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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, Emergency High-risk Abdominal Surgery Patients (19 years and older) undergoing emergency laparotomy or laparoscopy (inclusive reoperations after elective surgery) Patients undergoing minor emergency operations (uncomplicated appendectomy, laparoscopic cholecystectomy, diagnostic laparoscopy or laparotomy without intervention) | 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, Thyroidectomy patients aged 18 years and over scheduled to undergo thyroid surgery performed by one of two surgeons for benign or malignant thyroid disease during the study pre-existing vocal cord palsy or major vocal cord pathology; patients with invasive thyroid cancers; and patients undergoing concomitant lateral neck dissection | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 21.0-73.0, Stage I Papillary Thyroid Cancer Stage II Papillary Thyroid Cancer Stage III Papillary Thyroid Cancer Pre-operative diagnosis or suspicion of papillary thyroid cancer, usually by fine needle aspiration (FNA) No pre-operative evidence of cervical lymph node metastases on neck ultrasound (randomization arms only) No evidence of distant metastases Ability to read and write in English Largest papillary thyroid carcinoma < 1 cm in size on ultrasound Previous thyroid surgery Concurrent active malignancy of another type Inability to give informed consent or lacks decision making capacity T4 tumor Pre-existing vocal cord paralysis Chronic neurologic condition which affects voice or swallow (for instance, multiple sclerosis or Parkinson disease) Baseline laryngeal pathology that would warrant intervention that could affect voice or swallow function Becomes pregnant before surgery or at any time while on study INTRA-OPERATION (randomization arms only) | 1 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 21.0-90.0, Heart Failure Kidney Disease Subject is between 21 (twenty-one) and 90 (ninety) years of age at screening Subject will have one or more of the following clinical diagnoses related to fluid-management issues: ESRD, Heart Failure Subject and/or legally authorized person/representative is willing to undergo the Informed Consent process prior to enrollment in the study Subject is a candidate for this study based on the PI's opinion and knowledge of the subject's condition Subject is participating in another clinical study that may affect the results of either study Subject is unable or not willing to wear electrode patches as required Subject has skin sensitivity to adhesive or hydrogel materials used in electrode patches Subject has a pacemaker, implanted cardioverter-defibrillator, or ventricular assist device Subject is considered by the PI to be medically unsuitable for study participation | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Recurrent Squamous Cell Lung Carcinoma Stage IV Squamous Cell Lung Carcinoma AJCC v7 Patients must have pathologically proven squamous cell carcinoma (SCCA) cancer of the lung confirmed by tumor biopsy and/or fine-needle aspiration; disease must be stage IV SCCA, or recurrent; the primary diagnosis of SCCA should be established using the current World Health Organization (WHO)/International Association for the Study of Lung Cancer (IASLC)-classification of Thoracic Malignancies; the diagnosis is based on hematoxylin and eosin (H&E) stained slides with or without specific defined immunohistochemistry (IHC) characteristic (p40/p63 positive, transcription termination factor [TTF1] negative) if required for diagnosis; mixed histologies are not allowed Patients must either be eligible to be screened at progression on prior treatment or to be pre-screened prior to progression on current treatment; patients will either consent to the screening consent or the pre-screening consent, not both; these are Screening at progression on prior treatment: to be eligible for screening at progression, patients must have received at least one line of systemic therapy for any stage of disease (stages I-IV) and must have progressed during or following their most recent line of therapy; for patients whose prior systemic therapy was for stage I-III disease only (i.e. patient has not received any treatment for stage IV or recurrent disease), the prior systemic therapy must have been a platinum-based chemotherapy regimen and disease progression on the platinum-based chemotherapy must have occurred within one year from the last date that patient received that therapy; for patients whose prior therapy was for stage IV or recurrent disease, the patient must have received at least one line of a platinum-based chemotherapy regimen or checkpoint inhibitor therapy (e.g. nivolumab or pembrolizumab) Pre-screening prior to progression on current treatment: to be eligible for pre-screening, current treatment must be for stage IV or recurrent disease and patient must have received at least one dose of the current regimen; patients must have previously received or currently be receiving a platinum-based chemotherapy regimen or checkpoint inhibitor therapy (e.g. nivolumab or pembrolizumab); patients on first-line platinum-based treatment are eligible upon receiving cycle 1, day 1 infusion; Note: patients will not receive their sub-study assignment until they progress and the S1400 Notice of Progression is submitted Patients must have adequate tumor tissue available, defined as >= 20% tumor cells and >= 0.2 mm^3 tumor volume The local interpreting pathologist must review the specimen The pathologist must sign the S1400 Local Pathology Review Form confirming tissue adequacy prior to screening/pre-screening registration Patients must agree to have this tissue submitted to Foundation Medicine for common broad platform Clinical Laboratory Improvement Act (CLIA) biomarker profiling; if archival tumor material is exhausted, then a new fresh tumor biopsy that is formalin-fixed and paraffin-embedded (FFPE) must be obtained; a tumor block or FFPE slides 4-5 microns thick must be submitted; bone biopsies are not allowed; if FFPE slides are to be submitted, at least 12 unstained slides plus an H&E stained slide, or 13 unstained slides must be submitted; however it is strongly recommended that 20 FFPE slides be submitted; Note: previous next-generation deoxyribonucleic acid (DNA) sequencing (NGS) will be repeated if done outside this study for sub-study assignment; patients must agree to have any tissue that remains after NGS testing retained for the use of the translational medicine (TM) studies (if such TM studies are defined) within any sub-study the patient is enrolled in Patients must not have a known epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) fusion; EGFR/ALK testing is not required prior to registration and is included in the Foundation Medicine Incorporated (FMI) testing for screening/prescreening Patients must have Zubrod performance status 0-1 documented within 28 days prior to screening/pre-screening registration | 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 Biopsy proven Papillary Thyroid Cancer (regardless of genotype and including all subtypes such as follicular or mixed papillary follicular) or suspicious for Thyroid Cancer Thyroidectomy or lobectomy planned as definitive treatment for Thyroid Cancer or patients on active surveillance management approach Age ≥18 years Patient would require anesthesia for the study Patients who are claustrophobic Patients with tumor size greater than 5 cm in diameter as measured at imaging (ultrasonography or MRI) before treatment Patients who have presence of a known contraindication to MRI Pacemaker Aneurysmal clips Metal implants in field of view Pregnant Age and mental status wherein he/she is unable to cooperate for MRI study Patients who have presence of a known contraindication to DCE-MRI may not participate in that portion of the study Known reaction to Gd-DTPA, contrast agent Chronic kidney disease | 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, Hernia, Ventral Intestinal Fistula Fibromatosis, Abdominal Age > 18 Patients presenting for elective hernia repair, with Ventral Hernia Working Group (VHWG) grade 2 or above (Patients with a hernia who need hernia repair due to hernia size, discomfort, risk of bowel incarceration, effect on physical function), and who have comorbidities or contamination making the use of synthetic mesh contraindicated) Patients deemed to be good surgical candidates, with no active life-threatening cardiac disease, pulmonary disease, renal disease, hematologic disease (patients who can have a major surgical procedure without an exceedingly high risk of medical complications such as pulmonary edema, myocardial infarction, pulmonary embolism, renal failure, life-threatening bleeding, stroke) Patients presenting for resection of large abdominal wall tumors who are expected to undergo have tumor extirpative defect that would require biologic mesh for closure (patients with a large tumor of the abdominal wall who will have a large defect in their fascia after resection, who need biologic mesh for reinforcement) Known allergy to porcine products Active smokers (within the past 4 weeks) presenting for elective hernia repair Patients with active life-threatening cardiac disease, pulmonary disease, renal disease, hematologic disease presenting for elective hernia repair Patients presenting for emergent hernia repair (in the setting of bowel strangulation, necrosis, penetrating trauma) as it will be difficult to consent those patients for the study preoperatively Patients with severe systemic sepsis Patients with frank purulence in the wound | 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, Anaplastic Thyroid Cancer Thyroid Cancer Male or female patients 18 years or older Any number of prior chemotherapy or targeted agents including rapamycin analogues allowed Newly diagnosed or refractory/metastatic anaplastic thyroid cancer confirmed by histology, incurable by surgery, radiotherapy or chemoradiotherapy alone or in combination Must have measurable disease ECOG performance status 0-2 No active intracranial metastases Tissue for correlative studies must be available Ability to swallow oral medications Voluntary written consent must be given before performance of any study related procedure Adequate organ function, as specified below, within 21 days Female patients who are both lactating and breastfeeding or have a positive serum pregnancy test during the screening period Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment Treatment with any investigational products within 14 days Failed to recover from the reversible effects of prior anticancer therapies Manifestations of malabsorption due to prior gastrointestinal surgery or disease Poorly controlled diabetes mellitus History of any of the following within the last 6 months prior to study entry Ischemic myocardial event Ischemic cerebrovascular event Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia | 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, Non-malignant Thyroid Nodules Male or female patient 18 years or older Patient presenting with at least one thyroid nodule with no signs of malignancy: 1. Non suspect clinically and at ultrasonography imaging 2. Benign cytological diagnosis at fine-needle aspiration biopsy (FNAB) from the last 6 months 3. Normal serum calcitonin 4. No history of neck irradiation Normal thyroid-stimulating hormone (TSH) Targeted nodule accessible and eligible to HIFU Absence of abnormal vocal cord mobility at laryngoscopy Nodule diameter ≥ 10mm measured by ultrasound Nodule volume inferior to 10 cc Composition of the targeted nodule(s) : no more than 30% cystic Head and/or neck disease that prevents hyperextension of neck Known history of thyroid cancer or other neoplasias in the neck region History of neck irradiation Macrocalcification inducing a shadow in the thyroid significant enough to preclude the HIFU treatment Posterior position of the nodule if the thickness of the nodule is <15mm Pregnant or lactating woman Any contraindication to the assigned analgesia/anaesthesia | 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 Patients with treatment naive, resectable, stage III or IV squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx who are candidates for definitive surgical resection followed by standard risk adapted adjuvant therapy Histologic or cytologic diagnosis of a primary with no radiological evidence of metastatic disease is acceptable. Patients with bone or cartilage invasion and any T or N stage are acceptable Patients with oral cavity primaries will be managed using conventional transoral or transcervical techniques; oropharynx or hypopharynx tumor will be managed with transoral robotic surgery; and larynx tumors (T3/T4 with thyroid cartilage invasion) will be managed by either total laryngectomy or larynx preservation surgery Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 Laboratory values (performed within 28 days prior to enrollment) within protocol defined range Ability to give informed consent and comply with the protocol. Patients with a history of psychiatric illness must be judged able to understand the investigational nature of the study and the risks associated with the therapy No active gastrointestinal bleeding Anticipated lifespan greater than 12 weeks Locoregionally unresectable or Metastatic disease (stage IVB) Active infection Active autoimmune disease including patients with Inflammatory Bowel Disease as determined by an autoimmune questionnaire Previous treatment with mouse monoclonal antibodies Need for chronic maintenance oral steroids > 5mg prednisone daily equivalent Any medical or psychiatric condition that in the opinion of the investigator would preclude compliance with study procedures | 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): 21.0-45.0, Weight Loss Insulin Resistance Be willing and able to comply with study procedures and given written informed consent 2. Chinese, aged 21-45 years old 3. Body mass index (BMI) between 25 -35 kg/m2 and % body fat of more than 25 %. 4. Sedentary adults, with <1 episode of exercise per week 5. Not have a history of food allergies or food intolerances 6. Have maintained a stable body weight for at least 3 months prior to the study. 7. Be a non-smoker 8. Drinks less than 3 caffeinated beverages per day (coffee/tea/energy drinks) 9. Drinks less than 3 units of alcohol per day Subjects with diabetes, renal impairment, high blood pressure, gastrointestinal problems, asthma, eczema, anaemia or on medications that will affect glucose metabolism (e.g. corticosteroids) or lipid metabolism/insulin resistance (e.g. niacin, fibrates, metformin) and other significant medical conditions, which in the investigator's opinion would confound interpretation of results. 2. Recent changes (gain or loss) in weight of >5% over the past 3 months 3. Significant changes in diet over the past 3 months 4. Any use of weight-reduction drugs in the past 6 months 5. Use of any prescription medication that cannot be safely discontinued within 14 days prior to study entry 6. Have special dietary needs/restrictions e.g. vegetarian diet or unable to consume fish, seafood and beef 7. History of eating disorders or irregular eating habits 8. High level of physical activity (exercise > 5hr per week) 9. Women who are pregnant and lactating and women of reproductive age group who plan to conceive within 6 months. A pregnancy test will be performed for women in the reproductive age group. 10. Have contraindications to Magnetic Resonance Imaging (MRI) that includes metallic implants, pacemakers or stimulators, or any other methodology applied in the study. 11. Have been involved in any clinical or food study within the preceding month. 12. Presently consuming amino acid or protein-related supplements | 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 Carcinoma Cases with histological diagnosis of papillary carcinoma (CP) and previous cytological diagnosis in groups III, IV and V Bethesda, collected between October 1989 and July 2014 in Corporació Parc Taulí Non available cytological or histological material | 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): 20.0-70.0, Goiter all patients who presented with goiter proven by thyroid sono in euthyroid status without other preexisting major disorders and possible thyroid related symptoms, such as unexplained body weight loss with increased appetite, palpitation, hand tremors, neck swelling, hoarseness and abnormal sensation over throat all patients without definite goiter all patients with major illness as CAD, DM or CVA (CerebroVascular Accident) all patients with pregnancy or malignancy | 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, Carcinoma, Merkel Cell Histologically confirmed neuroendocrine carcinoma of the skin (Merkel cell carcinoma) with inoperable local-regional disease or distant metastatic disease (stages IIIB or IV AJCC 2010), cerebral nervous system metastases will be allowed First line of treatment or more Measurable disease: at least 20 mm by conventional techniques or 10 mm by spiral CT scan WHO performance status ECOG 0-3 premenopausal patients must use effective contraception No other prior malignancy within 5 years except adequately treated basal cell or squamous cell carcinoma or in situ cancer of the cervix No other concurrent chemotherapy, immunotherapy or hormone therapy At least 4 weeks since adjuvant chemotherapy, 14 days since radiotherapy and 2 weeks since surgery Biological functions: absolute neutrophil count at least 1000/mm3, platelet count at least 100000/mm3, haemoglobin at least 9g/dl (transfusion allowed), bilirubin no greater than 3 times upper limit of normal (ULN), SGOT and SGPT no greater than 2.5 times ULN, no untreated chronic liver disease, creatinine no greater than 1.5 times ULN, no untreated chronic renal disease, no untreated diabetes or infection Written informed consent previous hypersensibility to lanreotide treatment complicated and untreated cholelithiasis pregnancy or breast-feeding patient treated with cyclosporine | 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 Patients that undergo a clinically diagnostic thyroid FNA Children pregnant women | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 60.0-999.0, Pneumonia Neurological Dysphagia Tube fed for more than four weeks for reason of neurological dysphagia as recommended by a trained speech therapist clinical diagnosis of cerebrovascular diseases, confirmed by CT head scan. The reason for restricting the subjects to those with cerebrovascular disease is that previous studies which showed beneficial effects of ACEI on dysphagia were mostly based on stroke patients life expectancy less than six months live outside Shatin area systolic blood pressure less than 100 mm Hg known intolerance of ACEI existing use of ACEI or angiotensin receptor blockers symptomatic chronic lung disease or cardiac failure frequent withdrawal of enteral tube by patients serum creatinine >100 µmol/L serum potassium > 5.1 mmol/L | 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 Microcarcinoma Biopsy proven papillary thyroid cancer (or suspicious for papillary thyroid cancer) confirmed by MSKCC cytopathologist Being followed with active surveillance at MSKCC Biopsied index nodule less than or equal to 2 cm in maximum dimension Thyroid and neck US performed and interpreted by a MSKCC radiologist within 6 months prior to study entry Biopsied index nodule greater than 2 cm in any dimension Age less than 18 yrs old | 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, Deglutition Disorders Stroke Subject is over 18 years of age Subject is suspected of having oropharyngeal dysphagia Subject is able to comply with videofluoroscopy protocol Subject diagnosed with stroke Subject has no previous history of dysphagia Subjects who are able to give voluntary, written informed consent to participate in the clinical investigation and from whom consent has been obtained/ or a consultee has consented on the subjects behalf in line with nationally agreed guidelines concerning adults unable to consent for themselves Subject is not currently participating in any other interventional clinical study Subject is able to comply with the protocol requirements Subject scores 0 or 1 on question 1a of NIHSS Randomization • Subject has confirmed dysphagia (PAS of 2 or more on VFS screening or pharyngeal residue) Subject stroke event occurred less than 3 months ago Subject is pregnant or a nursing mother Subject, in the opinion of the investigator, has advanced dementia Subject fitted with a pacemaker or implantable cardiac defibrillator Subject is dysphagic from conditions other than stroke Subject has been diagnosed with a progressive neurological disorder, such as Parkinson's disease or Multiple Sclerosis Subject with active neoplasm or infection process | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Metastatic Thyroid Gland Carcinoma Poorly Differentiated Thyroid Gland Carcinoma Recurrent Thyroid Gland Carcinoma Stage IV Thyroid Gland Follicular Carcinoma AJCC v7 Stage IV Thyroid Gland Papillary Carcinoma AJCC v7 Stage IVA Thyroid Gland Follicular Carcinoma AJCC v7 Stage IVA Thyroid Gland Papillary Carcinoma AJCC v7 Stage IVB Thyroid Gland Follicular Carcinoma AJCC v7 Stage IVB Thyroid Gland Papillary Carcinoma AJCC v7 Stage IVC Thyroid Gland Follicular Carcinoma AJCC v7 Stage IVC Thyroid Gland Papillary Carcinoma AJCC v7 Diagnosis of recurrent and/or metastatic thyroid cancer Histological or cytological confirmation of thyroid carcinoma of follicular origin (including papillary, follicular, or poorly differentiated subtypes and their respective variants); NOTE: medullary and anaplastic thyroid cancers are excluded; Hurthle cell carcinomas are excluded (defined as having an invasive tumor composed of > 75% oncocytic [Hurthle] cells lacking the nuclear features of papillary carcinoma, tumor necrosis, and marked mitotic activity); patients with oncocytic (Hurthle cell) variants of papillary thyroid carcinoma (defined as a tumor composed of a majority of oncocytic [Hurthle] cells having the nuclear features of papillary carcinoma) are eligible to participate RAI-avid lesion on a radioiodine scan (a diagnostic, post-therapy, or post-ablation scans) performed =< 24 months prior to registration, which suggests that therapy with 131I is justifiable in the judgment of the investigator Clinically or radiographically evident structural disease; patients with measurable disease and those with only non-measurable ("non-target") structural disease (according to modified Response Evaluation in Solid Tumors [RECIST] version [v] 1.1 criteria) are eligible; NOTE 1: Modification of the v1.1 measurable disease includes a change in the definition of what is considered a measurable malignant lymph node; a malignant lymph node is considered measurable if any of the following apply It is noted to be RAI-avid on radioactive iodine imaging (diagnostic or post-therapy whole body scans acceptable) and it measures >= 1 cm in the long axis It is pathologically proven to be involved with thyroid cancer (by cytology or pathology) and it measures >= 1 cm in the long axis, or Its short axis is >= 1.5 cm when assessed by computed tomography (CT) scan NOTE 2: Patients only with biochemical evidence of disease without structural evidence of cancer are not eligible for this study For patients with non-measurable, structural disease the following must apply Undetectable thyroglobulin antibody AND A serum thyroglobulin of 10 ng/ml or greater in the context of suppressed thyroid-stimulating hormone (TSH) (TSH =< 0.4 mcU/ml) =< 28 days prior to study registration; use of any thyroglobulin assay is allowed, though all serum thyroglobulin measurements for study purposes must be conducted with the same thyroglobulin assay therapy =< 6 months prior to registration; Note: 131I administered solely for diagnostic purposes is not considered 131I therapy External beam radiation therapy =< 28 days prior to registration; note: previous treatment with radiation is allowed if the investigator judges it will not compromise patient safety on the study Having been treated with a total cumulative (lifetime) 131I therapeutic activity > 800 mCi (excluding 131I activity administered for diagnostic scans) Treatment with chemotherapy or targeted therapy (e.g. tyrosine kinase inhibitor) =< 28 days prior to registration Prior exposure to mitogen-activated protein kinase kinase (MEK), RAS, or RAF inhibitors (note: previous exposure to sorafenib is allowed) OR history of hypersensitivity to selumetinib, thyrotropin alpha (Thyrogen), or any excipient agents Unresolved toxicity > Common Terminology for Adverse Events (CTCAE) grade 2 from previous anti-cancer therapy, except for alopecia Cardiac conditions as follows Uncontrolled hypertension (blood pressure [BP] >=150/95 mmHg despite medical therapy) Left ventricular ejection fraction < 55% measured by echocardiography Atrial fibrillation with a ventricular rate > 100 beats per minute (bpm) on electrocardiogram (ECG) at rest | 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, Polycythemia Vera Essential Thrombocythemia (Patient should meet all the criteria) JAK2V617F-positive PV or JAK2V617F-positive ET (confirmed by WHO diagnostic criteria) High risk ET/PV [age >60; history of thrombosis] or low risk disease with symptoms [recurrent headaches, paresthesias, pruritus] Previously treated with at least one other agent [hydroxyurea, interferon, anagrelide] and determined to be either intolerant/resistant -≥18 years of age Eastern Cooperative Oncology Group (ECOG) Performance status 0-2 Acceptable pre-study organ function during screening as defined as: Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) unless due to Gilbert's disease or hemolysis, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN, Serum creatinine ≤ 1.5 x ULN Women of childbearing potential and males must agree to use adequate contraception (i.e., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a female subject become pregnant or suspect she is pregnant while participating in this study, she should inform the treating physician immediately Ability to understand and willingness to sign a written informed consent document Meets the for post ET/PV MF as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) Blast phase disease (>20% blasts in the marrow or peripheral blood) Acute thrombosis within 3 months of screening Uncontrolled intercurrent illness including, but not limited to hepatitis, human immunodeficiency virus (HIV) positive subjects receiving combination antiretroviral therapy, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, ventricular arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements | 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, Low-risk Papillary Thyroid Cancer Endocrine Malignancy Thyroid Cancer Patients must have histologically or cytologically confirmed at least 1 thyroid nodule that is greater than or equal to1 cm. but less than or equal to 4 cm measured in greatest dimension and confirmed by the Laboratory of Pathology, NCI or confirmed by the pathology laboratory of the enrolling institution Indeterminate thyroid biopsy per Bethesda System for reporting thyroid cytopathology with BRAF V600E mutation or RET/PTC rearrangement Cytologically or histologically suspicious or confirmed PTC per Bethesda System for reporting thyroid cytopathology Age greater than or equal to 18 years. Because PTC occurs rarely in patients <18 years of age, children are excluded from this study Absence of radiographic evidence of extrathyroidal extension Absence of abnormal lymphadenopathy suggesting metastatic PTC on physical examination and/or imaging studies ECOG performance status less than or equal to 2 Patients must have adequate organ function to safely undergo general anesthesia and thyroidectomy. Laboratory values obtained less than or equal to 4 weeks prior to surgery must demonstrate adequate bone marrow function (Hb greater than or equal to 6.0 mmol/L, absolute neutrophil count greater than or equal to 1.5 x 10^9/L, platelets greater than or equal to 80 x 10^9/L), liver function (serum bilirubin less than or equal to 2 x ULN, serum transaminases less than or equal to 3 x ULN). Patients with chronic kidney disease who are on chronic renal replacement therapy are allowed.. Other tests, such as pulmonary function tests, cardiac echocardiogram or stress test, will be performed if clinically indicated Ability of subject to understand and the willingness to sign a written informed consent document Women must not become pregnant prior to surgery or during the first 3 months after surgery. Women who can become pregnant will be asked to practice an effective form of birth control for up to 3 months after surgery Patients who have had previous thyroid surgery Patients whose tumors are deemed unresectable by clinical/imaging criteria Patients with known synchronous distant metastatic disease Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Pregnant women are excluded because we do not want to expose the unborn child to the procedures necessary to perform the surgery | 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): 20.0-70.0, Thyroid Cancer, Papillary no clinical and radiological evidence of lymph node metastasis no evidence of hyperparathyroidism pregnant women uncontrolled diabetes, hypertension, or chronic renal failure aspirin or anticoagulant medication within 7 days other clinical trial participation within 30 days radiation exposure to the head and neck previous operation to the neck advanced thyroid cancer including adjacent organ invasion | 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): 2.0-25.0, Tumors Solid Malignant Tumors Osteosarcoma Differentiated Thyroid Cancer (DTC) Histologically or cytologically confirmed diagnosis of solid malignant tumor. 1. Cohort 1: Any solid malignant tumor. 2. Cohort 2A: Differentiated Thyroid Cancer (DTC) with one of the following histological subtypes: i) Papillary thyroid cancer (PTC). i.a) Follicular variant. i.b) Other variants (including but not limited to tall cell, columnar cell, cribriform-morular, solid, oxyphil, Warthin's-like, trabecular, tumor with nodular fasciitis-like stroma, Hurthle cell variant of papillary carcinoma, or poorly differentiated carcinomas). ii) Follicular thyroid cancer (FTC). ii.a) Hurthle cell. ii.b) Clear cell. ii.c) Insular. c) Cohort 2B, 3A, and 3B: Relapsed or refractory osteosarcoma. 2. Relapsed or refractory solid tumor malignancy that has progressed on standard anticancer therapy with no available curative options. (Note: Osteosarcoma participants must be in first or subsequent relapse [greater than or equal to first relapse]). Only the osteosarcoma participants enrolled to Cohorts 3A and 3B must be deemed candidates for ifosfamide and etoposide chemotherapy). 3. Evaluable or measurable disease that meets the following 1. Participants must have evaluable or measurable disease based on 1.1 using computed tomography (CT)/magnetic resonance imaging (MRI). 2. Lesions that have had external beam radiotherapy (EBRT) or locoregional therapies such as radiofrequency (RF) ablation must have subsequently grown unequivocally to be deemed a target lesion. 4. DTC participants must be 131 iodine-refractory/ relapsed as defined by at least one of the following: 1. One or more evaluable or measurable lesions that do not demonstrate iodine uptake on any radioiodine scan; or 2. One or more evaluable or measurable lesions that have progressed based on 1.1, within 12 months of 131 iodine therapy, despite demonstration of radioiodine avidity at the time of that treatment by pre or post-treatment scanning. These participants must not be eligible for possible curative surgery; or 3. Cumulative activity of 131 iodine greater than 400 millicuries (mCi) or 14.8 gigabecquerels (GBq), with the last dose administered at least 6 months prior to study entry. 5. Participants with DTC must be receiving thyroxine suppression therapy and levels of thyroid stimulating hormone (TSH) should not be elevated (TSH should be less than or equal to 5.50 milliunits per liter (mU/L)). When tolerated by the participant, thyroxine dose should be changed to achieve TSH suppression (TSH less than 0.50 mU/L). 6. Participants with known central nervous system (CNS) primary tumors or metastases who have completed brain therapy (such as radiotherapy, stereotactic radiosurgery, or surgical resection) and have remained clinically stable, asymptomatic, and off of steroids for 2 weeks prior to Cycle 1 Day 1 will be eligible. 7. Male or female participants age 2 years to less than18 years and less than or equal to 25 years for osteosarcoma subjects at the time of informed consent. 8. Lansky play score greater than or equal to 50% or Karnofsky Performance Status score greater than or equal to 50%. Use Karnofsky for participants greater than or equal to 16 years of age and Lansky for participants less than 16 years of age. 9. Life expectancy greater than or equal to 3 months. 10. Adequate bone marrow function as evidenced by: 1. absolute neutrophil count (ANC) greater than or equal to 1.0 x 10^9/L (for Cohorts 3A and 3B leucocyte count greater than or equal to 2 x 10^9/L; participants with bone marrow involvement should have ANC greater than or equal to 0.8 x 10^9/L and leucocyte count greater than or equal to 1 x 10^9/L). 2. hemoglobin greater than or equal to 8.0 grams/deciliter (g/dL) (a hemoglobin less than 8.0 g/dL is acceptable if it is corrected by growth factor or transfusion before starting lenvatinib). 3. platelet count greater than or equal to 75 x 10^9/L. 11. Adequate liver function as evidenced by: 1. bilirubin less than or equal 1.5 times the upper limit of normal (ULN). 2. alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal to 3 times ULN. 12. Adequate renal function as evidenced by: a) Serum creatinine based on age/gender as below. If serum creatinine is greater than maximum serum creatinine for age/gender as shown in the table below, then creatinine clearance (or radioisotope glomerular filtration rate [GFR]) must be greater than 70 milliliter/minute/1.73 square meter (mL/min/1.73 m2). Maximum Serum Creatinine in milligrams/deciliter (mg/dL) for male: i. Age 2 to less than 6 years = 0.8 ii. Age 6 to less than 10 years = 1.0 iii. Age 10 to less than 13 years = 1.2 iv. Age 13 to less than 16 years = 1.5 v. Age greater than or equal to 16 years = 1.7 Maximum Serum Creatinine (mg/dL) for Female: vi. Age 2 to less than 6 years = 0.8 vii. Age 6 to less than 10 years = 1.0 viii. Age 10 to less than 13 years = 1.2 ix. Age 13 to less than 16 years = 1.4 x. Age greater than or equal to 16 years = 1.4 The threshold creatinine values in this Table were derived from the Schwartz formula for estimating glomerular filtration rate using child length and stature data published by the CDC. b) Urine dipstick less than 2+ for proteinuria. Participants who have greater than or equal to 2+ proteinuria on dipstick urinalysis should undergo a spot protein-creatinine (P/C) ratio that should be Grade less than 2. c) No clinical evidence of nephrotic syndrome. 13. Adequate cardiac function as evidenced by left ventricular ejection fraction (LVEF) greater than or equal to 50%) at baseline as determined by echocardiography. 14. Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as: BP less than 95th percentile for sex, age, and height/length at screening (as per National Heart Lung and Blood Institute guidelines) and no change in antihypertensive medications within 1-week prior to Cycle 1/Day 1. Osteosarcoma subjects 18 to 25 years should have BP ≤150/90 mm Hg at screening and no change in antihypertensive therapy within 1 week prior to Cycle 1/Day 1. 15. Washout of 3 weeks in case of prior chemotherapy, 6 weeks if treatment included nitrosoureas; 4 weeks for definitive radiotherapy, and 2 weeks for palliative radiotherapy; 3 months from high-dose chemotherapy and stem cell rescue; 3 weeks from major surgery. Participants must have recovered from the acute toxic effects of all prior anticancer therapy before enrollment into the study. 16. Written and signed informed consent from the parent(s) or legal representative (guardian) and assent from the minor participant. Written informed consent from subjects ≥18 years. 17. Willing and able to comply with the protocol, scheduled follow-up, and management of toxicity as judged by the Investigator. Cohort 3B (Combination Expansion): Osteosarcoma subjects who progressed in Cohorts 1 or 2B and opt to receive combination therapy. 18. Osteosarcoma participants receiving combination therapy of lenvatinib with ifosfamide and etoposide should meet only Numbers 6 through 17 (after progression in Cohort 2B) Any active infection or infectious illness unless fully recovered prior to dosing. 2. Any medical or other condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical study. 3. Other organ toxicity due to prior anticancer therapy (investigational agent, chemotherapy, or radiation therapy) except alopecia, and ototoxicity due to cisplatin not already covered in the inclusion/ which has not recovered to Grade less than 2 per Common Terminology for Adverse Events (CTCAE) v4.0. 4. Known hypersensitivity to any component of the product (lenvatinib or ingredients). 5. Concurrent administration of any other antitumor therapy. 6. Previous treatment with lenvatinib (except for participants previously enrolled into Cohorts 1 or 2B of this study). 7. Two or more prior vascular endothelial growth factor/vascular endothelial growth factor receptor (VEGF/VEGFR) targeted therapies. 8. Currently receiving any investigational drug or device in another clinical trial or within 30 days preceding informed consent. 9. A clinically significant ECG abnormality, including a marked baseline prolonged QT or QTc interval (eg, a repeated demonstration of a QTc interval greater than 480 msec). 10. Gastrointestinal malabsorption or any other condition that in the opinion of the investigator might affect the absorption of lenvatinib. 11. Gastrointestinal bleeding or active hemoptysis (bright red blood of at least half teaspoon) within 3 weeks prior to the first dose of study drug. 12. Active second malignancy within 2 years prior to enrollment ([in addition to the primary tumor types specified by cohort in Criterion Number 1], but not including definitively treated superficial melanoma, in-situ, basal or squamous cell carcinoma of the skin). 13. Previous treatment with ifosfamide and Grade greater than or equal to 3 nephrotoxicity or encephalopathy (Cohorts 3A and 3B). 14. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [ß-hCG] (or human chorionic gonadotropin [hCG]) test with a minimum sensitivity of 25 IU/L or equivalent units of ß-hCG [or hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug. Cohort 3B (Combination Expansion): Osteosarcoma participants who progressed in Cohorts 1 or 2B and opt to receive combination therapy. 15. Osteosarcoma participants receiving combination therapy of lenvatinib with ifosfamide and etoposide should meet all the with the exception of Criterion Number 6 | 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 Diagnosis of PTC and at least one sonographic examination of the cervical lymph nodes Patients can only be included in the study once. Thus, if they have two sonographic examinations, only one can be included in the study results All patients who fit the study after the start of the study will be included, using the first sonographic exam as the study exam Lymph node with oval shape, hypoechoic cortex, smooth border, hyperechoic hilum and hilar Doppler flow by ultrasound are considered to be normal and be excluded from FNAB per standard clinical practice Lymph node less than 5 mm in short axis on ultrasound | 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): 20.0-80.0, Goiter Patients undergoing hemi or total thyroidectomy for benign non-toxic goiter with pressure symptoms The patients must be able to understand, write and read Danish Previous surgery to the neck Diabetes or any neuromuscular disorders Present or previous head and neck malignancy, including malignancy found in the surgical thyroid specimen or suspicion hereof | 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, Arteriovenous Malformation Hemangioma Neoplasms Lymph Nodes Lymphedema Must be able to provide a written informed consent Males and females, ≥18 years old； Diagnostic CT or MRI suggesting a diagnosis of liver focal lesion(s). In suspicion of arteriovenous malformations. Newly diagnosed breast cancer and lymph node metastasis is not clear. The tumor will be surgically removed and histological diagnosis will be available. Evaluation of cardiac function Females planning to bear a child recently or with childbearing potential； Known severe allergy or hypersensitivity to IV radiographic contrast； Inability to lie still for the entire imaging time because of cough, pain, etc Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the investigator, may significantly interfere with study compliance | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Metastatic Pancreatic Ductal Adenocarcinoma Histologically or cytologically-confirmed metastatic pancreatic ductal adenocarcinoma Availability of a tumor tissue specimen. If no archived tumor tissue is available, then a de novo biopsy is required for patient participation Karnofsky Performance Status 70 or greater Adequate Bone Marrow, Renal, and Liver Function Prior treatment with a CDK 4/6 inhibitor Prior treatment with nab-P for the treatment of metastatic disease Patients with known CNS metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth Diagnosis of any other malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix QTc >480 msec, or family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes Uncontrolled electrolyte disorders Cardiac or pulmonary disorders within 6 months of enrollment Known human immunodeficiency virus infection History of interstitial lung disease or pneumonitis Other severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Interstitial Cystitis Chronic Prostatitis Patients are eligible for the SPS if they meet the following 1. Participant has signed and dated the appropriate Informed Consent document Agreed to participate in ALL required Symptoms Patterns Study procedures (including Biospecimen collections, Neuroimaging, and Quantitative Sensory Testing) Gave permission for use of DNA for genetics studies. 2. Participant is at least 18 years of age. 3. Participant is able to speak, read, and understand English. 4. In the past 3 months participant has had a feeling of pain, pressure, or discomfort in the lower abdomen or pelvic area - that is, the part of the body that is above the participant's legs and below the belly button. 5. These symptoms have been present for the majority of the time during the most recent 3 months. 6. Participant reports a response of at least 1 on the pain, pressure or discomfort scale for UCPPS symptoms during the past 2 weeks. 7. Participant has received a clinical diagnosis of either or both IC/BPS or CP/CPPS (per AUA guidelines) or a clinician familiar with UCPPS confirms participant meets UCPPS evaluation per-protocol Any patient meeting any one of the following will not be eligible for enrollment in the Symptom Patterns Study. However, participants who develop any of these during the follow-up phase of the study will continue to be followed. It will be recorded in the follow-up data if a patient has developed any of the 1. Participant has an on-going symptomatic urethral stricture. 2. Participant has an on-going neurological disease or disorder affecting the bladder or bowel fistula. 3. Participant has a history of cystitis caused by tuberculosis, radiation therapy or Cytoxan/cyclophosphamide therapy. 4. Participant has augmentation cystoplasty or cystectomy. 5. Participant has an active autoimmune or infectious disorder (such as Crohn's Disease or Ulcerative Colitis, Lupus, Rheumatoid Arthritis, Multiple Sclerosis, or HIV). 6. Participant has a history of cancer (with the exception of skin cancer). 7. Participant has current major psychiatric disorder or other psychiatric or medical issues that would interfere with study participation (e.g. dementia, psychosis, upcoming major surgery, etc.). 8. Participant has severe cardiac, pulmonary, renal, or hepatic disease that in the judgment of the study physician would preclude participation in this study for Males Only 1. Diagnosis of unilateral orchalgia, without pelvic symptoms. 2. History of transurethral microwave thermotherapy (TUMT), transurethral needle ablation (TUNA), balloon dilation, prostate cryo-surgery, or laser 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): 18.0-999.0, Cancer of Head and Neck Histologic proven squamous cell carcinoma of the oral cavity/larynx/oro or hypopharynx 2. Postoperative tumor status Oral cavity, oropharynx or larynx: pT1-3, pN0-pN2b Hypopharynx: pT1-2; pN1 3. Patients that fulfill one or both of the following ≤ pT2, R ≥ 5 mm, L0, Pn0 ≤ 3 ipsilateral lymph node metastases (if a contralateral adequate neck dissection is performed, no contralateral neck dissection is recommended in patients with strictly ipsilateral localised tumors of the oropharynx or oral cavity) 4. R0-Resection (resection margin ≥ 1mm) 5. No distant metastasis cM0 6. age ≥ 18 years, no upper age limit 7. ECOG ≤ 2 8. Patients that understood protocol contents and are able to behave according to protocol 9. Signed study-specific consent form prior to therapy 10. In case of indicated simultaneous chemotherapy adequate bone marrow function (leucocytes > 3,5x10^3, platelets > 100x 10^3, hemoglobin > 10g/dl sufficient liver function: bilirubin < 2,0mg/dl, ALT, AST < less than 3 times upper limit of normal sufficient renal function: normal serum creatinine, glomerular filtration rate > 60ml/min pregnant or lactating/nursing women 2. fertile patients that are not willing to use highly effective methods of contraception (per institutional standards) during treatment 3. Any condition potentially hampering compliance with the study protocol and follow-up schedule 4. On-treatment participation on other trials 5. R1 or R2 resection status 6. pN2c and pN3 7. cM1 8. prior radiotherapy in the head and neck region , prior chemo or immunotherapy (neoadjuvant/induction) 9. time between surgery and beginning of radio(chemo)therapy > 6 weeks 10. Prior (> 4 months before beginning of radio(chemo)therapy) neck dissection 11. In case of indicated simultaneous chemotherapy reduced hearing ability (especially upper frequency range) known dihydropyrimidindehydrogenase (DPD) deficiency simultaneous therapy with brivudin or other DPD-inhibitors uncontrolled serious disease, including physical and mental diseases, for example within last 6 months:instable angina pectoris, heart attack, serious cardiac dysrhythmias, stroke, serious carotid stenosis, neurologic or psychiatric disorders including epilepsy, dementia, psychosis; uncontrolled infection; liver cirrhosis Child B or C, severe hepatic impairment; severe blood count changes; severe renal impairment, HIV | 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, Environmental Exposure Adult volunteers with healthy intact skin Children will be excluded from the study Adults with a past history of dermal sensitization, skin allergy, or dermal irritation or dermatitis because of the potential to have compromised barrier function in the skin Adults who are unwilling to follow protocol requirements Adults who have a documented history of lead poisoning Adults who have a concurrent contagious illness or other stressor which in the opinion of the investigator may interfere with the subject's ability to perform the study's requirements Adults who have open wounds or otherwise compromised skin integrity on their hands Adults who are pregnant or nursing Adults who lack the capacity to provide informed voluntary consent to participate in the 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): 18.0-999.0, Metastatic Malignant Neoplasm Solid Neoplasm Unresectable Malignant Neoplasm Eligible and consent to the Institutional Review Board (IRB) 13-0002 registry trial protocol Subjects must have histologically confirmed solid malignancy that is metastatic or unresectable The patient should have received all established therapies where there is a clear, superior available regimen available for the patient and the patient should have demonstrated progressive disease on or since completion of the last treatment regimen Patients must have measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 2 cm with conventional techniques or as >= 1 cm with spiral CT scan Patients must have prior CT scan images available for investigators to collect Patients must have available tumor molecular profiling from Clinical Laboratory Improvement Amendments (CLIA)-certified labs or have available archived tissue to be sent to such a laboratory in the context of this investigation Molecular testing in a CLIA-certified laboratory must have demonstrated a deletion involving the CDKN2A locus or a mutation within the locus that can be deemed from best available evidence to be likely to cause inactivation of a gene within or protein encoded by CDKN2A; sequencing or fluorescence in situ hybridization (FISH)/chromogenic in situ hybridization (CISH) methods are acceptable; the investigators will consider analyses performed according to similar standards as applied by Foundation Medicine (likely to be the most common source of molecular diagnostic data for patients in this trial) At least 3 weeks must have passed since any prior anti-tumor therapies including chemotherapy, radiation therapy or any other anti-cancer treatments Serum creatinine value of < 1.5 times the upper limit of normal (ULN) and either an estimated creatinine clearance value of > 50 mL/min as determined by the Chronic Kidney Disease Epidemiology (CKD EPI) or MDRD (Modification of Diet in Renal Disease) formulae or a creatinine clearance value of > 50 mL/min based on a 24 hour urine collection Subject has adequate liver function as demonstrated by serum bilirubin < 2 x ULN and Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN. For subjects with liver metastasis, adequate liver function is demonstrated by serum bilirubin =< 2 x ULN and AST/ALT =< 5.0 x ULN Patients with hospitalization within 4 weeks of treatment initiation date for co-morbid conditions or any complication of disease or therapy that is deemed by the principal investigator as unstable or incompletely treated Patients with any psychiatric or social condition that leads them to be unlikely to adhere to the study schedule and contribute to the primary objectives Women that are pregnant or lactating are excluded from this study Subject has known active central nervous system (CNS) involvement; the subject has untreated brain or meningeal metastases; CT scans are not required to rule out brain or meningeal metastases unless there is a clinical suspicion of central nervous system disease; subjects with treated brain metastases that are radiographically or clinically stable for at least 4 weeks after therapy and have no evidence of cavitation or hemorrhage in the brain lesion(s) are eligible, providing that they are asymptomatic, and do not require corticosteroids (must have discontinued steroids at least 1 week prior to study drug administration) Subject has had major surgery within 28 days prior to study day 1 Subject has proteinuria defined by the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE version [v] 4.0) grade > 1 at baseline as measured by a urine dipstick (2+ or greater) and confirmed by a 24 hour urine collection (>= 1 g/24 hrs); subjects may be re-screened if proteinuria is shown to be controlled with or without intervention Subject is taking any oral anticoagulant History of Symptomatic congestive heart failure Unstable angina pectoris or cardiac arrhythmia (subjects with stable atrial fibrillation are not excluded) | 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 Carcinoma Bethesda system of reporting thyroid cytology (BSRTC) group 5-6 on pre-operative FNAB from the nodule (>1cm) Undergoing thyroid surgery (histology of index nodule) Not undergoing thyroid surgery | 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, Dyspepsia Male and female subjects with dyspeptic symptoms (B1 of FD) Subject who has not been treated for H pylori eradication in the past Age above 18 years No Alarm symptoms of Gastrointestinal Bleeding Anemia Early satiety Unexplained weight loss Progressive dysphagia Odynophagia Pregnant females Use of NSAIDs Use of anti secretory agent (H2 blockers) and proton pump inhibitors in previous 4 weeks Use of anti microbial agents (Clarithromycin, Metronidazole, Amoxacillin, quinalones) or bismuth in last 4 weeks Gastric and/or duodenal erosions or ulcers, polyps or malignancy if noted on endoscopy will be excluded Patients with predominant symptoms or gastro esophageal reflux disease (GERD) or Endoscopic evidence of esophagitis Patients with abnormal upper abdominal ultrasound | 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 Subject aged 18 years and above, male or female, with a valid social security coverage Subject willing to participate in the study with a signed informed consent Subject being operated for a papillary thyroid cancer, re-operated for persistent/relapsed lymphadenopathy, or for benign thyroid pathology (Graves disease, multinodular goitre, toxic nodule) Subject having had a blood test for plasma Tg levels and circulating anti-Tg antibodies in the week preceding the surgical intervention Subjects presenting with thyroid cancers of non follicular origin | 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, HIV-1 Infection Key Antiretroviral treatment naive (≤ 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection) except the use for pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), up to one month prior to screening Plasma HIV-1 RNA levels ≥ 500 copies/mL at screening Adequate renal function: Estimated glomerular filtration rate ≥ 30 mL/min (≥ 0.50 mL/sec) according to the Cockcroft-Gault formula Key An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening Decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding) Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance Females who are pregnant (as confirmed by positive serum pregnancy test) Females who are breastfeeding Note: Other protocol defined Inclusion/ | 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 Pathologically confirmed Bethesda V or VI thyroid nodules with papillary thyroid carcinoma or high clinical suspicion, or pathologically confirmed Bethesda III or IV nodules with BRAF mutation 0 cm or smaller nodules by ultrasonographic Ability to understand and the willingness to sign a written informed consent and HIPAA Authorization form Must be able to read and write English fluently to participate in the questionnaire portion of the study High-grade or poorly differentiated PTC variants Central or lateral neck lymphadenopathy suspicious for PTC Unfavorable nodule location (e.g. Near dorsal surface (by recurrent laryngeal nerve); Adjacent to trachea (risk of cartilage invasion) History of radiation to neck | 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): 15.0-60.0, Thyroid Papillary Carcinoma according by thyroid carcinoma TNM(tumor,lymph node, metastasis) staging of NCCN (National Comprehensive Cancer Network) Unilateral thyroid papillary carcinoma 2.TNM staging: T1~2N0M0 Bilateral thyroid papillary carcinoma 2.isthmus thyroid carcinoma 3.TNM staging: T3orT4 4.Clinic N1orM1 | 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): 20.0-80.0, Goiter Patients undergoing hemi or total thyroidectomy for benign non-toxic goiter with pressure symptoms The patients must be able to understand, read and write Danish Previous surgery to the neck Diabetes or any neuromuscular disorders Present or previous head and neck malignancy, including malignancy found in the surgical thyroid specimen or suspicion hereof | 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 Subjects must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure Age ≥ 18 years Life expectancy of at least 12 weeks (3 months) Eastern Cooperative Oncology Group performance status of ≤1 Histologically or cytologically confirmed diagnosis of metastatic medullary thyroid cancer Documented disease progression within 6 months prior to study registration, as defined by criteria Must have at least 1 site of measurable disease by by version 1.1 Archival tissue block or unstained slides (from primary or metastatic site) must be available, otherwise fresh tissue biopsy sample will be collected Any number of prior chemotherapies and targeted therapies are allowed Patients must have received at least one prior line of targeted therapy Prior treatment with regorafenib Previous assignment to treatment during this study. Subjects permanently withdrawn from study participation will not be allowed to re-enter study Uncontrolled hypertension (systolic pressure >140 mm Hg or diastolic pressure > 90 mm Hg [NCI-CTCAE v4.0] on repeated measurement) despite optimal medical management Active or clinically significant cardiac disease including Congestive heart failure New York Heart Association (NYHA) > Class II Active coronary artery disease Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before randomization, or myocardial infarction within 6 months before randomization Evidence or history of bleeding diathesis or coagulopathy | 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, Benign Thyroid Nodules Male or female patient 18 years or older Patient presenting with at least one thyroid nodule with no signs of malignancy: 1. Non suspicious clinically and at ultrasonography imaging 2. Benign cytological diagnosis at fine needle aspiration biopsy in the last 6 months 3. Normal serum calcitonin 4. No history of neck irradiation Serum TSH and free T4 levels within the normal range Targeted nodule deemed to be accessible and eligible to HIFU Absence of vocal cord paresis at laryngoscopy Nodule greatest diameter between ≥10 m as measured by ultrasound Composition of the targeted nodule(s) : predominantly solid Patient is mentally competent and has given informed consent Head and/or neck disease that prevents extension of neck Known history of thyroid cancer or other malignant tumors in the neck region History of neck irradiation Intranodular macrocalcification inducing a shadow in the thyroid significant enough to preclude HIFU treatment A nodule next to the posterior margin of the lobe with distance <15mm Pregnant or lactating woman Any contraindication to the assigned analgesia/anaesthesia | 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, Diabetes Mellitus Hypothyroidism Hyperthyroidism Goiter Thyroid Nodule Obesity Patients from counties with at least 5 endocrinology referrals waiting appointment Patients referred from primary care physicians Patients referred because one of the protocol conditions (Diabetes Mellitus, Hypothyroidism, Hyperthyroidism, Goiter, Thyroid nodule, Obesity) Patients from counties with more than one hundred endocrinology referrals waiting appointment | 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, Deglutition Disorders who have dysphagia symptoms and verified deglutition disorder by video fluoro swallowing study who reject the checkup their deglutition function by high resolution manometry who reject apply "Synchronized Electrical Stimulator" | 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 Cancer All patients were diagnosed with PTC by preoperative fine needle aspiration cytology Underwent the initial operation in our department, and had all tumors located in one lobe PTC with a tumor between 1 and 4 cm Nonthyroid cancer Previous thyroid or parathyroid surgery Preoperative hypoparathyroidism or hypocalcemia Pregnancy or lactation Presence or suspicion of lateral neck lymph node metastasis Age under 18 years Noncompliance with the follow-up protocol | 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, Thymic Epithelial Tumor patient with Thymic Epithelial Tumors histology other than Thymic Epithelial Tumors | 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): 65.0-79.0, Obesity Weight Loss Age 65-79 years BMI=30-40 kg/m2 Confirmation of self-reported mobility disability, as assessed by phone screen/clinical staff Self-reported sedentary behavior Non-impaired cognitive function (MoCA>18) Stability of residence for next 2 years Willing and able to follow dietary protocol Willing to provide informed consent Approved for participation by study physician Not involved in another behavioral or interventional research study Weight loss or gain (±5%) in past 6 months Prior bariatric surgery Multiple food allergies Difficulty with hearing/vision that interferes with study participation Excessive alcohol use (>14 drinks/week) Smoker (>1 cigarette/d within year) Insulin-dependent or uncontrolled diabetes (FBG >140 mg/dl) Uncontrolled hypertension (BP>160/100 mmHg) Abnormal kidney tests (GFR<40, creatinine >2.0) Regular use of medications that may influence body weight or composition | 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): 20.0-75.0, Rectal Cancer Age: 20-75 with rectal cancer s/p low anterior resection (double stapled anastomosis) Metastatic cancer Pregnancy Valvular heart disease s/p intersphincteric resection (index surgery) h/o anastomotic leakage (index surgery) medically unfit (cardiopulmonary dysfunction, sepsis etc) | 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, Carcinoma Breast Stage IV Subject for Part 1: Safety Run-in study 1. Women diagnosed with pathologically confirmed metastatic triple negative invasive breast cancer (centrally confirmed immunophenotype negative for all three receptors ER, PR and HER2). 2. Hormone receptor status (ER and PR) both ≤ 5% by immunohistochemistry, and HER2 status confirmed by means of immunohistochemistry (with 0 or 1+ indicating negative status) or fluorescence in situ hybridization (with amplification ratio < 2.0 indicating negative status). 3. Have either Evaluable disease, or have measurable clinical disease: Measurable disease, defined as at least 1 unidimensionally measurable lesion on a CT scan as defined by (version v1.1). 4. Age > 18 years. 5. Disease stage: Unresectable metastatic disease. 6. Patients received up to 2 prior regimens for their disease in the metastatic setting. 7. Patients are candidates for chemotherapy with carboplatin and gemcitabine. 8. ECOG performance status 0 9. Adequate organ function tests and hematologic indices within 10 days of registration. 10. Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. 11. Female subjects of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year. 12. Signed written Informed Consent in accordance with regulatory and institutional guidelines Subject for Part 1: Safety Run-in study 1. Patients participating in another trial of an investigational agent within 4 weeks of the first dose of the study. 2. Patients who received prior therapy using carboplatin/gemcitabine within 12 months prior to enrollment or subjects whose tumor progressed while on treatment with carboplatin or cisplatin. 3. Patients with baseline grade 2 neuropathy. 4. Patients with Hormone-receptor positive breast cancer (ER and/or PR > 5%), and with HER-2 positive breast cancer (by means of immunohistochemistry with 3+ indicating positive status or fluorescence in situ hybridization with amplification ratio ≥2.0 indicating positive status). 5. Diagnosis of immunosuppression or receiving steroid therapy or other immunosuppressive therapy within 4 weeks of the study. 6. Active autoimmune disease or a documented history of autoimmune disease, or a syndrome that has required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thryoxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc) is not considered a form of systemic treatment. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects who require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjögren's syndrome will not be excluded from the study. 7. Has evidence of interstitial lung disease or active, non-infectious pneumonitis. 8. Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. 9. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. 10. If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. 11. Known additional malignancy that progressed and/or required treatment in the last 5 years. Except that for basal and squamous cell carcinoma of the skin or in situ cervical carcinoma that has completed potentially curative therapy. 12. Life expectancy of less than 3 months. 13. Patients known to be carriers of Human Immunodeficiency Virus (HIV1/2). 14. Patients known to be carriers of hepatitis virus B and C. 15. Prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed cell death 1 ligand (PDL-1), anti-PD-L2, anti-CD137 antibody, or anti-cytotoxic T-lymphocyte -associated antigen-4 (CTLA-4) antibody. 16. Pregnant, breastfeeding, or expecting to conceive children within the projected time of the trial, starting with the pre-screening or screening visit and through 120 days after the last dose of trial treatment. 17. Active infection requiring systemic therapy. 18. Active substance abuse or psychiatric disorders. 19. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. 20. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. 21. Has received a live vaccine within 30 days prior to the first dose of trial treatment. Subject for Part 2 (Randomized Phase II Clinical Trial) 1. Women diagnosed with pathologically confirmed triple negative invasive breast cancer, metastatic (locally confirmed immunophenotype negative for all three receptors ER, PR, HER2). 2. Hormone receptor status (ER and PR) both ≤ 5% by immunohistochemistry, and HER2 status confirmed by means of immunohistochemistry (with 0 or 1+ indicating negative status) or fluorescence in situ hybridization (with amplification ratio < 2.0 indicating negative status). 3. Age > 18 years. 4. Disease stage IV, metastatic unresectable disease. 5. Have measurable clinical disease: Measurable disease, defined as at least 1 unidimensionally measurable lesion on a CT scan as defined by (version v1.1). 6. Patients received up to 3 prior regimens for their metastatic disease. Prior hormone therapy will not be counted towards the line of therapies. 7. Patients are candidates for chemotherapy with carboplatin and gemcitabine. 8. ECOG performance status 0-2. 9. Adequate organ function tests and hematologic indices within 10 days of registration. 10. Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. 11. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year. 12. Signed written Informed Consent in accordance with regulatory and institutional guidelines. 13. Have provided tissue from a newly obtained biopsy (an archival tissue sample may be substituted if new biopsy cannot be obtained and by discretion of Principal Investigator only) from a local or distant site and agreed to providing a second newly obtained biopsy after completion of 2 cycles of the study drugs. Subject for Part 2 (Randomized Phase II Clinical Trial) 1. Patients participating in another trial of an investigational agent within 4 weeks of the first dose of the study. 2. Patients with tumors that cannot be measured or clinically followed (i.e. evaluable disease). 3. Patients with metastatic breast cancer who received prior therapy using carboplatin/gemcitabine within 12months prior to their enrollment or subjects whose tumor progressed while on treatment with carboplatin or cisplatin. 4. Patients with baseline grade 2 neuropathy. 5. Patients with Hormone-receptor positive breast cancer (ER and/or PR > 5%), and with HER-2 positive breast cancer (by means of immunohistochemistry with 3+ indicating positive status or fluorescence in situ hybridization with amplification ratio ≥2.0 indicating positive status). 6. Diagnosis of immunosuppression or receiving steroid therapy or other immunosuppressive therapy within 4 weeks of the study. 7. Active autoimmune disease or a documented history of autoimmune disease, or a syndrome that has required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thryoxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc) is not considered a form of systemic treatment. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects who require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjögren's syndrome will not be excluded from the study. 8. Has evidence of interstitial lung disease or active, non-infectious pneumonitis. 9. Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. 10. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. 11. If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. 12. Known additional malignancy that progressed and/or required treatment in the last 5 years. Except that for basal and squamous cell carcinoma of the skin or in situ cervical carcinoma that has completed potentially curative therapy. 13. Life expectancy of less than 3 months. 14. Patients known to be carriers of Human Immunodeficiency Virus (HIV1/2). 15. Patients known to be carriers of hepatitis virus B and C . 16. Prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed cell death 1 ligand (PDL-1), anti-PD-L2, anti-CD137 antibody, or anti-cytotoxic T-lymphocyte -associated antigen-4 (CTLA-4) antibody. 17. Pregnant, breastfeeding, or expecting to conceive children within the projected time of the trial, starting with the pre-screening or screening visit and through 120 days after the last dose of trial treatment. 18. Active infection requiring systemic therapy. 19. Active substance abuse or psychiatric disorders. 20. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. 21. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. 22. Has received a live vaccine within 30 days prior to the first dose of trial treatment. 23. Subjects who do not consent to providing pre and post treatment tissue sample for future research would not be eligible to participate in the trial | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Melanoma Boron Neutron Capture Therapy Sign an informed consent form. 2. Age above 18, gender unlimited. 3. Expectation of life above 3 months. 4. Characteristic of disease: ① Pathological analysis confirms the diagnosis of melanoma. ② PET-CT and serum lactate dehydrogenase (LDH) can be used for auxiliary diagnosis. ③Diameter of at least one solid tumor ≥ 1cm. 5. KPS score: ≥70%. 6. Eastern Cooperative Oncology Group (ECOG) score: 0-2 grade. 7. (Within a week) Complete blood count: hemoglobin≥90g/L, leukocyte ≥ 4.0×109/L, neutrophilic granulocyte ≥ 2.0×109/L, platelet ≥ 100.0×109/L; Renal function: creatinine ≤ 180 umol/L. 8. Never accepted radiation or chemotherapy, or the interval of radiation or chemotherapy administered above 3 month. 9. Never accepted target drugs or biotherapeutics. 10. Urine pregnancy test negative (selectivity) Intolerable to BNCT treatment. 2. Sever coagulation disorders. 3. Poor compliance. 4. Sever complications or infection without control. 5. Pregnant woman or woman in lactation period. 6. Patients with metallic instruments (such as pacemaker, artificial limb). 7. Boron concentration in tumor tissue was <1.5 times that in blood. 8. Age<18 | 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, Locally Advanced Papillary Renal Cell Carcinoma Metastatic Papillary Renal Cell Carcinoma Stage III Renal Cell Cancer AJCC v7 Stage IV Renal Cell Cancer AJCC v7 Type 1 Papillary Renal Cell Carcinoma Type 2 Papillary Renal Cell Carcinoma Unresectable Renal Cell Carcinoma Patients must have histologically or cytologically confirmed papillary histology renal cell carcinoma which is metastatic or locally advanced disease not amenable to surgical resection; (NOTE: a designation of type I or type II should be made by the local pathologist if possible); mixed histologies containing type I or type II will be allowed provided that they contain >= 50% of the papillary component Patients must also have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension; disease X-rays, scans or physical examinations used for tumor measurement must have been completed within 28 days prior to registration; if there is clinical suspicion for bone metastases at the time of enrollment (at the discretion of the investigator), bone scan should be performed at baseline (within 42 days prior to registration); all disease must be assessed and documented on the Baseline Tumor Assessment form Patients with a history of treated brain metastases who are asymptomatic and have not received steroid therapy in the 14 days prior to registration are eligible; anti-seizure medications are allowed provided they are non-enzyme inducing (e.g. topiramate, levetiracetam, gabapentin) Patients must not have cavitating pulmonary lesions; patients must not have tumor invading the gastrointestinal (GI) tract or evidence of endotracheal or endobronchial tumor within 28 days prior to registration Patients may have received prior surgery; at least 28 days must have elapsed since surgery and patient must have recovered from any adverse effects of surgery Patients may have received up to one prior systemic therapy for advanced or metastatic renal cell carcinoma with the exception of another VEGF inhibitor Food and Drug Administration (FDA)-approved for advanced RCC (i.e., pazopanib, bevacizumab, sorafenib or axitinib); if a patient develops metastatic disease within six months of discontinuation of adjuvant therapy, this will constitute one prior systemic therapy for advanced or metastatic renal cell carcinoma (RCC); if a patient develops metastatic disease and more than six months has elapsed since discontinuation of adjuvant therapy, this will not constitute prior systemic therapy for advanced or metastatic RCC; patients may have also received prior immunotherapy; patients must not have received a MET/hepatocyte growth factor (HGF) inhibitor or sunitinib as prior therapy; at least 14 days must have elapsed since completion of prior systemic therapy; patients must have recovered from all associated toxicities at the time of registration Patients may have received prior radiation therapy, but must have measurable disease outside the radiation port; at least 14 days must have elapsed since completion of prior radiation therapy; patients must have recovered from all associated toxicities at the time of registration Patients must not be taking, nor plan to take while on protocol treatment, strong CYP3A4 inhibitors (e.g. boceprevir, cobicistat, danoprevir, elvitegravir/RIT, fluvoxamine, indinavir, itraconazole, ketoconazole, lopinavir/RIT, nefazodone, nelfinavir, posaconazole, ritonavir, telaprevir, telithromycin, tipravavir/RIT, or voriconazole); strong CYP3A4 inducers (e.g. avasimibe, phenytoin, rifampin, rifabutin); potent inhibitors of CYP1A2 (e.g. ciprofloxacin); and/or drugs known to be CYP3A4 substrates with a narrow therapeutic range (e.g., diergotamine, ergotamine) within 14 days prior to randomization; moderate inhibitors or inducers of isoenzyme CYP3A4 should be avoided, but if necessary can be used with caution Patients must not be receiving or planning to receive any other investigational agents Patients must have a complete physical examination and medical history within 28 days prior to registration | 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, Larynx The patients who underwent thyroidectomy Preoperative RLN palsy Thyroid cancer with massive extrathyroidal extension Intentional nerve transection because of cancer invasion The assessment failure of nerve function due to the technical deficiency of the IONM equipment | 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 Papillary Carcinoma Thyroidectomy the initial surgery 2. preoperative needle aspiration biopsy of thyroid cancer, and the diameter of no more than 1cm, no lateral neck lymph node metastasis 3. the tumor is confined to the thyroid membrane, not invading trachea and recurrent laryngeal nerve 4. intraoperative frozen section diagnosis of thyroid cancer 5. the patient informed consent high-frequency ultrasound preoperative tumor diameter greater than 1cm, or lateral neck lymph node metastasis in patients 2. there had been a history of thyroid surgery or neck radiation therapy 3. pregnant or lactating women 4. with severe Hashimoto's thyroiditis, thyroid volume greater than II ° 5. coagulation disorders, hyperthyroidism or hypothyroidism patients 6. sternal goiter | 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, Newly Diagnosed High Risk Neuroblastoma Patients with newly diagnosed high risk neuroblastoma Patients with informed consent Patients with progressive disease or relapse Patients who underwent high dose chemotherapy before Patients with organ dysfunction as follows (creatinine elevation > 3 x upper limit of normal, Total bilirubin > 3 x upper limit of normal, aspartate transaminase/alanine transaminase > 5 x upper limit of normal), ejection fraction <40% Pregnant or nursing women | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-70.0, Head-and-neck Cancer Squamous Cell Carcinoma Histologically confirmed squamous cell carcinoma of the head and neck.Site of tumor origin in the oral cavity, oropharynx, larynx, or hypopharynx (excluding nasopharynx, or sinuses) 2. Gross total resection, with pathology demonstrating one or more of the following risk factors: 1. Histologic extracapsular nodal extension 2. Histologic involvement of ≥ 2 regional lymph nodes 3. Invasive cancer seen on microscopic evaluation of the resection margin, with no evidence of gross tumor residual 3. No evidence of distant metastases 4. No synchronous or concurrent head and neck primary tumors 5. Karnofsky score over 60 6. Adequate organ function including the following: 1. Absolute neutrophil count (ANC) >= 1.5 * 10^9/l 2. Platelets count >= 100 * 10^9/l 3. Hemoglobin >= 10 g/dl 4. AST and ALT <= 2.5 times institutional upper limit of normal (ULN) 5. Total bilirubin <= 1.5 times institutional ULN 6. Creatinine clearance >= 50 ml/min 7. Serum creatine <= 1 times ULN 7. Signed written informed consent Evidence of distant metastasis 2. Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region 3. Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma 4. Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures 5. Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia | 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 Patients with a diagnosis of PTC and a family history of PTC in 3 or more living relatives Affected and unaffected family members of the proband* For familial cases (families with 4 or more cases of PTC), participation will be offered to all living family members with PTC or benign thyroid disease as well as selected unaffected first and second degree relatives. Participation may also be offered to spouses when needed for analyzing parent/offspring samples | 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): 19.0-90.0, Head and Neck Cancer Head and Neck Squamous Cell Carcinoma Subjects must have histologically or cytologically confirmed recurrent head and neck cancer Based on clinical and radiographic evidence the tumor needs to be deemed resectable preoperatively by the surgeon and when necessary (determined by the surgeon) tumor board review Patients must have potentially curable disease Karnofsky Performance status ≥ 60% (ECOG/Zubrod 0,1,or 2) Subjects must have normal organ and marrow function as defined below Hemoglobin ≥ 7.0 g/dl Absolute neutrophil count (ANC) > 500/mcL Platelet count ≥ 75,000/mcL Patients with recurrent/previous treated head and neck squamous cell carcinoma that is deemed surgically resectable by the treating physician but at high risk for recurrence due to concerns regarding close and/or margins due to locations on or near critical structures such as internal or common carotid, skull base, deep cervical musculature, and other areas that may limit the possibility of an enbloc resection. This group otherwise would be considered for retreatment with radiation and/or chemoradiation Subjects must have the ability to understand and the willingness to sign a written informed consent document Patients deemed to have un-resectable disease by the treating surgeon or upon tumor board review Patients with exposed carotid artery preoperatively requiring sacrifice or bypass intra-operatively Patients with active pharyngocutaneous fistula Patients may have had a recent previous hospital admission (within 30 days) or be admitted preoperatively but not for the following conditions Unstable angina Congestive heart failure Severe hypothyroidism TSH >10 --- Endocrine consult and intervention may allow participation at the discretion of the principal investigator for a thyroid-stimulating hormone (TSH) > 10 Patients deemed to be "High Risk" by pre admission testing (CPM) or by a preoperative risk assessment by the hospitalist for perioperative complications Subjects with more than one site of distant metastatic disease (beyond the head and neck) as evidenced by computerized tomography (CT) scan or positron emission tomography/CT (PET/CT) or biopsy --- | 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, Corneal Neovascularization In this study, included will be patients with corneal neovascularization secondary to various pathologies, including: Pterygium, Corneal chemical burn, S/P corneal transplantation, Herpetic keratitis, atopic keratoconjunctivitis, Chronic retinal detachment, Uveitis, panus secondary to blepharitis, S/P corneal foreign body Patients with a history of retinal vein/artery occlusion or diabetes, currently treated with anti-VEGF or with a history of such treatment 3 months prior to enrollment. 2. Prior treatment for corneal neovascularization with the injection of Avastin/Lucentis. 3. Patients under 18 4. Pregnant women 5. Contra indications for Eylea treatment, including intraocular or periocular infection/inflammation | 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, Papillary Thyroid Carcinoma Newly diagnosed papillary thyroid carcinoma Undergo thyroidectomy according to the China thyroid association guidelines forthe Management of thyroid nodule and thyroid cancer Current substance abuse/dependence Daily tobacco and alcohol use Whole neck irradiation or surgery Prior cancer diagnosis or chemotherapy treatment Active autoimmune disorder Uncontrolled allergic condition or asthma Chronic use of oral steroid medication Hormone therapy (estrogen, progestin compounds) | 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, Type 1 Diabetes Male and female patients age 18 to 65 years of age. 2. Ability to provide written informed consent. 3. Mentally stable and able to comply with the procedures of the study protocol. 4. Clinical history compatible with T1D with onset of disease at <40 years of age, insulin-dependence for > 5 years at the time of enrollment, and a sum of subject age and insulin-dependent diabetes duration of ≥28. 5. Absent stimulated c-peptide (<0.3 ng/mL) in response to a MMTT (Boost® 6 mL/kg body weight to a maximum of 360 mL; another product with equivalent caloric and nutrient content may be substituted for Boost®) measured at 60 and 90 min after the start of consumption. 6. Involvement in intensive diabetes management, defined as self-monitoring of glucose values no less than a mean of three times each day averaged over each week and by the administration of three or more insulin injections each day or insulin pump therapy. Such management must be under the direction of an endocrinologist, diabetologist, or diabetes specialist, with at least 3 clinical evaluations during the 12 months prior to study enrollment. 7. At least one episode of severe hypoglycemia in the 12 months prior to study enrollment. 8. Reduced awareness of hypoglycemia as defined by a Clarke score of 4 or more OR A HYPO score greater than or equal to the 90th percentile (1047) during the screening period; OR Marked glycemic lability characterized by wide swings in blood glucose (BG) despite optimal diabetes therapy and defined by an LI score greater than or equal to the 90th percentile (43 mmol/L2/h·wk-1) during the screening period; OR A composite of a Clarke score of 3 or less and a HYPO score greater than or equal to the 75th percentile (423) and a LI greater than or equal to the 75th percentile (329) during the screening period Body Mass Index (BMI) >30 kg/m2 or patient weight ≤50 kg. 2. Insulin requirement of >1.0 IU/kg/day or <15 U/day. 3. HbA1c >10%. 4. Untreated proliferative diabetic retinopathy. 5. Blood Pressure: systolic blood pressure (SBP) >160 mmHg or diastolic blood pressure (DBP) >100 mmHg. 6. Measured glomerular filtration rate <80 mL/min/1.73 m2 calculated using the subject's measured serum creatinine and Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation1 or Modification of Diet in Renal Disease [MDRD] study estimation formula). Strict vegetarians (vegans) with a calculated GFR <70 mL/min/1.73m2 are excluded. The absolute (raw) GFR value will be used for subjects with body surface areas >1.73m2 7. Presence or history of macroalbuminuria (>300mg/g creatinine). 8. Presence or history of panel-reactive anti-HLA antibodies above background by flow cytometry. 9. For female subjects: Serum or urine Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 4 months after discontinuation. For male subjects: intent to procreate during the duration of the study or within 4 months after discontinuation or unwillingness to use effective measures of contraception. If sexually active, subject must use at least two medically accepted methods of birth control from the following list: oral contraceptives, Norplant®, Depo-Provera®, intrauterine device (IUD), barrier devices with spermicide. Condoms used alone are not acceptable. Instead of the male condom, it is acceptable to use a female condom with one of the other methods for women listed above. 10. Presence or history of active infection including hepatitis B, hepatitis C, HIV, or tuberculosis (TB) Subjects with laboratory evidence of active infection are excluded even in the absence of clinical evidence of active infection. 11. Negative screen for Epstein-Barr Virus (EBV) by IgG determination. 12. Invasive aspergillus, histoplasmosis, and coccidioidomycosis infection within one year prior to study enrollment. 13. Any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin. 14. Known active alcohol or substance abuse. 15. Baseline Hb below the lower limits of normal at the local laboratory; lymphopenia (<1,000/µL), neutropenia (<1,500/µL), or thrombocytopenia (platelets <100,000/µL). Participants with lymphopenia are allowed if the investigator determines there is no additional risk and obtain clearance from a hematologist. 16. A history of Factor V deficiency. 17. Any coagulopathy or medical condition requiring long-term anticoagulant therapy (e.g., warfarin) after transplantation (low-dose aspirin treatment is allowed) or patients with an international normalized ratio (INR) >1.5. 18. Severe co-existing cardiac disease, characterized by any one of these conditions: 1. recent myocardial infarction (within past 6 months). 2. evidence of ischemia on functional cardiac exam within the last year. 3. left ventricular ejection fraction <30%. 19. Persistent elevation of liver function tests at the time of study entry. Persistent serum glutamic-oxaloacetic transaminase (SGOT [AST]), serum glutamate pyruvate transaminase (SGPT [ALT]), Alk Phos or total bilirubin, with values >1.5 times normal upper limits will a patient. 20. Symptomatic cholecystolithiasis. 21. Acute or chronic pancreatitis. 22. Symptomatic peptic ulcer disease. 23. Severe unremitting diarrhea, vomiting, or other gastrointestinal disorders potentially interfering with the ability to absorb oral medications. 24. Hyperlipidemia despite medical therapy (fasting low-density lipoprotein [LDL] cholesterol > 130 mg/dL (3.36 mmol/L), treated or untreated; and/or fasting triglycerides > 200 mg/dL (2.26 mmol/L)). 25. Receiving treatment for a medical condition requiring chronic use of systemic steroids, except for the use of ≤5 mg prednisone daily, or an equivalent dose of hydrocortisone, for physiological replacement only. 26. Treatment with any anti-diabetic medications other than insulin within 4 weeks of enrollment. 27. Use of any investigational agents within 4 weeks of enrollment. 28. Administration of live attenuated vaccine(s) within 2 months of enrollment. 29. Any medical condition that, in the opinion of the investigator, will interfere with the safe participation in the trial. 30. Treatment with any immunosuppressive regimen at the time of enrollment. 31. A previous islet transplant. 32. A previous pancreas transplant, unless the graft failed within the first week due to thrombosis, followed by pancreatectomy and the transplant occurred more than 6 months prior to enrollment. 33. Inflammatory bowel disease. 34. History of intestinal obstructions. 35. Previous major abdominal surgery. 36. History of peritonitis | 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, Knee Osteoarthritis Adult Chinese subjects, at age≥18, either gender, diagnosed with osteoarthritis of the target knee and Kellgren-Lawrence (KL) classification Grade 1~3, as evidenced by X-ray examination in the last 3 months (mild to moderate narrowing of joint space and / or marked osteophytes of tibiofemoral joint space) 2. Persist pain of the target knee after exercise, weight loss and physical therapy; 3. A baseline WOMAC A1 score for the target knee rated at 40-90mm (moderate to severe walk-associated pain) on 100mm Visual analogue scale(VAS); Able to understand and sign the Informed Consent Form (ICF) that has already been approved by the Independent Ethics Committee (IEC) Note: the informed consent may also be given by the duly authorized representative of the subject A diagnosis of bilateral knee osteoarthritis; 2. Clinically significant (requiring surgery) valgus or varus deformity of the knee joint, ligamentous laxity or unstable meniscus; 3. Complicated by inflammation or any other disease /condition (e.g., rheumatic arthritis, metabolic bone disease, psoriasis, gout, pseudogout, chondrocalcinosis, etc.) that may affect the knee joint; 4. A history of septicemia, clinically considered sub-acute infection of the target knee joint; 5. A history of surgery on the target knee (in the last 6 months); 6. A history of asthma, urticaria or allergy after use of aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs); 7. Severe hepatic or renal disease or hepatic /renal failure; 8. Any unscheduled surgery on the lower limb; 9. Clinically significant lower venous or lymphatic obstruction; 10. Clinically significant obvious exudation or inflammation of the target knee; 11. Skin disorders or infection at the injection site; 12. Pregnant or lactating women; 13. Known allergy to guanylin and / or any active ingredient or excipient of hyaluronic acid-based injection / diclofenac sodium; 14. Treatment with any hyaluronic acid (HA) or its derivatives for the target knee within six months before this trial; 15. Intra-articular (IA) injection of steroids into the target knee within 3 months before this trial; 16. Presence of any contraindication to IA injection, e.g., patients who are receiving anti-coagulation therapy or clinically have potential coagulation disorders (e.g., hepatic disease); 17. Presence of any clinically significant disease (e.g., significant mental or nervous disorders, alcohol/drug abuse), unstable/poorly controlled diseases, or other factors, which may affect their evaluation or participation in this study in the investigator's judgment 18. Perioperative pain associated with coronary artery bypass surgery (CABG); 19. A history of gastrointestinal bleeding or perforation following use of NSAIDs; 20. Presence of active gastrointestinal ulcer /bleeding, or a past history of recurrent ulcer/bleeding; Chief complaint complicated by pain beyond the target knee | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 20.0-999.0, Thyroid Cancer Newly diagnosed patients with thyroid papillary, follicular and anaplastic thyroid cancer Thyroid papillary, follicular and anaplastic thyroid cancer with prior operation, chemotherapy, or isotope treatment, or target 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): 20.0-80.0, Thyroid Diseases Age 20-80 years old Thyroid diseases, including nodular goiter, hyperthyroidism, hypothyroidism and thyroid cancer (before or after operation), consecutive follow-up in outpatient department, and we expected to enroll 800 patients in one year, and follow-up with observation for 5 years N/A | 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): 18.0-95.0, Thyroid Neoplasms Diagnosis of thyroid cancer Non applicable | 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): 19.0-999.0, Hepatocellular Carcinoma Intrahepatic Cholangiocarcinoma Stage IV Liver Cancer Stage IVA Liver Cancer Stage IVB Liver Cancer Vascular Thrombosis Patients with a diagnosis of hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma, or metastatic liver cancer planned to receive definitive doses of radiation or surgical resection are eligible Measurable hepatic disease and/or presence of vascular tumor thrombosis Diagnostic CT or magnetic resonance imaging (MRI) scan within 2 months of study entry There are no limits on prior therapy; patients are allowed to have prior systemic therapy, radiation therapy, radiofrequency ablation, catheter-based therapies, and surgery; patients are allowed to have concurrent chemotherapy with radiation treatment Ability to understand and the willingness to sign a written informed consent document Patients unable to tolerate a SPECT/CT 99mTc-SC scan Patients who are not planning to adhere to the required follow up schedule as outlined in this protocol Pregnant women Women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception Patients 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): 1.0-31.0, B Acute Lymphoblastic Leukemia Central Nervous System Leukemia Ph-Like Acute Lymphoblastic Leukemia Testicular Leukemia Patients must be enrolled on APEC14B1 and consented to Screening on the Part A consent form prior to enrollment on AALL1131 White Blood Cell Count (WBC) Age 1-9.99 years: WBC >= 50 000/uL Age 10-30.99 years: Any WBC Age 1-30.99 years: Any WBC with Testicular leukemia CNS leukemia (CNS3) Steroid pretreatment Patients must have newly diagnosed B lymphoblastic leukemia (2008 World Health Organization [WHO] classification) (also termed B-precursor acute lymphoblastic leukemia); patients with Down syndrome are also eligible Organ function requirements for patients with Ph-like ALL and a predicted TKI-sensitive mutation: patients identified as Ph-like with a TKI-sensitive kinase mutation must have assessment of organ function performed within 3 days of study entry onto the dasatinib arm of AALL1131 With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or any cancer diagnosed prior to the initiation of protocol therapy on AALL1131; patients cannot have secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy; patients receiving prior steroid therapy may be eligible for AALL1131 Patients with BCR-ABL1 fusion are not eligible for post-induction therapy on this study but may be eligible to enroll in a successor Children's Oncology Group (COG) Philadelphia positive (Ph+) ALL trial by day 15 Induction DS HR B-ALL patients with Induction failure or BCR-ABL1 Female patients who are pregnant are ineligible since fetal toxicities and teratogenic effects have been noted for several of the study drugs Lactating females are not eligible unless they have agreed not to breastfeed their infant Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation | 0 |
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): 12.0-17.0, Solid Organ Transplant Recipients Parent(s)/Guardian of Referenced Transplant Recipients The patient and/or their parent(s)/guardian must be able to understand and provide informed consent in English or Spanish is prescribed tacrolimus (either brand or generic formulation); and has been seen in the enrolling center's clinic at least twice in the last two years The patient received a transplant less than 18 months prior to enrollment has had more than one transplant (including marrow replacement) or their parent(s)/guardian is actively psychotic or severely disoriented due to any cause, including hepatic encephalopathy (temporary exclusion) or their parent(s)/guardian has been diagnosed with severe intellectual disability as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) is not medically stable or is hospitalized is currently enrolled in a study that aims to improve adherence to medical recommendations is receiving cognitive behavioral therapy for confirmed or suspected diagnosis of Post-Traumatic Stress Disorder (PTSD) at enrollment is receiving psychotropic medications for a confirmed or suspected diagnosis of PTSD | 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 of Head and Neck Patients with advanced head and neck cancer receiving radiotherapy Candidates to surgical treatment Previous head and neck cancer Dysphagia due to causes other than cancer Previous head or neck radiation therapy | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Head and Neck Cancer Males or females older than 18 years Performance Status 0 or 1 or 2 Locally advanced head and neck cancer treated with a curative intent treatment consisting of either concomitant chemo-radiotherapy or adjuvant radiation therapy or adjuvant chemo-radiotherapy Signed Informed Consent Other cancer or previous cancer within 2 years or evolutive cancer Performance Status 3 or 4 NGT or PEG at screening period Any legal, social, psychological reasons that could jeopardize the patient's compliance to the study constrains | 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): 1.5-999.0, Cerebral Palsy The are Age above 18 months Fed orally Referred due to parent complaints about their child's swallowing function Not admitted a swallowing center before. The are Age below 18 months Fed nonorally No parent complaints about their child's swallowing function Admitted a swallowing center before | 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): 65.0-999.0, Frail Elderly Exercise Therapy Physical Therapy Techniques volunteers above the age of 65 who are community residents and classified as frail according to the established by Fried et al. will be selected for in the study previous lower extremities orthopedic surgery, a history of fractures within the past year, an inability to walk unaided, carriers of neurological diseases, diagnosed acute inflammatory disease that could interfere in the assessments and the program, tumor growth in the last five years and cognitive impairment based on the mini-mental state examination [4]. Moreover, will be excluded volunteers who are absent more than three consecutive training and / or more than 25% of the sessions, and / or present the course of the physical program changes or decompensation and / or disease injury | 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): 2.0-8.0, Hyponatremia Age: 2 years American society of anesthesiologist (ASA) Laparoscopic surgical procedure of 2 hours duration requiring IV fluid administration for at least 24 hours Uncorrected plasma sodium level before surgery Diseases which cause abnormal ADH secretion Renal and cardiac disease Chronic lung disease Cranial/thoracic surgery Recent loop diuretics use | 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 Neoplasms years to 75 years Eastern Cooperative Oncology Group (ECOG) performance status of 0 Life expectancy of more than 12 weeks At least one measurable lesion according to 1.1 which has not received radiotherapy =< 3 months Histologically confirmed advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous head and neck cancer, including adenocarcinoma, mucoepidermoid carcinoma, acinar cell carcinoma and adenoid cystic carcinoma Recurrent and or metastatic lesions which are not suitable for local treatment For patients with mucoepidermoid carcinoma, acinar cell carcinoma or adenoid cystic carcinoma, metastatic disease documented as having shown progression on a scan (CT, MRI) compared to a previous scan taken at any time in the past 12 months For patients with adenocarcinoma, one regimen of prior chemotherapy was received for recurrent and or metastatic diseases Adequate hepatic, renal, heart, and hematologic functions: absolute neutrophil count (ANC) ≥ 1.5×109/L, platelet count (PLT) ≥ 100×109/L, hemoglobin (HB) ≥ 90 g/L, total bilirubin (TBIL) ≤ 1.5×upper limit of normal (ULN), alternate aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5×ULN (or ≤ 5×ULN in patients with liver metastases), Serum Cr ≤ 1×ULN, Cr clearance ≥ 50 mL/min, international normalized ratio (INR) < 1.5 or PT < ULN+4s or activated partial thromboplastin time (APTT) < 1.5×ULN, proteinuria < (++) or urinary protein ≤ 1.0 g/24 hrs For women of child-bearing age, the pregnancy test results (serum or urine) within 7 days before enrolment must be negative. They will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men (previous surgical sterilization accepted), will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug Accumulation of coelomic fluid (e.g. pleural effusion, ascites fluid, cardiac effusion) requiring treatment Other malignancy within the past five years other than basal cell skin cancer, or carcinoma in situ of the cervix Factors affecting the oral medication (e.g. inability to swallow, chronic diarrhea and intestinal obstruction) Major injuries and/or surgery =< 4 weeks prior to registration with incomplete wound healing. Patients who have received radiotherapy (except local palliative radiotherapy), chemotherapy, molecular targeted therapy =< 3 weeks, or nitrosoureas/mitomycin chemotherapy =< 6 weeks prior to registration Patients with poor-controlled arterial hypertension (systolic pressure ≥ 140 mmHg and/or diastolic pressure ≥ 90 mm Hg) despite standard medical management Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male ≥ 450 ms, female ≥ 470 ms). Grade III-IV cardiac insufficiency according to New York Heart Association (NYHA) or echocardiography check: left ventricular ejection fraction (LVEF)<50% History of clinically significant haemoptysis =< 2 months (more than half of one tea spoon of fresh blood per day) prior to registration. Coagulation disfunction, hemorrhagic tendency or receiving anticoagulant therapy History of clinically relevant major bleeding event (e.g. gastrointestinal hemorrhage, bleeding ulcer, occult blood ≥ (++), and vasculitis) =< 3 months prior to randomization Patients who have active brain metastases or leptomeningeal disease. Patients with treated brain metastases are eligible if they are clinically stable with regard to neurologic function, off steroids after cranial irradiation ending at least 3 weeks prior to randomization, or after surgical resection performed at least 3 weeks prior to randomization. No evidence of Grade greater than or equal to 1 central nervous system (CNS) hemorrhage based on pretreatment CT or MRI scan Centrally located tumors of local invasion of major blood vessels, or distinct interstitial lung disease by the chest radiographic findings (CT or MRI) | 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 is >1.5 cm Preoperative FNA biopsy that is positive for papillary thyroid cancer or suspicious for papillary thyroid cancer Prior thyroid/parathyroid surgery Clinical indications for total thyroidectomy including hypothyroidism, history of head or neck radiation when <18 years old Recurrent laryngeal nerve dysfunction Diagnosis of concurrent primary hyperparathyroidism | 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, Papillary < 1 cm solitary nodule 2. Surrounded by ≥ 2 mm normal thyroid parenchyma 3. Subcapsular locations not adjacent to surrounding structures, recurrent laryngeal nerve, trachea, or carotid artery 4. No evidence of invasion to surrounding structures, recurrent laryngeal nerve, trachea or carotid artery 5. No extrathyroidal extension 6. Clinically N0 and Clinically M0 7. ≥ 18 years 8. Combined severe comorbidities or Inoperable condition (optional) 9. No wish to surgery and Willingness to accept active surveillance 10. No history of radiotherapy on head and neck area 11. Accepted by the Board of Thyroid Cancer Meeting ≥ 1 cm nodule and multifocal nodules regardless of size 2. Papillary thyroid carcinoma variants associated with poor prognosis (tall cell variant, columnar variant, hobnail variant) or other types of thyroid cancer) 3. Subcapsular locations adjacent to surrounding structures, recurrent laryngeal nerve, trachea or carotid artery 4. Evidence of invasion to surrounding structures, recurrent laryngeal nerve, trachea or carotid artery 5. Extrathyroidal extension 6. Any of N1 or M1 7. Documented increase in size according to America Thyroid Association (ATA) guideline in a previously confirmed Papillary thyroid microcarcinoma 8. < 18 years 9. Not willing to accept observational active surveillance approach | 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, NonHodgkin Lymphoma Histological Diagnosis of NHL DLBCL Eligible for RT after R-CHOP ECOG 0-3 years Stage I-IV Patients should receive at least 4 cycles of R-CHOP chemotherapy Patients with all extranodal disease except the ones mentioned in the criteria Able to understand and willing to provide informed consent for participation in the trial HIV positive status Relapse or progression of disease during chemotherapy Prior history of chemotherapy Prior history of radiotherapy Systemic lymphomas with CNS involvement Primary extranodal Testicular Lymphomas Primary extranodal central nervous system (CNS) Lymphomas Primary extranodal Stomach DLBCL Primary extranodal Intestinal DLBCL Patients >3 extranodal sites | 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, Columnar Cell Variant Thyroid Gland Papillary Carcinoma Follicular Variant Thyroid Gland Papillary Carcinoma Metastatic Thyroid Gland Follicular Carcinoma Metastatic Thyroid Gland Papillary Carcinoma Poorly Differentiated Thyroid Gland Carcinoma Recurrent Differentiated Thyroid Gland Carcinoma Recurrent Thyroid Gland Follicular Carcinoma Recurrent Thyroid Gland Papillary Carcinoma Stage III Differentiated Thyroid Gland Carcinoma AJCC v7 Stage III Thyroid Gland Follicular Carcinoma AJCC v7 Stage III Thyroid Gland Papillary Carcinoma AJCC v7 Stage IV Thyroid Gland Follicular Carcinoma AJCC v7 Stage IV Thyroid Gland Papillary Carcinoma AJCC v7 Stage IVA Differentiated Thyroid Gland Carcinoma AJCC v7 Stage IVA Thyroid Gland Follicular Carcinoma AJCC v7 Stage IVA Thyroid Gland Papillary Carcinoma AJCC v7 Stage IVB Differentiated Thyroid Gland Carcinoma AJCC v7 Stage IVB Thyroid Gland Follicular Carcinoma AJCC v7 Stage IVB Thyroid Gland Papillary Carcinoma AJCC v7 Stage IVC Differentiated Thyroid Gland Carcinoma AJCC v7 Stage IVC Thyroid Gland Follicular Carcinoma AJCC v7 Stage IVC Thyroid Gland Papillary Carcinoma AJCC v7 Tall Cell Variant Thyroid Gland Papillary Carcinoma Thyroid Gland Hurthle Cell Carcinoma Unresectable Differentiated Thyroid Gland Carcinoma Unresectable Thyroid Gland Carcinoma Locally recurrent and unresectable and/or distant metastatic differentiated thyroid cancer (DTC), histologically or cytologically confirmed; the diagnosis of DTC includes the following subtypes: papillary thyroid cancer (PTC) (including but not limited to variants such as follicular variant, tall cell, columnar cell, Hurthle cell variant of papillary carcinoma, and poorly differentiated), follicular thyroid cancer (FTC), including insular variant, Hurthle cell carcinoma and poorly differentiated thyroid cancer Measurable disease meeting the following 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 which is serially measurable according to 1.1 using computerized tomography/magnetic resonance imaging (CT/MRI); if there is only one 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 (EBRT) or loco-regional therapies such as radiofrequency (RF) ablation must show evidence of progressive disease based on 1.1 to be deemed a target lesion For cohort 1 only: evidence of disease progression =< 14 months prior to registration according to 1.1, as confirmed by the site study principal investigator (PI) For cohort 2 only: progressive disease (PD) on lenvatinib per 1.1 =< 60 days prior to registration, as confirmed by the site study PI; patients need to have documented imaging and measurement of target lesions within 30 days of starting pembrolizumab Radioiodine (RAI)-resistant disease as defined by one or more of the following One or more measurable lesions that do not demonstrate RAI uptake One or more measurable lesions progressive by 1.1 =< 14 months of prior RAI therapy One or more measurable lesions present after cumulative RAI dose of >= 600 mCi Cohort 1 only: prior treatment with previous VEGFR active multikinase inhibitor Cohort 2 only: discontinued lenvatinib due to toxicity Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment Female subjects of childbearing potential: unwilling or unable to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication; NOTE: subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year Male subjects: unwilling or unable to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive (HIV 1/2 antibodies) and currently receiving antiretroviral therapy Currently participating and receiving study therapy (except lenvatinib for patients in cohort 2) or has participated in a study of an investigational agent and received study therapy within 4 weeks prior to registration Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy =< 7 days prior to the first dose of trial treatment Known history of active TB (Bacillus tuberculosis) | 2 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-75.0, Non-small Cell Lung Cancer Stage IIIA Radiotherapy Male or female, aged 18 years to 75 years Complete resection through a surgical procedure of lobectomy, sleeve lobectomy or bilobectomy with microscopically tumor-free resection margins and margin-negative resection of all gross disease; Has undergone systematic nodal assessment (lymph node dissection or sampling with a minimum of three N2 stations sampled or completely dissected, one of which must be the subcarinal station) Histologically proven lung adenocarcinoma or squamous cell lung carcinoma of stage pT1-3N2M0 (according to the TNM classification in the Union for International Cancer Control (UICC) 7th ed.) Determined as the postoperative high risk of locoregional recurrence No documented metastases (M1) and/or invasion (T4) by the pretreatment examination or at the time of surgery No prior neoadjuvant therapy (chemotherapy and/or RT) No prior adjuvant therapy (chemotherapy and/or RT) No severe perioperative complications and expected postoperative lifespan ≥4 months ECOG Performance Status 0-1 Voluntarily participated in this study and signed the informed consent form by himself or his agent. Had good compliance with the study procedures, and can cooperate with the relevant examination, treatment and follow-up Histologically confirmed large cell carcinoma, adenosquamous carcinoma, sarcomatoid carcinomas, neuroendocrine tumors (small cell carcinoma, large cell neuroendocrine carcinoma, carcinoid tumors, etc.), salivary-gland type tumors, adenomas, papillomas, or other and unclassified carcinomas Patients undergoing pneumonectomy Diagnosed with other prior or concurrent malignancies (neoplasm) except for basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 5 years Patients with severe postoperative complications; and time to beginning of the adjuvant therapy has been more than 2 months from the date of surgery Patients with any severe or uncontrolled systematic disease including severe cardiovascular, liver, kidney, hematopoietic, metabolic disease, or uncontrolled active infection that would preclude study participation Patients with positive mental disorder that would preclude study participation Contradictory to chest radiotherapy Pregnant or nursing women Concurrent other anti-cancer treatment Prior preoperative Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) treatment or other targeted 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): 18.0-75.0, Non-small Cell Lung Cancer Stage IIIA Radiotherapy Male or female, aged 18 years to 75 years Complete resection through a surgical procedure of lobectomy, sleeve lobectomy or bilobectomy with microscopically tumor-free resection margins and margin-negative resection of all gross disease; Has undergone systematic nodal assessment (lymph node dissection or sampling with a minimum of three N2 stations sampled or completely dissected, one of which must be the subcarinal station) Histologically proven lung adenocarcinoma or squamous cell lung carcinoma of stage pT1-3N2M0 (according to the TNM classification in the Union for International Cancer Control (UICC) 7th ed.) Determined as the postoperative low risk of locoregional recurrence No documented metastases (M1) and/or invasion (T4) by the pretreatment examination or at the time of surgery No prior neoadjuvant therapy (chemotherapy and/or RT) No prior adjuvant thoracic RT No severe perioperative complications and expected postoperative lifespan ≥4 months ECOG Performance Status 0-1 Voluntarily participated in this study and signed the informed consent form by himself or his agent. Had good compliance with the study procedures, and can cooperate with the relevant examination, treatment and follow-up Histologically confirmed large cell carcinoma, adenosquamous carcinoma, sarcomatoid carcinomas, neuroendocrine tumors (small cell carcinoma, large cell neuroendocrine carcinoma, carcinoid tumors, etc.), salivary-gland type tumors, adenomas, papillomas, or other and unclassified carcinomas Patients undergoing pneumonectomy Diagnosed with other prior or concurrent malignancies (neoplasm) except for basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 5 years Patients with severe postoperative complications; and time to beginning of the adjuvant therapy has been more than 2 months from the date of surgery Patients with any severe or uncontrolled systematic disease including severe cardiovascular, liver, kidney, hematopoietic, metabolic disease, or uncontrolled active infection that would preclude study participation Patients with positive mental disorder that would preclude study participation Contradictory to chest radiotherapy Pregnant or nursing women Concurrent other anti-cancer treatment Prior preoperative Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) treatment or other targeted 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): 18.0-100.0, Gastroenterology Lesions Age >18 years old 2. Patients referred for EUS-guided tissue sampling for lesions (i.e. pancreas, liver, mediastinal masses, left adrenal gland, lymph nodes, and subepithelial lesions). 3. Target lesion should be ≥ 15 mm in size (long axis) Any contraindication to performing endoscopy 2. 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): 18.0-75.0, Head and Neck Neoplasms years to 75 years Eastern Cooperative Oncology Group (ECOG) performance status of 0 Life expectancy of more than 12 weeks At least one measurable lesion according to 1.1 which has not received radiotherapy =< 3 months Histologically confirmed advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous head and neck cancer, including adenocarcinoma, mucoepidermoid carcinoma, acinar cell carcinoma and adenoid cystic carcinoma Recurrent and or metastatic lesions which are not suitable for local treatment For patients with mucoepidermoid carcinoma, acinar cell carcinoma or adenoid cystic carcinoma, metastatic disease documented as having shown progression on a scan (CT, MRI) compared to a previous scan taken at any time in the past 12 months For patients with adenocarcinoma, one regimen of prior chemotherapy was received for recurrent and or metastatic diseases Adequate hepatic, renal, heart, and hematologic functions: absolute neutrophil count (ANC) ≥ 1.5×109/L, platelet count (PLT) ≥ 100×109/L, hemoglobin (HB) ≥ 90 g/L, total bilirubin (TBIL) ≤ 1.5×upper limit of normal (ULN), alternate aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5×ULN (or ≤ 5×ULN in patients with liver metastases), Serum Cr ≤ 1×ULN, Cr clearance ≥ 50 mL/min, international normalized ratio (INR) < 1.5 or PT < ULN+4s or activated partial thromboplastin time (APTT) < 1.5×ULN, proteinuria < (++) or urinary protein ≤ 1.0 g/24 hrs For women of child-bearing age, the pregnancy test results (serum or urine) within 7 days before enrolment must be negative. They will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men (previous surgical sterilization accepted), will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug Accumulation of coelomic fluid (e.g. pleural effusion, ascites fluid, cardiac effusion) requiring treatment Other malignancy within the past five years other than basal cell skin cancer, or carcinoma in situ of the cervix Factors affecting the oral medication (e.g. inability to swallow, chronic diarrhea and intestinal obstruction) Major injuries and/or surgery =< 4 weeks prior to registration with incomplete wound healing. Patients who have received radiotherapy (except local palliative radiotherapy), chemotherapy, molecular targeted therapy =< 3 weeks, or nitrosoureas/mitomycin chemotherapy =< 6 weeks prior to registration Patients with poor-controlled arterial hypertension (systolic pressure ≥ 140 mmHg and/or diastolic pressure ≥ 90 mm Hg) despite standard medical management Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male ≥ 450 ms, female ≥ 470 ms). Grade III-IV cardiac insufficiency according to New York Heart Association (NYHA) or echocardiography check: left ventricular ejection fraction (LVEF)<50% History of clinically significant haemoptysis =< 2 months (more than half of one tea spoon of fresh blood per day) prior to registration. Coagulation disfunction, hemorrhagic tendency or receiving anticoagulant therapy History of clinically relevant major bleeding event (e.g. gastrointestinal hemorrhage, bleeding ulcer, occult blood ≥ (++), and vasculitis) =< 3 months prior to randomization Patients who have active brain metastases or leptomeningeal disease. Patients with treated brain metastases are eligible if they are clinically stable with regard to neurologic function, off steroids after cranial irradiation ending at least 3 weeks prior to randomization, or after surgical resection performed at least 3 weeks prior to randomization. No evidence of Grade greater than or equal to 1 central nervous system (CNS) hemorrhage based on pretreatment CT or MRI scan Centrally located tumors of local invasion of major blood vessels, or distinct interstitial lung disease by the chest radiographic findings (CT or MRI) | 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 Squamous Cell Carcinoma Tumor Growth clinical and anatomopathological diagnosis of a head and neck squamous cell carcinoma (T1 to T4) (oral cavity, oropharynx, larynx, hypopharynx) multidisciplinary decision for radiotherapy or concomitant radiochemotherapy metastatic disease primary surgical management contraindications to iodine contrast injection: anaphylaxis and renal insufficiency tumor not visible on CT | 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, Prostate Cancer Performance status ≤1 Age ≥18 years and ≤ 75 years old Histologically-confirmed adenocarcinoma of the prostate Treated with continuous androgen ablative therapy (either surgical castration or LHRH agonist/antagonist) with documented castrate level of serum testosterone (<50 ng/dl) Metastatic disease radiographically documented by CT or bone scan Patient must be HLA typed at high resolution using DNA based typing at the following loci: HLA-A, -B, -C, and DRB1 Patient must have available one or more potential first (biologic mother, sister, half-sister, or daughter) or second-degree related female donor. Mothers and daughters have a 100% chance of being haploidentical matches, sisters a 75% chance of being matched or haploidentical, and second degree relatives have a 50% chance of being haploidentical matches. The donor and recipient must be HLA identical for at least one antigen at HLA-A, -B, -C and HLA-DRB1 Screening PSA must be ≥ 1.0 ng/mL Prior therapy with one second line hormonal therapy is allowed (i.e. bicalutamide, nilutamide, flutamide, ketoconazole, abiraterone, enzalutamide, ARN-509) Prior docetaxel (≤ 6 cycles) as first line therapy Prior treatment with Sipuleucel-T, radium-223, strontium-89, or samarium-153 Prior chemotherapy (docetaxel, cabazitaxel) for castrate resistant prostate cancer Evidence of serious and/or unstable pre-existing medical, psychiatric or other condition (including laboratory abnormalities) that could interfere with patient safety or provision of informed consent to participate in this study Active uncontrolled infection, including known history of HIV/AIDS or hepatitis B or C Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule | 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): 18.0-100.0, Prostatic Neoplasms Benign Radiotherapy Side Effect Lymph Node Disease Men with high risk prostate cancer treated with radiotherapy to prostate/seminal vesicles or postoperative radiotherapy and pelvic lymph nodes at the Kantonssptial Graubuenden, Department of Radiation Oncology between 2010 and 2016 Men with prostate cancer other than high risk disease and no radiotherapy to pelvic lymph nodes | 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, Thyroid Neoplasms Poorly Differentiated and Undifferentiated Thyroid Cancer Differentiated Thyroid Cancer Subjects greater than or equal to 18 years of age Thyroid cancer histology or cytology that is aggressive (anaplastic/undifferentiated thyroid cancer, poorly differentiated thyroid cancer, Hurthle cell carcinoma, tall-cell variant of papillary thyroid cancer, sclerosing variant of papillary thyroid cancer) Measurable disease Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Absolute neutrophil count greater than or equal to 1,000/microL Platelets greater than or equal to 75,000/microL Creatinine less than or equal to 1.5 times upper limit of normal (ULN) or creatinine clearance > 60ml for patients with creatinine levels 1.5 times above institutional ULN (calculated based on age, weight and sex Total bilirubin less than or equal to 1.5 times ULN; aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than or equal to 2.5 times ULN. For subjects with documented liver metastases, the AST/ALT may be less than or equal to 5 times ULN Recovery to Grade 1 or baseline of any toxicity due to prior anticancer therapies (excluding alopecia) Platelet transfusions to help patients meet are not allowed within 3 days prior to screening complete blood count (CBC) or Cycle 1, Day 1 treatment Systemic anticancer therapy within 4 weeks of study entry, except for subjects with anaplastic/undifferentiated thyroid cancer who may be enrolled immediately after discontinuation of previous therapy Other investigational agents within 4 weeks prior to study treatment except for subjects with anaplastic/undifferentiated thyroid cancer who may be enrolled immediately of discontinuation of previous therapy Pregnant women are excluded from this study because the potential risk of teratogenic or abortifacient effects of CUDC-907 is unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CUDC-907, breastfeeding should be discontinued if the mother is treated with CUDC-907. These potential risks may also apply to other agents used in this study Diabetes mellitus that is not controlled with medication Serious infection requiring intravenous antibiotic therapy within 14 days prior to study treatment Evidence of central nervous system metastasis Uncontrolled or severe cardiovascular disease, including myocardial infarction, unstable angina, or atrial fibrillation (AFib) within 6 months prior to study treatment, New York Heart Association (NYHA) Class II or greater congestive heart failure, serious arrhythmias requiring medication for treatment, clinically significant pericardial disease, cardiac amyloidosis, or corrected QT interval (QTc) with Fridericia's (QTcF) correction that is unmeasurable or greater than or equal to 480 msec on screening electrocardiogram (ECG). (Note: for QTcF greater than or equal to 480 sec on the screening ECG, the ECG may be repeated twice at least 24 hours apart; the mean QTcF from the three screening ECGs must be < 480 msec in order to meet for trial participation) Gastrointestinal disease or disorder that could interfere with the swallowing, oral absorption, or tolerance of CUDC-907. This includes uncontrolled diarrhea (> 1 watery stool/day), major abdominal surgery, significant bowel obstruction and/or gastrointestinal diseases that could alter the assessment of pharmacokinetics or safety, including but not limited to: irritable bowel syndrome, ulcerative colitis, Crohn's disease and hemorrhagic coloproctitis Unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a subject and/or compliance with the protocol Second primary malignancy within 2 years of study entry other than adequately treated non-melanoma skin or superficial bladder cancer, curatively treated carcinoma in situ of the cervix or other curatively treated solid tumor deemed by the investigator to be at low risk for recurrence | 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, Pseudomonas Aeruginosa Pneumonia Informed consent ≥18 years of age, ≥ 20 years of age (Taiwan only),≥ 19 (S. Korea only) pneumonia due to P. aeruginosa ventilated intubated II score between 10 and 35 (main criteria) being moribund effective antibiotic therapy ≥48 hours immunocompromised underlying pulmonary disease that may preclude the assessment of a therapeutic response | 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, Thyroid Nodule Thyroid Neoplasms Thyroid Cancer The patients who underwent thyroidectomy at Khon Kaen University 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): 2.0-14.0, Pediatric Anesthesia Tracheal Intubation subject has elective head-and-neck surgery schedule subject will have orotracheal intubation under general anesthesia subject has malformations of the trachea or bronchus on chest X-ray subject has spinal deformity subject has difficulties in neck flexion or extension subject has neck pain | 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, Intraductal Papillary Mucinous Neoplasm Medical imaging showing cystic pancreatic lesions Medical imaging showing dilatation of the pancreatic duct Malignancy confirmed by previous examinations | 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, Medullary Thyroid Cancer (MTC) Diagnosis: Patients must have histologically confirmed medullary thyroid cancer by the Laboratory of Pathology or a pathology report and history consistent with medullary thyroid cancer. It is not uncommon for a secondary, minor pathologic focus of another form of thyroid cancer to be coincidentally found in 15-20% of patients with medullary thyroid cancer. In such cases, is based on the discretion of the investigator Patients must have evidence of metastatic medullary thyroid cancer including disease that is evaluable on bone, computed tomography (CT) scan or magnetic resonance imaging (MRI). (Patients who are surgical candidates and potentially rendered disease free with surgical resection are not eligible.) Patients must have elevated calcitonin levels greater than 40 pg/mL Patients must have minimal or no disease related-symptoms (Minimal symptoms will those that do not affect activities of daily living or pain that does not require regularly scheduled narcotics.) Patients must have evaluable disease on imaging No history of seizures, encephalitis, or multiple sclerosis Age greater than or equal to 18 years Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 at study entry (Karnofsky greater than or equal to 70) Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required Female subjects of childbearing potential must be willing to use an adequate method of contraception, Contraception, for the course of the study through 120 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment Has a known history of active TB (Bacillus Tuberculosis) Hypersensitivity to pembrolizumab or any of its excipients Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., less than or equal to Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier Has had prior targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., less than or equal to Grade 1 or at baseline) from adverse events due to a previously administered agent. Note: Subjects with less than or equal to Grade 2 neuropathy are an exception to this criterion and may qualify for the study. Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable for 6 months (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not carcinomatous meningitis which is excluded regardless of clinical stability Has history of (non-infectious) pneumonitis that required steroids, evidence of interstitial lung disease or active, non-infectious pneumonitis Has an active infection requiring systemic 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): 12.0-75.0, Thyroid all post thyroidectomy patients | 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, Exposure to Environmental Pollution Israeli Arabs, Jews from Russia, Jews from Ethiopia, Jews with an Ashkenazic background and Jews with a Sephardic background refuse to take part in the 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): 18.0-999.0, Sexuality Thyroid informed consent hyperthyroidic or hypothyroiditic women sexually active women age < 18 Y no sexual activity pregnancy psychiatric 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): 2.0-999.0, PIK3CA-Related Overgrowth Spectrum (PROS)/Proteus Syndrome Part A Signed informed consent and, when applicable, signed assent Male or female participants ≥ 2 years old with BSA of ≥ 0.33 m2 Have a clinical diagnosis of PROS or PS with documented somatic PIK3CA or AKT1 mutations Archival or fresh overgrowth tissue sample available to be shipped to Sponsor or designee Have poor prognosis, significant morbidity, and/or progressive disease (e.g., worsening of the disease/increase in number or size of the overgrowth lesions in the last 12 months) Have measurable disease (at least one overgrowth lesion that can be accurately measured in size by imaging and/or linear or circumference measure) Adequate organ function based on screening laboratory values If a female is of child-bearing potential, documentation of a negative pregnancy test is required prior to enrollment. Sexually active participants (male and female) must agree to use double-barrier contraceptive measures, oral contraception, or avoidance of intercourse while on study and for up to 90 days after ending treatment Ability to complete the Quality of Life (QoL) questionnaires by the participant or his/her caregiver Part B Part A History of Type 1 or 2 uncontrolled diabetes mellitus requiring regular medication (other than metformin or other oral hypoglycemic agents) or fasting glucose ≥ 160 mg/dL (if > 12 years old) and ≥ 180 mg/dL (if ≤ 12 years old) at the screening visit History of significant cardiac disorders Myocardial infarction (MI) or congestive heart failure defined as Class II-IV per the New York Heart Association (NYHA) classification within 6 months of the first dose of miransertib (MI occurring > 6 months of the first dose of miransertib will be permitted) Grade 2 (per NCI CTCAE version 4.03) or worse conduction defect (e.g., right or left bundle branch block); left ventricular ejection fraction (LVEF) < 50% assessed by echocardiogram/multigated acquisition (MUGA) scan Major surgery, radiotherapy, or immunotherapy within four weeks of the first dose of miransertib Any experimental systemic therapy for the purpose of treating PROS or PS (e.g., sirolimus, everolimus, high dose steroids) within two weeks of the first dose of miransertib, except for participants who were previously or are currently treated with miransertib under a Compassionate Use/Expanded Access program Intolerance of or severe toxicity attributed to AKT inhibitors (e.g., miransertib, uprosertib, afuresertib, ipatasertib) Concurrent severe uncontrolled illness not related to PROS or PS (ongoing or active infection, known human immunodeficiency virus (HIV) infection, malabsorption syndrome, psychiatric illness/substance abuse/social situation that would limit compliance with study requirements) Pregnant or 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): 20.0-50.0, Chronic Neck Pain Both genders between 20-50 years, had chronic neck pain Having disc hernia that causes neurological deficit Having malignity Having neck pain secondary neurological or vascular disease Pregnancy Having psychiatric disease Having arthritic disease Having any contraindication for electrotherapy | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Metastatic Anaplastic Thyroid Cancer Histopathologic confirmation of anaplastic thyroid cancer (or histopathologic report consistent with anaplastic thyroid cancer) at Memorial Sloan Kettering Cancer Center with clinical evidence of metastatic disease not curable by either surgery or radiation therapy Age ≥ 18 years at time of study entry ECOG Performance Status of 0-2 Adequate normal organ and marrow function as defined below Hemoglobin ≥ 9.0 g/dL Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (≥ 1500 per mm^3) Platelet count ≥ 100 x 109/L (≥100,000 per mm^3) Serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN). This will not apply to subjects with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinaemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤ 5x ULN Serum creatinine CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance Any previous treatment with an anti-CTLA4, including tremelimumab or any previous treatment with a PD1 or PDL1 inhibitor Receipt of the last dose of any line of anti-cancer therapy (chemotherapy, immunotherapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, and other investigational agent) 7 days prior to the first dose of study drug and within 6 weeks for nitrosourea or mitomycin C Prior radiation therapy to targets other than the site currently being treated is permitted Mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from a single electrocardiogram or average from 3 electrocardiograms (ECGs) using Frederica's Correction Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab (MEDI4736) or tremelimumab, with the exceptions of intranasal and inhaled corticosteroids, or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone or any corticosteroid for more than 4 consecutive days Any unresolved toxicity (CTCAE grade > 1) from previous anti-cancer systemic therapy unless approved by one of the principal investigators (Drs. Lee or Sherman) Rare exceptions that would not affect the study (e.g., radiaton induced dysphagia) allowed with the consent of either principal investigators (Drs. Lee or Sherman) Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1 Active or prior documented autoimmune disease within the past 2 years Note: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded. Rare exceptions allowed with the consent of both principal investigators (Drs. Lee and Sherman) Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis) Confirmed pneumonitis or interstitial lung disease History of primary 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): 0.0-60.0, Intraoperative Parathyroid Scores System postoperative pathology confirmed as thyroid papillary carcinoma; 2. for the first time to undergo thyroid surgery, no history of neck surgery and external radiotherapy; 3. preoperative serum calcium, parathyroid hormone levels were normal; 4. intraoperative and postoperative clinical data integrity, standardized follow-up patients; 5. parathyroid is a tumor violation serious underlying disease; 2. age greater than 60 years of age or combined with arteriosclerotic disease; 3. patients with postoperative loss; 4. patients with parathyroid disease | 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, Benign Esophageal Stricture Dysphagia due to benign esophageal stricture (e.g. surgery, radiation therapy, caustic ingestion, peptic injury, photodynamic therapy) requiring esophageal dilation Requiring first esophageal dilation for dysphagia due to a severe benign esophageal stricture with no patency for standard upper endoscope (9-10mm diameter) No history of esophageal endoscopic dilations for benign strictures the past 6 months Dysphagia for solid, semisolid or liquid food (dysphagia score ≥ 2 [Ogilvie]16, and dysphagia score ≤ 21 [Dakkak and Bennett]19, see appendix) Written informed consent Patient < 18 years old Patient is unwilling or unable to sign and date the informed consent Patient is unwilling or unable to comply with the follow-up schedule Patient is unable to understand informed consent and fill in the questionnaires due to a language barrier Patient is pregnant, breast-feeding, or planning to become pregnant in the next 12 month Patient is simultaneously participating in another drug or device study or the patient has completed the follow-up phase for the primary objective of any previous study less than 30 days prior to enrollment in this study Previous esophageal dilation for benign stricture within the past 6 months Patient with a life expectancy < 12 months Patient with a known eosinophilic esophagitis or motility disorder (such as achalasia) Patients with a known malignant esophageal stricture | 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-risk Myelodysplastic Syndromes With Excess Blasts Pre-inclusion patient benefiting from social welfcare patient followed at the University Hospital of Nancy patient aged 18 years or older patient informed on research organization and having signed an informed pre-inclusion consent No personal history of myelodysplastic syndrome clinical exam adapted to research one or more blood cytopenia patient benefiting from social welfcare patient followed at the University Hospital of Nancy personal history or current other cancer immediate acute myeloid leukemia personal history of demethylation treatment pregnant or breast feeding women life-theatening condition guardianship imprisoned patients | 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, Prostate Cancer Prosatatic Neoplasm Patients must have histologically confirmed locally recurrent adenocarcinoma of the prostate after prior radiation (EBRT or brachytherapy) PSA failure after definitive radiation as defined by the Phoenix (PSA elevation at least 2 ng/dL above post-radiotherapy nadir) Age greater than or equal to 18 years ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 60%) Ability of subject to understand and the willingness to sign a written informed consent document Patients who are receiving any other investigational agents PSA greater than or equal to 20 ng/dL if no prior DCFPyL scan obtained (If PSA > 20 and DCFPyL obtained within 3 months prior to enrollment shows no evidence of metastatic disease, subjects may be included in the study) Biochemical recurrence within one year of completion of radiotherapy Need for chronic anticoagulation therapy (chronic low dose aspirin is not an exclusion) Pre-existing and ongoing radiation-related grade 3 bowel or bladder toxicity Inflammatory bowel disease Active Lupus or Active scleroderma Patients with distant metastatic disease (prostate adjacent adenopathy is not an exclusion) Prior prostatectomy Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or 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): 18.0-100.0, Thyroid Cancer Stage I Patients 18 years of age or older 2. Newly diagnosed previously untreated papillary thyroid cancer (PTC) (fine needle aspiration biopsy positive for PTC or suspicious for PTC). 3. PTC must be less than 2 cm in maximal diameter on thyroid ultrasound 4. No evidence of metastatic cervical lymphadenopathy on ultrasound imaging of the neck (or other neck imaging) and no known distant metastatic thyroid cancer. 5. No other absolute indications for thyroid or parathyroid surgery 6. Permission for review of thyroid cancer-related medical records Regional or distant metastatic thyroid cancer 2. History of prior thyroid cancer surgery 3. High risk location of the PTC (e.g. adjacent to the recurrent laryngeal nerve or trachea) 4. The patient has clinical signs, imaging, or indirect laryngoscopy findings suggestive of locally advanced thyroid cancer (i.e. vocal cord paralysis or any clinical or radiographic signs of extrathyroidal invasion into adjacent structures such as the strap muscles of the neck, trachea or esophagus) 5. Known or suspected poorly differentiated or non-papillary thyroid cancer 6. Medically unfit for surgery due to co-morbidity 7. Another active malignancy with limited life expectancy of < 1 year. 8. Pregnancy at the time of study enrollment. 9. Other absolute indication for thyroid or parathyroid surgery 10. Unable to provide informed consent for the study or comply with study follow-up procedures due to current severe active cognitive or psychiatric impairment, substance abuse, 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): 20.0-70.0, Adhesion Thyroidectomy planned to perform thyroidectomy due to thyroid nodule no evidence of distant metastasis or invasion to adjacent organ in thyroid cancer normal preoperative vocal cord movement normal preoperative laboratory study uncontrolled hypertension, diabetes, chronic renal failure, coagulopathy history of keloid or hypertrophic scar Graves disease or hashimoto thyroiditis patients aspirin or anticoagulant medication within 7 days radiation exposure to the head and neck previous operation to the neck history of allergic reaction to drugs pregnant women | 0 |
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