires systemic steroids greater than dexamethasone 2 mg daily (or equivalent) or immunosuppressive agents within the past 3 months will be ineligible. Patients with a documented history of severe autoimmune disease but have been off of steroids and immunosuppressive agents for greater than 3 months, or only require intermittent steroid bursts may be eligible following discussion and approval from the Principal Investigator. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects who require intermittent use of inhaled steroids or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement, or psoriasis not requiring systemic therapy (within the past 3 years) or Type 1 diabetes on stable insulin will not be excluded from the study Histologically or cytologically documented Extensive Stage Small Cell Lung Cancer with documented disease progression after at least one prior systemic regimen, including one platinum-based regimen, with progression of disease on or after their most recent therapy. Patients previously diagnosed with limited stage Small Cell Lung Cancer treated with concurrent chemoradiation with a platinum doublet now diagnosed with recurrent extensive disease are eligible ECOG performance status of 0 to 2 Measurable disease with at least one tumor site amenable to biopsy Patients may have untreated asymptomatic Central Nervous System (CNS) metastases or treated CNS metastases if they are not currently receiving corticosteroids greater than dexamethasone 2 mg daily or equivalent for 7 days prior to the first dose of study drug. Patients should have completed stereotactic radiation or whole-brain radiation at least 2 weeks prior to Cycle 1, Day 1 Patients with an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids > dexamethasone 2 mg daily (or equivalent dose of other corticosteroids) or other immunosuppressive agents Treatment with systemic immunosuppressive medications including but not limited to, dexamethasone at doses > 2 mg or equivalent dose of other corticosteroids, cyclophosphamide, tacrolimus, sirolimus, azathioprine, methotrexate, thalidomide, and antitumor necrosis factor (anti-TNF) agents within 2 weeks prior to initiation of trial therapy. Inhaled or topically applied steroids, and acute and chronic standard-dose NSAIDs are permitted. Replacement steroids are also permitted Prior treatment with anti-CTLA4 antibodies. Prior anti-PD1 or anti-PDL1 therapy is allowed Symptomatic untreated CNS metastases. Patients with asymptomatic CNS metastases are eligible. Patients with symptomatic brain metastases are eligible, provided they meet all of the following Completed stereotactic radiosurgery or whole | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | eligible ages (years): 18.0-75.0, Acute Lymphoblastic Leukemia in Remission Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome Acute Myeloid Leukemia in Remission Chronic Myelomonocytic Leukemia Myelodysplastic Syndrome With Excess Blasts Recurrent Acute Lymphoblastic Leukemia Recurrent Acute Myeloid Leukemia Refractory Acute Lymphoblastic Leukemia Refractory Acute Myeloid Leukemia Recurrent Mixed Phenotype Acute Leukemia Refractory Mixed Phenotype Acute Leukemia Patients must have AML, ALL or high-risk MDS, or MPAL (also known as bipheontypic) meeting one of the following descriptions AML, ALL, or MPAL in first remission with evidence of measurable residual disease (MRD) by flow cytometry AML, ALL, or MPAL beyond first remission (i.e., having relapsed at least one time after achieving remission in response to a treatment regimen) AML, ALL, or MPAL representing primary refractory disease (i.e., having failed to achieve remission at any time following one or more prior treatment regimens) AML evolved from myelodysplastic or myeloproliferative syndromes MDS expressed as refractory anemia with excess blasts (RAEB) Chronic myelomonocytic leukemia (CMML) by French-American-British (FAB) criteria Patients not in remission must have CD45-expressing leukemic blasts. Patients in remission do not require phenotyping and may have leukemia previously documented to be CD45 negative (because in remission patients, virtually all antibody binding is to non-malignant cells which make up >= 95% of nucleated cells in the marrow) Patients should have a circulating blast count of less than 10,000/mm^3 (control with hydroxyurea or similar agent is allowed) Patients must have an estimated creatinine clearance greater than 50/ml per minute by the following formula (Cockcroft-Gault). Serum creatinine value must be within 28 days prior to registration Patients may not have symptomatic coronary artery disease and may not be on cardiac medications for anti-arrhythmic or inotropic effects Left ventricular ejection fraction < 45% Corrected diffusion capacity of the lung for carbon monoxide (DLCO) < 35% or receiving supplemental continuous oxygen. When pulmonary function tests (PFTs) cannot be obtained, the 6-minute walk test (6MWT, also known as exercise oximetry) will be used: Any patient with oxygen saturation on room air of < 89% during a 6MWT will be excluded Liver abnormalities: fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction as evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis, or symptomatic biliary disease Patients who are known to be seropositive for human immunodeficiency virus (HIV) Perceived inability to tolerate diagnostic or therapeutic procedures Active central nervous system (CNS) leukemia at time of treatment Patients with prior myeloablative allogeneic-HCT Women of childbearing potential who are pregnant (beta human chorionic gonadotropin [B-HCG]+) or breast feeding Fertile men and women unwilling to use contraceptives during and for 12 months post-transplant | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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, Multiple Myeloma Immune System Diseases Written informed consent and HIPAA authorization for release of personal health information. Patients must sign a consent to undergo cell procurement. Written informed consent to enroll in the CAR T-cell therapy trial must be obtained prior to lymphodepletion Age ≥ 18 years at the time of consent Karnofsky score of ≥ 60% Diagnosis of relapsed or refractory multiple myeloma (as defined by the Revised Uniform Response outlined by the IMWG Measurable disease as defined by one or more of the following: 1) serum M-protein ≥1.0 g/dL (≥0.5 g/dL for immunoglobulin A myeloma); 2) urine M-protein ≥200 mg/24 hours; 3) involved serum free light chain level ≥10 mg/dL AND an abnormal serum free light chain ratio. Patients with non-secretory disease and a baseline marrow burden of myeloma of at least 30% will also be eligible to participate Two lines of therapy will be allowed if the patient has disease that is refractory to both an immunomodulatory agent (lenalidomide or pomalidomide) and a proteasome inhibitor Received high dose melphalan followed by autologous stem-cell transplant or is not eligible for or has declined the procedure Allogeneic stem cell transplantation is allowed provided the patient is ≥ 1 year from transplant, not on immunosuppressive therapy to treat/prevent graft-versus-host disease, has no evidence of active graft-versus-host disease, and has no evidence of active graft-versus-host disease or infection Demonstrate adequate organ function prior to cell procurement as defined below Creatinine Clearance using the Cockcroft-Gault formula: ≥ 50 mL/min | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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 Lymphoma, B-Cell Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases for the Study: Unless otherwise noted, subjects must meet all of the following to participate in all stages of this study Written informed consent and HIPAA authorization for release of personal health information Adults ≥18 years of age Histologically confirmed B-cell NHL, including the following types defined by WHO 2016: Aggressive Lymphomas DLBCL not otherwise specified (NOS) T cell/histiocyte rich large B cell lymphoma; primary cutaneous DLBCL, leg type; EBV-positive DLBCL NOS; DLBCL associated with chronic inflammation; Lymphomatoid granulomatosis; Large B-cell lymphoma with IRF4 rearrangement; Intravascular large B-cell lymphoma; ALK-positive large B-cell lymphoma Primary mediastinal (thymic) large B-cell lymphoma High grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangement; high grade B-cell lymphoma, NOS B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma Transformation of indolent lymphoma or CLL to DLBCL will also be included Indolent Lymphomas for the Study: Subjects meeting any of the following will not be able to participate in this study (procurement, lymphodepletion and cell infusion) Subject is pregnant or lactating Tumor in a location where enlargement could cause airway obstruction Current use of systemic corticosteroids at doses ≥10mg prednisone daily or its equivalent; those receiving <10mg daily may be enrolled at discretion of investigator Active infection with HIV, HTLV, HBV, 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, negative HTLV1 and HTLV2 antibodies, negative Hepatitis B surface antigen, and negative HCV antibody or viral load. In addition, subjects with positive Hepatitis B core antibody, will have Hepatitis B viral load tested and subjects with positive Hepatitis B viral load will also be excluded Subject must either have core antibody negative HBV (results can be pending at the time of cell procurement) OR if a subject is hepatitis B core antibody positive they 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 Known additional malignancy that is active and/or progressive requiring treatment; exceptions basal cell or squamous cell skin cancer, in situ cervical or bladder cancer, or other cancer for which the subject has been disease-free for at least five years A history of intolerance to fludarabine. Note: subjects with history of intolerance to bendamustine may be considered for enrollment at the discretion of the clinical investigator if they are candidates for lymphodepletion with cyclophosphamide and fludarabine. to be met prior to procurement Subjects must sign a consent to undergo cell procurement | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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): 11.0-13.0, Sleep Sleep Hygiene, Inadequate specify that participants must 1. Be between the ages of 11-13, 2. Be in 6th-8th grades, 3. Reside in one of the targeted public school districts identified by zip code, 4. Attend one of the schools within these districts significant developmental delay, and/or severe psychiatric or chronic medical condition that preclude completion of study procedures or confound analyses. 2) current/prior sleep disorder diagnosis, such as sleep disordered breathing, restless leg syndrome, or periodic limb movement disorder (PLMD) | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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, Shoulder Arthritis Rotator Cuff Tear Arthropathy Subjects who have RSA for cuff tear arthropathy, massive irreparable rotator cuff tear with pseudoparalysis, or primary osteoarthritis Subjects who have a non-reverse total shoulder arthroplasty, RSA for fracture, tendon transfers as part of RSA, and revision RSA Subjects who had RSA and require discharge to skilled nursing facility, in-patient rehabilitation placement, or use of home health therapy prior to progressing in recovery Subjects who cannot speak, read, or write the English language Subjects who have cognitive deficits limiting ability to follow directions Subjects who have inability to attend physical therapy (i.e. transportation or financial limitations) | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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, Indolent Systemic Mastocytosis Key Patient must have SM, confirmed by Central Pathology Review of BM biopsy, and central review of B and C-findings by WHO diagnostic criteria Patient must have moderate-to-severe symptoms based on minimum mean total symptom score (TSS) of the ISM Symptom Assessment Form (ISM-SAF) over the 14-day screening period Patient must have failed to achieve adequate symptom control for 1 or more Baseline symptoms For patients receiving corticosteroids, the dose must be ≤ 20 mg/d prednisone or equivalent, and the dose must be stable for ≥ 14 days Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2. Key Patient has been diagnosed with any of the following WHO SM subclassifications: cutaneous mastocytosis only, smoldering SM, SM with associated hematologic neoplasm, aggressive SM, mast cell leukemia, or mast cell sarcoma Patient must not have received prior treatment with avapritinib Patient must not have had any cytoreductive therapy including but not limited to masitinib and midostaurin, or investigational agent for < 14 days or 5 half-lives of the drug (whichever is longer), and for cladribine, interferon alpha, pegylated interferon, or antibody therapy < 28 days or 5 half-lives of the drug (whichever is longer), before beginning the 14-day ISM-SAF TSS assessment Patient must not have received radiotherapy or psoralen and ultraviolet A (PUVA) therapy < 14 days before beginning the 14-day ISM-SAF TSS assessment Patient must not have received any hematopoietic growth factor the preceding 14 days before beginning the 14-day ISM-SAF TSS assessment Patient must not have a QT interval corrected using Fridericia's formula (QTcF) of > 480 msec | 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, Advanced Malignant Solid Neoplasm KRAS Gene Mutation Ovarian Carcinoma Refractory Malignant Solid Neoplasm Refractory Ovarian Carcinoma All patients have advanced malignancy (high-grade epithelial ovarian cancer or cancer harboring K-RAS mutation), either refractory to standard therapy or for which no effective standard therapy is available Patients must have measurable or evaluable disease, as defined by Response Evaluation in Solid Tumors (RECIST) 1.1 Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 and life expectancy of greater than 3 months and/or other performance status of 0 to 1 Female patients who Are postmenopausal for at least 1 year before the screening visit, OR Are surgically sterile, OR If they are of childbearing potential, agree to practice 1 highly effective method of contraception and one additional effective (barrier) method at the same time, from the time of signing the informed consent through 180 days after the last dose of study drug, OR Agree to practice true abstinence, when is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods), withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together) Agree not to donate eggs (ova) during the course of this study or 180 days after receiving their last dose of study drug Male patients, even if surgically sterilized (i.e., status post-vasectomy), who Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring intravenous antibiotics, symptomatic congestive heart failure (New York Heart Association [NYHA] Class III or IV), or history of myocardial infarction, unstable angina, stroke or transient ischemic attack within 6 months prior to study enrollment Active brain metastases or leptomeningeal metastases Known hypersensitivity (eg, anaphylactic and anaphylactoid reactions) to any particular combination drug will result in a patient being ineligible for in that particular cohort History of drug-induced pneumonitis requiring treatment with steroids; history of idiopathic pulmonary fibrosis, organizing pneumonia, or evidence of active pneumonitis on screening chest computed tomography (CT) scan; history of radiation pneumonitis in the radiation field (fibrosis) is permitted Female patients who are both 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 study drug Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol Life-threatening illness unrelated to cancer that could, in the investigator's opinion, make the patient not appropriate for this study Known human immunodeficiency virus (HIV) positive Known hepatitis B surface antigen positive, or known or suspected active hepatitis C infection Any treatment specific for systemic tumor control within 3 weeks prior to the initiation of the study drugs; or within 2 weeks if cytotoxic agents were given weekly (within 6 weeks for nitrosoureas or mitomycin C), or within 5 half-lives for targeted agents with half-lives and pharmacodynamic effects lasting less than 4 days (that includes but is not limited to erlotinib, sorafenib, sunitinib, bortezomib, and other similar agents), or failure to recover from toxic effects of any therapy prior to the study drug treatment | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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): 18.0-74.0, Indolent Systemic Mastocytosis Participants must meet all of the following to be enrolled in this study: 1. Male or female participant greater than or equal to 18 and < 75 years of age at screening. 2. Enrolled on NIAID protocol 02-I-0277. 3. Documented pathologic diagnosis of ISM. 4. MC-QoL score of at least 25% (which suggests participant is at least somewhat affected by all McQoL questions). 5. Willing and able to undergo a bone marrow biopsy and aspirate. 6. Absolute neutrophil count (ANC) greater than or equal to 2000/mL. 7. Hemoglobin greater than or equal to 12.0 g/dL (males), greater than or equal to 11 g/dL (females). 8. Platelet count greater than or equal to 150,000/microliters. 9. Alanine transaminase (ALT) and aspartate transaminase (AST) < 1.5 times the upper limit of normal (ULN). 10. Willing to allow storage of blood and bone marrow for future use in medical research. 11. Willing to allow genetic testing on biospecimens. 12. Able to provide informed consent. 13. Participants who can become pregnant must agree to use adequate contraception when engaging in sexual activities that can result in pregnancy. Adequate contraception must be used consistently, beginning at least 1 month before the beginning of dosing and lasting until 3 months after the final dose of study drug. Acceptable methods of contraception the following Hormonal contraception (non-oral only) Male or female condom with spermicide Diaphragm or cervical cap with a spermicide Intrauterine device Individuals meeting any of the following will be excluded from study participation: 1. Any abnormality that would be scored as a Grade 4 toxicity on the Common Terminology for Adverse Events (CTCAE) version 5.0. Only clinically significant lab results will deem the subject ineligible 2. Infected with HIV or has other known immunodeficiency. 3. Has an active infection, including localized infection. 4. Active diverticulitis. 5. Active or chronic viral hepatitis. 6. Active or latent tuberculosis. 7. Use of any other anti-IL-6 or anti-IL-6R agent within 1 year prior to the date informed consent was obtained. 8. Use of cytoreductive therapy for mastocytosis within 1 year prior to the date informed consent was obtained. 9. Known lymphoma or advanced and metastatic solid tumors on active therapy (including chemotherapy) within 1 year prior to the date informed consent was obtained 10. Use of chemotherapy within 1 year prior to the date informed consent was obtained. 11. Receipt of any marketed (eg, omalizumab) or investigational biologic or monoclonal antibody reported to affect mast cell activation within 5 half-lives prior to date informed consent was obtained. 12. Receipt of intravenous (IV) immunoglobulin within 30 days prior to the date informed consent was obtained. 13. Receipt of live attenuated vaccines within 30 days prior to the date informed consent was obtained. 14. History of alcohol or drug/abuse within 12 months prior to date informed consent was obtained. 15. Is allergic to any component of the sarilumab formulation. 16. Pregnant or breastfeeding. 17. Any condition that, in the opinion of the investigator, contraindicates participation in this study | 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, Hypertension ≥18 yr SBP ≥130 mmHg or DBP ≥80 mmHg or taking antihypertensive medication regardless of BP with a SBP <160 mmHg and DBP <100 mmHg Free of diagnosed cardiovascular, pulmonary, renal, metabolic, or other chronic diseases or depression Non-smokers for at least 6 mo prior to entry Consumed <2 alcoholic drinks daily Physically inactive defined as engaging in formal exercise ≤ 2d/wk Taking medications that influenced blood pressure such as inhaled or oral steroids, nonsteroidal anti-inflammatory agents, aspirin, and nutritional supplements with the exception of a 1-a-day vitamin, cold medications, and herbal supplements Osteoarthritis and orthopedic problems that compromised ability to exercise Past medical history of cancer-related lymphedema Seeking to gain or lose weight Pregnant, lactating, or planning to become pregnant Hormone-altering contraception administered in a bolus | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | eligible ages (years): 60.0-80.0, Vitamin D Deficiency Postmenopausal Caucasian Total plasma 25-hydroxy vitamin D < 50 nmol/L Understand oral and written Danish Able to consent Known allergic reaction/intolerance to Vitamin D supplementation / milk products / juice Known chronic kidney disease (creatinine > 90 µmol/L), previous kidney transplantation or known kidney artery stenosis Known liver disease Known gastrointestinal malabsorption Current malignant disease Hypercalcemia (ionised calcium ≥ 1.33 mmol/L) Treatment with diuretics, lithium or current use of steroids Current use of calcium and/or vitamin D supplementation Planned travel during the intervention period to areas where sun exposure is expected Use of solarium | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | eligible ages (years): 18.0-999.0, Chronic Spontaneous Urticaria Patients with spontaneous chronic urticaria, according to the of the European Academy of Allergology and Clinical Immunology (EAACI) in agreement with the European Dermatology Forum (EDF), and the World Allergy Organization (WAO), corresponding to an association of the following symptoms : urticarial eruptions and / or recurrent angioedema for at least 6 weeks Urticaria associated with a specific systemic disease including cutaneous and systemic mastocytosis, urticarial vasculitis, autoinflammatory diseases associated with cryopyrin Bradykinin angioedema and isolated angioedema whose origin is not clearly attributable to spontaneous chronic urticaria Presence of a contraindication to tranexamic acid and to levocetirizine | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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 Must be 18 years of age or over Must be diagnosed with Systemic Lupus Erythematosus (SLE) Must be exposed to hydroxychloroquine Must be enrolled at participating sites Under 18 years of age Not diagnosed with SLE Not exposed to hydroxychloroquine Not enrolled at participating sites | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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, Taping Ankle Sprains A history of at least one significant ankle sprain The initial sprain must have occurred at least 12 months prior to the study enrolment Was associated with inflammatory symptoms (pain, swelling, etc) Created at least one interrupted day of desired physical activity 2. A history of the previously injured ankle joint 'giving way' , and /or recurrent sprain and/or 'feelings of instability' A history of previous surgeries to the musculoskeletal structures (ie, bones, joint structures and nerves) in either lower extremity. 2. A history of a fracture in either lower extremity requiring realignment. 3. Acute injury to the musculoskeletal structures of other joints of the lower extremity in the previous 1 months, which impacted joint integrity and function (ie, sprains, fractures) resulting in at least 1 interrupted day of desired physical activity | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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, Sjogren's Syndrome Suspicion of Sjogren's syndrome based on 2016 American College of Rheumatology (ACR) criteria Age ≥ 18 years Being affiliated to health insurance Willing to participate Pregnant or breastfeeding women Patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their 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): 15.0-999.0, Aspirin Sensitivity Aspirin-exacerbated Respiratory Disease Aspirin-Induced Angioedema-Urticaria Aspirin Allergy NSAID-Induced Asthma NSAID-Induced Angioedema-Urticaria NSAID-Induced Anaphylactoid Reaction Aspirin-Induced Anaphylactoid Reaction Thai patients with a history of an immediate reaction to aspirin/paracetamol, or NSAIDs visiting King Chulalongkorn memorial Hospital 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, Pneumocystis HIV/AIDS Steroid Older than 18 years To have a gasometry at the admission that confirms moderate or severe PCP Patients receiving trimethoprim / sulfamethoxazole in doses of 15 to 20 mg / kg per day from the first 24 hours after admission Patients who have begun adjuvant treatment with steroids in the first 48 hours after admission No history of chronic pulmonary disease at hospitalization less than 20 points Allergic to TMP/SMX, who have not tolerated desensitization History of inflammatory, infectious, autoimmune or neoplastic diseases except Kaposi's sarcoma, which merit the chronic use of steroids Pleural or pericardial effusion and meningitis from any cause Septic shock not related to PCP Subjects who during the hospitalization have been diagnosed with any neoplasia (except Kaposi´s sarcoma) | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | eligible ages (years): 18.0-999.0, Lupus Erythematosus, Systemic Lupus erythematosus newly diagnosed or active Inactive lupus erythematosus Needing a blood sample for diagnosis or follow up Signed informed consent Other auto immune disease Pregnant or brest feeding Legal protection or protected adults | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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, Autoimmune Diseases autoimmune or infectious 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): 1.0-31.0, B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Down Syndrome All B-ALL patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to treatment and enrollment on AALL1731. APEC 14B1 is not a requirement for B-LLy patients. B-LLy patients may directly enroll on AALL1731 Age at diagnosis Patients must be >= 365 days and < 10 years of age (B-ALL patients without DS) Patients must be >= 365 days and =< 31 years of age (B-ALL patients with DS) Patients must be >= 365 days and =< 31 years of age (B-LLy patients with or without DS) B-ALL patients without DS must have an initial white blood cell count < 50,000/uL (performed within 7 days prior to enrollment) B-ALL patients with DS are eligible regardless of the presenting white blood cell count (WBC) (performed within 7 days prior to enrollment) Patient has newly diagnosed B-cell ALL, with or without Down syndrome: > 25% blasts on a bone marrow (BM) aspirate OR if a BM aspirate is not obtained or is not diagnostic of B-ALL, the diagnosis can be established by a pathologic diagnosis of B-ALL on a BM biopsy OR a complete blood count (CBC) documenting the presence of at least 1,000/uL circulating leukemic cells Patient must not have secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy. Note: patients with Down syndrome with a prior history of transient myeloproliferative disease (TMD) are not considered to have had a prior malignancy. They would therefore be eligible whether or not the TMD was treated with cytarabine 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 B LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1731 For patients receiving steroid pretreatment, the following additional apply Non-DS B-ALL patients must not have received steroids for more than 24 hours in the 2 weeks prior to diagnosis without a CBC obtained within 3 days prior to initiation of the steroids DS and non-DS B-LLy patients must not have received > 48 hours of oral or IV steroids within 4 weeks of diagnosis Patients who have received > 72 hours of hydroxyurea B-ALL patients who do not have sufficient diagnostic bone marrow submitted for APEC14B1 diagnostic testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells Patient must not have acute undifferentiated leukemia (AUL) Non-DS B-ALL patients with central nervous system [CNS]3 leukemia (CNS status must be known prior to enrollment) Note: DS patients with CNS3 disease are eligible but will be assigned to the DS-High B-ALL arm. CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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, Hypersensitivity, Immediate Perioperative Period Patients having experienced a perioperative immediate hypersensitivity (including the obstetrical setting) according to one grade of the Ring and Messmer clinical scale, for whom The clinical history is known and has been related to perioperative immediate hypersensitivity The biological assessment including plasma histamine and/or tryptase (and serum IgE when available) was performed after the onset of immediate hypersensitivity according to current guidelines The allergological assessment including skin tests performed by the collaborators of this study was carried out according to current guidelines in surviving patients • Patients who decline to be involved in 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, Gout Flare Patients (> 18 years old) with gout flare defined by following items Identification of sodium urate crystals in synovial fluid analysis Or gout flare diagnosis according to Nijmegen (score > 8/13) Man (2 pts) History of flare (2 pts) Flare involving first metatarsophalangeal joint (2.5 pts) Maximum of flare within 24h (0.5pt) Redness (1 pt) History of hypertension or cardiovascular diseases (1.5 pts) Serum urate level > 360 µmol/l during flare (3.5 pts) Hypersensitivity to colchicine, fexofenadine, benzodiazepine or the excipients of these drugs Contra-indication to colchicine : chronic kidney disease stage 4-5, severe hepatic impairment, treatment by macrolide antibiotics Used of pain-killers other than acetaminophen Involvement in another clinical trial with drug administration Illiteracy Pregnant woman or breastfeeding | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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, Neonatal Jaundice The mothers are at late 2nd or early 3rd trimester of their pregnancy and agreed to enroll as study participants They are planning to stay in the study village for the next 12 months (if a mother is planning to give birth at her natal home and then return, she will still not be a candidate for enrollment) Pregnant mother with confirmed multiple pregnancy Pregnant mother with medically identified psychological disorder Any known maternal danger sign | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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, Hodgkin Disease Lymphoma, Large-cell, Anaplastic Male and female participants 18 years or older by the time of enrollment. 2. Histologically confirmed diagnosis of cHL or sALCL. 3. Newly diagnosed participants, or participants with RR cHL or RR sALCL at the time of enrollment, or participants with RR cHL or RR sALCL within 3 years prior to in the Study Unconfirmed diagnosis of cHL or sALCL. 2. Current, previous (within the last 3 years) or planned (for the next 2 years) participation in interventional clinical trials. 3. Participation in the non-interventional study CHL-5001 "An international, multi-centre, non-interventional retrospective study to describe treatment pathways, outcomes, and resource use in participants with classical Hodgkin lymphoma (B-HOLISTIC)" (Sponsor is Takeda Pharmaceuticals International AG). 4. Participants for whom the minimum study dataset was not available from their hospital medical records | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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 Positive ANA-titer (≥ 1:80) or Anti-dsDNA (≥ 200 IU/ml) or Highly avid-dsDNA autoantibody (≥ 30 IU/ml) Stable immunosuppressive therapy more than 30 days before beginning of the study with steroid (0-20 mg/day) or other immunosuppressive medication like Hydroxchloroquin, Chloroquin, Azathioprin, Methotrexat, Mycophenolatmofetil, Cyclosporin, Belimumab, Rituximab Pregnancy, Active lupus nephritits, Physical activity more than two times a week | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | eligible ages (years): 1.0-24.0, B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Central Nervous System Leukemia Mixed Phenotype Acute Leukemia Testicular Leukemia B-ALL and MPAL patients must be enrolled on APEC14B1 and consented to studies (Part A) prior to treatment and enrollment on AALL1732. Note that central confirmation of MPAL diagnosis must occur within 7 business days after enrollment for MPAL patients. If not performed within this time frame, patients will be taken off protocol APEC14B1 is not a requirement for B-LLy patients but for institutional compliance every patient should be offered participation in APEC14B1. B-LLy patients may directly enroll on AALL1732 White blood cell count (WBC) for patients with B-ALL (within 7 days prior to the start of protocol-directed systemic therapy) Age 1-9.99 years: WBC >= 50,000/uL Age 10-24.99 years: Any WBC Age 1-9.99 years: WBC < 50,000/uL with Testicular leukemia CNS leukemia (CNS3) Steroid pretreatment White blood cell count (WBC) for patients with MPAL (within 7 days prior to the start of protocol-directed systemic therapy) Patients with Down syndrome are not eligible (patients with Down syndrome and B-ALL are eligible for AALL1731, regardless of NCI risk group) With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for the current diagnosis of B-ALL, MPAL, or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1732 Patients who have received > 72 hours of hydroxyurea within one week prior to start of systemic protocol therapy Patients with B-ALL or MPAL who do not have sufficient diagnostic bone marrow submitted for APEC14B1 testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells Patients with acute undifferentiated leukemia (AUL) are not eligible For Murphy stage III/IV B-LLy patients, or stage I/II patients with steroid pretreatment, the following additional apply T-lymphoblastic lymphoma Morphologically unclassifiable lymphoma Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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): 18.0-100.0, Brugada Syndrome Cardiac Arrest Athletes Heart Atrial Fibrillation Ventricular Ectopic Beat Patients with Brugada syndrome requiring risk stratification 2. Patients without Brugada syndrome acting as a control group 1. Patients undergoing ablation with ECGi system for other arrhythmias 2. Patient with AF undergoing ablation with ECGi system 3. Relatives of Brugada patients with confirmation of no pathology 4. Out-of-hospital cardiac arrest primary PCI with full recovery of left ventricular function and full revascularisation (n=10) 5. Athletic Hypertrophy (n=10) Pregnancy or not using a highly effective form of contraception 2. Patients unable to exercise 3. Patients unable to provide consent 4. Patients who have contraindications to an electrophysiological study. 5. Patients with no Brugada syndrome that are known to be high-risk for SCD for another reason e.g. Hypertrophic cardiomyopathy, ischaemic cardiomyopathy with severely impaired left ventricular 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): 25.0-40.0, Traumatic Brain Injury Neurobehavioral Manifestation Sleep Disorder Fatigue Are 25 to 40 years of age Are active duty service members or veterans May be NIH employees/staff who are either active duty service members or veterans; except for those who are employed by NINR or subordinates, relatives, and/or co-workers of NINR employees/staff Have sustained at least 1 TBI, >= 6 months and <= 5 years since their most recent TBI, which includes any self-reported loss of consciousness (LOC) established by the OSU during the pre-screening phone call Are able to provide their own consent Are able to understand the protocol, as shown by scoring a 6 out of 6 on a consent quiz Currently receiving treatment for a medical illness or recent injury that precludes protocol participation, may interfere with study participation, and/or should be treated/stabilized prior to study participation for safety reasons (e.g., cancer, recent fracture(s) requiring therapy and/or pain medication, severe infection). Individuals with stable medical conditions such as hypertension that are controlled by medication will be included Current physical health status will be assessed by self-report, history and physical exam by a credentialed physician or nurse practitioner, and standard laboratory tests Current unstable endocrine disorder (e.g., uncontrolled diabetes). Unstable endocrine disorders require treatment to ensure health and safety of the patient before participation is possible. Individuals with stable endocrine disorders (e.g., controlled diabetes) may participate in the protocol but they will be excluded from the hydrocortisone stimulation test. This will be assessed by self-report during the history and physical exam and by standard laboratory tests Have a major medical illness that is associated with fatigue (e.g., chronic fatigue [diagnosed prior to their TBI or less than 6 months following TBI], multiple sclerosis, or cancer). This will ensure that symptoms of fatigue are as a result of TBI and not another co-morbid illness. This will be assessed by self-report Currently consuming any of the following sleep modifying medications: benzodiazepines; benzodiazepine receptor agonists; opiates; or sedatives. These medications will directly affect the results of the PSG and actigraphy analysis, as such participants currently taking these medications will be excluded. This will be assessed by self-report Currently using the sleep modifying medications melatonin and/or Benadryl greater than 2 times per week and/or unable or unwilling refrain from using them during protocol participation. These medications will directly affect the results of the PSG and actigraphy analysis, as such participants who are unwilling/unable to refrain from using these medications will be excluded. This will be assessed by self-report Current psychiatric condition for which immediate treatment is required to prevent harm to self or others such as active suicidality or active manic phase in someone who has bi-polar disorder. This is to ensure patient safety and care. This will be assessed by self-report and as part of the history and physical exam Are pregnant. Pregnancy is associated with increased fatigue and sleep disturbances, as such this condition will affect the outcomes of this analysis.his will be assessed by self-report. This will also be assessed on visit 2 by a urine pregnancy test. Individuals who are nursing are eligible but will not participate in the hydrocortisone stimulation test Received a diagnosis of severe obstructive sleep apnea (OSA) and/or current reliance on continuous positive airway pressure (CPAP) therapy to aid sleep. Severe OSA and CPAP use will directly affect the result s of this study, as such these participants will be excluded. This will be assessed by self-report. **Participant may be able to participate in the protocol but will not be able to have an MRI if they have any of the following Metal in the body such as pacemakers, stimulators, pumps, aneurysm clips, metallic prostheses, artificial heart valves, cochlear implants or shrapnel fragments, or if they are a welder or metal worker | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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, Heart Failure Salt; Edema heart failure in NYHA 2-3 class patients under optimal and full medical therapy for HF patients treated with CRTd patients without neoplastic diseases patients without inflammatory sistemic diseases decompensated HF unstable HF patients without full anti-HF medical therapy patients without indication to receive CRTd patients with renal failure | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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): 30.0-75.0, Cardiovascular Diseases Heart Failure Coronary Artery Disease Mesenchymal Stem Cell Transplantation Regenerative Medicine Patients with a diagnosis of coronary disease, performed by coronary angiography, requiring conventional coronary revascularization surgery History of myocardial infarction; evidence of akinesia or regional dyskinesia more than 1 week old Ejection fraction less than 40% Age between 30 and 75 years Negative serology for HIV, hepatitis B virus (HBV), and hepatitis C virus HCV Negative pregnancy test for women of childbearing age Patients who sign the informed consent complying with all of the provisions of current regulations in Colombia History of myocardial infarction with ST-segment elevation within 2 weeks prior to surgery History of myocardial infarction without ST-segment elevation within the previous week (the decision to these patients within the first week after suffering a non-ST elevation infarction is at the discretion of the research team) Previous history of tachycardia or ventricular fibrillation History of active neoplasia or previous chemotherapy treatment Severe or uncontrolled concomitant disease (i.e., poorly controlled chronic kidney or liver failure) Patients who, due to their place of residence, mental health or social situation, have difficulty meeting the conditions of the protocol Women who are pregnant or breast-feeding Patients or legal representatives withdrawing informed consent at any time during the study Previous history of heart transplant Patients with functional organ impairment: liver function: total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase greater than 2 times the upper reference limit; kidney function: serum creatinine > 1.5 mg/dl or creatinine clearance < 60 ml/min | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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, Hyperkalemia Patient older than 18 years old Patient admitted to the emergency department Patient with local laboratory serum potassium level superior or equal to 6 mmol/l Patient who provide written informed consent prior to participation in the study Hemolysis or thrombocytosis > 106/mm3 or hyperleukocytosis > 105/mm3 on the first blood sample suspecting a pseudohyperkalemia Diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome Pregnant or lactating woman, women with childbearing potential who didn't have effective contraception* Patient expected to require emergency intubation and ventilation Patient expected to require dialysis, diuretics or bicarbonate within the first 60 minutes Patient with heart rhythm disorders or high grade atrioventricular bloc who require urgent medication as soon as admission or serum potassium level result Hypersensitivity to the tested active substance or excipients Acute coronary syndrome Patient not affiliated to a health insurance plan Patient under guardianship, curatorship or safeguard of justice | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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, Aging Subjects must be able to walk for 60 minutes in a 90-minute time frame Subjects are apparently free of cardiovascular, metabolic, and renal disease, which includes no signs or symptoms suggestive of cardiovascular, metabolic or renal disease Subjects have no current musculoskeletal injury Subjects need to be either 18-45 or 65+ years old. These meet the ACSM's 2015 guidelines for participant health screening prior to joining a moderate or moderate-to-vigorous exercise protocol. (Riebe et al., 2015) Have dementia or an inability to give informed consent Have a musculoskeletal injury or feel pain while walking Have a history of dizziness and/or balance problems Have cardiovascular, heart, metabolic, or renal disease, or respiratory problems Smoke cigarettes Asthma Feel pain or discomfort in the chest, neck, jaw, arms during rest or exercise Have orthopnea or paroxysmal nocturnal dyspnea Have ankle edema Have palpitations or tachycardia | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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, Hypersensitivity Reaction ASA 1-2, no allergy and perioperative hypersensitivity reactions during anaesthesia steroid therapy, allergy in medical history, mastocytosis | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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, Stage IV Non-small Cell Lung Cancer Stage IV Malignant Melanoma of Uvea Stage IV Small Cell Lung Cancer Stage III Malignant Melanoma Cancer patients with stage IV NSCLC or stage IV malignant melanoma Patient must have at least one measurable lesion and the relevant images in order to enable assessment of response ECOG PS 1-2 Normal hematologic, renal and liver function: 1. Absolute neutrophil count higher than 1500/mm3 2. Platelets count higher than 100,000/mm3 3. haemoglobin higher than 9 g/dL 4. Creatinine concentration ≤1.4 mg/dL, or creatinine clearance higher than 40 mL/min 5. Total bilirubin lower than 1.5 mg/dL, ALT and AST levels ≤ 3 times above the upper normal limit Concurrent and/or other active malignancy that has required systemic treatment within 2 years of first dose of study drug Generalized impairment or mental incompetence that would render the patient unable to understand his/her participation in 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, Steroid Dependent Crohn's Disease Patients with biopsy confirmed, active, steroid dependent CD, without nutrient absorbance problems (Definition of steroid dependency: CD being treated with at least 5 mg/day steroids for the last 3 months; an attempt to reduce the dose induces flare of disease as determined by physician assessment). 2. Age ≥18 years 3. Steroid treatment of at least 3 months and stable steroid dose for at least 2 weeks .If thiopurines and/or biologics are also being administered, then must be administered at stable dose(s) for at least 3 months. 4. Patients will undergo an ECG and QT parameters will be measured for further analysis. 5. Female subjects who are postmenopausal (absence of menses for ≥ 2 years confirmed by a follicle stimulating hormone test), or who are surgically sterilized may be enrolled. Similarly, women of childbearing potential who had a negative pregnancy test at screening, who are willing to use two medically acceptable methods of contraception for the duration of the study as well as for at least three months after cessation of CBD treatment and who are willing to undergo pregnancy testing according to the study protocol may be enrolled. 6. Female subjects who are not breast-feeding and who have no intention to breast-feed during the term of the trial and for at least three months after cessation of CBD treatment may be enrolled. 7. Subject able to provide written informed consent Viral Hepatitis (HAV, HBV, HCV) 2. HIV 3. Serious psychiatric or psychological disorders 4. Active consumption of illicit drugs including cannabis or derivatives for at least 3 months prior to the study 5. Patients with short bowel syndrome, symptomatic stricture, abscess, recent history (within the previous 3 months) of abdominal surgery, nutrient absorbance problems 6. Patients whose disease is inaccessible by endoscopy 7. Patients with significant cardiac, respiratory or active malignance disease (except Basel Cell Carcinoma) comorbidities. 8. Any uncontrolled infection at time of registration 9. Renal comorbidity: eGFR < 30 mL/min/1.73 m2 (note: CKD Grade 4 is defined as eGFR 15-29 mL/min/1.73 m2) 10. Patient who is taking immunomodulatory medications for other indication 11. Women of child-bearing potential who intend to become pregnant or who are pregnant or breastfeeding - | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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, Kidney Failure Liver transplant recipients >= 18 years old Normal baseline renal dysfunction (GFR > 60 mL/min) Rabbit anti-thymocyte globulin (rATG) induction (cumulative dose 1.5 mg/kg) Indication for transplant: ethanol, hepatitis C, or nonalcoholic steatohepatitis or any combination of these Increased risk of rejection: autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, positive crossmatch, retransplantation Incompletely healed incision or other wound healing issues at time of randomization Multiple or previous organ transplantation Severe, uncontrolled hypercholesterolemia (> 9mmol/L) or hypertriglyceridemia (>8.5 mmol/L) in the 6 months prior to transplantation Insurance company unwilling to pay for the cost of the everolimus or patient does not qualify for the Novartis Patient Assistance Program Pregnant women Unable to provide informed consent | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | eligible ages (years): 18.0-99.0, Steroid Refractory GVHD Graft Vs Host Disease Adult men and women who are at least 18 years of age Recipients of their first allogeneic hematopoietic stem cell transplant from any donor source (including bone marrow, mobilized peripheral blood, cord blood) and human leukocyte antigen (HLA)-match (includes matched related, matched unrelated, mismatched unrelated, and haploidentical) Recipients of allogeneic stem cell transplant after any conditioning regimen intensity and those who have received any GVHD prophylaxis regimen, unless it included tocilizumab and/or itacitinib Steroid refractory acute GVHD (SR-aGVHD) that has been clinically diagnosed as per the MAGIC and/or pathologically confirmed. Biopsies should be attempted whenever possible according to the investigator's discretion but it is not required as long as alternative diagnoses such as infection or medication side effects have been adequately ruled out. SR-aGVHD is defined as acute GVHD that has failed to exhibit a response after treatment for at least 7 days with a corticosteroid dose of 2 mg/kg of methylprednisolone or prednisone equivalent. SR-aGVHD is also defined as GVHD that flares when steroids are tapered prohibiting further taper Adequate renal function determined by creatinine clearance ≥ 40 mL/min measured or calculated by Cockcroft-Gault equation Absence of history of irreversible liver disease such as cirrhosis or veno-occlusive disease (VOD) that has not responded to therapy Total bilirubin and/or transaminases (AST and/or ALT) that are ≤2.5 above institutional upper limit of normal that is not attributable to acute GVHD by biopsy Non-pregnant females or men and women willing to avoid pregnancy or fathering a child as evidenced by negative pregnancy test (females), non-childbearing potential (history of hysterectomy, oophorectomy, amenorrhea for 12 months) or agree to use barrier or chemical contraception for the duration of the study Ability to swallow oral medication Able to give consent and comply with study visits and procedures Primary disease not in complete remission, requiring active treatment, or having required treatment for relapsed disease Uncontrolled bacterial, viral, or fungal infections which is evidenced by hemodynamic instability, new radiological findings, new signs or symptoms, or persistently positive blood cultures as determined by the investigator History of viral infection with HIV History of infection or exposure to hepatitis B or C with a risk of infection reactivation History of active or latent tuberculosis infection that has not been adequately treated Use of any JAK inhibitor or IL-6 antagonists for therapy or prophylaxis of acute GVHD. Continuation of calcineurin inhibitors intended for GVHD prophylaxis is allowed. Resumption of therapeutic dosing of calcineurin inhibitors that is being tapered is also allowed Severe organ dysfunction unrelated to GVHD that includes cholestatic disorders or unresolved VOD (defined as ongoing organ dysfunction and bilirubin elevation unrelated to GVHD > 2.5 the institutional upper limit of normal), clinically significant or uncontrolled cardiac disease (including unstable angina, acute myocardial infarction within 6 months of enrollment, New York Heart Association, Class III or IV congestive heart failure, circulatory collapse requiring vasopressor or inotropic support, or arrhythmia that requires therapy) or clinically significant respiratory disease that requires mechanical ventilation support or 50% or greater supplemental oxygen Receipt of live attenuated vaccine or the need for such a vaccine during the duration of the study Treatment with any other investigational agent within 7 days of enrollment (or 5 half-lives, whichever is greater) Treatment with any JAK inhibitor or IL-6 antagonist after stem cell transplant. Treatment with a JAK inhibitor before transplant is allowed. Treatment with IL-6 antagonist before transplant is allowed only if last dose was at least 4 weeks prior to transplant | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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 Large Cell Neuroendocrine Carcinoma Metastatic Neuroendocrine Carcinoma Metastatic Neuroendocrine Neoplasm Metastatic Small Cell Neuroendocrine Carcinoma Patients must have metastatic, histologically confirmed poorly-differentiated neuroendocrine neoplasms per 2018 World Health Organization (WHO) classification, with the exception of small cell lung cancer and merkel cell carcinoma. All variations of poorly differentiated neuroendocrine carcinoma (small cell, large cell and mixed cells) are eligible Failure of only one line of prior systemic cancer treatment Patients must have measurable disease as defined by Response Evaluation in Solid Tumors (RECIST) version (v)1.1 Patients must have lesions that can be safely biopsied and be willing to have a pre-treatment and an on-treatment biopsy (after 1 month of treatment with the combination regimen) and a blood collection at baseline Prior systemic cancer therapy must have been completed at least 4 weeks prior to cycle 1 day 1 of treatment with the combination regimen Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%) Leukocytes >= 3,000/mcL Absolute neutrophil count >= 1,500/mcL without granulocyte-colony stimulating (GCSF) factor support Hemoglobin >= 9 g/dL Serum thyroid stimulating hormone (TSH) within institutional normal limits Patients must not require systemic corticosteroids treatment (>= 10 mg/day prednisone equivalents) or other immunosuppressive medications within 28 days prior to study drug administration. Inhaled or topical steroids and adrenal replacement doses < 10 mg/day prednisone equivalents are permitted in the absence of active autoimmune disease. Patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids in patients with adrenal insufficiency are permitted, even if >= 10 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted, as is steroid pre-medication for contrast allergy Patients must not have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways Patients must not have had prior treatment with XL184 (cabozantinib), or any MET-targeting tyrosine kinase inhibitor (TKI), or any MET-targeting monoclonal antibody (MetMAb), such as onartuzumab Patients must not have received radiation therapy to any part of the body within 28 days Patients must not have clinically relevant, ongoing complications from prior radiation therapy. No radiation therapy is allowed while the patient is on study. Palliative radiation therapy, if needed, should be completed at least 28 days prior to enrollment into the study as described above Patients must not require concomitant treatment with oral anticoagulants (e.g., warfarin, direct thrombin, and factor Xa inhibitors) or platelet inhibitors (e.g., clopidogrel). The following anticoagulants are allowed Low-dose aspirin for cardioprotection (per local applicable guidelines) Low-dose low molecular weight heparins (LMWH) Therapeutic doses of LMWH are allowed in patients without known brain metastases who are on a stable dose of LMWH for at least 6 weeks before the first dose of study treatment, and who have had no clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor Patients must not have had major surgery (e.g., gastrointestinal [GI] surgery or removal or biopsy of brain metastasis) within 4 weeks before first dose of study treatment. Complete wound healing from major surgery must have occurred 1 month before the first dose of study treatment and from minor surgery (e.g., simple excision or tooth extraction) at least 10 days before the first dose. Patients with clinically relevant ongoing complications from prior surgery are not eligible | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | eligible ages (years): 18.0-999.0, Infection Heart Failure Chronic Obstructive Pulmonary Disease 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 Method2 Cannot establish peripheral access in emergency department (or access requires ultrasound guidance, unless point-of-care ultrasound is available) Secondary condition: end-stage renal disease on hemodialysis, 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): 65.0-999.0, Older Patients Patients aged 65 years and over Admitted for any reason to the hospital via A&E Patients presenting either alone or confused or with a diagnosis of dementia Patients who received the ICCI while in A&E Patients referred to the Dementia Care Team (which support patients admitted into the hospital who have a cognitive impairment either as a result of an underlying dementia -diagnosed or otherwise or who are experiencing transitory cognitive symptoms such as confusion as a result of a delirium) Patients who are able to give informed consent to participate in the study as identified by a registered health care professional Patients who cannot give informed consent Any patient with a physical condition that is immediately life-threatening or unstable Patients who are involved in other clinical trials which present a significant burden to them | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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): 1.0-16.0, Peanut Hypersensitivity Age 1-16 years History of immediate hypersensitivity reaction to peanut Evidence of IgE mediated peanut hypersensitivity within a 12 month period of study enrollment SPT with wheal/flare of at least 3 x 6 mm and/or Peanut specific IgE >0.35 kU/L History of life threatening peanut anaphylaxis Asthma requiring more than medium dose ICS Prior participation in oral immunotherapy, sublingual immunotherapy or epicutaneous immunotherapy Oat allergy Cardiovascular Disease Use of beta-blockers (oral), angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or calcium channel blockers Use of steroid medications in the following manners Daily oral steroid dosing for greater than 1 month during the past year Burst or steroid course in the past 3 month before Greater than 2 bursts oral steroid courses in the past year of at least 1 week duration | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | eligible ages (years): 18.0-64.0, Schizophrenia Spectrum and Other Psychotic Disorders Age: 18-64 years, both inclusive Diagnosis: schizophrenia spectrum disorder (F20-F29, ICD-10) Outpatient status IQ≤70 as measured by the short form of the Wechsler Adults Intelligence Scale (WAIS) (Wechsler, 1981) History of head injury and/or a neurological condition Having received a metacognitively oriented therapy within the previous 12 months Low level of Spanish Lack of cooperativeness with the assessment and/or "intervention" | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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, Stage IV Prostate Cancer Stage IV Colon Cancer Stage IV Breast Cancer Stage IV Cancer of the Cervix Age: Greater than 12 years Documented histologic evidence of cancer Staged as stage IV World Health Organization (WHO) Performance Status of between 0 and 2 Radiological confirmation of metastases with bone scan or X ray, CT and/or MRI scan Cancer stages less than stage 4 Pregnant women Children 0 years | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | eligible ages (years): 18.0-75.0, Gout Key 1. Females and males, age 18 to 75 years of age. 2. Diagnosis of gout using ACR/EULAR (must have a score of equal to or greater than 8) 3. Subjects must have experienced ≥2 gout flares in the 12 months prior to screening; 4. Subjects that have not changed their urate lowering therapy (ULT) in the 2 weeks prior to the start of the gout flare and who will remain on the same dose throughout the follow-up period of the trial. 5. If taking NSAID, oral steroids, opioids, or other pain medications at standard doses (as stated on drug label) for pain unrelated to their gout flare, must be taking the same drug for at least 7 days prior to the gout flare and throughout the length of the trial. 6. Women of childbearing potential are excluded. Women not considered of childbearing potential must have one of the following documented in their study medical history: 1. Postmenopausal for at least 12 months prior to study; 2. Without a uterus and/or both ovaries; or 3. Bilateral tubal ligation at least six months prior to study enrollment. Key BMI of >40kg/m2 at the time of screening 2. Subjects that have not changed their urate lowering therapy (ULT) in the 2 weeks prior to the start of the gout flare and who will remain on the same dose throughout the follow-up period of the trial. 3. Subjects who are contraindicated for the use of colchicine or whom are unable to take the SOC dose of 1.2mg followed by 0.6mg an hour later. 4. Subjects with rheumatoid arthritis, psoriatic arthritis, evidence/suspicion of infectious/septic arthritis, acute polyarticular gout (4 or more joints), with arthritis due to any cause other than gout that may confound any study assessments per Investigator discretion. 5. Subjects who have experienced >2 gout flares per month, or >12 attacks overall in the months prior to randomization. - | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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): 20.0-60.0, Vitamin D Deficiency Crohn Disease Clinical diagnosis of Crohn's Disease 2. Must be able to swallow tablets 3. Have certain factors increase the risk of surgery in CD current smoking fistulizing and stricturing disease behaviour early steroid use (medical need for steroids for treatment of first flare) disease in the end of the small bowel (i.e. ileum) disease in the middle part of the small bowel (i.e. jejunum), and young age at the time of the diagnosis Other serious gastrointestinal diseases 2. pregnancy 3. hypercalcemia 4. hyperparathyroidism 5. chronic kidney disease and cardiovascular 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): 18.0-100.0, Clostridium Difficile Infection All consecutive adult patients (inpatients and outpatients) who have a treated first episode or first recurrence of CDI CDI will be defined by a positive PCR for toxin gene and/or detection of toxin by EIA or CCA along with three or more episodes of diarrhea within 24 hours Patients with a positive test with less than three bowel movements may be included if they initially presented with ileus or if they had pseudomembranous colitis visualized on colonoscopy Clinical: 1. Toxic megacolon at presentation not resolved by day 10 2. For the current episode of CDI: use of fidaxomicin, fecal microbiota transplant or intravenous immunoglobulins 3. Previous or current colectomy 4. Severe allergy/intolerance to oral vancomycin 5. Patient is expected to die within 3 months from another disease or is expected to be admitted to a palliative care unit 6. Failure to achieve clinical cure (as above) by day 10 7. More than 2 lifetime episodes of C. difficile Administrative: 1. Expected transfer to a palliative care unit or non-study hospital; 2. No provincial health insurance 3. Previously enrolled 4. No reliable means of outpatient contact 5. Incompetent without healthcare proxy 6. Patient stated inability to come to follow up appointments | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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 Graft-Versus-Host Disease (Gvhd) Grade Hematopoietic Cell Transplantation Fecal Microbiota Transplant Men or women ≥ 18 years old Patient has undergone allogeneic hematopoietic cell transplantation from any donor (related or unrelated with any degree of HLA matching) and any donor source (bone marrow, peripheral blood stem cells, or cord blood) for a hematologic malignancy or disorder. Recipients of myeloablative and reduced-intensity conditioning regimens are eligible Evidence of myeloid engraftment (eg, absolute neutrophil count ≥ 0.5 × 109/L for 3 consecutive assessments if ablative therapy was previously used). Use of growth factor supplementation is allowed Patient must have clinically suspected Grade II to IV aGVHD as per MAGIC criteria. Clinical suspicion of aGVHD by the treating physician is sufficient and biopsies are not required to pathologically confirm aGVHD. However, in situations where alternative diagnoses of drug effects or infection are not adequately ruled out on clinical suspicion alone, biopsies are recommended Patients must have a diagnosis of high-risk acute GVHD, defined as either: - Steroid-refractory GVHD Progressive GVHD after at least 3 days of systemic corticosteroids (≥ 1 mg/kg/day of prednisone equivalent), OR No improvement in GVHD after at least 7 days on ≥ 1 mg/kg/day of prednisone equivalent or insufficient improvement which warrants the addition of another agent, OR Flare of GVHD symptoms during taper High-risk, treatment-naïve GVHD Participants who have initiated a new systemic treatment for steroid-refractory GVHD (institutional standard or investigational agent) within the 2 weeks prior to first dose of FMT. Treatment with FMT is allowed once the time since initiation of newest systemic therapy is 2 weeks or longer Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Delayed gastric emptying syndrome or large hiatal hernia Known chronic aspiration Participants with a history of significant allergy to foods not excluded from the donor diet (excluded foods are tree nuts, peanuts, shellfish, eggs) Pregnant and breast-feeding women are ineligible because they are not eligible for hematopoietic stem cell transplantation HIV-positive participants are ineligible Participants who are unable to swallow pills Participants with end-stage liver disease (cirrhosis) Participants with acute, active gastrointestinal infection (e.g., typhlitis, diverticulitis, appendicitis) | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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, Staphylococcal Infections Osteomyelitis CNS Infection Septic Arthritis Diabetic Foot Infection Vertebral Osteomyelitis Abscess Coagulase Negative Staphylococcal Infection are 18 years of age or older were referred to and assessed by an Infectious Disease physician in the form of a clinical consult as either an inpatient at the Royal Jubilee or Victoria General Hospitals an outpatient at the emergency department of one of the aforementioned hospitals an outpatient at the Outpatient Parenteral Antibiotic Therapy (OPAT) clinic have a clinically and/or radiographically diagnosed deep-seated MSSA or coagulase-negative Staphylococcal infection as defined in Table 1 of the protocol (Osteomyelitis, Discitis/Epidural abscess, Central Nervous System (CNS) infection, Abscess, Septic Arthritis (including Prosthetic Joint Infection), Diabetic foot infection) and the diagnosis has been made or confirmed by the Infectious Disease physician have had the causative pathogen confirmed microbiologically as either MSSA or CoNS through a laboratory sample indicative of the current site of infection are deemed to require prolonged IV antibiotic therapy and subsequently referred for assessment by the home IV program by the Infectious Disease physician are an appropriate candidate for the home IV program as determined by the assessing Home IV nurse, and are eligible for treatment with BOTH ceftriaxone AND at least one of the usual alternatives, namely cloxacillin, cefazolin or daptomycin provide written informed consent to participate in the study younger than 18 years of age pregnant involved in another therapeutic trial are not under the care of an Infectious Disease physician are unable to provide informed consent due to language or cognitive barriers are not appropriate for Home IV therapy as determined by the assessing Home IV nurse are concurrently receiving other anti-staphylococcal antibiotics (excluding the synergistic use of rifampin for prosthetic joint infections) at the time of discharge on the home IV program have relevant cultures indicating a polymicrobial infection (except in the case of diabetic foot infections where they may be included if MSSA or CoNS is determined to be the dominant pathogen by the Infectious Disease physician and any additional antibiotics used do not exhibit activity against MSSA or CoNS) have concurrent or incompletely treated bacteremia with MSSA or CoNS (as defined in protocol) have infective endocarditis based on imaging or clinical judgement | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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): 5.0-17.0, Systemic Lupus Erythematosus Participant must be between 5 and 17 years of age inclusive, at the time of Day 1 Participants who meet the 1997 American College of Rheumatology (ACR) for the classification of SLE Have or have had in series 4 or more of the 11 ACR for the classification of SLE Have active SLE disease defined as a safety of estrogen in lupus erythematosus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score >=6 at screening Have documented positive autoantibody test results within the study screening period, defined as an anti-nuclear antibody (ANA) titre >= 1:80 and/or a positive anti-dsDNA (>=30 international units per milliliter [IU/mL]) serum antibody test based on either the study's central laboratory results or the local laboratory results. Only unequivocally positive values as defined in the laboratory's reference range are acceptable; borderline values will not be accepted Are on a stable SLE treatment regimen, "Stable treatment at Baseline" consists of any of the following medications (alone or in combination) administered for a period of at least 30 days prior to Day 1 Corticosteroids [prednisone or prednisone equivalent up to 0.5 milligram per kilogram per day (mg/kg/day)], for those participants on alternating day doses of steroids, use the average of 2 daily doses to calculate the average daily steroid dose Other immunosuppressive or immunomodulatory agents including methotrexate, azathioprine, leflunomide, mycophenolate (including mycophenolate mofetil, mycophenolate mofetil hydrochloride, and mycophenolate sodium), calcineurin inhibitors (e.g. tacrolimus, cyclosporine), sirolimus, oral cyclophosphamide, 6-mercaptopurine or thalidomide Anti-malarials (e.g. hydroxychloroquine, chloroquine, quinacrine) Non-steroidal anti-inflammatory drugs (NSAIDs) Have an estimated glomerular filtration rate (eGFR) as calculated by Schwartz Formula of less than 30 milliliter/minute (mL/min) Have acute severe nephritis defined as significant renal disease (e.g., the presence of urinary sediments and other laboratory abnormalities) that, in the opinion of the study investigator, may lead to the participant requiring induction therapy during the first 12 weeks of the trial Have a history of a major organ transplant (e.g., heart, lung, kidney, liver) or hematopoetic stem cell/marrow transplant Have clinical evidence of significant, unstable or uncontrolled, acute or chronic diseases not due to SLE (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy or infectious diseases) which, in the opinion of the investigator, could confound the results of the study or put the participant at undue risk Have a planned surgical procedure or a history of any other medical disease (e.g., cardiopulmonary), laboratory abnormality, or condition (e.g., poor venous access) that, in the opinion of the investigator, makes the participant unsuitable for the study Have a history of malignant neoplasm within the last 5 years Have evidence of serious suicide risk including any history of suicidal behavior in the last 6 months, or who in the investigator's opinion, pose a significant suicide risk Have a history of a primary immunodeficiency Have an immunoglobulin A (IgA) deficiency (IgA level <10 milligrams per deciliter [mg/dL]) Have acute or chronic infections requiring management, as follows | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | eligible ages (years): 18.0-999.0, Non Hodgkin Lymphoma (NHL) Mantle Cell Lymphoma (MCL) FOR ALL 1. Patients must be aged ≥18 years with relapsed or refractory B-cell non-Hodgkin Lymphoma. 2. Absolute cluster of differentiation 3 (CD3) count ≥50 mm3. 3. Magnetic resonance imaging (MRI) brain and Lumbar Puncture with cerebrospinal fluid (CSF) analysis by cytology and flow cytometry without evidence of central nervous system (CNS) involvement ONLY in patients with history of CNS involvement or clinical suspicion at the time of enrollment. 4. Measurable disease must be documented within four weeks of the time of consent defined as nodal lesions greater than 20 mm in the long axis or extranodal lesions >10 mm in long and short axis OR bone marrow involvement that is biopsy proven. 5. Karnofsky performance score ≥60. 6. Adequate hepatic function, defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <5 x upper limit of normal (ULN); serum bilirubin and alkaline phosphatase <5 x ULN, or considered not clinically significant as per the clinical PIs discretion (e.g. Gilbert's or indirect hyperbilirubinemia) or felt to be due to underlying disease. 7. Adequate renal function, defined as creatinine clearance>40 ml/min. 8. Able to provide written informed consent. 9. Agree to practice birth control during the study. 10. Adequate cardiac function as indicated by New York Heart Association (NYHA) classification I or II AND left ventricular ejection fraction of ≥35% (by cardiac echocardiogram (ECHO) or multigated acquisition scan (MUGA)) and adequate pulmonary function as indicated by room air oxygen saturation of ≥92%. 11. Expected survival >12 weeks. 12. Negative urine or serum pregnancy test in females of child bearing potential at study entry. 13. Meet for regarding fertility and contraception. 14. No contraindication to central line access. Phase 1: 3+3 1. Diagnosis of B-cell NHL including Follicular Lymphoma, Marginal Zone Lymphoma (splenic, nodal, extranodal), Mantle Cell Lymphoma, and Diffuse large B-cell lymphoma (DLBCL) with associated subtypes (aggressive B-cell lymphoma, T-cell/histocyte rich B-cell lymphoma, primary mediastinal B-cell lymphoma, Epstein-Barr virus-positive (EBV+) diffuse large B-cell lymphoma, transformed lymphoma such as transformed follicular or marginal zone, and Richter's transformation). 2. Patients must have active, measurable disease as defined and meet one of the following criteria. 1. Must have received Rituximab or another cluster of differentiation 20 (CD20) antibody and at minimum two different chemotherapy regimens appropriate for their disease and be ineligible to receive autologous transplant. 2. Relapse post-autologous transplant 3. Relapse post-allogeneic transplant 4. Patients not previously treated with CAR-T cell therapy PHASE 1b and 2 1: 6-9 patient expansion with 8-day manufacturing (Phase 1b) 1. Diagnosis of B-cell NHL including Follicular Lymphoma, Marginal Zone Lymphoma (splenic, nodal, extranodal), and DLBCL with associated subtypes (aggressive B-cell lymphoma, T-cell/histocyte rich B-cell lymphoma, primary mediastinal B-cell lymphoma, EBV+ diffuse large B-cell lymphoma, transformed lymphoma such as transformed follicular or marginal zone, and Richter's transformation). 2. Patients must have active, measurable disease as defined and meet one of the following 1. Must have received Rituximab or another cluster of differentiation 20 (CD20) antibody and at minimum two different chemotherapy regimens appropriate for their disease and be ineligible to receive autologous transplant. 2. Relapse post-autologous transplant. 3. Relapse post-allogeneic transplant. 4. Relapse post-anti-cluster of differentiation 19 (CD19) CAR-T cell therapy. i. A maximum of 2 patients with prior CAR-T will be allowed in this cohort. 2: 6-9 patient expansion with 12-day manufacturing (Phase 1b) 1. Diagnosis of B-cell NHL including Follicular Lymphoma, Marginal Zone Lymphoma (splenic, nodal, extranodal), and DLBCL with associated subtypes (aggressive B-cell lymphoma, T-cell/histocyte rich B-cell lymphoma, primary mediastinal B-cell lymphoma, EBV+ diffuse large B-cell lymphoma, transformed lymphoma such as transformed follicular or marginal zone, and Richter's transformation). 2. Patients must have active, measurable disease as defined and meet one of the following 1. Must have received Rituximab or another CD20 antibody and at minimum two different chemotherapy regimens appropriate for their disease and be ineligible to receive autologous transplant. 2. Relapse post-autologous transplant. 3. Relapse post-allogeneic transplant. 4. Relapse post-anti-CD19 CAR-T cell therapy. i. A maximum of 2 patients with prior CAR-T will be allowed in this cohort. 3: Mantle Cell Lymphoma (Phase 2) 1. Diagnosis of Mantle Cell Lymphoma. 2. Patients must have active, measurable disease as previously designed and have relapsed, refractory disease as defined as one of the following: 1. Relapsed disease after two lines of cytotoxic chemotherapy including administration of anti-CD20 antibody. 2. Progressive disease after ≥second line Bruton tyrosine kinase (BTK) inhibitor. 3. Relapse post-autologous transplant. 4. Relapse post-allogeneic transplant. 5. Relapse post anti-CD19 CAR-T cell therapy. i. A maximum of four patients with history of prior anti-CD19 CAR-T will be allowed in this cohort (all patients) A potential subject who meets any of the following is ineligible to participate in the study. 1. Positive beta-human chorionic gonadotropin (HCG) in female of child-bearing potential defined as per table 1. 2. Confirmed active human immunodeficiency virus (HIV), Hepatitis B or C infection. 3. History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon requiring steroid therapy defined as >20 mg of prednisone or equivalent daily. 4. Presence of ≥grade 3 non-hematologic toxicities as per Common Terminology for Adverse Events (CTCAE) version 5.0 from any previous treatment unless it is felt to be due to underlying disease. 5. Concurrent use of investigational therapeutic agents or enrollment on another therapeutic clinical trial at any institution. Minimum of 14 days or 5 half-lives of the drug (whichever is shorter) washout prior to apheresis. 6. Refusal to participate in the long-term follow-up protocol. 7. Patients with active CNS involvement by malignancy on magnetic resonance imaging (MRI) or by lumbar puncture. a. Patients with prior CNS disease that has been effectively treated will be eligible providing treatment was >4 weeks before enrollment and a remission documented within 8 weeks of planned CAR-T cell infusion by MRI brain and CSF analysis. 8. Previous recipients of allogeneic hematopoietic stem cell transplantation (AHCT) are excluded if they are <100 days' post-transplant, have evidence of active graft-versus-host-disease (GVHD) of any grade, or are currently on immunosuppression. 9. Previous recipients of CAR-T cell therapy directed at either CD19 or CD20 are excluded if they are <100 days post prior CAR-T cell treatment (does not re-enrollment). a. Patients with prior CAR-T treatment against CD19 or CD20 must have repeat biopsy post-CAR-T cell therapy confirming a minimum of 5% CD19 or CD20 positivity by immunohistochemistry or flow cytometry. 10. Anti-CD20 antibody treatment within 4 weeks of cell infusion. 11. Anti-CD19 antibody treatment within 4 weeks of cell infusion. 12. Cytotoxic chemotherapy other than lymphodepletion within 14 days of CAR-T cell infusion (corticosteroids or targeted therapies for bridging allowable e.g. venetoclax, BTK inhibitors, lenalidomide, etc). 13. Cytotoxic chemotherapy treatment within 10 days or steroid treatment (other than replacement dose steroids) within 7 days prior to apheresis collection for CAR-T cells. 14. Patients post solid organ transplant who develop high grade lymphomas or leukemias. 15. Concurrent active malignancy other than basal or squamous cell carcinomas of the skin | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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, Beta-Thalassemia Thalassemia Sickle Cell Disease Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn Sickle Cell Anemia Subjects or legal representative or guardian (if applicable) must sign and date informed consent form (ICF) Subjects must have received CTX001 infusion There are no | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | eligible ages (years): 18.0-70.0, Crohn Disease for Crohn's disease Male or Female ≥18 and ≤70 years old and lives with someone that is involved in daily diet Documented diagnosed of Crohn's Disease sCDAI less than 400 Patients on oral 5-aminosalicylates, mesalamine or sulfasalazine must be on a stable dose for ≥2 weeks prior to screening Treated with anti-Tumor Necrotic Factors (TNFs) or immunosuppressants (AZA, 6-Mercaptopurine (6-MP), or methotrexate) at screening must have been on a stable dose for ≥4 weeks On steroids can be on no more than prednisone 20 mg daily or budesonide 9 mg daily at the screening. If clinically indicated, tapering of steroids after 4 weeks of intervention may occur. Prednisone may be tapered by no more than 2.5mg/wk and budesonide by no more than 3 mg/wk No antibiotic use or probiotic use within 2 weeks prior to screening for Crohn's disease: Patients with Ulcerative Colitis and Celiac Disease Abdominal abscess, symptomatic Intestinal stricture, patients with altered anatomy: prior total colectomy or proctocolectomy or anticipated colectomy during the study period and presence of ileal pouch or ostomy Other clinically meaningful laboratory abnormalities: pregnancy or lactation, an unstable or uncontrolled medical disorder, colonic dysplasia or adenomas, and malignant neoplasms. Toxic megacolon situations such as Patients with short life expectancy Use of cyclosporine, mycophenolate mofetil, sirolimus, thalidomide or tacrolimus within 2 months prior to screening Need for prednisone > 20 mg daily or budesonide > 9 mg daily at the time of screening. Received intravenous corticosteroids within 2 weeks prior to screening, during screening, or during the study period except as premedication for anti-TNFs Use of Total Parenteral Nutrition at the time of screening and during the study period Presence of any of the following laboratory abnormalities during screening period or at least <12 weeks; Hemoglobin <8.0g/dl, Albumin <2.8g/dl Uncooperative behavior or any condition that could make the patient potentially noncompliant to the study procedure Other significant or life-threatening co-morbidities in which low fat/high fiber diet intervention could negatively affect The need for antibiotic use during the study period | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | eligible ages (years): 18.0-50.0, Alopecia Areata early localized scalp alopecia areata patients who did not receive any medication for at least 2 months before starting the study Patients who agreed to join the study and signed written consent pregnant, and lactating females and those with unrealistic expectation Alopecia totalis or universalis or ophiasis or cicatrising alopecia Usage of systemic treatment of alopecia areata 2 months prior to the study Any scalp lesion within the treated area Bleeding diathesis, severe anemia or platelet disorders Medical conditions such as autoimmune diseases | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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): 0.333-25.0, Primary Immune Deficiency Disorder Immune Deficiency Disease Bone Marrow Failure Confirmed diagnosis of Primary Immune Deficiencies Chronic granulomatous disease (CGD) Wiskott-Aldrich syndrome (WAS) Hyper-Immunoglobulin M (IgM) syndrome Common variable immunodeficiency (CVID) Leukocyte adhesion deficiency-1 (LAD-1) Severe Combined Immunodeficiency (SCID) Immune Dysregulatory Syndromes Immunodysregulation polyendocrinopathy enteropathy X-linked (IPEX) syndrome Patients will not be excluded on the basis of sex, racial or ethnic background Positive leukocytotoxic crossmatch Prior allogeneic stem cell transplant Uncontrolled bacterial, viral, or fungal infection at the time of enrollment. Uncontrolled is defined as currently taking medication and with progression or no clinical improvement on adequate medical treatment Diagnosis of idiopathic aplastic anemia, Fanconi Anemia, Dyskeratosis Congenita, or other short telomere syndrome Seropositivity for the human immunodeficiency virus (HIV) Active Hepatitis B or C determined by serology and/or nucleic acid test (NAT) Female patients who are diagnosed as pregnant by beta h uman chorionic gonadotropin (bHCG) testing (per institutional practice) or who are breast-feeding. Donor Donor must be medically, socially, and psychologically fit to donate Bone marrow should be requested from all allogeneic donors. Peripheral blood stem cells (PBSCs) are allowed only if the donor is unable or unwilling to give marrow, and no other bone marrow donor is available. Cord blood is not permitted | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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): 30.0-70.0, Dental Implant Failed After evaluation, individuals may be allocated into groups according to the characteristics observed, for example: carriers of single implants, patients with overdentures, individuals with systemic diseases, smokers Individuals who need to use or suspend systemic medication to perform the proposed clinical exams will be excluded from 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): 13.0-60.0, Psoriasis minimum age 13 years maximum age 60 years both males and females affected with mild, moderate and severe psoriasis hypertension cardiovascular disorders pregnancy lactation renal failure liver failure hypersensitivity to 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): 18.0-999.0, Kidney Failure Liver transplant recipients ≥ 18 years old Baseline renal dysfunction (GFR ≤ 60 mL/min) Rabbit anti-thymocyte globulin (rATG) induction (cumulative dose 3 mg/kg) Indication for transplant: ethanol, hepatitis C, or nonalcoholic steatohepatitis Increased risk of rejection: autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, positive crossmatch, retransplantation Incompletely healed incision or other wound healing issues at time of randomization Multiple or previous organ transplantation Severe, uncontrolled hypercholesterolemia (> 9mmol/L) or hypertriglyceridemia (>8.5 mmol/L) in the 6 mo prior to transplantation Insurance company unwilling to pay for the cost of the everolimus Pregnant women Unable to provide informed consent | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | eligible ages (years): 18.0-999.0, Recurrent Head and Neck Squamous Cell Carcinoma Head and Neck Cancer Stage IV Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care. 2. Histologically confirmed HNSCC (oral cavity, oropharynx, hypopharynx, larynx) not amenable to therapy with curative intent (surgery or radiation therapy with or without chemotherapy). 3. Patients not previously treated for recurrent/metastatic disease. 4. Radiographically measurable disease as defined by version 1.1. Previously irradiated lesions can only be considered as measurable disease if disease progression according to version 1.1. 5. Patients unable for cisplatin-based chemotherapy, defined "unable" by: 1. Karnofsky 70% or 2. Karnofsky 80-100% and amenable to chemotherapy, but: i. Impaired renal function, creatinine clearance >30 mL/min and <80 mL/min GFR could be assessed by direct measurement (EDTA or creatinine clearance) if available or by calculation from serum or plasma creatinine (see annex 5), or ii. grade ≥2 hearing loss, according to the NCI CTCAE v 5.0, or iii. Class III heart failure according to the New York Heart Association (annex 9), or iv. History of allergic reactions to cisplatin, carboplatin, or other platinum-containing compounds or v. Prior dose of cisplatin ≥225 mg/m² for locally advanced disease (a patient who received prior RT + 3 cycles of cisplatin 100 mg/m2 or 3 cycles induction TPF (with cisplatin ≥75/m2) for locally advanced primary HN cancer can be included), or vi. Disease progression or relapse during or within 6 months of receiving platinum-based therapy administered as neoadjuvant, adjuvant therapy or as concomitant chemotherapy with radiotherapy and have received at least 200 mg/m2 of cisplatin. 6. Male or female patients aged ≥18 years. Patients aged ≥70 years old can only be included with a G8 (Geriatric 8) health status screening score ≥ 14. 7. Clinical laboratory values as specified below within 28 days before the first dose of study drug: 1. Total bilirubin must be ≤2 × the upper limit of normal (ULN). 2. Magnesium ≥ lower limit of normal. 3. Calcium ≥ lower limit of normal. 4. ALT and AST must be ≤3 × ULN unless liver metastases are present, in which case they must be ≤5x ULN. 5. Hemoglobin must be ≥9 g/dL, absolute neutrophil count (ANC) must be ≥1.500/µL, WBC must be ≥2.000/µL and platelet count must be ≥100.000/µL. 8. Subjects who have received radiation as primary therapy are eligible if radiation therapy treatment was completed > 4 weeks prior to inclusion. 9. Documentation of PD-L1 status by IHC performed by the central lab at randomization. A pre-treatment tumor tissue sample should be sent. A newly obtained biopsy (within 6 months prior to start of study treatment) is preferred but an archival sample is acceptable, if several tumor samples are available, testing should be performed on the most recently obtained tumor sample. 10. Documentation of HPV p16 status (OPC) is required for HNSCC tumor of the oropharynx. For subjects with oropharyngeal cancer, sites are defined in annex 8. HPV status of tumor tissue has to be locally determined at screening by any of the following methods: p16 IHC, in situ hybridization, or polymerase chain reaction based assay. If HPV status by p16 IHC is positive result confirmation by PCR is mandatory Male or female patients aged <18 years. Patients aged ≥ 70 years old should not be included with a G8 (Geriatric 8) health status screening score < 14. 2. Karnofsky <70%. 3. Patients that meets more than one of the following 1. Karnofsky 70%, 2. Impaired renal function, creatinine clearance >30 mL/min and <80 mL/min GFR could be assessed by direct measurement (EDTA or creatinine clearance) if available or by calculation from serum or plasma creatinine (see annex 5), 3. Class III heart failure according to the New York Heart Association (annex 9). 4. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy except for alopecia, vitiligo, hear loss and the laboratory values defined in the criteria. 5. Histologically confirmed recurrent or metastatic squamous cell carcinoma of unknown primary, of the nasopharynx or non-squamous histologies (eg, mucosal melanoma). 6. Active brain metastases or leptomeningeal metastases. 7. Carcinomatous meningitis. 8. Active, known, or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or unexpected conditions of recurrence in the absence of an external trigger are allowed to be included. 9. Diagnosis of immunodeficiency or any condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment. 10. History of pneumonitis requiring treatment with steroids; history of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan; history of radiation pneumonitis in the radiation field (fibrosis) is permitted. 11. Patients with a history of interstitial lung disease cannot be included if they have symptomatic ILD (Grade 3-4) and/or poor lung function. 12. Prior therapy with experimental antitumor vaccines; any T-cell co-stimulation agents or inhibitors of checkpoint pathways, such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody; or other agents specifically targeting T cells are prohibited. 13. Any serious medical or psychiatric illness, including drug or alcohol abuse, that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol. 14. Life-threatening illness unrelated to cancer. 15. Female patients who are lactating and breast-feeding or a positive serum pregnancy test during the screening period. 16. Systemic anticancer treatment or radiotherapy less than 4 weeks or 5 half-lives, whichever is longer, before the first dose of study treatment or not recovered from acute toxic effects from prior chemotherapy and radiotherapy. 17. Prior treatment with investigational agents ≤21 days (≤4 weeks for monoclonal antibodies with evidence of PD) or ≤5 their half-lives (whichever is shorter) before the first dose of study treatment. A minimum of 10 days should elapse from prior therapy to initiating protocol therapy. 18. Major surgery within 14 days before the first dose of study drug and not recovered fully from any complications from surgery. 19. Systemic infection requiring IV antibiotic therapy or other serious infection within 14 days before the first dose of study drug. 20. Known human immunodeficiency virus (HIV) positive (testing not required), or known acquired immunodeficiency syndrome (AIDS). 21. Patients with positive test for hepatitis B virus or hepatitis C virus indicating presence of virus, eg, Hepatitis B surface antigen (HBsAg) positive, or Hepatitis C antibody (anti-HCV) positive (except if HCV-RNA negative). 22. Active secondary malignancy that requires treatment. Patients with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry and no additional therapy is required during the study period 23. Any clinically significant co-morbidities, such as uncontrolled pulmonary disease, known impaired cardiac function or clinically significant cardiac disease, active central nervous system disease, active infection, or any other condition that could compromise the patient's participation in the study. 24. Patients with history of hypersensitivity reactions to study drugs (nivolumab, cetuximab or paclitaxel) or any of their excipients. 25. Symptomatic peripheral neuropathy of Grade ≥ 2 based on the CTCAE v5.0 26. Pulmonary embolism, deep vein thrombosis, or other significant thromboembolic event ≤ 8 weeks prior to starting the study treatment. 27. History of severe skin disorder that in the opinion of the investigator may interfere with study conduct | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | eligible ages (years): 18.0-999.0, Anaphylaxis Being > 18 years old suffered an anaphylactic reaction, regardless of the location or causative allergen transferred alive in an ICU dead within less than one hour after admission | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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-graft-versus-host Disease New onset high risk acute GvHD (Ann Arbor score 2/3 as defined in Appendix A) following allogeneic SCT. Any clinical severity in accordance with Glucksberg grade II-IV is eligible. 2. Any donor type (e.g., related, unrelated) or stem cell source (bone marrow, peripheral blood, cord blood). Recipients of non-myeloablative and myeloablative transplants are eligible. 3. No prior systemic treatment for acute GvHD except for a Maximum of 3 days of prednisone ≤2 mg/kg/day (or IV methylprednisolone equivalent). Topical skin steroid treatment and non-absorbable oral steroid treatment for GI GvHD are permissible. 4. Age 18 years or older. 5. Platelet count > 25.000 (including platelet support) 6. Eastern Coorperative Oncology Group (ECOG) score of 0≤2 7. Negative pregnancy test within 10 days before start of study if the patient is a woman of child-bearing Age 8. Direct bilirubin must be <2 mg/dL unless the elevation is known to be due to Gilbert syndrome or aGvHD within 3 days of enrollment. 9. ALT/SGPT and AST/SGOT must be <5 x the upper limit of the normal range within 3 days of enrollment. 10. Females/Males who agree to comply with the applicable contraceptive requirements of the protocol. 11. Written informed consent from patient. 12. Biopsy of acute GvHD target organ is strongly recommended but not required. Enrollment should not be delayed for biopsy or pathology results. Patients who do not enroll within 5 days of Initiation of systemic steroid treatment for acute GvHD are not permitted to participate Progressive or relapsed malignancy 2. Uncontrolled active infection 3. Patients with chronic GvHD 4. History of or current diagnosis of progressive multifocal leukoencephalopathy (PML) 5. Pregnant or nursing (lactating) women 6. Use of other drugs for the treatment of acute GvHD apart from ongoing GvHD prophylaxis and corticosteroids 7. Patients on dialysis 8. Patients requiring ventilator support 9. Evidence of known infection with human immunodeficiency virus (HIV) or active hepatitis B 10. Investigational agent within 30 days of enrollment without approval from the Sponsor/ Investigator (PI). (Off-label use of medication is not considered investigational unless in context of a formal study) 11. History of allergic reaction to 8-MOP 12. Concomitant diagnosis of malignant melanoma or basal cell carcinoma 13. Hypersensitivity or allergy to both heparin and citrate products (if hypersensitive or allergic only to one, does not apply) 14. Inability to tolerate extracorporeal volume shifts associated with ECP 15. Presence of aphakia 16. History of splenectomy 17. Leucocyte count > 25.000/μl 18. Coagulopathy 19. Known photosensitive disease like systemic lupus erythematosus, porphyrias or albinism | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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): 0.0-22.0, Acute Myeloid Leukemia All patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to enrollment and treatment on AAML1831. Submission of diagnostic specimens must be done according to the Manual of Procedures). Risk stratification will not be possible without the submission of viable samples. Given there are multiple required samples, bone marrow acquisition techniques such as frequent repositioning or performing bilateral bone marrow testing should be considered to avoid insufficient material for required studies. Consider a repeat marrow prior to starting treatment if there is insufficient diagnostic material for the required studies Patients must be less than 22 years of age at the time of study enrollment Patient must be newly diagnosed with de novo AML according to the 2016 World Health Organization (WHO) classification with or without extramedullary disease Patient must have 1 of the following >= 20% bone marrow blasts (obtained within 14 days prior to enrollment) In cases where extensive fibrosis may result in a dry tap, blast count can be obtained from touch imprints or estimated from an adequate bone marrow core biopsy < 20% bone marrow blasts with one or more of the genetic abnormalities (sample obtained within 14 days prior to enrollment) A complete blood count (CBC) documenting the presence of at least 1,000/uL (i.e., a white blood cell [WBC] count >= 10,000/uL with >= 10% blasts or a WBC count of >= 5,000/uL with >= 20% blasts) circulating leukemic cells (blasts) if a bone marrow aspirate or biopsy cannot be performed (performed within 7 days prior to enrollment) ARM C: Patient must be >= 2 years of age at the time of Late Callback ARM C: Patient must have FLT3/ITD allelic ratio > 0.1 as reported by Molecular Oncology Patients with myeloid neoplasms with germline predisposition are not eligible Fanconi anemia Shwachman Diamond syndrome Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21 Any other known bone marrow failure syndrome Any concurrent malignancy Juvenile myelomonocytic leukemia (JMML) Philadelphia chromosome positive AML Mixed phenotype acute leukemia Acute promyelocytic leukemia | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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, Rheumatoid Arthritis Interstitial Lung Disease Due to Systemic Disease (Disorder) RA ILD The subject has given written consent to participate in the study. 2. Diagnosis of seropositive (i.e., presence of RF and/or anti-CCP antibodies) rheumatoid arthritis (RA) according to the ACR/EULAR 2010 within 24 months. 3. No previous treatment with disease modifying anti-rheumatic drugs (DMARDs). History of prednisone use is allowed but should have been discontinued 2 weeks before baseline measurement. 4. Active disease with ≥2 painful and ≥2 swollen joints in 66/68 joints and CRP ≥2.0 mg/dl 5. Aged 18-80 years 6. Willing to undergo HRCT and pulmonary function tests (PFTs) Current active inflammatory joint disease other than RA. 2. Significant and/or uncontrolled cardiac, pulmonary disease, nervous system, renal, hepatic, endocrine or gastrointestinal disorders or severe RA which in the investigator's opinion would preclude patient participation. 3. Malignancy within the past 5 years, except for successfully treated cervical carcinoma in situ, basal cell and squamous cell carcinoma of the skin, with no evidence of recurrence or metastatic disease for at least 3 years. 4. Primary or secondary immunodeficiency (history of, or currently active), including known history of HIV infection. 5. Active infection (excluding fungal infections of nail beds) requiring i.v. anti-infectives within 4 weeks, or oral anti-infectives within 2 weeks prior to baseline. 6. Women of childbearing potential not willing or able to use highly effective methods of birth control per ICH M3 (R2) for 28 days prior and 3 months after end of study. 7. Pregnant or lactating women. 8. Positive tests for hepatitis B (HBsAg or HBV DNA) or hepatitis C serology. 9. History of herpes zoster infection during last 10 years. 10. History of venous thromboembolism or diverticulitis. 11. Positive tuberculosis history and/or positive Quantiferon test. 12. Hemoglobin <90 g/L. 13. Absolute neutrophil count < 1500 cells/uL. 14. ASAT or ALAT >2.0 times the upper limit of normal | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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 Malignant Solid Neoplasm Metastatic Malignant Solid Neoplasm Refractory Malignant Solid Neoplasm Unresectable Malignant Solid Neoplasm Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective Patients must be >= 4 weeks beyond treatment with any chemotherapy or other investigational therapy to hormonal, biological, or targeted agents; or at least 5 half-lives from hormonal, biological, or targeted agents, whichever is shorter at the time of treatment initiation Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 Absolute neutrophil count (ANC) >= 1,500 /mcL Platelets >= 100,000 / mcL Hemoglobin >= 9 g/dL Serum creatinine =< 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate [GFR] can also be used in place of creatinine or creatine clearance [CrCl]) >= 60 mL/min for subject with creatinine levels > 1.5 x institutional ULN (creatinine clearance should be calculated per institutional standard) Serum total bilirubin =< 1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 x ULN Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN OR =< 5 x ULN for subjects with liver metastases International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants Patients who are receiving any other investigational agents Pregnant or breastfeeding women will be excluded from participation in this trial, as there is no significant clinical information regarding the effects of copanlisib, nivolumab, and ipilimumab on a fetus or newborn infant Known active hepatitis B or hepatitis C infection. All patients must be screened for hepatitis B virus (HBV) and hepatitis C virus (HCV) up to 28 days prior to study drug start using the routine hepatitis virus lab panel. Patients positive for hepatitis B virus surface antigen (HBsAg) and/or hepatitis B virus core antibody (HBcAb) will be eligible if they are negative for HBV DNA, these patients should receive prophylactic antiviral therapy. Patients positive for anti-HCV antibody will be eligible if they are negative for HCV RNA Human immunodeficiency virus (HIV)-infected (HIV1/2 antibody-positive) patients may participate IF they meet all the following requirements They must be on an anti-retroviral regimen with evidence of at least two undetectable viral loads within the past 6 months on this same regimen; the most recent undetectable viral load must be within the past 12 weeks They must have a CD4 count >= 250 cells/mcL over the past 6 months on this same anti-retroviral regimen and must not have had a CD4 count < 200 cells/ mcL over the past 2 years, unless it was deemed related to the cancer and/or chemotherapy-induced bone marrow suppression For patients who have received chemotherapy in the past 6 months, a CD4 count < 250 cells/mcL during chemotherapy is permitted as long as viral loads were undetectable during this same chemotherapy They must have an undetectable viral load and a CD4 count >= 250 cells/mcL within 7 days of enrollment They must not be currently receiving prophylactic therapy for an opportunistic infection and must not have had an opportunistic infection within the past 6 months Active infection requiring intravenous (IV) antibiotics or other uncontrolled intercurrent illness requiring hospitalization | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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, Pelvic Organ Prolapse Stage II-IV pelvic organ prolapse Bothersome bulge symptoms At least 725 MET-minutes/week on International Physical Activity Questionnaire Short Form English-speaking Undergoing treatment of prolapse Surgery occurring at least 7 days from date of randomization (to allow for collection of at least 7 days of preoperative accelerometer data) Able and willing to follow up at 3 months for in-office exam Enrollment in another research study of pelvic organ prolapse Concomitant non-urogynecologic surgery Planned further surgery in the next 3 months or anticipated treatment which would result in prolonged inactivity (such as a cancer diagnosis) 3 months postoperatively | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | eligible ages (years): 18.0-75.0, Indolent Systemic Mastocytosis Patient with one of the following documented mastocytosis subtypes (variants): Smouldering Systemic Mastocytosis, Indolent Systemic Mastocytosis 2. An excess of mast cells or a presence of abnormal mast cells in at least two organs (among skin, bone-marrow and GI Tract). 3. Patient with documented systemic mastocytosis and evaluable disease based upon histological 4. Patient with documented treatment failure of his/her symptom(s) (within the past 2 years) with at least two of the symptomatic treatments used at optimized dose: Anti H1, Anti H2, Proton pump inhibitor, Antidepressants, Cromoglycate Sodium, Antileukotriene. 5. Patient with severe symptoms of mastocytosis over the 14-day run-in period including at least one among pruritus, flushes, and depression: pruritus score ≥ 9, number of flushes per week ≥ 8, Hamilton rating scale for depression (HAMD-17) score ≥ 19 Patient with one of the following mastocytosis: Cutaneous Mastocytosis, Systemic Mastocytosis with an Associated clonal Hematologic Non Mast cell lineage Disease (SM-AHNMD), Mast cell leukemia (MCL), Aggressive systemic mastocytosis (ASM) 2. Previous treatment with any Tyrosine Kinase Inhibitor 3. Treatment with any investigational agent within 8 weeks prior to screening | 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): 19.0-999.0, Corona Virus Infection Prevention Study 1. Capable of understanding and providing signed informed consent and ability to adhere to the requirements and restrictions of this protocol; 2. Men and Women ≥ 19 years of age unless local laws dictate otherwise; 3. English speaking; 4. Must be willing to use an adequate form of contraception (or abstinence) from the time of the first dose with the IMP until after the last dose of IMP. 5. Be symptom-free at screening/baseline. 6. Work/live in contact with COVID-19 infected patients or scheduled to work in a setting with high likelihood of contact with COVID-19 infected patients. Prevention Study Prior Tracheostomy; 2. Concomitant treatment of respiratory support (involving any form of oxygen therapy); 3. Any clinical contraindications, as judged by the attending physician; 4. Any symptoms consistent with COVID-19; 5. Pregnant; 6. Mentally or neurologically disabled patients who are considered not fit to consent to their participation in the study; 7. Prior COVID-19 infection. Treatment Sub study 1. Capable of understanding and providing signed informed consent and ability to adhere to the requirements and restrictions of this protocol; 2. Men and Women ≥ 19 years of age unless local laws dictate otherwise; 3. English speaking; 4. Must be willing to use an adequate form of contraception (or abstinence) from the time of the first dose with the IMP until after the last dose of IMP; 5. Positive COVID-19 test or presentation of clinical symptoms defined as fatigue with either fever >37.2 (oral) and/or a persistent cough. Treatment Sub Study Prior Tracheostomy; 2. Concomitant treatment of respiratory support (involving any form of oxygen therapy); Any clinical contraindications, as judged by the attending physician; 3. Mentally or neurologically disabled patients who are considered not fit to consent to their participation in the study; 4. Pregnant; 5. Currently hospitalized for symptoms of COVID-19 | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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): 20.0-50.0, Socket Preservation Systemically healthy individuals within the age group of 20-50 years with presence of teeth with hopeless prognosis requiring extraction Medically compromised patients Subjects who underwent radiotherapy or chemotherapy in the past 12 months Patients having uncontrolled periodontal disease or having an active sinus infection Smokers | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | eligible ages (years): 18.0-64.0, Covid-19 Virus Disease ETH employee or ETH student and their family members living in the same household at the start of the study Between 18 and 64 years of age at the start of the study Signed informed consent Age over 64 years at the start of the study In quarantine or self-confinement at the start of the study Active COVID-19 infection at the start of the study Diagnosed with a laboratory test Suspected based on typical symptoms such as fever (>38°C), acute pulmonary ex-acerbation or sudden loss of gustatory taste The following medical condition With continuous steroid therapy/ chemotherapy/immunsuppressive therapy In treatment for cancer With severe autoimmune 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): 18.0-999.0, Cutaneous Mastocytosis Patient with mastocytosis (diagnosis confirmed clinically according to international criteria) Patient with pigmented skin lesions, of moderate to very severe severity (by comparison with a 4-point photographic scale: light, moderate, severe and very severe) Major patient aged ≥ 18 years Patient with social security coverage Patient having given written, free and informed consent to participate in the study Patients with mastocytosis, without skin lesions Patient with pigmented skin lesions, only of mild severity (by comparison with a 4-point photographic scale: mild, moderate, severe and very severe) Patient with another cutaneous mastocytosis phenotype Patient treated by a treatment known as a cytoreductive for mastocytosis: alpha interferon, cladribine, imatinib, midostaurin or any cytoreductive treatment being evaluated by clinical trial in mastocytosis Patient under guardianship, or under curatorship, or not fluent in the French language or unable to understand and complete the study questionnaires pregnant or breastfeeding women Patients with tanned skin following photoexposure within 3 weeks of starting 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): 3.0-24.0, Nephrotic Syndrome Steroid-Dependent To be eligible for into this study, participants will have to fulfil the following Age between 3 and 24 years Prednison dependent steroid syndrome 0.3-1mg/Kg/day and receive prednisone for at least six months before enrolment. Steroid dependence is defined by two consecutive relapse during corticosteroid therapy or within 14 days of ceasing therapy Ability to provide consent and assent: parents'/guardian's written informed consent, and child's assent given before any study-related procedure not part of the subject's normal medical care, with the understanding that consent may be withdrawn by the subject any time without prejudice to his or her future medical care Children will be excluded if any of the following apply Positivity to autoimmunity tests (ANA, nDNA, ANCA) Reduction of C3 levels eGFR<90/ml/min/1,73 m2 valuated according to revised Bedside Schwartz Formula for patients between 2 and 17 years and with CKD-EPI Creatinine 2009 Equation for 18 years old patients Pregnancy Neoplasm Infections: previous or actual HBV (with HBeAb positivity) or HCV infection CD20 B lymphocytes count <2,5% Treatment with Rituximab or cyclophosphamide in the last 6 months | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | eligible ages (years): 18.0-80.0, Bell Palsy Adult patients (≥18 years) diagnosed with BP within 72 hour of onset. 2. Adult patients willing to get treatment, attending follow up visits and signing informed consent Patients treated with antivirals (i.e acyclovir) for any reason simultaneously, such as Herpes Zoster (Ramsay Hunt syndrome). 2. Palsy onset > 72 hours before diagnosis or unknown onset. 3. Previous episodes of BP. 4. Patients suspected for hypothalamic-pituitary-adrenal (HPA) axis suppression who have to be cautiously tapered due to high risk for adrenal insufficiency: steroid treatment in any dosage for more the 3 weeks (due to other indication) or cushingoid appearance. 5. Contraindication for steroid use: uncontrolled diabetes or hypertension, psychosis, peptic ulcer or upper GI bleeding, liver cirrhosis or portal hypertension, known allergy to prednisone, etc. Any case in which steroid treatment was stopped earlier than planned by the patient or the physician. 6. Any conditions suspicious for non-idiopathic facial palsy: chronic otitis media, acute otitis media, mastoiditis, temporal bone/middle ear trauma, other cranial nerve neuropathies (i.e cranial nerve VIII), cerebrovascular disorders, tumor affecting facial nerve (i.e, parotid malignancy, schwannoma) or systemic causes (i.e multiple sclerosis, meningitis, sarcoidosis, HIV infection, etc). 7. Patients with low compliance for treatment according to the physician. 8. Pregnancy or breast-feeding patients | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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, COVID-19 Age = or > than 18 years; Laboratory-proven COVID-19 infection by RT-PCR in any clinical sample . Time since symptom onset less than 10 days at the time of screening Presence of COVID-19 pneumonia, with a typical, indeterminate or atypical compatible image in a chest tomography exam (see definition below) - Presence of one of the following Need for> 3L of O2 in the catheter / mask or> 25% in the Venturi mask to maintain O2 saturation> 92% B presence of respiratory distress syndrome with PaO2 / FiO2 <300mmHg If intubated, within 48 hours of orotracheal intubation Absence of a history of serious adverse reactions to transfusion, for example, anaphylaxis Participation approval by the research clinician Already enrolled in another clinical trial evaluating antiviral or immunobiological therapy for the treatment of COVID-19 IgA deficiency Presence of a clinical condition that does not allow infusion of 400 ml of volume at clinical discretion Pregnancy or breastfeeding Receipt of immunoglobulin in the last 30 days Presence of significant risk of death within the next 48 hours at clinical discretion | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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, Oesophageal Cancer Esophageal Stent Stenosis Patients presenting with dysphagia due to a non-operable malignant obstruction of the esophagus or esophagogastric junction including extrinsic malignant compression and recurrence in post-esophagectomy patients Requiring treatment for dysphagia (Ogilvie score of 2-41) Life expectancy of less than 12 months Stenosis after laryngectomy Distance between the upper edge of the stent less than 2 cm from the upper esophageal sphincter Tumor length of more than 14 cm Previous stent placement for the same condition Inappropriate cultural level and understanding of the study Coagulopathy Patients with eosinophilic esophagitis or an esophageal motility disorder Nickel titanium (Nitinol) allergy | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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, Sexual Dysfunction Pelvic Floor Disorders Pelvic Organ Prolapse Urinary Incontinence Constipation being between the ages of 18-65 being a woman having sex partner no smoking, no alcohol physical, psychological, cognitive impairment having a non-Sjögren additional disease malignancy pregnancy no urogenital disease sarcoidosis AIDS anticholinergic drug use had a gynecological or urological operation other than cesarean | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd 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, To Evaluate the Efficacy of Flushing the Uterine Cavity With Lidocaine Before Hysterosalpingo-Foam Sonography to Reduce Procedure-related Pain *all women who were referred for tubal patency evaluation as part of their fertility workup known allergy to lidocaine unprotected intercourse profuse vaginal bleeding and genital tract inflammation or infections (e.g. pelvic inflammatory disease (PID) suspected sexually transmitted diseases (purulent vaginal discharge upon speculum insertion), salpingitis or tubo-ovarian abscess) psychological or neurological lesions affecting sensation, prior cervical surgery, cervical stenosis | 0 |
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