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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, Chronic Spontaneous Urticaria Patients with active CSU for at least 4 months which was treated with anti-histamines as well as at least one course of steroids (ex. Prednisone) Age ≥18 years Patients will undergo an ECG and QT parameters will be measured for further analysis 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 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 Subject able to provide written informed consent Viral Hepatitis (HAV, HBV, HCV) HIV Serious psychiatric or psychological disorders Other chronic dermatological conditions under active treatment Active consumption of illicit drugs including cannabis or derivatives for at least three months prior to the study Patients with significant cardiac, respiratory or active malignance disease (except Basel Cell Carcinoma) comorbidities Any uncontrolled infection at time of registration Renal comorbidity: eGFR < 30 mL/min/1.73m2 (note: CKD Grade 4 is defined as eGFR 15-29 mL/min/1.73 m2) Patient who is taking immunomodulatory medications for other indication 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, T-LGL Leukemia Clpd-Nk The gender of the patient is not limited, and the age is ≥18 years old; 2. Must meet diagnostic of T-LGLL or CLPD-NK according to WHO 2016 version; 3. The patient is treatment naive or received single methotrexate less than 4 weeks and without response. If relapsed or refractory patients, the patients must be naive for both thalidomide and methotrexate. 4. With LGLL treatment indications, it mainly includes (meets at least one of the following conditions): 1. ANC <0.5 × 10^9 / L 2. HGB <100g / L or need red blood cell infusion to maintain 3. PLT <50 × 10^9 / L 4. Combining autoimmune diseases that require treatment 5. symptomatic splenomegaly 6. Severe B symptoms 7. Pulmonary hypertension. 5. ECOG performance status score is 0-2; 6. The patient's expected survival time is ≥ 6 months Unable to understand or follow the research procedure; 2. Co-occurrent malignant tumors that has to be treated or course the symptom; 3. Other serious diseases, such as liver, kidney, heart, lung, nerve or metabolic diseases, may impede the ability of patients to tolerate methotrexate, cyclophosphamide or cyclosporin A; 4. ALAT / ASAT or alkaline phosphatase> 3 times the normal value; 5. Creatinine clearance <60ml / min; 6. Serological evidence of active infection of HIV, hepatitis C or hepatitis B; 7. Ineffective contraception; 8. Positive pregnancy test; 9. Pregnant women | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | eligible ages (years): 18.0-65.0, Addiction Opiate Chronic Pain Fractures, Bone Buprenorphine Dependence Orthopaedic trauma patient with history of suboxone use for greater than 30 days. Trauma must involve major long bone fracture(s) (femur, tibia, fibula, humerus, radius, ulna) 2.Must have taken suboxone in the last 24 hours and have participated in addiction treatment for greater than one month. 3.Age 18-65 4.ASA I-III 5.Willing to participate in post-operative psychiatric care 6.Glascow Coma Scale 15 Severe renal disease (Creatinine clearance < 40) 2.History of chronicSevere liver disease or an (AST/ALT greater than 2 times normal, direct/indirect bilirubin outside normal limits and INR> 1.4 if drawn as standard of care) or evidence of acute liver failure? 3.Acute Ethanol Intoxication (serum ethanol > 0.080 at time of informed consent) 4.Severe distracting injury that is close to pain levels expected from the orthopedic trauma (Ex surgical abdominal process, neurosurgical process, massive soft tissue trauma, severe spinal injury, multiple rib fractures) 5.Pregnancy 6.Polysubstance abuse on urine or serum drug screen (excluding marijuana due to its new legality in multiple states) | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and 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, Dry Eye Patients with Sjögren's syndrome, both in primary and secondary forms, whose diagnoses were established according to the defined by the American-European Consensus for the diagnosis of Sjögren's syndrome Patients with the secondary form of the syndrome, collagen disease considered controlled by a rheumatologist, before the start of the trial and stable until the end of the study Systemic therapy instituted up to two months before the beginning of the protocol Literate patients Signature of the informed consent form Eye or eyelid surface disease not attributed to Sjogren's syndrome Temporary or permanent occlusion of tear points Use of contact lenses Use of systemic medication that is known to influence tear flow Need to modify the systemic treatment of the underlying disease during the trial Pregnancy or breastfeeding Known hypersensitivity reaction to pilocarpine hydrochloride Severe cardio-pulmonary 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): 21.0-60.0, Thyroid Diseases Patient acceptance. BMI < 35kg/m2. ASA I and ASA II. Scheduled for elective thyroidectomy under general anesthesia Patient refusal. History or anticipated difficult intubation. Chronic respiratory disease such as chronic obstructive pulmonary disease or asthma. Recent respiratory tract infection in the last month, chronic cough, and current smoking. History of laryngeal or tracheal surgery or pathology. Patients with symptomatic gastric reflux. Patients with a known history of allergy to study drugs | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | eligible ages (years): 20.0-45.0, Thermal Burn Age ranged between 20 and 45 years Deep 2nd degree of thermal burn of lower limb and trunk with (35-40%) surface area of burn as measured by "rule of nine" method, with complete wound healing or after 6 weeks from the injury Body mass index of between 17 and 35, with no history of neurological disorders or injuries to the lower extremities Patients with open burn wound Patients diagnosed with acute rheumatoid arthritis Joint replacement within the past year History of traumatic spine within the past six months Prosthesis Recent fracture or bone 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): 0.0-999.0, Patients Undergoing Elective Surgery With Anesthesia ≥18 years estimated ASA I/II classification based on the American Society of Anesthesiologists (ASA) classification elective surgery surgery at least 14 days in the future patient access to a Windows-10-based personal computer with webcam language or cognitive barriers (e.g. dementia, laryngectomy...) high risk surgeries with need of postoperative ICU stay acute infection with required auscultation | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and 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, Myocarditis Ventricular Arrythmia Inflammatory Cardiomyopathy Genetic Predisposition Autoimmunity Arrhythmia Cardiomyopathies Immunosuppression Catheter Ablation Written informed consent Age ≥ 18 years Clinically suspected myocarditis Enrollment performed by one of the participating Centers Absence of written informed consent Age < 18 years (paediatric population) | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and 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 Inclusion/ for INDEX CASES: 1. Adults aged 18 years or older who are newly diagnosed with COVID-19 infection within 7 days of testing. 2. Ability and willingness to understand and provide informed consent Known current pregnancy. 2. Current hospitalization. 3. Unable to complete online questionnaires or adhere to study requirements. 4. Consume more than 1000 IU per day of vitamin D from all supplemental sources combined (individual vitamin D supplements, calcium plus vitamin D supplements, medications with vitamin D [e.g., Fosamax Plus D], and multivitamins) in the past 4 weeks. 5. Use of prescription vitamin D treatments (Calcitriol [Rocaltrol, Calcitrol, Vectical, Calcijex] or Paricalcitol [Zemplar]). 6. Consume supplements with more than 1200 mg calcium per day. 7. Known diagnosis of hypercalcemia or a condition associated with vitamin D hypersensitivity. 8. Prior diagnosis of cancer *AND* currently undergoing radiation, chemotherapy, or immunotherapy. 9. Kidney failure or dialysis; severe liver disease or cirrhosis. 10. Any parathyroid conditions. 11. Use of medications for seizures or epilepsy. Examples: Carbamazepine (Carbatrol, Tegretol), Phenytoin (Dilantin, Phenytek), Valproic acid (Depakene), Oxcarbazepine (Oxtellar, Trileptal), Phenobarbital, Topiramate (Topamax). 12. Use of digoxin. 13. Inability to receive an overnight express mail shipment of study pills at a home address. 14. Participation in other COVID-19 trials. Inclusion/ for 1. Persons aged 18 years or older who live in the same household with an index individual and have been identified as the closest household contact within the same household (limited to 1 per household). 2. Persons aged 18 years or older who live in household with someone who tested positive for COVID-19 within past 7 days but not participating in VIVID. 3. Ability and willingness to understand and provide informed consent Known current pregnancy. 2. History of SARS-CoV-2 infection. 3. Receipt of a SARS-CoV-2 vaccination or monoclonal antibody. 4. Unable to complete online questionnaires or adhere to study requirements. 5. Consume more than 1000 IU per day of vitamin D from all supplemental sources combined (individual vitamin D supplements, calcium plus vitamin D supplements, medications with vitamin D [e.g., Fosamax Plus D], and multivitamins) in the past 4 weeks. 6. Use of prescription vitamin D treatments (Calcitriol [Rocaltrol, Calcitrol, Vectical, Calcijex] or Paricalcitol [Zemplar]). 7. Consume supplements with more than 1200 mg calcium per day. 8. Known diagnosis of hypercalcemia or a condition associated with vitamin D hypersensitivity. 9. Prior diagnosis of cancer *AND* currently undergoing radiation, chemotherapy, or immunotherapy. 10. Kidney failure or dialysis; severe liver disease or cirrhosis. 11. Any parathyroid condition. 12. Use of medications for seizures or epilepsy. Examples: Carbamazepine (Carbatrol, Tegretol), Phenytoin (Dilantin, Phenytek), Valproic acid (Depakene), Oxcarbazepine (Oxtellar, Trileptal), Phenobarbital, Topiramate (Topamax). 13. Use of digoxin. 14. Inability to receive an overnight express mail shipment of study pills at a home address. 15. Participation in other COVID-19 trials | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and 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, Clinical Stage III Human Papillomavirus (HPV)-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Locally Advanced Head and Neck Squamous Cell Carcinoma Locally Advanced Hypopharyngeal Squamous Cell Carcinoma Locally Advanced Laryngeal Squamous Cell Carcinoma Locally Advanced Oral Cavity Squamous Cell Carcinoma Locally Advanced Oropharyngeal Squamous Cell Carcinoma Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Pathologic Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Stage III Hypopharyngeal Carcinoma AJCC v8 Stage III Laryngeal Cancer AJCC v8 Stage III Lip and Oral Cavity Cancer AJCC v8 Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8 Stage IV Hypopharyngeal Carcinoma AJCC v8 Stage IV Laryngeal Cancer AJCC v8 Stage IV Lip and Oral Cavity Cancer AJCC v8 Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8 Stage IVA Hypopharyngeal Carcinoma AJCC v8 Stage IVA Laryngeal Cancer AJCC v8 Stage IVA Lip and Oral Cavity Cancer AJCC v8 Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8 Stage IVB Hypopharyngeal Carcinoma AJCC v8 Stage IVB Laryngeal Cancer AJCC v8 Stage IVB Lip and Oral Cavity Cancer AJCC v8 Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8 Stage IVC Hypopharyngeal Carcinoma AJCC v8 Stage IVC Laryngeal Cancer AJCC v8 Stage IVC Lip and Oral Cavity Cancer AJCC v8 Stage IVC Oropharyngeal (p16-Negative) Carcinoma AJCC v8 Participants must have histologically or cytologically confirmed locoregionally advanced squamous cell carcinomas of mucosal surfaces of head and neck who are being treated with concurrent chemoradiation with cisplatin Participants must be eligible for cisplatin-based concurrent chemotherapy in conjunction with at least 6 weeks of daily fractionated radiation therapy Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 50%) Absolute neutrophil count >= 1,000/microliter (mcL) Platelets >= 100,000/mcL Total bilirubin within normal institutional limits, unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase (SGOT)) =< 3 X institutional upper limit of normal Alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase (SGPT)) =< 3 X institutional upper limit of normal Creatinine =< 1.5 x within institutional upper limit of normal OR creatinine clearance glomerular filtration rate (GFR) >= 60 mL/min/1.73 m^2, calculated using the Cockcroft-Gault equation, unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m^2 Ability to understand a written informed consent document, and the willingness to sign it Participants that are not eligible for cisplatin-based chemoradiation for reasons such as chronic kidney disease, severe hearing loss, and severe peripheral neuropathy Uncontrolled inter-current illness or psychiatric illness/social situation that would limit compliance with study requirements Has known hypersensitivity to cisplatin, sodium thiosulfate or any of its excipients Participants with uncompensated congestive heart failure New York Heart Association (NYHA) class 3 or above Participants who cannot get secure venous access using either a Mediport or a peripherally inserted central catheter (PICC) line for safe administration of intravenous sodium thiosulfate Pregnant women are excluded from this study because cisplatin is a cytotoxic agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with cisplatin or sodium thiosulfate, breastfeeding should be discontinued if the mother is treated with either agent | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and 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, Clinical Trial Proven cases of COVID-19 infection by real-time polymerase chain reaction (PCR) of the nasopharyngeal and oropharyngeal swabs and presented with recent onset of anosmia alone or with ageusia or other symptoms of the disease were enrolled in the current study. - Patients with pregnancy, children <18 year, psychological disturbances, previous anosmia, severe sinonasal diseases, previous sinonasal surgery, refuse to participate in the study, and those who lost to follow-up were 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): 18.0-999.0, Breast Cancer Melanoma Thoracic Cancer Lymphedema of Upper Arm History of bilateral or unilateral axillary SLNP (sentinel biopsy, lymphadenectomy or dissection) and a previous or current failed contralateral IV attempt or at the discretion of the treating radiologist, a participant who has a history of multiple failed IV placement attempts in the contralateral arm may proceed to IV placement in the ipsilateral arm on the first attempt 2. Scheduled to undergo routine imaging scan with contrast 3. 18 years of age and older 4. Read, reviewed and signed study-specific consent Active swelling, rash, or injury in bilateral upper extremities 2. Subjects with diabetes, sickle cell disease, and/or peripheral vascular insufficiency as vascular inflammatory processes pose a lymphedema risk | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and 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 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 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 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): 16.0-30.0, Orthodontic Appliance Age ≥ 16 years Proclined upper and lower incisors (Ui/max >115 o, Li/mand >99o) Mild upper and lower arch crowding (<4mm) or no crowding Need for upper and lower first premolars extraction Skeletal I malocclusion (1<ANB <5) Average lower facial height and maxillomandibular plane angle (22 o <MM<32 o) Class I canine relationship Good oral hygiene and healthy periodontium Poor oral hygiene Diseases and medications that were likely to affect bone biology Previous orthodontic treatment Evidence of bone loss Active periodontal disease Smoking | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | eligible ages (years): 40.0-70.0, Coronary Artery Disease Asymptomatic subjects age 40-70y 2. Statin naïve 3. TC ≤ 6.5 mmol/L and LDLC <5 mmol/L, and 4. 5 year Australian risk ≥2% Symptomatic coronary, cerebrovascular, or peripheral vascular disease 2. Intolerance of statins or currently on statins for any length of time 3. Pre-existing muscle disease (eg polymyositis, fibromyalgia) this may be confused with myalgia from statins 4. Patients on drugs that increase the risk of myopathy/rhabdomyolysis such as cyclosporine and strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, and HIV/hepatitis C protease inhibitors) 5. Atrial fibrillation (interferes with CTCA) 6. Chronic kidney disease on haemodialysis (because of vascular calcification) or GFR <50ml/min per 1.73m2 using the Modification of Diet in Renal Disease (MDRD) formula 7. Inability to provide informed consent 8. Major systemic illness eg. malignancy; rheumatoid arthritis 9. Women of child bearing potential (due to performance of CT) 10. Poorly controlled hypertension: SBP> 200 and or DBP > 100 11. Severe psychiatric disorder (eg bipolar depression; psychosis) 12. Patients eligible for treatment based on current Australian guidelines (5 year risk >15%) 13. Patients eligible for treatment based on current PBS thresholds TC >7.5 mmol/l and other (see below) | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and 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, Peritonitis Age ≥ 18 years 2. Patients operated for purulent or fecal peritonitis (Hinchey grade III and IV) secondary to perforated diverticulitis of the left colon and treated by resection with primary anastomosis 3. Person informed and having signed his consent. If the patient is unable to sign his consent, the consent will be signed by his representative ((1) the trusted person, or failing that, (2) a family member, or (3) a relative of the person concerned) (Article L1122-1-1 of the CSP). In this case, consent to continue the study will subsequently be requested from the patient. --> In addition, due to the vital urgency represented by hospitalisation in intensive care for purulent or fecal peritonitis, without prior collection of the consent of the patient or his/her representative is possible in the case where the patient is not capable of giving consent and his/her representative is not present at the time of (Article L1122-1-3 of the CSP). In this case, the patient or his/her representative will be informed as soon as possible and his/her written consent will be requested for the possible continuation of this research and the use of the data concerning him/her. 4. Patient able to comply with the study protocol, in the investigator's judgment 5. Patient affiliated with, or beneficiary of a social security (health insurance) category Non-inclusion 1. Physical states that prevent patient participation (e.g. septic shock or multivisceral failure) 2. Steroid treatment > 20 mg daily 3. Prior pelvic irradiation 4. Immunocompromised status 5. Known progressive cancer 6. American Society of Anesthesiologists grade IV 7. Peritonitis secondary to perforated diverticulitis of the right colon 8. Patient is a pregnant (positive blood pregnancy test) or breastfeeding (lactating) woman or intending to become pregnant during the study 9. Person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision) 10. Simultaneous participation in another interventional research Failure to obtain the consent of the patient or the patient's representative | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | eligible ages (years): 18.0-999.0, Facial Papulopustular Rosacea Moderate-to-severe rosacea (as per the IGA score) on the proposed facial treatment area consisting of: 1. At least 15 and not more than 75 facial papules and pustules, excluding lesions involving the eyes and scalp; 2. No more than 2 nodules on the face. 2. Presence of or history of erythema and/or flushing on the face Presence of any skin condition and/or Excessive facial hair, on the face that would interfere with the diagnosis or assessment of rosacea. 2. Moderate or severe rhinophyma, dense telangiectasia (score 3, severe), or plaque-like facial edema. 3. History of hypersensitivity or allergy to minocycline, any other tetracycline, or of any other component of the formulation. 4. Active ocular rosacea (eg, conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | eligible ages (years): 18.0-999.0, Irritable Bowel Syndrome Dermatographism Post-prandial Diarrhea Age 18 years and older Prior to Diagnosis of IBS + diarrhea based on ICD 10 codes with or without constipation unresponsive to prior treatments Moderate to severe symptom severity score (>175 points) based on IBS symptom severity scale Seeking evaluation by a health care professional Negative serologic celiac panel No response to lactose elimination diet by history Normal colonoscopy Able to complete symptoms diaries and global evaluations Confirmed IgE dependent food allergy as a cause of the gastrointestinal symptoms Lactose intolerance by history Celiac disease by serology Inflammatory bowel disease or colitis Bile acid diarrhea by history Post-surgical GI symptoms (e.g., dumping syndrome) by history No colonoscopy performed GI malabsorption Current pregnancy Current severe depression or history of psychosis | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | eligible ages (years): 1.5-5.417, Mastocytosis Cutaneous Adult patient (> 18 years old) with confirmed mast cell disorder according to international Patient affiliated to social security regime Patient under legal protection (guardianship, curators or court order) Patient does not speak French | 1 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | eligible ages (years): 35.0-65.0, Obstructive Sleep Apnea Heart Rhythm Disorder Obesity, Abdominal gender: female or male age 35-65 years old visceral obesity lack of acute or chronic diseases that may have an influence on rhythm or conduction disorders not undergoing Continuous Positive Airway Pressure therapy (CPAP) or taking drugs that have or may have an influence on QT interval duration [according to Credible Meds list (Woosley et al, 2019)] not consuming grapefruits or grapefruit juice for at least 2 weeks before Holter-ECG examination revealing that information about patient's chronic illness or drugs therapy was obfuscated, revealing increased fasting serum glucose concentration or ionic disturbances. It was strongly recommended to every patient to visit their GP for further diagnostics revealing any important deviation in physical examination i.a. blood pressure taken twice at the visit ≥140/ ≥90 mmHg revealing, upon Holter ECG examination, tachycardia or too numerous artifacts making QT interval assessment incredible too short total sleep time (< 6 hours) registered on polygraphy | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | eligible ages (years): 18.0-90.0, Covid19 Coronavirus Infection SARS-CoV Infection Patients with COVID-19 typical symptoms (cough, fever, anosmia) present for not more than 96 hours. 2. 18 years or older. 3. No use of ivermectin prior to the study. 4. No known history of ivermectin allergy. 5. The patient can give his consent to take part in the study. 6. Not current use of CYP 3A4 or P-gp inhibitor drugs such as quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir or cobicistat. Use of critical CYP3A4 substrate drugs such as warfarin COVID-19 pneumonia Diagnosed by the attending physician (oxygen saturation < 95% or lung crackles) 2. Positive pregnancy test for women of childbearing age* 3. Positive IgG against SARS-CoV-2 by rapid diagnostic test. 4. Negative SARS-CoV-2 PCR from a nasopharyngeal swab Women of child bearing age may participate if they use a safe contraceptive method for the entire period of the study. A woman is considered to not have childbearing capacity if she is post-menopausal (minimum of 2 years without menstruation) or has undergone surgical sterilization (at least one month before 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): 60.0-90.0, Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Cognitive Impairment Participated in a double-blind treatment period of a sponsor-approved originating donanemab trial, for example the study Have a study partner Stable symptomatic Alzheimer's Disease (AD) medications and other medication that may impact cognition for at least 30 days prior to randomization into Part A Current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with outcome assessments or the analyses in this study Have received treatment with a passive anti-amyloid immunotherapy after completion of originating donanemab study or received active immunization against Aβ in any other study Poor venous access Contraindication to PET or MRI imaging | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and 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, High-dose Steroids, Myocardial Function, Longitudinal Strain Age above 18 Patient with rheumatic disease that need high dose steroids due to exacerbation Patient whom echocardiographic study can be performed with a good quality age below 18 | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and 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, Primary Sclerosing Cholangitis In order to be eligible to participate in this study, an individual must meet all of the following 1. Stated willingness to comply with all study procedures and availability for the duration of the study 2. Male or nonpregnant female, greater than or equal to 18 years of age 3. Evidence of PSC established by biochemical testing and either MRCP or ERCP. Participant must have evidence of large duct disease on imaging. 4. Agreement to adhere to Lifestyle Considerations throughout study duration An individual who meets any of the following will be excluded from participation in this study: 1. Pregnant or lactating women or females of child-bearing age not taking measures to prevent pregnancy during the period of study. 2. History of clinical, serologic, or histopathologic evidence supporting etiologies of chronic liver disease other than PSC 3. History of liver transplantation 4. Diagnosis consistent with secondary sclerosing cholangitis (cholelithiasis, bile duct strictures secondary to ischemia, HIV cholangiopathy, etc.). 5. Current or past clinical evidence of decompensated liver disease (e.g. ascites, bleeding esophageal varices, spontaneous bacterial peritonitis, encephalopathy, etc.). 6. History of liver or bile duct lesions concerning for malignancy. 7. Ca-19-9 >130 U/microL 8. Alpha-fetoprotein level greater than 200 ng/microL. 9. Patients with active bacterial, viral, or fungal, systemic or localized infection. 10. Unwillingness to refrain from ingesting probiotics during study. 11. History of systemic disease not related to PSC that is poorly controlled or associated with declining functional status. Examples but are not limited to: poorly controlled diabetes mellitus, chronic renal failure with eGFR is <60 microl/min/1.73m^2, chronic symptomatic heart failure or severe COPD. 12. Patients with history of malignancy other than superficial skin cancer (BCC/SCC) in the last 3 years prior to enrolment. 13. History of portal vein thrombosis 14. Patients with severe allergic reactions to iodine or other contrast, which cannot be controlled by premedication with antihistamines or steroids. 15. History of gastric and/or proximal small bowel surgery including bariatric surgery such as Roux-en-Y gastric bypass 16. Contraindication to monitored anesthesia care and/or medications that are commonly used for conscious sedation during GI Endoscopy 17. Use of anti-coagulant and anti-platelet agents excluding aspirin and NSAIDs 18. Contraindications to completing MRCP or MRI 19. Absolute neutrophil count below 1000/mm^3 20. Hemoglobin level below 10.0 g/dl 21. Platelet count lower than 50,000/mm^3. 22. INR greater than or equal to 1.5, PTT greater thna or equal to 1.3 times control and/or any known history of disease associated with increased bleeding diathesis. 23. Inability to provide informed consent In order to be eligible to participate in this study, an individual must meet all of the following 1. Male or female greater than or equal to 18 years of age 2. Any individual who is either a parent, sibling or child of a PSC patient enrolled to the study, or an unrelated person who has been living with the patient for at least 3 consecutive months before study enrollment An individual who meets any of the following will be excluded from participation in this study: 1. History suggestive of PSC 2. History of chronic liver disease (except for steatosis) 3. History of malignancy other than superficial skin cancer (BCC/SCC) in the last 3 years prior to enrollment. 4. History of Inflammatory Bowel Disease 5. Antibiotic use within the last 6 weeks 6. Pregnancy 7. Inability 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, Advanced Systemic Mastocytosis Aggressive Systemic Mastocytosis Systemic Mastocytosis With an Associated Hematological Neoplasm Mast Cell Leukemia for Patients in the External Control Arm: 1. Diagnosed with AdvSM, with known subtype including SM-AHN, ASM, or MCL 2. Received at least one line of systemic therapy for AdvSM, which may but not limited to regimens containing: Midostaurin Cytoreductive therapy: cladribine, interferon alpha, azacitidine, decitabine Selective TKIs: imatinib, nilotinib, dasatinib Hydroxyurea Antibody therapy: brentuximab vedotin 3. Adult (≥18 years of age) at the initiation of first systemic line of therapy at the participating site 4. Had available performance status (e.g., ECOG score or Karnofsky score) 5. Had an index date at least 3 months prior to the start of data collection (in order to patients with at least 3 months of follow-up after index date), unless date of death occurred less than three months from index date 6. Had an approved waiver of informed consent or signed informed consent for participation in the retrospective chart review study, if no institutional waiver from the site was granted for Patients in the External Control Arm 1. Malignancy that is not in remission at time of SM diagnosis, or new non-hematological malignancy diagnosed after SM diagnosis, except for: completely resected basal cell and squamous cell skin cancer, curatively treated localized prostate cancer, and completely resected carcinoma in situ of any site 2. Among patients with SM-AHN, presence of either of the following Patients in whom the SM component is consistent with an indolent systemic mastocytosis (ISM) or SSM or the AHN component is a lymphoid malignancy, or one of the following myeloid malignancies: acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) that is very high-or high-risk as defined by the IPSS-R, or a Philadelphia chromosome positive malignancy or there is a known FIP1L1/PDGFRA fusion gene (including those with CHIC-2 deletion and partial deletion of independent of KIT mutational status 3. Received avapritinib as the first line of systemic therapy for AdvSM at participating site, or prior to initiation of first systemic therapy at participating site | 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): 12.0-999.0, Advanced Systemic Mastocytosis Aggressive Systemic Mastocytosis Systemic Mastocytosis With an Associated Hematological Neoplasm Mast Cell Leukemia Patients who are ≥ 15 years of age, or ≥ 12 years of age AND ≥ 35 kg. 2. Patients must have a diagnosis of advanced systemic mastocytosis (AdvSM) or smoldering systemic mastocytosis (SSM). AdvSM includes the following Aggressive systemic mastocytosis (ASM) Systemic mastocytosis with an associated hematological neoplasm of non-mast-cell lineage (SM-AHN) Mast cell leukemia (MCL) 3. Patient or legal guardian, if permitted by local regulatory authorities, provides written informed consent. 4. Patient is not eligible for an ongoing study of avapritinib or cannot access an ongoing study of avapritinib Patient meets any of the following laboratory Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3.0 × upper limit of normal (ULN); no restriction if due to suspected liver infiltration by mast cells Bilirubin > 1.5 × ULN (>3 x ULN in the case of Gilbert's disease); no restriction if due to suspected liver infiltration by mast cells or Gilbert's disease Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 or creatinine> 1.5 × ULN Platelet count < 50,000/μL (within 4 weeks of the first dose of avapritinib) or receiving platelet transfusion(s). 2. Patient has a history of a cerebrovascular accident or transient ischemic attacks within 1 year before the first dose of avapritinib or any other known risks of intracranial bleeding. 3. Patient has a known risk or recent history (12 months before the first dose of avapritinib) of intracranial bleeding (e.g., brain aneurysm, concomitant vitamin K antagonist use). 4. Patient has a primary brain malignancy or metastases to the brain. 5. Patient has clinically significant, uncontrolled cardiovascular disease, including Grade III or IV congestive heart failure according to the New York Heart Association classification; myocardial infarction or unstable angina within the previous 6 months; clinically significant, uncontrolled arrhythmias; or uncontrolled hypertension. 6. Female patients who are unwilling, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ highly effective contraception during the avapritinib administration period and for at least 30 days after the last dose of avapritinib. Men who are unwilling, if not surgically sterile, to abstain from sexual intercourse or employ highly effective contraception during the avapritinib administration period and for at least 90 days after the last dose of avapritinib. 7. Women who are pregnant or breast feeding. 8. Patient has had a major surgical procedure (minor surgical procedures such as central venous catheter placement, tumor needle biopsy, and feeding tube placement are not considered major surgical procedures) within 14 days prior to the first dose of avapritinib. 9. Hypersensitivity to avapritinib or to any of the excipients. 10. Patient is participating in another interventional 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): 0.0-999.0, Anaphylaxis Biphasic Anaphylactic Reaction Rebound Anaphylactic Reaction Patients of all ages with anaphylaxis (meeting the NIAID/FAAN criteria) Patients of all ages considered to be inevitably evolving torwards overt anaphylaxis by the threading physician Adverse reaction to a medication (eg ACEI) Hereditary angioedema Known immune mediated Angioedema Anaphylactoid reaction | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and 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, Death, Sudden Ventricular Tachycardia Implantable Defibrillator User Myocardial Infarction Myocardial Dysfunction AMI patients over 18 years old LVEF equal or lower than 40% determined by a transthoracic echocardiography 4 days after the onset of the AMI Revascularization during hospitalization according to the clinical practice guidelines Signed informed consent Non-ischemic etiology of left ventricular dysfunction by cMRI Patient already implanted with a cardiac device (pacemaker, ICD or ICD-TRC) Indication of pacemaker, ICD or ICD-TRC implantation during hospitalization Allergy or hypersensitivity to any implatable device component Contraindication for cMRI performance Life expectancy under 1 year due to a non-cardiac cause Concomitant valvulopathy with indication for surgery High functional class (NYHA IV) No possibility to connect to the remote monitoring | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and 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 in Intestine Steroid Refractory GVHD Age ≥ 18 years old Allo-HSCT with any type of donor, stem cell source, GVHD prophylaxis or conditioning regimen Acute GvHD episode with GI involvement per MAGIC guidelines (= grades II to IV), with or without involvement of other organs Patients resistant to steroids AND either resistant to OR with intolerance to ruxolitinib OR with contra-indication to ruxolitinib Grade IV hyper-acute GvHD Overlap chronic GvHD Relapsed/persistent malignancy requiring rapid immune suppression withdrawal Active uncontrolled infection according to the attending physician Severe organ dysfunction unrelated to underlying GvHD, including: Cholestatic disorders or unresolved veno-occlusive disease of the liver (defined as persistent bilirubin abnormalities not attributable to GvHD and ongoing organ dysfunction). Clinically significant or uncontrolled cardiac disease including unstable angina, acute myocardial infarction within 6 months before Day 1 of study drug administration, New York Heart Association Class III or IV congestive heart failure, circulatory collapse requiring vasopressor or inotropic support, or arrhythmia that requires therapy. Clinically significant respiratory disease that requires mechanical ventilation support or 50% oxygen Current or past veno-occlusive disease or other uncontrolled complication unless otherwise agreed in writing by the sponsor Absolute neutrophil count <500/µL for 3 consecutive days. Use of growth factor supplementation is allowed Absolute platelet count < 10 000/µL. Use of platelet infusion is allowed Patient with negative IgG EBV serology Current or past evidence of toxic megacolon, bowel obstruction or gastrointestinal perforation | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and 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 Was a subject in the Brigham and Women's Home Hospital study and has a completed record in the study's database | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and 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, Sjögren Syndrome Sicca Syndrome Agreement to participate in the study according to signed informed consent Filling the pSS classification criteria Absence of other autoimmune associates systemic diseases EULAR Sjögren Syndrome Disease Activity Index (ESSDAI) <= 5 Prednisone dose < 20 mg/day at study inclusion Without pilocarpine or cevimeline use at study inclusion No use of N-acetylcysteine for at least 1 month before study inclusion Diabetes, sarcoidosis, previous history of head and neck radiotherapy or iodine therapy, positive serologies for HIV, hepatitis B and C, graft versus host disease, IgG4 (immunoglobulin G4) related disease, and current use of antidepressants tricyclics Current use of biological therapy Current smoking Alcoholism Liver cirrhosis and chronic kidney 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, Systemic Mast Cell Activation KIT D816V Mutation Presenting with at least one of the three below as evidence of systemic mast cell activation: 1. Involvement of 2 or more organ systems, characterized by skin (pruritus, urticaria, flushing and angioedema), cardiovascular (tachycardia, syncope, and hypotension), gastrointestinal (diarrhea, nausea, vomiting, and gastrointestinal cramping) or respiratory/naso-ocular (wheezing, conjunctival injection, and nasal stuffiness) AND serum basal tryptase levels ≥8 ng/ml. One of the organ systems must be the cardiovascular system. 2. Severe, recurrent anaphylaxis (Ring and Messmer grading ≥II) due to Hymenoptera sting, regardless of serum basal tryptase levels. 3. Severe, recurrent anaphylaxis (Ring and Messmer grading ≥II), with cardiovascular involvement and documented event-related tryptase elevation fitting the formula 20% of baseline plus 2 ng/ml evaluated in at least 1 event Patient previously diagnosed with any of the following WHO systemic mastocytosis (SM) sub-classifications: cutaneous mastocytosis only, indolent SM, smoldering SM, SM with associated hematological neoplasm, aggressive SM, mast cell leukemia, mast cell sarcoma Patient diagnosed with other myelo or lympho-proliferative diseases, e.g., myelodysplastic syndrome, myeloproliferative neoplasm, etc | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | eligible ages (years): 18.0-999.0, Liver Cirrhosis Liver Tumor Liver Transplant Failure and Rejection age >18 years deceased-donor liver transplantation provision of informed consent donation after cardiac death either reduced or split graft | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and 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, Attention Deficit Hyperactivity Disorder The participant has provided signed informed consent. 2. Males and/or females aged 18-70 (extremes included). 3. Participants with a primary diagnosis of ADHD according to DSM-5 (314.01) (diagnosis to be made using the Mini-International Neuropsychiatric Interview (MINI) 7.0.2 and confirmed by the Diagnostic Interview for ADHD in Adults (DIVA 5.0). Participants with a comorbid anxiety and depressive disorder will be permitted, as long as ADHD is judged to be the primary diagnosis. 4. Participants who score an ASRS of ≥ 4 in Part A at both Screening and Baseline, representing non-response to current stable psychostimulant treatment 5. Participants are on a stable dose (> 4 weeks) of their existing long-acting psychostimulant (any type) prior to entry into the study. 6. Participants are on a stable dose of any other psychotropic medication (> 8 weeks) to treat comorbid conditions, except antipsychotics. 7. On the basis of a physical examination, medical history and basic laboratory screening, the patient is, in the investigator's opinion, in a suitable condition. Basic laboratory screening includes: Chemistry: Electrolytes, ALT, Albumin, Alkaline Phosphatase, AST, Bilirubin Total protein, Creatinine, Urea (BUN), CK, GGT, Potassium, Sodium, Calcium, Glucose (Fasting), Bilirubin Direct, Bicarbonate, Chloride, Urate (for Uric Acid), LD, Magnesium, Phosphorus, Amylase CBC: Hematocrit, Hemoglobin, RBC, WBC + differential, abs. Platelet Count Drug Screen (urine-8 tests): amphetamines, benzodiazepines, barbiturates, methadone, cocaine, opiates, cannabinoids, PCP Standard Urinalysis Lipid Assessment: Cholesterol, HDL, LDL-calc, Triglycerides Prolactin 8. Willing and able to attend study appointments in the correct time windows Participants meeting one or more of the following cannot be selected for 1. Any other primary mental health disorder in the previous six months. 2. Alcohol or drug abuse as defined in the DSM-5 within the last six months. 3. Mania, hypomania as defined in the DSM-5 criteria. 4. Any psychotic disorder. 5. Eating disorders as defined in the DSM-5 criteria. 6. Any cognitive disorder or dementia within 3 months before the baseline visit. 7. A history of Seizure Disorder (Epilepsy or other). 8. Clinical interpretation of apparent suicide risk. 9. Commencement of formal psychotherapy for 4 weeks prior to entry into the study and/or during the course of the study. 10. Existing treatment with any antipsychotic as mono or adjunct therapy at the time of the study. 11. Change in use of medications. 12. Laboratory values at screening or in medical history that may be considered through clinical interpretation to be significant, including positive drug and alcohol tests. 13. Diseases that could through clinical interpretation interfere with the assessments of safety, tolerability and efficacy of study treatment. 14. Serious illness: liver or renal insufficiency, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic or metabolic disturbance. 15. If female, the subject is pregnant or lactating or intending to become pregnant before, during, or within 30 days after participating in this study, or intending to donate ova during such time period. 16. The participant has received electroconvulsive therapy, vagal nerve stimulation, or repetitive transcranial magnetic stimulation within 6 months prior to Screening. 17. The participant is, in the opinion of the investigator, unlikely to be able to comply with the clinical trial protocol or is unsuitable for any other reasons. 18. Contraindications and Warning Precautions as per the U.S. Product Monograph will be followed. Participants must discontinue the use of recreational drugs including cannabis for at least 2 weeks prior to entry into the study. Participants must limit alcohol intake to a maximum of 3 standard drinks per week 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): 18.0-999.0, Gout Chronic Kidney Disease Renal Transplantation Adults aged over 18 years old Gout confirmed by identification of urate crystals by joint fluid or tophus analysis or by ultrasound of the affected joint or Gout according to Nijmegen (presence of a score ≥ 8/13) depending on the following items: Man (2 pts) Previous crisis (2 pts) Involvement of first metatarsophalangeal joint (MTP1) (2.5 pts) Maximum pain within 24 hours (0.5pt) Redness (1 pt) HTA or cardiovascular disease (1.5 pts) SUL > 360 μmol/l during the crisis (3.5 pts) Chronic kidney disease stage 4/5 or renal transplantation Flare ≤ 5 days Pain assessed by visual analogical scale ≥ 5 Participating in another trial including the administration of a drug Active infection History of anakinra or prednisone allergy Contra-indication of anakinra or prednisone Neutrophil count < 1000/mm3 (not due to ethnic cause) Difficulty understanding French Illiteracy Pregnant women or breastfeeding mothers (see PHC article L.1121-5) Persons deprived of liberty by judicial or administrative decision, persons receiving psychiatric care under Sections L. 3212-1 and L. 3213-1 and persons admitted to a health or social institution for purposes other than research (see CSP Article L.1121-6) Major persons subject to a measure of legal protection or unseeding to express consent (see PHC Article L.1121-8) | 0 |
Pt is a 22yo F otherwise healthy with a 5 yr history of the systemic mastocytosis, with flares normally 3/year, presenting with flushing and tachycardia concerning for another flare. This is patient's 3rd flare in 2 months, while still on steroid taper which is new for her. She responded well to 125 mg IV steroids q 8 hrs and IV diphenydramine in addition to her continuing home regimen. CBC was at her baseline, w/normal differential. Serum tryptase revealed a high value at 84. The patient failed aspirin challenge due to adverse reaction. She was stabilized on IV steroids and IV benadryl and transferred back to the medical floor. She continued on her home histamine receptor blockers and was transitioned from IV to PO steroids and benadryl and observed overnight and was discharged on her home meds, prednisone taper, GI prophylaxis with PPI, Calcium and vitamin D, and SS bactrim for PCP. | eligible ages (years): 4.0-55.0, Food Allergy Age 4 to 55 (inclusive) Clinical history of allergy to at least 1 of the foods contained in ADP101 Experience dose-limiting symptoms at or below the 100-mg dose level to 1 or multiple food sources in ADP101 Experience dose limiting symptoms at or below the 100 mg challenge dose level to more than 5 food sources contained in ADP101 History of severe or life-threatening episode(s) of anaphylaxis or anaphylactic shock within 60 days of screening History of EoE, other eosinophilic gastrointestinal disease, chronic, recurrent or severe GERD, symptoms of dysphagia Severe asthma Mild or moderate asthma, if uncontrolled or difficult to control History of mast cell disorder, including mastocytosis, urticaria pigmentosa or angioedema History of chronic disease (other than asthma, atopic dermatitis, or allergic rhinitis) at risk of becoming unstable or requiring a change in chronic therapeutic regimen e.g. uncontrolled diabetes History of cardiovascular disease, including hypertension requiring > 2 antihypertensive medications History of interstitial lung disease History of celiac disease | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 0.5-999.0, Hurthle Cell Thyroid Cancer Tall Cell Variant Thyroid Cancer Follicular Thyroid Cancer Thyroid Cancer Papillary Thyroid Cancer In order to be eligible to participate in this study, an individual must meet all of the following 1. Male or female, adults or children >= 6 months+. 2. Patients with known or suspected thyroid nodules and/or thyroid cancer. 3. At risk family members of patients who have a genetic susceptibility to developing thyroid cancer An individual who meets any of the following will be excluded from participation in this study: 1. Serious underlying medical conditions that restrict diagnostic testing or therapy such as renal failure, congestive cardiac failure or active coexisting non-thyroid carcinoma requiring intervention before thyroid cancer is addressed | 2 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Islet Cell Adenoma Zollinger Ellison Syndrome Subjects selected for this study will be patients with Zollinger-Ellison syndrome who are being evaluated under the protocol entitled "Diagnostic evaluation of patients with suspected abnormalities of gastric secretion" (80-DK-123). To be entered into the study a patient must meet each of 3 1. histologically proven gastrinoma; 2. evidence of metastatic tumor by one or more of angiography, ultrasound, computerized axial tomography, bone scan or octreoscan; 3. progression of tumor size during the preceding 6 months as assessed by repeated imaging studies For treatment with interferon-(alpha): 1. Congestive heart failure 2. Proteinuria, 3 + or greater 3. Creatinine clearance less than 30 ml/min 4. Platelet count less than 30 x 10(9)/1 5. White blood count less than 4 x 10(9)/1 6. Bilirubin greater than 3 mg/dl 7. Positive test for HIV antibody 8. Pregnancy For treatment with octreotide: 1. Presence of cholelithiases | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 0.0-999.0, Head and Neck Neoplasm Squamous Cell Carcinoma Patients must satisfy the following The patient must have a biopsy proven diagnosis of carcinoma of the oral cavity, oropharynx, hypopharynx, nasopharynx, larynx, maxillary sinus. Squamous cell, lymphoepithelioma, transitional cell and undifferentiated histologies will be included. We will accept AJCC stages III-IV for all the sites, except base of tongue, nasopharynx, and maxillary sinus where we will accept stage II patients as well. Patients must have no surgical option or have refused surgery. Patients with evidence of distant metastasis not confined to the region of the head and neck will be excluded. All patients will be evaluated by either the NIH or National Naval Medical Center (NNMC) Otolaryngology-head and neck surgery center. Patients must have had no prior radiotherapy to the head and neck region and no prior treatment with chemotherapy for their head and neck cancers. Patients must have a performance status of less then or equal to 2 (ECOG Criteria). Patients must have an absolute granulocyte count of greater than or equal to 2000/mm(3) and a platelet count of greater than or equal to 100,000/mm(3). Patients should have adequate hepatic and renal function as indicated by a serum bilirubin of less than or equal to 2.0 mg/dl and SGOT of less than or equal to 4.0 times the upper limit of the institutional norm and a serum creatinine of less than or equal to 1.5 mg/dl. No other serious concurrent medical or psychiatric illness which would jeopardize the ability of the patient to receive with reasonable safety the chemotherapy and radiation therapy outlined in this protocol is allowed. No other active, concomitant malignancy other than curatively treated carcinoma in situ of the cervix or basal cell carcinoma of the skin is allowed. Patients must be at least 18 years old. Signed informed consent: Each patient must be aware of the neoplastic nature of his/her disease and willingly consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts. Pregnant women and nursing mothers are ineligible. Eligible patients of childbearing potential should use contraception. Patients will be registered on the protocol by telephone. An authorized physician will telephone information concerning a potential candidate for this protocol to the Orkand personnel in their Central Clinical Data Management Registration Office at (301) 402-1732 between the hours of 8:30 am to 5:00 pm Monday through Friday | 1 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 0.0-999.0, Hypothyroidism Thyroid Neoplasms Patients greater than or equal to 18 years of age, with well-differentiated, non-medullary thyroid cancer, including papillary (including follicular-variant), follicular, and Hurthle cell. Patients who recently have undergone a total or near-total thyroidectomy and are scheduled to undergo initial 131I diagnostic studies and ablation. Patients must have evidence of residual thyroid tissue after thyroid surgery confirmed by ultrasound or other imaging technique (e.g., a technetium [Tc 99] pertechnetate or thallium scan). Patients who have undergone thyroidectomy or other thyroid surgery at least 6 weeks prior to enrollment. All patients who have been sustained on maintenance THST for at least 4 weeks, but not longer than 12 weeks after thyroidectomy. All patients who have confirmed serum TSH levels less than or equal to 0.5 mU per liter within 7 days prior to the first Thyrogen dose, and prior to randomization. Female patients of childbearing age must have a negative serum human chorionic gonadotropin (HCG) pregnancy test prior to entering the study and within 5 days of any 131I administration and must be following an approved method of contraception. Patients who are committed to following the protocol requirements as evidenced by providing written informed consent. Patients for whom a 131I scan is currently contraindicated because withdrawal from THST is not an option due to pituitary dysfunction or other compelling medical reasons are excluded. Patients should not have a concurrent major medical disorder (e.g., documented cardiac disease, debilitating cardiopulmonary disease, advanced renal failure, advanced liver disease or advanced pulmonary disease) who may be too ill to adequately comply with the requirements of this study. Patients with non-thyroidal conditions known to effect 131I uptake (e.g., congestive heart failure, renal failure) are excluded. Patients should not have undergone any intravenous water soluble radiographic contrast administration within the previous 4 weeks. Patients should not have received intrathecal or cholecystographic iodinated contrast agent administration within 3 months prior to enrollment. Patients should not be taking drugs that affect thyroid or renal function (e.g., renal drugs, lithium, or corticosteroids). Patients should not be participating in another investigational drug study or in such a study within 30 days of their enrollment in this study. No patients with a recent history of alcoholism or drug abuse, severe emotional behavioral or psychiatric problems who, in the opinion of the investigator, would not be able to comply with the requirements of this study | 2 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Head and Neck Cancer Biopsy-proven squamous cell carcinoma of one of the following sites: Hypopharynx Larynx Oral cavity Oropharynx At least 1 of the following high-risk factors required: Histologic extracapsular nodal extension Histologic involvement of 2 or more regional lymph nodes Microscopically positive mucosal margins Complete resection of all visible and palpable disease Therapy must begin within 8 weeks of tumor-related surgery Bilateral resections may or may not be performed simultaneously window begins with first definitive surgery Neck dissection not required for T4 N0, truly midline supraglottic tumors No tumors of the lip, nasopharynx, or sinuses No synchronous or concurrent head and neck tumors No evidence of distant metastasis Concurrent registration on Fixed Tumor Repository Study allowed Age: 18 and over Performance status: Karnofsky 60%-100% Hematopoietic: WBC at least 3,500 Platelets at least 100,000 Hepatic: Not specified Renal: Creatinine clearance greater than 50 mL/min Other: No medical contraindication to protocol therapy No second malignancy within 5 years No pregnant or nursing women PRIOR Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to head and neck region Surgery: See Disease Characteristics | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 16.0-999.0, Breast Cancer Histologically confirmed metastatic breast cancer Bidimensionally measurable disease of any of the following types required: Bidimensionally measurable lung lesions on chest X-ray, CT scan, or MRI Palpable and quantifiable lymph nodes at least 2 x 2 cm Abdominal mass at least 2 x 2 cm quantifiable by CT scan Bidimensionally measurable liver metastases at least 2 x 2 cm Palpable hepatomegaly if liver edge is clearly defined and extends at least 5 cm below the costal margin of the xiphoid process Unacceptable as measurable disease: Diffuse lung infiltration or unidimensionally measurable hilar lesions Pelvic mass of indefinite dimension Bone metastases Pleural effusion or ascites No brain metastases Must have failed or progressed on prior therapy or relapsed less than 12 months after therapy discontinuation Hormone receptor status: Not specified Age: 16 and over Sex: Female Menopausal status: Not specified Performance status: SWOG 0-2 Life expectancy: At least 6 months Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: SGOT no greater than 2.5 times upper limit of normal Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No history of congestive heart failure, myocardial infarction within past 6 months, ventricular arrhythmia, or ischemic heart disease requiring medication If necessary, ejection fraction at least 50% by MUGA Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other prior malignancies in past 5 years other than basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix No other serious illnesses or active infections No seizure disorder requiring anticonvulsant therapy PRIOR Biologic therapy: No concurrent biologic therapy Chemotherapy: See Disease Characteristics No more than 2 prior chemotherapy regimens for metastatic disease One prior adjuvant chemotherapy regimen for metastatic disease allowed At least 4 weeks since prior chemotherapy No other concurrent chemotherapy Endocrine therapy: One prior regimen of hormonal therapy for metastatic disease allowed At least 3 weeks since prior hormonal therapy and recovered No concurrent hormonal or corticosteroid therapy Radiotherapy: At least 4 weeks since prior radiotherapy to less than 25% bone marrow No concurrent radiotherapy Surgery: At least 4 weeks since prior surgery and recovered No concurrent surgery Other: At least 4 weeks since any prior treatment directed at the tumor and recovered No other concurrent anticancer or investigational therapy No concurrent participation on another therapeutic clinical trial | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Head and Neck Cancer Histologically confirmed recurrent, refractory, or second primary squamous cell cancer of the head and neck that is incurable with surgery or radiotherapy Any N, Any M, single or multiple tumor(s) Locally accessible, discrete tumor(s) by CT or MRI scan Must be considered incurable with surgery or radiotherapy, for example: Distant disease (e.g., lung and/or liver metastases) OR Cervical disease fixed to surrounding structures (e.g., carotid artery or prevertebral fascia) OR Metastases in the site of prior radiotherapy OR Not suitable for anesthesia or reconstructive surgery OR Multiple cutaneous metastases Age: Over 18 Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No disease exacerbated by light, including systemic lupus erythematosus, psoriasis, porphyria, actinic reticuloid, or xeroderma pigmentosum Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR Biologic therapy: Not specified Chemotherapy: At least 30 days since prior chemotherapy (6 weeks since nitrosoureas) Endocrine therapy: Concurrent steroid therapy allowed Radiotherapy: At least 30 days since prior radiotherapy to the head and neck Surgery: At least 30 days since prior surgery and recovered Other: At least 30 days since prior light activated therapy or medication (e.g.,PUVA or Accutane) No prior photodynamic therapy At least 30 days since prior experimental drugs | 2 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 0.0-999.0, Head and Neck Cancer Radiologically confirmed persistent or metastatic follicular or papillary thyroid cancer following total thyroidectomy and radioiodine ablation therapy Metastatic disease confirmed histologically or cytologically or by elevated thyroglobulin levels No radioiodine uptake by whole body scanning Stable iodine contamination from radiologic contrast material within the past 10 months allowed, if absence of current contamination demonstrated by less than 80 micrograms of iodine in a 24 hour urine collection Age: Any age Performance status: Not specified Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: SGOT/SGPT no greater than 2.5 times upper limit of normal (ULN) Bilirubin no greater than 1.5 times ULN Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance at least 50 mL/min Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR At least 4 weeks since prior levothyroxine Any prior therapy for restoration of radioiodine uptake allowed, if unsuccessful and did not exceed treatment schedules planned for this study | 2 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-120.0, Head and Neck Cancer Histologically confirmed follicular, papillary, insular, or medullary thyroid carcinoma Must meet for 1 of the following Unresectable, distantly metastatic tumor that does not concentrate radioactive iodine Follicular or papillary thyroid carcinoma with a large distant tumor burden that has not sufficiently responded to cumulative iodine I 131 doses exceeding 800 mCi Radiographic evidence of tumor progression, meeting 1 of the following Evidence gathered over a period of at least 1 year with at least 3 separate x-ray studies, defining tumor volume Similar radiographic evidence over a shorter period of time, delineating more than 30% increase in tumor volume Age and over Performance status Karnofsky 70-100% Life expectancy Not specified Hematopoietic | 2 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 25.0-80.0, Stiff-Person Syndrome All patients who fulfill the recently revised clinical for SPS Lack of anti-GAD antibodies in the serum; Very advanced disease state that precludes traveling; Severe cardiovascular, renal, or other end-organ-disease states | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-120.0, Carcinoma of Unknown Primary Histologically confirmed squamous cell carcinoma in cervical lymph node metastasis from an unknown primary tumor Histopathological grade WHO 1-3 Pathological stage N1, N2a, N2b, or N3 No N2c (i.e., bilateral metastatic nodes) No single node in supraclavicular fossa or submandibular area No evidence of primary tumor in head and neck, lung, esophageal, or other site Prior radical, radical modified, or extended radical dissection within the past 8 weeks Selective neck dissection allowed (surgeon must justify why standard procedure was not performed) No node excision alone R0 or R1 disease after dissection | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Cervical Cancer Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer Histologically confirmed ovarian epithelial cancer or cervical cancer (open to accrual for cervical cancer patients only as of 4/5/2005) Relapsed or refractory The following are also eligible: (open to accrual for cervical cancer patients only as of 4/5/2005) Cancer of the fallopian tube Primary peritoneal cancer Cancer with low malignant potential and an invasive recurrence Block or recuts of primary tumor or recent resection specimen of a metastatic site required Measurable disease with a sentinel lesion adequate for core biopsy by percutaneous biopsy or laparoscopy No CNS involvement Age and over Performance status | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Head and Neck Cancer Histologically confirmed* anaplastic or poorly differentiated variant thyroid cancer, including 1 of the following Recurrent/regionally advanced disease no longer amenable to definitive curative surgery or radiotherapy Untreated metastatic disease NOTE: *If original/diagnostic tumor blocks are unavailable, tumor must be accessible for pretreatment core needle biopsy Must have relapsed or progressed during or after prior combined modality therapy (e.g., systemic chemotherapy and radiotherapy) for regionally advanced (but not metastatic) disease Measurable or evaluable disease Patent trachea and airway by screening direct and indirect laryngoscopy* NOTE: *For patients with bulky thyroid/neck masses and/or suspected airway obstruction No active brain metastases, as evidenced by any of the following Symptomatic involvement Cerebral edema by CT scan or MRI Radiographic evidence of progression since definitive therapy | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Head and Neck Cancer Histologically confirmed thyroid carcinoma, including 1 of the following subtypes Papillary Follicular Hurthle cell Insular Assessable disease, defined by at least 1 of the following Metastatic (including neck lymph nodes) measurable disease At least 20 mm by conventional techniques or at least 10 mm by spiral CT scan The following are not considered measurable disease Leptomeningeal disease | 2 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Colorectal Cancer Head and Neck Cancer Metastatic Cancer Histologically or cytologically confirmed solid tumor of 1 of the following malignant tumor types Squamous cell cancer of the head and neck Thyroid cancer Liver metastases* secondary to colorectal adenocarcinoma NOTE: *Liver metastases are eligible provided colorectal adenocarcinoma has been histopathologically proven and CT scan/MRI shows metastatic lesions in the liver Operable disease for which a surgical excision is planned Primary, metastatic, or locally recurrent disease Age and over Performance status WHO 0-2 Life expectancy Not specified Hematopoietic Neutrophil count at least 2,000/mm^3 | 1 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Head and Neck Cancer Histologically confirmed anaplastic or poorly differentiated variant thyroid carcinoma of either of the following Regionally advanced disease Confined to the neck and/or superior mediastinum (i.e., above the level of the carina) Measurable or evaluable* disease Completely resected disease without measurable or evaluable disease NOTE: *At a minimum, abnormalities on physical exam or radiographic studies that may not be precisely measured but readily followed Must have original/diagnostic tumor blocks available to confirm histopathology and for tumor microvessel density immunohistochemistry Patients with no available original/diagnostic tumor blocks must have tumor accessible for pretreatment needle core biopsy Must undergo indirect and direct laryngoscopy to ensure patency of the trachea/airway if deemed inoperable, with bulky thyroid/neck masses and/or suspicion of airway obstruction No distant metastases, including but not limited to, brain metastases, disease below the level of the carina, pulmonary parenchyma, and hepatic or bony metastases Superior mediastinal disease (i.e., above the level of the carina) in addition to regional neck disease is allowed provided the disease can be contained in a single radiotherapy port Age | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Head and Neck Cancer Diagnosis of squamous cell carcinoma of the head and neck Selected stage III or IV (no distant metastasis) disease The following TNM stages are excluded T3, N0, M0 T4a, N0, M0 T4b, N3, M0 Any T, any N, M1 Complete total resection within the past 56 days AND has one or more of the following risk factors Multiple pathologically confirmed lymph node metastases One or more lymph nodes with extracapsular extension of tumor | 2 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Recurrent Thyroid Cancer Stage IVA Follicular Thyroid Cancer Stage IVA Papillary Thyroid Cancer Stage IVB Follicular Thyroid Cancer Stage IVB Papillary Thyroid Cancer Stage IVC Follicular Thyroid Cancer Stage IVC Papillary Thyroid Cancer Histologically confirmed papillary thyroid or follicular thyroid carcinoma Differentiated disease Metastatic disease documented by ultrasound, computed tomography (CT) scan (without iodinated contrast), or MRI All metastatic disease foci =< 10 mm in all dimensions Must have been treated with total or near-total thyroidectomy AND at least 1 course of iodine I 131 (131I)(>=29.9 mCi) OR demonstrated negative uptake on a postoperative low-dose131I scan Must have undergone whole body 131I scan 1-3 days after administration of =< 5.5 mCi of 131I demonstrating no visible iodine uptake within the lesions unless demonstrated negative uptake on a postoperative low-dose131I scan within the past 12 weeks Must have 24-hour urine iodine excretion =< 500 mcg within 1 week of 131I scan Must be receiving thyroid hormone therapy AND have thyroid-stimulating hormone level =< 0.5 mU/L No known brain metastases Performance status | 2 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Recurrent Head and Neck Cancer Metastatic Head and Neck Cancer Histologically or cytologically confirmed squamous cell carcinoma of the head and neck; patient must not have nasopharyngeal carcinoma of histologic types World Health Organization (WHO) 2 and 3 Metastatic or locally recurrent carcinoma of the head and neck that is considered incurable by local therapies Any number of prior chemotherapy or biologic/targeted therapy regimens is allowed No prior systemic EGFR inhibitors, such as ZD1839 (Iressa, gefitinib)/Iressa (AstraZeneca), ABX-EBX (Abgenix), MDX-447 (Medarex/Merck), OSI-774/Tarceva (OSI pharmaceuticals), C225/Cetuximab (ImClone), PKI166 (Novartis), CI-1033 (Parke-Davis), EKB-569 (Wyeth Ayerst); treatment with paclitaxel is allowed if the patient did not progress while on paclitaxel NOTE: the use of cetuximab given concurrently with radiation or chemoradiotherapy for up to 9 total weekly doses, as part of initial potentially curative therapy is allowed, if completed > 6 months prior to registration Patients must not receiving any other investigational agent while on the study Patients must have either Strata A Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2 (in bed 50% of the time. Ambulatory and capable of all self-care, but unable to carry out any work activities; up and about more than 50% of waking hours), AND no prior chemotherapy for recurrent metastatic head and neck cancer OR Strata B Prior therapy with docetaxel at any time (even if part of prior curative treatment) Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or serious arrhythmia requiring medication Hypercalcemia related to head and neck cancer Brain metastasis Current peripheral neuropathy >= grade 2 at time of randomization Patients have co-existing condition that would preclude full compliance with the study Known hypersensitivity to ZD1839 (Iressa, gefitinib) or any excipients of this product; prior history of severe hypersensitivity reaction to Docetaxel or other drugs formulated with polysorbate 80 HIV positive patient's receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with ZD1839 (Iressa, gefitinib) Patients have had tumor-related hemorrhagic events in the previous three months that required as major medical intervention, such as surgery or embolization Patients are on therapeutic anticoagulation or have tumors that are unequivocally invading major vessels (e.g. carotid artery) | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Thyroid Neoplasms Histologically documented thyroid cancer with metastases Failure of radioactive iodine (131I) to control the disease or radioactive iodine (131I) is not an appropriate therapy (e.g. due to lack of iodine uptake by the tumor) Central lung lesions involving major blood vessels (arteries or veins).(Central lesions that maintain the structural integrity of vessels have the potential to bleed if the tumor lesion undergoes necrosis. MRI or CT angiography should be used in any case where there is any question as to whether blood vessels are involved.) Patients with a history of hemoptysis | 2 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-120.0, Head and Neck Cancer Histologically confirmed medullary thyroid cancer Metastatic or inoperable locoregional disease Measurable disease by CT scan years and over ECOG PS 0-1 Adequate lab functions including Granulocyte count > 1,000/mm^3 Platelet count > 100,000/mm^3 Bilirubin < 1.5 mg/dL ALT and AST < 2.5 times upper limit of normal No unstable or uncompensated hepatic disease | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 21.0-999.0, Head and Neck Cancer Cytologically confirmed papillary thyroid cancer by fine needle aspiration Low-risk disease No poorly differentiated cytology Intrathyroidal tumor Located within the anterior two-thirds of the thyroid lobe Tumor not adjacent to the trachea by neck ultrasound Tumor ≤ 1.5 cm by neck ultrasound Requires thyroidectomy No cervical lymphadenopathy No multicentric tumors by neck ultrasound | 1 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Thyroid Neoplasms Total or near total thyroidectomy performed for papillary or follicular thyroid cancer R0-1 resection, no macroscopic cancer left behind at surgery Physically and emotionally able to undergo radioiodine treatment A written informed consent Pregnancy Physical or psychiatric illness that may deteriorate during the isolation period required by radioiodine therapy | 2 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Stroke Malnutrition Weight Loss Dysphagia Acute stroke based on clinical symptoms years old and above < 7 days since debut of stroke symptoms and either body mass index (BMI) = or < 20 Weight loss > 5% in 3-6 months or there has been little or is likely to be no or very little nutritional intake for > 5 days Subarachnoidal bleeding and planned operation Severe dementia Reduced consciousness Immobility Expected short-time survival | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 0.0-999.0, Head and Neck Neoplasms actual or suspected malignant or non-malignant tumors of the head and neck planned biopsy and/or resection, or availability of paraffin embedded or stored frozen tumor tissue for non-genetic analysis insufficient tissue available for both standard diagnostic evaluation and study specimen | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 16.0-999.0, Thyroid Cancer Differentiated Thyroid Carcinoma Patients older than 16 years with well-differentiated papillary or follicular thyroid cancer stage I or II, according to the classification at time of surgery 2. Patients younger than 45 years with any size of primary papillary or follicular tumor 3. Patients older than 45 years with: 1. primary papillary tumor less than 4 cm or 2. primary follicular tumor less than 1 cm Patients with postsurgical thyroid remnant more than 5 g 2. Patients with distant metastases 3. Patients above 45 years of age having: 1. known cervical lymph nodes metastases 2. microscopic multifocal follicular cancer 3. microscopic extraglandular invasion of follicular cancer 4. gross extraglandular invasion of papillary or follicular cancer 4. Patients with confirmed histological subtypes of well-differentiated thyroid cancer such as Hurtle cell carcinoma, insular and tall cell variants of papillary cancer. 5. Pregnant or lactating women 6. Patients with renal impairment defined as repeat serum creatinine concentrations above 1.5 mg/dl on thyroid hormone 7. Patients on chronic lithium therapy for psychiatric illness 8. Patients with current unstable cardiovascular conditions 9. Patients with severe chronic medical conditions (liver failure, severe debilitation, dehydration, sodium depletion, any other cancer requiring therapy, etc) | 1 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Head and Neck Cancer All subjects must have histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the head and neck region. Primary tumor sites oral cavity, pharynx (oropharynx, hypopharynx), or larynx (supraglottis, glottis subglottis). Nasopharynx primary will be excluded The resected tumor must have one or more of the following high risk features: histologic extracapsular nodal extension involvement of ≥ 2 regional lymph nodes, mucosal margin of resection with invasive cancer (limited to microscopic detection only), tumor with perineural invasion, tumor with lymphovascular invasion, oral cavity and oropharynx carcinomas with positive lymph nodes metastasis at level IV or V Radiation must begin within 28 to 56 days after surgical resection All subjects must be 18 years of age or older Subjects must have a Zubrod performance of 0-2 Subjects must not have distant metastatic disease (M1) Subjects must NOT have prior therapy with oxaliplatin Subjects with any evidence of active or uncontrolled infection, recent myocardial infection, unstable angina, or life-threatening arrhythmia are not eligible Patients with severe psychiatric disorder are not eligible No other prior malignancy is allowed except for adequately treated basal cell or squamous cell carcinoma, in situ cervical cancer, or adequately treated Stage I and II cancer from which the patient is in complete remission, or any other malignancy from which the patient has been disease-free for 5 years | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Metastatic Hormone-sensitive Prostate Cancer Histologically or cytologically confirmed prostate cancer Metastatic disease On androgen-deprivation therapy for < 120 days Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 PS 2 eligible only if decline in PS is due to metastatic prostate cancer Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Bilirubin ≤ upper limit of normal (ULN) Alanine aminotransferase (ALT) ≤ 2.5 times ULN Creatinine clearance ≥ 30 mL/min Prostate-specific antigen (PSA) level has risen and met for progression from its lowest point between the start of androgen-deprivation therapy and randomization Prior malignancy in the past 5 years except for basal cell or squamous cell carcinoma of the skin Other malignancies that are considered to have low potential to progress (e.g., grade 2, T1a transitional cell carcinoma) may be allowed if approved by study chair Peripheral neuropathy > grade 1 History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 Active cardiac disease, including the following Active angina Symptomatic congestive heart failure Myocardial infarction within the past 6 months Prior chemotherapy in adjuvant or neoadjuvant setting | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Head and Neck Cancer All patients must have histologically or cytologically confirmed carcinoma of the head and neck region. Primary tumor sites lip and oral cavity, major salivary glands, pharynx (oropharynx, nasopharynx, hypopharynx), or larynx (supraglottis, glottis, subglottis), nasal cavity and paranasal sinuses, and thyroid Patients must have metastatic or locally recurrent squamous cell carcinoma of the head and neck. Patients with locoregional disease must be considered incurable by means of locoregional therapy All sites of disease must be assessed and designated as measurable or non-measurable disease as documented by CT, MRI, X-ray physical exam or nuclear exam. All measurable and non-measurable disease must be assessed within 28 days prior to registration Patients may have prior chemotherapy for recurrent/metastatic disease. However, all chemotherapy must be completed at least 21 days prior to scheduled start of Abraxane Patients must have adequate bone marrow reserve as documented by absolute neutrophil count (ANC) > 1,500 μl and platelets > 100,000/ μl obtained within 14 days prior to registration Patients must have adequate hepatic as documented by serum bilirubin < 1.5 x the institutional upper limit of normal. These tests must be obtained within 14 days prior to registration All patients must be 18 years of age or older Patients must have a Zubrod performance of 0-3 Patients must not have prior therapy with Abraxane Patients with any evidence of active or uncontrolled infection, recent myocardial infection, unstable angina, or life-threatening arrhythmia are not eligible Patients with baseline grade 3 peripheral neuropathy are not eligible Patients with known brain metastasis are not eligible. However, brain-imaging studies are not required for if the patient has no neurological signs or symptoms. If brain-imaging studies are performed, they must be negative for disease | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Gastroesophageal Reflux Main Written informed consent Inpatients (hospitalization during the entire study period is mandatory) Symptomatic (heartburn, acid regurgitation or dysphagia for at least 1 day since admission to the hospital) non-erosive reflux disease (NERD) or erosive gastroesophageal reflux disease (GERD, LA Grade A-D) Main Known Zollinger-Ellison syndrome or other gastric hypersecretory condition Previous acid-lowering surgery or other surgery of the esophagus and/or upper gastrointestinal tract (exception: polypectomy and cholecystectomy) On initial endoscopy, presence of obstructive esophageal strictures, Schatzki's ring, esophageal diverticula, esophageal varices, achalasia or Barrett's esophagus with known high-grade dysplasia or longer than 3 cm Acute peptic ulcer and/or ulcer complications Pyloric stenosis Known inflammatory bowel diseases | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Joint Pain Musculoskeletal Pain Stiffness Soft Tissue Inflammation in Designated Target Area(s) at least 18 years or older agree to refrain from chronic usage of NSAIDs or any other analgesics or anti-inflammatory drugs other than those provided during the course of the study or documented sporadic concomitant analgesics joint pain, musculoskeletal pain, stiffness, or soft tissue inflammation in designated target area(s) that are appropriate for self-treatment with a topical analgesic or where availability of a second person can be guaranteed in case self-treatment is not possible healthy skin in the target area(s) known hypersensitivity to IDEA-033 or other NSAIDs history of coagulation disorders history of peptic ulcers or gastric intolerance with NSAIDs urinary tract infection clinically significant renal, hepatic, or gastric disease acute or chronic coexisting illness qualifying for according to clinical judgement of the investigator clinical laboratory values outside normal range deemed clinically significant by the investigator Narcotics-containing products within 7 days of administering IMP Malignancy within the past 2 years | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Head and Neck Cancer years or older Diagnosed with head and neck cancer including the lip, oral cavity, salivary glands, paranasal sinuses, oropharynx, nasopharynx, hypopharynx, larynx, and thyroid All histological types of cancer All tumour stages according to American Joint Committee for Cancer (AJCC) Staging All forms of RT including standard or investigational and/or concurrent standard or investigational chemotherapy for head and neck cancers Alert and mentally competent English speaking Unwilling to participate | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Differentiated Thyroid Gland Carcinoma Recurrent Thyroid Gland Carcinoma Refractory Thyroid Gland Carcinoma Stage III Thyroid Gland Follicular Carcinoma AJCC v7 Stage III Thyroid Gland Medullary Carcinoma AJCC v7 Stage IV Thyroid Gland Follicular Carcinoma AJCC v7 Stage IV Thyroid Gland Medullary Carcinoma AJCC v7 Stage IV Thyroid Gland Papillary Carcinoma AJCC v7 Stage IVA Thyroid Gland Follicular Carcinoma AJCC v7 Stage IVA Thyroid Gland Medullary Carcinoma AJCC v7 Stage IVA Thyroid Gland Papillary Carcinoma AJCC v7 Stage IVB Thyroid Gland Follicular Carcinoma AJCC v7 Stage IVB Thyroid Gland Medullary Carcinoma AJCC v7 Stage IVB Thyroid Gland Papillary Carcinoma AJCC v7 Stage IVC Thyroid Gland Follicular Carcinoma AJCC v7 Stage IVC Thyroid Gland Medullary Carcinoma AJCC v7 Stage IVC Thyroid Gland Papillary Carcinoma AJCC v7 Thyroid Gland Hurthle Cell Carcinoma Unresectable Thyroid Gland Carcinoma Patients must have histologically or cytologically confirmed papillary, follicular, or Hurthle cell carcinoma (cohort A) or medullary thyroid carcinoma (cohort B); their disease must have progressed despite treatment with iodine-131 therapy or they are not candidates for iodine-131 therapy and their disease cannot be completely removed by surgery; all patients with WDTC are expected to be on thyroxine suppression therapy Patients must have radiographically or biochemically measurable disease; radiographically measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan; biochemically measurable disease is defined as an elevated thyroglobulin (WDTC patients) or calcitonin (MTC patients) Patients must have evidence of disease progression (objective growth of existing tumors or rising thyroglobulin or calcitonin levels) within the last 6 months Patients cannot have received prior receptor tyrosine kinase inhibitors; patients cannot have received more than one prior chemotherapy regimen for metastatic disease; patients cannot have received prior external beam radiation to the measured tumor constituting the target lesion(s) Life expectancy of greater than 12 weeks Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky >= 60%) Leukocytes >= 3,000/mcL Absolute neutrophil count >= 1,500/mcL Platelets >= 100,000/mcL Hemoglobin >= 9 g/dL Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier; at least 4 weeks must have elapsed since any major surgery Patients may not be receiving any other investigational agents Patients who have received prior treatment with any other antiangiogenic agent (e.g., bevacizumab, sorafenib, pazopanib, AZD2171, PTK787, vascular endothelial growth factor [VEGF] Trap, etc.) History of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib Patients with QTc prolongation (defined as a QTc interval equal to or greater than 500 msec), serious ventricular arrhythmia (ventricular fibrillation or ventricular tachycardia greater than or equal to 3 beats in a row) or other significant electrocardiogram (ECG) abnormalities are excluded Patients with poorly controlled hypertension (systolic blood pressure of 140 mmHg or higher or diastolic blood pressure of 90 mmHg or higher) are ineligible Patients who require use of therapeutic doses of coumarin-derivative anticoagulants such as warfarin are excluded, although doses of up to 2 mg daily are permitted for prophylaxis of thrombosis; Note: Low molecular weight heparin is permitted provided the patient's prothrombin time (PT) international normalized ratio (INR) is =< 1.5 Patients with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous [IV] alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow and retain sunitinib tablets are excluded Patients with any of the following conditions are excluded Serious or non-healing wound, ulcer, or bone fracture | 2 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Thyroid Cancer Confirmed diagnosis of unresectable, locally advanced or metastatic hereditary or sporadic Medullary Thyroid Cancer Presence of measurable tumor Able to swallow medication Major surgery within 4 weeks before randomization Last dose of prior chemotherapy received less than 4 weeks prior to randomization Radiation therapy within the last 4 weeks prior to randomization(with exception of palliative radiotherapy) Brain metastases or spinal cord compression, unless treated at least 4 weeks before first dose and stable without steroid treatment for 10 days Significant cardiac events Previous ZD6474 treatment | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 16.0-80.0, Head and Neck Cancer Histologically confirmed differentiated thyroid cancer T1-T3, Nx, N0, N1, M0 disease Has undergone one or two-stage total thyroidectomy with or without lymph node dissection All known tumor resected (R0) Requires radioiodine remnant ablation Does not require mandatory recombinant thyroid-stimulating hormone No Hurthle cell carcinoma or aggressive variants, including any of the following Tall cell, insular, poorly differentiated disease with diffuse sclerosing Anaplastic or medullary carcinoma | 1 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-100.0, Head and Neck Cancer Diagnosis of thyroid cancer Measurable disease by CT scan or nuclear medicine imaging Eligible, by standard of care for iodine I 131 therapy Not pregnant or nursing Negative pregnancy test Fertile patients must use effective non-barrier method contraception (e.g., combined or progesterone-only oral contraceptive pill, intrauterine device, depot progesterone, or stable relationship with a partner who has had a vasectomy) No other malignancy within the past 5 years except squamous cell or basal cell carcinoma of the skin No nonthyroidal conditions known to affect iodine I 131 uptake (e.g., New York Heart Association class III or IV congestive heart failure or renal failure) No alcoholism or drug abuse within the past 2 years No severe emotional, behavioral, or psychiatric problems that would preclude study compliance (e.g., severe claustrophobia) PRIOR | 2 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 0.0-999.0, Differentiated Thyroid Carcinoma Hiostologically proved DTC (M0) Preoperative metastasis | 1 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 10.0-90.0, Thyroid Neoplasms Papillary thyroid cancer diagnosed in NTUH from 1977 to 2000 Patient without complete medical record | 2 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-99.0, Tumor Cancer cancer which is refractory to standard therapies WHO performance status 0-2 evidence of post-menopausal status or negative pregnancy test Radiotherapy/chemotherapy within 21 days prior to entry brain metastases/spinal cord compression unless stable off steroids/anticonvulsants evidence of severe/uncontrolled systemic disease participated in an investigational drug study within 30 days | 2 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 0.0-999.0, Hemorrhage Hypocalcemia Vocal Cord Palsy patients with total thyroidectomy plus central neck dissection if primary tumor size was more than 1 cm in papillary thyroid cancer there was any evidence of lymph node enlargement in paratracheal lymph node group preoperatively or intraoperatively patients who underwent minimal resection of the surrounding soft tissues, including the sternothyroid or sternohyoid muscle, for extracapsular extension of thyroid cancer patients who required lateral compartment neck dissection or mediastinal dissection for preexisting lymph node metastasis patients had clinical or laboratory indicators of coagulation disorders patients with preexisiting vocal cord palsy, fixation of the tumor to the recurrent laryngeal nerve requiring trnasection of the nerve patients with massive extracapsular extension to the surrounding soft tissues | 1 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 30.0-70.0, Obesity BMI between 30-40 Age between 30-70 At least moderately interested in losing weight (Self-reported 3,4, or 5 on 5 point scale) Unstable medical conditions that would likely prevent the subject from completing the study Myocardial infarction within 6 months Uncontrolled hypertension, defined as BP>170 mm Hg systolic or BP>110 mm Hg diastolic Metastatic cancer Self-report of 6 or more alcoholic beverages per day Severe depression Active substance abuse Schizophrenia Inability to read or severe cognitive deficits that would preclude ability to read consent form or fill out surveys Baseline participation in other weight loss programs | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 40.0-80.0, Patients Undergoing High Risk PCI. Signed Informed Consent Non emergent PCI of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft EF <35% ST Myocardial Infarction Cardiac Arrest Cardiogenic Shock Thrombus Left Ventricle | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Thyroid Neoplasms Previously confirmed histological diagnosis of locally advanced or metastatic papillary or follicular thyroid carcinoma, without anaplastic component. Tumor sample available for centralized exploratory analysis Presence of one or more measurable lesions at least 1 cm in the longest diameter by spiral CT scan or 2 cm with conventional techniques Progressive disease following RAI131 or patient unsuitable for RAI131 after surgery Serum TSH<0.5mU/L Major surgery within 4 weeks before randomization Prior chemotherapy within the last 4 weeks prior to randomization RAI131 therapy within 3 months in patients with radioiodine uptake Radiation therapy within the last 4 weeks prior to randomization (with the exception of palliative radiotherapy) Serum bilirubin >1.5 x the upper limit of reference range (ULRR) Creatinine clearance < 30 ml/min (calculated by Cockcroft-Gault formula) Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) greater than 2.5 × ULRR, or greater than 5.0 × ULRR if judged by the investigator to be related to liver metastases Clinically significant cardiovascular event (eg myocardial infarction), superior vena cava [SVC] syndrome, New York Heart Association [NYHA] classification of heart failure >II within 3 months before entry, or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia History of arrhythmia (multifocal premature ventricular contractions [PVCs], bigeminy, trigeminy, ventricular tachycardia or uncontrolled atrial fibrillation), which is symptomatic or requires treatment (CTCAE grade 3), , or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication are permitted Congenital long QT syndrome or 1st degree relative with unexplained sudden death under 40 years of age | 2 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Recurrent Thyroid Gland Carcinoma Stage I Thyroid Gland Papillary Carcinoma Stage II Thyroid Gland Papillary Carcinoma Stage III Thyroid Gland Papillary Carcinoma Stage IV Thyroid Gland Papillary Carcinoma Histologically or cytologically confirmed papillary thyroid cancer or papillary thyroid cancer with follicular elements No longer amenable to radioactive iodine therapy or curative surgical resection Tumor is no longer iodine avid Tumor did not respond to the most recent radioactive iodine treatment Patient is ineligible for further radioactive iodine therapy due to medical contraindications (e.g., lung toxicity) Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan Evidence of disease progression (objective growth of existing tumors) New or enlarging measurable lesions within the past 12 months If the most recent imaging study is older than 12 months, patients will still be eligible if objectively measurable disease progression is associated with clinical symptoms Archival tumor tissue available for mutational analysis | 2 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-120.0, Head and Neck Cancer * Histologically or cytologically confirmed diagnosis of recurrent or second primary squamous cell carcinoma (SCC) of the head and neck, including any of the following Oral cavity Oropharynx Hypopharynx Larynx Recurrent neck metastases with unknown primary Exception from pathology confirmation of tumor recurrence is accepted for patients who originally had pathologically confirmed SCC of the Head and Neck, the new tumor is located in the head and neck area and it is clinically considered as a recurrence of the original tumor, and a tumor biopsy is technically difficult and would expose the patient to unjustified risk. The treating physicians should agree and document the clinical definition of tumor recurrence and should document the increased risk for biopsy Measurable disease by CT scan or MRI OR evaluable disease No definitive evidence of distant metastasis Unresectable disease by a preliminary ENT evaluation OR refused surgery Patients may have received chemotherapy as a component of their primary tumor treatment but not for recurrent or metastatic disease. No prior treatment with systemic anti-EGFR inhibitors or Pemetrexed is permitted | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Esophagitis Inflammation Gastritis Abdominal Pain Heartburn Patients referred for upper endoscopy for any reason including those with acid reflux, dyspepsia, weight loss, Barrett's esophagus,suspected Helicobacter pylori infection. 2. Patients able to provide written informed consent Lack of severe comorbid conditions precluding an upper endoscopy. 2. Patients with history of esophageal or gastric cancer. 3. Patients status post esophageal or gastric resection. 4. Patients with esophageal varices. 5. Patients with severe esophageal strictures. 6. Patients with acute upper gastrointestinal bleeding. 7. Inability to provide informed written consent | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Blood Pressure Cardiac Transplantation s/p cardiac transplantation scheduled for clinical right heart catheterization age > 18 years significant tricuspid regurgitation inability to safely swallow 500 ml of water other major medical comorbidities such as advanced renal disease where water ingestion may be harmful to patient | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Dysphagia complaints of dysphagia scheduled to undergo videofluoroscopy able to tolerate both videofluoroscopic evaluation of swallowing and FEES age less than 18 contraindications to videofluoroscopy (reaction to barium, possible pregnancy) contraindications to FEES (bilateral obstructing nasal pathology or nasopharyngeal stenosis) specific/vulnerable populations (children, mentally handicapped, pregnant women, fetuses, prisoners, cognitive impairment, life-threatening disease, social or economic disadvantage) | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, CNS Brain Metastasis Head and Neck Cancer Lung Cancer Prostate Cancer Esophageal Cancer Able to tolerate a PET/CT scan Age of 18 or older signed informed consent being considered for radiotherapy for treatment of CNS mets, Head and neck cancer, lung cancer, prostate cancer or esophageal cancer Prior XRT to site being studied severe claustrophobia or inability to tolerate PET/CT unable to provide written consent pregnant or breastfeeding women | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 1.0-999.0, Thyroid Cancer Age 1 Benign or malignant thyroid lesion, other malignancy or no thyroid abnormality Pathologic specimen available for analysis Ability to provide informed consent (for prospective study, Part Two) Age greater than age 18 (for normal controls) Patients without adequate data for analysis Histopathologic or cytopathologic diagnosis of for medullary thyroid carcinoma (not derived from the thyroid follicular epithelium), thyroid lymphoma Unwilling to participate or unable to provide informed consent | 2 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-75.0, Thyroid Cancer Follicular or papillary thyroid cancer < 18 or > 75 years old Pregnant or lactating women | 2 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 0.0-999.0, Thyroid Nodule Thyroid Cancer Thyroid Neoplasms Nodular Goiter Histologically or cytologically documented benign thyroid nodule, or cold thyroid nodule as documented by thyroid scan Patient has been evaluated by endocrinology and endocrine surgery and has been deemed suitable candidate for procedure The patient's nodule(s) size and number must be no larger than 5cm and a maximum of 3 nodules, respectively All nodules must be greater than 1cm from the expected location of the recurrent laryngeal and vagus nerves determined under ultrasound Required initial laboratory values: T3, T4. TSH, and Thyroglobulin (for treated metastatic lymph nodes) All patients must understand and sign a study-specific informed consent Thyroid mass in contact with trachea or esophagus Uncontrolled coagulopathy or bleeding diathesis that cannot be corrected with FFP and platelets prior to procedure. (Platelets must be ≥ 70,000/ul.) Aspirin and nonsteroidal anti-inflammatory medications, antiplatelet medications, or warfarin must be discontinued prior to the procedure for a time period that is appropriate given the drug half-life and the drugs known antiplatelet activity (e.g. aspirin for 7 days and ibuprofen 24 hours). Low molecular weight heparin preparations must be discontinued 24 hours prior to procedure | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 19.0-999.0, Recurrent Thyroid Gland Carcinoma Stage III Differentiated Thyroid Gland Carcinoma AJCC v7 Stage III Thyroid Gland Medullary Carcinoma AJCC v7 Stage IVA Differentiated Thyroid Gland Carcinoma AJCC v7 Stage IVA Thyroid Gland Anaplastic Carcinoma AJCC v7 Stage IVA Thyroid Gland Medullary Carcinoma AJCC v7 Stage IVB Differentiated Thyroid Gland Carcinoma AJCC v7 Stage IVB Thyroid Gland Anaplastic Carcinoma AJCC v7 Stage IVB Thyroid Gland Medullary Carcinoma AJCC v7 Stage IVC Differentiated Thyroid Gland Carcinoma AJCC v7 Stage IVC Thyroid Gland Anaplastic Carcinoma AJCC v7 Stage IVC Thyroid Gland Medullary Carcinoma AJCC v7 Thyroid Gland Anaplastic Carcinoma Histologically or cytologically confirmed differentiated, medullary or anaplastic thyroid cancer that is now advanced or metastatic; NOTE: patients with thyroid lymphomas or sarcomas are specifically excluded, as are patients with metastatic disease from other sites of origin to thyroid Patients with confirmed differentiated thyroid cancer to be enrolled in the expanded/additional differentiated thyroid cancer (DTC) cohort must be thyroglobulin antibody negative Zero, one or two prior therapeutic regimens (this includes cytotoxic plus non-cytotoxic therapeutic regimens) Absence of sensitivity to therapeutic radioiodine (differentiated only) Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm with spiral computed tomography (CT) scan; NOTE: disease that is measurable by physical examination only is not eligible Life expectancy > 3 months Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2 (Karnofsky >= 60%) Leukocytes > 3,000/mcL obtained =< 7 days prior to registration Absolute neutrophil count > 1,500/mcL obtained =< 7 days prior to registration Platelets > 100,000/mcL obtained =< 7 days prior to registration Anaplastic, differentiated, medullary: a total of > 2 prior therapeutic regimens (this total includes cytotoxic plus non-cytotoxic regimens); Note: enrollment of anaplastic, differentiated, and medullary patients who have had zero, one or two prior therapeutic regimens (cytotoxic plus non-cytotoxic regimens) is allowed provided therapy ceased > 21 days prior to registration NOTE: the principal investigator of the study should be contacted in the event of uncertainty related patient based upon prior therapies Disease that is measurable by physical examination only Any of the following Radiotherapy =< 4 weeks prior to registration Major surgery =< 4 weeks prior to registration Radiotherapy to >= 25% of bone marrow Concurrent therapy with octreotide unless tumor progression on this therapy has been demonstrated Any other ongoing investigational agents | 1 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 21.0-999.0, Dysphagia Male or female ages 21+ At least 3 months post-radiation therapy for head & neck cancer Treatment for their cancer can chemotherapy Surgery for their cancer, if done, must meet these diagnostic biopsy less than ½ of oral tongue resected less than ½ of tongue base resected no floor of mouth muscles resected less than 50% of any other part of the oral cavity, pharynx or larynx resected no resection of hyoid Inability to cooperate with the examination and treatment An implanted electrical device (e.g., pacemaker, deep brain stimulator, defibrillator, vagal nerve stimulator) Previous e-stim treatment to the head & neck Any current or previous neurological disease which may adversely affect swallowing History of oropharyngeal swallowing disorder prior to cancer History of pre-cancer oral intake that was limited due to a swallowing problem Previous neurosurgery on the brain that could compromise swallowing or ability to follow protocol Severe COPD (oxygen dependent) Need for dilation of the upper esophageal sphincter or esophagus at time of entry Females who are currently pregnant will be excluded from participation | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 15.0-85.0, Hypocalcemia Differentiated papillary thyroid carcinoma Undergoing total thyroidectomy plus central neck dissection Previous thyroid or neck surgery Patients with parathyroid diseases Other thyroid malignancies Early loss of follow-up without proper evaluation of postoperative serum calcium levels and symptoms | 1 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-80.0, Head and Neck Squamous Cell Carcinoma Biopsy-proven HNSCC Clinical stage: unpreviously treated T1-T4 oral cavity, oropharynx, hypopharynx, larynx Only patients suitable for at least a neck dissection after chemoradiotherapy will be included. Consequently, are thus : T1-T4 , N1 N2a, N2b N2c N3 M0 Patient scheduled for an organ preservation treatment protocol based on concomitant chemoradiation (induction chemotherapy is allowed if this approach is followed by concomitant chemoradiation) | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 6.0-999.0, Cystic Fibrosis Lung Infection Pseudomonas Aeruginosa Participants ≥ 6 years of age Documentation of CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following Sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test Two well characterized mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene Abnormal nasal potential difference PA present in expectorated sputum or throat swab culture at Visit 1 OR documented PA in 2 expectorated sputum or throat swab cultures within the 12 months prior to Visit 1 (one of the previous PA positive cultures must have been no more than 3 months prior to Visit 1) FEV1 > 75% predicted at Visit 1 Participants must have exhibited two or more of the following chronic and/or intermittent CF symptoms, for a minimum of 28 days prior to randomization and with no worsening of symptoms within 7 days prior to randomization Chest congestion Daily cough Administration of any investigational drug or device within 28 days prior to Visit 1 or within 6 half-lives of the investigational drug (whichever was longer) Administration of any IV, oral, or inhaled antipseudomonal antibiotic within 28 days prior to Visit 1 Known local or systemic hypersensitivity to monobactam antibiotics Inability to tolerate short-acting bronchodilator (BD) use at least TID Changes in or initiation of chronic azithromycin treatment within 28 days prior to Visit 1 Changes in or initiation of chronic hypertonic saline treatment within 28 days prior to Visit 1 Changes in or initiation of dornase alfa within 28 days prior to Visit 1 Changes in antimicrobial, BD, or corticosteroid medications within 7 days prior to Visit 1 Changes in physiotherapy technique or schedule within 7 days prior to Visit 1 History of lung transplantation | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Head and Neck Cancer Histologically confirmed head and neck squamous cell carcinoma (HNSCC), including any of the following subtypes Oropharyngeal Laryngeal Oral Hypopharyngeal No primary nasopharyngeal carcinoma Must have clinical and CT/MRI evidence of nodal metastases staged N2 (a, b, or c) or N3 No occult nodal metastasis (i.e., large nodal metastasis but no proven primary site on clinical assessment) No N1 nodal metastasis Planning to receive curative radical concurrent chemoradiotherapy (approved by study) for primary disease | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 20.0-999.0, Colorectal Cancer Histologically proved adenocarcinoma (colorectal cancer) Age: 20 ≤ at enrollment No prior treatment (ex. radiation therapy, chemotherapy, hormonal therapy) to advanced disease. Patients who received adjuvant chemotherapy more than 180 days before enrollment can be allowed but those who received S-1 or Oxaliplatin containing treatment shall be excluded At least one measurable lesion by Serious drug hypersensitivity Prior history of peripheral neuropathy Diarrhea Simultaneously active double cancer | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Recurrent Thyroid Gland Carcinoma Stage III Thyroid Gland Follicular Carcinoma Stage III Thyroid Gland Papillary Carcinoma Stage IV Thyroid Gland Follicular Carcinoma Stage IV Thyroid Gland Papillary Carcinoma Histopathologically confirmed differentiated thyroid carcinoma of follicular cell origin, including any of the following histologies and their respective variants Papillary Follicular Hürthle cell Must have surgically inoperable and/or recurrent or metastatic disease At least one fludeoxyglucose F 18 (FDG)-PET-avid lesion, defined as any focus of increased FDG uptake > normal mediastinal activity with standard uptake variable (SUV) maximum levels ≥ 3, as documented by baseline PET scan Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan Progressive disease, defined by ≥ 1 of the following occurring during or after prior treatment (e.g., radioactive isotope [RAI] treatment) Presence of new or progressive lesions on CT scan or MRI New lesions on bone scan or PET scan | 2 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 40.0-999.0, Osteoporosis Men and postmenopausal women who have a previous vertebral osteoporotic fracture that was sustained at least 6 weeks prior to joining the study Patients who are free of severe or chronically disabling conditions other than osteoporosis Patients who are not currently receiving and have not previously received teriparatide Patients who agree to participate, return to follow-up visits, and who have signed informed consent to participate in the study Patients, who in the opinion of the prescribing physician, are eligible to receive the intended treatment and comply with all the recommendations stated in the relevant product information Are investigator site personnel directly affiliated with the study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted Are Lilly employees (that is, employees, temporary contract workers, or designees responsible for conducting the study). Immediate family of Lilly employees may participate in Lilly-sponsored clinical trials, but are not permitted to participate at a Lilly facility Patients who have any contraindications according to the relevant product information in the country in which they are being treated Patients who are simultaneously participating in a different study that includes a treatment intervention and/or an investigational drug | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-80.0, Diabetes s/p open heart or kidney or liver transplant surgery admission blood glucose less than 120 mg/dl | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-70.0, Thyroid Cancer Age: 18 to 70 Sonographically node-negative cytology confirmed thyroid papillary carcinoma Tumor size less than 1 cm in sonography Tumor confined to the one lobe of the thyroid gland One who provides the informed consent History of radiation treatment to head and neck area History of other malignancy except thyroid cancer Poor performance status (ECOG 3-4) | 1 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 0.0-999.0, Thyroid Neoplasms Carcinoma Thyroid Cancer Metastatic Cancer cytologically or histologically verified anaplastic thyroid cancer completed standard therapy operated with R0 or R1 surgery Performance Status 0-2 (if pulmonary mets PS 0-1) normal wound healing neutrophils > 1,5 million/ml platelets > 100 million/ml bilirubin < 2 ULN creatinin < 150mikromol/L PS 3-4 (if pulmonary mets 2-4) R2 resection of primary tumor | 0 |
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