topic
stringlengths 245
1.29k
| doc
stringlengths 52
16.9k
| label
stringclasses 3
values |
|---|---|---|
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 Cancer of the Head and Neck Adults aged 18 years or older will be considered eligible Patients with head and neck malignancies, such as melanoma, non-melanoma cutaneous malignancies, or oral cavity squamous cell carcinoma. Patients with central neck pathology including thyroid neoplasms, parathyroid neoplasms, and laryngeal neoplasms undergoing surgical resection Candidates for sentinel lymph node biopsy or central neck surgery Newly diagnosed with clinically node negative head and neck cancer being staged with sentinel lymph node biopsy Not pregnant or breast feeding Able to understand and willing to sign an IRB-approved written informed consent document Able to understand written or spoken English History of allergy to iodide drugs or shellfish (iodine allergy) Pregnant or breast feeding Do not fit age Prisoners Unable to provide written consent Contraindications for surgery *Presence of uncontrolled intercurrent illness including, but not limited to, ongoing or active infection of the head and neck, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Receiving any other investigational agents | 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 Cancer Able to read, write, and communicate in English Patients who have been diagnosed with LR-PTC as described above For Aim 1, adults with recently diagnosed LR-PTC who have not yet made a choice between surgery and AS For Aim 2, adults with LR-PTC who made a decision about surgery or AS at least 3 months prior, but no more than 4 years prior to their routine follow-up visit at which they are being recruited for this study Active patients of MSK and participating institutions Patients who have been diagnosed with a tumor greater than 2 cm Patients with clinically suspicious lymphadenopathy in the neck Patients with evidence of gross ETE after a biopsy of the papillary thyroid tumor | 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, Hormone Sensitive Oligometastatic Prostate Cancer Able to provide informed consent Histologic confirmation of prostate adenocarcinoma Stage IV disease with ≤ 5 metastases outside of the pelvis ≤ 3 metastases in any one organ system ECOG performance 0-1 All metastatic tumours amenable to SBRT Patient eligible for either RP or RT to the prostate Castration resistant prostate cancer Previous RP or RT to prostate Inability to treat all metastases with SBRT Prior malignancy within the past 5 years, excluding non-melanoma skin cancer, in-situ cancer, superficial bladder cancer, chronic lymphocytic leukemia or low grade lymphoma which is being observed | 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): 19.0-74.0, Papillary Thyroid Microcarcinoma Have a thyroid nodule ≤10mm in the largest dimension that is confirmed on FNAC to be PTC (Bethesda class VI cytology) or suspicious of PTC (Bethesda V cytology). For the latter, the nodule needs to have an additional suspicious sonographic feature (i.e. marked hypoechogenicity, irregular margins, height-to-wide ratio >1 and intravascular microcalcifications) Have not expressed a strong desire for immediate surgery after PTMC has been confirmed Age ≤ 18 or ≥ 75 years old Have another thyroid nodule that is either indeterminate or malignant on FNAC Have concomitant hypo or hyperthyroidism (i.e. thyroid stimulating hormone (TSH) and/or free thyroxine levels outside the normal ranges) Have sonographic evidence of chronic lymphocytic thyroiditis (because this generally makes it difficult to assess and reassess tumor size accurately on USG alone) Have a tumor considered not suitable for AS. This includes a PTMC with extrathyroidal extension, concomitant nodal or distant metastasis or a PTMC located within 3mm from trachea-esophageal groove or recurrent laryngeal nerve Have a condition considered not suitable for HIFU treatment (pregnancy, history of neck irradiation, known contralateral vocal cord palsy, a tumor with coarse, macroscopic intranodular calcifications or located outside the treatable depth of 5-30 mm from the skin, family history of non-medullary thyroid carcinoma and medical conditions precluding intravenous sedation) | 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): 45.0-75.0, Osteoarthritis Patients 45 to 75 years with Hip or Knee OA stage I to III Patient started current treatment with Theraflex not more than 2 weeks prior to into the study Personally signed and dated informed consent Patients participating in an investigational program with interventions outside of routine clinical practice Patients with Hip or Knee OA stage 0 or stage IV Patients who have both Hip and Knee OA and OA of any other location Contraindications for use of Theraflex in accordance with approved label(known hypersensitivity, severe chronic renal failure) Females who are pregnant or breastfeeding Patients who completed a treatment with Theraflex or another combination of Gl+ Ch less than 5 months before start of the current treatment Patients who completed intra-articular corticosteroids treatment in the last 3 months to Patients who completed hyaluronic injections of the lower limbs in the last 6 months | 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): 18.0-75.0, Head and Neck Squamous Cell Carcinoma Squamous cell carcinoma of the larynx or hypopharynx, histologically proven, locally advanced T2 not accessible to a supra-cricoid partial laryngectomy or not T3 without massive infiltration by endolarynx transglottic injury N0 to N2c No distant metastasis No associated cancer or earlier Patients Previously Untreated Age> 18 years and <75 years PS 0 or 1 according to WHO Tumor volume assessable by transglottic T3 with massive infiltration of hemilarynx or T4 with massive cartilaginous tumor lysis or reverse cricoarythénoïdenne region or posterior hypopharyngeal wall tumor requiring the completion of an immediately tracheotomy Tumour available immediately to partial surgery tumor requiring circular hypopharyngectomie N3 nodal injury Vaccination against yellow fever recent or anticipated Deficit known dihydropyrimidine dehydrogenase (DPD) Other malignancies within 5 years prior to randomization, with the exception of adequately treated basal skin cancer and carcinoma in situ of the cervix Patients with AST or ALT> 1.5xULN associated with alkaline phosphatase > 2.5x LNS will not be eligible for testing symptomatic neuropathy grade ≥2 with NCI-CTC | 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, Papillary Thyroid Cancer Pre-operative thyroidectomy patients with pathology-proven papillary thyroid cancer (PTC) needing lymph node staging for potential neck dissection Patients with history of prior surgery within the head and neck Patients with history of prior radiation to the head and neck Patients with history of lymphoma, leukemia, or other lymphoproliferative disorders affecting the head and neck Pregnant/breast feeding patients (by question) | 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): 18.0-30.0, Pain Exercise Posture Participants who were aged between 18 and 30, using technological devices as tablets and smartphones for more than 5 hours and having neck pain for more than 3 months were included in our study The included those: 1. who had any diagnosed pathology for neck region diagnosed by MR or BT, 2. who had any shoulder pathology, 3. with any neck or shoulder surgery, 4. had whiplash syndrome, 5. had fibromyalgia, Myofasial Pain Syndrome or vascular pathology and 6. women who are breastfeeding | 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 Nodule Thyroid Neoplasm Thyroid Cancer a diagnosis of thyroid nodule considerable chance for surgical procedure following biopsy result patient's consent for collection of material during routine fine needle aspiration biopsy age below 18 years the presence of contraindications that make surgical treatment impossible prior diagnosis of thyroid cancer antithrombotic treatment except of acetylsalicylic acid or low molecular weight heparin at a prophylactic dose | 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): 18.0-75.0, Carcinoma, Pancreatic Ductal Patients aged 18 years old at the time of signing the ICF. 2. Patients with pathologically proved adenocarcinoma of pancreatic cancer and diagnosed with inoperable/metastatic disease (previous systemic chemotherapy, neoadjuvant or adjuvant are acceptable without Irinotecan, Oxaliplatin, or S1). 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 4. Adequate hematologic function defined as: absolute neutrophil count (ANC) >= 2,000/μL; platelets count >= 100,000/μL; hemoglobin must be >= 10 g/dL (can be corrected by growth factor or transfusion). 5. Adequate hepatic function defined as: serum bilirubin =< 1.5-fold upper limit of normal (ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) =< 3-fold ULN (5-fold ULN if liver metastasis is observed). 6. Adequate renal function with: serum creatinine =< 1.3 mg/dL or calculated creatinine clearance >= 60 mL/minute according to the Cockcroft and Gault formula. 7. At least one measurable disease according to the Response Evaluation in Solid Tumors (RECIST) version 1.1. 8. Life expectancy over 12 weeks. 9. Women must be either of non-child bearing potential, or women with child-bearing potential agree to use effective a highly contraceptive method or a contraceptive implant, exception of hormonal contraception (estrogen/progesterone), during treatment from time of Screening Visit and after cessation of therapy at least 3 months. 10. Willing and able to comply with all aspects of the treatment protocol. 11. Provide written informed consent Patients who are unwilling or unable to comply with the study protocol; 2. Existing anticancer treatment-related toxicities of Grades >= 2 (except for alopecia and neuropathy) according to Common Terminology for Adverse Events (CTCAE v4.03). 3. Simultaneously using targeted therapies, such as Erlotinib, Nimotuzumab etc; 4. Any severe or uncontrolled systemic disease (e.g., unstable or decompensated breathing, heart, liver or kidney disease, HIV infection, hypertension, severe arrhythmia, diabetes mellitus, massive active bleeding); 5. Large operations were performed within 14 days before entering the study, or there were surgical incisions that were not completely healed; 6. Women who are pregnant or breastfeeding; 7. Ascertained hypersensitivity to investigational product, Oxaliplatin, Irinotecan, and S1 or any of the excipients used in the study. 8. History of other malignancies within 5 years, except for adequately treated basal cell carcinoma or squamous cell carcinoma or carcinoma in situ; 9. Obvious gastrointestinal injury history, the researchers estimate may significantly affect the absorption of S1 on the whole, including the ability to swallow drugs; 10. Other combinations of anticancer therapies (including LHRH agonists, anticancer herbs, immunotherapy), except steroid hormones; 11. Patients with UGT1A1 mutations or congenital disease lack of UGT1A1 expression (e.g. Crigler-Najjar syndrome and Gilbert syndrome); 12. Patients with DPD enzyme deficiency. 13. Judged to be not applicable to this study by investigator such as difficulty of follow-up observation, psychiatric disorder, with any other serious diseases/medical history | 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 Cancer Patients over age of 18 years with differentiated thyroid cancer (papillary, follicular) histologically confirmed, and absence of anaplastic component Previous treatment by total thyroidectomy and cervical lymph node dissection Previous treatment by at least 1 therapeutic radioactive iodine (minimum activity 740MBq) Persistence on cervical ultrasound of at least 1 cervical metastatic lymph node, visible at ultrasound, small diameter between ≥10 mm and ≤30mm, volume maximum 20ml, spotted on a picture, and confirmed by cyto-punction Signed informed consent Location of LN metastasis with significant risk of local complication (nervous, vascular) according baseline ultrasound assessment Patient carrier of a pacemaker or a defibrillator Congenital or acquired hemostasis abnormality, anticoagulant therapy or double platelet antiaggregatory (aspirin and clopidogrel) Hypersensitivity to local anesthetic Poor general condition (performance status Eastern Cooperative Oncology Group (ECOG) > 1) Survival estimated less than 12 months Patient who can't follow the instructions of RF therapy or who can't be followed during 2 years in order to meet the objectives of the study Non affiliation to a social security Pregnant or breast feeding women at the time of RF Beta hormone chorionic gonadotrope (HCG) positive test (pregnancy) before RF therapy | 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): 19.0-60.0, Papillary Thyroid Microcarcinoma Thyroid Cancer who agrees to the consent form aged from 19 to 60 years old who has been diagnosed with Bethesda category V or VI by fine needle aspiration or needle biopsy whose thyroid cancer is 1 cm or smaller than 1 cm length who does not have lymph node or distant metastasis whose thyroid cancer does not have extrathyroidal extension in whom it seems technically possible to completely ablate thyroid cancer using RF who cannot routinely followed up according to the study schedule who has been with Bethesda category I, II, III, or IV by fine needle aspiration or needle biopsy who has hyperthyroidism that requires treatment who has bleeding tendency multifocal papillary thyroid microcarcinoma who is pregnant | 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): 27.0-78.0, Functional Voice and Swallowing Outcomes patients undergoing thyroidectomy Patients who were diagnosed with thyroid carcinoma preoperatively Having history of previous neck surgery History of radiotherapy at head and neck region Vocal cord paralysis neuromuscular dysfunction larynx, esophagus and chest pathology who did not want to be involved in the study | 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): 18.0-75.0, Cancer of Oropharynx Cancer of Nasopharynx Histological diagnosis of squamous cell carcinoma or undifferentiated carcinoma of the otoiatric district 2. Subsider of the primitive: (Nasopharynx Stage II and III); Oropharynx Stage III-IVA 3. ECOG Status 0-2 4. Chemiotherapy concomitant at radiotherapy (Cisplatin 100mg / m2 every 21 days or 40mg / m2 weekly) Histological diagnosis different from squamous or undifferentiated cell carcinoma 2. Subsider of the primitive different from Nasopharynx, Oropharynx 3. Nasopharynx Stage IV; Oropharynx Stage IVB and C 4. ECOG ≥3 5. Prior induction chemotherapy 6. Prior oncological surgery on the otoiatric district 7. Prior radiation treatment on the otoiatric district 8. Concomitant diseases that could modify the swallowing function (ex Amyotrophic Lateral Sclerosis or Multiple Sclerosis) 9. A history of excessive use of benzodiazepines or similar (ex patients in psychiatric therapy) or eostroesophageal reflux resistant at medical 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, Serrated Polyposis Syndrome Colorectal Cancer Patients with SPS WHO 1 criterion (cumulative ≥ 5 histologically diagnosed SPs proximal to the sigmoid colon, of which 2 ≥ 10mm in diameter) and/or WHO 3 criterion (cumulative ≥ 20 SPs spread throughout the colon, at least 3 of the SPs will have to be situated proximal to the sigmoid colon) Age 18 years or older Germline mutation for hereditary colorectal cancer syndrome (e.g. familial adenomatous polyposis, Lynch syndrome. Not including heterozygous MUTYH mutation) Inflammatory bowel disease Proctocolectomy History of radiotherapy in abdominal region | 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, Thyroidectomy Thyroid Cancer Central Compartment Neck Dissction Tumor diameter less than 1cm The tumor is located in the lower part of the gland No lateral cervical lymph node metastases Traditional open surgery Select the endoscopic surgery or robotic surgery patients Tumor invades the surrounding trachea and esophagus Patients refused to participate | 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): 18.0-70.0, Endoscopy Robotics Thyroidectomy Papillary Thyroid Carcinoma Thyroid papillary carcinoma The tumor diameter is less than or equal to 1cm The lymph nodes are limited to the VI level Voluntary choice of endoscopy or robotic surgery Patients without beauty needs There is lateral neck or mediastinal lymph node metastasis The tumor invades the nerve and surrounding organs | 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): 18.0-75.0, Thyroid Diseases who underwent thyroid surgery Perioperative loss of electromyographic(EMG) signal (LOS) during intraoperative nerve monitorization patients with additional pathology that may affect vocal cord function abnormal preoperative laryngeal examination history of thyroid, vocal cord or other neck surgery advanced cancer, RLN, esophageal or trachea invasion | 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, Papillary Thyroid Cancer Cytologically or histologically confirmed papillary thyroid cancer consisting of papillary or follicular variants. 2. Radioiodine-refractory disease (iodine-refractory thyroid cancer) by at least one of the following 1. an index metastatic lesion that was not radioiodine-avid on diagnostic radioiodine scanning performed within 28 days of enrolment; 2. a radioiodine-avid metastatic lesion that remained stable in size or progressed despite radioiodine treatment 3 months or more before entry into the study; or 3. 18F-fluorodeoxyglucose (FDG)-avid lesions on PET scan (if available). 3. Recurrent, advanced, or metastatic (Stage IV) disease that is not amenable to surgical resection or radiation with curative intent. 4. Minimal or no radioactive iodine uptake demonstrated by whole body iodine scans. 5. Age ≥ 18. 6. Eastern Cooperative Oncology (ECOG) performance status of ≤ 1. 7. Presence of measurable disease, defined as at least 1 unidimensional measurable lesion on a computed tomography (CT) scan as defined by 1.1. 8. Hematology: WBC ≥ 3.0 x 109/L or granulocytes (polymorphs + bands) ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L within 4 weeks prior to enrolment. 9. AST (SGOT) and/or ALT (SGPT) and alkaline phosphatase ≤ 5 x the upper limit of normal (ULN). Creatinine ≤ 1.5 x ULN. 10. Serum amylase and lipase ≤ 1.5 x ULN 11. Serum potassium, phosphorus, magnesium and calcium ≥ lower limit of normal or correctable with supplements prior to first dose of study drug. 12. Be able to comply with study procedures and follow-up examinations. 13. Not pregnant or lactating. Male and female patients who are fertile must agree to use an effective means of birth control (i.e., latex condom, diaphragm, cervical cap, etc.) to avoid pregnancy. 14. Sign a written informed consent Has received radiation therapy within 21 days of Study Day 1. 2. Has had major surgery within 21 days of Study Day 1. 3. Has untreated brain or meningeal metastases. Patients who have treated brain metastasis (via local radiation standards or surgical resection or local ablative techniques) and who are either off steroids or on a stable dose of steroids for at least one month (30 days), AND who are off anticonvulsants, AND have radiological documented stability of lesions for at least 3 months may be eligible. Each case should be discussed with the Principal Investigator. 4. Has a central thoracic tumor lesion as defined by location within the hilar structures. 5. Has proteinuria CTCAE v.4.0 Grade > 1 at baseline. 6. Has a history of, or currently exhibits clinically significant cancer related events of bleeding. 7. Currently exhibits untreated, symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure (BP) > 90 mm Hg or systolic BP > 140 mm Hg. 8. Has a history of myocardial infarction, stroke or Transient Ischemic Attack (TIA) within 6 months of Study Day 1. 9. Impaired cardiac function including any of the following: 1. Has a documented left ventricular (LV) ejection fraction < 50%; 2. Long QT syndrome or family history of long QT syndrome; 3. Clinically significant resting bradycardia (<50 bpm); 4. Other clinically significant heart disease (e.g. congestive heart failure, uncontrolled hypertension, unstable angina, significant ventricular or atrial tachyarrhythmia). 10. Treatment with strong CYP3A4 inhibitors (e.g. erythromycin, ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, ritonavir, mibefradil) and the treatment cannot be discontinued or switched to a different medication prior to starting study drug. 11. Treatment with strong CYP3A4 inducers (e.g. dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, St. John's Wort), and the treatment cannot be discontinued or switched to a different medication prior to starting study drug. 12. Patients using medication that have been documented to prolong QT interval should be avoided. In the case it is not possible to avoid or switch to other medication, patients should be followed with caution and ECG testing should be requested at least every 3 months after starting study or if any dose change occurs or if clinical symptoms appear. 13. Has known autoimmune disease with renal involvement (e.g. lupus). 14. Receiving combination anti-retroviral therapy for HIV. 15. Has clinically significant uncontrolled condition(s). 16. Previous or concurrent malignancies, excluding curatively treated in situ carcinoma of the cervix or uterus or non-melanoma skin cancer or in-situ carcinoma of the prostate (Gleason score ≤ 7, with all treatment being completed 6 months prior to enrollment, unless at least 5 years have elapsed since last treatment and the patient is considered cured). 17. Has active ulcerative colitis, Crohn's disease, celiac disease, short gut syndrome from any cause, or any other conditions that interfere with absorption. 18. History of acute pancreatitis within one year of study entry or medical history of chronic pancreatitis. 19. Has a medical condition, which in the opinion of the study investigator places them at an unacceptably high risk for toxicities. 20. Pregnant or breast feeding. 21. History of non-compliance to medical regimens or inability to grant consent. 22. Use of an investigational agent within 28 days prior to enrollment in the study or foreseen use of an investigational agent during the 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): 20.0-999.0, Thyroid Cancer patient with thyroid mass no other known organ malignancy no previous chemotherapy | 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, Papillary Thyroid Cancer Lymph Node Metastases Age ≥ 18 years, eligible for surgery 2. Bethesda VI fine needle aspiration (FNA) thyroid or FNA proven PTC metastasis (primary or recurrence). 3. Scheduled to undergo central and/or lateral lymph node dissection with or without thyroidectomy as discussed in the Multi-Disciplinary Thyroid Board. 4. WHO performance score of 0-2. 5. Written informed consent. 6. Mentally competent person who is able and willing to comply with study procedures. 7. For female subjects who are of childbearing potential are premenopausal with intact reproductive organs or are less than two years post-menopausal A negative serum pregnancy test prior to receiving the tracer Willing to ensure that she or her partner uses effective contraception during the trial and for 3 months thereafter Pregnancy or breast feeding 2. Advanced stage thyroid cancer not suitable for surgical resection 3. Medical or psychiatric conditions that compromise the patient's ability to give informed consent 4. Concurrent anticancer therapy (chemotherapy, radiotherapy, vaccines, immunotherapy) delivered within the last three months prior to the start of the treatment 5. The subject has been included previously in this study or has been injected with another investigational medicinal product within the past six months 6. History of myocardial infarction (MI), TIA, CVA, pulmonary embolism, uncontrolled congestive heart failure (CHF), significant liver disease, unstable angina within 6 months prior to enrollment 7. Any significant change in their regular prescription or non-prescription medication between 14 days and 1 day prior to IMP administration | 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 Age ≥ 18 years Group 1 patients: Presence of a suspicious metastatic lesion or suspicious for recurrent disease in the head and neck region Group 2 patients Biopsy proven recurrent or metastatic or definitive head and neck cancer or thyroid cancer in the head and neck region only Patients planning to undergo reatment at MSK Patient would require anesthesia for the study Patients who are claustrophobic Patients selecting treatment outside of MSK Known reaction to Gd based contrast agent Patients who have presence of a known contradiction to MRI Pacemaker Aneurysm clips Patients with implants that are contradicted for MR imaging will be excluded Pregnant Age and mental status wherein he /she is unable to cooperate for MRI study | 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): 20.0-80.0, Thyroid Cancer Criteria:diagnosed patients with thyroid papillary, follicular and anaplastic thyroid cancer, post-operation follow up - Unclearly diagnosed patients with thyroid papillary, follicular and anaplastic thyroid cancer | 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): 18.0-70.0, Thyroid Carcinoma Robot Surgery Endoscopic Surgery papillary thyroid carcinoma with clinically suspected or confirmed lateral lymph node metastasis; 2. patient's concerns of neck scars and cosmetic requirement. The were as follows: 1) tumor size >4cm; 2) previous neck surgical history； 3）residual or recurrent tumors; 4) suspicious primary tumor or metastatic lymph node invasion of major vascular structures or recurrent laryngeal nerve. 5）metastatic lymph nodes occurred below the sternoclavicular joint | 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, Thyroid Associated Ophthalmopathy Patients of Grave's disease with the history of more than 1 years 2. Informed consent signed by a patient or legal guardian, or having the ability to comply with study assessments for the full duration of the study Pregnancy (positive test) or lactation 2. Participating in another simultaneous medical investigation or clinical trial within 3 months 3. Having received cellular therapy 4. With a history of psychotropic drugs abuse 5. With a history of mental disorder 6. With a history of malignant tumor 7. Any medical or social condition that in the judgment of the investigator would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed 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, Head and Neck Cancer Cachexia; Cancer Resistance Training planned inpatient or outpatient radiotherapy ≥ 18 years of age diagnosed state of cachexia (weight loss greater than 5 % over the past 6 months) or pre-cachexia (unintentional weight loss of 5 % or less of usual body weight during the last 6 months) metastatic disease severe neurological problems or other contraindications for resistance training | 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 Neck Cancer Recurrent Laryngeal Nerve Injuries Accessory Nerve Injuries EMG: Repetitive Nerve Stimulation Abnormality Thyroid papillary carcinoma Lateral cervical lymph node metastasis The diameter of the metastatic lymph nodes is less than 3cm Without internal jugular vein invasion Lidocaine allergy sufferers | 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, Esophageal Stenosis Deglutition Disorders Head and Neck Neoplasms Esophageal Neoplasms Patients with dysphagia following head and neck cancer treatment Patients without endoscopic or radiological evidence suggestive of tumor recurrence Patients refractory to endoscopic treatment Endoscopic or radiological signs suggestive of tumor recurrence | 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, High Cardiovascular Risk Patients Low Cardiovascular Risk Patients Person who gave oral consent High cardiovascular risk group: Adult patients hospitalized in the Cardiology Department of the University Hospital of Dijon Burgundy for acute coronary syndrome, patients between D1 and D5 of acute coronary syndrome, who can be moved for an ophthalmology consultation where the retinal imaging is done (heart monitoring in the presence of an experienced cardiologist if necessary) Low cardiovascular risk group: Adult patients over 40 years of age recruited in the Ophthalmology Department of the University Hospital of Dijon Burgundy following a standard consultation for cataract surgery, ocular surface pathologies and optical correction Person not affiliated to national health insurance Patient refusal Minor patient Protected patient Ophthalmological history (macular vascular or degenerative disorders) | 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 Cancer Thyroid nodule measuring 11-40 mm on ultrasound (cT1bT2) AND with fine-needle aspiration biopsy (FNAB) cytology in favor of "papillary thyroid carcinoma" (Type 6 according to the Bethesda classification (Appendix 2) OR with FNAB cytology "suspicious for malignancy" (Type 5 according to the Bethesda classification). In this latter case, randomization will be performed if confirmation of papillary carcinoma on intraoperative frozen section analysis 2. cN0: absence of lymph nodes suspicious for malignancy on preoperative ultrasound performed by the center's designated radiologist according to a standardized report 3. Absence of a medical contra indication to performing a total thyroidectomy with or without bilateral prophylactic neck dissection of the central compartment 4. Women of childbearing potential should have a negative pregnancy test (serum or urine) before any radioiodine administration. Sexually active patients must agree to use an effective method of contraception or to abstain from sexual activity during the study and for at least 6 months after last dose of radioiodine. 5. Patient affiliated to a social security regimen or beneficiary of such regimen 6. Patients age ≥ 18 years old, french-speaking 7. Patients should understand, sign and date the written informed consent form prior to any protocol specific procedures. Patients should be able and willing to comply with study visits Tumors > 40 mm (cT3) or ≤ 10 mm 2. Tumors with extrathyroidal extension suspected or obvious on the pre-operative work-up or intra-operatively (cT3T4) 3. Metastatic neck lymph nodes or suspicious neck nodes on preoperative ultrasound (cN1); for suspicious nodes, FNAB cytology and thyroglobulin assay on the needle washout fluid will be performed 4. Metastatic neck lymph nodes found during the thyroidectomy and confirmed with intra-operative frozen section analysis 5. Medullary thyroid carcinoma on FNAB cytology and/or with basal serum calcitonin >50 pg/ml 6. Preoperative or intra-operative suspicion of non-papillary thyroid carcinoma or aggressive histopathological subtype or poorly differentiated carcinoma 7. Distant metastases (M1) apparent pre-operatively (found due to symptoms or fortuitously; no specific pre-operative work-up will be performed, however, in accordance with current clinical practice) 8. Recurrent nerve paralysis visualized on systematic pre-operative laryngoscopy and/or abnormal preoperative serum calcium 9. Pregnant or breast feeding women 10. Participation in another therapeutic clinical trial within one year from study entry 11. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent | 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): 18.0-65.0, Microbiota Age 18 years old, 65 years old, male and female Histologically confirmed differentiated thyroid cancer After total thyroidectomy, patients who have undergone 131I therapy for the second time or more after recurrence or regional lymph node metastasis after 131I treatment for the first time are required. Or after the first 131I treatment, patients with differentiated thyroid who were treated with 131I for more than 3 months Use of various antibiotics within three months Having a history of alcoholism for more than 2 years and a history of smoking throughout the year pregnancy or lactation having oral, respiratory and gastrointestinal diseases has a variety of metabolic diseases, such as obesity, hypertension, diabetes, stones, various liver diseases, etc having other autoimmune diseases such as rheumatoid arthritis, ankylosing spondylitis, inflammatory bowel disease, etc History of gastrointestinal surgery or other recent surgical history Has a family history of genetic disease, mental illness, etc Research subjects are participating in other research topics The researchers believe that other reasons are not suitable for continuing clinical trials | 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): 25.0-65.0, Pediatric Anesthesia Intubation;Difficult are informed consent, no previous experience in FONA none | 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, Control arm_Bolstered Care Treatment arm_HIVRR+S+FL Treatment arm_HIVRR+S+FLM at least 18 years old 2. report having engaged in vaginal or anal intercourse in the past 90 days in exchange for money, alcohol, or other goods 3. report at least one episode of unprotected sexual intercourse in the past 90 days with either a paying, casual, or regular sexual partner have a cognitive or severe psychiatric impairment that would prevent comprehension of study procedures as assessed during Informed Consent process 2. are unwilling or unable to commit to completing the study 3. have previously been randomized | 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, Intoxication Alcohol Must be server/bartender in sampled on-premises alcohol serving establishment Establishment must have at least 3 servers/bartenders on staff | 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, Cancer Survivor Dysphagia Fibrosis Head and Neck Carcinoma Late Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) grade >= 2 dysphagia on Modified Barium Swallow (MBS) >= 2 years after curative-intent radiotherapy for head and neck cancer Grade >= 2 Common Terminology for Adverse Events (CTCAE) fibrosis Willing and able to return for 10 sessions over 6 weeks of therapy Active recurrent or second primary head and neck, central nervous system, or thoracic cancer at time of enrollment Active osteoradionecrosis or other non-healing wounds (e.g., fistula, ulcer, soft tissue necrosis) in manual therapy (MT) regions of interest at time of enrollment History of subtotal or total glossectomy or total laryngectomy Functionally limiting cardiac, pulmonary, or neuromuscular disease Current tracheostomy | 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, HPV Related Oropharyngeal Squamous Cell Carcinoma Histologically or cytologically confirmed HPV-related stages I-III OPSCC (8th edition of AJCC/UICC Staging Manual) or HPV-related neck node with unknown primary. HPV-related may be defined by p16 IHC stain and/or HPV-ISH or PCR using standard definitions of positive and negative test results Primary tumor that will be resected via a transoral oral approach (conventional surgery, transoral laser microsurgery, transoral robotic surgery) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2 Normal organ and marrow function defined as Creatinine clearance > 50 cc/min ANC > 1,000/mcL Platelet count >100,000/mcL At least 18 years of age Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately Patient (or legally authorized representative) must be able to understand and willing to sign a written informed consent document Prior curative therapy for HNSCC Patient must not have known distant metastatic disease at presentation History of prior invasive malignancy diagnosed within 2 years prior to study enrollment; exceptions are malignancies with a low risk of metastasis or death (e.g., expected 5-year overall survival (OS) > 90%) that were treated with an expected curative outcome, such as squamous cell carcinoma of the skin, in-situ carcinoma of the cervix uteri, non-melanomatous skin cancer, carcinoma in situ of the breast, or incidental histological finding of prostate cancer (TNM stage of T1a or T1b) Receiving any other investigational agents Uncontrolled serious inter-current illness or serious psychiatric illness/social situations that would limit compliance with study requirements Pregnant and/or breastfeeding. A negative serum or urine pregnancy test is required at screening for all female patients of childbearing potential | 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, Papillary Thyroid Cancer clinical doagnosis of papillary thyroid cancer living in the Marne or Ardennes departments of France cancer stage not determined | 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 Carcinoma Metastatic Thyroid Carcinoma Adults with thyroid carcinoma confirmed by pathology Adult thyroid carcinoma patients who have undergone total thyroidectomy Adult thyroid carcinoma patients have metastatic disease or suspicion for metastatic disease, or are under a protocol intended to explore re-induction therapy for 131I uptake, and are about to undergo Thyrogen-assisted dosimetry, unless Thyrogen-assisted dosimetry is not required per standard of care The patient and physician are planning to administer 131I for therapy if persistent radioiodine-avid metastases are present All subjects must have measurable disease, documented within the previous six months by ultrasonography (US), MRI, FDG PET/CT, or CT scanning Age less than 18 years Patients who are pregnant | 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, Porocarcinoma Sentinel Lymph Node patients affected to moderate and high risk porocarcinoma, in according to hystophatological findings, submitted to SNLB. 1. Thickness greater than or equal to 5mm 2. mitoses per 10 high-power field greater than or equal to 7 3. Immunohistochemical (IHC) analysis positive for :carcinoembryonic antigen (CEA), cytokeratin (CK) 5,7 and epithelial membrane antigen (EMA). 4. Informed consent obtained for the SNLB 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): 18.0-70.0, Thyroid Cancer Stage IV Radiation Toxicity A) All patients of differentiated thyroid cancer (papillary/follicular/poorly differentiated/) who have undergone total/completion thyroidectomy at our institute and having at least two of the following features (listed below) intra-operatively and/or on histopathology 1. Gross extrathyroidal spread into soft tissues of the neck, trachea, esophagus, recurrent laryngeal nerve (constituting stage T4a) 2. R1/ shave resections (minimal residual disease) 3. R2 resections (gross residual disease) 4. Multiple lymph nodes positive(>2) with perinodal extension at level VI B) Normal baseline haematological and biochemical parameters Anaplastic or medullary thyroid cancer 2. Previous history of radiation 3. Pregnancy 4. < 18 years Patient unwilling to participate in the study | 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, Pancreatic Cancer Age> 18 years Tumor of the body or tail of the pancreas compatible with pancreatic ductal adenocarcinoma before surgery Intraductal papillary mucinous neoplasms (IPMN) with invasive carcinoma Resectable tumor Absence of medical contraindication Borderline* resectable tumors with preoperative treatment could be enlisted in the protocol Patients with legal protection Pregnancy Preoperative distant metastasis and unresectable tumor (ie tumor interface with the celiac axis and superior mesenteric artery > 180°, aortic involvement or unreconstructible superior mesenteric venous resection due to tumor involvement or occlusion) | 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): 18.0-64.0, Acromegaly Muscle Dysfunction Physical Activity Exercise Patients with acromegaly, of both sexes, older than 18 and younger than 65 years, either with active or controlled disease Patients who present clinical stability and who are eligible for the treatment protocol (patients with hormone deficiency will continue on replacement therapy - SILVA et al., 2013) Signature of the Informed Consent Term (TCLE) Patients with inability to perform the 6MWT, according to ATS criteria Patients who have cognitive impairment by mini mental state examination (MEEN) Abandonment of treatment during the application of the protocol Uncontrolled hypertension (> 180/100 mmHg with medication use) Use of psychotropic drugs Any significant limitations due to osteoarthropathy History of surgery in the previous year with exercise restriction. Não Untreated hypothyroidism or hypocortisolism (HUBBLE et al., 2014) IPAQ with very active classification | 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, Renal Cell Carcinoma Any subjects from the participating sites (dead or alive) who have received at least one dose of cabozantinib within the ATU program or between 10/12/2016 and 16/02/2018 and for whom the medical file is available Patients alive at study initiation who have not received information notice who have opposed to data collection | 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): 18.0-60.0, Loop Bipartition Patients whose body mass index (BMI) exceeds 40. 2. Patients with BMIs between 35 and 40 with high-risk co-morbid conditions or lifestyle-limiting obesity-induced physical conditions. 3. Age between 18 and 60 years old. 4. Both sexes Patients younger than 18 and older than 60 years old. 2. BMI < 35. 3. Obesity due to medical diseases as hypothyroidism, cushing's , ……etc. 4. Surgically-unfit patients as those with contraindications to general anesthesia or uncorrectable coagulopathy. 5. Patients with limited life expectancy due to irreversible cardiopulmonary or other end-organ failure or metastatic or in-operable malignancy. 6. Patients who are pregnant or who expect to be pregnant within 12 months | 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 Carcinoma Documentation of a head and neck cancer diagnosis as evidenced by tissue biopsy Patients diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Patients with recurrent disease or a new primary will be allowed Planned standard of care surgery with curative intent for squamous cell carcinoma Have life expectancy of more than 12 weeks Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)/Zubrod level 1 Hemoglobin >= 9 gm/dL White blood cell count > 3000/mm^3 Platelet count >= 100,000/mm^3 Serum creatinine =< 1.5 mg/dL Liver enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT], and total bilirubin) =< 1.5 times the upper reference range Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study Allergy to iodine or iodinated materials Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment | 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, Stiff-Person Syndrome Patient must be 18 years of age or older Must have symptoms of SPS for less than 3 years If taking corticosteroids, the patients must be on a stabile dose for 30 days prior to enrolment Patients will have a diagnosis of SPS spectrum disorder based on both of clinical and serological status Patients on immune suppressants initiated/dose increased in the prior 6 months History of thrombotic episodes within the 2 years prior to enrollment Known allergic or other severe reactions to blood products including intolerability to previous IVIG Previous adequate trial of IVIG as determined by the Principal Investigator IgA deficiency Reproductive status Women who are pregnant, breastfeeding Women and men of childbearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period, as evaluated by the investigator Any surgical procedure within 4 weeks prior to baseline Evidence of serious uncontrolled concomitant diseases that may preclude patient participation; Other nervous system disease, cardiovascular disease, hematologic/hematopoiesis disease, respiratory disease, muscular disease, endocrine disease, renal/urologic disease, digestive system disease, congenital or acquired severe immunodeficiency | 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, Pulmonary Nodule, Solitary Pulmonary Nodule, Multiple Lung Cancer Male or Female, aged 18 years or above CT scans identified as having pulmonary nodule(s) of 5-15mm Patients with solid or predominantly solid nodules referred to the pulmonary nodule clinic or for CT scan review by a specialist CT scan section thickness of 3mm and less The CT scans are technically inadequate Having received treatment for cancer in the last 5 years Patient has more than five reported qualifying nodules | 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, Dysphagia Aspiration Pneumonia Deglutition Disorders Intensive Care Neurological Disorder Treatment on neurological ICU Clinical suspicion of Dysphagia none | 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, Locoregionally-advanced Oropharyngeal Squamous Cell Carcinoma Signed written and voluntary informed consent. 2. Patient must be willing and able to provide collection for saliva, OP swab and stool specimen analyses at 2 time points. Rectal swab is optional. 3. Age > 18 years, male or female. 4. Patient must be diagnosed with histologically confirmed squamous cell carcinoma of the oropharynx (soft palate, tonsils, base of tongue). 5. Patients must be eligible for curative-intent concurrent treatment with radiotherapy and chemotherapy Any condition that, in the opinion of the Investigator, would interfere with patient safety, or evaluation of the collected specimen and interpretation of study result | 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, Chronic Kidney Disease Stage V The investigators will enroll non-diabetic hypertensive and hyperlipidemic patients undergoing chronic HD Hypertension will be defined as having a systolic blood pressure of >130 mmHg and a diastolic blood pressure >80 mmHg or having any antihypertensive agents Hyperlipidemia will be defined as having LDL cholesterol values more than 100 mg/dl or receiving statins at any dose Eligible patients may be of any age Diabetes mellitus type 1 or 2 Severe heart failure (NYHA class IV) Patients with low compliance or severe psychiatric illnesses Smoking, intake of antioxidant supplements (eg, carotenoids, vitamin C, vitamin E and glutathione), aspirin, or any other drug with established antioxidant properties, hyperlipidemia, obesity (body mass index >30 kg/m2), diabetes, celiac or other intestinal disease, life-threatening Survival expectancy <6 months based on managing physicians assessment Inability to participate in the trial based on managing physicians assessment | 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, Papillary Thyroid Microcarcinoma Newly diagnosis of PTMC (largest dimension<10mm) Age >=18 years old Bethesda Category V or VI Single nodule without thyroid capsule contact Nodule has more than 3mm distance far from recurrent laryngeal nerve, carotid artery and trachea No clinical evidences show there is local or distant metastasis Without chemotherapy, radiotherapy and other related therapies Patients and their family member totally understand and sign the informed consent Multifocal PTMC Combined with other types of thyroid cancer or hyperthyroidism Contralateral vocal cord paralysis With local or distant metastasis Pregnant woman With radiation exposure history | 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, Lymph Node Metastases Phase I and II: 1. aged 18 to 80 years old; 2. the primary treatment of patients with unilateral or bilateral PTC; 3. ultrasound showed that the tumor was localized in the thyroid gland, and the maximum diameter of each lesion was less than 4cm; 4. ultrasonography of cervical VI lymph nodes: the shortest diameter < 4 mm, no calcification, no cystic change, no local or global echo enhancement; 5. CT scan of cervical VI lymph nodes: the shortest diameter < 4 mm, no calcification, no cystic change, no enhancement (CT value 40HU or not higher than banded muscle level), no cluster distribution; 6. patients will voluntarily enter the study after informed consent; Phase III: 1. aged from 18 to 80 years old; 2. ultrasound showed that the tumor was localized in the thyroid gland, and the maximum diameter of each lesion was less than 4cm; 3. Unilateral or bilateral PTC without lymph node metastasis assessed by "cNo-pN+ PTC prediction model"; 4. patients will voluntarily enter the study after informed consent (1) patients refused to participate in the study; (2) non first operation patients; (3) Lateral cervical lymph nodes or distant metastasis; (4) Hashimoto's disease; (5) history of neck trauma | 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, Lymph Node Metastases Phase I: 1. aged from 18 years old to 80 years old; 2. the primary treatment of patients with right or bilateral PTC; 3. patients will voluntarily enter the study after informed consent. Phase II: 1. aged from 18 years old to 80 years old; 2. the primary treatment of patients with right or bilateral PTC predicted to have no LN-prRLN metastasis by the "prediction model of LN-prRLN"; 3. patients will voluntarily enter the study after informed consent patients refused to participate in the study; 2. non first operation patients; 3. other malignant tumor history; 4. distant metastasis; 5. history of neck trauma | 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, Hyperphosphatemia Signed and dated informed consent prior to any study specific procedures Males or females aged 18 to 80 years, inclusive, at Screening Females must be non-pregnant, non-lactating and either be post-menopausal for at least -2 months, have documentation of irreversible surgical sterilization, use of acceptable -contraceptive method, or sexual abstinence, or a sterile sexual partner from Screening -until 30 days after the last subject visit Males must agree to avoid fathering a child (or donating sperm), and therefore be either sterile (documented) or agree to use approved methods of contraception, from the time of enrollment until 30 days after end of study Chronic maintenance hemodialysis (HD) 3x/week for at least 3 months or chronic maintenance peritoneal dialysis (PD) for a minimum of 6 months If receiving active vitamin D or calcimimetics, the dose should have been unchanged for the last 4 weeks prior to Screening Kt/V ≥1.2 at most recent measurement prior to Screening Prescribed and taking phosphate binder medication at least 3 times per day, and the prescribed dose should have been unchanged during the last 4 weeks prior to Screening Serum phosphorus levels must be ≥5.5 and ≤10.0 mg/dL at Screening and the end of the run-in period, analyzed at the central laboratory used in the study Severe hyperphosphatemia defined as having an s-P level >10.0 mg/dL on phosphate-binders at any time point during routine clinical monitoring for the 3 preceding months before Screening Serum/plasma parathyroid hormone >1200 pg/mL Clinical signs of hypovolemia at Screening as judged by the Investigator History of inflammatory bowel disease (IBD) or irritable bowel syndrome with diarrhea (IBS-D) Scheduled for living donor kidney transplant or plans to relocate to another center during the study period Use of an investigational agent within 30 days prior to Screening Involvement in the planning and/or conduct of the study (applies to both Ardelyx/Contract Research Organization (CRO) staff and/or staff at the study site) If, in the opinion of the Investigator, the subject is unable or unwilling to fulfill the requirements of the protocol or has a condition which would render the results uninterpretable | 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): 18.0-65.0, Positron-Emission Tomography Lymph Node Metastases Thyroid Cancer • Accurately diagnosing primary papillary thyroid cancer according to pathological diagnostic Thyroid papillary carcinoma was suspected by thyroid ultrasound text and/or neck CT The age is more than 18 years old and less than 65 years old. There is no gender restriction Untreated patients who have not received surgery, interventional therapy,chemotherapy, biotherapy, and radiation therapy Physical condition score of Eastern Cooperative Oncology Group（ECOG）: 0-2; no major organ dysfunction; oxygen partial pressure ≥ 10.64 kilopascal（kPa）; white blood cell count≥ 4 × 109/L; hemoglobin≥ 9.5g/dL; neutrophil absolute count ≥ 1.5 × 109 / L; platelet count ≥ 100× 109 / L; total bilirubin ≤ 1.5 times of the upper limit of normal value;creatinine ≤ 1.25 times of the upper limit of normal value; and creatinine clearance ≥ 60ml / min Be able to obtain complete follow-up information, understand the situation of this study and sign informed consent • Poorly controlled diabetics (fasting blood glucose levels > 200 mg/dL).• In addition to four types of malignant tumors that can be treated with radical resection, such as cervical cancer in situ, basal or squamous cell skin cancer, (breast) ductal carcinoma in situ, and organ localized prostate cancer, suffering from any other malignant tumors within 5 years.• Breastfeeding and/or pregnant women Patients with severe bleeding tendencies (prothrombin time less than 50%,cannot be corrected by treatment with vitamin K, etc.) Recent severe hemoptysis, severe cough, dyspnea or patients are not able to cooperate People with severe emphysema, pulmonary congestion, and pulmonary heart disease Researchers believe that the subject may not be able to complete this study or may not be able to comply with the requirements of this study (for management reasons or other reasons) | 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 Cancer Patients with established thyroid cancer diagnosis based on the pathology report reviewed at the National Institutes of Health, who underwent total thyroidectomy +/ neck lymph node dissection as clinically indicated are presenting with known per structural imaging (US neck, CT or MRI neck/chest/abdomen/pelvis) persistent/recurrent disease either locally advanced or presenting with distant metastases; or are presenting with suspected persistent/recurrent locoregional or distant metastases based on the high risk features such as advanced tumor per pathology report (tumor size >4 cm, exrathyroidal extension, higher risk pathology such as tall cell, columnar cell, poorly differentiated variant, follicular thyroid cancer with gross vascular invasion, positive margins after the surgery, bulky lymphadenopathy in the central and/or lateral neck), detectable/increasing baseline/suppressed thyroglobulin (Tg) level or detectable/increasing anti-Tg antibody titers if anti-Tg antibodies are present are either RAI-naive or requiring repeated RAI therapy for locally advanced disease or distant metastases Underwent imaging with MRI of the brain and spine with gadolinium contrast to screen for the brain/spine metastases Age greater than or equal to 18 years of age hour urine iodine excretion of less than or equal to 150 micro grams/24 hour -Patients with non-RAI avid disease documented by negative post-therapy whole body scans performed after previous RAI treatments Serious underlying medical conditions that restrict diagnostic testing or therapy such as renal failure, congestive cardiac failure or active coexisting non-thyroid carcinoma, severe depression which might be exacerbated by thyroid hormone withdrawal Patients with spinal or brain metastases as they are at risk of TSH-stimulation induced swelling of metastatic lesions leading to potentially detrimental side effects. These patients will be evaluated per the standard of care protocol 77-DK-0096 Pregnant or lactating women Adults who are incapable of providing informed 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): 18.0-65.0, Lymph Node Dissection Lymph Node Metastases Differentiated Thyroid Carcinoma Accurately diagnosing primary differentiated thyroid carcinoma according to pathological diagnostic Differentiated thyroid carcinoma with cN0(Clinically N0) was diagnosed by thyroid ultrasound text and/or neck CT,and was confirmed with differentiated thyroid carcinoma by postoperative pathological examination The age is more than 18 years old and less than 65 years old. There is no gender restriction Untreated patients who have not received surgery, interventional therapy,chemotherapy, biotherapy, and radiation therapy Physical condition score of Eastern Cooperative Oncology Group（ECOG）: 0-2; no major organ dysfunction; oxygen partial pressure ≥ 10.64 kilopascal（kPa）; white blood cell count≥ 4 × 109/ L; hemoglobin≥ 9.5g/dL; neutrophil absolute count ≥ 1.5 × 109 / L; platelet count ≥ 100× 109 / L; total bilirubin ≤ 1.5 times of the upper limit of normal value;creatinine ≤ 1.25 times of the upper limit of normal value; and creatinine clearance ≥ 60ml / min Be able to obtain complete follow-up information, understand the situation of this study and sign informed consent • ①Bilateral DTC(differentiated thyroid cancer) patients ②Non-DTC(differentiated thyroid cancer)patients ③ Non-cn0(Clinically N0) patients ④ cN0(Clinically N0) patients but could not be operated on Poorly controlled diabetics (fasting blood glucose levels > 200 mg/dL). In addition to four types of malignant tumors that can be treated with radical resection, such as cervical cancer in situ, basal or squamous cell skin cancer, (breast) ductal carcinoma in situ, and organ localized prostate cancer, suffering from any other malignant tumors within 5 years.• Breastfeeding and/or pregnant women Patients with severe bleeding tendencies (prothrombin time less than 50%,cannot be corrected by treatment with vitamin K, etc.) Recent severe hemoptysis, severe cough, dyspnea or patients are not able to cooperate People with severe emphysema, pulmonary congestion, and pulmonary heart disease Researchers believe that the subject may not be able to complete this study or may not be able to comply with the requirements of this study (for management reasons or other reasons) | 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 Squamous Cell Carcinoma Head and Neck Cancer Head and Neck Cancer Metastatic Cohort 1: Subjects must have histologically confirmed previously untreated squamous cell carcinoma of the head and neck which is amenable to surgical resection as part of standard of care. Cohort 2: Subjects must have histologically confirmed recurrent squamous cell carcinoma of head and neck, which is amenable for salvage surgery. Sites of recurrence may either be locoregional or distant if resection can be done ideally in one surgical field The primary site should be a head and neck squamous cell carcinoma (including, but not limited to oral cavity, oropharynx, hypopharynx, or larynx, paranasal sinuses, nasal cavity). Squamous cell carcinoma of unknown primary, diagnosed in lymph nodes in neck, can be included but should be tested for p16 and confirmed specific assay Subjects with oropharyngeal primary tumors must have confirmation of HPV tumor status per clinical standards, although not necessary at enrollment Subjects must have been determined to be candidates for surgical resection by a multidisciplinary team including a surgeon, a medical oncologist and a radiation oncologist Subjects must have at least one lesion that can be biopsied at baseline Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 Age >18 years Life expectancy of greater than 6 months Patients must have normal organ and marrow function as defined below leukocytes ≥ 1,500/mcL Any active history of a known autoimmune disease. Subjects with vitiligo, type 1 diabetes mellitus, residual hypothyroidism requiring hormone replacement, or conditions not expected to recur in the absence of an external trigger are permitted to enroll Patients who have had prior chemotherapy for newly diagnosed (cohort 1) or recurrent (cohort 2) head and neck cancer. In cohort 2 only, previous perioperative chemotherapy or chemoradiation for the management of localized or locally advanced disease permitted Patients who had prior surgical resection of distant metastasis (metastatectomy) within 3 months of enrollment Patients who received prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti CD137, anti-CTLA-4 antibody therapies, any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. Any live / attenuated vaccine (eg varicella, zoster, yellow fever, rotavirus, oral polio and measles, mumps, rubella (MMR)) during treatment and until 100 days post last dose Patients with uncontrolled brain metastases Patients with brain metastases must have stable neurologic status following local therapy (surgery or radiation) for at least 2 weeks without the use of steroids or on stable or decreasing dose of < 10mg daily prednisone (or equivalent), and must be without neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Patients with a history of carcinomatous meningitis are not eligible Patients who have an active concurrent malignancy that is not controlled/cured and could impact life expectancy within the next 3 years. E.g. patients with localized cutaneous squamous cell carcinoma or basal cell carcinoma or treated prostate cancer with no evidence of disease progression may be allowed to enroll after review by the study team Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, administration of live vaccination in the prior 3 months, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, myocardial infarction or new onset angina within six months of enrollment, or psychiatric illness/social situations that would limit compliance with study requirements Women who are pregnant or nursing Men with female partners who are not willing to use contraception | 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): 18.0-75.0, Thyroid Nodule all patient presented by thyroid nodules either discovered clinically or incidentally | 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): 65.0-999.0, Cancer Solid mass or nodule suspicious for cancer Aged 65 or older Being considered for surgical resection of the solid mass or nodule, with anticipated hospital length of stay of at least two days Completed the eRFA per routine care Unable to read or comprehend English Not having a completed electronic Rapid Fitness Assessment within 2 months of surgery**Note) To avoid excluding patients based this item, patients have to complete another eRFA within two months of surgery Being discharged in one day or earlier from the hospital | 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, Papillary Thyroid Cancer Lymph Node Metastases Preoperative diagnosis of thyroid carcinoma | 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 Decision 1: total thyroidectomy vs. hemithyroidectomy patients with nodules >1 cm and <4 cm, with cytology result suspicious or malignant (Bethesda 5 or 6) with no clinical or radiological evidence of pathological lymph nodes and/or distant metastases before the primary (diagnostic) surgery patients with histologically (after diagnostic hemithyroidectomy) proven TC but are defined as low-risk according to the ATA classification patients with multifocal TC patients with incomplete resection of the primary tumor patients with ATA defined intermediate risk or high risk Decision 2: no treatment with RAI vs. treatment with RAI: • patients with ATA defined low-risk and patients with multifocal papillary TC in the absence of other adverse features • patients with ATA defined intermediate and high risk Decision 3: active surveillance vs. systemic treatment • patients with asymptomatic or mildly symptomatic RAI-refractory (slowly) progressive metastatic disease • patients with coexisting conditions that do not allow prescription of TKI's Other lack of Dutch language proficiency mental incompetence hampering the process of shared decision making as judged by the physician | 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): 1.0-31.0, B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Down Syndrome All B-ALL patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to treatment and enrollment on AALL1731. APEC 14B1 is not a requirement for B-LLy patients. B-LLy patients may directly enroll on AALL1731 Age at diagnosis Patients must be >= 365 days and < 10 years of age (B-ALL patients without DS) Patients must be >= 365 days and =< 31 years of age (B-ALL patients with DS) Patients must be >= 365 days and =< 31 years of age (B-LLy patients with or without DS) B-ALL patients without DS must have an initial white blood cell count < 50,000/uL (performed within 7 days prior to enrollment) B-ALL patients with DS are eligible regardless of the presenting white blood cell count (WBC) (performed within 7 days prior to enrollment) Patient has newly diagnosed B-cell ALL, with or without Down syndrome: > 25% blasts on a bone marrow (BM) aspirate OR if a BM aspirate is not obtained or is not diagnostic of B-ALL, the diagnosis can be established by a pathologic diagnosis of B-ALL on a BM biopsy OR a complete blood count (CBC) documenting the presence of at least 1,000/uL circulating leukemic cells Patient must not have secondary ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy. Note: patients with Down syndrome with a prior history of transient myeloproliferative disease (TMD) are not considered to have had a prior malignancy. They would therefore be eligible whether or not the TMD was treated with cytarabine With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B ALL or B LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL1731 For patients receiving steroid pretreatment, the following additional apply Non-DS B-ALL patients must not have received steroids for more than 24 hours in the 2 weeks prior to diagnosis without a CBC obtained within 3 days prior to initiation of the steroids DS and non-DS B-LLy patients must not have received > 48 hours of oral or IV steroids within 4 weeks of diagnosis Patients who have received > 72 hours of hydroxyurea B-ALL patients who do not have sufficient diagnostic bone marrow submitted for APEC14B1 diagnostic testing and who do not have a peripheral blood sample submitted containing > 1,000/uL circulating leukemia cells Patient must not have acute undifferentiated leukemia (AUL) Non-DS B-ALL patients with central nervous system [CNS]3 leukemia (CNS status must be known prior to enrollment) Note: DS patients with CNS3 disease are eligible but will be assigned to the DS-High B-ALL arm. CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment | 0 |
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, Stage IV Non-small Cell Lung Cancer Have voluntarily agreed to participate by giving written informed consent/assent for the trial Have a histologically or cytologically confirmed diagnosis of stage IV NSCLC on first-line (1L) systemic treatment Have received at least their first dose of the selected systemic treatment and a maximum of 1 cycle of the same treatment. Patients that were selected to receive best supportive care will not have to comply to this criterion Be ≥ 18 years of age on day of signing informed consent Has received prior systemic treatment for their metastatic NSCLC before the first dose of trial treatment. However, subjects who received adjuvant or neoadjuvant therapy during an earlier stage of their disease, but evolved to stage IV, are eligible TKI selected as first-line systemic treatment Is participating in an interventional trial or medical need program | 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, BRAF NP_004324.2:p.V600E BRAF V600K Mutation Present Thyroid Gland Anaplastic Carcinoma Pathologic (histologic or cytologic) diagnosis of anaplastic thyroid cancer (a diagnosis that is noted to be ?consistent with anaplastic thyroid cancer? with the presence of a thyroid mass is acceptable; pathology showing additional types of thyroid cancer is allowed) Note: Tissue collection for central review is mandatory, but central review is not required for eligibility. Due to the aggressiveness of this disease, treatment will be started prior to central review Presence of BRAF mutation (V600E or V600K) in tumor tissue Eastern Cooperative Oncology Group (ECOG) performance status < 2 Absolute neutrophil count > 1,000/mcL Hemoglobin >= 9.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 9.0 g/dl is acceptable) Platelets > 75,000/mcL Total bilirubin < 1.5 x institutional upper limit of normal (unless due to Gilbert?s disease) Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 x institutional upper limit of normal Serum creatinine < 1.5 x institutional upper limit of normal Patients with resectable stage IVA anaplastic thyroid cancer who are candidates for surgery and wish to proceed with surgery Patients who have had external beam radiotherapy to neck or chest for cancer that would result in overlap of radiation therapy fields Patients who have had cytotoxic chemotherapy, stereotactic brain radiation or external beam radiation within 2 weeks prior to study treatment initiation Patients who have had oral multikinase inhibitors within 1 week prior to study treatment initiation Patients that have not recovered from adverse events related to prior therapy for cancer to Common Terminology for Adverse Events (CTCAE) 4.03 grade 2 or less except for alopecia Patients previously treated with potent BRAF inhibitor or MEK inhibitor. Previous treatment with sorafenib is permitted Patients that are receiving any other investigational agent Patients that are currently taking any prohibitive medication Patients with a history of other active malignancy requiring cancer treatment Patients with uncontrolled brain metastases. Patients who are on a stable dose of corticosteroids for more than 1 week or off corticosteroids for 2 weeks prior to study enrollment can be enrolled. Enzyme-inducing anti-epileptic drugs are not 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, Ventricular Tachycardia Ventricular Ectopic Beat(S) Subjects who are at least 18 years or older 2. Subjects who are scheduled for PVC/VT ablation procedure 3. Subjects who have signed an IRB/EC approved Informed Consent Form and applicable subject privacy protection authorization per local law 4. Subjects will be selected without regard to gender or age (unless precluded by local regulatory requirements) 5. Subjects with or without cardiac structural disease Reversible causes of PVC/VT 2. Subjects with recent (within 3 months) acute coronary syndrome 3. Subjects who are contraindicated for CT or MRI (must be able to get one) 4. Subject whose MRI or CT scan does not comply with the requirements of this protocol 5. Subjects who are contraindicated for an electrophysiology procedure and/or fluoroscopy INR > 3.5 Active infection Pregnancy: Females of childbearing potential with a positive pregnancy test. 6. Existing mechanical heart valve 7. Subjects with structural cardiac 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, Patients With a Thyroid Tumor Who Received Radioactive Iodine Treatment patients with a thyroid tumor (metastatic or not) patients who received radioactive Iodine treatment age >= 18 Objection to collect medical data records | 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 Diseases Thyroid Cancer Patients undergoing routine diagnostic thyroid biopsy at surgery Patients are unable to provide informed consent Patients not attending for standard diagnostic biopsy for thyroid 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, Patient Satisfaction Surgery Individuals having any of the following surgical procedure at the Jewish General Hospital over the next 12 months: head and neck cancer resection with or without reconstruction, excision of parotid lesion, thyroidectomy, parathyroidectomy, laryngectomy, or trans-oral robotic resection Individuals who are undergoing a surgical procedure not included in the ones listed above, or those who are having revision surgery or have previously had surgery in the otolaryngology, head and neck surgery department | 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, BRAF NP_004324.2:p.V600M BRAF V600E Mutation Present Metastatic Thyroid Gland Carcinoma Refractory Thyroid Gland Carcinoma Stage IV Differentiated Thyroid Gland Carcinoma AJCC v8 Stage IVA Differentiated Thyroid Gland Carcinoma AJCC v8 Stage IVB Differentiated Thyroid Gland Carcinoma AJCC v8 Ability to understand and the willingness to sign a written informed consent document Histologically (or cytologically) confirmed diagnosis of metastatic, radioiodine (RAI) refractory, BRAFV600E/M mutant differentiated thyroid cancer (DTC) Note: RAI refractoriness is defined as The absence of uptake of RAI on either a low-dose diagnostic whole body scan, or a post-treatment RAI scan in measurable lesions Radiographic progression of disease within 12 months of the last course of RAI treatment, or Having a cumulative lifetime administered dose of > 600 mCi of RAI Measurable disease meeting the following and confirmed by radiography review At least 1 lesion of >= 1.0 cm in the longest diameter for a non-lymph node or > 1.5 cm in the short-axis diameter for a lymph node metastasis that is serially measurable according to Response Evaluation in Solid Tumors (RECIST) 1.1 using computed tomography/magnetic resonance imaging (CT/MRI). If there is only 1 target lesion and it is a non-lymph node, it should have a longest diameter of >= 1.5 cm Lesions that have had external beam radiotherapy or locoregional therapies such as radiofrequency (RF) ablation must show evidence of progressive disease based on 1.1 to be deemed a target lesion Eastern Cooperative Oncology Group (ECOG) performance status =< 1 Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational agent/device within 4 weeks of first dose of study intervention Note: Individuals in the follow-up phase of a prior investigational study may participate as long as it has been 4 weeks since last dose of the previous investigational agent of device Participants with active, known, or suspected autoimmune disease. Participants with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll Prior treatment with selective/potent BRAF/MEK inhibitors including vemurafenib, dabrafenib, encorafenib, selumetinib, trametinib, cobimetinib, binimetinib Note: Prior therapy with oral multikinase inhibitors (e.g., lenvatinib, sorafenib, cabozantinib, pazopanib, sunitinib, etc.) remain eligible for study participation Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T cell co-stimulation or immune checkpoint pathways) Participants with a condition requiring systemic treatment with either corticosteroids (>= 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids are permitted in the absence of active autoimmune disease History of allergy or hypersensitivity to any monoclonal antibody History or current evidence of retinal vein occlusion (RVO) or current risk factors to RVO (e.g. uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes); history of retinal degenerative disease Previous or concurrent malignancy within 3 years of study entry, with the following exceptions | 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, Advanced Renal Cell Carcinoma Chromophobe Renal Cell Carcinoma Clear Cell Renal Cell Carcinoma Collecting Duct Carcinoma Kidney Medullary Carcinoma Metastatic Malignant Neoplasm in the Bone Papillary Renal Cell Carcinoma Stage IV Renal Cell Cancer AJCC v8 Unclassified Renal Cell Carcinoma Documented histologic or cytologic diagnosis of renal cell cancer (RCC). All subtypes of RCC are eligible including but not limited to clear cell, papillary, chromophobe, translocation, collecting duct carcinoma, medullary carcinoma, and unclassified categories. Enrollment of non-clear cell patients will be limited to 20% of the total sample size (~ 42 patients). Once this goal is met, accrual of non-clear cell patients will be discontinued (a notice will be sent out 2 weeks in advance). Sarcomatoid and rhabdoid differentiation are allowed Presence of at least 2 metastatic bone lesions not treated with prior radiation is required The presence of bone metastases can be detected by computed tomography (CT), magnetic resonance imaging (MRI), Tc-99m bone scan or positron emission tomography (PET) (fludeoxyglucose F-18 [FDG] or sodium fluoride [NaF]) imaging. Patients with non-measurable bone-only disease are allowed. Patients may have received prior radiation therapy for bone metastases or other external radiation >= 14 days prior to registration, as long as they still have at least 2 metastatic bone lesions that were not treated with radiation. Patients with visceral metastases are allowed, as long as they have at least two untreated bone metastases No more than 2 prior lines of systemic therapy including but not limited to anti-angiogenic therapy, checkpoint inhibitors, mammalian target of rapamycin (mTOR) inhibitors, clinical trial compounds or cytokine-based therapy. Prior radiation therapy does not count as a prior systemic therapy No prior treatment with cabozantinb No treatment with any type of small molecular kinase inhibitor (including investigational kinase inhibitors) within 2 weeks or 5 half-lives (whichever is shorter) of registration or receipt of any anti-cancer therapy (including investigational therapy, monoclonal antibodies, cytokine therapy) within 3 weeks of registration No prior hemibody external radiotherapy No prior therapy with radium-223 dichloride or systemic radiotherapy (such as samarium, strontium) No major surgery within 6 weeks of randomization. Procedures such as thoracentesis, paracentesis, percutaneous biopsy, Moh's or other topical skin surgery, Lasik eye surgery are not considered major surgery. Patients who have had a nephrectomy may be registered >= 3 weeks after surgery, providing there are no wound-healing complications. Subjects with clinically relevant ongoing complications from prior surgery are not eligible Recovery to baseline or =< grade 1 CTCAE version 5.0 from toxicity related to any prior treatment, unless adverse events are clinically nonsignificant and/or stable on supportive 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): 16.0-999.0, Papillary Thyroid Cancer patients with papillary thyroid cancer with clinically node negative patients with clinical evidence of nodal metastases patients with a previous history of thyroidectomy patients with mixed-type papillary thyroid cancer | 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, Pulmonary Nodule, Solitary Pulmonary Nodule, Multiple Patients with known lung lesion(s) Patients having undergone a chest CT Patients 18 years of age and older Patients able to provide informed consent Patients who may not fit on a 35 x 35 detector (BMI > 35) Planned procedures or therapies during study (in between SOC scans and study scan on s-DCT) (biopsy or removal of lung lesion) Any woman who is pregnant, has reason to believe she is pregnant, or is lactating | 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): 18.0-99.0, Peripheral T Cell Lymphoma for the Study 1. Written informed consent and HIPAA authorization for release of personal health information explained to, understood by and signed by the subject or legally authorized representative. 2. Age ≥ 18 years at the time of consent. 3. Karnofsky score of >60% 4. Histological or cytological evidence/confirmation of CD30+ peripheral T-cell lymphoma per the 2017 World Health Organization Classification of Haematopoietic and Lymphoid Tissues. 5. CD30+ disease determined by biopsy after the subject's most recent anti-CD30 therapy prior to (result can be pending at the time of cell procurement, but must be confirmed prior to treatment with the first infusion of cells). NOTE: CD30+ disease requires documented CD30 expression by immunohistochemistry based on the institutional hematopathology standard. 6. Subjects must have received at least two prior lines of therapy for their lymphoma. If transplant is given as a preplanned consolidation in first remission, it will not be counted as a second line of therapy. 7. Subjects relapsed after autologous stem cell transplant are eligible for this study. 8. Subjects relapsed after allogeneic stem cell transplantation are eligible provided the patient is >180 days from transplant, not on immunosuppresive therapy to treat/prevent graft-versus-host disease, and has no evidence of active graft-versus-host disease. 9. Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to cell procurement. Note: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months. Documentation of postmenopausal status must be provided. 10. Female subjects of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 6 months after study treatment discontinuation. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method or an intrauterine device that meets <1% failure rate for protection from pregnancy in the product label. Women of childbearing potential will also be instructed to tell their male partners to use a condom. 11. Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee for the Study 1. Subject is pregnant or lactating (Note: Breast milk cannot be stored for future use while the mother is being treated on study). 2. Subject has a known additional malignancy that is active and/or progressive requiring treatment; exceptions basal cell or squamous cell skin cancer, in situ cervical or bladder cancer, or other cancer for which the subject has been disease-free for at least five years. 3. Subjects diagnosed with cutaneous T-cell lymphoma including mycosis fungoides, Sézary syndrome, or any other variant of cutaneous T-cell lymphoma. 4. Current use of systemic corticosteroids at doses ≥10 mg prednisone daily or its equivalent; those receiving <10 mg daily may be enrolled at discretion of investigator. Inhaled steroids are allowed. 5. Active infection with HIV, HTLV, HCV (tests can be pending at the time of cell procurement; only those samples confirming lack of active infection will be used to generate transduced cells). Note: To meet subjects are required to be negative for HIV antibody, negative for HTLV1 and 2 antibody or PCR negative for HTLV1 and 2, negative for HCV antibody or HCV viral load. 6. Subjects who are positive for hepatitis B surface antigen (can be pending at the time of cell procurement; only those samples confirming lack of active infection will be used to generate transduced cells) are excluded. Subjects who are hepatitis B surface antigen negative but hepatitis B core antibody positive must have their hepatitis B viral load checked. These subjects will be excluded if their viral load is positive at baseline. Subjects who are core antibody positive and viral load negative at baseline will be considered eligible. Prior to Cell Procurement 1. Informed consent to undergo cell procurement understood by and signed by the subject or legally authorized representative; subject and/or legally authorized representative given a copy of informed consent form for cell procurement. 2. Subject has life expectancy ≥ 6 weeks. 3. Subject has evidence of adequate organ function as defined by Hemoglobin ≥8.0 g/dL (transfusion independent for 2 weeks prior to procurement) Total bilirubin ≤ 2 × ULN, unless attributed to Gilbert's Syndrome AST ≤ 3 × ULN ALT < 3 x ULN Creatinine ≤ 2 × ULN Pulse oximetry of >90% on room air 4. Imaging results from within 90 days prior to procurement to assess presence of active disease. 5. Negative serum pregnancy test within 72 hours prior to procurement or documentation that the subject is post-menopausal. Post-menopausal status must be confirmed with documentation of absence of menses for >1 year, or documentation of surgical menopause (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months. Prior to Lymphodepletion #1 1. Written informed consent explained to, understood by and signed by the subject or legally authorized representative; subject and/or legally authorized representative given a copy of informed consent form. 2. Imaging results from within 10 days prior to lymphodepletion. Imaging must occur at least 3 weeks after most recent therapy (used as baseline measure for documentation of progression before the lymphodepletion) to document measurable or assessable disease. 3. Subject must demonstrate adequate organ function prior to lymphodepletion as defined below. All tests must be obtained within 72 hours prior to lymphodepletion Absolute neutrophil count ≥ 1.0 × 109/L Platelet count ≥ 50 × 109/L Total bilirubin < 2 x ULN unless attributed to Gilbert's syndrome | 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): 18.0-65.0, Thyroidectomy benign and malignant thyroid disease normal voice controlled thyroid hormones level Age below 18 years any cardiac, renal,hepatic, respiratory, mental can interfere with the surgery any voice changes due to any cause before surgery previous head and neck surgery neurological dysfunctions | 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): 18.0-99.0, Colorectal Cancer Metastatic Colon Cancer Metastatic Colorectal Cancer Rectal Cancer Liver Metastasis Colon Cancer Colo-rectal Cancer Colorectal Adenocarcinoma Colorectal Neoplasms Liver Metastases Colorectal Carcinoma Age ≥18 years Histological or cytological confirmation of colorectal cancer with metastasis to the liver. Mismatch repair or microsatellite instability status of the tumor needs to be known. Tumors need to be mismatch repair proficient (for mismatch repair deficient tumors immunotherapy is already approved) Patient must have at least 1 liver lesion measurable as defined in the protocol Must have liver metastases and be appropriate for treatment with Y-90 radioembolization therapy as determined by the treating medical oncologist and interventional radiologist/oncologist, and nuclear medicine physician(s). NOTE: the goal of therapy is safety and parenchymal sparing. Typically, since the treatment is personalized, the goal is to have at least 30% liver parenchymal sparing post treatment Must have a metastatic focus amendable to biopsy. It is permissible to use same or alternative lesion for biopsy for assessment for tumor response and changes in microenvironment (mandatory pre and post-Y90-RE biopsy) At least 2 but no more than 3 lines of therapy allowed in metastatic setting. These at least treatment with a fluoropyrimidine, oxaliplatin, and/or irinotecan-based therapy, an anti-VEGF therapy and, if RAS wild-type, an anti-EGFR therapy, unless deemed intolerant or not suitable by the treating oncologist. NOTE: adjuvant and/or maintenance chemotherapy does not count as an additional line of therapy. (Patients with more than 3 lines of therapy are at risk for liver disease from prior systemic therapies and would not be reasonable candidates for Y90-RE) ECOG Performance Status (PS) 0 or 1 Negative serum pregnancy test done ≤7 days prior to registration, for persons of childbearing potential only Females of childbearing potential (FOCBP), must use appropriate method(s) of contraception. FOCBP are defined as those who are not surgically sterile (i.e., bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause). Additionally, FOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with durvalumab plus 5 half-lives of durvalumab (13 weeks) plus 30 days (duration of ovulatory cycle) for a total of 17 weeks post-treatment completion (details in appendix) Any of the following laboratory abnormalities Hemoglobin <8.0 g/dL Absolute neutrophil count (ANC) <1500/mm3 Platelet count <100,000/mm3 Total bilirubin >1.5 x ULN (except in subjects with Gilbert Syndrome, who cannot have a total bilirubin > 3.0 mg/dL) Alanine aminotransferase (ALT) and Aspartate transaminase (AST) >2.5 x ULN Serum creatinine > 1.5 x ULN OR Calculated creatinine clearance <30 ml/min using the Cockcroft-Gault formula Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects Pregnant persons | 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): 18.0-75.0, Hypothyroidism Thyroid Disease Euthyroid Thyroid Gland Thyroid Hormones Participants who have a diagnosis of primary hypothyroidism made ≥ 12 months before study entry (Visit 1) Be on continuous thyroid replacement therapy with synthetic T4 for primary hypothyroidism for at least 12 months immediately prior to the Screening Visit (Visit 1) Be on a stable FDA-approved daily dose of synthetic T4 for a minimum of 3 months prior to the Screening Visit (Visit 1). Must enter the study on the same stable dose Have euthyroid status indicated by at least 1 documented TSH value within normal reference range (0.45 4.12 mIU/L, inclusive) at a minimum of 6 weeks and maximum of 12 months prior to the Screening Visit (Visit 1). Also have a confirmed TSH value within the normal reference range drawn at the Screening Visit (Visit 1) Male and female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period (35 days after last dose of study intervention) Any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation, or excretion of Armour Thyroid or synthetic T4 History of alcohol or other substance abuse within the previous 5 years Known or suspected allergy or intolerance to any ingredients of Armour Thyroid, including its excipients, levothyroxine (T4), other thyroid replacement medications, or pork products Have received active treatment with an investigational drug within 30 days or 5 half lives, whichever is longer, of Screening Visit (Visit 1) Current enrollment in an investigational drug or device study or participation in such a study within 60 days of entry into this study | 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): 10.0-80.0, Thyroid Cancer · This study will thyroid cancer patients of wide age ranges, who underwent total thyroidectomy with negative radioactive iodine whole body scan (I-WBS) and elevated stimulated thyroglobulin (sTg) or thyroglobulin antibody (TgAb) levels Patients able to sleep in a fixed position for 20 minutes Patients unable to sit calm without movement during imaging Severely ill patients Patients' blood glucose > 11.1 mmol/L (200 mg/dL) measured by glucometer immediately prior to scan Pregnancy | 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): 18.0-85.0, Papillary Thyroid Cancer Papillary Thyroid Microcarcinoma Are adults Nodule with Papillary thyroid carcinoma meeting the below Diagnosed by FNA cytology Size < 1.5 cm Non-surgical therapy is considered acceptable by the treating physician Radiology evaluation deems the lesion amenable to RFA therapy with minimal risk of complication Clinical evidence for a multifocal papillary thyroid malignancy Clinical evidence for local or distant metastatic disease Pregnancy Vocal cord paralysis on contralateral side Coagulopathy or patients on anticoagulation therapy Patients with prior neck surgery or neck radiation Patients with neck anatomy that precludes easy access by RFA Patients with comorbidities deemed too high of a risk for general anesthesia Treatment with another investigational drug or intervention (within 6 weeks of planned RFA) Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements | 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 Neoplasm Gastrostomy Esophageal Stenosis and Obstruction Placement of PEG tube for dysphagia Inability of participant to undergo conventional Pull PEG (for any reason) Attempt at placement of a Push PEG Age > 18 years and able to consent Successful placement of Pull PEG Ascites, pregnancy | 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, Cancer Malignancies Multiple Malignant Solid Tumor Cancer, Therapy-Related Molecular Sequence Variation Genetic Alteration Gene Fusion Receptor Tyrosine Kinase Gene Mutation RTK Family Gene Mutation Patients ≥ 18 years at cancer diagnosis Diagnosed with malignant tumour(s) with molecular testing completed that identified rare molecular alterations Accessible/available molecular testing reports/documentation to confirm type(s) of molecular alteration(s) (resulting from the conduct of polymerase chain reaction [PCR] based next generation sequencing [NGS], immunohistochemistry [IHC], fluorescence in situ hybridization [FISH]) Canadian resident received follow-up for cancer care in Canada or is currently receiving/planning follow-up for cancer care to occur in Canada at time of enrollment Previous refusal of the deceased patient, when living, to enroll in this study or patient approached for this study is unable to provide informed 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): 19.0-999.0, Thyroid Cancer Thyroid Nodule All thyroid nodule identified as benign or as thyroid cancer Patient refuses to participate in the study or withdraws 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): 18.0-999.0, Pancreatic Ductal Adenocarcinoma Non-small Cell Lung Cancer Squamous Cell Carcinoma of Head and Neck Age ≥ 18 years at the time of screening or age of consent 2. Written informed consent and any locally required authorization (eg, data privacy) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations 3. ECOG of 0 or 1 4. Weight ≥ 35 kg 5. Must have a life expectancy of at least 12 weeeks 6. Histological or cytological confirmation 7. At least 1 measurable lesion according to version 1.1 8. Archival tumor formalin-fixed, paraffin-embedded (FFPE) specimens for correlative biomarker studies are required (1 H&E and 15 unstained slides) unless no such sample is available or insufficient sample exists. Subjects with insufficient archived tumor samples are still eligible 9. Adequate organ and marrow function 10. Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception from screening to 180 days after the final dose of study treatment 11. Nonsterilized male subjects who are sexually active with a female partner of childbearing potential must use a male condom with spermicide from screening to 180 days after receipt of the final dose of study treatment Receipt of any conventional or investigational anticancer therapy within 21 days or palliative radiotherapy within 14 days prior to the scheduled first dose of study treatment. 2. Prior receipt of any immune-mediated therapy 3. Concurrent enrollment in another therapeutic clinical study. Enrollment in observational studies will be allowed 4. Any toxicity (excluding alopecia) from prior standard therapy that has not been completely resolved to baseline at the time of consent 5. Subjects with a history of Grade 3 or greater thromboembolic events in the prior 12 months or thromboembolic event of any grade with ongoing symptoms 6. Subjects with prior history of myocardial infarction, transient ischemic attack, congestive heart failure ≥ Class 3 based on New York Heart Association Functional Classification or stroke within the past 3 months prior to the scheduled first dose of study treatment 7. Active or prior documented autoimmune disorders within the past 3 years prior to the scheduled first dose of study treatment 8. HIV, Hep A, B, or C 9. History of primary immunodeficiency, solid organ transplantation, or active tuberculosis 10. Other invasive malignancy within 2 years 11. Known allergy or hypersensitivity to investigational product formulations 12. History of more than one event of infusion related reactions (IRR) requiring permanent discontinuation of IV drug treatment 13. Active grade 3 or greater edema 14. Uncontrolled intercurrent illness 15. Any history of leptomeningeal disease or cord compression 16. Untreated CNS metastatic disease. 17. Current or prior use of immunosuppressive medication within 14 days prior to the scheduled first dose of study treatment. 18. Receipt of live, attenuated vaccine within 30 days prior to the scheduled first dose of study treatment 19. Major surgery within 28 days prior to scheduled first dose of study treatment or still recovering from prior surgery 20. Females who are pregnant, lactating, or intend to become pregnant during their participation in the study 21. Subjects who are involuntarily incarcerated or are unable to willingly provide consent or are unable to comply with the protocol procedures 22. Any condition that, in the opinion of the investigator, would interfere with safe administration or evaluation of the investigational products or interpretation of subject safety or study results | 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, Solid Tumor Medullary Thyroid Cancer Participants with a locally advanced or metastatic solid tumor Evidence of a RET gene alteration in tumor and/or blood Measurable or non-measurable disease as determined by Response Evaluation in Solid Tumors (RECIST) v1.1 Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2, with no sudden deterioration 2 weeks prior to the first dose of study treatment Archived tumor tissue sample available for cohort 1 and 2 Cohorts 1 and 2: failed or intolerant to standard of care Cohorts 1-2: enrollment will be restricted to participants with evidence of a RET gene alteration in tumor (i.e., not just blood). However, a positive germline DNA test for a RET gene mutation as defined in the protocol is acceptable in the absence of tumor tissue testing for participants with MTC Cohorts 1-2: at least one measurable lesion as defined by v1.1 and not previously irradiated (unless progressive disease for the irradiated lesion[s] has been radiographically documented) Cohorts 1-2, an additional validated oncogenic driver that could cause resistance to selpercatinib treatment if known Prior treatment with a selective RET inhibitor(s) (including investigational selective RET inhibitor(s), such as BLU-667, RXDX-105, etc) Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study Any unresolved toxicities from prior therapy greater than common terminology for adverse events (CTCAE) Grade 1 except where otherwise noted in this at the time of starting study treatment with the exception of alopecia and Grade 2, prior platinum therapy-related neuropathy Symptomatic primary central nervous system (CNS) tumor, symptomatic CNS metastasis, leptomeningeal carcinomatosis, or untreated spinal cord compression Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of selpercatinib or prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF) > 470 milliseconds History of Human Immunodeficiency Virus (known HIV 1/2 antibodies positive); participants with unknown HIV status do not need to be tested History of active hepatitis B (known positive hepatitis B surface antigen [HbsAg] and quantitative hepatitis B DNA greater than the upper limit of detection of the assay) or C (known positive hepatitis C antibody and quantitative hepatitis C RNA greater than the upper limit of detection of the assay); participants with unknown hepatitis B/hepatitis C status do not need to be tested Active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing intercurrent illness, such as hypertension or diabetes, despite optimal treatment. Screening for chronic conditions is not required Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug | 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 Intermediate Risk Subgroup of patients with differentiated thyroid cancer and intermediate-risk defined as follows according to TNM 2017 Papillary thyroid cancer (PTC) without aggressive subtype, follicular thyroid cancer (FTC) (with < 4 foci of vascular invasion) or Hürthle cell carcinoma (HCC) T1b or T2 with minimal extra-thyroid extension into the perithyroidal soft tissues and/or pN1 with largest nodal dimension between 2 and 10 mm, without extra-capsular invasion and with a number of metastatic nodes ≤ 5 T1aN1 with largest nodal dimension between 2 and 10 mm, without extra-capsular invasion and with a number of metastatic nodes ≤ 5 Patient treated by total thyroidectomy with macroscopically complete tumor resection (R0 or R1) ± neck dissection Total thyroidectomy performed within 6 to 14 10 weeks before randomization Patient with or without anti-thyroglobulin antibodies (TgAb) No known distant metastases Normal post-operative neck ultrasound (US) or if doubtful US, negative cytology and normal Tg value (<10 ng/ml) in FNA washout fluid Post-operative LT4 treatment initiated at least 6 weeks before randomization • Patients with medullary or anaplastic thyroid cancer or poorly differentiated carcinoma or well differentiated FTC with at least more than 4 foci of vascular invasion or PTC with aggressive variants (tall cell or columnar cell carcinoma, diffuse sclerosing papillary, hobnail variant) NIFTP (Noninvasive follicular thyroid neoplasm with papillary-like nuclear features) • Low-risk or high-risk DTC patients according to ATA 2015, and intermediate-risk patients with extra-thyroid extension into the perithyroidal muscles (pT3b according to pTNM 2017), and/or pN1 with nodal largest dimension >10 mm or with extra-capsular invasion or more than 5 metastatic nodes. This excludes the following patients All pT1a, pT3 or pT4 pT1aN0/x with or without minimal extra-thyroid extension pT1bN0/x, pT2N0/Nx without minimal extra-thyroid extension pT1aN1 or pT1bN1 or pT2N1 without extra-thyroid extension and with nodal largest dimension <2mm | 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): 0.0-22.0, Acute Myeloid Leukemia All patients must be enrolled on APEC14B1 and consented to Screening (Part A) prior to enrollment and treatment on AAML1831. Submission of diagnostic specimens must be done according to the Manual of Procedures). Risk stratification will not be possible without the submission of viable samples. Given there are multiple required samples, bone marrow acquisition techniques such as frequent repositioning or performing bilateral bone marrow testing should be considered to avoid insufficient material for required studies. Consider a repeat marrow prior to starting treatment if there is insufficient diagnostic material for the required studies Patients must be less than 22 years of age at the time of study enrollment Patient must be newly diagnosed with de novo AML according to the 2016 World Health Organization (WHO) classification with or without extramedullary disease Patient must have 1 of the following >= 20% bone marrow blasts (obtained within 14 days prior to enrollment) In cases where extensive fibrosis may result in a dry tap, blast count can be obtained from touch imprints or estimated from an adequate bone marrow core biopsy < 20% bone marrow blasts with one or more of the genetic abnormalities (sample obtained within 14 days prior to enrollment) A complete blood count (CBC) documenting the presence of at least 1,000/uL (i.e., a white blood cell [WBC] count >= 10,000/uL with >= 10% blasts or a WBC count of >= 5,000/uL with >= 20% blasts) circulating leukemic cells (blasts) if a bone marrow aspirate or biopsy cannot be performed (performed within 7 days prior to enrollment) ARM C: Patient must be >= 2 years of age at the time of Late Callback ARM C: Patient must have FLT3/ITD allelic ratio > 0.1 as reported by Molecular Oncology Patients with myeloid neoplasms with germline predisposition are not eligible Fanconi anemia Shwachman Diamond syndrome Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21 Any other known bone marrow failure syndrome Any concurrent malignancy Juvenile myelomonocytic leukemia (JMML) Philadelphia chromosome positive AML Mixed phenotype acute leukemia Acute promyelocytic leukemia | 0 |
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, Huntington Disease Confirmed diagnosis of HD Symptoms of dysphagia Must be able to swallow tablets Other confounding diseases that affect swallowing Depression Hepatic impairment Renal impairment Dementia | 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 Dysphagia, Oropharyngeal Patients with oropharyngeal dysphagia for liquids diagnosed before admission or during hospitalization and who need thickener Patients with expected hospital length of stay less than 24 hours Patients with food allergy to any of the ingredients of the thickener or flavorings used in the study Patients with cognitive impairment that prevents collaborating in obtaining data Patients in terminal situations, in which death is expected in the following hours | 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, Bronchiectasis Confirmed diagnosis of CF (confirmed genetics) or diagnosis of non-CF bronchiectasis through high resolution computed tomography Aged ≥ 18 years Clinically stable at the time of recruitment Chronic sputum production (able to produce spontaneous sputum daily) Current hypertonic saline user Able to provide written informed consent and perform the trial Current smoker or >10 pack-year history of tobacco use Patient in transplantation or retransplantation list | 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): 14.0-80.0, Thyroid Cancer Newly diagnosed papillary thyroid cancer The maximum diameter of the thyroid cancer <3 cm with enough normal thyroid tissue for tracer injection Unpalpable lateral neck lymph nodes Ultrasound and CT showed suspected lateral neck lymph nodes <2 cm Previously treated thyroid cancer High risk thyroid cancer (e.g. with severe extra-adenial invasion or extensive lymph node metastasis or poorly differentiated thyroid cancer) Patients with distant 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): 42.0-55.0, Papillary Thyroid Carcinoma Age ≥20 years, Histopathology proved PTC, with no lymph nodes detected (N0) Younger age ≤20 years. Prior thyroidectomy, previous radiation exposure, postoperative radioactive iodine therapy, Histopathology report of any type of malignancy other than PTC or patients did not complete their postoperative follow-up period. PTC With N1 or N2 | 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): 0.0-16.0, Acute Lymphoblastic Leukemia Children and adolescents newly diagnosed with acute lymphoblastic leukaemia. A complete personal and family history will be recorded for each participant from every group with particular emphasis on the presence of dyslipidaemia, early cardiovascular disease or cerebrovascular accident in the individual or in the family. A thorough clinical examination will be performed and the vital signs, blood pressure, weight (kg), height (m) and a Body/Mass Index (BMI) will be recorded and calculate. The are the following Thyroid Disorder (Abnormal thyroid function) Familial Hypercholesterolemia High Body/ Mass Index (BMI) Administration of corticosteroids some time during the past 2 weeks before diagnosis Administration of total parenteral nutrition before the diagnosis Administration of plasma before the diagnosis Changes or variation of the parameters under study before the start of treatment and the 11th day (before the start of asparagine administration) | 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, Papillary Thyroid Microcarcinoma Microbiome Patients who are going to have surgery for some thyroid disease, benign or malignant Recent, less than 3 months, infection of any system Receiving antibiotic or antiviral medication in the previous trimester Patient with chronic virus or bacterial infection Patient with dermatological 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): 16.0-80.0, Recurrent Laryngeal Nerve Injuries Multinoduler Goitre Thyroid papillary cancer Solitary thyroid nodule previous thyroid or parathyroid surgery substernal goiter preoperative VCP evidence of lateral lymph node metastasis intentional transection of the RLN due to tumor invasion failure to assess RLN functioning due to equipment issues with the IONM setup presurgical dissection amplitude of <500µV patient's refusal 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): 0.0-999.0, Septoplasty The patient will be eligible for the study if he or she meets all of the following at the baseline screening: 1. Able and willing to give informed consent by voluntarily providing written informed consent in accordance with governing Institutional Review Board (IRB); 2. Clinically significant deviation of the nasal septum; 3. Willing and able to make all required study visits; 4. Able to read and understand the approved informed consent form and patient reported outcome assessments (written and oral) The patient will be ineligible for the study if he or she meets any of the following at the baseline screening or during surgery: 1. Prolonged tissue approximation beyond that needed for normal tissue closure is necessary or desired; 2. Traditional suturing techniques is necessary; 3. Radiopacity is necessary or desired since septal staples are radiotransparent; 4. Known to be allergic to foreign body of materials of investigational product; 5. Concomitant procedures other than turbinectomy, turbinate reduction, and/or sinus surgery; 6. Pregnancy at time of procedure; 7. Presence of infection at the site; 8. Severe drug and alcohol abusers; 9. Autoimmune disease deemed clinically significant by Principal Investigator (PI) | 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): 17.0-999.0, Iatrogenic Hypocalcemia Iatrogenic Hypoparathyroidism Vocal Cord Paralysis Vocal Cord Paresis Vocal Cord; Injury, Superficial Thyroid Cancer, Papillary Thyroid Cancer Multinodular Goiter Thyroid Neoplasms Thyroid Nodule Calcium Deficiency PTH Patients with total thyroidectomy indication, for either benign (e.g. multinodular goitre) or malign (e.g. thyroid carcinoma) thyroid disease >17 year-old Available for close follow-ups at outpatient clinic Available for close vocal cord exams Patients with recurrent thyroid disease (benign/malign), prepared for a second operation Preferance of thyroid surgery other than total thyroidectomy | 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): 17.0-999.0, Dysphagia, Esophageal Dysphagia, Oral Phase Dysphagia Comes and Goes Thyroiditis Thyroid Cancer Thyroid Neoplasms Thyroid Goiter Thyroid Nodule (Benign) Patients with benign or malignant thyroid disorder (multinodular goitre, toxic goitre, thyroid carcinoma) Patients with total thyroidectomy (TT) indication Patients over 17 year-old Patients without thyroid disease Patients with thyroid disorder, but prepared for surgery other than TT Healthy volunteers Patients below 17 y/o | 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): 17.0-80.0, Thyroid Cancer Thyroid Carcinoma, Papillary Thyroid Metastases Thyroid Neoplasms Sentinel Lymph Node Lymph Node Metastases Thyroid carcinoma patients (biopsy/cytology-proven) suitable for total thyroidectomy procedure Patients at or over 17 years Previous thyroid surgery Patients below 17 years | 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, Soft Tissue Sarcomas Histologically confirmed newly diagnosed intermediate to high grade soft tissue sarcoma localized to the extremities, trunk and chest wall or the head and neck area, for which the standard treatment is a combination of and radiotherapy and surgery (deep seated and/or > 5cm in largest tumor diameter and/or an anticipated close resection margin and/or grade II/III according to the definition) • Absence of regional and/or distant disease. Patients staged by at least a CT scan of the chest (. Staging may also be performed by FDG-PET scanning and or total body MRI scans. Patients with an uncertain metastatic status (e.g. small indifferent lung nodules) and patients with a low metastatic burden not precluding the application of both preoperative radiotherapy and definitive surgery, are allowed to participate WHO Performance Status ≤ 2 Able and willing to undergo preoperative radiotherapy Able and willing to undergo definitive surgery Able and willing to comply with regular follow-up visits Able and willing to complete patient reported outcome questionnaires (health-related quality of life and cost effectiveness); • Able and willing to undergo randomization Age ≥ 18 years Signed written informed consent Prior malignancies; except another malignancy and disease-free for ≥ 5 years, or completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma Patients with recurrent sarcomas who underwent prior radiotherapy to the target lesion (if the primary sarcoma was managed by surgery only and no perioperative RT, patients are eligible) Ewing sarcoma and other PNET family tumors, rhabdomyosarcomas (both pediatric and adult), osteosarcomas Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial Female patients who are pregnant Intention to perform an isolated limb perfusion, instead of a tumor resection Neoadjuvant chemotherapy to be scheduled between end of radiotherapy and definitive surgery (neoadjuvant chemotherapy before radiotherapy is allowed) | 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): 18.0-75.0, Differentiated Thyroid Cancer Pathological diagnosis of differentiated thyroid cancer, including papillary thyroid cancer (including papillary carcinoma follicular subtype), follicular thyroid cancer, and Hurthle cell thyroid cancer Patients who were at 18~75 years old (male or female) Patients with a total or near-total thyroidectomy within 12 weeks prior to enrollment and plan to performing radioactive iodine((131)Ⅰ) thyroid remnant ablation Serum TSH ≤ 0.5 mU/L； Women of childbearing age are HCG-negative Low iodine diet before enrollment for more than 4 weeks Patients are voluntarily enrolled, and written informed consent forms can be used for treatment and visits as required by the program Any significant clinical and laboratory abnormalities (eg, severe cardiopulmonary disease, hepatic insufficiency, renal function Incomplete, congestive heart failure, advanced lung disease or advanced cardiovascular and cerebrovascular disease, active infection) Patients who have used any water-soluble radiographic contrast agent intravenously, underwent intrathecal iodine angiography or gallbladder iodine imaging within 3 months before administration Taken/eaten within 4 weeks prior to administration Drugs/foods that affect iodine uptake or metabolism, such as multivitamins, glucocorticoids, diuretics, lithium, thiouracil, tazobactam, algae, iodine (except thyroid hormone replacement therapy) Before administration Stroke, unstable angina (CCS class II or higher), atrial fibrillation or medication (within beta blocker or digoxin) within 6 months Patients with a history of arrhythmia Pregnant or lactating women Patients who are allergic to rhTSH and its excipients Patients with positive infection-related tests : Includes hepatitis C、syphilis and AIDS Participated in any drug or medical device clinical trial within 1 month prior to the trial | 1 |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.